CN104780873B - 用于获得脉管装置的预定孔隙率的系统和方法 - Google Patents

用于获得脉管装置的预定孔隙率的系统和方法 Download PDF

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CN104780873B
CN104780873B CN201380056973.0A CN201380056973A CN104780873B CN 104780873 B CN104780873 B CN 104780873B CN 201380056973 A CN201380056973 A CN 201380056973A CN 104780873 B CN104780873 B CN 104780873B
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M·L·洛索尔多
R·库斯雷卡
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Nellcor Puritan Bennett LLC
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/844Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents folded prior to deployment
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2250/0023Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity
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Abstract

提供了一种用于治疗患者的系统,其包括可膨胀的脉管装置,所述脉管装置具有本体,所述本体具有大体一致的孔隙率,通过调节体的轴向长度可以改变所述孔隙率。系统还包括膨胀构件,所述膨胀构件定位在装置的中央管腔内,所述膨胀构件构造成当本体从塌缩构造径向膨胀时接合本体,并且减小本体内区域的本体孔隙率,所述孔隙率的减小程度大于区域外侧的孔隙率的减小程度。

Description

用于获得脉管装置的预定孔隙率的系统和方法
相关领域的交叉引用
本申请要求在2012年10月30日提交的美国临时专利申请序列No.61/720,154、在2013年3月14日提交的美国专利申请序列No.13/826971和在2013年3月14日提交的美国专利申请序列No.13/827030的优先权,其全部内容在此以引用的方式并入本发明。
背景技术
患者体内的管腔能够改变尺寸、形状和/或通畅性,并且这种变化能够引发与身体功能有关的并发症或者感染。例如,脉管壁,特别地动脉壁可能发展出通常称作动脉瘤的病理性增大。观察到动脉瘤从动脉壁膨胀出。因疾病、损伤或者先天性畸形导致血管壁变薄弱而产生动脉瘤。动脉瘤具有脆弱的薄壁,具有破裂的趋势,而且通常因高血压导致或者恶化。能够在身体的不同部分中发现动脉瘤;最常见的是腹主动脉动脉瘤(AAA)和脑或者脑干动脉瘤。仅仅动脉瘤的存在通常不威胁生命,但是动脉瘤能够导致严重的健康后果,诸如因脑中的动脉瘤破裂而引发的中风。另外,破裂的动脉瘤能够导致死亡。
发明内容
例如根据下文描述的各个方面阐释了本技术。为了便捷用编号(1、2、3等)的条款描述了本技术的方面的各个示例。其提供作为示例而非限制本技术。应当注意的是,附属条款中的任意一条均可以以任意组合组合并且放入到相应的独立条款中,例如条款1、16和23。能够以类似的方式呈现其它条款。
1、一种用于治疗患者的系统,所述系统包括:
可膨胀的脉管装置,其包括本体,所述本体具有基本均匀的孔隙率,通过调节所述本体的轴向长度适于改变所述孔隙率;和
膨胀构件,所述膨胀构件定位在所述脉管装置的中央管腔内,所述膨胀构件构造成当所述本体从塌缩构造径向膨胀时接合所述本体并且减小本体区域内的本体的孔隙率,所述孔隙率的减小程度大于所述区域外侧的本体孔隙率的减小程度。
2、根据条款1所述的系统,其中,所述本体包括编织结构。
3、根据条款1所述的系统,其中,所述本体包括切割金属管。
4、根据条款1所述的系统,其中,所述本体包括自膨胀结构。
5、根据条款1所述的系统,其中,处于塌缩构造中的所述膨胀构件的轴向长度是处于膨胀构造中的所述膨胀构件的轴向长度的大约200%至500%。
6、根据条款5所述的系统,其中,所述膨胀构件从所述塌缩构造至所述膨胀构造的轴向长度的变化与所述本体从本体塌缩构造至本体膨胀构造的轴向长度的变化相同。
7、根据条款1所述的系统,还包括粘合剂,所述粘合剂布置在所述膨胀构件和所述区域之间,用于将所述区域的一部分粘合到所述膨胀构件。
8、根据条款7所述的系统,其中,所述粘合剂包括生物可降解的材料。
9、根据条款1所述的系统,还包括波纹管,所述波纹管布置在所述膨胀构件内,所述波纹管构造成当所述膨胀构件扩张时轴向缩短。
10、根据条款1所述的系统,其中,所述膨胀构件在膨胀时包括扩大区域,所述扩大区域具有相对于所述膨胀构件的其它区域的扩大的直径,所述扩大区域与所述本体区域基本轴向对齐。
11、根据条款10所述的系统,还包括粘合剂,所述粘合剂布置在所述膨胀构件的所述扩大区域和所述本体区域之间。
12、根据条款1所述的系统,其中,所述膨胀构件在膨胀时包括减小区域,所述减小区域相对于所述膨胀构件的其它区域具有减小的直径,所述减小区域与所述本体区域基本轴向对齐。
13、根据条款12所述的系统,还包括粘合剂,所述粘合剂布置在所述膨胀构件的所述减小区域的近侧或者远侧。
14、根据条款1所述的系统,其中,所述膨胀构件在膨胀时包括两个扩大区域,所述两个扩大区域相对于位于其间的具有减小直径的减小区域具有扩大的直径,所述减小区域与所述本体区域基本轴向对齐。
15、根据条款14所述的系统,还包括粘合剂,所述粘合剂布置在所述扩大区域和所述本体之间。
16、一种用于脉管装置的输送系统,所述输送系统包括:
导管,所述导管具有管腔;
导丝,所述导丝延伸通过所述导管的管腔;
