TW202023496A - 使用編織植入物之系統及方法 - Google Patents

使用編織植入物之系統及方法 Download PDF

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TW202023496A
TW202023496A TW108127690A TW108127690A TW202023496A TW 202023496 A TW202023496 A TW 202023496A TW 108127690 A TW108127690 A TW 108127690A TW 108127690 A TW108127690 A TW 108127690A TW 202023496 A TW202023496 A TW 202023496A
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blood vessel
diameter
implant
braided
porosity
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羅伯特 斯拉薩斯
杰弗里 彼得斯
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美商德派信迪思產品公司
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Abstract

一種經組態為用於治療一動脈瘤之一流動轉向器的編織植入物。該植入物可包括一編織網，該編織網經組態以在一漸縮血管中之一預定長度內在至多1mm的一血管直徑範圍內維持實質上一致的一目標孔隙度。

Description

使用編織植入物之系統及方法
本揭露關於身體血管內的植入物，並且更具體地，關於包括由材料股件(strand)形成的編織植入物的流動轉向器、支架、及相關方法。
諸如動脈瘤和其他動靜脈畸形的血管病症及缺陷在位於關鍵組織附近或者無法容易到達畸形處時係尤其難以治療的。這兩個困難因素對於顱內動脈瘤而言尤其如此。因為顱內血管周圍的敏感腦組織及受限的到達，因此手術治療顱內脈管系統缺陷非常具有挑戰性並且常係有風險的。
一般而言，首先使用遞送導管將類支架血管重建裝置引導至待治療的動脈瘤下方。一種市售可得的重建產品係如所述之CERENOVOUS ENTERPRISE®血管重建裝置及系統，藉此CERENOVOUS ENTERPRISE®支架裝置由中心遞送線承載並且最初藉由鞘型導引器在塌縮狀態下保持就位在遞送線上。一般而言，諸如PROWLER® SELECT®Plus微導管的遞送導管(市售可得自Cerenovous及如由Gore et al.在美國專利第5,662,622號中揭露)例如首先係定位在血管內，其中其遠側端稍微超出動脈瘤的頸部。該導引器的漸縮遠側端與遞送導管的近端襯套緊密配合，然後前移遞送線穿過遞送導管。
CERENOVOUS ENTERPRISE®支架裝置具有高度可撓性的自擴張閉孔設計，該閉孔設計在該裝置的各外擴端(flared end)具有不透輻射(radiopaque)的線之多個線圈以作用為標記物。因為支架的尺寸小並且需要多次圍繞支架上的支柱纏繞射線不透輻射的線，其在支架的閉孔內尤其困難，所以此類標記物的製造相對耗時且昂貴。
血管動脈瘤具有多種可用的治療方法。一種方法包括流動轉向支架，其可係足夠密集的血管內支架，使得血流轉向避免進入動脈瘤。此類流動轉向器係最近且增長的治療選項。否則，大多數目前一代的流動轉向器係由類似於手指捕集玩具(finger trap toy)操作之金屬線的管狀編織物構成。然後將這些管狀編織物徑向壓縮，通過小孔導管遞送至治療部位，然後就位擴張。
此外，神經脈管系統的脆弱及非線性性質限制了此類支架在程序中(例如在修復神經血管缺陷中)的適用性。另外，已知的遞送方法在血管閉塞手術中不太有用，尤其是當需要治療微小血管(諸如大腦中所發現者)時。據此，需要在神經血管缺陷的血管閉塞治療中與遞送技術一起使用的編織植入物，該編織植入物在神經血管缺陷附近提供選擇性強化。亦需要減小對血管造成的創傷或降低血管破裂的風險的編織支架。本揭露的解決方案解決所屬技術領域的此等及其他問題。
本文揭示可解決上述需要的本揭露的各種例示性裝置、系統、及方法。
本解決方案的一目的係提供一或多個編織植入物，該一或多個編織植入物經組態為流動轉向器，該等流動轉向器對漸縮血管提供較長的血管直徑範圍並在一預定長度內維持該目標孔隙度(例如，1mm血管直徑範圍)。
本解決方案的一目的係增加編織植入物的適用血管直徑範圍，以最小化從業人員在治療一動脈瘤時所需的裝置數量。在一實例中，一或多個編織植入物包含該特徵孔隙度曲線的一寬平臺(plateau)區域，而指定用於該平臺內的血管直徑的該(等)編織植入物(導致1.0mm寬的經指定範圍)，及重疊裝置之該等經指定的範圍，所以醫師具有取決於所呈現的該解剖結構之最佳選擇的選項。
