CN105358212B - 用于可植入医疗装置的固定 - Google Patents
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Abstract
一种用于可植入医疗装置的穿透组织的固定部件,该部件包括基座部分(603)和至少一个尖齿部分(630),该基座部分限定纵向轴线并被构造成固定地附接至医疗装置,以使得纵向轴线大致平行于装置的纵向轴线延伸。尖齿部分包括钩段(631)和由组织刺穿顶端(622)端接的远侧段(632)。钩段预设成沿着预设曲率从靠近基座部分的钩段的近端到钩段的远端延伸,该预设曲率包含在135度和270度之间的角度,并且钩段能从预设曲率弹性变形至打开位置。远侧段预设成从钩段的远端沿着大致相切于钩段的远端的相对直的线延伸至顶端。钩段(631)从靠近钩段的近端的其第一宽度(W1)渐缩至靠近钩段的远端的其第二宽度(W2),并且尖齿部分的组织穿透顶端(622)的宽度(W3)大于钩段的第二宽度(W2)。
Description
技术领域
本发明涉及可植入医疗装置,并且更具体地涉及可植入医疗装置的穿透组织的固定部件。
背景技术
一种用于提供刺激治疗和/或用于诊断感测的可植入医疗装置可包括构造成将装置保持在植入位置处的至少一个穿透组织的固定部件。图1是示意图,示出用于这样的装置的潜在心脏植入部位,例如,在右心房RA的附器102内,在冠状静脉CV内(经由冠状窦口CSOS)、或靠近右心室RV的尖部103。图2是示例性的可植入医疗装置200的平面图,该装置包括由多个尖齿部分230形成的穿透组织的固定部件。图2还示出了包括气密密封外壳220的装置200,外壳220包含控制电子器件和功率源(未示出)并且限定装置200的纵向轴线2。外壳220可由医用级不锈钢或钛合金形成,并且具有形成于其上的绝缘层,例如聚对二甲苯、聚酰亚胺或氨基甲酸乙酯。进一步参照图2,装置200包括一对电极261、262,其可形成用于心脏起搏和感测的双极对;尖齿部分230围绕电极261并且被构造成例如在上述植入部位之一处穿透组织以便使电极261与组织保持紧密接触,同时固连或固定装置200以慢性植入在该部位。装置200的合适构造的进一步描述可见于具有预授予的公开号2012/0172690 A1的共同待审和共同转让的美国专利申请中。
参照图3A,装置200可经由递送导管300递送至植入位置。例如,参照图1,如果目标植入部位位于右心房RA、冠状静脉CV或右心室RV中,那么导管300的远端310可根据本领域已知的经静脉递送方法通过上腔静脉SVC或下腔静脉IVC操纵进入心脏中。图3A示出了导管300的远端310的局部剖视图,其形成为杯状物以保持和包含装置200,从而递送至植入部位。图3A示出了已加载到远端310中的装置200,使得每个尖齿部分230的钩段231从其预设曲率弹性地变形至打开位置,在打开位置处,每个尖齿部分230的远侧段232朝导管远端310的开口313向远端延伸。每个尖齿部分230优选地由诸如镍钛诺的超弹性材料形成。图3A还示出了部署元件320,其邻接装置200的近端并且从装置200向近端延伸穿过导管300的管腔且从导管300的近端开口301出去。元件320可由操作者沿箭头M移动,以将装置200从远端310的开口313沿箭头P推出去,例如,当开口313已被操作者定位成紧邻目标植入部位处的组织时。
图3B是尖齿部分230之一的远侧段232的放大视图,其中端接远侧段232的组织刺穿顶端322已通过导管300的远端310的开口313被推出并且与组织T形成接触。图3B示出了由靠近开口313的远端310的周围壁支撑的远侧段232,使得部署元件320的推力被有效地传递通过顶端322以首先压缩组织T,如图所示,然后刺穿组织T以穿透其中,这在图3C-D中示出。图3C-D分别示出了当部署元件320继续将装置200推出开口313时的部分尖齿穿透和完全尖齿穿透。可以看到,一旦撤走远端310的约束,每个尖齿部分230的弹性性质就允许对应的钩段231在组织内朝其预设曲率回弹。图3D所示尖齿部分230的完全穿透代表装置200在植入部位处的急性固定,例如以用于评估装置性能(例如,通过电极261、262起搏和感测)。应当指出,在某些植入部位处,尖齿部分230在完全穿透时可例如大体上朝导管300的远端310从组织T向后延伸退出。
