JPWO2018129194A5 - - Google Patents
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- JPWO2018129194A5 JPWO2018129194A5 JP2019536852A JP2019536852A JPWO2018129194A5 JP WO2018129194 A5 JPWO2018129194 A5 JP WO2018129194A5 JP 2019536852 A JP2019536852 A JP 2019536852A JP 2019536852 A JP2019536852 A JP 2019536852A JP WO2018129194 A5 JPWO2018129194 A5 JP WO2018129194A5
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本発明の別の態様では、コーティングは均一ではなく、共形のパターンの形をとって装置に施されており、さらに有利な生物学的結果を実現する設計を生み出す。装置は、管腔を含んでいてもよく、この場合、管腔の内面は、主に血栓形成を低減するように設計され、そして管腔の外面は、主に内皮化を促進するように設計される。加えてまたは代わりに、コーティングは、勾配として施されてもよく、この場合、装置の近位および遠位の端部は、主に血栓形成を低減するように設計され、そして装置の中央部は、内皮化を促進するように設計される。コーティングの特性は、コーティングの加工または組成のいずれかを変更することにより、変動させてもよい。コーティングは、あらゆる適切な材料から作製してもよいが、特に、プラズマ堆積させたフッ素、プラズマ堆積させたグライム(glyme)、ホスホリルコリン、ダイヤモンド状炭素(DLC)またはフッ素化したDLC、ポリビニルピロリドンおよびフッ素化またはペルフルオロ化したポリマー類とともに、ポリフッ化ビニリデンコポリマー類もしくはフルオロホスファゼンなどの溶媒噴霧した、または浸漬させたフルオロポリマー類を含んでいてもよい。プラズマ堆積させたプロセスはまた、基材材料を、機械的な摩耗、化学エッチング、またはポリ(p-キシリレン)ポリマー類またはポリ(n-ブチルメタクリレート)などの下地処理材料の予備的なコーティングなどの加工方法により下地処理する手段を含むことができる。コーティングは、異なる材料を異なる比で組み合わせて、装置の生物学的特性を調節してもよい。いくつかの実施形態では、コーティングはまた、ストラット(例えば、基材メッシュ材料のワイヤ)間の間質間隙または開口部を充填してもよい。コーティングは、溶媒浸漬コーティングを介して施されてもよい。コーティングは、弾性ポリマー類、例えばポリテトラフルオロエチレン、またはその他の適切なポリマー類を含んでいてもよい。間質間隙を覆うコーティングを施すことで、ジャケット付き組み立て体を形成してもよく、この組み立て体が、内側管腔を通る血流のうっ滞ゾーンを低減させる場合がある。 In another aspect of the invention, the coating is applied to the device in a non-uniform, conformal pattern, yielding a design that achieves more favorable biological results. The device may include a lumen, where the inner surface of the lumen is designed primarily to reduce thrombus formation and the outer surface of the lumen is designed primarily to promote endothelialization. be done. Additionally or alternatively, the coating may be applied as a gradient, where the proximal and distal ends of the device are designed primarily to reduce thrombus formation, and the central portion of the device is , designed to promote endothelialization. The properties of the coating may be varied by changing either the processing or the composition of the coating. The coating may be made from any suitable material, but in particular plasma deposited fluorine, plasma deposited glyme, phosphorylcholine, diamond-like carbon (DLC) or fluorinated DLC, polyvinylpyrrolidone and fluorine. Solvent sprayed or impregnated fluoropolymers such as polyvinylidene fluoride copolymers or fluorophosphazenes may be included, along with the perfluorinated or perfluorinated polymers. Plasma-deposited processes may also remove substrate materials by mechanical abrasion, chemical etching, or pre-coating of priming materials such as poly(p-xylylene) polymers or poly(n-butyl methacrylate). A means for priming according to the processing method can be included. The coating may combine different materials in different ratios to adjust the biological properties of the device. In some embodiments, the coating may also fill interstitial gaps or openings between struts (eg, wires of the base mesh material). The coating may be applied via solvent dip coating. The coating may comprise elastomeric polymers such as polytetrafluoroethylene, or other suitable polymers. A coating over the interstitial space may be applied to form a jacketed assembly, which may reduce stasis zones for blood flow through the inner lumen.
本明細書で開示されるのは、血管管腔の中に挿入して動脈瘤を治療する装置である。装置は、概して円筒形のメッシュ区画と、近位テーパ付き区画とを含む。概して円筒形のメッシュ区画は、複数のストラットを含み、ストラットは、間質間隙をストラット間に形成しており、近位面と遠位面とを有する。概して円筒形のメッシュ区画は、近位面から遠位面まで軸方向に沿って延びる装置管腔を画定する。管腔は、装置に血流を通すように構成される。近位テーパ付き区画は、近位面の外周から近位尖端まで延びる複数のストラットを含む。近位尖端は、半径方向に近位面の外周と整列している、または近位面の外周の半径方向外側に配置される。近位テーパ付き区画の複数のストラットは、近位面の外周上の異なる場所から軸方向および外周方向に、近位尖端まで延びており、複数のストラットはいずれも、装置管腔により画定された断面領域を通って横切らないようにしてある。 Disclosed herein are devices for insertion into a vessel lumen to treat aneurysms. The device includes a generally cylindrical mesh section and a proximal tapered section. The generally cylindrical mesh compartment includes a plurality of struts defining interstitial spaces between the struts and having a proximal surface and a distal surface. A generally cylindrical mesh section defines a device lumen extending axially from the proximal face to the distal face. The lumen is configured to allow blood flow through the device. The proximal tapered section includes a plurality of struts extending from the circumference of the proximal face to the proximal apex. The proximal tip is radially aligned with the perimeter of the proximal face or disposed radially outward of the perimeter of the proximal face. A plurality of struts of the proximal tapered section extend axially and circumferentially from different locations on the circumference of the proximal face to the proximal apex, each strut being defined by the device lumen. Avoid traversing through the cross-sectional area.
概して円筒形のメッシュ区画の複数のストラットは、編み込まれたワイヤから形成されてもよい。近位テーパ付き区画の複数のストラットは、概して円筒形のメッシュ区画の編み込まれたワイヤから形成されてもよい。編み込まれたワイヤは、近位テーパ付き区画の内部に少なくとも部分的に編み込まれていてもよい。一つまたは複数のストラットは、近位テーパ付き区画の内部で反転させて、一つまたは複数の反転したストラットが、近位テーパ付き区画の内部で半径方向外向きに、そして近位尖端に向かって屈曲するようにしてあっても、そして近位尖端が、近位面の外周の半径方向外側に配置されるようにしてあってもよい。複数のストラットは、近位尖端から、または近傍から延びる、そして近位面の外周まで延びる縁部を形成してもよい。この縁部は、流入する血流と界面をなすように構成されてもよい。縁部は、軸寸法に平行な近位尖端を通って延びる長手方向の軸に対する取り出し角を画定することができる。いくつかの実施形態では、取り出し角は、約80度以下、または約70度以下である。いくつかの実施形態では、取り出し角は、少なくとも約30度、または少なくとも約40度である。装置は、近位面の外径により画定される断面領域の或る割合を占めていていもよい。いくつかの実施形態では、その割合は、約0.2、0.1、0.05、または0.01以下であってもよい。いくつかの実施形態では、近位テーパ付き区画の複数のストラット、および概して円筒形のメッシュ区画は、約0.01インチまたは0.005インチ以下の直径を有する。 A plurality of struts of the generally cylindrical mesh section may be formed from braided wires. The plurality of struts of the proximal tapered section may be formed from braided wires of the generally cylindrical mesh section. The braided wire may be at least partially braided within the proximal tapered section. The one or more struts are inverted within the proximal tapered section such that the one or more inverted struts are directed radially outward within the proximal tapered section and towards the proximal tip. and the proximal tip may be positioned radially outward of the circumference of the proximal face. A plurality of struts may form edges extending from or near the proximal apex and extending to the perimeter of the proximal face. This edge may be configured to interface with incoming blood flow. The edge can define a take-off angle with respect to a longitudinal axis extending through the proximal tip parallel to the axial dimension. In some embodiments, the take-off angle is about 80 degrees or less, or about 70 degrees or less. In some embodiments, the take-off angle is at least about 30 degrees, or at least about 40 degrees. The device may occupy a percentage of the cross-sectional area defined by the outer diameter of the proximal face. In some embodiments, the percentage may be less than or equal to about 0.2, 0.1, 0.05, or 0.01. In some embodiments, the multiple struts of the proximal tapered section and the generally cylindrical mesh section have a diameter of about 0.01 inch or 0.005 inch or less.
概して円筒形のメッシュ区画は、動脈瘤に隣接して配置されるように構成された中央区画を含んでいてもよい。この中央区画は、概して円筒形のメッシュ区画の残りの少なくとも一部分より、実質的にさらに高いストラット密度を含んでいてもよい。中央区画は、拘束のない構成での近位面の外径より大きい外径を含んでいてもよい。さらに高いストラット密度は、編み込まれたワイヤのピッチが、概して円筒形のメッシュ区画のさらに低密度部分におけるよりも小さい結果、および/または織りのパターンが、概して円筒形のメッシュ区画のさらに低密度部分とは異なる結果である場合がある。いくつかの実施形態では、中央区画は、差し渡し約0.008インチ、または差し渡し0.01インチ以下の、間質間隙を含んでいてもよい。概して円筒形のメッシュ区画は、概して円筒形のメッシュ区画の中央近傍での半径方向外向きの圧縮反力よりも大きい、隣接する近位面での半径方向外向きの圧縮反力を与えるように構成されてもよい。 The generally cylindrical mesh compartment may include a central compartment configured to be positioned adjacent an aneurysm. This central section may include a substantially higher strut density than at least a portion of the remainder of the generally cylindrical mesh section. The central section may include an outer diameter that is greater than the outer diameter of the proximal face in the unconstrained configuration. Higher strut densities are a result of the pitch of the woven wires being smaller than in the less dense portions of the generally cylindrical mesh section, and/or the weave pattern being less dense than in the less dense portions of the generally cylindrical mesh section. may give different results. In some embodiments, the central section may include an interstitial space of about 0.008 inches across, or less than or equal to 0.01 inches across. The generally cylindrical mesh section provides a radially outward compressive reaction force at the adjacent proximal surface that is greater than the radially outward compressive reaction force near the center of the generally cylindrical mesh section. may be configured.
いくつかの実施形態では、装置は、遠位テーパ付き区画をさらに含んでいてもよい。遠位テーパ付き区画は、遠位面の外周から遠位尖端まで延びている複数のストラットを含んでいてもよい。遠位尖端は、半径方向に遠位面の外周と整列していても、または遠位面の外周の半径方向外側に配置されていてもよい。遠位テーパ付き区画の複数のストラットは、遠位面の外周上の異なる場所から軸方向および外周方向に、遠位尖端まで延びて、複数のストラットのいずれも、装置管腔により画定された断面領域を通って横切ることのないようにしてあってもよい。遠位テーパ付き部分からの複数のストラットは、近位尖端から遠位に位置する放射線不透過性のマーカー環を通って延びていてもよい。遠位テーパ付き部分からの複数のストラットは、遠位尖端から遠位に平行に整列して、遠位引き出し区分を形成してもよい。装置は、遠位引き出し区分の周りに配置された金属性ヘリカルコイルをさらに含んでいてもよい。金属性ヘリカルコイルは、白金またはイリジウムを含んでいてもよい。いくつかの実施形態では、遠位面は、開口していて軸方向に対して実質的に垂直であってもよい。開口した遠位の面は、概して円筒形のメッシュ区画の内部の複数のストラットの内部に無外傷性屈曲により形成された周縁部を含んでいてもよい。 In some embodiments, the device may further include a distal tapered section. The distal tapered section may include a plurality of struts extending from the circumference of the distal face to the distal tip. The distal tip may be radially aligned with the perimeter of the distal face or may be positioned radially outward of the perimeter of the distal face. The plurality of struts of the distal tapered section extend axially and circumferentially from different locations on the circumference of the distal surface to the distal apex such that any of the plurality of struts has a cross-section defined by the device lumen. It may be arranged not to traverse through the area. A plurality of struts from the distal tapered portion may extend through a radiopaque marker ring located distally from the proximal tip. A plurality of struts from the distal tapered portion may be aligned in parallel distally from the distal tip to form a distal drawer section. The device may further include a metallic helical coil disposed around the distal drawer section. The metallic helical coil may contain platinum or iridium. In some embodiments, the distal face may be open and substantially perpendicular to the axial direction. The open distal face may include a rim formed by atraumatic bending within a plurality of struts within the generally cylindrical mesh section.
近位テーパ付き区画の内部の複数のストラットは、近位面の外周の周りに実質的に均一に分配されていてもよい。装置は、近位尖端と共線関係にある押し出しワイヤをさらに含んでいてもよい。近位テーパ付き区画の内部の複数のストラットは、近位尖端から近位に平行に整列させることができる。複数のストラットの近位端部は、押し出しワイヤの遠位端部に接合させてもよい。複数のストラットは、押し出しワイヤの外周の周りに実質的に均一に分配させることができる。押し出しワイヤは、近位テーパ付き区画に永久に接合してもよい。押し出しワイヤは、近位テーパ付き区画に取り外し可能に接合してもよい。押し出しワイヤの遠位端部は、テーパ付き部分を含んでいてもよい。押し出しワイヤの遠位端部は、押し出しワイヤを取り巻く複数のプラスチック製の環を含んでいてもよい。近位テーパ付き区画からの複数のストラットの近位端部は、プラスチック製の環を取り巻いていてもよい。複数のプラスチック製の環は、互いから少なくとも約1cm離して軸方向に沿って離間していてもよい。近位テーパ付き部分からの複数のストラットは、近位尖端から近位に位置する放射線不透過性のマーカー環を通って延びていてもよい。 The plurality of struts within the proximal tapered section may be substantially evenly distributed around the circumference of the proximal face. The device may further include a pusher wire collinear with the proximal tip. A plurality of struts within the proximal tapered section can be aligned in parallel proximally from the proximal apex. A proximal end of the plurality of struts may be joined to a distal end of the pusher wire. The plurality of struts can be distributed substantially evenly around the circumference of the extruded wire. The pusher wire may be permanently joined to the proximal tapered section. A pusher wire may be removably joined to the proximal tapered section. The distal end of the pusher wire may include a tapered portion. The distal end of the pusher wire may include multiple plastic rings surrounding the pusher wire. A proximal end of the plurality of struts from the proximal tapered section may encircle a plastic ring. The plurality of plastic rings may be axially spaced apart from each other by at least about 1 cm. A plurality of struts from the proximal tapered portion may extend through a radiopaque marker ring located proximally from the proximal tip.
装置は、収縮した構成および拡張した構成を含んでいてもよい。装置は、拡張した構成におけるよりも収縮した構成において、装置の近位尖端から遠位端部までの軸長がさらに長く、装置管腔の直径がさらに小さくてもよい。概して円筒形のメッシュ区画の複数のストラットおよび近位テーパ付き区画は、形状記憶材料を含んでいてもよい。装置は、記憶された形状として、拡張した構成を呈するように構成されてもよい。 The device may include a contracted configuration and an expanded configuration. The device may have a longer axial length from the proximal tip to the distal end of the device and a smaller diameter device lumen in the contracted configuration than in the expanded configuration. The plurality of struts and the proximal tapered section of the generally cylindrical mesh section may comprise shape memory material. The device may be configured to assume an expanded configuration as the stored shape.