脉管装置,所述脉管装置具有孔隙率,通过调节所述脉管装置的轴向长度来改变所述孔隙率;和
膨胀构件,所述膨胀构件布置在所述导管的远侧部分内,所述膨胀构件构造成当所述膨胀构件径向膨胀时轴向缩短;
其中,所述膨胀构件构造成接合所述脉管装置的区域并且当所述膨胀构件轴向缩短时减小所述区域内的装置孔隙率,所述孔隙率的减小程度大于所述区域外侧的孔隙率的减小程度。
17、根据条款16所述的系统,其中,处于塌缩构造中的所述膨胀构件的轴向长度是处于径向膨胀构造中的所述膨胀构件的所述轴向长度的大约200%至500%。
18、根据条款17所述的系统,其中,所述膨胀构件从塌缩构造至径向膨胀构造的轴向长度的变化与所述装置从装置塌缩构造至装置膨胀构造的轴向长度的变化相同。
19、根据条款16所述的系统,还包括粘合剂,所述粘合剂布置在所述膨胀构件和所述区域之间,用于将所述区域的一部分粘合到所述膨胀构件。
20、根据条款16所述的系统,其中,所述膨胀构件在径向膨胀时包括扩大区域,所述扩大区域相对于所述膨胀构件的其它区域具有扩大的直径,所述扩大区域与装置的区域基本轴向对齐。
21、根据条款16所述的系统,其中,所述膨胀构件在径向膨胀时包括减小区域,所述减小区域相对于所述膨胀构件的其它区域具有减小的直径,所述减小区域与装置的区域基本轴向对齐。
22、根据条款16所述的系统,其中,所述膨胀构件在径向膨胀时包括两个扩大区域,所述两个扩大区域相对于位于其间的具有减小直径的减小区域具有扩大的直径,所述减小区域与装置的区域基本轴向对齐。
23、一种用于制造脉管装置的方法,包括:
将脉管装置布置在膨胀构件上,所述装置包括本体,所述本体具有基本均匀的孔隙率,通过调节所述本体的轴向长度适于改变所述孔隙率;和
将所述本体的一部分粘附到所述膨胀构件,使得在所述膨胀构件径向膨胀时本体部分和所述膨胀构件之间的粘合减小了所述本体部分内的本体的孔隙率,所述孔隙率的减小程度大于所述部分外侧的孔隙率的减小程度。
24、根据条款23所述的方法,其中,在所述膨胀构件处于膨胀构造中时发生粘合。
25、根据条款24所述的方法,其中,处于所述膨胀构造中的所述膨胀构件在不受约束时均匀伸展。
26、根据条款23所述的方法,其中,当所述膨胀构件处于塌缩构造中时发生粘合。
27、根据条款23所述的方法,其中,所述本体部分和所述膨胀构件之间的粘合构造成在所述膨胀构件至少部分膨胀时断开。
28、根据条款23所述的方法,其中,所述本体部分和所述膨胀构件之间的粘合构造成当所述膨胀构件膨胀成大于所述膨胀构件的完全膨胀构造的80%时断开。
29、根据条款23所述的方法,其中,所述本体部分和所述膨胀构件之间的粘合构造成在所述膨胀构件膨胀时因所述粘合中的剪切应变而断开。
30、一种用于制造脉管装置的方法,包括:
使得脉管装置的区域与膨胀构件的区域对齐,所述脉管装置具有孔隙率,通过调节所述装置的轴向长度改变所述孔隙率;和
将所述装置的区域粘合到所述膨胀构件的区域,使得在所述膨胀构件径向膨胀时,所述装置和所述膨胀构件之间的粘合减小了所述膨胀构件的区域的孔隙率,所述孔隙率的减小程度大于在所述膨胀构件的区域外侧的孔隙率的减小程度。
31、根据条款30所述的方法,其中,当所述膨胀构件处于径向膨胀构造时发生粘合。
32、根据条款30所述的方法,其中,当所述膨胀构件处于塌缩构造中时发生粘合。
33、根据条款30所述的方法,其中,所述装置的区域和所述膨胀构件的区域之间的粘合构造成当所述膨胀构件至少部分膨胀时断开。
34、根据条款30所述的方法,其中,所述装置的区域和所述膨胀构件的区域之间的粘合构造成当所述膨胀构件膨胀成大于所述膨胀构件的完全膨胀构造的80%时断开。
35、根据条款30所述的方法,其中,所述装置的区域和所述膨胀构件的区域之间的粘合构造成在所述膨胀构件膨胀时因所述粘合中的剪切应变而断开。
36、一种用于治疗动脉瘤的方法,所述方法包括:
将脉管装置在血管中定位在动脉瘤口处,所述脉管装置包括本体,所述本体具有基本均匀的孔隙率,通过调节所述本体的轴向长度适于改变所述孔隙率;和;
使得定位在所述本体的中央管腔内的膨胀构件扩张;和
通过使得所述本体与所述膨胀构件接合,在所述本体径向膨胀时减小本体区域内的本体孔隙率,所述孔隙率的减小程度大于所述区域外侧的本体孔隙率的减小程度。
37、根据条款36所述的方法,其中,所述定位包括在所述装置膨胀之前使得所述区域相对于所述动脉瘤口轴向偏移。
38、根据条款36所述的方法,还包括通过使得定位在所述膨胀构件内的波纹管轴向塌缩而减小所述膨胀构件的轴向长度。
39、根据条款36所述的方法,还包括溶解粘合剂,所述粘合剂将所述本体的部分粘合到所述膨胀构件。
40、根据条款36所述的方法,还包括使得所述本体膨胀,其中,所述本体包括自膨胀的编织结构或者切割金属管。
41、根据条款36所述的方法,其中,处于塌缩构造中的所述膨胀构件的轴向长度是处于径向膨胀构造中的所述膨胀构件的轴向长度的大约200%至500%。
42、根据条款41所述的方法,其中,所述膨胀构件从所述塌缩构造至所述膨胀构造的轴向长度的变化与所述本体从本体塌缩构造至本体膨胀构造的轴向长度的变化相同。
43、一种用于治疗动脉瘤的方法,所述方法包括:
将脉管装置在血管中定位在动脉瘤口处,所述脉管装置具有孔隙率,通过调节所述装置的轴向长度改变所述孔隙率;
使得定位在所述装置的管腔内的膨胀构件膨胀;和
通过使得一区域随着所述膨胀构件轴向缩短,减小所述区域内的装置的孔隙率,所述孔隙率的减小程度大于所述区域外侧的孔隙率的减小程度。
44、根据条款43所述的方法,其中,所述定位包括在所述膨胀构件膨胀之前使得所述区域相对于所述动脉瘤口轴向偏移。
45、根据条款43所述的方法,还包括通过使得定位在所述膨胀构件内的波纹管轴向塌缩而减小所述膨胀构件的轴向长度。
46、根据条款43所述的方法,还包括溶解粘合剂,所述粘合剂将所述装置的部分粘合到所述膨胀构件的部分。
47、根据条款43所述的方法,其中,处于塌缩构造中的所述膨胀构件的轴向长度是处于膨胀构造中的所述膨胀构件的轴向长度的大约200%至500%。
48、根据条款47所述的方法,其中,所述膨胀构件从所述塌缩构造至所述膨胀构造的轴向长度的变化与所述装置从装置塌缩构造至装置膨胀构造的轴向长度的变化相同。