进一步参照图3D,栓系件350示出为穿过形成于装置200的近端处的眼特征205;拴系件350向近端延伸穿过部署元件320的管腔至其近端351,伸出部署元件320的近端之外,这可以在图3A中看到。因此,如果急性固定的装置200不满意,操作者可使用栓系件350将装置200拉回到远端310内,从而将尖齿部分230从组织撤走,以使得装置可由递送导管300移动至另一个潜在的植入部位。备选地,如果急性固定的装置200满意地进行,栓系件350的近端351可被切断,以将栓系件350从装置200的眼特征205拉出,并且完全穿透的尖齿部分230继续固定装置200以用于慢性植入。
上述共同待审且共同转让的美国专利申请‘690公开了具有类似于尖齿部分230的尖齿部分的固定部件的适当的实施例,其中尖齿部分表现出适当的基线性能,例如,在部署力、急性回缩力(用于再定位)、无损伤回缩、以及急性和慢性固定力方面。然而,仍存在对用于诸如装置200的可植入装置的尖齿部分的新构型的需求,该尖齿部分可进一步加强固定。
发明内容
本发明的一些实施例涵盖可植入医疗装置(例如,心脏起搏器)及其穿透组织的固定部件,该部件包括一个或多个尖齿部分,所述一个或多个尖齿部分被构造用于在其挠曲期间增加应变减轻,或者在初始植入时(特别是在为了再定位装置而有必要使穿透的尖齿回缩的情况下),或者当在固定的装置慢性植入到例如跳动的心脏内期间经受循环荷载时。这些尖齿部分优选地也被构造用于降低在其例如为了再定位而从组织回缩期间组织受伤的风险。在某些实施例中,用于可植入医疗装置的穿透组织的固定部件包括尖齿部分,该尖齿部分被构造用于减小压缩靠近植入部位的血管(例如,到闭塞的程度)的风险,而不以慢性固定性能为代价,同时保持足够的应变减轻。
根据一些实施例,可植入医疗装置的穿透组织的部件的尖齿部分包括钩段和由组织刺穿顶端端接的远侧段。钩段预设成沿着包含在135度和270度之间的角度的曲率从靠近基座部分的钩段的近端延伸至钩段的远端,并且能够从预设曲率弹性变形至打开位置,该钩段从靠近钩段的近端的钩段的第一宽度渐缩至靠近钩段的远端的钩段的第二宽度,第二宽度小于第一宽度。远侧段预设成沿着大致相切于钩段的远端的相对直的线从钩段的远端延伸,该远侧段由组织刺穿顶端端接,组织刺穿顶端优选地具有比钩段的第二宽度大的宽度。钩段的第一宽度可以比其第二宽度大大致两至五倍,并且组织穿透顶端的宽度可以比第二宽度大两至三倍。
根据其中尖齿部分的远侧段的长度相对较短的一些实施例,为了减小血管压缩的风险,当钩段适形于预设曲率时,远侧段或者大致平行于部件/装置的纵向轴线或者远离纵向轴线延伸。
根据其中穿透组织的部件还包括例如呈环的形式的基座部分的一些实施例,该环限定上述纵向轴线并且被构造成固定地附接到可植入医疗装置,尖齿部分还包括近端段,该近端段在钩段和基座部分之间延伸,其中,近端段可以从基座部分朝纵向轴线延伸。
附图说明
以下附图说明了本发明的特定实施例,并且因此不限制本发明的范围。附图未按比例绘制(除非如此说明)并且旨在用于结合以下具体实施方式中的解释使用。下面将结合附图描述各实施例,在附图中,相同的标号/字母表示相同的元件,并且:
图1是示出用于本发明的实施例的可能植入部位的示意图;
图2是示例性的可植入医疗装置的平面图;
图3A是根据一些实施例的加载到递送导管中的医疗装置的平面图,其中装置的穿透组织的固定部件的尖齿部分弹性变形到打开位置;
图3B是在植入部位初始地接触组织的尖齿部分之一的放大细部图;
图3C-D是当尖齿部分已穿透组织时在植入该装置的后续步骤中的装置和导管的平面图;
图4A是挠曲的尖齿部分的示意图;
图4B是根据本发明的一些实施例的渐缩的尖齿部分的透视图;
图5是图2中示出的示例性装置的尖齿部分的估计穿透路径和“设定的”松弛图线;
图6A是根据本发明的一些实施例的可植入医疗装置的平面图;
图6B是与图6A的装置分离的根据本发明的一些实施例的穿透组织的固定部件的透视图;
图6C是根据一些实施例的图7B的部件的立面图;
图6D是根据一些实施例的图7B的部件的尖齿部分的平面图;
图7A是可并入图6A的装置中的根据一些备选实施例的穿透组织的固定部件的立面图;
图7B是图7A所示部件的尖齿部分的估计穿透路径和“设定的”松弛图线;
图8A-B是根据一些备选实施例的尖齿部分的平面图;
图9A-D是根据附加实施例的各个尖齿部分的轮廓和对应的估计穿透路径和“设定的”松弛图线;
图10A是根据本发明的一些备选实施例的可植入医疗装置的平面图;