概して円筒形の区画の複数のストラットは、コーティング材料を用いてコーティングされていてもよい。コーティング材料は、プラズマ堆積させたフッ素、プラズマ堆積させたグライム、ホスホリルコリン、ダイヤモンド状炭素、フッ素化したダイヤモンド状炭素、ポリビニルピロリドン(PVP)、フッ素化したエチレンプロピレン(FEP)、ポリテトラフルオロエチレン(PTFE)、ポリフッ化ビニリデン(PVDF)、ポリ(フッ化ビニリデンコヘキサフルオロプロピレン)(PVDF-HFP)、フルオロホスファゼン、カルボシキベタイン、スルホベタイン、メタクリル化したカルボキシベタイン、メタクリル化したスルホベタイン、フルオロシラン、ヘパリン、またはヘパリン状分子;ヒルジン;クルクミン;トロンボモジュリン;プロスタサイクリン;DMP 728血小板GPIIb/IIIa拮抗薬;キトサン、硫酸化キトサン;ヒアルロン酸;タンタルをドープした酸化チタン;酸窒化物、酸化物層、または炭化ケイ素を含んでいてもよい。装置は、複数のストラットとコーティング材料との間に、ポリn-ブチルメタクリレート(PBMA)またはポリ(p-キシリレン)ポリマーの下地材層を含んでいてもよい。コーティング材料は、間質間隙の少なくともいくつかを完全に覆ってもよい。コーティング材料は、動脈瘤に隣接して配置されるように構成された間質間隙の一部分を覆って、その部分が動脈瘤の頚部を覆うようにしてあってもよい。コーティング材料は、交互の列をなす間質間隙を覆ってもよい。 A plurality of struts of the generally cylindrical section may be coated with a coating material. Coating materials include plasma-deposited fluorine, plasma-deposited glyme, phosphorylcholine, diamond-like carbon, fluorinated diamond-like carbon, polyvinylpyrrolidone (PVP), fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE). ), polyvinylidene fluoride (PVDF), poly(vinylidene fluoride cohexafluoropropylene) (PVDF-HFP), fluorophosphazenes, carboxybetaines, sulfobetaines, methacrylated carboxybetaines, methacrylated sulfobetaines, fluorosilanes, thrombomodulin; prostacyclin; DMP 728 platelet GPIIb/IIIa antagonist; chitosan, sulfated chitosan; hyaluronic acid; tantalum-doped titanium oxide; It may contain silicon carbide. The device may include a liner layer of poly n-butyl methacrylate (PBMA) or poly(p-xylylene) polymer between the struts and the coating material. The coating material may completely cover at least some of the interstitial spaces. The coating material may cover a portion of the interstitial space configured to be positioned adjacent to the aneurysm such that that portion covers the neck of the aneurysm. The coating material may cover alternating rows of interstitial spaces.
いくつかの実施形態では、装置は、少なくとも24本のワイヤまたは48本のワイヤを含んでいてもよい。概して円筒形の区画の複数のストラットは、ニチノール、DFT(登録商標)、白金、コバルトクロム、ステンレス鋼、フルオロポリマー、ポリエチレン、ポリウレタン、ポリエーテルブロックアミド、または形状記憶ポリマーを含んでいてもよい。概して円筒形の区画の複数のストラットは、ポリテトラフルオロエチレン(PTFE)、ポリフッ化ビニリデン(PVDF)、ポリビニリデン-ヘキサフルオロプロピレン(PVDF-HFP)、ペルフルオロプロピレン、オクタフルオロプロパン、パリレン(Parylene)HT、パリレンAF-4、パリレンF、パリレンVT-4;1H,1H,2H,2H-ペルフルオロドデシルトリクロロシラン、(トリデカフルオロ-1,1,2,2,テトラヒドロオクチル)シラン、ヘキサデカフルオロドデク-11-エン-1-イルトリメトキシシラン、またはポリ(p-キシリレン)ポリマーを用いて被覆してもよい。装置の近位尖端は、近位面の外周の半径方向外側に配置してもよい。 In some embodiments, the device may include at least 24 wires or 48 wires. The plurality of struts of the generally cylindrical section may comprise nitinol, DFT®, platinum, cobalt chromium, stainless steel, fluoropolymer, polyethylene, polyurethane, polyether block amide, or shape memory polymer. The plurality of struts of the generally cylindrical section are made of polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), polyvinylidene-hexafluoropropylene (PVDF-HFP), perfluoropropylene, octafluoropropane, Parylene HT. , Parylene AF-4, Parylene F, Parylene VT-4; 1H,1H,2H,2H-perfluorododecyltrichlorosilane, (tridecafluoro-1,1,2,2,tetrahydrooctyl)silane, hexadecafluorododec -11-en-1-yltrimethoxysilane, or poly(p-xylylene) polymers may be used for coating. The proximal tip of the device may be located radially outward of the circumference of the proximal face.
本明細書で開示されるのは、血管の内部の動脈瘤を治療する方法である。方法は、血管の中に動脈瘤治療装置を挿入することを含む。装置は概して、円筒形のメッシュ区画と、近位テーパ付き区画とを含む。概して円筒形のメッシュ区画は、複数のストラットを含み、それらのストラットの間に、間質間隙が形成される。概して円筒形のメッシュ区画は、近位面および遠位面を有しており、軸方向に沿って近位面から遠位面まで延びる装置管腔を画定している。管腔は、装置に血流を通すように構成される。近位テーパ付き区画は、概して円筒形のメッシュ区画を押し出しワイヤに接合する。 Disclosed herein are methods of treating an aneurysm within a blood vessel. The method includes inserting an aneurysm treatment device into a blood vessel. The device generally includes a cylindrical mesh section and a proximal tapered section. A generally cylindrical mesh compartment includes a plurality of struts with interstitial spaces formed between the struts . A generally cylindrical mesh section has a proximal surface and a distal surface and defines a device lumen extending axially from the proximal surface to the distal surface. The lumen is configured to allow blood flow through the device. A proximal tapered section joins the generally cylindrical mesh section to the extrusion wire.
概して円筒形のメッシュ区画は、概して円筒形のメッシュ区画の残りの部分より高いストラット密度を有する中央区画を含んでいてもよい。方法は、中央区画が動脈瘤の頚部を実質的に覆うようにして、動脈瘤に隣接させて中央区画を配置することをさらに含んでいてもよい。概して円筒形のメッシュ区画は、その長さの少なくとも一部分に沿ってチューブ状のスリーブを含んでいてもよい。方法は、中央区画が動脈瘤の頚部を実質的に覆うようにして、動脈瘤に隣接させてチューブ状のスリーブを配置することをさらに含んでいてもよい。 A generally cylindrical mesh section may include a central section having a higher strut density than the remainder of the generally cylindrical mesh section. The method may further comprise positioning the central compartment adjacent to the aneurysm such that the central compartment substantially covers the neck of the aneurysm. The generally cylindrical mesh section may include a tubular sleeve along at least a portion of its length. The method may further comprise placing a tubular sleeve adjacent to the aneurysm such that the central compartment substantially covers the neck of the aneurysm.
方法は、動脈瘤の中にまたはこれに隣接させてマイクロカテーテルを挿入すること、および複数の動脈瘤充填用コイルを動脈瘤に送達することを含んでいてもよい。いくつかの実施形態では、マイクロカテーテルは、血管の壁と動脈瘤治療装置との間に挿入することができる。いくつかの実施形態では、マイクロカテーテルは、装置管腔の内部に、そして概して円筒形のメッシュ区画の、間質間隙の一つを通して挿入することができる。いくつかの実施形態では、方法は、複数の動脈瘤充填用コイルを送達した後に押し出しワイヤを近位に後退させることにより、動脈瘤治療装置を取り出すことを、さらに含んでいてもよい。方法は、動脈瘤治療装置を永久ステントに置き換えることを含んでいてもよい。いくつかの実施形態では、方法は、押し出しワイヤの少なくとも一部分を装置の残りから取り外して、概して円筒形のメッシュ区画を、動脈瘤に隣接させて配置しそのまま永久に残すことを含んでいてもよい。近位テーパ付き区画は、近位面の外周から近位尖端まで延びる複数のストラットを含んでいてもよい。近位尖端は、半径方向に近位面の外周と整列していてもよい、または近位面の外周の半径方向外側に配置されてもよい。近位テーパ付き区画の複数のストラットは、近位面の外周上の異なる場所から軸方向および外周方向に、近位尖端まで延びていてもよく、複数のストラットはいずれも、装置管腔により画定された断面領域を通って横切らないようにしてある。 The method may include inserting a microcatheter into or adjacent to the aneurysm and delivering multiple aneurysm filling coils to the aneurysm. In some embodiments, the microcatheter can be inserted between the vessel wall and the aneurysm treatment device. In some embodiments, a microcatheter can be inserted inside the device lumen and through one of the interstitial spaces of the generally cylindrical mesh compartment. In some embodiments, the method may further include retrieving the aneurysm treatment device by proximally retracting the pusher wire after delivering the multiple aneurysm filling coils. The method may include replacing the aneurysm treatment device with a permanent stent. In some embodiments, the method may include removing at least a portion of the pusher wire from the rest of the device to permanently leave a generally cylindrical mesh section positioned adjacent the aneurysm. . The proximal tapered section may include a plurality of struts extending from the circumference of the proximal face to the proximal apex. The proximal tip may be radially aligned with the perimeter of the proximal face or may be positioned radially outward of the perimeter of the proximal face. The plurality of struts of the proximal tapered section may extend axially and circumferentially from different locations on the circumference of the proximal face to the proximal apex, each of the plurality of struts being defined by the device lumen. not traverse through the cross-sectional area defined by the
いくつかの実施形態では、装置は、コーティングの付着に先立って下地処理してもよい。装置を下地処理することにより、装置(例えば装置のストラットまたはワイヤ)にコーティングを取り付け易くする場合がある。表面の下地処理は、機械的な手段、例えば媒体の吹き付け、研磨、スクライブ等によるものであってもよい。機械的な下地処理は、装置の表面積を増加させる場合がある。表面積を増加させることは、コーティング分子および/または細胞(例えば、内皮細胞)の接着を促進させる場合がある。表面の下地処理は、エッチングなどの化学的手段、またはその他の表面官能化、例えば、水素または窒素イオンを衝突させることによる分子の結合部位の活性化、または最終的なポリマーコーティングの接着に役立つ基材を用いたプレコーティングによるものであってもよい。いくつかの実施形態では、コーティングの多層または複数のコーティングを装置に付着させてもよい。下地処理は、下にある装置上に、および/またはその装置の一つまたは複数のコーティング上に行ってもよい。 In some embodiments, the device may be primed prior to coating application. Preparing the device may facilitate attachment of the coating to the device (eg, struts or wires of the device). Surface preparation may be by mechanical means such as media blasting, grinding, scribing, and the like. Mechanical preparation may increase the surface area of the device. Increasing surface area may promote adhesion of coating molecules and/or cells (eg, endothelial cells). Surface preparation may include chemical means such as etching, or other surface functionalization, e.g., activation of molecular binding sites by bombardment with hydrogen or nitrogen ions, or groups that aid in the adhesion of the final polymer coating. Pre-coating using material may be used. In some embodiments, multiple layers of coatings or multiple coatings may be applied to the device. The priming may be performed on the underlying device and/or on one or more coatings of the device.
コーティングは、特に神経血管に適用した際に危険な塞栓を生じさせる破片のリスクを低減するためには、薄いことが好ましい。同一の理由から、コーティングは、耐久性があるのが好ましく、装置を広げた場合(例えば、ストラットが互いにこすれる場合)に生じる摩擦で破片が生じる傾向の少ないことが好ましい。いくつかの実施形態では、コーティングは、約300nm以下の厚さである。機械的に堅牢であって、コーティングの後に剥がれるまたは破壊しないコーティング材料は、さらに厚いコーティング(例えば、300nm厚のコーティング)に特に好適な場合がある。いくつかの実施形態では、コーティングは、約3nm、5nm、10nm、15nm、20nm、25nm、30nm、40nm、50nm、60nm、75nm、100nm、150nm、200nm、または300nm以下の厚さである。いくつかの実施形態では、コーティングは、300nm超の厚さ、または3nm未満(例えば、オングストロームのレベル)であってもよい。さらに薄いコーティング(例えば、75nm以下の厚さ)は、装置の中央管腔を通る流れ特性へのコーティングの機械的な寄与を最小限にしつつ、内皮化および/または抗血栓形成性における堅牢な性能を提供する場合がある。さらに薄いコーティングでは、塞栓、例えば脳卒中のリスクをもたらす可能性のあるさらに大きいサイズの粒子状の破片を生成する可能性は、低くなる場合がある。好適な実施形態では、コーティングは、約25~50nm間の厚さ、30~50nmの厚さ、30~40nmの厚さ、40~50nmの厚さ、35~40nmの厚さ、40~60nmの厚さ、50~60nmの厚さ、25nm未満の厚さ、または60nm超の厚さであってもよい。最適な範囲内のコーティングは、考えられる毒性の懸念を最小限にしつつ、充分な表面カバレッジを提供し、低減された血栓形成性を提供する場合がある。例えば、いくつかの実施形態では、すべてのコーティングが装置からはぎとられたとしても、薄いコーティングでのコーティング材料の量は、毒性の閾値を下回るであろう。コーティングのカバレッジおよび厚さは、走査型電子顕微鏡(SEM)により決定してもよい。いくつかの実施形態では、100%の表面カバレッジが実現される。いくつかの実施形態では、100%未満の表面カバレッジが実現される(例えば、25%、50%、75%、80%、90%、25%未満、90~100%の間、またはそれらの間のいずれかの範囲)。いくつかの実施形態では、装置は、充分な抗血栓形成の特性を実現するのに100%の表面カバレッジを必要としなくともよい。耐久性は、シミュレートされた疲労の前後でSEMを実行することにより評価してもよい。また、好適な実施形態では、コーティングされた装置は、USP 788規格を満足させる。すなわち、その実施形態では、25μm以上である600個以下の粒子、および10μmと25μmの間である6000個以下の粒子が生じる。さらには、装置は、サイズが約2μm未満の粒子状物質を発生させないことが好ましい。 The coating is preferably thin to reduce the risk of debris causing dangerous embolism, especially in neurovascular applications. For the same reasons, the coating is preferably durable and less prone to debris from the friction that occurs when the device is unfolded (eg, when the struts rub against each other). In some embodiments, the coating is about 300 nm thick or less. Coating materials that are mechanically robust and do not flake or break after coating may be particularly suitable for thicker coatings (eg, 300 nm thick coatings). In some embodiments, the coating is about 3 nm, 5 nm, 10 nm, 15 nm, 20 nm, 25 nm, 30 nm, 40 nm, 50 nm, 60 nm, 75 nm, 100 nm, 150 nm, 200 nm, or 300 nm thick or less. In some embodiments, the coating may be greater than 300 nm thick, or less than 3 nm (eg, at the Angstrom level). Thinner coatings (e.g., thicknesses of 75 nm or less) minimize mechanical contributions of the coatings to flow characteristics through the central lumen of the device, while robust performance in endothelialization and/or anti-thrombogenicity may provide. Thinner coatings may be less likely to produce emboli, eg, larger sized particulate debris that can pose a risk of stroke. In preferred embodiments, the coating is between about 25-50 nm thick, 30-50 nm thick, 30-40 nm thick, 40-50 nm thick, 35-40 nm thick, 40-60 nm thick. It may be 50-60 nm thick, less than 25 nm thick, or greater than 60 nm thick. Coatings within the optimal range may provide sufficient surface coverage and provide reduced thrombogenicity while minimizing potential toxicity concerns. For example, in some embodiments, even if all the coating is stripped from the device, the amount of coating material in a thin coating will be below the toxicity threshold. Coating coverage and thickness may be determined by scanning electron microscopy (SEM). In some embodiments, 100% surface coverage is achieved. In some embodiments, less than 100% surface coverage is achieved (eg, 25%, 50%, 75%, 80%, 90%, less than 25%, between 90-100%, or between range of either). In some embodiments, the device may not require 100% surface coverage to achieve sufficient anti-thrombogenic properties. Durability may be assessed by running SEM before and after simulated fatigue. Also, in preferred embodiments, the coated device meets the USP 788 standard. That is, in that embodiment no more than 600 particles that are greater than or equal to 25 μm and no more than 6000 particles that are between 10 μm and 25 μm are produced. Additionally, the apparatus preferably does not generate particulate matter less than about 2 microns in size.