应当理解的是,从以下详细描述中本技术的构造对本领域中的技术人员将变得显而易见,其中,通过图释的方式示出并且描述了本技术的多种构造。将认识到,本技术能够具有其它不同的构造并且能够就多个方面对若干细节加以修改,这都不脱离本技术的范围。因此,附图和详细描述本质旨在阐释而非限制。
附图说明
将参照附图进行详细描述:
图1A示出了根据本技术的一些实施例的用于可控地部署处于塌缩构造中的脉管装置的系统;
图1B示出了根据本技术的一些实施例的用于可控地部署处于中间构造中的脉管装置的系统;
图1C示出了根据本技术的一些实施例的用于可控地部署处于膨胀构造中的脉管装置的系统;
图2示出了根据本技术的一些实施例的脉管装置;
图3A示出了根据本技术的一些实施例的用于制造膨胀构件的型坯;
图3B示出了根据本技术的一些实施例的用于制造膨胀构件的示例处理;
图3C示出了根据本技术的一些实施例的用于制造膨胀构件的示例处理;
图3D示出了根据本技术的一些实施例的膨胀构件;
图3E示出了根据本技术的一些实施例的膨胀构件;
图4A示出了根据本技术的一些实施例的使用粘合剂联接到膨胀构件的脉管装置;
图4B示出了根据本技术的一些实施例的使用粘合剂联接到膨胀构件的脉管装置;
图4C示出了根据本技术的一些实施例的使用粘合剂联接到膨胀构件的脉管装置;
图4D示出了根据本技术的一些实施例的使用粘合剂联接到膨胀的膨胀构件的脉管装置;
图5A示出了根据本技术的一些实施例的具有扩大区域的膨胀构件;
图5B示出了根据本技术的一些实施例的具有布置在血管中的扩大区域的膨胀构件;
图6A示出了根据本技术的一些实施例的具有减小区域的膨胀构件;
图6B示出了根据本技术的一些实施例的具有布置在血管内的减小区域的膨胀构件;
图7A示出了根据本技术的一些实施例的具有两个扩大区域的膨胀构件;
图7B示出了根据本技术的一些实施例的具有布置在血管中的两个扩大区域的膨胀构件;
图8A示出了根据本技术的一些实施例的导管的示例;
图8B示出了根据本技术的一些实施例的导管的另一个示例;
图9示出了根据本技术的一些实施例的血管以及脉管装置的输送的剖视图;
图10示出了根据本技术的一些实施例的血管以及脉管装置的输送的剖视图;
图11示出了根据本技术的一些实施例的血管以及脉管装置的输送的剖视图;
图12示出了根据本技术的一些实施例的血管以及脉管装置的输送的剖视图;
图13示出了根据本技术的一些实施例的血管以及脉管装置的输送的剖视图;
图14示出了根据本技术的一些实施例的血管以及脉管装置的输送的剖视图。
具体实施方式
在下文中给出的详细描述旨在描述本技术的多个构造而不旨在表示可以实践本技术的唯一构造。附图包括在详细描述中并且作为详细描述的一部分。详细描述包括特定细节,以全面理解本技术。然而,对于本领域中的技术人员显而易见的是可以在不包含这些特定细节的情况下实践本技术。在一些情况中,以方块图形式示出了众所周知的结构和部件,以避免模糊本技术的概念。
动脉瘤可以例如沿血管侧壁定位。动脉瘤的颈部通常限定了介于大约2mm至25mm之间的开口,不过其它尺寸和范围也是可行的。颈部将解剖管腔连接到动脉瘤的底部。在一些实施例中,“脉管”或者“管腔”可以指血管(包括动脉和静脉)或者其它适当的具有管腔的身体器官,诸如,胃肠道(例如,食道、胃、小肠、结肠、直肠)、胆管、膀胱、输尿管、尿道、气管、细支气管等。解剖管腔内的血流流动通过颈部并且进入到底部。响应于流入到动脉瘤底部中的恒定的血流,动脉瘤壁持续扩张并且存在破裂的风险。当动脉瘤内的血液产生的作用于动脉瘤壁上的压力大于壁强度时,动脉瘤破裂。
减小流至动脉瘤或者动脉瘤内的血流导致减小了作用在动脉瘤壁上的力并且对应地减小了破裂风险。可以通过闭塞装置减小力和进入动脉瘤的血量。在部署期间闭塞装置可以依赖于医师的技术,以便确保在动脉瘤颈部处获得所需的孔隙率。如果颈部处的孔隙率太高,则闭塞装置可能未能充分减小流入到底部中的血流。可以通过朝向远侧部分的方向将纵向压缩力施加到闭塞装置的近侧部分来减小一些闭塞装置的孔隙率。因为可以通过施加压缩力来修改闭塞装置的孔隙率,所以持续可靠地实现所需孔隙率高度依赖于医师的技术。
本技术的方法和系统通过控制脉管装置的部署使得装置持续可靠地阻塞进入到动脉瘤中的血流,由此防止或者减小动脉瘤破裂的可能性来解决上述问题中的一些或者全部。这种系统包括可膨胀的脉管装置和膨胀构件,所述膨胀构件定位在脉管装置的中央管腔内。膨胀构件构造成在部署期间获得针对装置的区域而言的预定孔隙率。因此,使用膨胀构件控制脉管装置的部署以获得针对区域的预定孔隙率减小或者停止了层流流入到动脉瘤中,由此允许动脉瘤内的血液开始停滞。与持续流动通过动脉瘤的底部相反,血液停滞导致动脉瘤形成血栓,这还有助于防止动脉瘤破裂。
图1A至图1C示出了根据本技术的一些实施例的用于可控地部署脉管装置110的系统100。系统100包括可膨胀脉管装置110、定位在脉管装置110的中央管腔中的膨胀构件120和导管130。
参照图2,脉管装置110包括本体111,所述本体111具有基本均匀的孔隙率。本体111可以由多个基本均匀间隔开的构件112形成。通过调节本体111的轴向长度来改变本体111的孔隙率。例如,本体111可以构造成在沿着直径或者径向膨胀期间和/或之后因轴向缩短而减小孔隙率。本体111可以是自膨胀支架,所述自膨胀支架由两个或更多个圆形或者卵形的丝112制成,因此,本体111具有第一塌缩构造和第二膨胀构造。丝112可以由已知柔性材料制成,所述已知柔性材料包括形状记忆材料,诸如镍钛诺、铂和不锈钢。本体111可以由铂/8%钨和35N LT(钴镍合金,其为MP35N合金的低钛版本)合金丝制造而成。在其它实施例中,丝112中的一根或者多根可以由生物相容金属材料或者生物相容聚合物形成。丝112可以编织成最终的格架状结构。在至少一个实施例中,在编织或者缠绕本体111期间,可以使用1根丝位于2根丝之上而2根丝又位于2根丝下方(1-over-2-under-2)的系统松散地编织丝112。然而,在不背离本公开的范围的前提下,在其它实施例中,可以使用其它编织方法。
替代地,本体111可以例如通过激光切割预形成管或者板、通过激光熔接来互连多个构件112、或者通过诸如电化学蚀刻、研磨、刺穿、电成形或者其它手段的其它适当方法来互连多个构件112而形成。在另一个示例中,本体111可以包括管状支架。