图10B是与图10A的装置分离的根据一些实施例的穿透组织的固定部件的透视图;
图10C是在植入部位初始地接触组织的图10B的尖齿部分之一的远侧段的放大细部图;
图11A是根据本发明的另外的实施例的穿透组织的固定部件的立面图,其可并入图10A的示例性装置中;以及
图11B是根据一些实施例的图11A的部件的尖齿部分的平面图。
具体实施方式
以下详细描述在本质上为示例性的,而并非意图以任何方式限制本发明的范围、适用性或构型。相反,以下描述提供了实用示例,并且本领域的技术人员将认识到,示例中的一些可以具有合适的备选方案。
图4A是与上述可植入医疗装置200分离的尖齿部分230之一的示意图,其中示出了尖齿部分230沿箭头F的示例性挠曲。一旦尖齿部分230已穿透组织以将装置200固定在慢性植入部位以用于心脏监测和/或治疗,这样的挠曲可由尖齿部分230遭遇,例如,如图3D所示。因此,疲劳寿命是影响用于在其植入寿命内可能经受由数亿次心跳造成的循环荷载的那些可植入医疗装置的尖齿部分的构型的考虑因素。在图4A中,例如响应于沿箭头F的挠曲的应力集中区SC被圈中;区SC位于靠近尖齿部分230的钩段231的近端31处,在那里,钩段231与基座部分203接合。基座部分203和尖齿部分230可一体地形成,其中基座部分203被构造成固定地附接到装置200。区SC中的应力集中也可由钩段231向打开位置的变形导致(图3A),例如,在装置200的初始加载和装置200回缩回导管的远端310内以重定位时,这种变形与反复的部署力结合潜在地会将尖齿部分230推向弹性极限,并且可能使尖齿部分230随后在上述循环荷载作用下更易于疲劳。虽然尖齿部分230的倒圆边缘有效地减少了应力集中,如在前述共同转让的美国专利申请‘690中此前描述的那样,但本发明的一些实施例并入具有渐缩的钩段的尖齿部分,以进一步解决应力集中问题,例如,如图4B所示。
图4B是根据一些实施例的尖齿部分430的透视图,尖齿部分430中的一个或多个可并入装置200中,以代替尖齿部分230。根据一些优选实施例,基座部分403示出为与尖齿部分430一体地形成,其中基座部分403被构造用于附接到诸如装置200的医疗装置。图4B示出了从其第一端部41(靠近基座部分403)延伸至其第二端部42(靠近尖齿部分430的远侧段432)的尖齿部分430的钩段431,其中钩段431从靠近近端41的第一宽度W1渐缩至靠近钩段431的远端42的较小的第二宽度W2。钩段431的渐缩在上述变形/挠曲期间提供应变减轻,以缓解上述应力集中。图4B进一步示出了可选狭槽48(虚线),其可穿过尖齿部分430的厚度t形成,并且在第一宽度W1和第二宽度W2之间延伸。狭槽48的并入提供了用于提供应变减轻的额外手段,例如当关于第二宽度W2多窄的限制可能例如不小于大致0.020-0.025英寸时,以使得远侧段432不会在其回缩时撕裂组织。根据一些实施例,可选狭槽48可包括内部剪力片(未示出)以帮助分布例如正交于沿图4A的箭头F的图示挠曲方向的面外荷载。
进一步参照图4A-B,尖齿部分430的远侧段432示出为具有比尖齿部分230的远侧段232短的长度,例如,以便在选择合适的植入部位时提供更多柔韧性,而不会在尖齿部分430在所选部位穿透时冒险不当地损伤组织。较短的长度可有助于防止在某些植入部位处通过例如心脏的结构的壁的穿孔,并且可以减小穿透的尖齿部分430妨碍血管的可能性,这种妨碍例如可能危及冠状动脉供血,如下文结合图5将描述的。
图5是装置200的尖齿部分230(图2)的估计的组织穿透路径和“设定的”松弛图线,其中尖齿部分230由大致0.005英寸厚的镍钛诺形成。图5包括实线,其表示当装置200被加载到导管300的远端310(图3A)时尖齿部分230的轮廓,其中钩段231变形至打开位置。重新参照图3A-D,原点或沿纵坐标轴线的零坐标大体对应于递送导管300的远侧段310的约束壁。图5的图线由连接圆的分段线和虚线构成,分段线对应于例如当装置200被从远端310推出且进入组织T(图3B-D)时的尖齿部分230的估计穿透路径,虚线表示根据预设曲率的尖齿部分230的轮廓,穿透的尖齿部分230随时间推移而朝该虚线松弛。在分段线和虚线之间的组织的体积接近在穿透的尖齿部分230随时间推移而松弛时由其挤压或压缩的体积;该体积越大,穿透的尖齿压缩或夹住遍布组织的一个或多个血管的可能性就越大。例如,图5中的虚线表示可能被尖齿部分230压缩或夹住的潜在的冠状动脉。