CN101394955B - 三维的复合线圈 - Google Patents

三维的复合线圈 Download PDF

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CN101394955B
CN101394955B CN2006800512639A CN200680051263A CN101394955B CN 101394955 B CN101394955 B CN 101394955B CN 2006800512639 A CN2006800512639 A CN 2006800512639A CN 200680051263 A CN200680051263 A CN 200680051263A CN 101394955 B CN101394955 B CN 101394955B
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R·莫内蒂
G·马丁尼斯
M·费茨
D·J·佩雷斯
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Abstract

一种复合线圈和用于形成复合线圈的支架，该复合线圈构形成使得各环路形成为相对彼此具有各种构形。这些构形提供了对血栓生成的改善以及一旦植入后使转动或翻转降低。复合线圈由一种材料制成，该材料可进行变形，目的是把复合线圈置入到导管中，并且一旦使用时包括所述环路的复合线圈可以回复至复合的形状。

Description

三维的复合线圈
相关文件的相互参考
本申请要求下列专利的优先权并把它们全部地结合入本文中作为参考：2005年11月17日由Monetti等人提交的题为“ThreeDimensional Complex Coil”的美国临时专利申请系列NO.60/738,087和2006年8月17日由Monetti等人提交的题为“Three Dimensional ComplexCoin”的美国临时专利申请系列NO.60/822,656。
背景技术
现有技术设想了许多采用三维(3-D)形状的线圈用于治疗人体动脉瘤的方法及装置，上述线圈有时称为“复合(或合成)”线圈。例如：其内容被结合进来作为参考的Horton的5,766,219示出了一种中空结构；其内容被结合进来作为参考的Phelps的5,3 82,259及Ritchart的4,994,069示出了其它的3-D线圈设计；其内容被结合进来作为参考的Teoh的6,635,069教导了一系列的非重叠的环路；其内容被结合进来作为参考的Wallace的6,860,893示出了复合线圈；其内容被结合进来作为参考的Ferrera的6,638,291示出了一种除去J形状的近端段延伸离开装置的复合部分之外类似于Teoh的及Wallace的装置的装置。
下列专利文件提供了进一步的背景并也被结合于本文中作为参考：Guglielmi的6,010,498；Gandhi的6,478,773；Schaefer的2002/0107534；Mariant的5,957,948；Pham的5,911,731；Lahille的4,957,501；Porter的2005/0192618；Wallace的2005/0192621。
然而，存在着提供更先进的以及改进的复合线圈的现实需求，以便提供动脉瘤的更好治疗。
发明内容
因此本发明的目的是提供超过现有技术的用于治疗动脉瘤的改进的装置及方法。
这个目的及此处未特别列举的其它目的通过本发明来实现，本发明的至少一个实施例包括围绕支架缠绕的圆环形装置，使得装置的长度的各部分在圆环的中心相遇或重叠。这使装置的外部分能够形成架子，而装置的内部分设置成闭合，以防止血液的涌入和防止助长血栓生成。
一个实施例包含有一种材料的导线(或一束材料)，所述材料自动生成圆环形系列的环路，并被设计成在体腔(或人体腔)内提供稳定的结构，能使体腔闭合并用作保持附加治疗装置的框架。
本发明的另一个实施例提供了一种材料的导线，所述材料自动生成十字形系列的环路，并被设计用来在体腔内提供稳定的结构，能使体腔闭合并用作保持附加治疗装置的框架。
在另一方面，本发明包含有制造的工具及方法以实施本发明的上述实施例。