本体111具有这样的孔隙率,所述孔隙率构造成减小例如流入到动脉瘤中的血液动力学流。可以通过轴向缩短本体111来调节本体111的由多个构件112确定的孔隙率。本体111的端部可以切割成段并且因此保持自由径向膨胀和收缩。本体111因所使用的材料、本体111的孔隙率和没有固定端部的事实而具有高柔性。
参照图1A至图1C,膨胀构件120构造成当本体111从第一塌缩构造膨胀时接合脉管装置110的本体111。膨胀构件120可以包括弹性体球囊,所述弹性体球囊非常具有弹性,使得处于塌缩构造中的膨胀构件120的轴向长度是处于膨胀构造中的膨胀构件120的轴向长度的大约200%-500%。膨胀构件120可以由聚氨酯、硅酮或者其它类似的材料形成。
膨胀构件120构造成当本体111从第一塌缩构造运动到第二膨胀构造时以与脉管装置110类似的方式发生几何结构变形。例如,膨胀构件120可以构造成在膨胀构件120从塌缩构造至膨胀构造膨胀期间沿着轴向长度缩短,并且当本体111从第一塌缩构造运动到第二膨胀构造时膨胀构件120的径向尺寸或者直径的增加量等于本体111的径向尺寸或者直径的增加量。换言之,膨胀构件120的轴向长度和径向尺寸在从塌缩构造运动到膨胀构造期间的变化与本体111从第一塌缩构造至第二膨胀构造期间的轴向长度和径向尺寸的变化相同。
膨胀构件120可以具有内构件125,所述内构件125布置在膨胀构件120的中央纵向轴线内,所述内构件125构造成在膨胀构件120膨胀或者扩张期间轴向缩短。内构件125可以构造成在膨胀或者扩张期间轴向缩短的程度与膨胀构件120轴向缩短的程度相同。内构件125可以例如包括波纹管、伸缩管或者其它构造成轴向缩短或者塌缩的结构。膨胀构件120的近端和远端可以附接、联接或者粘附到内构件125的近侧部分和远侧部分。
在一些方面中,为了减小膨胀构件120蠕变或者应力松弛的趋势,可以交联膨胀构件120的材料。交联是结合物、双功能聚合物链或者多功能聚合物链,它们将膨胀构件120的一个聚合物链链接到另一个。能够通过化学反应来形成交联,通过加热、压力、pH值变化、辐射或者其它方式来开始化学反应。例如,将未聚合或部分聚合的树脂与称作交联剂的特定化学物混合导致形成膨胀构件120材料的聚合物链之间的交联的化学反应。在需要进一步防止蠕变或者应力松弛的情况中,能够在轴向缩短和径向膨胀构造或者在膨胀构造中运送膨胀构件120。在这个示例中,膨胀构件120可以构造成当膨胀构件120处于其最大直径和其最短长度的情况中“静止”。
参照图3A至图3D,可以使用模具310制造膨胀构件120。在这个处理中,将一段聚合物管(型坯)320放入到模具中。加热器元件将型坯处于工作(操作)温度并且然后对型坯进行轴向拉伸和内部增压“P”,以便形成膨胀构件120。使用这种处理,膨胀构件120可以沿着膨胀构件120的长度或者正交于膨胀构件120的纵向轴线、或者沿着膨胀构件120长度并正交于膨胀构件的纵向轴线这两者具有变化的横截面形状。这种膨胀构件120制造处理可以赋予可以构成膨胀构件120的聚合物链轴向或者双轴定向。
替代地,可以通过溶液铸模法来制造膨胀构件120。溶液铸模法是这样的处理,在所述处理中,使得模具旋转,从而致使模具中的溶液因离心力顺应模具的内表面。在溶液固化成薄膜之后,拆卸模具,由此释放膨胀构件120。
其它已知方法还可以用于制造膨胀构件120。在一些示例中,膨胀构件120由嵌入在弹性体聚合物中的卷绕或者编织的丝构成。在另一个示例中,膨胀构件120可以由编织丝构成,所述编织丝能够通过使用伸缩棒或者管而轴向延长或者缩短,所述棒附接到编织丝的远端而管附接到编织丝的近端。
膨胀构件120可以具有近侧套箍122A和远侧套箍122B,用于附接到导管130。在另一个实施例中,膨胀构件120可以仅仅具有近侧套箍122A,如图3E所示。这个实施例对于附接到固定导丝导管的远端部分尤为有效,如下文讨论。
图4A至图7B示出了根据本技术的一些实施例的脉管装置110和膨胀构件120。在脉管装置110在患者脉管系统内部署之前和期间,膨胀构件120定位在脉管装置110的中央管腔内。膨胀构件120可以构造成使得脉管装置110受控地膨胀,使得脉管装置110在诸如可以靠近动脉瘤颈部的治疗部位附近的特定区域处获得预定孔隙率。例如,在部署期间,膨胀构件120可以致使区域115A-D内的本体111的孔隙率减小,由此获得针对区域115A-D的预定孔隙率,所述孔隙率的减小程度大于区域115A-D外侧的本体111的孔隙率的减小程度。
替代地,膨胀构件120可以构造成使得脉管装置110受控地膨胀,使得脉管装置110在多于一个的区域中获得预定孔隙率,所述区域诸如是动脉瘤颈部的近侧和远侧(在该处压力可能更高)。
参照图4A至图4D,膨胀构件120可以使得脉管装置110受控地膨胀,并且通过在部署之前和期间确定地接合脉管装置110的一部分而获得针对区域115A的预定孔隙率。例如,粘合剂117可以用于将脉管装置110的一部分确定地接合、联接、附接或者粘合到膨胀构件120的外表面。粘合剂117有助于利用膨胀构件120的轴向收缩和径向膨胀特征通过将膨胀构件120确定地接合、联接、附接或者粘附到脉管装置110来控制脉管装置110的孔隙率。
粘合剂117可以包括生物可降解材料或者这样的材料,所述材料可以溶解在身体或者血流中。例如,粘合剂117可以包括糖、聚乙二醇、聚氧化乙烯、聚乙烯醇、聚乳酸(PLA)、聚乙醇酸(PGA)、聚乳酸-乙醇酸(PLGA)、聚(c-己内酯)共聚物、聚二恶烷酮、聚富马酸丙二醇酯聚三亚甲基碳酸酯共聚物、聚羟基脂肪酸酯、聚磷腈、聚酸酐、聚(原酸酯)、聚(氨基酸)或者“伪”聚(氨基酸)。
在一些方面中,膨胀构件120可以构造成在膨胀构件120膨胀或者扩张期间允许灌注膨胀构件下游的组织。通过允许灌注下游组织还有助于溶解粘合剂117。
参照图4A,在一个示例中,粘合剂117可以布置在膨胀构件120和区域115A之间。粘合剂117将区域115A的一部分粘附到膨胀构件120的外表面。粘合剂117可以施加在膨胀构件120和/或脉管装置110上,使得其仅仅粘附区域115A的近侧和/或远侧部分。参照图4C,替代地,粘合剂117可以施加在区域115A的整个区域上或者特定部分处。参照图4B,根据粘合剂117的可溶解性和/或脆性,粘合剂117可以连续或者间歇施加在膨胀构件120的外表面或者脉管装置110上。可以通过喷涂、浸渍或者其它处理施加粘合剂117。
