CN102596083B - 植入物递送系统 - Google Patents
植入物递送系统 Download PDFInfo
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- A61F2/00—Filters 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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Abstract
在一实施例中,本发明涉及可机械释放的递送系统。更具体而言,此实施例包括在递送系统远端由系绳固定的可植入装置。该系绳固定到可植入装置且绕可选择性地滑动的芯杆打环。当芯杆缩回以暴露其远端时,打环的系绳滑离芯杆,释放可植入装置。替代地,该系绳可固定到递送系统,绕可植入装置的一部分缠绕且向可滑动的芯杆上打环。优选地,通过对递送系统把手进行促动控制来控制芯杆移动,在医疗手术期间允许使用者选择性地释放该可植入装置。
Description
相关申请
本申请要求在2009年4月15日提交的名称为“Implant Delivery
System”的美国临时申请No. 61/169,632的优先权,该专利申请通过引用结合到本文中。
技术领域
本发明涉及用于递送可植入医疗装置的改进的递送系统。更具体而言,本发明涉及一种具有改进的可植入装置释放机构的植入物递送系统。
背景技术
可植入医疗装置和其所附随的递送系统是本领域中熟知的。这些可植入装置包括支架、微线圈、阀和类似类型的装置,其用于治疗多种不同的医疗症状。
许多可植入装置由导管型递送装置在患者体内递送。通常用于自膨胀可植入装置的一种类型的递送装置利用两个同心布置的导管或轴杆。可植入装置绕内部导管的远端或推动器同轴安置且由外部套筒保持在压缩位置。一旦将可植入装置定位于目标位置,抽回外部轴杆,在目标位置释放该可植入装置。
常常与这种类型的递送系统相关联的一种缺陷在于使用者不能在释放后重新定位该可植入装置。在此方面,如果该可植入装置部署于不当位置或配置,使用者不能将该装置重新俘获或重新定位到所需位置。当均匀地抽回外部轴杆时穿过人体的导管路径中的弯曲可造成摩擦和另外的困难且因此可进一步导致不当的装置部署。
其它部署系统通常也包括用于使可植入装置从递送系统选择性地拆开的机构。举例而言,用于不可膨胀植入物的一些递送系统包括固定到递送导管和可植入装置上的系绳。当使用者希望释放该可植入装置时,附近的加热器使得系绳熔化,从而释放该装置。
在此递送系统中,熔化系绳的一部分保持在可植入装置上。在一些手术中,此系绳残余可造成患者并发症,诸如血液凝块,特别是在位于血管内的情况下。在其它手术下,此系绳残余可带来并发症的较小风险且因此可受到外科医生更少关注。
在本领域中仍需要克服了现有技术缺陷的可植入装置递送系统。
发明内容
根据本发明的一个优选实施例涉及可机械释放的递送系统。更具体而言,此实施例包括可在递送系统的远端由系绳固定的可植入装置。该系绳固定(例如,扭结、粘合、焊接等)到可植入装置且绕可选择性地滑动的芯杆打环。当芯杆缩回以暴露其远端时,打环的系绳滑离芯杆,释放可植入装置。替代地,该系绳可固定到递送系统,绕可植入装置的一部分缠绕且向可滑动的芯杆上打环。优选地,通过在芯杆的近端抓住芯杆且使得芯杆在近端方向滑动来控制芯杆移动,从而使得可植入装置在患者体内释放。
附图说明
参看附图,通过下文本发明的实施例的描述,本发明的这些和其它方面、特点和优点将会显然并被阐明,在附图中:
图1示出根据本发明的递送系统的优选实施例的侧视图;
图2示出根据本发明的释放机构的优选实施例的分解图;
图3示出图2的释放机构的组装透视图;
图4示出区域4-4的放大视图,其示出图3的释放机构;
图5示出根据本发明的释放机构的另一优选实施例的分解图;
图6示出图5的释放机构的组装透视图;
图7示出区域7-7的放大视图,其示出图6的释放机构;
图8示出根据本发明的释放机构的另一优选实施例的透视图;以及
图9示出图8的释放机构处于释放配置或部署配置的透视图。
具体实施方式
现将参看附图来描述本发明的具体实施例。但本发明可以许多不同形式实施且不应被认为限于本文所述的实施例;而是,提供这些实施例使得本公开全面且完整,且将向本领域技术人员全面传达本发明的范围。在附图示出的实施例的详细描述中所用的术语预期并不限制本发明。在附图中,相似的附图标记指相似元件。