コーティングは、装置の異なる領域に差別化して施してもよい。いくつかの実施形態では、装置管腔の内径には、抗血栓性を最適化するコーティングを施し、その一方で装置の外径には、内皮化を最適化するコーティングを施す、またはその逆もしかりである。いくつかの実施形態では、コーティングは、装置の中央に向かって(例えば、動脈瘤頸部に近接して配置されるように構成された部分に沿って)内皮化を促進するように、そして装置の近位および遠位の端部に向かって血栓を低減させるように、最適化される。動脈瘤頸部の近傍での内皮化を促進させることにより、血管から動脈瘤を閉塞する内膜層の成長が容易になる場合がある。また、先に言及したものの様々な組み合わせを施してもよい。さらには、装置の長さに沿った特性のそうした変動は、明確に異なる特性を有する明確に異なる領域としてではなく、特性の勾配として達成してもよい。特性の差は、コーティングの組成を変更することによって、および/またはコーティングをその施している最中に差別化して加工することによって、実現してもよい。いかなる場所でのコーティングの組成も、上で考察した材料の一つまたは複数を含んでいてもよい。いくつかの実施形態では、そうした共形のコーティング戦略を使用して、動脈瘤が最終的に血管の先天的な管腔から封鎖されるようにして、動脈瘤頸部に沿って装置の内皮化を促進してもよい。いくつかの実施形態では、装置は、浸漬コーティングされるが、これは、ポリマーコーティングが、空洞、または間質間隙、または装置ストラット間もしくはワイヤ間の空間を充填する膜として形成されるようにして、なされる。介在空間の一つまたは複数にわたって延びるコーティングを形成するその他のプロセスを、同様に使用してもよい。いくつかの実施形態では、膜は、装置上にその膜を形成した後に、レーザにより選択的に除去してもよい。膜は、多孔度の可変領域を有していてもよい。例えば、膜は、装置の長さまたは長さの一部分に沿って多孔度の勾配を有するように(例えば、レーザを用いて)作ってもよい。レーザまたはその他の手段によって作られた穿孔は、メッシュ装置の間質間隙の内部に配置されていてもよい。穿孔は様々なサイズのものであってもよい。いくつかの実施形態では、穿孔は、(例えば、目一杯に拡張した構成において)間質間隙のサイズにほぼ等しくても、間質間隙のサイズより実質的に小さくても、またはそれらの間の様々なサイズであってもよい。いくつかの実施形態では、一つより多い穿孔が、間質間隙の内部に配置されていてもよい。 Coatings may be applied differentially to different areas of the device. In some embodiments, the inner diameter of the device lumen is coated to optimize antithrombotic properties, while the outer diameter of the device is coated to optimize endothelialization, or vice versa. Yes. In some embodiments, the coating is directed toward the center of the device (e.g., along a portion configured to be placed proximate the aneurysm neck) to promote endothelialization and are optimized to reduce thrombus towards the proximal and distal ends of the . Promoting endothelialization near the aneurysm neck may facilitate the growth of an intimal layer that occludes the aneurysm from the blood vessel. Also, various combinations of the above mentioned may be applied. Moreover, such variations in properties along the length of the device may be achieved as gradients of properties rather than as distinct regions with distinct properties. Differences in properties may be achieved by changing the composition of the coating and/or by differentially processing the coating during its application. The composition of the coating at any location may include one or more of the materials discussed above. In some embodiments, such conformal coating strategies are used to endothelialize the device along the aneurysm neck such that the aneurysm is ultimately sealed from the native lumen of the vessel. may promote In some embodiments, the device is dip coated such that the polymer coating is formed as a film that fills cavities, or interstitial spaces, or spaces between device struts or wires. , is done. Other processes that form coatings that extend over one or more of the interstitial spaces may be used as well. In some embodiments, the film may be selectively removed with a laser after forming the film on the device. The membrane may have regions of variable porosity. For example, the membrane may be made (eg, using a laser) with a porosity gradient along the length or portion of the length of the device. Perforations made by laser or other means may be located within the interstitial spaces of the mesh device. The perforations may be of various sizes. In some embodiments, the perforations are approximately equal to the size of the interstitial space (e.g., in a fully expanded configuration), substantially smaller than the size of the interstitial space, or are between It may be of various sizes. In some embodiments, more than one perforation may be positioned within the interstitial space.
装置10の本体は、離間したストラットまたはワイヤ(例えば、織られたまたは編み込まれたワイヤ)を含んでいてもよく、これらは一体に接合されてまたは重なり合って、ストラット間またはワイヤ間に開いた小室または間質間隙(例えば、ダイヤモンド形状の小室)を形成するものである。いくつかの実装では、本体は、装置10の軸方向に沿うととともに第1外周方向(例えば、時計回りの方向)に延びるストラットまたはワイヤと、軸方向に沿うとともに第1外周方向の反対(例えば、反時計回り)の第2外周方向にも延びるストラットまたはワイヤとを含む。対向するワイヤは、様々な角度(拡張した構成において、例えば、10度、20度、45度、60度、80度、90度、100度、120度、125度、130度、135度、140度、145度、160度等)で接合しても、交差しても、および/または重なり合ってもよい。いくつかの実施形態では、角度は、約60度と約155度の間であってもよい。いくつかの実施形態では、角度は、約120度と約130度の間であってもよい。対向するワイヤまたはストラットどうしの間の角度は、装置10が拡張または収縮するにつれて変化してもよい。いくつかの実装では、ストラットまたはワイヤは、装置10の軸方向に実質的に平行に、少なくとも装置10の部分に沿って延びていてもよい。様々な区分では、小室は、サイズおよび形状が比較的均一であってもよい。小室のサイズおよび形状は、装置の拡張/収縮時に変化してもよい。いくつかの実施形態では、比較的大きな小室面積を含む装置の区画は、比較的低密度であってもよい。いくつかの実施形態では、円錐状区画16、18は、血流の妨害を最小限にするおよび/または血栓形成を低減させるため、可能な限り開いていても(すなわち低密度であっても)よい。いくつかの実施形態では、円錐状区画16、18は、植え込み物本体の中心区画20から遠ざかるように半径方向内向きに傾斜して、尖端、例えば近位尖端26を形成する、少なくとも二つ、または三つ、または四つ以上のさらなるストラット13を含んでいてもよい。ストラット13は、装置10の外周の周りに、概して均一に離間していてもよい。遠位のストラット13を含む実施形態では、近位端部でのストラット13は、遠位端部でのストラット13と外周方向に整列していてもよい、または外周方向にずらしてあってもよい。近位の円錐状区画16および遠位の円錐状区画18は、同一のまたは異なる数のストラット13を有していてもよい。 The body of device 10 may include spaced apart struts or wires (e.g., woven or braided wires) that are joined together or overlapped to provide open chambers between the struts or wires. or form interstitial spaces (eg, diamond-shaped chambers). In some implementations, the body includes struts or wires that extend along the axial direction of the device 10 and in a first circumferential direction (e.g., a clockwise direction) and struts or wires that extend axially along the first circumferential direction (e.g., a , counterclockwise) and struts or wires also extending in a second circumferential direction. The opposing wires are angled at various angles (e.g., 10, 20, 45, 60, 80, 90, 100, 120, 125, 130, 135, 140 degrees in the expanded configuration). degrees, 145 degrees, 160 degrees, etc.), intersect, and/or overlap. In some embodiments, the angle may be between about 60 degrees and about 155 degrees. In some embodiments, the angle may be between about 120 degrees and about 130 degrees. The angle between opposing wires or struts may change as device 10 expands or contracts. In some implementations, the struts or wires may extend along at least portions of device 10 substantially parallel to the axial direction of device 10 . In the various sections, the cells may be relatively uniform in size and shape. The size and shape of the chamber may change upon expansion/contraction of the device. In some embodiments, the compartments of the device that contain relatively large chamber areas may be of relatively low density. In some embodiments, the conical sections 16, 18 are as open (i.e., low density) as possible to minimize obstruction of blood flow and/or reduce thrombus formation. good. In some embodiments, at least two of the conical sections 16, 18 slope radially inward away from the central section 20 of the implant body to form a point, e.g., a proximal point 26; Or it may include three, or four or more additional struts 13 . Struts 13 may be generally evenly spaced around the circumference of device 10 . In embodiments including distal struts 13, the struts 13 at the proximal end may be circumferentially aligned with the struts 13 at the distal end, or they may be circumferentially offset. . The proximal conical section 16 and distal conical section 18 may have the same or different numbers of struts 13 .
いくつかの実施形態では、装置10は、緊密に編み込まれた金属ワイヤ、レーザ切断されたチューブ原料、または両方の混成物からなっていてもよい。多くの実施形態では、装置を含むワイヤの数は少なくとも約24本である。いくつかの実施形態では、ワイヤの数は、少なくとも約48本または64本またはそれより多い。ワイヤは、1対1、2対2、2対1、1対2等に編み込んでもよい。ワイヤ密度は、装置の区画に応じて変化していてもよい。ワイヤは、ニチノール、DFT(登録商標)、白金、スプリング強化ステンレス鋼、その他の金属、またはポリマー類などの材料から形成してもよい。いくつかの実施形態では、ワイヤは、ニチノール製鞘とともに30%の白金製の芯を含む。いくつかの実施形態では、装置10は、フルオロポリマー類または形状記憶ポリマー類から作製してもよい。図2Di~2Dviに、本明細書のここにまたは別途開示のメッシュ装置10のワイヤまたはストラットをコーティングするのに使用してもよいフルオロポリマーモノマー類またはポリマー類の様々な例を図示する。例えば、装置10は、ポリフッ化ビニリデン(PVDF)(図2Di);ポリ(フッ化ビニリデンコヘキサフルオロプロピレン)(PVDF-HFP)コポリマー類(図2Dii);ペルフルオロプロピレン(C3F6);オクタフルオロプロパン(C3F8);ポリ(p-キシリレン)ポリマー類、例えばパリレンHTおよび/またはパリレンAF-4から誘導されたもの(図2Diii);ポリ(p-キシリレン)ポリマー類、例えばパリレンFおよび/またはパリレンVT-4から誘導されたもの(図2Div);ポリ(p-キシリレン)ポリマー類、例えば図2Dvに図示されたもの;1H,1H,2H,2H-ペルフルオロドデシルトリクロロシラン(CF3 (CF2)9CH2CH2SiCl3);(トリデカフルオロ-1,1,2,2,テトラヒドロオクチル)シラン(CF3 (CF2)5CH2CH2SiH3);および/またはヘキサデカフルオロデク(hexadecafluordodec)-11-エン-1-イルトリメトキシシラン(図2Dvi)のコーティングを含んでいてもよい。いくつかの実施形態では、これらのコーティングは、最終的なコーティングとして働いてもよい。いくつかの実施形態では、これらのコーティングは、中間のコーティングとして使用してもよい。中間のコーティングは、例えば、引き続いて施されるコーティングの表面カバレッジを増加させるのに役立つ場合があり、このコーティングは、中間のコーティングと同一または異なっていてもよい。 In some embodiments, device 10 may be made of tightly woven metal wire, laser cut tubing stock, or a hybrid of both. In many embodiments, the number of wires comprising the device is at least about 24. In some embodiments, the number of wires is at least about 48 or 64 or more. The wires may be braided 1:1, 2:2, 2:1, 1:2, and so on. Wire densities may vary depending on the section of the device. Wires may be formed from materials such as Nitinol, DFT®, platinum, spring-strengthened stainless steel, other metals, or polymers. In some embodiments, the wire includes a 30% platinum core with a nitinol sheath. In some embodiments, device 10 may be made from fluoropolymers or shape memory polymers. Figures 2Di-2Dvi illustrate various examples of fluoropolymer monomers or polymers that may be used to coat the wires or struts of the mesh device 10 disclosed herein or elsewhere herein. For example, device 10 may include polyvinylidene fluoride (PVDF) (Figure 2Di); poly(vinylidene fluoride cohexafluoropropylene) (PVDF-HFP) copolymers (Figure 2Dii); perfluoropropylene (C3F6); octafluoropropane (C3F8); ); poly(p-xylylene) polymers such as those derived from parylene HT and/or parylene AF-4 (FIG. 2Diii); poly(p-xylylene) polymers such as parylene F and/or parylene VT-4. (Fig . 2Div); poly(p-xylylene) polymers such as those illustrated in Fig. 2Dv ; ( tridecafluoro-1,1,2,2,tetrahydrooctyl)silane (CF 3 (CF 2 )5CH 2 CH 2 SiH 3 ); and /or hexadecafluordodec-11- A coating of en-1-yltrimethoxysilane (FIG. 2Dvi) may be included. In some embodiments, these coatings may serve as final coatings. In some embodiments, these coatings may be used as intermediate coatings. Intermediate coatings may serve, for example, to increase the surface coverage of subsequently applied coatings, which may be the same or different from the intermediate coatings.
いくつかの実施形態では、装置10は、すべてニチノール製ワイヤから成っている。その他の実施形態では、装置は、ニチノール製ワイヤとその他の材料のワイヤから成っている。可視化に充分な放射線不透過性を装置に与えるためには、DFT(登録商標)ワイヤまたは別の放射線不透過性の金属を装置の中に組み込んでもよい、ワイヤを放射線不透過性の金属(例えば、金、白金、またはタンタル)を用いてコーティングしてもよい、または印刷された粒子またはその他のマーカー帯を装置に施してもよい。例えば64本の繊維織りのうち、少なくとも2本、または4本、または6本、またはさらなる繊維が、白金などの放射線不透過性の材料を含んでいてもよい。いくつかの実施形態では、ワイヤの直径は、約0.0005インチ、約0.001インチ、0.002インチ、0.003インチ、0.004インチ、0.005インチ、約0.006インチ、約0.007インチ、約0.008インチ、約0.009インチ、約0.01インチ、0.0005インチ未満、0.01インチ超、またはそれらの間の範囲内にある。いくつかの実施形態では、装置10は、少なくとも二本の異なる直径のワイヤから成っており、径の小さい方のワイヤを使用して、径の大きい方のワイヤの間の間隙を充填し、装置10の表面のカバレッジを増加させる。いくつかの実施形態では、編み込みおよび/またはストラットの接合部は、コーティングせずに残しておいて、植え込みの最中の疲労時に破片が発生するリスクを回避するようにする。 In some embodiments, device 10 is made entirely of Nitinol wire. In other embodiments, the device consists of Nitinol wire and wire of other materials. To provide the device with sufficient radiopacity for visualization, DFT® wire or another radiopaque metal may be incorporated into the device. , gold, platinum, or tantalum), or printed particles or other marker strips may be applied to the device. For example, out of a 64-fiber weave, at least 2, or 4, or 6, or additional fibers may comprise a radiopaque material such as platinum. In some embodiments, the wire diameter is about 0.0005 inch, about 0.001 inch, 0.002 inch, 0.003 inch, 0.004 inch, 0.005 inch, about 0.006 inch, about 0.007 inch, about 0.008 inch, about 0.009 inch, about 0.01 inch, less than 0.0005 inch, greater than 0.01 inch, or any range therebetween. In some embodiments, device 10 is comprised of at least two wires of different diameters, the smaller diameter wire being used to fill the gaps between the larger diameter wires and Increases coverage of 10 surfaces. In some embodiments, braid and/or strut joints are left uncoated to avoid the risk of splinters upon fatigue during implantation.