如上文暗示的,远侧段232的长度是有助于由穿透的尖齿部分230挤压的体积的因素,从而减小远侧段232的长度可能是期望的。然而,如果远侧段232的长度减小,而不改变尖齿部分230的其它方面,那么当钩段231处于打开位置时尖齿部分230相对于组织T的取向会被影响,使得尖齿部分230可能较不可能有效地穿透组织T,例如在通过导管300的远端310的开口313(图3A-B)离开时。因此,参照图4B,当钩段431处于打开位置时,尖齿部分430的钩段431的渐缩不但减轻应变,而且允许更短的远侧段432对于组织穿透来说更有利的取向(例如,沿着更靠近组织表面的法线的线导向)。
例如,如下所述,用于固定可植入医疗装置的尖齿部分的各种实施例并入渐缩的钩段和/或较短的远侧段,以解决上述循环荷载和/或潜在的组织创伤问题。下面的实施例已参照用于医疗装置的穿透组织的固定部件的现有技术尖齿部分,例如在前述共同转让的美国专利申请‘690中描述的那些(大体对应于尖齿部分230),以便允许诸如装置200的装置在递送导管内的类似装配,例如,使尖齿部分在导管300的远端部分310内变形到打开位置,并且例如在部署力(例如,对于具有四个尖齿部分的固定部件来说不大于大致1-2牛顿)、用于重定位的急性回缩力(例如,对于具有四个尖齿部分的固定部件来说在大致3-4牛顿之间)、无创伤回缩、以及足够的急性固定力(例如,对于具有四个尖齿部分的固定部件来说大于大致2.5牛顿)方面保持合适的基线性能。
图6A是根据本发明的一些实施例的医疗装置600的平面图。图6A示出了包括气密密封外壳620和一对电极661、662的装置600;类似于装置200的外壳220,外壳620包含控制电子器件和功率源(未示出),其例如与电极661、662一起适于心脏起搏和感测。图6A进一步示出了包括已从递送导管300的远端310(图3A-D)部署的尖齿部分630的装置600,尖齿部分630适于穿透组织,以便将装置600固定在植入部位,例如在右心房RA或右心室RV中的心脏部位(图1)。根据一些实施例,尖齿部分630包括在穿透组织的固定部件63中,穿透组织的固定部件63在图6B中示出为与装置600分离。
图6B示出了还包括基座部分603的部件63,尖齿部分630从基座部分603延伸,优选地与其一体地形成,如下文所述。根据图示实施例,固定部件63的基座部分603限定部件63的纵向轴线6,并且被构造用于附接到装置600,使得轴线6与装置600的纵向轴线20大致对准。部件63可以是子组件的一部分,该子组件形成装置600的远端,并且也包括电极661;这样的子组件在前述共同转让的美国专利申请‘690中结合其图3A-4B有所描述,该申请的描述以引用方式并入本文中。图6B进一步示出了穿透组织的部件63的每个尖齿部分630,其包括钩段631和远侧段632。
图6C是部件63的立面图,参照图6C,每个钩段631沿着包围角度θ的预设曲率从其近端61延伸至其远端62。图6C示出了沿着相对直的线延伸的每个远侧段632,该线大致相切于钩段631的远端62。根据图示实施例,角度θ小于180度,使得远侧段632远离轴线6延伸。图6C进一步示出了由单个半径R限定的钩段631的预设曲率。根据一个示例性实施例,半径R为大致0.085英寸,远侧段相对于轴线6延伸的角度β为大致20度,并且远侧段632的长度LD在大致0.05英寸和大致0.1英寸之间。
根据一些优选实施例,部件63通过以下方式制造:首先从超弹性且生物相容的金属(例如,镍钛诺)的管一起激光切割基座部分603和尖齿部分630,然后将每个尖齿部分630围绕心轴包裹和保持,以用于预设每个钩段631的所示曲率的热定形过程。诸如这些的制造方法是镍钛诺部件成形领域的技术人员熟知的。虽然图6B示出了形成为环的部件63的基座部分603,其中尖齿部分630与其一体地形成并且围绕环的周边彼此间隔开,但在穿透组织的固定部件的备选实施例中,一个或多个尖齿部分可单独地形成,然后附接到基座部分,该基座部分以任何适当的方式构造以附接到装置600。