参照图4D,在一个方面中,在膨胀构件120均匀伸展、扩张、部分膨胀和/或处于膨胀构造中的同时,粘合剂117可以施加在膨胀构件120的外表面上。例如,当膨胀构件120处于膨胀构造中并且沿着其长度均匀伸展时,粘合剂117可以施加在膨胀构件120的外表面上。在这个示例中,粘合剂117可以间歇施加在区域115A中,使得形成未粘合区域,如图4C所示。当膨胀构件120和脉管装置准备在脉管系统内部署并且运动成塌缩构造时,未粘合区域有助于折叠或者塌缩膨胀构件120和脉管装置110。
替代地,在膨胀构件120缩小、部分塌缩和/或处于塌缩构造中的同时,粘合剂117可以施加在膨胀构件120的外表面上。在这个示例中,粘合剂117可以连续施加在区域115A中,如图4B所示。
在另一个示例中,在膨胀构件120具有沿着其长度伸展的部分的同时,粘合剂117可以施加在膨胀构件120的外表面上。伸展部分可以对应于脉管装置110的区域115A。
在一些方面中,膨胀构件120和脉管装置110确定地接合、联接、附接或者粘附,使得当膨胀构件120和脉管装置110处于膨胀构造中时在粘合剂117中不存在剪切应变。在其它方面中,膨胀构件120和脉管装置110确定地接合、联接、附接或者粘附,使得当膨胀构件120和脉管装置110完全膨胀或者处于膨胀构造中时在粘合剂117中存在足够的剪切应变,以便使得粘合剂117断裂或者断开并且由此从膨胀构件120释放脉管装置110。在其它方面中,膨胀构件120和脉管装置110确定地接合、联接、附接或者粘附,使得当膨胀构件117和脉管装置110部分膨胀时在粘合剂117中存在足够的剪切应变,以便使得粘合剂117断裂或者断开并且由此在膨胀构件120完全膨胀之前从膨胀构件120释放脉管装置110。所述的剪切应变能够是轴向应变、环向应变或者其组合。
在部署之前,膨胀构件120可以运动成塌缩构造,脉管装置110布置在其上。当处于塌缩构造中时,较之本体111的其它部分,本体111的区域115A因将区域115A粘合到膨胀构件120的粘合剂117而将具有更高的编织密度和更低的孔隙率。在膨胀构件120和脉管装置110的后续膨胀期间,本体111的整体孔隙率将随着脉管装置110的直径的增加和脉管装置110的轴向长度缩短而减小。然而,在膨胀期间或者之后,较之本体111的其它区域,区域115A的孔隙率还将减小并且保持更少的孔。
参照图5A至图5B,膨胀构件120可以使得脉管装置110可控地膨胀,并且通过将脉管装置110的区域115B的直径增加到大于脉管装置110的其它部分的直径而保持针对区域115B的预定孔隙率。膨胀构件120可以在膨胀时包括扩大区域123A,所述扩大区域123A具有相对于膨胀构件120的其它区域的扩大的直径。扩大区域123A与区域115B基本轴向对齐。
膨胀构件120的扩大区域123A使得区域115B的直径增加至大于本体111的其它部分的直径。通过扩大区域115B的直径致使布置在本体111的其它部分上的构件112被拉向区域115B,由此减小了区域115B内的孔隙率。因此,膨胀构件120致使区域115B内的本体111的孔隙率减小,由此获得针对区域115B的预定孔隙率,所述区域115B内的本体111的孔隙率的减小程度大于区域115B外侧的本体111的孔隙率减小程度。
在一个方面中,粘合剂117可以用于将脉管装置110的区域115B确定地接合、联接、附接或者粘合到膨胀构件120的扩大区域123A。粘合剂117有助于利用膨胀构件120的轴向收缩和径向膨胀特征,以便通过将膨胀构件120确定地接合、联接、附接或者粘附到脉管装置110而控制脉管装置110的孔隙率。脉管装置110的区域115B和膨胀构件120之间的粘合确保在部署时区域115B保持预定孔隙率。
一旦在治疗部位附近,粘合剂117就将开始溶解。当膨胀构件120膨胀时,剩余粘合剂117将断裂,由此还有助于溶解粘合剂117。膨胀构件120和脉管装置110将以相同的方式膨胀,从而在直径增加的同时轴向长度缩短。膨胀构件120的扩大区域123A将膨胀成大于膨胀构件120的其它部分的直径,由此致使区域115B内的密度增加而区域115B内的孔隙率减小,所述密度增加的程度和孔隙率的减小程度均大于本体111的其它部分的密度增加程度和孔隙率的减小程度。
参照图6A至图6B,膨胀构件120可以使得脉管装置110受控地膨胀,并且通过将脉管装置110的区域115C的多余材料存储在膨胀构件120的减小区域123B内而保持针对区域115C的预定孔隙率。例如,膨胀构件120可以在膨胀时包括减小区域123B,所述减小区域123B相对于膨胀构件120的其它区域具有减小的直径。减小区域123B与区域115C基本轴向对齐并且提供了存储区域115C的多余材料的区域。换言之,脉管装置110可以布置在膨胀构件120上,使得区域115C的材料可以聚在一起并以高致密布置收集在膨胀构件120的减小区域123B内。
在一个方面中,粘合剂117可以用于将本体111的近侧部分和/或远侧部分粘合到膨胀构件120,而区域115C没有粘合到膨胀构件120。在另一个示例中,粘合剂117可以沿着减小区域123B间歇布置,如图6A所示。粘合剂117有助于将区域115C的多余材料保持在膨胀构件120的减小区域123B内,使得在部署时,区域115C保持预定孔隙率。因此,在膨胀构件120膨胀时,区域115C的存储在膨胀构件120的减小区域123B处的多余材料将以相对减小的孔隙率部署。
一旦位于治疗部位附近,粘合剂117就将开始溶解。当膨胀构件120膨胀时,剩余粘合剂117将断裂,由此进一步有助于溶解粘合剂117。膨胀构件120和脉管装置110将以相同的方式膨胀,从而轴向长度缩短而直径增大。膨胀构件120的容纳区域115C的多余材料的减小区域123B将开始扩大并且部署包含在其中的多余材料。