図3Bにおける端面図に見られるように、一端または両端の区画28および30は、中心区画20の表面形状(例えば円筒形状)に一致するように成形してもよい。テーパ付き区画28、30は、軸方向に、そして外周方向に延びて、尖端26、27にそれぞれ終端していてもよく、尖端は、中心区画20の外周に沿って整列する結果、完全に開いた中心管腔40が装置10の軸長の全体を通して後に残り、横切って流れ乱流を生みだすいかなるものストラットもない。妨害のない管腔を有する装置は、装置の血栓形成性を低減させる場合がある。その他の実施形態では、近位尖端26および/または遠位尖端は、中心区画20の断面により画定される管腔40のわずかに半径方向外側に配置してもよい。いくつかの実装では、尖端26、27は、それらが概して共線になるようにして、中心区画20の外周に沿って外周方向に整列させてもよい。いくつかの実装では、装置10は、編み込まれたワイヤから形成してもよく、これは本明細書に別途記載のとおりである。編み込まれたワイヤは、尖端26、27の一つまたは両方で整列させてもよい。整列したワイヤは、一体にまとまった後、遠目には互いに対して平行に延びていて、概して直線の区分を形成してもよい。押し出しワイヤ24は、近位尖端27から近位に配置された近位の直線区分の近位端部に接続されていてもよく、これは例えば、本明細書に別途記載のとおりである。遠位の引き出し区分25は、遠位の直線区分が存在する場合には、その遠位端部に接続されていてもよい、またはそれにより形成されてもよい。 As seen in the end view in FIG. 3B, one or both end sections 28 and 30 may be molded to match the surface shape (eg, cylindrical shape) of central section 20 . The tapered sections 28, 30 may extend axially and circumferentially and terminate in nibs 26, 27, respectively, which are aligned along the circumference of the central section 20 and thus fully open. A central lumen 40 remains behind throughout the axial length of the device 10 without any struts across it to create flow turbulence. A device with an unobstructed lumen may reduce the thrombogenicity of the device. In other embodiments, proximal tip 26 and/or distal tip may be positioned slightly radially outward of lumen 40 defined by the cross-section of central section 20 . In some implementations, the nibs 26, 27 may be circumferentially aligned along the perimeter of the central section 20 such that they are generally collinear. In some implementations, device 10 may be formed from braided wire, as described elsewhere herein. The braided wires may be aligned at one or both of the nibs 26,27. The aligned wires may extend parallel to each other in the distance after being brought together to form generally straight segments. The pusher wire 24 may be connected to the proximal end of a proximal straight section located proximally from the proximal tip 27, eg, as described elsewhere herein. The distal drawer section 25 may be connected to or formed by a distal straight section, if present.
いくつかの実施形態では、近位テーパ付き区画28および/または遠位テーパ付き区画30は、中心区画20より低い密度を有していてもよい。いくつかの実施形態では、装置10の低密度部分は、近位尖端26から、および/または遠位尖端27から、中心区画20内部の場所に(例えば、中間区画22に)延びていてもよい。いくつかの実施形態では、低密度部分は、テーパ付き近位区画28および/またはテーパ付き遠位区画30の全長に延びていなくてもよい。いくつかの実施形態では、装置10は、密度勾配(例えば、近位および/または遠位の端部から中心に向かって連続した、または一定増分ごとの密度増加)を含んでいてもよい。いくつかの実装では、テーパ付き区画28、30は、集中した比較的高密度の領域を(例えば、尖端に)有していてもよいが、中心区画20より低い密度(例えば、平均密度)を概して含んでいてもよい。いくつかの実装では、テーパ付き区画28、30、または装置10の相対的にさらに低い密度を有するように構成されてもよいその他の部分は、全体としてさらに低密度を生み出すパターンとなるように構成されたストラットまたはワイヤを有していてもよい。例えば、ワイヤのピッチは、比較的低密度を有するように構成された装置10の長さに沿って大きく、比較的高密度を有するように構成された装置10の長さに沿って小さくしてもよい。低密度区画(例えば、テーパ付き区画28、30、および/または中心区画20の近位および遠位の端部)は、高密度区画(例えば、中心区画20または中間区画22)より少ない数のストラットとワイヤとを有していてもよい。例えば、中心区画20のすべてのストラットまたはワイヤが、近位尖端26まで続いていないといけないわけではない。装置10の低密度区画の内部の間質間隙は、装置の高密度区画内部の間隙の面積よりも大きい面積を概して有していてもよい。 In some embodiments, proximal tapered section 28 and/or distal tapered section 30 may have a lower density than central section 20 . In some embodiments, the low density portion of device 10 may extend from proximal tip 26 and/or from distal tip 27 to a location within central section 20 (e.g., to intermediate section 22). . In some embodiments, the reduced density portion may not extend the entire length of tapered proximal section 28 and/or tapered distal section 30 . In some embodiments, device 10 may include a density gradient (eg, a continuous or incremental increase in density from the proximal and/or distal ends toward the center). In some implementations, the tapered sections 28, 30 may have concentrated relatively dense regions (e.g., at the apex), but have a lower density (e.g., average density) than the central section 20. may generally include In some implementations, tapered sections 28, 30, or other portions of device 10 that may be configured to have a relatively lower density, are configured in a pattern that produces a lower overall density. may have struts or wires attached. For example, the wire pitch may be larger along the length of device 10 configured to have a relatively low density and smaller along the length of device 10 configured to have a relatively high density. good too. Low density sections (e.g., tapered sections 28, 30, and/or proximal and distal ends of central section 20) have fewer struts than high density sections (e.g., central section 20 or intermediate section 22) and wires. For example, not all struts or wires in central section 20 must continue to proximal tip 26 . The interstitial voids within the low density compartments of device 10 may generally have an area greater than the area of the voids within the high density compartments of the device.
図4A~5Bに装置10の実施形態を例示するが、この装置では、遠位テーパ付き区画30はすべて、完全に取り除いてもよい。図4A~4Cに、片側が開口面となっている装置10の一実施形態を模式的に例示する。図4Aに、装置10の側立面図を示す。遠位端部14は、中央管腔40につながる遠位の開口面31で終わっていてもよい。遠位の開口面31は、装置10の軸長に対して近似的に垂直であってもよい。その他の実施形態では、遠位の開放面31は、装置10の長手方向の軸に対して角度をなしていてもよい。角度は、鋭角または鈍角のいずれかであってもよく、本明細書に別途記載のとおりである。図4Bに、図4Aの装置10の近位斜視図を示す。図4Cに、そうした開いた構成を含む装置10の縁部(例えば、遠位縁部)の詳細な図を示す。図4Cに、装置10の遠位縁部を示すが、この装置では、遠位に延びている各フィラメント(例えば、ストラットまたはワイヤ)が、屈曲して無外傷性の尖端を形成し、そしてその後、中心区画20に沿って近位に延びていてもよい。さらなる実施形態では、装置10の遠位および近位の端部12、14の両方が、取り除かれたテーパ付き区画28、30両方の開口端部と、中心区画20の外周に隣接するまたはこれに直接的に取り付けられた押し出しワイヤ24とを含んでいてもよい。いくつかの実施形態では、押し出しワイヤ24は、装置10の近位端部12から装置の遠位端部14まで、またはその間の場所まで延びていてもよい。好適な実施形態では、装置10のワイヤは、開口端部において折り重ね、そして切断するのではなく装置の中に織り返して、縁部が無外傷性となるようにしてもよく、これは図4Cに示すとおりである。装置縁部を無外傷性にするためにその他の適切な方法も同様に使用してもよい。 4A-5B illustrate an embodiment of the device 10 in which the distal tapered section 30 may be completely eliminated. 4A-4C schematically illustrate one embodiment of the device 10 with an open side on one side. A side elevational view of device 10 is shown in FIG. 4A. Distal end 14 may terminate in a distal open face 31 leading to central lumen 40 . Distal aperture plane 31 may be approximately perpendicular to the axial length of device 10 . In other embodiments, distal open face 31 may be angled with respect to the longitudinal axis of device 10 . The angles may be either acute or obtuse, as described elsewhere herein. FIG. 4B shows a proximal perspective view of the device 10 of FIG. 4A. FIG. 4C shows a detailed view of an edge (eg, distal edge) of device 10 including such an open configuration. FIG. 4C shows the distal edge of device 10, in which each distally extending filament (e.g., strut or wire) is bent to form an atraumatic tip and then , may extend proximally along central section 20 . In further embodiments, both the distal and proximal ends 12, 14 of the device 10 are adjacent to or on the open ends of both removed tapered sections 28, 30 and the outer periphery of the central section 20. A directly attached pusher wire 24 may also be included. In some embodiments, the pusher wire 24 may extend from the proximal end 12 of the device 10 to the distal end 14 of the device, or anywhere in between. In a preferred embodiment, the wires of device 10 may be folded over at the open end and woven back into the device rather than cut so that the edges are atraumatic, which is shown in FIG. As shown in 4C. Other suitable methods for atraumaticizing device edges may be used as well.
装置10の物理的設計によっては、特に、それが自然な血流を妨害するようにして、その生体適合性に影響する場合がある。血小板の活性化は、血液が装置10の端から端まで流れる際に血小板の受けるストレスを減少させると低減される場合がある。血液が流れる際にそれが遭遇する装置材料の量(すなわち装置により占められる血管断面の割合)だけでなく、装置が血流と界面をなす角度(脱出角)の両方が、血小板の受けるストレス、およびその結果として生じる活性化に影響することになる。いくつかの実施形態では、装置全体を流れる血小板の受けるストレスは、以下の方程式に従って近似的にモデル化することができ、ここでΔPは、押し出しワイヤ24から装置10の中心区画20の開始点までの装置10の近位区画(例えばテーパ付き近位区画28)の両端の圧力差を表し;ρは流体密度を表し;φは装置10により消費される断面領域の割合(すなわち流路)を表し;θは、取り出し角であって、0°は、装置ワイヤまたはストラットが血管および/または血流の方向に完全に平行であることを表し、そして90°は、装置ワイヤまたはストラットが血管および/または血流の方向に対して完全に垂直であることを表し;Uは流体速度を表し;Rはワイヤまたはストラットの半径を表し;そしてμは流体粘度を表す: The physical design of the device 10 can affect its biocompatibility, especially by causing it to interfere with natural blood flow. Platelet activation may be reduced by reducing the stress that platelets experience as blood flows across device 10 . Both the amount of device material it encounters as the blood flows (i.e., the percentage of the vessel cross-section occupied by the device), as well as the angle at which the device interfaces with the blood flow (escape angle), affect the stress that the platelets experience, and the resulting activation. In some embodiments, the stress experienced by platelets flowing throughout the device can be approximately modeled according to the following equation, where ΔP is from the pusher wire 24 to the starting point of the central section 20 of the device 10: represents the pressure difference across the proximal section of device 10 (e.g., tapered proximal section 28) of device 10; ρ represents fluid density; θ is the take-off angle, 0° representing that the device wire or strut is perfectly parallel to the direction of the vessel and/or blood flow, and 90° representing that the device wire or strut is or perfectly perpendicular to the direction of blood flow; U represents the fluid velocity; R represents the radius of the wire or strut ; and μ represents the fluid viscosity:
よって、所与のサイズのワイヤまたはストラットから構築された装置に対する上記方程式では、圧力差は、取り出し角、θ、および/または流路中の装置の割合、φのいずれかを調節することにより変更してもよい。図7Aに、x軸にプロットされたφの範囲にわたり一定のθ(ここでは20°)について、血小板の受ける相対的なストレス(ΔPに比例)をy軸に図示する。図7Bには、逆に、x軸にプロットされた流路中の装置の割合の範囲にわたり一定のφ(ここでは0.08)について、血小板の受ける相対的なストレス(ΔPに比例)をy軸に図示する。いくつかの実施形態では、装置10は、装置の内部で充分な安定性を維持しつつ、可能な限りゼロに近いθ値を有する。制限なしに、θ値は、例えば、約85度またはそれ以下、80度、75度、65度、60度、55度、50度、45度、40度、35度、30度、20度、15度、10度、5度、85度超、または5度未満であってもよい。いくつかの実施形態では、θ値は、少なくとも約10度、15度、30度、45度、50度、60度、または80度であってもよい。いくつかの実施形態では、θ値(取り出し角)は、充分な構造的高品質性を提供して血栓形成を最低限にするには、約30~80度、約40~70度、約50~60度、またはそれらの間の範囲の間にあると最適な場合がある。近位区画(例えば、テーパ付き近位区画30)は、さらに小さい取り出し角を含む装置10についてはさらに長い長さを含んでいてもよい。いくつかの実施形態では、近位区画(例えば、テーパ付き近位区画28)の長さおよび/または遠位区画(例えば、テーパ付き遠位区画30)の長さは、約1cm、2cm、3cm、4cm、5cm、6cm、7cm、8cm、9cm、10cm、11cm、12cm、13cm、14cm、15cm、20cm、25cm、30cm、35cm、40cm、45cm、50cm、1cm未満、50cm超、またはそれらの間のあらゆる範囲の長さであってもよい。いくつかの実施形態では、近位区画(例えば、テーパ付き近位区画28)の長さ、および/または遠位区画(例えば、テーパ付き遠位区画30)の長さは、中心区画20の長さの約5%、10%、15%、20%、25%、30%、40%、50%、60%、70%、80%、90%、100%、5%未満、100%超、またはそれらの間で画定された範囲内の長さであってもよい。 Thus, in the above equation for a device constructed from wires or struts of a given size, the pressure difference is varied by adjusting either the take-off angle, θ, and/or the fraction of the device in the channel, φ. You may FIG. 7A illustrates on the y-axis the relative stress experienced by platelets (proportional to ΔP) for a constant θ (here 20°) over the range of φ plotted on the x-axis. Conversely, FIG. 7B plots the relative stress experienced by platelets (proportional to ΔP) for a constant φ (here 0.08) over the range of fractions of devices in the channel plotted on the x-axis. illustrated on the axis. In some embodiments, device 10 has a θ value as close to zero as possible while maintaining sufficient stability within the device. Without limitation, the θ values can be, for example, about 85 degrees or less, 80 degrees, 75 degrees, 65 degrees, 60 degrees, 55 degrees, 50 degrees, 45 degrees, 40 degrees, 35 degrees, 30 degrees, 20 degrees, It may be 15 degrees, 10 degrees, 5 degrees, more than 85 degrees, or less than 5 degrees. In some embodiments, the θ value may be at least about 10 degrees, 15 degrees, 30 degrees, 45 degrees, 50 degrees, 60 degrees, or 80 degrees. In some embodiments, the theta value (take-off angle) is about 30-80 degrees, about 40-70 degrees, about 50 degrees to provide sufficient structural quality and minimize thrombus formation. ~60 degrees, or any range therebetween, may be optimal. A proximal section (eg, tapered proximal section 30) may include a longer length for devices 10 that include a smaller take-off angle. In some embodiments, the length of the proximal section (eg, tapered proximal section 28) and/or the length of the distal section (eg, tapered distal section 30) is about 1 cm, 2 cm, 3 cm. , 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 20 cm, 25 cm, 30 cm, 35 cm, 40 cm, 45 cm, 50 cm, less than 1 cm, greater than 50 cm, or between Any range of lengths is possible. In some embodiments, the length of the proximal section (eg, tapered proximal section 28) and/or the length of the distal section (eg, tapered distal section 30) is the length of central section 20. about 5%, 10%, 15%, 20%, 25%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, less than 5%, greater than 100%, or any length within a defined range therebetween.