图6D是在形成其预设曲率之前的尖齿部分630中的一个的平面图,其中可以看到沿着钩段631从第一宽度W1到较小的第二宽度W2的用于应变减轻的上述渐缩。例如在前述示例性实施例中,当部件63由具有大致0.005英寸的厚度的镍钛诺配管制成并且其钩段631具有大致0.23英寸的长度LH时,第一宽度W1可以比第二宽度W2大在大致2至5之间的倍数,以便为提高疲劳寿命而提供应变减轻。然而,如果例如大致0.010英寸的较小的第二宽度W2将限定整个远侧段632,那么远侧段632可能会在从组织回缩时撕裂组织,例如在重定位装置600时。因此,进一步参照图6D,尖齿部分630的远侧段632由具有宽度W3的组织刺穿顶端622端接,宽度W3大于第二宽度W2,例如大大致2至3倍,以便对组织无损伤。在前述示例性实施例中,第一宽度W1在大致0.034英寸和大致0.05英寸之间,第二宽度W2为大致0.010英寸,并且第三宽度W3为大致0.02英寸。
图7A是根据本发明的一些备选实施例的穿透组织的固定部件73的立面图,其可以作为部件63的替代形式并入装置600中,使得部件73的纵向轴线7与装置600的纵向轴线20大致对准。图7A示出了包括基座部分703和多个尖齿部分730的部件73,基座部分703类似于部件63的基座部分603,尖齿部分730中的每一个包括钩段731和远侧段732。尖齿部分730和基座部分703优选地根据上文针对部件63所述的方法一体地形成。此外,在钩段731的曲率的预设之前,每个尖齿部分730可被构造成类似于上文结合图6D所述的尖齿部分630,其中用于宽度W1、W2、W3、厚度t和长度LD、LH的前述示例性值是合适的。然而,进一步参照图7A,钩段731沿其从钩段731的第一端部71延伸至钩段731的第二端部72的预设曲率包围180度的角度以使得远侧段732在其组织刺穿顶端722和钩段731的第二端部72之间沿着大致平行于轴线7的线延伸。类似于钩段631,钩段731的预设曲率由单个半径R限定,该半径可以是大致0.085英寸。
图7B是部件73的尖齿部分730的估计穿透路径和“设定的”松弛图线,其可与尖齿部分230的图线(图5)相比较。图7B以实线示出了已弹性变形至打开位置的尖齿部分730,例如,如在装置600包括部件73并且被加载到递送导管(例如,递送导管300的远端310(图3A))内的情况那样。通过比较图5和图7B的虚线可以理解,渐缩的应变减轻使尖齿部分730的变形的轮廓相对于尖齿部分230的轮廓变平,并且尖齿部分730的打开位置使尖齿部分730的远侧段732沿着几乎垂直于纵坐标轴线的线取向,该纵坐标轴线大体上对应于上述组织表面,以实现有效的组织穿透。此外,相对于对应的放松轮廓(虚线),在比较尖齿部分230和730的估计的组织穿透路径(连接圆的分段线)的过程中可以看到,由于更短的长度和更开放的预设曲率,相对于穿透的尖齿部分730在完全穿透时随时间推移朝其放松的预设曲率,尖齿部分730不包围同样大体积的组织,从而降低了穿孔和/或夹住血管的上述风险。
图8A-B是根据一些备选实施例的尖齿部分830A、830B在预设其曲率之前的平面图,两者均可以代替尖齿部分630、730形成于部件63、73中,例如以增加公差控制和检查的容易度。图8A-B示出了具有单侧或不对称锥形的尖齿部分830A、830B的钩段831A、831B。根据图示实施例,宽度W1、W2和W3标示在沿钩段831A、831B和远侧段832A、832B大体上相同的位置处,如此前针对尖齿部分630和730所述。此外,应当理解,根据一些优选实施例,每个尖齿部分830A、830B的厚度(进入页面),例如大致0.005英寸,沿着每个尖齿部分830A、830B的整个长度是大致恒定的,因为将包括尖齿部分830A、830B的部件优选地根据上文所述方法由镍钛诺管形成。图8A进一步示出了端接于组织刺穿顶端822中的尖齿部分830A的远侧段832A,其中宽度W3具有与第二宽度W2中心线错开的中心线;而图8B示出了远侧段832B的组织刺穿顶端822B,其中宽度W3具有与第二宽度W2的中心线大致对准的中心线。根据一些示例性实施例,第一宽度W1在大致0.034英寸和大致0.05英寸之间,第二宽度W2为大致0.010英寸,并且第三宽度W3为大致0.02英寸。
图9A-D是根据本发明的另外的实施例的各种尖齿部分930A、930B、930C、930D的轮廓和对应的估计穿透路径和“设定的”松弛图线,其中钩段931A-D的轮廓沿着预设的曲率适应其远侧段932A-D例如相比尖齿部分230的长度(图5)的相对短的长度。图9A-D示出了由两个半径R1和R2限定的每个钩段931A-D的预设曲率,其中R2大于R1。根据尖齿部分930A、930B的示例性实施例,半径R1为大致1.04mm,半径R2为大致1.65mm,而在尖齿部分930C的示例性实施例中,半径R1为大致0.5mm,半径R2为大致1.65mm,并且在尖齿部分930D的示例性实施例中,半径R1为0.25mm,半径R2为大致2.4mm。应当指出,如在对应的图线中所描绘的,尖齿部分930A-D均不包括沿着其对应的钩段931A-D的渐缩。然而,可以构想,例如类似于上文所述那样,钩段931A-D的渐缩将为提高的疲劳寿命提供应变减轻,并且允许更短的尖齿部分930A-D,而在钩段931A-D变形至打开位置时不以远侧段932A-D的取向为代价。