在本发明再一方面，其中的实施例包含有围绕支架缠绕的十字形装置，所述支架包括至少两个平行的销，所述两个平行的销以一定角度相对至少一个附加销设置。这个构造使得装置的外部分能够形成架子，而装置的内部分设置成闭合，以防止血液涌入和防止助长血栓生成。这个实施例还有益地阻止在应用过程中出现转动或翻滚。
附图说明
图1是本发明的支架及复合线圈的实施例的立体视图；
图2是本发明的复合线圈的实施例的立体视图；
图3是本发明的支架及复合线圈的实施例的立体视图；
图4是本发明的复合线圈的立体视图；
图5-8是围绕本发明的各种支架的复合线圈的图像(或图案)；
图9-10是根据本发明的一种方法制成的复合线圈的图像；
图11是围绕以虚线表示的本发明的支架实施例而制成的本发明的复合线圈实施例的立体视图；
图12是本发明的复合线圈实施例的立体视图；
图13是本发明的复合线圈实施例的立体视图；
图14是本发明的支架实施例的立体视图；
图15是图14中所示的支架的前视图；和
图16-19是应用根据本发明的方法及支架制成的若干复合线圈的图像。
具体实施方式
环形的三维线圈
现在参考各附图和首先参考图1-6，描述了线圈或复合线圈10，该线圈采用圆环形支架12来成形的。在图1中线圈10已经围绕支架12被卷绕了4次，从而形成了4条环路14，每条环路被定位成与相邻的环路成大约90°。当配置于诸如血管或动脉瘤的体腔中时，围绕支架12卷绕的线圈10使线圈10形成为复合的形状。所述装置可由一定长度的导线制成，所述导线已被螺旋地缠绕而形成细长的线圈导线。另一方面，所述导线可通过本领域中已知的方法进行编织或针织来形成次级的形状。所述导线优选是记忆金属，诸如镍钛诺，但也可以是铂、钽(或钽铝青铜)、钨、不锈钢或其它生物相容的材料制成。其它材料，诸如涤纶或尼龙纤维，诸如聚交酸(polylactic)或聚乙醇酸(polylycolic acid)及可膨胀的和不膨胀的水凝胶材料的生物可降解的聚合物，可被置于线圈或编织结构的内部或外部，以增强所述装置的性能。
仅出于描述的目的，对于有关复合线圈10的形状进行了观察，线圈10是由围绕圆环形支架12卷绕盘绕(或成线圈)的导线而得到的。如图2中所图示的，环路14a-d的每条环路大致地包含在相应的平面16a-d之内。各个平面大约在靠近复合线圈10的中心的公共相交轴线18处彼此相交。如本领域技术人员将理解的，围绕圆环形支架12形成的任何环路将仅大约被包含在这些平面内，而它们被包含在这些平面内的程度仅是它们围绕圆环如何缠绕的函数，并对它们的性能具有小的影响或没有任何影响
如图3及4所示，任意数量的环路可用来形成本发明的复合线圈。在图3中，复合线圈20通过围绕圆环形支架12卷绕8条环路22形成。环路22围绕圆环支架12相对均匀地分布，但可以任何数量的构形间隔开。结果是图4中所示的8条环路的复合线圈20。
图5及6显示复合线圈30是采用16条环路32围绕圆环支架12形成的。环路32按两个一组进行分组，从而仅出现8条不同的环路。
用于治疗诸如大脑动脉瘤状况的一个示例包含铂/钨合金复合线圈(Pt 92％，W 8％，可从纽约的Sigmund Cohn Mount Vernon购得)，直径范围为约0.125mm-约0.625mm，而长度为约5mm-约1000mm。复合线圈是围绕类似于图1、3、5及6中所示的支架12的陶瓷或金属的圆环形支架形成。图1-6中所示的缠绕图案围绕圆环支架12形成第一环路14a，然后第二环路14b距第一环路大约180°围绕圆环形支架。在这个示例中，一个数字8的图案用来缠绕第一及第二环路。然后第三环路14c以相对第二环路一定角度，通常5°-175°角度围绕圆环的中心形成。第四环路14d采用数字8的图案从第三环路形成。根据所要求的装置尺寸可增加更多的环路14。
本领域技术人员将会理解，所述圆环形复合线圈构形的一个优点是，它可通过改变环路的数目针对治疗位置的尺寸进行调节(或确定适当的比例(scale))。例如，非常小的(0.5-3mm)的创口可用2-4条环路构形进行治疗，中等尺寸的(4-10mm)用4-12条环路构形进行治疗，大的(超过10mm)用8-36条环路构形进行治疗，等等。环路可形成诸如“O”形(例如圆形、蛋形、正方形、椭圆形、星形等)的封闭结构，或是诸如“C”或“U”形的开放的结构。环路可以是任何尺寸的，并且通常针对治疗位置的近似尺寸进行调节。在先前的示例中，环路的直径范围可为5mm-50mm的范围。关于这点，“直径”不应狭隘地解释为意指圆环的尺寸。而是“直径”用于广义地包含回路的近似尺寸及形状。