参照图7A至图7B,膨胀构件120可以使得脉管装置110受控地膨胀,并且通过将脉管装置110的区域115D的多余材料存储在布置在膨胀构件120的两个扩大区域124之间的区域123C内而保持针对区域115D的预定孔隙率。例如,膨胀构件120可以在膨胀时包括两个扩大区域124,所述两个扩大区域124相对于位于其间的减小区域123C具有扩大的直径。减小区域123C具有减小的直径,与区域115D基本轴向对齐而且提供了存储区域115D的多余材料的区域。换言之,脉管装置110可以布置在膨胀构件120上,使得区域115D的材料可以聚在一起并且以高度致密的布置收集在膨胀构件120的减小区域123C内。
在一个方面中,粘合剂117可以用于将本体111的近侧部分和/或远侧部分粘合到膨胀构件120的扩大区域124,而区域115D没有粘合到所述扩大区域124。粘合剂117有助于将区域115D的多余材料保持在膨胀构件120的减小区域123C内,使得在部署时,区域115D保持预定孔隙率。因此,在膨胀构件120膨胀时,区域115D的存储在膨胀构件120的减小区域123C处的多余材料将以相对减小的孔隙率部署。
一旦位于治疗部位附近,粘合剂117就将开始溶解。当膨胀构件120膨胀时,剩余粘合剂117将断裂,由此进一步有助于溶解粘合剂117。膨胀构件120和脉管装置110将以相同的方式膨胀,从而轴向长度缩短而直径增大。膨胀构件120的容纳区域115D的多余材料的减小区域123C将开始扩大并且部署容纳在其中的多余材料。
不透射线标记物可以毗邻脉管装置110的近侧部分或者远侧部分定位,并且可以在沿着脉管装置110的长度位于脉管装置110的近端和远端之间包括区域115A-D的任何位置定位。标记物可以通过诸如粘合剂、热熔、干涉配合、紧固件、中间构件、涂层之类的技术或者其它技术附接到脉管装置110。
在一些实施例中,标记物包括超声标记物、MRI(核磁共振)安全标记物或者其它标记物。在一些实施例中,超声标记物允许医师在超声显像法的作用下准确地确定脉管装置110在患者体内的位置。用于超声标记物的材料具有与脉管装置110充分不同的声密度,以便经由超声技术提供适当的显像。示例性材料包括聚合物、金属(诸如钛、铂、金、钨和这些金属的合金)、空心玻璃球或微珠和其它材料。
在一些实施例中,MRI安全标记物允许医师在磁共振成像的作用下准确地确定脉管装置110在患者体内的位置。用于制造MRI安全标记物的示例性材料具有与脉管装置110充分不同的磁性,以便经由MRI技术提供适当的成像。示例性材料包括聚合物、金属(诸如钛、铂、金、钨和这些金属的合金)、非铁材料和其它材料。
现在将参照图8A至图14讨论用于治疗动脉瘤的技术。使用系统100可以将脉管装置110输送到治疗部位中。系统100包括导管130,所述导管可以例如是导丝上(OTW)导管、快速交换(多管腔)导管或者固定导丝导管。
参照图8A,OTW导管包括轴131。轴131的近侧部分具有固定到此的歧管132。轴131的远侧部分具有固定到此的膨胀构件120。轴131还包括两个管腔——导丝管腔133和用于使得膨胀构件120膨胀或者扩张的扩张管腔134。每个管腔133、134的近端均构造成与歧管132交界。
参照图8B,快速交换导管包括轴131,所述轴131具有延伸贯穿其中的扩张管腔134。轴131的近侧部分具有固定到此的衬套135。轴131的远侧部分具有固定到此的膨胀构件120。轴131在远侧部分上仅仅具有两个管腔。扩张管腔134和导丝管腔133从轴131的远端延伸至薄片(skive)136。在薄片136处,导丝管腔133终结而导丝与轴131的外表面连通。扩张管腔134构造成使得膨胀构件120膨胀或者扩张。
固定导丝导管包括轴,所述轴仅仅具有扩张管腔,所述扩张管腔固定到衬套和膨胀构件120。
参照图9,在输送之前,利用粘合剂或者不利用粘合剂117将脉管装置110安装到膨胀构件120。外护套140布置在脉管装置110和膨胀构件120上,以便在外护套140和膨胀构件120之间的环形空间内将脉管装置110限制在第一塌缩构造中。外护套140还保持脉管装置110和膨胀构件120处于纵向伸长和径向减小的构造中。
脉管装置110和膨胀构件120可以在外护套140内配合运动,以将脉管装置110输送至患者脉管系统内的治疗部位,诸如动脉瘤。
外护套140可以构造成通过患者的脉管系统被引入和推进。外护套140可以由多种热塑材料制成,例如,PTFE(聚四氟乙烯)、FEP(聚全氟乙丙烯)、HDPE(高密度聚乙烯)、PEEK(聚醚醚酮)等,所述热塑材料可选地作为外护套140的内表面的衬里或者具有诸如PVP(聚乙烯吡咯烷酮)的亲水材料或者某些其它塑料涂层的邻接表面的衬里。另外,根据所需结果,任一表面可以覆盖有不同材料的多种组合。
轴131包括导丝管腔133,用于允许导丝150延伸贯穿其中。轴131还可以在远侧区域137处包括减小的直径,以便提供充分的环形空间,在所述环形空间中存放脉管装置110。在这个示例中,膨胀构件120将布置在轴131的减小的直径区域137上。
不透射线标记物可以沿着系统100的长度设置在不同位置处。例如,轴131的扩大的远侧末端138可以不透射线。在另一个示例中,不透射线标记物可以设置在轴的减小直径远侧区域137上,在脉管装置110的远端和近端下方。在另一个示例中,不透射线标记物160可以布置在轴131上,毗邻脉管装置110和/或膨胀构件120的纵向中心。
在一个方面中,脉管装置110可以构造有具有不同轴向长度的区域115A-D。医师可以基于动脉瘤的颈部尺寸和区域115A-D的轴向长度选择适当的脉管装置110。例如,基于区域115A-D的轴向长度和动脉瘤“Ln”的颈部的长度,可以选择脉管装置110,使得在脉管装置110处于第二膨胀构造中时区域115A-D的轴向长度比动脉瘤的颈部的长度长。
在另一个方面中,系统100可以制造成在膨胀构件120和脉管装置110处于膨胀构造中的情况下运输。在这个示例中,在选择系统100,使得已输送的区域115A-D的轴向长度比动脉瘤的长度长之后,医师可以将脉管装置110和膨胀构件120组件向近侧拉动到外护套140中,以便压缩脉管装置和膨胀构件120组件。在替代实施例中,系统100可以制造成在膨胀构件120和脉管装置110处于塌缩构造中并被预装载在外护套140上的情况下运输。
