CN101217916B - 穿刺和闭合装置以及方法 - Google Patents
穿刺和闭合装置以及方法 Download PDFInfo
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Abstract
本发明公开了用于穿刺和闭合脉管上的位置的装置和方法。公开了自动密封的闭合装置和方法。公开了可以形成进入脉管管腔的陡斜面和扁平穿刺通道的装置。所述装置也可以在血管的内膜和外膜之间形成部分切分开的动脉切开部。本发明还公开了使用所述装置的方法。
Description
对相关申请的交叉参考
本申请根据35 U.S.C§119(e)要求享有于2005年5月12日提交的美国临时申请60/680,388的权益,该申请的全文引用在此作为参考。
技术领域
本发明涉及穿刺(access)生物管腔以及闭合由此产生的穿刺口的领域。
背景技术
现在许多诊断和介入脉管手术通过穿腔方式进行,其中,导管在方便的穿刺位置例如股动脉、臂动脉或锁骨下动脉插入脉管系统,并且穿过脉管系统导向到目标位置,以进行治疗或诊断。当不再需要脉管穿刺(口)时,导管和其它脉管穿刺装置必须从脉管入口移除,并且必须使刺穿处停止出血。
一种用于提供止血的常用方法是在刺穿处的附近和上游典型地通过人工压迫施加外力。该方法费时,在止血之前经常需要半个小时或更多时间的按压。该方法对于病人是不舒服的,并且经常需要服用止痛剂。过大的压力可能还存在血管完全封堵的危险,导致了局部缺血和/或血栓形成。
在通过人工按压实现止血之后,病人需要在观察下保持斜躺着六到十八个小时以确保持续的止血。在这段时间内,脉管穿刺的伤口可能重新流血,从而可能导致大的并发症。这些并发症可能需要输血和/或外科介入。
生物可吸收紧固件也已经用于止血。通常,这些方法依靠将凝血酶原的和生物可吸收的材料例如胶原质置于刺穿处的表面动脉壁上。该方法通常难以定位血管的覆盖组织与外膜表面的接触面。在离期望位置太远处植入紧固件会导致不能提供止血。然而,如果紧固件插入脉管的管腔,则在紧固件上会形成血栓。血栓会在下游发生栓塞和/或堵塞血栓处的正常血流。被植入的紧固件也会造成感染和植入件的自动免疫反应/排斥。
在进行血管穿刺之后也可以使用缝合方法以提供止血。缝合装置利用设置在脉管刺穿处的该装置的远端穿过组织的管道。所述装置中的针将缝合线拉过刺穿处相对侧的血管壁,并且缝合线直接固定在血管壁的外膜表面上以闭合血管穿刺的伤口。
为了成功闭合,缝合方法需要精确控制地进行。针需要适当地穿过血管壁,从而缝合线成功地固定在组织上,以提供紧密的闭合。对于外科医生,缝合方法还需要其它步骤。
由于以上方法和装置的不足,需要更可靠的脉管闭合的方法和装置。也需要自动密封和固定的脉管闭合装置和方法。还需要无需或需要很少步骤来闭合脉管上的位置的脉管闭合装置和方法。
发明内容
本发明公开一种穿刺具有管腔壁和周围组织的生物管腔的方法。该方法包括在管腔壁和周围组织之间形成通道。该方法还包括将所述通道延伸穿过管腔壁。该方法还包括使通道通入管腔。
形成通道的方法可以包括将一装置插入到管腔壁和周围组织之间。使通道延伸可以包括将所述装置插入并穿过管腔壁。使通道通入(管腔)可以包括将所述装置插入管腔内。该方法可以包括将填料输送到通道内。
该方法可以包括对通道进行填充。对通道进行填充可以包括将填料输送到通道内。填料可以包括凝成固态的(solid-setting)液体。填料可以包括环氧树脂。
该方法可以包括向通道施加压力。向通道施加压力可以包括将填料输送到通道的附近。将填料输送到通道附近可以包括将填料输送到管腔壁和周围组织之间。输送填料可以包括将填料输送到管腔壁内。输送填料可以包括将填料输送到周围组织内。