缠绕之后，支架及复合线圈通过本领域中已知的方法进行热定形。例如，用于铂复合线圈的通常退火步骤大约在1100°F下经5-40分钟。
一旦被退火，当基本不受约束或处于其最小能量状态时，复合线圈将近似地保持经缠绕的状态。然后复合线圈可经进一步处理，诸如：形成尖头，增加用于附加于传送系统的联接(或耦合)机构，在复合线圈上或里面放置水凝胶或纤维，在复合线圈内部或外部放置抗松扩件，等等。然后可将复合线圈接附于传送系统，这在本领域内是已知的，诸如题为“Thermal Detachment System for Implantable Devices”的美国专利申请系列号11/212,830中所公开的那些内容，上述专利全部地被结合于本文作为参考。传送系统的其它示例公开于Guglielmi的6,010,498或Gandhi的6,478,773中。一旦接附于输送推进器，复合线圈就以基本线性的构形被置于导管中，以输送至治疗位置。
在一种典型的程序中，线性的复合线圈被馈送通过诸如微导管(或微导尿管)的导管，这是通过用输送推进器使它前进经过所述导管来实现的。根据先有的微导管，而后复合线圈自动形成治疗位置内的结构，所述结构接近其经退火的形状。
用于制作植入物的支架12被表示为封闭的圆形的圆环。然而，可以采用诸如椭圆形、正方形及星形的图案的其它非圆形的形状。此外，圆环不需要是封闭的结构。事实上，如果在结构内留有间隙可更容易缠绕，使得利用悬置重量而在复合线圈上保持张力。
十字形的三维线圈
现在参考图7-12，示出了采用支架42的复合线圈40的生产，支架42包含有多个彼此成直角布置的销44。像图1-6中所示的实施例，采用图7-12中的支架42形成的复合线圈40的实施例可由一定长度的导线制成，所述导线已被螺旋地缠绕来形成盘绕的导线。另一方面，导线可通过本领域内已知的方法被编织或针织以形成次级的形状。导线可以是铂、钽(或钽铝青铜)、钨、不锈钢、镍钛诺或其它生物相容的材料制成。诸如涤纶或尼龙纤维、诸如聚交酸或聚乙醇酸的生物可降解的聚合物以及可膨胀的或不膨胀的水凝胶材料的其它材料，可被置于复合线圈或编织结构的内部或外部，以增强所述装置的性能。仅作为示例，一个实施例可使用铂/钨合金复合线圈10(Pt 92％，W 8％，可从纽约的Sigmund Cohn Mount Vernon购得)来治疗诸如大脑动脉瘤的状况，铂/钨合金复合线圈10的直径范围为约0.125mm-约0.625mm，而长度为约5mm-约1000mm。
复合线圈40通过围绕支架42卷绕盘绕的导线而形成，如图7-8所示。支架42优选是陶瓷的或金属的十字形支架并包含有多个沿轴线X、Y及Z彼此成直角布置的销44。更准确地说，支架42包含有：两个平行于X轴线的销44X，两个平行于Y轴线的销44Y和两个平行于Z轴线的销44Z。
图9-12示出了可使用图7-8的支架42制成的复合线圈40的示例。在图11-12中最清楚地示出的这个实施例中的缠绕图案形成：围绕第一销44Y1的第一环路46a；然后是围绕第二销44X1的第二环路46b，第二销44X1设置成与第一销44Y1成一定角度。在这个实施例中，环路46a与46b之间的角度近似为45°-135°。然后在近似地与第二环路46b相同的平面中形式第三环路46c。在这个示例中，第三环路46c围绕销44X2以数字8的图案与第二环路46b一起形成。然后将第四环路46d与第三环路46c成一定角度形成。在这个示例中，第四环路46d与第三环路46c近似地成45°-135°并围绕销44Y2形成，并且也近似地与第一环路46a共平面。然后第五环路46e通过使导线围绕销44X1进行卷绕与第四环路46d成一定角度并与第二环路46b间隔开而形成，并且也围绕销44X1而形成。第六环路46f位于近似与第五环路46e相同的平面中，以与第五环路46e成数字8的图案。第六环路46f通过围绕销44X2卷绕导线并与第三环路46c间隔开而形成，第六环路46f也是围绕销44X2形成。在这个示例中，第五环路46e及第六环路46f分别地与第二环路46b及第三环回路46c近似地同心。
可应用少于六条环路来形成较短的复合线圈，同时可以缠绕附加的环路来制作较长的装置。例如，图7-8中所示的销44Z延伸穿过销44X及44Y，并因此被用于将销44X及44Y保持在其位置上。然而，如果需要较长的装置，将通过围绕从销44Y延伸的销44Z的各部分卷绕导线来形成环路。