押し出しワイヤ24は好ましくは、充分な構造的高品質性を伴って植え込み物10に接続され、留置鞘の中に植え込み物10を引き戻すために、押し出しワイヤ24の近位の退縮を可能にする。近位区画28における、少なくとも一つ、または二つ、または四つ、または六つ、またはさらなるストラットが、中心区画20の織りを構成するフィラメントの断面領域より大きい断面領域を有していてもよい。これらの補強用ストラットは、中心区画20のフィラメントに直接的にまたは間接的に結合されていてもよく、その結果、さらに大きい面積に押力が分配されて、はずれるリスクは低減する。代わりに、押し出しワイヤ24は、植え込み装置10の長さ全体を通して軸方向に延びていてもよく、そしてさらに延びて、引き出し区分25を形成してもよい。装置10のチューブ本体は、テーパ付き近位区画28およびテーパ付き遠位区画30両方において押し出しワイヤ24に、そして随意に中心区画20の長さに沿って、結合されていてもよい。 The pusher wire 24 is preferably connected to the implant 10 with sufficient structural integrity to allow proximal retraction of the pusher wire 24 to pull the implant 10 back into the indwelling sheath. At least one, or two, or four, or six, or more struts in the proximal section 28 may have a cross-sectional area greater than the cross-sectional area of the filaments that make up the weave of the central section 20. . These reinforcing struts may be directly or indirectly bonded to the filaments of the central section 20 so that the pushing force is distributed over a larger area and the risk of disengagement is reduced. Alternatively, pusher wire 24 may extend axially through the entire length of implant device 10 and may extend further to form puller section 25 . The tubing body of device 10 may be coupled to pusher wire 24 at both tapered proximal section 28 and tapered distal section 30 and optionally along the length of central section 20 .
いくつかの実施形態では、装置10は、編み込まれたワイヤからではなく従来のステントと同様にして形成してもよい。実例としては、装置10は、金属性のチューブをレーザ切断してストラットを形成することにより作製してもよく、これは本明細書に別途記載のとおりである。さらなる実施形態では、装置は、ステント構造と編み込まれたワイヤの両方から作製してもよい。編み込まれたワイヤは、ステント構造にレーザ溶接してもよく、安定性が増大し、その上にさらに自由な設計が可能になる。いくつかの実施形態では、中心区画20および/または中間区画22(比較的さらに高密度であってもよい区画)は、編み込まれたワイヤから主に成っており、その一方で、近位および遠位の低密度区画は、金属チューブから作製される。 In some embodiments, device 10 may be formed similar to conventional stents rather than from braided wires. Illustratively, device 10 may be fabricated by laser cutting a metallic tube to form struts , as described elsewhere herein. In further embodiments, the device may be made from both stent structures and braided wires. The braided wires may be laser welded to the stent structure to increase stability and allow more design freedom as well. In some embodiments, the central section 20 and/or the intermediate section 22 (which may be relatively denser) consist primarily of braided wires, while the proximal and distal The lower density compartments are made from metal tubes.
いくつかの実施形態では、装置10は、個々のストラット上に、コーティングに加えて、またはその代わりに、チューブ状のスリーブ60を備えていてもよい。いくつかの実施形態では、コーティングを、装置10の部分を完全にまたは部分的に覆うように施して、スリーブ60または部分的なスリーブを形成してもよい。図11Aに、装置10へのスリーブ60の施しを模式的に図示する。スリーブ60および/または間質コーティングは、動脈瘤の内部にコイルを固定するのに役立つ働きをする場合がある、および/または装置10に抗血栓性の、またはそうでなければ生体適合性の表面を与える場合がある。スリーブ60および/または間質コーティングは、自然な血流が途絶するのを、例えばメッシュ装置10の間質間隙を通る血流を防ぐことにより、最低限にする場合がある。スリーブ60および/またはコーティングは、さらに血栓形成性の少ないさらに堅牢な流れ分散装置に役立つ場合がある。スリーブ60および/またはコーティングは、動脈瘤頸部を覆うように施すと、有益である場合がある。スリーブ60および/またはコーティングを用いて動脈瘤を血管の血流から閉塞するまたは部分的に閉塞することにより、動脈瘤の断裂/破裂を防げる場合がある、および/または動脈瘤が実際に破裂する事象での血液損失が減少する場合がある。 In some embodiments, device 10 may include tubular sleeves 60 on individual struts in addition to or instead of coatings. In some embodiments, the coating may be applied completely or partially over portions of device 10 to form sleeve 60 or a partial sleeve. FIG. 11A schematically illustrates the application of sleeve 60 to device 10 . The sleeve 60 and/or the stromal coating may serve to help secure the coil within the aneurysm and/or provide an antithrombotic or otherwise biocompatible surface to the device 10. may give The sleeve 60 and/or the interstitial coating may minimize disruption of natural blood flow, eg, by preventing blood flow through the interstitial spaces of the mesh device 10 . The sleeve 60 and/or coating may contribute to a less thrombogenic and more robust flow distribution device. A sleeve 60 and/or coating may be beneficial when applied over the aneurysm neck. Occluding or partially occluding the aneurysm from vascular blood flow with the sleeve 60 and/or coating may prevent rupture/rupture of the aneurysm and/or the aneurysm actually ruptures. Blood loss in the event may be reduced.
スリーブ60は、例えば、フッ素化したエチレンプロピレン(FEP)、ポリテトラフルオロエチレン(PTFE)、ポリフッ化ビニリデン(PVDF)、またはポリ(フッ化ビニリデンコヘキサフルオロプロピレン)(PVDF-HFP)コポリマー類を含め、フルオロポリマー(例えば、高度に弾性のフルオロポリマーまたはフルオロエラストマー)などのポリマー性材料から形成してもよい。いくつかの実施形態では、スリーブは、ポリジメチルシロキサン(PDMS)、または先に言及したフルオロポリマー類の一つなどの別のポリマーと混合されたPDMSを含んでいてもよい。例えば、PDMSは、PVDF-HFPと混合して基層を形成し、これを随意にPVDF-HFPの別の層でコーティングしてもよい。PDMSは、適切な柔軟性を装置コーティングに与える場合がある。その他の適切なシリコーン類(例えば、シラスティック)もまた同様に使用してもよい。いくつかの実施形態では、スリーブ60および/または装置10のメッシュの間質間隙に施したコーティングは、高い弾性材料(例えば、フルオロエラストマー)を含むことになる。スリーブ60および/またはコーティングの弾性特性は、有利には、スリーブ60および/またはコーティングを破壊する、破裂させる、引き裂く、またはそうでなければ損傷させることなく、装置10を拡張させる場合がある。図11Bに、ストラットの間に延びている相対的に拡張していない構成での装置10の一方の側に施したPDMSのコーティングを含む装置10のメッシュの詳細な画像を図示する。図11Cに、相対的に拡張した構成での装置10の一方の側に施したPDMSのコーティングを含む装置10のメッシュの詳細な画像を図示する。図11Cに見られるように、PDMSコーティングは、コーティングを損傷させる、またはコーティングを装置10からはぎとることなく、引き伸ばされる場合がある。 Sleeve 60 may include, for example, fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), or poly(vinylidene fluoride cohexafluoropropylene) (PVDF-HFP) copolymers. , fluoropolymers (eg, highly elastic fluoropolymers or fluoroelastomers). In some embodiments, the sleeve may comprise polydimethylsiloxane (PDMS) or PDMS mixed with another polymer such as one of the fluoropolymers mentioned above. For example, PDMS may be mixed with PVDF-HFP to form a base layer, which is optionally coated with another layer of PVDF-HFP. PDMS may provide suitable flexibility for device coatings. Other suitable silicones (eg, Silastic) may be used as well. In some embodiments, the coating applied to the interstitial spaces of the sleeve 60 and/or the mesh of the device 10 will comprise a highly elastic material (eg, fluoroelastomer). The elastic properties of sleeve 60 and/or coating may advantageously allow device 10 to expand without rupturing, rupturing, tearing or otherwise damaging sleeve 60 and/or coating. FIG. 11B illustrates a detailed image of the mesh of device 10 including a coating of PDMS applied to one side of device 10 in a relatively unexpanded configuration extending between struts . FIG. 11C illustrates a detailed image of the mesh of device 10 including a coating of PDMS on one side of device 10 in a relatively expanded configuration. As seen in FIG. 11C, the PDMS coating may be stretched without damaging the coating or stripping the coating from device 10 .
スリーブ60を、中央管腔40を取り巻く装置10の内部表面に、装置10の外面に、または内部表面および外面の両方に施してもよい(例えば、担持されてもよい)。内側および外側のスリーブ60A、60Bは、もし両方に施す場合であれば、同一のまたは異なる材料、長さ、厚さ、および/またはその他の特性から出来ていてもよく、そして二つのスリーブ60A、60Bの間に側壁のストラットを挟みこんでいてもよい。いくつかの実施形態では、内径は、装置10の外径よりもさらに厚いコーティング、またはさらに数の多いコーティングを含んでいてもよい。内径は、外径よりも滑かな表面を形成するためにコーティングされていてもよい。これは、さらに厚い、および/または複数のコーティングにより実現される。滑かな表面ほど、血栓形成の少ない表面を与える場合がある。 Sleeve 60 may be applied to (eg, carried by) the inner surface of device 10 surrounding central lumen 40, the outer surface of device 10, or both the inner and outer surfaces. The inner and outer sleeves 60A, 60B, if applied to both, may be made of the same or different materials, lengths, thicknesses, and/or other properties, and the two sleeves 60A, 60B A sidewall strut may be sandwiched between 60B. In some embodiments, the inner diameter may include a thicker coating, or a greater number of coatings, than the outer diameter of device 10 . The inner diameter may be coated to create a smoother surface than the outer diameter. This is accomplished with thicker and/or multiple coatings. A smoother surface may provide a less thrombogenic surface.