在某些實例中，一種編織植入物係揭示經組態為用於治療一動脈瘤之一流動轉向器。該植入物可包括一編織網，該編織網以在至少1mm的血管直徑範圍之一漸縮血管中維持實質上一致的一目標孔隙度。該編織網亦可經組態以在該漸縮血管中的同時於該編織網的近端及遠端之間維持實質上一致的該目標孔隙度。
在某些實例中，該漸縮血管包含一近端直徑及一遠端直徑，該近端直徑及該遠端直徑相差至多1mm，其中該至多1mm的血管直徑範圍係藉由比較該近端直徑及該遠端直徑來界定。然而，如需要或要求，設想該直徑可相差至少.5mm或任何其他直徑差。
在某些實例中，實質上一致的該目標孔隙度係大約70%。
在某些實例中，在該漸縮血管中的該編織網的近端及遠端之間的該預定長度係至少3cm。
在某些實例中，在該漸縮血管中的該編織網的近端及遠端之間的該預定長度係至少2cm。
在某些實例中，在該漸縮血管中的該編織網的近端及遠端之間的該預定長度係至少1cm。
在某些實例中，在該漸縮血管中的該編織網的近端及遠端之間的該預定長度係界定在該近側海綿狀內頸動脈及內頸動脈末端之間。
在某些實例中，一種編織植入物係揭露用於醫療用途。該植入物可包括具有一近端及一遠端的一網，其中該網包含在血管直徑中的1mm徑向範圍內在該近端及該遠端之間實質上一致的一孔隙度。
在某些實例中，在血管直徑中的該1mm徑向範圍內，該孔隙度係大約70%。
在某些實例中，該編織植入物進一步包含經指定的一血管直徑，且其中該編織植入物係組態使得經指定的該血管直徑與該編織植入物的一孔隙度曲線的一峰重合。該編織植入物可包括一孔隙度平臺，該孔隙度平臺對應於血管直徑中圍繞該孔隙度曲線的該峰設置的該1mm徑向範圍。
在某些實例中，在2至3mm的一血管直徑範圍內，該編織植入物的一孔隙度範圍在65%和70%之間。
在某些實例中，在2.5至3.5mm的一血管直徑範圍內，該編織植入物的一孔隙度範圍在65%和70%之間。
在某些實例中，在3.0至4.0mm的一血管直徑範圍內，該編織植入物的一孔隙度範圍在65%和70%之間。
在某些實例中，在3.5至4.5mm的一血管直徑範圍內，該編織植入物的一孔隙度範圍在65%和70%之間。
在某些實例中，整個編織植入物經組態用於3.5至4.5mm的一血管直徑範圍內，且其中該編織植入物在3.5mm的一血管直徑處包括69%的一孔隙度；在4.0mm的一血管直徑處包括69%的一孔隙度；及在4.5mm的一血管直徑處包括67%的一孔隙度。
在某些實例中，在4.5至5.5mm的一血管直徑範圍內，該編織植入物的一孔隙度範圍在65%和70%之間。
在某些實例中，該編織植入物的一孔密度係18孔/mm2。
在某些實例中，該編織植入物的一孔密度係23孔/mm2。
在某些實例中，該編織植入物的一孔密度係19孔/mm2。
在某些實例中，該編織植入物的一孔密度係大約18至23孔/mm2。
在某些實例中，由該編織植入物治療的一目標血管係漸縮的。
在某些實例中，該編織植入物係實質上圓柱形的一多孔結構。
在某些實例中，該編織植入物係一支架。
在某些實例中，該編織植入物係一流動轉向器。
在某些實例中，該編織植入物由複數個單股件及一或多個不透輻射的多股件形成，該複數個單股件由至少一個第一材料構成。
在某些實例中，該編織植入物係織造以包括至少一個第二多股件。
在某些實例中，該編織植入物係由各自分別與單絲一起放置之單絲形成的複數個多形成。
在某些實例中，該編織植入物進一步包括織造的一圖案，其中該圖案包含由在一第一方向定向的複數個單股件及在橫向於該第一方向的一第二方向定向的複數個單股件界定的開口。
在某些實例中，該編織植入物進一步包括編織的一圖案，其中該圖案包含由在一第一方向定向的複數個單股件及在橫向於該第一方向的一第二方向定向的複數個單股件界定的開口。
在某些實例中，揭示一種用於治療一動脈瘤的系統。該系統可包括複數個編織植入物，其中各編織植入物包含在血管直徑中的不同的1mm徑向範圍內實質上一致的一孔隙度，各編織植入物經組態以在不同的1mm直徑範圍內提供實質上一致的孔隙度。
在某些實例中，該編織植入物經組態用於一漸縮血管中。該漸縮血管可包括相差至多1mm的一近端直徑和一遠端直徑。血管直徑中的不同1mm徑向範圍可藉由比較該近端直徑和該遠端直徑而判定。然而，血管直徑中的不同的該1mm徑向範圍亦可藉由測量該治療部位處的兩個單獨位置處的該血管直徑而判定。
在某些實例中，該系統的該複數個編織植入物經組態以治療1.5mm至6mm的直徑範圍內的任何血管。
在某些實例中，該系統的該複數個編織植入物包括一第一編織植入物(10)，其經組態以治療2至3mm的一血管直徑範圍；一第二編織植入物(10)，其經組態以治療2.5至3.5mm的一血管直徑範圍；一第三編織植入物(10)，其經組態以治療3.0至4.0mm的一血管直徑範圍；一第四編織植入物(10)，其經組態以治療3.5至4.5mm的一血管直徑範圍；一第五編織植入物(10)，其經組態以治療4.0至5.0mm的一血管直徑範圍；及一第六編織植入物(10)，其經組態以治療4.5至5.5mm的一血管直徑範圍。在該各別植入物的經指定之該血管範圍，各編織植入物(10)的該孔隙度範圍可在65%和70%之間。在一些實例中，各編織植入物的該孔隙度係大約70%。在一些實例中，各編織植入物進一步包含經指定的一血管直徑，且其中該編織植入物係組態使得經指定的該血管直徑與該編織植入物的一孔隙度曲線的一峰重合。在一些實例中，各編織植入物進一步包括一孔隙度平臺，該孔隙度平臺對應於血管直徑中圍繞該孔隙度曲線的該峰設置的該1mm範圍。在一些實例中，各編織植入物包括範圍在大約18至23孔/mm2之間內的一孔密度。