此外，本领域技术人员将会理解，通过逆转刚描述过的缠绕图案可获得相同的最终结果，即：围绕第一销缠绕第一环路，在近似与第一环路相同的平面内缠绕第二环路，以与第二环路成一定角度缠绕第三环路，以与第三环路成一定角度缠绕第四环路，在近似与第四环路相同的平面内缠绕第五环路，以及以与第五环路成一定角度缠绕第六环路等等，。
各环路可形成诸如“O”形(例如圆形、蛋形、正方形、椭圆形、星形等)的封闭结构或是诸如“C”或“U”形的开放结构。环路可以是任何尺寸的，并且通常针对治疗位置的近似尺寸进行调节。在先前的示例中，环路的直径范围为0.5mm-50mm。关于这点，“直径”不应被狭隘地解释为意指圆形的尺寸。而是直径被用于广泛地包含回路的近似尺寸及形状。
例如，图13中所示的线圈50具有开放的及封闭的环路52。开放的环路通过围绕销卷绕导线但在完成重叠的环路之前过渡到相邻销来形成。更准确地说，图13的复合线圈50具有采用图7及8的支架42形成的六条环路52a-f。环路52a是围绕其中一个销44Y形成的完整环路。然后导线围绕两个相邻的销44X以数字8的图案被卷绕形成开放环路52d及52c。接着导线围绕另外的Y销44Y完整地被卷绕以形成完整的环路52d。接着，在销44X的相对侧上围绕两个销44Y以数字8的图案卷绕导线以形成环路52e及52f。环路52e是开放的，而环路52f是封闭的，成为最后的环路。
采用图14-15所示的支架60可引出进一步的复杂程度。图14-15中的支架60也具有多个销62，但这些销以三个显著的方式不同于图7及8中的支架42。首先，销62在平行于X及Y轴线的方向上延伸，但没有平行于Z轴线延伸的销。而是矩形块64沿Z轴线延伸。其次，只存在有两个平行于X轴线延伸的同轴销62X1及62X2。第三，存在有四个销62Y1-4，其中每个销具有独立的纵轴线。采用支架60缠绕导致诸如图16-19中所示的那些复合线圈70。这些附图示出的复合线圈70带有第一和第二环路74a及74b以及第三和第四环路74c及74d，其中，第一和第二环路74a及74b基本上共平面并以数字8的图案布置；第三和第四环路74c及74d类似地基本上共平面并以数字8的图案布置，所述数字8的图案是从第一和第二环路74a及74b的数字8的图案转动而得到的。图16-19中所示的示例示出了相对彼此转动了90°的两个数字8的图案。此外，复合线圈70包含有相对同心的第五及第六环路74e及74f。
在缠绕之后，支架及复合线圈通过本领域内已知的方法进行热定形。例如，用于铂复合线圈的典型退火步骤是约1100°F下经历5-60分钟。
一旦被退火，当基本处于最小能量状态时，复合线圈将近似地保持经缠绕的形状。然后复合线圈可经进一步处理，诸如形成尖头，增加接附于传送系统的联接机构，在复合线圈上或里面放置水凝胶或纤维，在复合线圈的内部或外部放置抗松扩件等。然后复合线圈可接附于本领域内已知的传送系统，诸如题目为“Thermal Detachment Systemfor Implantable Device”的美国专利申请系列号11/212,830中所公开的系统，所述专利全部地被结合于本文作为参考。传送系统的其它示例公开于Guglielmi的6,010,498或Gandhi的6,478,773中。一旦接附于输送推进器，复合线圈10基本上以线性构形被置于管子内，用于传送至治疗位置。
在典型的程序中，线性复合线圈通过诸如微导管(或微导尿管)的导管来馈送，这是通过用输送推进器使它前进经过导管来实现的。根据现有的微导尿管，而后复合线圈在治疗位置内自动形成为近似于其经退火的形状的结构。
虽然本发明借助具体的实施例及应用进行了描述，但本领域技术人员借助于这些教导，可产生附加的实施例及变型而不背离本申请发明的精神或超过其范围。因此，应当理解，本文中的附图及说明是作为示例而提供的，以便易于理解本发明而不应该解释为限制其范围。

Claims (16)

1.一种复合线圈，它包括：
第一及第二环路，所述第一及第二环路直接地相互连接以形成位于第一平面中的第一数字8的图案；
第三及第四环路，所述第三及第四环路直接地相互连接以形成位于第二平面中的第二数字8的图案；
所述第一数字8的图案与所述第二数字8的图案在空间上隔开的平行方向上彼此面对。
2.如权利要求1所述的复合线圈，其特征在于：所述第一、第二、第三及第四环路中没有一个环路共用公共的纵轴线。