除非另外定义,本文所用的所有术语(包括科技术语)具有与本发明所属领域的普通技术人员通常理解的相同的意义。还应了解诸如在常用字典中定义的术语应被理解为具有与其在相关技术的情境中的意义一致的意义且不应理解为理想化或过于正式的意义,除非在本文中明确如此定义。
图1示出根据本发明的递送系统100的优选实施例。优选地,递送系统100包括细长主体102,诸如推动器主体,用于在患者体内前移(例如,在预先定位的导管内或者利用可缩回的外鞘)。
递送系统100的远端包括可植入装置104(例如,支架、阀、微线圈等)。递送装置100的近端可包括握把或把手106用于抓住装置100且使之前移到患者体内。优选地,外鞘用于将微导管引入到所需目标位置。递送系统引入到微导管内且前移到目标位置。
递送装置100的近端还包括可植入装置释放控制件108,释放控制件108允许使用者造成可植入装置104从递送系统释放且留在患者体内。更具体而言且如在下文中更详细地讨论的,释放控制件108允许使用者缩回(即,向近端移动)脱离芯杆118(即,植入物俘获构件,促动构件或细长锁定构件)。随着脱离芯杆118的远端缩回,其释放将可植入装置104固定到递送系统100上的系绳116。
优选地,由脱离机构的近端形成释放控制件108,其相对于主体102或把手106滑动。在把手106附近或把手106中还可包括海波管(hypotube),脱离芯杆118滑动通过海波管。
虽然脱离芯杆118的近端可简单地暴露以允许使用者根据需要来移动,线也可连接到脱离芯杆118,允许使用者拉该线且因此向近端拉该脱离芯杆118。另外,脱离芯杆118可弹簧偏压到关闭位置,例如通过将弹簧安置于把手106内脱离芯杆118的近端处。
在其它实例中,此释放控制件108可为滑件、杠杆、机械按钮、电按钮或任何其它类型的促动机构。释放机构110优选地位于主体102的通路内在主体102的远端附近。
图2示出根据本发明的优选实施例的释放机构110的分解图。图3示出机构110的组装视图,而图4示出区域4-4的放大图。
如将在下文中进一步详细地解释的,释放机构110通过滑动该脱离芯杆118以释放绕脱离芯杆118打环的系绳116而选择性地释放可植入装置104。更具体而言,芯杆118的自由端(例如,远自由端)滑动超过位于递送装置100的远端附近的开口、自由空间或孔口。系绳116附连到可植入装置104(例如,通过粘合剂、扭结、卡夹等)。因此,当脱离芯杆18的自由端缩回到预定位置时(例如,使得其向孔口暴露或移动超过孔口),系绳116的环滑离芯杆118,将可植入装置104从递送系统100释放。
或者,系绳116的两端可固定到递送系统100(例如,外线圈112),穿置于可植入装置104的一部分中(例如,环或线圈),然后在芯杆118上打环。在此方面,芯杆118充当滑动或横向移动的闩锁构件。
优选地,芯杆118为细长圆柱形构件,其延伸到递送装置100的近端,或者附连到延伸到递送装置100远端的其它机构,从而允许使用者在近端控制该芯杆118。应了解芯杆可具有多种截面形状,诸如圆形、正方形、矩形和六边形。此外,此芯杆118优选地延伸到近端或递送装置100或者机械地连接到近端以允许使用者在近端操纵芯杆118且由此造成植入物释放。
释放系统110至少部分地包含于外线圈112内,其提供对释放机构110的支承和保护。优选地,此外线圈112位于主体102的远端,但其也可完全或部分地嵌入于主体102、外鞘或外层内。外线圈112优选地包括半刚性材料(例如,镍钛诺(Nitinol)、不锈钢或不透辐射的材料)以维持装置的总体形状,但在其穿过患者时会挠曲。
释放系统110还包括远端管构件122和近端管构件124,每一个管构件沿着其外表面附连到支承芯杆114上。优选地,管构件122和124定位成彼此成直线以便留有足够大的间隙或开放空间供系绳116穿过,如在图3中最佳地看出的那样。管构件122和124的大小优选地适于装配于主体102的通路内(即,在线圈112内),且进一步包括诸如镍钛诺或不锈钢的刚性或半刚性材料。支承芯杆114也优选地包括诸如镍钛诺或不锈钢的刚性材料且固定到管122、124和外线圈112上。
脱离芯杆118和在管122和124内的内部通路的大小使得脱离芯杆118可在轴向自由移动穿过这些通路。优选地,脱离芯杆118的远端还可至少部分地滑动经过间隙或开放空间,暴露远端(使得系绳116能滑离,释放植入物104)。在此方面,管122和124充当用于脱离芯杆118的外壳。