特許請求の範囲は、上に例示された正確な構成および構成要素に制限されないことは理解されるものとする。様々な修正、変更、および変形は、上記の方法および装置の、編成、動作、および詳細において行ってもよい。
本発明は、以下の発明を含む。
[1]血管管腔の中に挿入して動脈瘤を治療する装置であって、
複数のストラットを含む概して円筒形のメッシュ区画であって、前記ストラットが、前記ストラット間に間質間隙を形成し、近位面および遠位面を有し、かつ前記近位面から前記遠位面まで軸方向に沿って延びる装置管腔を画定し、前記管腔が前記装置に血流を通すように構成される、メッシュ区画と、
前記近位面の外周から近位尖端まで延びる複数のストラットを含む近位テーパ付き区画と、を備え、
前記近位尖端が、半径方向に前記近位面の外周と整列し、または前記近位面の前記外周の半径方向外側に配置され、
前記近位テーパ付き区画の複数の前記ストラットは、前記複数の前記ストラットがいずれも前記装置管腔により画定された断面領域を横断しないように、前記近位面の前記外周上の異なる場所から前記近位尖端まで、軸方向および外周方向に延びる、装置。
[2]前記概して円筒形のメッシュ区画の複数のストラットが、編み込まれたワイヤから形成される、上記[1]に記載の装置。
[3]前記近位テーパ付き区画の複数のストラットが、前記概して円筒形のメッシュ区画の編み込まれたワイヤから形成される、上記[2]に記載の装置。
[4]前記編み込まれたワイヤが、前記近位テーパ付き区画の内部で少なくとも部分的に編み込まれる、上記[2]または[3]に記載の装置。
[5]前記複数のストラットの一つまたは複数が、前記近位テーパ付き区画の内部で反転させられ、前記反転したストラットの一つまたは複数が、前記近位のテーパ付き区画の内部で半径方向外向きおよび前記近位尖端に向かって屈曲するように、かつ前記近位尖端が、前記近位面の前記外周の半径方向外側に配置されるようにする、上記[1]ないし[4]のいずれか一項に記載の装置。
[6]前記複数のストラットが、前記近位尖端からまたはその近傍から延び、かつ流入する血流と界面をなすように構成された前記近位面の前記外周まで延びる縁部を形成しており、かつ前記縁部が、前記軸方向寸法に平行に前記近位尖端を通って延びる長手方向の軸に対する取り出し角を画定し、前記取り出し角が、約80度以下である、上記[1]ないし[5]のいずれか一項に記載の装置。
[7]前記取り出し角が約70度以下である、上記[6]に記載の装置。
[8]前記取り出し角が少なくとも約30度である、上記[6]または[7]に記載の装置。
[9]前記取り出し角が少なくとも約40度である、上記[8]に記載の装置。
[10]前記装置が、前記近位面の外径により画定される、約0.2以下である断面領域の割合を占める、上記[1]ないし[9]のいずれか一項に記載の装置。
[11]前記割合が約0.1以下である、上記[10]に記載の装置。
[12]前記割合が約0.05以下である、上記[11]に記載の装置。
[13]前記割合が約0.01以下である、上記[12]に記載の装置。
[14]前記近位テーパ付き区画の前記複数のストラットおよび前記概して円筒形のメッシュ区画が、約0.01インチ以下の直径を有する、上記[1]ないし[13]のいずれか一項に記載の装置。
[15]前記近位テーパ付き区画の前記複数のストラットおよび前記概して円筒形のメッシュ区画が、約0.005インチ以下の直径を有する、上記[14]に記載の装置。
[16]前記概して円筒形のメッシュ区画が、前記動脈瘤に隣接して位置するように構成された中央区画を含み、前記中央区画が、前記概して円筒形のメッシュ区画の残りの少なくとも一部分よりも実質的に高ストラット密度を含む、上記[1]ないし[15]のいずれか一項に記載の装置。
[17]前記中央区画が、拘束のない構成において前記近位面の外径より大きい外径を含む、[16]に記載の装置。
[18]前記高ストラット密度が、前記概して円筒形のメッシュ区画の低密度部分におけるよりも小さいピッチの編み込まれたワイヤの結果である、上記[16]または[17]に記載の装置。
[19]前記高ストラット密度が、前記概して円筒形のメッシュ区画の低密度部分とは異なる織りパターンの結果である、上記[16]ないし[18]のいずれか一項に記載の装置。
[20]前記中央区画が、差し渡し約0.01インチ以下の間質間隙を含む、上記[16]ないし[19]のいずれか一項に記載の装置。
[21]前記中央区画が、差し渡し約0.008インチ以下の間質間隙を含む、上記[20]に記載の装置。
[22]前記概して円筒形のメッシュ区画が、前記概して円筒形のメッシュ区画の中央近傍の半径方向外向きの圧縮反力よりも大きい、前記近位面に隣接する半径方向外向きの圧縮反力を与えるように構成される、上記[1]ないし[21]のいずれか一項に記載の装置。
[23]前記遠位面の外周から遠位尖端まで延びている複数のストラットを含む遠位テーパ付き区画をさらに含み、
前記遠位尖端が、半径方向に前記遠位面の前記外周と整列し、または前記遠位面の前記外周の半径方向外側に配置され、
前記遠位テーパ付き区画の前記複数のストラットは、前記複数のストラットがいずれも、前記装置管腔により画定された断面領域を横断しないように、前記遠位面の前記周上の異なる場所から前記遠位尖端まで、軸方向および外周方向に延びる、上記[1]ないし[22]のいずか一項に記載の装置。
[24]前記遠位テーパ付き部分からの前記複数のストラットが、前記近位尖端から遠位に位置する放射線不透過性のマーカー環を通って延びている、上記[23]に記載の装置。
[25]前記遠位テーパ付き部分からの前記複数のストラットが、前記遠位尖端に遠位となるようにして平行に整列して、遠位引き出し区分を形成する、上記[23]または[24]に記載の装置。
[26]前記遠位引き出し区分の周りに配置された金属性ヘリカルコイルをさらに含む、上記[25]に記載の装置。
[27]前記金属性ヘリカルコイルが白金またはイリジウムを含む、上記[26]に記載の装置。
[28]前記遠位面が開口しており、前記軸方向に対して実質的に垂直である、上記[1]ないし[22]のいずれか一項に記載の装置。
[29]前記開口した遠位面が、前記概して円筒形のメッシュ区画の内部の前記複数のストラットの内部に、無外傷性屈曲により形成された周縁部を含む、上記[28]に記載の装置。
[30]前記近位テーパ付き区画の内部の前記複数のストラットが、前記近位面の前記外周の周りに実質的に均一に分配される、上記[1]ないし[29]のいずれか一項に記載の装置。
[31]前記近位尖端と共線関係にある押し出しワイヤをさらに含む、上記[1]ないし[30]のいずれか一項に記載の装置。
[32]前記近位テーパ付き区画の内部の前記複数のストラットが、前記近位尖端に近位に平行となるようにして整列し、前記複数のストラットの近位端部が、前記押し出しワイヤの遠位端部に接合されており、前記複数のストラットが、前記押し出しワイヤの外周の周りに実質的に均一に分配される、上記[31]に記載の装置。
[33]前記押し出しワイヤが、前記近位テーパ付き区画に永久に接合される、上記[31]ないし[32]のいずれか一項に記載の装置。
[34]前記押し出しワイヤが、前記近位テーパ付き区画に取り外し可能に接合される、上記[31]または[32]に記載の装置。
[35]前記押し出しワイヤの前記遠位端部が、テーパ付き部分を含む、上記[31]ないし[34]のいずれか一項に記載の装置。
[36]前記押し出しワイヤの前記遠位端部が、前記押し出しワイヤを取り巻く複数のプラスチック環を含み、前記近位テーパ付き区画からの前記複数のストラットの近位端部が前記プラスチック環を取り巻く、上記[22]ないし[35]のいずれか一項に記載の装置。
[37]前記複数のプラスチック環が、互いから少なくとも約1cm離れて軸方向に沿って離間している、上記[36]に記載の装置。
[38]前記近位テーパ付き部分からの前記複数のストラットが、前記近位尖端に近位に位置する放射線不透過性のマーカー環を通って延びている、上記[1]ないし[37]のいずれか一項に記載の装置。
[39]前記装置が、収縮した構成および拡張した構成を含み、前記装置が、前記拡張した構成よりも前記収縮した構成において、前記近位尖端から前記装置の遠位端部までのさらに長軸長さ、および装置管腔の小径を有する、上記[1]から[38]のいずれか一項に記載の装置。
[40]前記概して円筒形のメッシュ区画の前記複数のストラット、および前記近位テーパ付き区画が、形状記憶材料を含み、前記装置が、記憶された形状として前記拡張した構成を呈するように構成される、上記[39]に記載の装置。
[41]前記装置管腔の少なくとも一部分の周りに配置されたポリマースリーブをさらに含む、上記[1]ないし[40]のいずれか一項に記載の装置。
[42]前記スリーブが、前記概して円筒形のメッシュ区画の内径に施される、上記[41]に記載の装置。
[43]前記スリーブが、前記概して円筒形のメッシュ区画の外径に施される、上記[41]または[42]に記載の装置。
[44]前記スリーブが内層および外層を含み、前記概して円筒形の区画の少なくとも一部分が、前記内層と前記外層の間に挟まれている、上記[41]ないし[43]のいずれか一項に記載の装置。
[45]前記内層および外層が、前記間質間隙の少なくともいくつかの内部で一体に結合されている、上記[44]に記載の装置。
[46]前記スリーブが、前記スリーブの近位端部の近傍および前記スリーブの遠位端部の近傍に配置されるが前記スリーブの中央区画の内部には配置されない開口を含む、上記[41]ないし[45]のいずれか一項に記載の装置。
[47]前記スリーブがフルオロエラストマーを含む、上記[41]ないし[46]のいずれか一項に記載の装置。
[48]前記スリーブが、フッ素化エチレンプロピレン(FEP)、ポリテトラフルオロエチレン(PTFE)、ポリフッ化ビニリデン(PVDF)、またはポリ(塩化ビニリデンコヘキサフルオロプロピレン)(PVDF-HFP)を含む、上記[41]ないし[47]のいずれか一項に記載の装置。
[49]前記スリーブがシラスティック(silastic)を含む、上記[41]ないし[48]のいずれか一項に記載の装置。
[50]前記スリーブがポリジメチルシロキサン(PDMS)を含む、上記[49]に記載の装置。
[51]前記スリーブが、A:B:Aトリブロックコポリマーを含み、前記Aブロックが、テトラフルオロエチレン(TFE)、エチレン、およびヘキサフルオロプロピレン(HFP)を含み、前記Bブロックが、フッ化ビニリデン(VDF)、ヘキサフルオロプロピレン(HFP)、およびテトラフルオロエチレン(TFE)を含む、上記[41]ないし[50]のいずれか一項に記載の装置。
[52]前記スリーブが、ポリビニルピロリドン(PVP)、ホスホリルコリン(PC)、ポリエチレングリコール(PEG)、セリーン(商標)、PEG化した分子、またはフッ素化した分子で含侵され、またはコーティングされて、抗血栓性の表面を与える、上記[41]ないし[51]のいずれか一項に記載の装置。
[53]前記概して円筒形の区画の前記複数のストラットが、コーティング材料でコーティングされている、上記[1]ないし[52]のいずれか一項に記載の装置。
[54]前記コーティング材料が、プラズマ堆積させたフッ素、プラズマ堆積させたグライム(glyme)、ホスホリルコリン、ダイヤモンド状炭素、フッ素化したダイヤモンド状炭素、ポリビニルピロリドン(PVP)、フッ素化エチレンプロピレン(FEP)、ポリテトラフルオロエチレン(PTFE)、ポリフッ化ビニリデン(PVDF)、ポリ(フッ化ビニリデンコヘキサフルオロプロピレン)(PVDF-HFP)、フルオロホスファゼン、カルボシキベタイン、スルホベタイン、メタクリル化したカルボキシベタイン、メタクリル化したスルホベタイン、フルオロシラン、ヘパリンまたはヘパリン状分子;ヒルジン;クルクミン;トロンボモジュリン;プロスタサイクリン;DMP728血小板GPIIb/IIIa拮抗薬;キトサン、硫酸化キトサン;ヒアルロン酸;タンタルをドープした酸化チタン;酸窒化物、酸化物層、または炭化ケイ素を含む、上記[53]に記載の装置。
[55]前記複数のストラットと前記コーティング材料との間にポリn-ブチルメタクリレート(PBMA)、またはポリ(p-キシリレン)ポリマーの下地材層を含む、上記[53]または[54]に記載の装置。
[56]前記コーティング材料が、前記間質間隙の少なくとも一部分を完全に覆う、上記[53]ないし[55]のいずれか一項に記載の装置。
[57]前記コーティング材料が、前記間質間隙の一部分を覆っており、前記部分は、前記動脈瘤の頚部を前記部分が覆うようにして、動脈瘤に隣接して配置されるように構成される、上記[56]に記載の装置。
[58]前記コーティング材料が、前記間質間隙の交互の列を覆う、上記[56]に記載の装置。
[59]前記装置管腔が、内径を有する内面および外径を有する外面を含み、かつ前記コーティングが、前記内面に施された第1のコーティングおよび前記外面に施された第2のコーティングを含み、前記第1および前記第2のコーティングが、明確に異なる生物学的特性を有する、上記[53]ないし[58]のいずれか一項に記載の装置。
[60]前記装置が、前記第1のコーティングが、主に血栓形成を低減するように設計され、かつ前記第2のコーティングが、主に内皮化を促進するように設計される、上記[59]に記載の装置。
[61]前記コーティングが、前記装置管腔と整列した方向に、前記装置の長さに沿って少なくとも一つの生物学的特性に勾配を形成する、上記[53]ないし[60]のいずれか一項に記載の装置。
[62]前記勾配が、少なくとも前記近位面から前記概して円筒形のメッシュ区画の前記中央に向かって延び、かつその後、前記概して円筒形のメッシュ区画の前記中央から前記遠位面に向かって反転する、上記[61]に記載の装置。
[63]前記少なくとも一つの生物学的特性が、内皮化の促進であり、内皮化が、前記近位面および前記遠位面の近傍よりも前記概して円筒形のメッシュ区画の前記中央に向かってさらに促進される、上記[62]に記載の装置。
[64]前記少なくとも一つの生物学的特性が、血栓形成の低減であり、血栓形成が、前記概して円筒形のメッシュ区画の前記中央よりも前記近位面および前記遠位面に向かってさらに低減される、上記[62]に記載の装置。
[65]前記少なくとも一つの生物学的特性が、血栓形成の低減および内皮化の促進を含み、内皮化の促進が減少するにつれ前記血栓形成の低減が増加する、上記[62]に記載の装置。
[66]前記勾配が、前記装置の前記長さに沿って変動する加工条件に従って前記装置の前記表面に前記コーティングを施すことにより形成される、上記[61]ないし[65]のいずれか一項に記載の装置。
[67]前記勾配が、前記装置の前記長さに沿って前記コーティングの組成を変動させることにより形成される、上記[61]ないし[65]のいずれか一項に記載の装置。
[68]前記編み込まれたワイヤが少なくとも24本のワイヤを含む、上記[2]ないし[67]のいずれか一項に記載の装置。
[69]前記編み込まれたワイヤが少なくとも48本のワイヤを含む、上記[68]に記載の装置。
[70]前記概して円筒形の区画の前記複数のストラットが、ニチノール、DFT(登録商標)、白金、コバルトクロム、ステンレス鋼、フルオロポリマー、ポリエチレン、ポリウレタン、ポリエーテルブロックアミド、または形状記憶ポリマーを含む、上記[1]ないし[69]のいずれか一項に記載の装置。
[71]前記概して円筒形の区画の前記複数のストラットが、ポリテトラフルオロエチレン(PTFE)、ポリフッ化ビニリデン(PVDF)、ポリビニリデン-ヘキサフルオロプロピレン(PVDF-HFP)、ペルフルオロプロピレン、オクタフルオロプロパン、パリレンHT(Parylene HT)、パリレンAF-4、パリレンF、パリレンVT-4;1H,1H,2H,2H-ペルフルオロドデシルトリクロロシラン、(トリデカフルオロ-1,1,2,2,テトラヒドロオクチル)シラン、ヘキサデカフルオロデク(hexadecafluordodec)-11-エン-1-イルトリメトキシシラン、またはポリ(p-キシリレン)ポリマーでコーティングされる、上記[70]に記載の装置。
[72]前記近位尖端が、前記近位面の前記外周の半径方向外側に配置される、上記[1]ないし[71]のいずれか一項に記載の装置。
[73]血管管腔の中に挿入して動脈瘤を治療する装置であって、
近位端部および遠位端部であって、前記遠位端部が前記近位端部よりも血管管腔の下流に位置する、近位端部および遠位端部と;
装置表面と;
前記装置表面に施されたコーティングと、を含み、前記コーティングが、前記装置表面上での血栓形成を低減させるように、かつ前記装置表面での内皮化を促進するように設計される、装置。
[74]前記装置が前記血管管腔と整列した管腔を形成し、前記管腔が、内径を有する内面および外径を有する外面を含み、かつ前記コーティングが、前記内面に施された第1のコーティングおよび前記外面に施された第2のコーティングを含み、前記第1および第2のコーティングが、明確に異なる生物学的特性を有する、上記[73]に記載の装置。
[75]前記第1のコーティングが主に血栓形成を低減するように設計され、前記第2のコーティングが主に内皮化を促進するように設計される、上記[74]に記載の装置。
[76]前記コーティングが、前記管腔と整列した前記装置の長さに沿って、少なくとも一つの生物学的特性に勾配を形成する、上記[71]ないし[74]のいずれか一項に記載の装置。
[77]前記勾配が、前記近位端部から前記装置の前記中央に向かって延び、かつその後、前記装置の前記中央から前記遠位端部に向かって反転する、上記[76]に記載の装置。
[78]前記少なくとも一つの生物学的特性が、内皮化の促進であり、内皮化が、前記近位端部および前記遠位端部よりも前記装置の前記中央に向かってさらに促進される、上記[77]に記載の装置。
[79]前記少なくとも一つの生物学的特性が、血栓形成の低減であり、血栓形成が、前記装置の前記中央よりも前記近位端部および前記遠位端部に向かって低減される、上記[77]に記載の装置。
[80]前記少なくとも一つの生物学的特性が、血栓形成の低減および内皮化の促進を含み、前記血栓形成の低減が、前記内皮化の促進が減少するにつれ増加する、上記[77]に記載の装置。
[81]前記勾配が、前記装置の長さに沿って変動する加工条件に従って前記装置の前記表面に前記コーティングを施すことにより形成される、上記[76]ないし[80]のいずれか一項に記載の装置。
[82]前記勾配が、前記装置の前記長さに沿って前記コーティングの組成を変動させることにより形成される、上記[76]ないし[80]のいずれか一項に記載の装置。
[83]前記コーティングが、プラズマ堆積させたフッ素、プラズマ堆積させたグライム、ホスホリルコリン、ダイヤモンド状炭素、フッ素化したダイヤモンド状炭素、ポリビニルピロリドン(PVP)、フッ素化したエチレンプロピレン(FEP)、ポリテトラフルオロエチレン(PTFE)、ポリフッ化ビニリデン(PVDF)、ポリ(フッ化ビニリデンコヘキサフルオロプロピレン)(PVDF-HFP)、フルオロホスファゼン、カルボシキベタイン、スルホベタイン、メタクリル化したカルボキシベタイン、メタクリル化したスルホベタイン、フルオロシラン、ヘパリンまたはヘパリン状分子;ヒルジン;クルクミン;トロンボモジュリン;プロスタサイクリン;DMP728血小板GPIIb/IIIa拮抗薬;キトサン、硫酸化キトサン;ヒアルロン酸;タンタルをドープした酸化チタン;酸窒化物、酸化物層、および炭化ケイ素からなる群から選択される少なくとも一つの材料を含む、上記[73]ないし[82]のいずれか一項に記載の装置。
[84]前記コーティングが、プラズマ堆積させたフッ素、プラズマ堆積させたグライム、ホスホリルコリン、ダイヤモンド状炭素、フッ素化したダイヤモンド状炭素、ポリビニルピロリドン(PVP)、フッ素化したエチレンプロピレン(FEP)、ポリテトラフルオロエチレン(PTFE)、ポリフッ化ビニリデン(PVDF)、ポリ(フッ化ビニリデンコヘキサフルオロプロピレン)(PVDF-HFP)、フルオロホスファゼン、カルボシキベタイン、スルホベタイン、メタクリル化したカルボキシベタイン、メタクリル化したスルホベタイン、フルオロシラン、ヘパリンまたはヘパリン状分子;ヒルジン;クルクミン;トロンボモジュリン;プロスタサイクリン;DMP728血小板GPIIb/IIIa拮抗薬;キトサン、硫酸化キトサン;ヒアルロン酸;タンタルをドープした酸化チタン;酸窒化物、酸化物層、および炭化ケイ素の群からから選択される少なくとも二つの材料を含む、上記[73]ないし[83]のいずれか一項に記載の装置。
[85]血管の管腔内に挿入して動脈瘤を治療する装置であって、
前記血管管腔と整列するように構成された管腔を有する概して円筒形の区画、および
前記管腔の両端に配置された近位端部および遠位端部、を含み、
前記装置が、編み込まれたワイヤから形成される、装置。
[86]前記編み込まれたワイヤが、少なくとも24本のワイヤを含む、上記[85]に記載の装置。
[87]前記編み込まれたワイヤが、少なくとも48本のワイヤを含む、上記[85]または[86]に記載の装置。
[88]前記編み込まれたワイヤが、前記装置の前記中央に向かって前記装置の高密度部分を形成して動脈瘤と界面をなすように織り込まれる、上記[85]ないし[87]のいずれか一項に記載の任意の装置。
[89]前記装置の高密度部分が、差し渡し約0.01インチ以下の、前記ワイヤ間の間隙を有する、上記[87]の装置。
[90]前記装置の高密度部分が、差し渡し約0.008インチ以下の、前記ワイヤ間の間隙を有する、上記[89]の装置。
[91]前記ワイヤが、前記近位端部および前記遠位端部において前記装置の低密度部分を形成するように配置される、上記[85]から[89]のいずれか一項に記載の任意の装置。
[92]前記低密度部分が、前記管腔の近似的に中心において整列した尖端を有する円錐として形成される、上記[91]に記載の装置。
[93]前記低密度部分が、前記管腔の前記外周に沿って整列した尖端と一体になる前記円筒形区画の前記ワイヤの漸減として形成され、前記近位端部の前記尖端が、外周方向に前記遠位端部の前記尖端と整列した、上記[91]に記載の装置。
[94]ニチノール、DFT(登録商標)、白金、コバルトクロム、ステンレス鋼、フルオロポリマー類、ポリエチレン、ポリウレタン、ポリエーテルブロックアミド類、ポリテトラフルオロエチレン(PTFE)、および形状記憶ポリマー類からなる群から選択された少なくとも一つの材料から形成されたワイヤを含む、上記[85]ないし[93]のいずれか一項に記載の装置。
[95]前記装置に、ポリ(p-キシリレン)ポリマー類、ポリフッ化ビニリデン(PVDF)、ポリビニリデン-ヘキサフルオロプロピレン(PVDF-HFP)、ペルフルオロプロピレン、オクタフルオロプロパン、パリレンHT、パリレンAF-4、パリレンF、パリレンVT-4;1H,1H,2H,2H-ペルフルオロドデシルトリクロロシラン、(トリデカフルオロ-1、1、2、2、テトラヒドロオクチル)シラン;またはヘキサデカフルオロドデク-11-エン-1-イルトリメトキシシランを少なくとも部分的にコーティングした、上記[85]ないし[94]のいずれか一項に記載の装置。
[96]血管内部の動脈瘤を治療する方法であって、
前記血管中に動脈瘤治療装置を挿入することを含み、
前記装置が、
複数のストラットを含む概して円筒形のメッシュ区画であって、前記ストラットが、前記ストラット間に間質間隙を形成し、近位面および遠位面を有し、かつ前記近位面から前記遠位面まで軸方向に沿って延びる装置管腔を画定し、前記管腔が前記装置に血流を通すように構成される、メッシュ区画と、
前記概して円筒形のメッシュ区画を押し出しワイヤに接合する近位テーパ付き区画と、を含む、方法。
[97]前記概して円筒形のメッシュ区画が、前記概して円筒形のメッシュ区画の残りよりも高いストラット密度を有する中央区画を含み、前記方法が、前記動脈瘤の頚部を前記中央区画が実質的に覆うようにして、前記中央区画を前記動脈瘤に隣接させて配置することをさらに含む、上記[96]に記載の方法。
[98]前記概して円筒形のメッシュ区画が、その長さの少なくとも一部分に沿ってチューブ状のスリーブを含み、前記方法が、前記動脈瘤の頚部を前記中央区画が実質的に覆うようにして、前記チューブ状のスリーブを前記動脈瘤に隣接させて配置することをさらに含む、上記[96]または[97]に記載の方法。
[99]前記動脈瘤の中に、または隣接させてマイクロカテーテルを挿入すること、および複数の動脈瘤充填用コイルを前記動脈瘤中に送達することをさらに含む、上記[96]ないし[98]のいずれか一項に記載の方法。