尖齿部分930A-D中的每一个可以是多个中的一个,其包括在穿透组织的部件中并且从部件的基座部分903延伸,其中基座部分903限定部件的轴线9,并且可以类似于上文所述部件63、73的基座部分603、703。图9A-D进一步示出了包括近端段933A-D的尖齿部分930A-D中的每一个,近端段933A-D在基座部分903和对应的钩部分931A-D之间延伸。近端段933A、933B中的每一个示出为大致平行于轴线9延伸,而近端段933C、933D中的每一个示出为从基座部分903朝轴线9延伸,例如以增加尖齿部分930C、930D中的每一个的总弧长,以便在对应的钩段931C、931D弹性变形至打开位置(图中的实线)时回缩到导管远端310内期间(图3A-C)增加柔韧性。此外,虽然远侧段932C、932D的取向在尖齿部分930C、930D处于打开位置时相比其它实施例较不利于容易的组织穿透,但近端段933C、933D朝轴线9的延伸可有助于在没有钩段931C、931D的渐缩的情况下减少压缩的组织体积。
进一步参照图9B-C,每个钩部分931B、931C也由在半径R1、R2之间延伸的直部段S限定。进一步参照图9A-D的图线中的实线,可以看到直部段S如何能在一定程度上使尖齿部分930B、930C的打开的轮廓变平。最后,通过比较图9A-D的图线的分段线(其对应于尖齿部分930A-D中的每一个的估计的组织穿透路径)与针对尖齿部分230的图5的图线的分段线可以理解,远侧段932A-D的相对较短的长度结合尖齿部分930A-D的对应轮廓导致在朝预设曲率(虚线)的后续松弛期间可能地由穿透的尖齿部分930A-D中的每一个压缩的组织体积的减少。
由于长度的减小和/或用于尖齿部分的应变减轻的渐缩在某些情况下在部署时会阻碍初始的尖齿穿透(例如,根据上文结合图3B-C所述方法),下文结合图10A-C和图11A-B所述的本发明的附加实施例包括构造成加强初始尖齿穿透的组织刺穿远端顶端。参照图3A-B,尖齿部分230的初始穿透依赖于尖齿部分230的硬度大于组织T的硬度,并且依赖于当装置200被加载到导管远端310内(其中钩段31弹性地变形至打开位置)时组织刺穿顶端322相对于组织T的取向。
图10A是根据本发明的一些实施例的可植入医疗装置500的平面图。图10A示出了包括气密密封外壳520和一对电极561、562的装置500;类似于装置200的外壳220,外壳520包含控制电子器件和功率源(未示出),其例如与电极561、562一起适于心脏起搏和感测。图10A进一步示出了包括尖齿部分530的装置500,尖齿部分530适于穿透组织,以便将装置500固定在植入部位,例如在右心房RA或右心室RV中的心脏部位(图1)。
图10B是根据本发明的一些实施例的穿透组织的固定部件53的透视图,其示出为与装置500分离并且包括尖齿部分530。图10B示出了也包括基座部分503的部件53,尖齿部分530从基座部分503延伸。根据图示实施例,固定部件53的基座部分503限定部件53的纵向轴线5并且被构造用于附接到装置500,以使得轴线5与装置500的纵向轴线25大致对准。部件53可以是子组件的一部分,该子组件形成装置500的远端并且也包括电极561,例如,类似于在共同转让的美国专利申请‘690的详细描述的上文引用且以引用方式并入的篇幅中所公开的前述子组件。
图10B进一步示出了穿透组织的固定部件53的每个尖齿部分530,其包括钩段531和远侧段532。每个钩段531示出为沿着包围角度ψ的曲率从其近端51延伸至其远端52;并且每个远侧段532示出为沿着大致相切于钩段531的远端52的相对直的线延伸。每个远侧段532示出为朝轴线5延伸,并且根据一个示例性实施例,角度ψ为大致200度。根据一些优选实施例,部件53通过以下方式制造:首先从超弹性且生物相容的金属(例如,镍钛诺)的管一起激光切割基座部分503和尖齿部分530,然后将每个尖齿部分530围绕心轴包裹和保持,以用于预设每个钩段531的所示曲率的热定形过程。如上所述,诸如这样的制造方法是镍钛诺部件成形领域的技术人员熟知的。虽然图10B示出了形成为环的部件53的基座部分503,其中尖齿部分530与其一体地形成并且围绕环的周边彼此间隔开,但在穿透组织的固定部件的备选实施例中,一个或多个尖齿部分可独立地形成,然后附接到以任何合适方式构造用于附接到装置500的基座部分。