递送系统100还包括内线圈120,在脱离芯杆118前后滑动以释放系绳116时内线圈120充当脱离芯杆118的引导件或通路且提供抗扭结性。在此方面,内线圈120安置于脱离芯杆118周围且进一步固定到近端管124。内线圈120还包括不同于外线圈112的节距,这帮助防止内线圈120楔入于外线圈112的匝之间。优选地,内线圈120包括诸如镍钛诺或不锈钢的刚性材料且向近端延伸超过外线圈112,如在图3中最佳地看出。
在操作中,使用者前移递送系统100的远端到患者体内的目标位置。当使用者对可植入装置104的放置满意之后,促动可植入装置释放控制件108(例如,向近端拉脱离芯杆118),造成脱离芯杆118的远端在近端方向中移动。脱离芯杆118的远端移动超过远端管122的近端,在芯杆118与管122之间造成间隙。优选地,系绳116处于张力下且因此只要一打开先前所提到的间隙,系绳116就立即滑离芯杆118。在这点,可植入装置104从递送系统100释放且可从患者移除递送系统100。
应了解对于递送系统100,本领域中已知的额外递送控制或选择也是可能的。举例而言,鞘可用在主体102上以控制可植入装置104的膨胀(例如,防止支架膨胀直到将鞘拉离该装置104)。在另一实例中,包含额外工具或控制件的额外管腔也是可能的。
图5至图7示出根据本发明的可植入装置释放机构130的另一优选实施例。一般而言,释放机构130类似于先前描述的释放机构110。但是,本释放机构130包括单个管132而不是两个先前的管122和124。
在本优选实施例中,单个管132包括孔口或切除部132A。系绳116在脱离芯杆118上打环且穿过切除部132A。在此方面,在脱离芯杆118由先前所提到的装置释放控制件108向近端移动时,系绳116的打环部滑离该脱离芯杆118且从切除部132A出来,释放该装置104。
优选地,孔口或切除部132A能由激光或机械切割管或将两个管粘附在一起而形成。而且,切除部132A优选地包括成角度的切割(即,并不与管132长度成90度的边缘表面)以防止对系绳116造成碰摩或摩擦且由此最小化对系绳116的损害。优选地,孔口132A的至少远端部具有非90度切割角(即,上面搁置系绳116的部分)。在一实例中,孔口132A的至少远端部相对于管132长度轴线具有在大约10度与80度之间的切割角。
如先前关于释放机构110和130所述的那样,系绳116的自由端能连接到递送装置100(例如,线圈112)用于系绳116可能会向患者带来高并发症风险的手术。替代地,系绳116可在植入后保持植入物104(即,系绳的两个自由端连接到植入物104)以用于系绳116可能对患者带来低并发症风险的手术。系绳116保持在患者体中或者如果由可生物降解的材料构成,则会降解。
图8和图9示出了作为根据本发明的释放机构140的另一优选实施例的部分的替代系绳配置。如在图8的未释放位置最佳地看出,系绳116的自由端固定(例如,粘合、系结或类似固定方法)到外线圈112上。系绳116穿过孔口或者围绕装置104的辐条(spoke)或线圈,然后穿过切除部132A且围绕脱离芯杆118。
如在图9中看出,当脱离芯杆118向近端移动时,系绳116的环部滑离脱离芯杆118。系绳116滑动通过装置104,释放装置104。在此方面,系绳126随着递送系统100从患者移除,防止系绳116否则在患者体中造成并发症(例如,当结合支架使用时的血液凝块)。
尽管关于特定实施例和应用描述了本发明,但本领域技术人员根据本教导内容能产生额外实施例和修改而不会偏离所要求保护的发明的精神或超过所要求保护的发明的范围。因此应了解本文的附图和描述以举例说明的方式提供以便于理解本发明,不应认为限制本发明的范围。
Claims (13)
1.一种用于植入物的递送系统,包括:
细长主体;
植入物俘获构件,其与所述细长主体相关联且沿着所述细长主体可移动地对准;
柔性系绳,其永久连接到所述植入物且至少部分地定位于所述植入物俘获构件周围;
所述植入物俘获构件可在预定方向移动以便操纵所述柔性系绳的所述定位且造成所述植入物和所述柔性系绳的释放。
2.根据权利要求1所述的递送系统,还包括位于所述细长主体的远端附近的开放空间,所述系绳穿入到所述开放空间内。
3.根据权利要求2所述的递送系统,其中,所述植入物俘获构件的自由端超过所述开放空间的至少一部分的移动从所述植入物俘获构件释放所述系绳。
4.根据权利要求3所述的递送系统,其中,所述细长主体包括第一圆柱形构件和第二圆柱形构件,且在所述第一圆柱形构件与所述第二圆柱形构件之间形成所述开放空间。
5.根据权利要求3所述的递送系统,其中,所述细长主体包括圆柱形构件且所述开放空间由所述圆柱形构件中的孔口构成。
6.根据权利要求3所述的递送系统,其中,所述系绳包括第一自由端和第二自由端,每一个自由端固定到所述植入物。