[100]前記マイクロカテーテルが、前記血管の壁と前記動脈瘤治療装置との間に挿入される、上記[99]に記載の方法。
[101]前記マイクロカテーテルが、前記装置管腔の内部に、かつ前記概して円筒形のメッシュ区画の前記間質間隙の一つを通して挿入される、上記[99]に記載の方法。
[102]前記複数の動脈瘤充填用コイルを送達した後に前記押し出しワイヤを近位に退縮させることにより前記動脈瘤治療装置を除去することをさらに含む、上記[99]ないし[101]のいずれか一項に記載の方法。
[103]前記動脈瘤治療装置を永久ステントに置き換えることをさらに含む、上記[102]に記載の方法。
[104]前記押し出しワイヤの少なくとも一部分を前記装置の残りから取り外し、前記動脈瘤に隣接して永久に配置された前記概して円筒形のメッシュ区画を残すことをさらに含む、上記[99]ないし[101]のいずれか一項に記載の方法。
[105]前記近位テーパ付き区画が、前記近位面の外周から近位尖端まで延びる複数のストラットを含み、前記近位尖端は、半径方向に前記近位面の前記外周と整列し、または前記近位面の前記外周の半径方向外側に配置されており、前記近位テーパ付き区画の複数のストラットは、前記複数のストラットがいずれも、前記装置管腔により画定された断面領域を横断しないように、前記近位面の外周上の異なる場所から軸方向および周方向に、前記近位尖端まで延びる、上記[96]ないし[104]のいずれか一項に記載の方法。
It is to be understood that the claims are not limited to the precise configuration and components illustrated above. Various modifications, changes, and variations may be made in the organization, operation, and details of the methods and apparatus described above.
The present invention includes the following inventions.
[1] A device for treating an aneurysm by inserting it into a blood vessel lumen,
A generally cylindrical mesh section comprising a plurality of struts , said struts forming interstitial spaces between said struts , having a proximal surface and a distal surface, and from said proximal surface to said distal surface. a mesh section defining a device lumen extending axially to a lateral plane, said lumen configured to provide blood flow to said device;
a proximal tapered section including a plurality of struts extending from the circumference of the proximal face to a proximal apex;
said proximal tip is radially aligned with the perimeter of said proximal face or disposed radially outward of said perimeter of said proximal face;
A plurality of the struts of the proximal tapered section are arranged from different locations on the circumference of the proximal face such that none of the plurality of struts traverses a cross-sectional area defined by the device lumen. A device extending axially and circumferentially to a proximal tip.
[2] The apparatus of [1] above, wherein the plurality of struts of the generally cylindrical mesh section is formed from woven wire.
[3] The apparatus of [2] above, wherein the plurality of struts of the proximal tapered section are formed from woven wires of the generally cylindrical mesh section.
[4] The apparatus of [2] or [3] above, wherein the braided wire is at least partially braided within the proximal tapered section.
[5] one or more of the plurality of struts are inverted within the proximal tapered section, one or more of the inverted struts being radially within the proximal tapered section; [1] to [4] above, which is bent outward and toward the proximal tip, and the proximal tip is disposed radially outward of the outer circumference of the proximal face. A device according to any one of the preceding clauses.
[6] the plurality of struts form edges extending from or near the proximal tip and extending to the perimeter of the proximal face configured to interface with incoming blood flow; and said edge defines a take-off angle with respect to a longitudinal axis extending through said proximal tip parallel to said axial dimension, said take-off angle being no more than about 80 degrees. The device according to any one of [5].
[7] The apparatus according to [6] above, wherein the take-off angle is about 70 degrees or less.
[8] The apparatus of [6] or [7] above, wherein the take-off angle is at least about 30 degrees.
[9] The apparatus of [8] above, wherein the take-off angle is at least about 40 degrees.
[10] The device of any one of [1] to [9] above, wherein the device occupies a percentage of the cross-sectional area defined by the outer diameter of the proximal face that is less than or equal to about 0.2. .
[11] The apparatus according to [10] above, wherein the ratio is about 0.1 or less.
[12] The apparatus according to [11] above, wherein the ratio is about 0.05 or less.
[13] The apparatus according to [12] above, wherein the ratio is about 0.01 or less.
[14] The above [1]-[13], wherein the plurality of struts of the proximal tapered section and the generally cylindrical mesh section have a diameter of about 0.01 inches or less. equipment.
[15] The apparatus of [14] above, wherein the plurality of struts of the proximal tapered section and the generally cylindrical mesh section have a diameter of about 0.005 inches or less.
[16] the generally cylindrical mesh section includes a central section configured to be positioned adjacent to the aneurysm, the central section being greater than at least a portion of the remainder of the generally cylindrical mesh section; The device according to any one of [1] to [15] above, comprising a substantially high strut density.
[17] The device of [16], wherein the central section includes an outer diameter that is greater than the outer diameter of the proximal face in an unconstrained configuration.
[18] The apparatus of [16] or [17] above, wherein the high strut density is a result of a smaller pitch of braided wires than in the low density portion of the generally cylindrical mesh section.
[19] The apparatus of any one of [16]-[18] above, wherein the high strut density is the result of a different weave pattern than the low density portion of the generally cylindrical mesh section.
[20] The apparatus of any one of [16] to [19] above, wherein the central section includes an interstitial space of about 0.01 inch or less across.
[21] The device of [20] above, wherein the central section comprises an interstitial space of about 0.008 inch or less across.
[22] the generally cylindrical mesh section has a radially outward compression reaction force adjacent to the proximal face that is greater than a radially outward compression reaction force near the center of the generally cylindrical mesh section; The apparatus according to any one of [1] to [21] above, configured to provide
[23] further comprising a distal tapered section including a plurality of struts extending from the periphery of said distal face to a distal tip;
said distal tip is radially aligned with said perimeter of said distal face or disposed radially outward of said perimeter of said distal face;
The plurality of struts of the distal tapered section are arranged from different locations on the circumference of the distal surface such that none of the plurality of struts traverses the cross-sectional area defined by the device lumen. A device according to any one of [1] to [22] above, extending axially and circumferentially to the distal tip.
[24] The apparatus of [23], wherein the plurality of struts from the distal tapered portion extend through a radiopaque marker ring located distally from the proximal tip.
[25] above [23] or [24], wherein the plurality of struts from the distal tapered portion are aligned parallel and distal to the distal tip to form a distal drawer section; ].
[26] The apparatus of [25] above, further comprising a metallic helical coil disposed around the distal drawer section.
[27] The apparatus according to [26] above, wherein the metallic helical coil comprises platinum or iridium.
[28] The apparatus of any one of [1] to [22] above, wherein the distal face is open and substantially perpendicular to the axial direction.
[29] The apparatus of [28], wherein the open distal face includes a perimeter formed by atraumatic bending within the plurality of struts within the generally cylindrical mesh section. .
[30] Any one of [1] to [29] above, wherein the plurality of struts within the proximal tapered section are substantially evenly distributed around the perimeter of the proximal face. The apparatus described in .
[31] The apparatus of any one of [1] to [30] above, further comprising a pusher wire collinear with the proximal tip.
[32] the plurality of struts within the proximal tapered section are aligned proximally parallel to the proximal tip, and proximal ends of the plurality of struts extend from the pusher wire; The device of [31] above, joined to a distal end, wherein the plurality of struts are substantially evenly distributed around the circumference of the pusher wire.
[33] The apparatus of any one of [31]-[32] above, wherein the pusher wire is permanently joined to the proximal tapered section.
[34] The apparatus of [31] or [32] above, wherein the pusher wire is removably joined to the proximal tapered section.
[35] The apparatus of any one of [31]-[34] above, wherein the distal end of the pusher wire includes a tapered portion.
[36] the distal end of the pusher wire includes a plurality of plastic rings surrounding the pusher wire, and proximal ends of the plurality of struts from the proximal tapered section surround the plastic rings; The apparatus according to any one of [22] to [35] above.
[37] The apparatus of [36] above, wherein the plurality of plastic rings are axially spaced apart from each other by at least about 1 cm.
[38] The above [1]-[37], wherein the plurality of struts from the proximal tapered portion extend through a radiopaque marker ring located proximal to the proximal tip. A device according to any one of the preceding clauses.
[39] The device includes a contracted configuration and an expanded configuration, wherein the device has a longer axis from the proximal tip to the distal end of the device in the contracted configuration than in the expanded configuration. The device of any one of [1] to [38] above, having a length and a small diameter of the device lumen.
[40] the plurality of struts of the generally cylindrical mesh section and the proximal tapered section comprise a shape memory material, the device configured to assume the expanded configuration as a memorized shape; The device according to [39] above.
[41] The device of any one of [1]-[40] above, further comprising a polymeric sleeve disposed around at least a portion of the device lumen.
[42] The apparatus of [41] above, wherein the sleeve is applied to the inner diameter of the generally cylindrical mesh section.
[43] The apparatus of [41] or [42] above, wherein the sleeve is applied to the outer diameter of the generally cylindrical mesh section.
[44] Any one of [41] to [43] above, wherein the sleeve includes an inner layer and an outer layer, and at least a portion of the generally cylindrical section is sandwiched between the inner layer and the outer layer. Apparatus as described.
[45] The device of [44] above, wherein the inner and outer layers are bonded together within at least some of the interstitial spaces.
[46] The above [41], wherein the sleeve includes openings located near the proximal end of the sleeve and near the distal end of the sleeve but not within the central section of the sleeve. The apparatus of any one of [45].