为了在选择装置500的合适植入位置过程中提供更大的柔韧性,相比尖齿部分230的远侧段232的长度,每个尖齿部分630的远侧段632的长度相对较短,例如,在大致0.05英寸和大致0.1英寸之间。较短的长度可有助于防止在某些植入位置穿过例如心脏的结构的壁的穿孔,并且可以减小穿透的尖齿部分530妨碍血管的可能性,这种妨碍例如可能危及冠状动脉供血,如上所述。然而,重新参照图3A-C,在装置500被加载到导管300的远端310内并且远端310的开口313在潜在植入部位处靠近组织定位之后,尖齿部分530的减小的长度可阻碍初始尖齿穿透。远侧段532的较锋利的末端可解决这个问题,但可能在插入和/或回缩时导致组织撕裂;因此,远侧段532的相对钝的末端是优选的。因此,进一步参照图10B,每个远侧段532包括齿状物520和围绕齿状物520的相对钝的端部540。
图10B示出了包括一对腿部541和远端拱形物542的端部540,远端拱形物542在腿部541之间延伸,在齿状物520的顶端522远端,例如与其间隔开大致0.005英寸。每个齿状物520具有从其底部521到其组织刺穿顶端522限定的长度,例如,在大致0.025英寸和大致0.045英寸之间,并且腿部541沿着齿状物520的长度在其相对侧上延伸。每个齿状物520和对应的端部540可以在与从前述管上切割尖齿部分530和基座部分503同时激光切割。
根据图示实施例,端部540的腿部541被构造成当远端拱形物542在潜在的植入部位处抵靠组织被推动(例如,如图10C所示)以使得构造成抵抗弯曲的齿状物520的顶端522暴露以刺穿组织时在弹性变形中弯曲。图10C是当尖齿部分530被推至与植入部位处的组织T接触时远侧段532的放大细部图。重新参照图3A-B,应当理解,如上文针对装置200所述,抵靠组织T推动远端拱形物542可以在装置500被加载到导管300的远端310内使得尖齿部分530的钩段531弹性变形到打开位置之后实现,在该位置处,远侧段532向远端指向远端310的开口313。在每个齿状物520的顶端522已刺穿组织之后,响应于用于初始部署的相对高的推力,端部540的腿部541可放松回到与齿状物520共线,以使得远端拱形物542在尖齿部分530向组织内的后续穿透/插入时和在其从组织的回缩(如果需要)时防止顶端522撕裂组织。重新参照图10B,根据一个示例性实施例,沿其整个长度相对恒定的每个尖齿部分530的厚度t为大致0.005英寸,齿状物520的底部521的宽度wf在大致0.010英寸和大致0.015英寸之间,齿状物520的顶端522的宽度wt为大致0.003英寸,并且腿部541和远端拱形物542的宽度we为大致0.005英寸。
图11A是根据本发明的一些备选实施例的穿透组织的固定部件83的立面图,其也可并入图10A的示例性装置中。图11A示出了包括基座部分803和从基座部分803延伸的多个尖齿部分830的部件83(类似于部件53),其中每个尖齿部分830包括钩段831和远侧段832,它们被构造成解决与组织穿透和疲劳寿命有关的前述问题两者。部件83可由镍钛诺管以类似于上文针对部件53所述的方式切割和形成。图10A进一步示出了每个钩段831,其预设成沿着包围角度的曲率从其近端81延伸至其远端82;并且每个远侧段832示出为沿着大致相切于钩段831的远端82的相对直的线延伸。根据图示实施例,角度为大致180度,以使得每个远侧段832大致平行于部件83的纵向轴线8延伸。钩段831的预设曲率由单个半径R限定,其可以为大致0.085英寸。
图11B是在形成其预设曲率之前的尖齿部分830的平面图。图11A-B示出了每个尖齿部分830,其包括渐缩的钩部分831,类似于上文所述尖齿部分630、730的钩部分631、731,其中靠近钩段831的远端82的第二宽度W2小于靠近钩段831的近端81的第一宽度W1。图11A-B进一步示出了远侧段832,其具有大于第二宽度W2的宽度W3。类似于部件53的远侧段532,远侧段832包括齿状物520和端部540,以有利于组织刺穿而不撕裂,如上所述。类似于部件53,沿其整个长度相对恒定的每个尖齿部分830的厚度t可以为大致0.005英寸,并且其远侧段832可适形于齿状物520和端部540的前述示例性尺寸。