参照图9,系统100在导丝150上经由皮肤前进至治疗部位,在这个示例中前进至动脉瘤210的部位。具体地,脉管装置110可以定位在血管200中动脉瘤210的口或者颈部处。在一个方面中,不透射线标记物160可以定位在动脉瘤210的远侧横向壁的远侧,由此在使得脉管装置110膨胀之前区域115A-D相对于动脉瘤210的口偏移。在输送期间,外护套140防止布置在脉管装置110和膨胀构件120之间的任何可溶解的粘合剂117溶解。具体地,外护套140覆盖脉管装置110和膨胀构件120组件并且由此防止任何流体(诸如血液)与粘合剂117接触。
参照图10,在将系统100引导到患者体内的治疗部位之后,在保持轴131的位置的同时向近侧拉回外护套140,由此暴露出轴131的远侧部分、膨胀构件120和脉管装置110。拉回外护套140,直到外护套140的远端位于脉管装置110和膨胀构件120组件的近侧为止。
如果脉管装置110包括自膨胀支架,则脉管装置的没有粘附到膨胀构件120的部分可以部分径向膨胀而部分轴向缩短。在这个示例中,在部署期间和之后,由于布置在区域115A-D和膨胀构件120之间的粘合剂117,因此区域115A-D将保持比本体111的其它部分高的密度和更低的孔隙率。粘合剂117由此允许可膨胀构件120使得脉管装置110可控地膨胀并且通过确定地接合脉管装置110而保持针对区域115A-D的预定孔隙率。替代地,如果脉管装置110没有包括自膨胀支架,则脉管装置110保留在膨胀构件120上。当拉回外护套140由此暴露出脉管装置110和膨胀构件120组件时,粘合剂117开始与诸如血液的流体接触。粘合剂117开始因与流体接触而溶解。
参照图11,当膨胀构件120使用扩张管腔134部分膨胀或者扩张时,膨胀构件120并且因此脉管装置110部分地径向膨胀而部分轴向缩短。在膨胀构件膨胀期间,内构件125也轴向缩短与膨胀构件120和/或脉管装置110相同的量。
参照图12,随后向近侧收回系统100,直到不透射线标记物160沿着动脉瘤210的口或者颈部的长度居中。换言之,在已经重新定位脉管装置110使得区域115A-D沿着口的长度居中之后,当脉管装置110处于第二膨胀构造中时区域115A-D将覆盖动脉瘤210的口或者颈部。
随后膨胀构件120膨胀至完全膨胀构造,由此完全部署脉管装置110。膨胀构件120将径向膨胀而轴向收缩,与此同时因布置在脉管装置110和膨胀构件之间的剩余粘合剂117而将脉管装置110保持到其外表面。膨胀构件120使得脉管装置110可控地膨胀,使得脉管装置110保持在区域115A-D处的预定孔隙率。在部署期间,膨胀构件120致使区域115A-D内的本体111的孔隙率减小,由此保持针对区域115A-D的预定孔隙率,所述孔隙率的减小程度大于区域115A-D外侧的本体111的孔隙率的减小程度。
在膨胀构件120膨胀期间或者之后,布置在膨胀构件120和脉管装置110之间的粘合剂117可以溶解和/或断裂,由此从膨胀构件120释放脉管装置110。
膨胀构件120由此致使区域115A-D不受在脉管装置110部署期间能够发生的各种医师诱发运动的影响获得而预编程的孔隙率。换句话说,区域115A-D的孔隙率对于在脉管装置110部署期间医师施加的动作较不敏感。
参照图13,一旦整个脉管装置110完全膨胀,则膨胀构件120塌缩或者缩小。参照图14,此后,可以从本体收回导管130连同外护套140、轴131、膨胀构件120和导丝150。
脉管装置100的区域115A-D较之本体111的其它部分具有显著更低的孔隙率。由于区域115A-D的更低的孔隙率,因此更少的血液流入到动脉瘤210中,使得可以在动脉瘤210中发生明显血栓。
在一个布置方案中,脉管装置110可以由金属、聚合物、陶瓷、永久耐用材料构成,并且可以包括非生物可吸收和生物可吸收材料中的任一或两者。示例性材料包括但不局限于不锈钢、钴铬合金、埃尔吉诺伊非磁性合金、镁合金、聚乳酸、聚乙醇酸、聚酯酰胺(PEA)、聚醚氨酯(PEU)、氨基酸系仿生聚合物、钨、钽、铂、聚合物、生物聚合物、陶瓷、生物陶瓷或金属玻璃。医疗装置的部分或者全部可以随着时间推移来洗提这样的物质,诸如,药物、生物制剂、基因治疗物、抗血栓物质、凝结剂、抗炎症药物、免疫调控药物、抗增生物质、抗迁移剂、细胞外基质调控药物、治疗促进剂、再内皮化促进剂或者其它材料。在一些实施例中,脉管装置110可以由具有形状记忆性能的材料形成。在一些实施例中,可以通过处理移除渣质而精整脉管装置110。在一些实施例中,脉管装置110可以在通常施加到材料的温度条件下承受回火处理,使得永久建立印记结构。
脉管装置110可以具有不同长度和直径。例如,脉管装置110可以具有特定的横截面直径,当脉管装置110完全自由膨胀时测量的所述直径处于大约2mm至大约6mm。如果脉管装置110具有介于3mm和4mm之间的直径,则其可以应用在尺寸18的微型导管中(即,微型导管的内径为大约0.21英寸)。如果脉管装置110的直径介于5mm和6mm之间,则其可以应用在尺寸27的微型导管中(即,微型导管的内径为大约0.027英寸)。然而,可以使用其它适当的横截面直径而不脱离本技术的范围。在一些实施例中,脉管装置110沿着脉管装置110的纵向轴线由近及远测量的长度处于15mm至40mm的范围内,尽管其它范围和尺寸也是可行的。
技术人员可以针对每个具体应用以不同方式实施所述功能。可以以不同方式布置各个部件和方块(例如,以不同顺序布置或者以不同方式隔开)而不脱离本技术的范围。应当理解的是,公开的处理中的步骤的具体顺序或者层级是示例性方法的说明。应理解,基于设计偏好,可以重新布置处理中的步骤的具体顺序或者层级。可以同步实施步骤中的一些。附随方法权利要求以样本顺序呈现各个步骤中的元件,并且不旨在限制于列出的具体顺序或者层级。
先前描述使得本领域中的技术人员能够实践在此描述的各个方面。先前描述提供了本技术的各个示例,并且本技术并不局限于这些示例。对于本领域中的技术人员而言这些方面的多种修改方案显而易见,并且在此限定的一般原理可以应用于其它方面。因此,权利要求并不旨在局限于在此示出的方面,而是应赋予与语言权利要求一致的完整范围,其中,单数指代的元件并不旨在描述“一个或者仅仅一个”除非如此明确说明,而是表示“一个或者多个”。除非明确说明,否则术语“一些”指的是一个或者多个。阳性代词(例如,他的)包括阴性和中性(例如,她的和它的)并且反之亦然。标题和副标题(如果存在)仅仅为了便捷而非限制本发明。