在一些實例中，該第一編織植入物的一孔密度係18孔/mm2。
在一些實例中，該第二編織植入物的一孔密度係23孔/mm2。
在一些實例中，該第三編織植入物的一孔密度係18孔/mm2。
在一些實例中，該第四編織植入物的一孔密度係19孔/mm2。
在一些實例中，該第五編織植入物的一孔密度係23孔/mm2。
在一些實例中，該第六編織植入物的一孔密度係21孔/mm2。在一些實例中，該編織植入物包括不透輻射的材料，諸如鉑、鉻、鈷、鉭、鎢、金、銀、及其等的合金。
在一些實例中，揭示一種用於治療一動脈瘤的系統。該系統可包括複數個編織植入物，其中各編織植入物在血管直徑中的不同的.5mm徑向範圍內實質上一致的一孔隙度，各編織植入物(10)經組態以在不同的.5mm徑向直徑範圍內提供實質上一致的孔隙度。然而，如系統的需要或要求，可使用其他不同的徑向範圍，包括.3mm、.4mm、.6mm、.7mm、.8mm、.9mm、或類似者的不同血管直徑範圍。
在一些實例中，揭示一種用於治療一動脈瘤的方法。該方法可包括判定與該動脈瘤的一血管相關的一血管直徑；選擇複數個編織植入物中的一者以用於治療該血管(例如基於所判定之該血管直徑)，其中各編織植入物包括在至少1mm血管直徑範圍內實質上一致的一孔隙度，各編織植入物經組態以在不同的1mm直徑範圍內提供實質上一致的孔隙度；及以該複數個編織植入物的一者治療該血管。
在一些實例中，該血管係漸縮的且包括相差至多1mm的一近端直徑和一遠端直徑，其中判定該血管直徑包括比較該近端直徑和該遠端直徑或直徑。
在一些實例中，該血管係漸縮的且具有大約1mm的血管直徑差，該方法進一步包括在大約1mm的血管直徑差內維持實質上一致的該孔隙度。
在一些實例中，該方法包括組態各編織植入物以覆蓋一血管直徑範圍，其中各別其他編織植入物之間具有0.5mm重疊。
在一些實例中，該血管直徑係漸縮的且範圍在大約3至4mm之間。
在一些實例中，該血管直徑係漸縮的且範圍在大約3.5至4.5mm之間。
在一些實例中，該血管直徑係漸縮的且範圍在大約4至5mm之間。
在一些實例中，該血管直徑係漸縮的且範圍在大約4.5至5.5mm之間。
在一些實例中，該血管直徑係漸縮的且範圍在大約5.0至6.0mm之間。
在一些實例中，該血管直徑係漸縮的，且該複數個編織植入物經組態以治療範圍在1.5至6mm之間的血管直徑。
在一些實例中，該判定一血管直徑係藉由X射線、螢光鏡檢查、MRI、或其他可視化手段來實現。
在一些實例中，該治療該血管包括將該編織植入物前移到一動脈瘤；及藉由使用該複數個編織植入物的一者將該動脈瘤排除及使血流從該動脈瘤轉向來重建該血管中的血流。
為了達成前述者及相關目的，本文中描述了某些說明性態樣，以另下列實施方式及隨附圖式。然而，這些態樣係陳述性的，但所請求標的之原理可採用該等不同方式中之幾種，並且所請求標的係意欲包括所有此等態樣及其均等者。其他優點及新穎特徵可由下列實施方式並結合圖式思考而變得清楚易見。
10‧‧‧編織植入物/植入物
12‧‧‧單股件
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24‧‧‧單絲/單股件
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30‧‧‧開口
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700‧‧‧方法
710‧‧‧步驟
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本解決方案之以上及進一步態樣會參考下列實施方式並結合隨附圖式來進一步論述，圖式中相似之標號表示各個不同圖式中相似之結構元件及特徵。圖式未必按比例繪製，相反，將重點放在繪示本發明的原理。圖式僅以舉例方式而非限制方式描繪本發明裝置的一或多種實施方案。
〔圖1〕係根據本發明的由單股件及一或多個不透輻射的多股件形成的一植入物本體的一部分的示意性放大視圖；
〔圖2〕描繪設想與本揭露的編織植入物使用的實例血管的側平面圖；
〔圖3〕係顯示本揭露的實例編織植入物的孔隙度對血管直徑的圖；
〔圖4〕係比較本揭露的實例編織植入物對習知裝置的孔隙度對血管直徑的圖；
〔圖5〕係顯示本揭露的一組實例編織植入物的孔密度和線數目對血管直徑的圖；
〔圖6〕係比較本揭露的一組實例編織植入物對一組習知裝置的孔隙度對血管直徑的圖；
〔圖7〕描繪概述本揭露的實例方法步驟的流程圖；及
〔圖8〕描繪概述本揭露的實例方法步驟的流程圖。
儘管本文詳細解釋所揭示技術的實例實施例，但應當理解可設想其他實施例。因此，並不旨在將所揭示技術的範圍限制在以下描述中闡述的或附圖中繪示的組件的構造及配置的細節。所揭示技術能夠具有其他實施例且能夠以各種方式實踐或實施。