[47] The apparatus of any one of [41] to [46] above, wherein the sleeve comprises a fluoroelastomer.
[48] The above [ 41] to [47].
[49] The apparatus of any one of [41]-[48] above, wherein the sleeve comprises a silastic.
[50] The device of [49] above, wherein the sleeve comprises polydimethylsiloxane (PDMS).
[51] The sleeve comprises an A:B:A triblock copolymer, the A block comprises tetrafluoroethylene (TFE), ethylene, and hexafluoropropylene (HFP), and the B block comprises vinylidene fluoride. (VDF), hexafluoropropylene (HFP), and tetrafluoroethylene (TFE).
[52] The sleeve is impregnated or coated with polyvinylpyrrolidone (PVP), phosphorylcholine (PC), polyethylene glycol (PEG), Serine™, PEGylated molecules, or fluorinated molecules to A device according to any one of [41] to [51] above, which provides a thrombogenic surface.
[53] The apparatus of any one of [1]-[52] above, wherein the plurality of struts of the generally cylindrical section is coated with a coating material.
[54] the coating material comprises plasma-deposited fluorine, plasma-deposited glyme, phosphorylcholine, diamond-like carbon, fluorinated diamond-like carbon, polyvinylpyrrolidone (PVP), fluorinated ethylene propylene (FEP), Polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), poly(vinylidene fluoride cohexafluoropropylene) (PVDF-HFP), fluorophosphazene, carboxybetaine, sulfobetaine, methacrylated carboxybetaine, methacrylated sulfobetaine, fluorosilane, heparin or heparin-like molecule; hirudin; curcumin; thrombomodulin; prostacyclin; The device according to [53] above, comprising a material layer, or silicon carbide.
[55] The above [53] or [54], including a poly n-butyl methacrylate (PBMA) or poly(p-xylylene) polymer primer layer between the plurality of struts and the coating material. Device.
[56] The apparatus of any one of [53]-[55] above, wherein the coating material completely covers at least a portion of the interstitial space.
[57] The coating material covers a portion of the interstitial space, and the portion is configured to be positioned adjacent to the aneurysm such that the portion covers the neck of the aneurysm. The device according to [56] above.
[58] The apparatus of [56] above, wherein the coating material covers alternating rows of the interstitial spaces.
[59] said device lumen comprises an inner surface having an inner diameter and an outer surface having an outer diameter, and said coating comprises a first coating applied to said inner surface and a second coating applied to said outer surface; , the device according to any one of [53] to [58] above, wherein said first and said second coatings have distinctly different biological properties.
[60] The device, wherein the first coating is designed primarily to reduce thrombus formation and the second coating is designed primarily to promote endothelialization above [59] ].
[61] Any one of [53] to [60] above, wherein the coating forms a gradient in at least one biological property along the length of the device in a direction aligned with the device lumen. 3. Apparatus according to paragraph.
[62] the gradient extends from at least the proximal face toward the center of the generally cylindrical mesh section and then reverses from the center of the generally cylindrical mesh section toward the distal face; The device according to [61] above.
[63] the at least one biological property is promotion of endothelialization, wherein endothelialization is toward the center of the generally cylindrical mesh compartment rather than near the proximal and distal surfaces; The apparatus of [62] above, further facilitated.
[64] the at least one biological property is reduced thrombus formation, and thrombus formation is further reduced toward the proximal and distal surfaces than the middle of the generally cylindrical mesh section; The apparatus of [62] above, wherein
[65] The device of [62] above, wherein said at least one biological property comprises reduced thrombus formation and enhanced endothelialization, wherein said reduced thrombus formation increases as enhanced endothelialization decreases. .
[66] Any one of [61] to [65] above, wherein the gradient is formed by applying the coating to the surface of the device according to processing conditions that vary along the length of the device. The apparatus described in .
[67] The device of any one of [61]-[65] above, wherein the gradient is formed by varying the composition of the coating along the length of the device.
[68] The apparatus of any one of [2]-[67] above, wherein the braided wires comprise at least 24 wires.
[69] The apparatus of [68] above, wherein the braided wires comprise at least 48 wires.
[70] said plurality of struts of said generally cylindrical section comprises nitinol, DFT®, platinum, cobalt chromium, stainless steel, fluoropolymer, polyethylene, polyurethane, polyether block amide, or shape memory polymer; , the device according to any one of [1] to [69] above.
[71] the plurality of struts of the generally cylindrical section comprising polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), polyvinylidene-hexafluoropropylene (PVDF-HFP), perfluoropropylene, octafluoropropane; Parylene HT, Parylene AF-4, Parylene F, Parylene VT-4; 1H,1H,2H,2H-perfluorododecyltrichlorosilane, (tridecafluoro-1,1,2,2,tetrahydrooctyl)silane , hexadecafluordodec-11-en-1-yltrimethoxysilane, or poly(p-xylylene) polymer.
[72] The apparatus of any one of [1]-[71] above, wherein the proximal tip is positioned radially outward of the outer circumference of the proximal face.
[73] A device for inserting into a vessel lumen to treat an aneurysm, comprising:
a proximal end and a distal end, wherein the distal end is located downstream of the vessel lumen from the proximal end;
a device surface;
a coating applied to the device surface, wherein the coating is designed to reduce thrombus formation on the device surface and to promote endothelialization on the device surface.
[74] A first method wherein the device forms a lumen aligned with the vessel lumen, the lumen includes an inner surface having an inner diameter and an outer surface having an outer diameter, and the coating is applied to the inner surface. and a second coating applied to said outer surface, said first and second coatings having distinctly different biological properties.
[75] The device of [74] above, wherein the first coating is designed primarily to reduce thrombus formation and the second coating is designed primarily to promote endothelialization.
[76] Any one of [71]-[74] above, wherein the coating forms a gradient in at least one biological property along the length of the device aligned with the lumen. equipment.
[77] The above [76], wherein the gradient extends from the proximal end toward the center of the device and then reverses from the center of the device toward the distal end. Device.
[78] the at least one biological property is promotion of endothelialization, wherein endothelialization is promoted more toward the center of the device than toward the proximal and distal ends; The device according to [77] above.
[79] The above, wherein the at least one biological property is reduced thrombus formation, and thrombus formation is reduced toward the proximal and distal ends relative to the center of the device. The apparatus of [77].
[80] The above [77], wherein the at least one biological property comprises reduced thrombus formation and enhanced endothelialization, wherein the reduced thrombus formation increases as the enhanced endothelialization decreases. equipment.
[81] Any one of [76] to [80] above, wherein the gradient is formed by applying the coating to the surface of the device according to processing conditions that vary along the length of the device. Apparatus as described.
[82] The device of any one of [76]-[80] above, wherein the gradient is formed by varying the composition of the coating along the length of the device.
[83] The coating is plasma-deposited fluorine, plasma-deposited glyme, phosphorylcholine, diamond-like carbon, fluorinated diamond-like carbon, polyvinylpyrrolidone (PVP), fluorinated ethylene propylene (FEP), polytetrafluoro ethylene (PTFE), polyvinylidene fluoride (PVDF), poly(vinylidene fluoride cohexafluoropropylene) (PVDF-HFP), fluorophosphazenes, carboxybetaines, sulfobetaines, methacrylated carboxybetaines, methacrylated sulfobetaines, fluorosilanes, heparin or heparin-like molecules; hirudin; curcumin; thrombomodulin; prostacyclin; and silicon carbide.
[84] The coating is plasma-deposited fluorine, plasma-deposited glyme, phosphorylcholine, diamond-like carbon, fluorinated diamond-like carbon, polyvinylpyrrolidone (PVP), fluorinated ethylene propylene (FEP), polytetrafluoro ethylene (PTFE), polyvinylidene fluoride (PVDF), poly(vinylidene fluoride cohexafluoropropylene) (PVDF-HFP), fluorophosphazenes, carboxybetaines, sulfobetaines, methacrylated carboxybetaines, methacrylated sulfobetaines, fluorosilanes, heparin or heparin-like molecules; hirudin; curcumin; thrombomodulin; prostacyclin; and silicon carbide.
[85] A device for inserting into the lumen of a blood vessel to treat an aneurysm, comprising:
a generally cylindrical section having a lumen configured to align with the vessel lumen; and proximal and distal ends disposed at opposite ends of the lumen;
A device, wherein said device is formed from braided wires.
[86] The apparatus of [85] above, wherein the braided wires comprise at least 24 wires.
[87] The apparatus of [85] or [86] above, wherein the braided wires comprise at least 48 wires.
[88] Any of the above [85] to [87], wherein the braided wires are woven to form a dense portion of the device toward the center of the device to interface with an aneurysm. Any device according to paragraph 1.
[89] The device of [87] above, wherein the high density portion of the device has a gap between the wires of about 0.01 inch or less across.
[90] The device of [89] above, wherein the high density portion of the device has a gap between the wires of about 0.008 inch or less across.
[91] The wire of any one of [85] to [89] above, wherein the wires are arranged to form a low density portion of the device at the proximal end and the distal end. any device.
[92] The apparatus of [91] above, wherein the low density portion is formed as a cone with apex aligned approximately in the center of the lumen.
[93] The low density portion is formed as a taper of the wire in the cylindrical section that merges with cusps aligned along the circumference of the lumen, the cusps at the proximal end extending circumferentially. aligned with the tip of the distal end.
[94] from the group consisting of nitinol, DFT®, platinum, cobalt chromium, stainless steel, fluoropolymers, polyethylene, polyurethane, polyether block amides, polytetrafluoroethylene (PTFE), and shape memory polymers The apparatus of any one of [85]-[93] above, including a wire formed from at least one selected material.
[95] The device contains poly(p-xylylene) polymers, polyvinylidene fluoride (PVDF), polyvinylidene-hexafluoropropylene (PVDF-HFP), perfluoropropylene, octafluoropropane, parylene HT, parylene AF-4, Parylene F, Parylene VT-4; 1H,1H,2H,2H-perfluorododecyltrichlorosilane, (tridecafluoro-1,1,2,2,tetrahydrooctyl)silane; or hexadecafluorododec-11-ene- The device according to any one of [85] to [94] above, at least partially coated with 1-yltrimethoxysilane.
[96] A method of treating an aneurysm within a blood vessel comprising:
inserting an aneurysm treatment device into the blood vessel;
said device comprising:
A generally cylindrical mesh section comprising a plurality of struts forming an interstitial space between the struts , having a proximal surface and a distal surface, and from the proximal surface to the distal surface. a mesh section defining a device lumen extending axially to a surface, the lumen configured to provide blood flow to the device;
and a proximal tapered section joining said generally cylindrical mesh section to an extrusion wire.
[97] the generally cylindrical mesh section includes a central section having a higher strut density than the remainder of the generally cylindrical mesh section, and the method comprises: The method of [96] above, further comprising placing the central compartment adjacent to the aneurysm in a covering manner.
[98] the generally cylindrical mesh section includes a tubular sleeve along at least a portion of its length, the method wherein the central section substantially covers the neck of the aneurysm; The method of [96] or [97] above, further comprising placing the tubular sleeve adjacent to the aneurysm.
[99] The above [96]-[98], further comprising inserting a microcatheter into or adjacent to the aneurysm and delivering a plurality of aneurysm-filling coils into the aneurysm. The method according to any one of .
[100] The method of [99] above, wherein the microcatheter is inserted between the wall of the blood vessel and the aneurysm treatment device.
[101] The method of [99] above, wherein the microcatheter is inserted inside the device lumen and through one of the interstitial spaces of the generally cylindrical mesh compartment.
[102] Any of the above [99] to [101], further comprising removing the aneurysm treatment device by proximally retracting the pusher wire after delivering the plurality of aneurysm filling coils. The method according to item 1.
[103] The method of [102] above, further comprising replacing the aneurysm treatment device with a permanent stent.
[104] above [99] to [101], further comprising removing at least a portion of said pusher wire from the remainder of said device, leaving said generally cylindrical mesh section permanently positioned adjacent said aneurysm; ] The method according to any one of the above.
[105] the proximal tapered section includes a plurality of struts extending from a perimeter of the proximal face to a proximal apex, the proximal apex being radially aligned with the perimeter of the proximal face; or A plurality of struts of the proximal tapered section are disposed radially outward of the perimeter of the proximal face, and wherein none of the struts traverses a cross-sectional area defined by the device lumen. The method of any one of [96] to [104] above, extending axially and circumferentially from different locations on the circumference of the proximal face to the proximal tip.
Claims (8)
複数のストラットを含む円筒形の区画であって、前記複数のストラットが前記ストラット間に間質間隙を形成し、前記円筒形の区画が近位面および遠位面を有し、前記円筒形の区画が前記近位面から前記遠位面まで軸方向に沿って延びる装置管腔を画定し、前記装置管腔が前記装置に血流を通すように構成され、前記円筒形の区画が、前記円筒形の区画の中央近傍での半径方向外向きの圧縮反力よりも大きい、前記近位面に隣接する半径方向外向きの圧縮反力を与えるように構成されている、区画と、
前記近位面の外周から近位尖端まで延びる複数のストラットを含む近位テーパ付き区画と、を備え、
前記近位尖端が、半径方向に前記近位面の外周と整列し、または前記近位面の前記外周の半径方向外側に配置され、
前記近位テーパ付き区画の複数の前記ストラットは、前記軸方向から前記複数のストラットを見たとき、前記複数の前記ストラットがいずれも前記装置管腔の断面領域を横断しないように、前記近位面の前記外周から前記近位尖端まで、軸方向および外周方向に延びる、装置。 A device for inserting into a vessel lumen to treat an aneurysm, comprising:
a cylindrical section comprising a plurality of struts , said plurality of struts forming interstitial spaces between said struts , said cylindrical section having a proximal surface and a distal surface; defines a device lumen extending axially from the proximal face to the distal face, the device lumen configured to provide blood flow to the device, the cylindrical section comprising: a section configured to provide a radially outward compression reaction force adjacent the proximal face that is greater than a radially outward compression reaction force proximate the center of the cylindrical section;
a proximal tapered section including a plurality of struts extending from the circumference of the proximal face to a proximal apex;
said proximal tip is radially aligned with the perimeter of said proximal face or disposed radially outward of said perimeter of said proximal face;
The plurality of struts of the proximal tapered section are arranged in the proximal direction such that none of the plurality of struts traverses a cross-sectional area of the device lumen when the plurality of struts are viewed from the axial direction. A device extending axially and circumferentially from said perimeter of the face to said proximal tip.
前記遠位尖端が、半径方向に前記遠位面の前記外周と整列し、または前記遠位面の前記外周の半径方向外側に配置され、
前記遠位テーパ付き区画の前記複数のストラットは、前記軸方向から前記複数のストラットを見たとき、前記複数のストラットがいずれも、前記装置管腔の断面領域を横断しないように、前記遠位面の前記外周から前記遠位尖端まで、軸方向および外周方向に延びる、請求項1ないし4のいずか一項に記載の装置。 further comprising a distal tapered section comprising a plurality of struts extending from the periphery of said distal face to a distal tip;
said distal tip is radially aligned with said perimeter of said distal face or disposed radially outward of said perimeter of said distal face;
The plurality of struts of the distal tapered section are configured such that none of the plurality of struts traverses a cross-sectional area of the device lumen when viewed from the axial direction. 5. The device of any one of claims 1-4, extending axially and circumferentially from the perimeter of the face to the distal tip.
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