7.一种用于植入物的递送系统,包括:
细长主体;
植入物释放机构,其安置于所述细长主体的远端附近,所述植入物释放机构包括可滑动地安置于所述细长主体内的促动构件;
柔性系绳,其永久连接到所述植入物和可连接到所述促动构件以便将所述植入物保持到所述细长主体上;
所述促动构件可在预定轴向方向滑动从而释放所述系绳不将所述植入物保持到所述细长主体上。
8.根据权利要求7所述的递送系统,还包括具有第一通路的第一外壳构件和具有第二通路的第二外壳构件,所述第一外壳构件和所述第二外壳构件彼此间隔开;其中,所述促动构件可滑动地安置于所述第一外壳构件和所述第二外壳构件内。
9.根据权利要求7所述的递送系统,还包括第一外壳构件,其具有穿过它的通路和位于所述第一外壳的壁中的孔口;其中,所述促动构件可滑动地安置于所述第一外壳构件内。
10.根据权利要求7所述的递送系统,还包括位于所述细长主体的近端附近的促动机构,其用于在轴向移动所述促动构件。
11.根据权利要求7所述的递送系统,其中,所述促动构件具有覆盖所述促动构件的远端的第一位置和暴露所述促动构件的远端的第二位置。
12.根据权利要求11所述的递送系统,其中,所述系绳还包括第一自由端和第二自由端,每一个自由端固定到所述植入物。
13.根据权利要求9所述的递送系统,其中,所述孔口包括相对于所述第一外壳构件的长度轴线成在10度-80度之间的切割角的远端部。
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- 2010-04-15 EP EP10765197.8A patent/EP2419041B1/en active Active
- 2010-04-15 JP JP2012506233A patent/JP5771188B2/ja active Active
- 2010-04-15 US US12/761,187 patent/US9968358B2/en active Active
- 2010-04-15 WO PCT/US2010/031268 patent/WO2010121049A1/en active Application Filing
- 2010-04-15 BR BRPI1014971A patent/BRPI1014971A2/pt not_active Application Discontinuation
- 2010-04-15 KR KR1020117026779A patent/KR101828088B1/ko not_active Expired - Fee Related
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Also Published As
Publication number | Publication date |
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KR101828088B1 (ko) | 2018-02-09 |
KR20120025466A (ko) | 2012-03-15 |
WO2010121049A9 (en) | 2010-12-02 |
EP2419041A1 (en) | 2012-02-22 |
JP2015110113A (ja) | 2015-06-18 |
EP2419041B1 (en) | 2017-06-21 |
US20100268201A1 (en) | 2010-10-21 |
CA2758511C (en) | 2017-06-27 |
JP2012523933A (ja) | 2012-10-11 |
EP2419041A4 (en) | 2015-11-04 |
AU2010236349A1 (en) | 2011-11-17 |
US9968358B2 (en) | 2018-05-15 |
CA2758511A1 (en) | 2010-10-21 |
WO2010121049A1 (en) | 2010-10-21 |
BRPI1014971A2 (pt) | 2016-04-26 |
CN102596083A (zh) | 2012-07-18 |
AU2010236349B2 (en) | 2015-04-02 |
JP5771188B2 (ja) | 2015-08-26 |
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