亦應注意的是，除非上下文清楚地指明，否則本說明書及所附申請專利範圍中所用的單數形式「一(a/an)」及「該(the)」包括複數指代物。所謂「包含(comprising)」或「含有(containing)」或「包括(including)」係指至少命名的化合物、元素、粒子、或方法步驟存在於組成物或物品或方法中，但不排除存在其他化合物、材料、粒子、方法步驟，即使其他此類化合物、材料、粒子、方法步驟具有與命名的彼等相同的功能。
在描述實例實施例時，為了清楚起見，將採用術語。旨在使各術語設想所屬技術領域中具有通常知識者理解的最廣泛的含義，且包括以類似方式操作以完成類似目的的所有技術等同物。亦應理解，提到方法的一或多個步驟不排除存在附加的方法步驟或在彼等明確識別的步驟之間的中間方法步驟。在不脫離所揭示技術的範圍的情況下，可以與本文所述的順序不同的順序執行方法的步驟。類似地，亦應理解，提到裝置或系統中的一或多個組件不排除存在附加的組件或在彼等明確識別的組件之間的中間組件。
如本文所討論者，「對象(subject)」或「患者(patient)」的脈管系統可係人類或任何動物的脈管系統。應當理解，動物可係各種任何適用的類型，包括但不限於哺乳動物、獸醫動物、家畜動物、或寵物類動物等。作為一實例，動物可係專門選擇具有與人類相似的某些特性的實驗動物(例如，鼠、狗、豬、猴、或類似者)。應當理解，對象可係例如任何適用的人類患者。
如本文所討論的，「操作者(operator)」可包括醫生、外科醫生、或與將編織物本體遞送至對象的脈管系統相關聯的任何其他個體或遞送儀器。
如本文所討論者，「股件(strand)」在其最廣泛意義上旨在包括線、纖維、細絲、或其他單一伸長部件。
如本文所討論者，利用「不透輻射(radiopaque)」以用於係不透射線(radiodense)的正常意義，也就是說，由抑制電磁輻射通過以在成像期間增加可視性的一或多種材料形成。根據本發明使用的合適的不透輻射的材料包括鉑、鉻、鈷、鉭、鎢、金、銀、及其等的合金。
當觀看附到本揭露的圖式時，可更佳理解本揭露的編織植入物10。例如，在圖1中，根據本揭露的實例顯示編織植入物10的一部分的示意性放大視圖。編織植入物10可由單股件12和一或多個不透輻射的多股件14形成，該單股件由至少第一材料形成。在此構造中，植入物10係織造以包括至少第二多股件16。在由虛線指示的另一構造中，植入物10進一步包括由各自分別與單絲26和28一起放置之單絲22和24形成的多股件18和20。在一些構造中織造且在其他構造中編織的植入物10的圖案包括由在第一方向定向的單股件12和由在例如橫向於第一方向的第二方向定向的單股件24和25界定的開口30。植入物10進一步包括由在與多股件14相同的方向定向的單股件13和15、及由在橫向方向定向的單股件24、25、和27界定在多股件14的任一側上的開口32和34。在一些構造中，開口32和34稍微比僅由單股件界定的開口30大；在其他構造中，所有開口30、32、和34實質上相同。
設想用於本揭露的植入物10的其他實施例，並且亦可在美國專利公開案第2016/0058524號中觀察到，其全文以引用方式併入本文。在一些實例中，本揭露的編織植入物10構造被認為具有如同僅由單股件材料形成的植入物10之實質上相同圖案。由於多股件以相同的方式編織、織造、或以其他方 式平行於彼此放置，如同利用不透輻射的材料的單股件，並且尤其是當多股件的各細絲具有與單股件相同的直徑時，對於諸如彈性、擴張能力、及捲曲輪廓的植入物性能有極少或沒有機械影響。
轉至圖2，顯示設想與本揭露的植入物10使用的實例血管的側平面圖。可以看出，實例血管沿其內頸動脈(internal carotid artery,ICA)的縱軸漸縮。參見Rai AT,Hogg JP,Cline B,et al.J NeuroIntervent Surg(2012)，其全部內容在此併入作為參考資料。Rai研究著手判定前大腦循環中血管的典型長度、直徑、和錐度(taper)。在近端海綿狀ICA、ICA末端、中大腦動脈(middle cerebral artery)MCA起點、和M2起點測量動脈直徑。沿中心線計算這些端點之間的長度。將ICA的血管錐度計算為每單位長度的口徑變化。進行此研究中，Rai研究判定海綿狀ICA和ICA末端的平均直徑分別係5±0.6mm和3.6±0.4mm。平均ICA錐度係0.04±0.02mm/1mm。對於MCA，MCA和M2起點處的直徑分別測量為3.1±0.4mm和2.4±0.4mm。
圖2提供從近側海綿狀ICA朝向ICA末端所取的各別長度處的直徑測量的非限制性實例，而進一步舉例血管的漸縮本質。Rai研究確認，ICA從其近側海綿區段到植入物10經組態以治療的ICA末端漸縮。