诸如“方面”的短语并不意味着这个方面对于本技术必不可少或者这个方面应用于本技术的所有构造。关于一个方面的公开内容可以应用于所有构造或者一个或者多个构造。一个方面可以提供一个或者多个示例。诸如方面的短语可以指的是一个或者多个方面并且反之亦然。诸如“方面”的短语不表示这个方面对于本技术必不可少或者这个方面应用于本技术的所有构造。关于一个方面的公开内容可以应用于所有方面或者一个或者多个方面。一个方面可以提供一个或者多个示例。诸如“方面”的短语可以指的是一个或者多个方面并且反之亦然。诸如“构造”的短语不意味着这种构造对于本技术必不可少或者这种构造应用于本技术的所有构造。关于一个构造的公开可以应用于所有构造或者一个或者多个构造。构造可以提供一个或者多个示例。诸如“构造”的短语可以指的是一种或者多种构造并且反之亦然。
在此使用的词语“示例性”表示“作为示例或者解释”。在此描述为“示例性”的任何方面或者设计均不必理解为比其它方面或者设计优选或者有利。
与本公开中描述的、本领域技术人员已知或者稍后了解的各个方面的元件等效的所有结构和功能均以引用的方式并入本公开并且旨在由权利要求笼括。而且,不管是否在权利要求中明确叙述列举这种公开内容,在此没有公开的内容旨在致力于公共。没有要素要根据35U.S.C§112第六段的条例来理解,除非使用短语“用于…的装置”明确叙述要素或者在方法权利要求的情况中使用短语“用于…的步骤”叙述要素。而且,在某种程度上,在说明书或者权利要求中使用术语“包括”、“具有”,当应用于权利要求中的过渡词时,这种术语旨在近似理解为术语“包括”。

Claims (22)

1.一种用于治疗患者的系统,所述系统包括:
可膨胀的脉管装置,其包括本体,所述本体具有基本均匀的孔隙率,通过调节所述本体的轴向长度适于改变所述孔隙率;和
膨胀构件,所述膨胀构件定位在所述脉管装置的中央管腔内,所述膨胀构件构造成当所述膨胀构件径向膨胀时接合所述本体并且轴向缩短,并且当所述本体从塌缩构造径向膨胀时使得在本体的一个区域内的本体孔隙率的减小程度大于在本体的所述区域外侧的本体孔隙率的减小程度。
2.根据权利要求1所述的系统,其中,所述本体包括编织结构。
3.根据权利要求1所述的系统,其中,所述本体包括切割金属管。
4.根据权利要求1所述的系统,其中,所述本体包括自膨胀结构。
5.根据权利要求1所述的系统,其中,处于塌缩构造中的所述膨胀构件的轴向长度是处于膨胀构造中的所述膨胀构件的轴向长度的200%至500%。
6.根据权利要求5所述的系统,其中,所述膨胀构件从所述塌缩构造至所述膨胀构造的轴向长度的变化与所述本体从本体塌缩构造至本体膨胀构造的轴向长度的变化相同。
7.根据权利要求1所述的系统,还包括粘合剂,所述粘合剂布置在所述膨胀构件和本体的所述区域之间,用于将本体的所述区域的一部分粘合到所述膨胀构件。
8.根据权利要求7所述的系统,其中,所述粘合剂包括生物可降解的材料。
9.根据权利要求1所述的系统,还包括波纹管,所述波纹管布置在所述膨胀构件内,所述波纹管构造成当所述膨胀构件扩张时轴向缩短。
10.根据权利要求1所述的系统,其中,所述膨胀构件在膨胀时包括扩大区域,所述扩大区域具有相对于所述膨胀构件的其它区域的扩大的直径,所述扩大区域与本体的所述区域基本轴向对齐。
11.根据权利要求10所述的系统,还包括粘合剂,所述粘合剂布置在所述膨胀构件的所述扩大区域和本体的所述区域之间。
12.根据权利要求1所述的系统,其中,所述膨胀构件在膨胀时包括减小区域,所述减小区域相对于所述膨胀构件的其它区域具有减小的直径,所述减小区域与本体的所述区域基本轴向对齐。
13.根据权利要求12所述的系统,还包括粘合剂,所述粘合剂布置在所述膨胀构件的所述减小区域的近侧或者远侧。
14.根据权利要求1所述的系统,其中,所述膨胀构件在膨胀时包括两个扩大区域,所述两个扩大区域相对于位于其间的具有减小直径的减小区域具有扩大的直径,所述减小区域与本体的所述区域基本轴向对齐。
15.根据权利要求14所述的系统,还包括粘合剂,所述粘合剂布置在所述扩大区域和所述本体之间。
16.一种用于脉管装置的输送系统,所述输送系统包括:
导管,所述导管具有管腔;
导丝,所述导丝延伸通过所述导管的管腔;
脉管装置,所述脉管装置具有孔隙率,通过调节所述脉管装置的轴向长度来改变所述孔隙率;和
膨胀构件,所述膨胀构件布置在所述导管的远侧部分内,所述膨胀构件构造成当所述膨胀构件径向膨胀时轴向缩短;
其中,所述膨胀构件构造成接合所述脉管装置的一区域并且当所述膨胀构件轴向缩短时使得脉管装置在所述区域内的孔隙率的减小程度大于所述区域外侧的孔隙率的减小程度。
17.根据权利要求16所述的系统,其中,处于塌缩构造中的所述膨胀构件的轴向长度是处于径向膨胀构造中的所述膨胀构件的所述轴向长度的200%至500%。
18.根据权利要求17所述的系统,其中,所述膨胀构件从塌缩构造至径向膨胀构造的轴向长度的变化与所述脉管装置从装置塌缩构造至装置膨胀构造的轴向长度的变化相同。
19.根据权利要求16所述的系统,还包括粘合剂,所述粘合剂布置在所述膨胀构件和所述区域之间,用于将所述区域的一部分粘合到所述膨胀构件。
20.根据权利要求16所述的系统,其中,所述膨胀构件在径向膨胀时包括扩大区域,所述扩大区域相对于所述膨胀构件的其它区域具有扩大的直径,所述扩大区域与脉管装置的所述区域基本轴向对齐。
21.根据权利要求16所述的系统,其中,所述膨胀构件在径向膨胀时包括减小区域,所述减小区域相对于所述膨胀构件的其它区域具有减小的直径,所述减小区域与脉管装置的所述区域基本轴向对齐。
22.根据权利要求16所述的系统,其中,所述膨胀构件在径向膨胀时包括两个扩大区域,所述两个扩大区域相对于位于其间的具有减小直径的减小区域具有扩大的直径,所述减小区域与脉管装置的所述区域基本轴向对齐。
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US9301831B2 (en) 2016-04-05
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