在上述详细描述中,已参照具体实施例描述了本发明。然而,可以理解,在不脱离所附权利要求中阐述的本发明的范围的情况下,可以进行各种修改和改变。
Claims (13)
1.一种用于可植入医疗装置的穿透组织的固定部件,所述固定部件包括基座部分和至少一个尖齿部分,所述基座部分限定纵向轴线并被构造成固定地附接至所述可植入医疗装置,以使得所述纵向轴线大致平行于所述可植入医疗装置的纵向轴线延伸,所述至少一个尖齿部分包括钩段和由组织刺穿顶端端接的远侧段,所述钩段预设成沿着预设曲率从靠近所述基座部分的所述钩段的近端到所述钩段的远端延伸,所述预设曲率包含在135度和270度之间的角度,所述远侧段预设成从所述钩段的所述远端沿着大致相切于所述钩段的所述远端的相对直的线延伸至所述组织刺穿顶端,并且所述钩段能从所述预设曲率弹性变形至打开位置;并且其中:
所述至少一个尖齿部分的所述钩段从靠近所述钩段的所述近端的所述钩段的第一宽度渐缩至靠近所述钩段的所述远端的所述钩段的第二宽度,所述第二宽度小于所述第一宽度;并且
所述至少一个尖齿部分的所述组织穿透顶端的宽度大于所述钩段的所述第二宽度。
2.根据权利要求1所述的部件,其特征在于,所述钩段的所述第一宽度比所述钩段的所述第二宽度大大致两至五倍,并且所述组织穿透顶端的所述宽度比所述第二宽度大大致两至三倍。
3.根据权利要求1所述的部件,其特征在于,所述至少一个尖齿部分还包括穿过所述至少一个尖齿部分的厚度形成的狭槽,所述狭槽在所述钩段的所述第一和第二宽度之间延伸。
4.根据权利要求2所述的部件,其特征在于,所述至少一个尖齿部分还包括穿过所述至少一个尖齿部分的厚度形成的狭槽,所述狭槽在所述钩段的所述第一和第二宽度之间延伸。
5.根据权利要求1-4中的任一项所述的部件,其特征在于,当所述至少一个尖齿部分的所述钩段适形于所述预设曲率时,所述至少一个尖齿部分的所述远侧段大致平行于所述纵向轴线延伸。
6.根据权利要求1-4中的任一项所述的部件,其特征在于,所述至少一个尖齿部分的所述钩段的所述预设曲率由单个半径限定,所述半径为大致0.085英寸,并且所述远侧段的长度在大致0.05英寸和大致0.1英寸之间。
7.根据权利要求1-4中的任一项所述的部件,其特征在于,当所述钩段适形于所述预设曲率时,所述至少一个尖齿部分的所述远侧段延伸远离所述纵向轴线。
8.根据权利要求7所述的部件,其特征在于,所述远侧段以大致20度的角度延伸远离所述纵向轴线。
9.根据权利要求8所述的部件,其特征在于,所述至少一个尖齿部分的所述钩段的所述预设曲率由单个半径限定,所述半径为大致0.085英寸,并且所述远侧段的长度在大致0.05英寸和大致0.1英寸之间。
10.根据权利要求1-4中的任一项所述的部件,其特征在于:
所述基座部分包括围绕所述纵向轴线延伸的环;并且
所述至少一个尖齿部分包括围绕所述环的圆周彼此间隔开的多个尖齿部分。
11.根据权利要求1-4中的任一项所述的部件,其特征在于,所述至少一个尖齿部分具有沿其整个长度从所述钩段的所述近端到所述组织刺穿顶端的基本上恒定的厚度。
12.根据权利要求11所述的部件,其特征在于:
所述至少一个尖齿部分的所述钩段的所述第一和第二宽度、以及所述至少一个尖齿部分的所述组织穿透顶端的所述宽度均限定在所述至少一个尖齿部分的平面中,所述平面沿着所述尖齿部分的整个长度正交于所述厚度;并且
所述组织穿透顶端的所述宽度的中心线沿着所述平面从所述第二宽度的中心线偏移。
13.根据权利要求1-4中的任一项所述的部件,其特征在于,所述至少一个尖齿部分的所述钩段仅沿着所述钩段的单个侧面渐缩。
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US10071243B2 (en) | 2018-09-11 |
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US11400281B2 (en) | 2022-08-02 |
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