轉至圖3，提供顯示本揭露的實例編織植入物10的孔隙度與本揭露所探討的血管直徑相比的百分比之圖。可以看出，本揭露的編織植入物10在1mm血管直徑範圍內保持相對一致的孔徑和孔隙度。在本揭露整份中，當係指血管直徑範圍時，旨在此用語意指在由編織植入物10治療的血管中的兩個單獨位置之間測量的直徑範圍。例如，使用X射線可視化的從業人員可將近側海綿狀ICA的血管直徑測量為4.2mm，而朝向ICA末端的血管直徑可係3.2。在這 方面，此實例漸縮血管中的血管直徑範圍將係1mm。本揭露的植入物10係設計以在這些實例血管直徑範圍內容納此類漸縮血管，同時亦維持實質上一致的目標孔隙度。此係特別有利的，因為這意味著需要更少的植入物以容納比習知裝置漸縮更大(例如，大約.25mm之血管直徑範圍)或一般在神經血管系統中看到的曲折更大的血管。
以此，圖3描繪具有在3.5mm至4.5mm之間的1mm血管直徑範圍的實例血管。在此實例中，本揭露的編織植入物10維持大約70%的孔隙度。具體地，在3.5mm的直徑處，編織物的孔隙度大約69%。在4.0mm的直徑處，編織物的孔隙度大約69%。在4.5mm的直徑處，編織物的孔隙度大約67%。
轉至圖4，提供彙總所進行的比較的圖，藉此顯示本揭露的實例植入物10對Medtronic在1mm血管直徑範圍內的PipelineTM栓塞裝置(PipelineTM Embolization Device,PED)的孔隙度對血管直徑。具體地，在3.5mm至4.5mm的血管直徑範圍之間比較編織植入物10和PED裝置。可以看出，本揭露的編織植入物10在圖3中先前顯示的相同範圍內在1mm血管直徑範圍內保持約70%的相對一致的孔徑和孔隙度。反之，PED裝置在3.5mm血管直徑展示80%的孔隙度，在4mm的血管直徑展示70%的孔隙度，且在4.5mm的血管直徑展示小於50%的孔隙度。不同地陳述，隨著血管的直徑在1mm範圍內增加，PED裝置的孔隙度顯著減小，而本揭露的實例編織植入物10在1mm直徑範圍內展示實質上一致的孔隙度。
圖4亦顯示各裝置在擴張時其變化的孔隙度，且其特徵相同。在某些實例中，編織植入物10係設計使得經指定的血管直徑與孔隙度曲線的峰 及圍繞其的平臺區域(其與目標孔隙度的偏差非常小)重合。例如，在圖3中，所示的編織植入物10係指定用於從3.5mm至4.5mm的動脈直徑範圍。此裝置在其整個擴張範圍保持非常接近70%的目標孔隙度，其具有1.0mm的寬度。
例如，當裝置被壓縮時，其係密集的，所以其孔隙度非常低(參見例如圖3的左下方)。隨著裝置擴張，孔隙度由於編織植入物10的孔開啟而增加。在某個點處，孔隙度達到峰，其係當編織角度係90度時，因為各孔可係正方形，並且盡可能大，如圖3的中心箭頭所示者。此峰之後的直徑進一步擴張於是降低各孔的大小並因此降低孔隙度。當編織植入物10在其擴張極限處達到最大直徑時，編織植入物10再次非常密集且孔隙度係對應地低(參見例如圖3的右下方)。
相反地，已知的其他裝置可係不同地設計，使得孔隙度曲線的平臺區域不如1.0mm般寬，或者其等可指示與平臺區域不重合的動脈直徑。在此等較舊的方法中，與目標孔隙度重合的直徑範圍將係窄的，因為在平臺外，動脈直徑的小變化導致與目標孔隙度的大偏差。據此，已知的其他裝置將無法治療較寬範圍的血管直徑。
轉至圖5，提供彙總本揭露的實例編織植入物10的孔隙度對血管直徑的圖。具體地，圖5顯示六個單獨的編織植入物(10)，各者具有大約1mm的血管直徑範圍，並且彼此偏移大約該範圍的一半(0.5mm)。圖例顯示從最小值到最大值的血管直徑範圍及適用的編織植入物(10)的對應標示。例如，第一編織植入物(10)經組態用於在2.0mm和3.0mm之間的血管直徑範圍，以2.5mm標示。第一編織植入物(10)具有48線，其中孔密度(mm2)18。第二編織植入物(10)經組態用於在2.5mm和3.5mm之間的血管直徑範圍，以3mm標示。第二 編織植入物(10)具有64線，其中孔密度(mm2)23。第三編織植入物(10)經組態用於在3.0mm和4.0mm之間的血管直徑範圍，以3.5mm標示。第三編織植入物(10)具有64線，其中孔密度(mm2)18。第四編織植入物(10)經組態用於在3.5mm和4.5mm之間的血管直徑範圍，以4.0mm標示。第四編織植入物(10)具有72線，其中孔密度(mm2)19。第五編織植入物(10)經組態用於在4.0mm和5.0mm之間的血管直徑範圍，以4.5mm標示。第五編織植入物(10)具有96線，其中孔密度(mm2)21。第六編織植入物(10)經組態用於在4.5mm和5.5mm之間的血管直徑範圍，以5mm標示。第六編織植入物(10)具有96線，其中孔密度(mm2)21。
轉至圖6，提供彙總所進行的比較的圖，藉此顯示針對本揭露的一組實例植入物(10)對一組PED裝置在不同血管直徑範圍內(包括從2mm至6mm)的孔隙度對血管直徑。具體地，在經指定為經組態用於2mm至3mm血管直徑範圍內的第一編織植入物10中，觀察編織植入物10提供大約70%的孔隙度，而相當的PED裝置僅能夠在2.5mm至2.75mm的血管直徑範圍內(即僅.25mm血管直徑範圍)維持大約70%的孔隙度。如所示，對於該PED裝置，相關直徑範圍內的另一PED裝置係必要的，僅以完成從2.75mm至3.0mm血管直徑範圍的間隙。第一編織植入物(10)由48股線建構，且PED裝置由48股線類似地建構。對於2.0mm至2.5mm的範圍，亦需要另外兩個PED裝置，因為PED裝置僅展示在使用期間能夠維持70%孔隙度的0.25mm範圍。