3.如权利要求1所述的复合线圈，其特征在于：所述第一数字8的图案在所述第一平面内相对于所述第二数字8的图案转动。
4.如权利要求3所述的复合线圈，其特征在于：所述第一数字8的图案在所述第一平面内相对于所述第二数字8的图案大约转动90°。
5.如权利要求1所述的复合线圈，其特征在于：所述第一与第三环路具有公共的纵轴线。
6.如权利要求1所述的复合线圈，其特征在于：所述第二与第四环路具有公共的纵轴线。
7.如权利要求1所述的复合线圈，其特征在于：其还包括具有纵轴线的第五及第六环路，所述纵轴线相对于第一、第二、第三及第四环路的纵轴线大约成90°角。
8.如权利要求7所述的复合线圈，其特征在于：所述第五与第六环路具有公共的纵轴线。
9.一组制作复合线圈的方法，它包括：
以包含于第一平面中的第一数字8的图案形成直接地相互连接的第一及第二环路；
以包含于第二平面中的第二数字8的图案形成直接地相互连接的第三及第四环路；
其中，所述第一数字8的图案与所述第二数字8的图案在空间上隔开的平行方向上彼此面对。
10.如权利要求9所述的方法，其特征在于：其还包括形成至少一个连接于所述第一及第二数字8的图案的环路，所述至少一个完整环路确定垂直于所述第一及第二平面的第三平面。
11.如权利要求10所述的方法，其特征在于：形成至少一个连接于所述第一及第二数字8的图案的环路包括：形成两个环路，所述两个环路确定都垂直于所述第一及第二平面的第三及第四平面。
12.如权利要求11所述的方法，其特征在于：形成两个确定都垂直于所述第一及第二平面的第三及第四平面的环路包括：两个确定第三及第四平面的环路，所述第三及第四平面都垂直于所述第一及第二平面并且还相互平行。
13.如权利要求9所述的方法，其特征在于：以相对地包含在第一平面中的第一数字8的图案形成第一及第二环路包括：形成至少一个开放的环路。
14.如权利要求9所述的方法，其特征在于：以相对地包含在第二平面中的第二数字8的图案形成第三及第四环路包括：形成至少一个开放的环路。
15.一组复合线圈，它包括多个连接的完整环路，所述连接的完整环路形成至少两个数字8的图案，每个所述数字8的图案包括两个直接地连接的位于同一平面内的环路，其中，所述至少两个数字8图案在空间上隔开的基本平行方向上彼此面对。
16.一种复合线圈，它包括：
直接地相互连接在数字8的图案中且基本被包含在第一平面中的第一对环路；
基本被包含在第二平面中的第二对环路；
所述第一平面基本上与所述第二平面成直角。
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EP1973680B1 (en) 2018-01-10
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WO2007076179A3 (en) 2008-05-29
US20070175536A1 (en) 2007-08-02
AU2006330786B2 (en) 2012-02-02
US10081048B2 (en) 2018-09-25
US8066036B2 (en) 2011-11-29
JP2012120869A (ja) 2012-06-28
US20170072452A1 (en) 2017-03-16
US20120041464A1 (en) 2012-02-16
WO2007076179A2 (en) 2007-07-05
US9533344B2 (en) 2017-01-03
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JP5154432B2 (ja) 2013-02-27
EP1973680A4 (en) 2015-03-25
CA2630021A1 (en) 2007-07-05
AU2006330786A1 (en) 2007-07-05
US20180354020A1 (en) 2018-12-13
US10857589B2 (en) 2020-12-08
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WO2007076179A9 (en) 2007-08-23

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