圖6亦描繪經指定為經組態用於2.5mm至3.5mm血管直徑範圍內的第二編織植入物(10)，觀察編織植入物(10)提供大約70%的孔隙度，而相當的PED裝置僅能夠在3.0mm至3.25mm的血管直徑範圍內(即僅.25mm血管直 徑範圍)維持大約70%的孔隙度。此實例中的第二編織植入物(10)由64股線建構，而PED裝置由48股線建構。換言之，在血管直徑為3mm處，第二編織植入物(10)使用大約21.3股/mm的血管直徑，而PED裝置使用16股/mm的血管直徑。由於每直徑使用較少的股件，PED裝置的孔隙度對直徑曲線具有比第二編織植入物(10)窄的平臺區段。此外，如所示，對於該PED裝置，相關直徑範圍內的另一PED裝置係必要的，僅以完成從3.25mm至3.50mm血管直徑範圍的間隙。此外，如所示，相對於2.5mm至3.0mm的範圍及第一編織植入物(10)，亦需要另外兩個PED裝置，因為PED裝置僅展示在使用期間能夠維持70%孔隙度的.25mm範圍。
圖6亦描繪經指定為經組態用於3.0mm至4.0mm血管直徑範圍內的第三編織植入物(10)，觀察編織植入物(10)提供大約70%的孔隙度，而相當的PED裝置僅能夠在3.5mm至3.75mm的血管直徑範圍內(即僅.25mm血管直徑範圍)維持大約70%的孔隙度。此實例中的第三編織植入物(10)由64股線建構，而PED裝置由48股線建構。換言之，在血管直徑為3.5mm處，第三編織植入物(10)使用大約18.3股/mm的血管直徑，而PED裝置使用13.7股/mm的血管直徑。由於每直徑使用較少的股件，PED裝置的孔隙度對直徑曲線具有比第三編織植入物(10)窄的平臺區段。此外，如所示，對於該PED裝置，相關直徑範圍內的另一PED裝置係必要的，僅以完成從3.75mm至4.00mm血管直徑範圍的間隙。
圖6亦描繪經指定為經組態用於3.5mm至4.5mm血管直徑範圍內的第四編織植入物(10)，觀察編織植入物(10)提供大約70%的孔隙度，而相當的PED裝置僅能夠在4.0mm至4.25mm的血管直徑範圍內(即僅.25mm血管直 徑範圍)維持大約70%的孔隙度。此實例中的第四編織植入物(10)由72股線建構，而PED裝置由48股線建構。換言之，在血管直徑為4mm處，第四編織植入物(10)使用大約18股/mm的血管直徑，而PED裝置使用12股/mm的血管直徑。由於每直徑使用較少的股件，PED裝置的孔隙度對直徑曲線具有比第四編織植入物(10)窄的平臺區段。此外，如所示，對於該PED裝置，相關直徑範圍內的另一PED裝置係必要的，僅以完成從4.25mm至4.50mm血管直徑範圍的間隙。
圖6亦描繪經指定為經組態用於4.0mm至5.0mm血管直徑範圍內的第五編織植入物(10)，觀察編織植入物(10)提供大約70%的孔隙度，而相當的PED裝置僅能夠在4.5mm至4.75mm的血管直徑範圍內(即僅.25mm血管直徑範圍)維持大約70%的孔隙度。此實例中的第五編織植入物(10)由96股線建構，而PED裝置由48股線建構。換言之，在血管直徑為4.5mm處，第五編織植入物(10)使用大約21.3股/mm的血管直徑，而PED裝置使用10.7股/mm的血管直徑。由於每直徑使用較少的股件，PED裝置的孔隙度對直徑曲線具有比第五編織植入物(10)窄的平臺區段。此外，如所示，對於該PED裝置，相關直徑範圍內的另一PED裝置係必要的，僅以完成從4.75mm至5.00mm血管直徑範圍的間隙。
圖6亦描繪經指定為經組態用於4.5mm至5.5mm血管直徑範圍內的第六編織植入物(10)，觀察編織植入物(10)提供大約70%的孔隙度，而相當的PED裝置僅能夠在5.0mm至5.25mm的血管直徑範圍內(即僅.25mm血管直徑範圍)維持大約70%的孔隙度。此實例中的第六編織植入物(10)由96股線建構，而PED裝置由48股線建構。換言之，在血管直徑為5.0mm處，第六編織植入物(10)使用大約19.2股/mm的血管直徑，而PED裝置使用9.6股/mm的血管直 徑。由於每直徑使用較少的股件，PED裝置的孔隙度對直徑曲線具有比第六編織植入物(10)窄的平臺區段。此外，如所示，對於該PED裝置，相關直徑範圍內的另一PED裝置係必要的，僅以完成從5.25mm至5.50mm血管直徑範圍的間隙。
如圖6中所見，對於由編織植入物(10)的一者覆蓋的各經指定的1mm血管範圍，從業人員將需要四個單獨的PED裝置用於對應血管中的類似覆蓋，考慮到血管罹患出血事件的本質和顯著漸縮的傾向，其係既不方便、浪費、又可能相當不安全。例如，如果血管係漸縮大於.25mm，則目前沒有PED裝置將以維持70%的實質上一致的目標孔隙度的方式充分地治療患病血管。
在圖7中，流程圖描繪一實例方法700和對應步驟。步驟710包括判定與具有該動脈瘤的一血管相關的一血管直徑。步驟720包括選擇複數個編織植入物(10)中的一者以用於治療該血管，其中各編織植入物(10)包含在至多1mm血管直徑範圍內實質上一致的孔隙度，各編織植入物(10)經組態以在不同的1mm直徑範圍內提供實質上一致的孔隙度。步驟730包括以該複數個編織植入物(10)的一者治療該血管。
在圖8中，流程圖描繪一實例方法800和對應步驟。步驟810包括判定與含有動脈瘤的血管相關的血管直徑。步驟820包括選擇複數個編織植入物(10)中的一者以用於治療該血管，其中各編織植入物(10)包含在至少0.5mm血管直徑範圍內實質上一致的孔隙度，各編織植入物(10)經組態以在不同的0.5mm直徑範圍內提供實質上一致的孔隙度。步驟830包括以該複數個編織植入物(10)的一個治療該血管。
本揭露的編織植入物(10)是特別有利的，因為醫師可從較寬的經指定直徑範圍獲益，因為其可針對測量不準確性及/或誤差得到一些寬容(例如，在X射線或任何其他可視化手段上測量的動脈在其實際係3.5mm時係3.3mm)。醫師也可獲益，因為較寬的指示直徑範圍可維持接近目標孔隙度的一致孔隙度，其係常見的。本揭露的植入物(10)也是有利的，因為動脈直徑的解剖範圍可以較少的裝置來治療，而簡化裝置選擇程序並為其等必須保持在手邊的庫存節省儲存空間。
在某些實例中，揭示一組或一家族植入物(10)(各者具有1.0mm寬的經指定直徑範圍)係配置使得其等覆蓋0.5mm重疊的解剖範圍，如圖5至圖6所示。應注意，整個所描繪和描述的範圍係針對各別編織植入物(10)的至多1mm的血管直徑範圍。然而，設想編織植入物(10)可適於大於1mm的血管直徑範圍。本揭露的編織植入物(10)是特別有利的，因為對於任何給定的動脈直徑，存在可被選擇的裝置的兩種不同選項。例如，具有3.25mm直徑的動脈可處於脈管系統中的所欲治療位置處。如果當移動遠離治療位置時動脈逐漸減小(即變小)，則醫師可藉由例如選擇列在2.5mm(而非3.5mm)的植入物而從該組或家族植入物中選擇較小的植入物。在此方面，動脈區段在較長的長度上暴露至目標孔隙度。反之，如果當移動遠離治療位置時動脈逐漸變大(即變大)，則醫師可以藉由例如選擇列在3.0mm至4.0mm的植入物而從該組或家族植入物中選擇較大的植入物。在此方面，類似於前面的實例，動脈區段在較長的長度上暴露至目標孔隙度。
本揭露的優點起因於提供具有特徵孔隙度曲線的寬平臺區域的編織植入物，使得植入物或者該家族或該組植入物能夠治療大約1.0mm寬的 經指定範圍的平臺內的動脈直徑，並且重疊經指定的直徑範圍，所以醫師具有取決於所呈現的解剖結構之最佳選擇的選項。
在某些實例中，本揭露的編織植入物的並排細絲之各者包括不透輻射材料的單絲。在一構造中，具有多股件的載體實質上與用於單股件的載體相同。該多股件的並排細絲中的各者係不透輻射的材料的單絲。較佳地，各並排細絲的直徑實質上與單股件的直徑相同。形成本體包括建立第一間距圖案(諸如開口的編織物圖案或開口的編織圖案)及第一壁厚度，並且各多股件以第一間距圖案接合，而實質上不偏離該圖案並且實質上不改變第一壁厚度。
在某些技術中，針對每數十個單股載體利用至少一個多股載體。一些機器具有至少42個載體(諸如48個載體)，並且該等載體中的至少6者(諸如8個載體)係載有不透輻射材料的多股件。此仍然導致48載體編織，但當8個載體係載有不透輻射材料的單股件時具有不透輻射股件的雙倍數目。
本揭露的編織植入物(包括流動轉向器)可係設計用於在其等已經遞送並在治療部位就位擴張之後的每個動脈區域的覆蓋區域的特定百分比，或者相反地，本揭露中已知為「孔隙度」的每個動脈區域剩餘的開口區域的百分比。所設計的孔隙度可藉由編織參數來調整，諸如線的數目、線的寬度、編織直徑、和編織角度，其可替代地測量為PPI或節距。一旦基於這些因素識別目標孔隙度，就可調整編織設計，使得其在經擴張至經指定的動脈直徑時達到目標孔隙度。
本揭露的編織植入物(包括流動轉向器)可在不同動脈直徑處達到目標孔隙度的一組或家族內具有許多變化。因此，該組或家族裝置一起 允許醫師治療解剖範圍內的任何直徑動脈(1.5mm至6mm對於神經血管係典型的)。
本文所含有的描述係說明各種實施例的實例，且不旨在限制本揭露的範圍。如本文所述，本發明設想到可使用的系統、裝置、或方法的許多變型及修改。變化型可包括但不限於本文所述元件及組件的替代性幾何形狀、針對各組件或元件利用各種材料中的任一種(例如，不透輻射材料、記憶形狀金屬等)。這些修改將對本發明所屬技術領域中具有通常知識者顯而易見，並且旨在處於以下申請專利範圍的範疇內。
具體的構型、材料的選擇、及各種元件的大小及形狀可以根據需要根據所揭示技術的原理構造的系統或方法的特定的設計規格或約束而變化。此類改變旨在包含在所揭示技術的範圍內。因此，本揭露的實施例在所有方面都被認為係說明性的而非限制性的。因此，從前述內容顯而易見的是，雖然已經繪示及描述本揭露的特定形式，在不脫離本揭露的精神及範圍的情況下，可以進行各種修改，且在其等同物的含義及範圍內的所有改變都旨在包含在其中。
10‧‧‧編織植入物/植入物
12‧‧‧單股件
13‧‧‧單股件
14‧‧‧多股件
15‧‧‧單股件
16‧‧‧多股件
18‧‧‧多股件
20‧‧‧多股件
22‧‧‧單絲
24‧‧‧單絲/單股件
25‧‧‧單股件
26‧‧‧單絲
27‧‧‧單股件
28‧‧‧單絲
30‧‧‧開口
32‧‧‧開口
34‧‧‧開口

Claims (20)

  1. 一種經組態為用於治療一動脈瘤之一流動轉向器的編織植入物，該植入物包含：
    一編織網，其經組態以在至多1mm的血管直徑範圍之一漸縮血管中維持實質上一致的一目標孔隙度；
    其中該編織網經組態以在該漸縮血管中的同時於該編織網的近端及遠端之間維持實質上一致的該目標孔隙度。
  2. 如請求項1所述之植入物，其中該漸縮血管包含一近端直徑及一遠端直徑，該近端直徑及該遠端直徑相差至多1mm，其中該至多1mm的血管直徑範圍係藉由比較該近端直徑及該遠端直徑來界定。
  3. 如請求項1所述之植入物，其中實質上一致的該目標孔隙度係大約70%。
  4. 如請求項1所述之植入物，其中在該漸縮血管中的該編織網的近端及遠端之間的一預定長度係至少3cm。
  5. 如請求項1所述之植入物，其中在該漸縮血管中的該編織網的近端及遠端之間的一預定長度係至少1cm。
  6. 如請求項1所述之植入物，其中該編織植入物進一步包含經指定的一血管直徑，且其中該編織植入物經組態使得經指定的該血管直徑與該編織植入物的一孔隙度曲線的一峰重合。
  7. 如請求項6所述之植入物，其中該編織植入物進一步包含一孔隙度平臺，該孔隙度平臺對應於血管直徑中圍繞該孔隙度曲線的該峰設置的該1mm徑向範圍。
  8. 如請求項6所述之植入物，其中該編織植入物進一步包含一孔隙度平臺，該孔隙度平臺與血管直徑中圍繞該孔隙度曲線的該峰設置的該1mm徑向範圍重合。
  9. 如請求項1所述之植入物，其中該編織植入物的一孔密度係大約18至23孔/mm2。
  10. 如請求項1所述之植入物，其中該編織植入物係實質上圓柱形的一多孔結構。
  11. 如請求項1所述之植入物，其中該編織植入物由複數個單股件及一或多個不透輻射的多股件形成，該複數個單股件由至少一個第一材料構成。
  12. 如請求項1所述之植入物，其中該編織植入物由各自分別與單絲一起放置之單絲形成的複數個多股線形成。
  13. 一種用於治療一動脈瘤的系統，其包含：
    複數個編織植入物，其中各編織植入物包含在血管直徑中的不同的1mm徑向範圍內實質上一致的一孔隙度，各編織植入物經組態以在不同的1mm徑向直徑範圍內提供實質上一致的孔隙度。
  14. 如請求項13所述之系統，其中該編織植入物經組態用於在一漸縮血管中使用，其中該漸縮血管包含相差至多1mm的一近端直徑及一遠端直徑，其中血管直徑中的該不同的1mm徑向範圍係藉由比較該近端直徑及該遠端直徑來界定。
  15. 如請求項13所述之系統，其中該複數個編織植入物包含：
    一第一編織植入物，其經組態以治療2至3mm的一血管直徑範圍；
    一第二編織植入物，其經組態以治療2.5至3.5mm的一血管直徑範圍；
    一第三編織植入物，其經組態以治療3.0至4.0mm的一血管直徑範圍；
    一第四編織植入物，其經組態以治療3.5至4.5mm的一血管直徑範圍；
    一第五編織植入物，其經組態以治療4.0至5.0mm的一血管直徑範圍；及
    一第六編織植入物，其經組態以治療4.5至5.5mm的一血管直徑範圍；
    其中各編織植入物的該孔隙度範圍在65%及70%之間。
  16. 如請求項15所述之系統，其中各編織植入物包含範圍在大約18至23孔/mm2之間的一孔密度。
  17. 如請求項13所述之系統，其中該複數個編織植入物之各者彼此偏移該複數個編織植入物的次一最小編織植入物的血管直徑中的該徑向範圍的大約一半。
  18. 一種治療一動脈瘤的方法，該方法包含：
    判定與具有該動脈瘤的一血管相關的一血管直徑；
    選擇複數個編織植入物中的一者以用於治療該血管，其中各編織植入物包含在至多1mm血管直徑範圍內實質上一致的一孔隙度，各編織植入物經組態以在不同血管直徑範圍內提供實質上一致的孔隙度；及
    以該複數個編織植入物的一者治療該血管。
  19. 如請求項18所述之方法，其中該血管係漸縮的，且該漸縮血管包含相差至多1mm的一近端直徑及一遠端直徑，其中該判定該血管直徑包含比較該近端直徑及該遠端直徑，該方法進一步包含：
    在整個該漸縮血管中維持實質上一致的該孔隙度。
  20. 如請求項18所述之方法，其中該治療該血管包含：
    將該編織植入物前移到一動脈瘤；及
    藉由使用該複數個編織植入物的一者將該動脈瘤排除及使血流從該動脈瘤轉向來重建該血管中的血流。
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US12004977B2 (en) 2024-06-11
US10463510B1 (en) 2019-11-05
AU2019213303A1 (en) 2020-02-20
US10456280B1 (en) 2019-10-29
CO2019008574A1 (es) 2021-02-08
JP2020022750A (ja) 2020-02-13
RU2019124732A (ru) 2021-02-05

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