本发明还公开了在具有管腔壁和周围组织的管腔内形成动脉切开部的方法。该方法包括将一装置移动到基本上位于管腔壁和周围组织之间。该方法还包括向管腔转动所述装置。该方法也包括将所述装置移动穿过管腔壁。该方法还包括将所述装置从管腔壁移除。
周围组织可以具有外膜。转动可以包括使所述装置中预先形成的构型松弛。
该方法也可以包括将一引导件移动穿过所述装置。移动引导件可以包括将引导件移动到管腔内。该方法还包括将一引导件移动到管腔内。移动引导件可以包括将引导件移动通过所述装置。
本发明公开了一种用于穿刺生物管腔的穿刺装置。所述装置包括具有松弛构型的引入装置。松弛构型具有第一扁平部、位于第一扁平部的末端上的第一弯曲部、以及在第一末端从第一弯曲部延伸出的第一斜面。引入装置构造成相对于穿刺装置移动。
引入装置的松弛构型可以具有位于第一斜面的第二末端的第二弯曲部、在第一末端从第二弯曲部延伸出的第二扁平部、位于第二扁平部的第二末端的第三弯曲部、以及从第三弯曲部延伸出的第二斜面。所述穿刺装置可以具有一输送引导件。所述输送引导件可以构造成输送引入装置。
所述穿刺装置可以具有一锚固件。所述锚固件可以从所述输送引导件延伸出。所述锚固件可以构造成使所述穿刺装置相对于管腔稳定。
本发明公开一种用于穿刺生物管腔的装置。生物管腔包括具有纵向管腔壁轴线的管腔壁。所述装置具有一带有纵向构件轴线的细长构件。所述构件构造成以第一角穿刺管腔。
附图说明
图1是在管腔截面中使用动脉切开装置的方法的实施例;
图2到5示出在管腔截面中使用动脉切开装置的方法;
图6示出动脉被切开的管腔的一部分;
图7到11示出图6的截面A-A的多个实施例;
图12示出处于第一构型的动脉切开装置的实施例;
图13是图12的部分B的实施例的特写视图;
图14示出图12的动脉切开装置在第二构型时的实施例;
图15是图14的部分C的实施例的特写视图;
图16示出图12的动脉切开装置在第三构型时的实施例;
图17是图16的部分D的实施例的特写视图;
图18示出图12的动脉切开装置在第四构造时的实施例;
图19是图18的部分E的实施例的特写视图;
图20示出图12的动脉切开装置在第四构型时的实施例;
图21和22是图20的部分F的多个实施例的特写视图;
图23示出动脉切开装置的实施例;
图24示出图12的动脉切开装置在第五构型时的实施例;
图25是图24的部分G的实施例的特写视图;
图26示出动脉切开装置的实施例;
图27是图26的部分H的实施例的特写视图;
图28到32示出图27的截面I-I的多个实施例;
图33和34分别是图26的部分H的实施例的透视图和侧视图;
图35示出在管腔截面中使用动脉切开装置的方法的实施例;
图36是图35的部分J的实施例的特写视图;
图37示出在管腔截面中使用图35的动脉切开装置的方法的实施例;
图38是图37的部分K的实施例的特写视图;
图39和40示出使用动脉切开装置的多个方法;
图41和42示出输送引导件的实施例的截面视图;
图43到48示出引入装置的多个实施例;
图49和50是图48的截面K-K的多个实施例;
图51到53示出引入装置的多个实施例;
图54和55示出引入装置在松弛构型时的多个实施例。
具体实施方式
2004年5月12日申请的美国专利申请No.10/844,247的全文引用在此作为参考。该美国申请中公开的装置和方法的各个方面、特征、构件或整个实施例可以与本发明公开的任何内容结合使用。
图1到图6示出了动脉切开装置2的实施例,以及(例如经由皮肤)穿刺生物管腔4并布置可具有一个或多个预先形成的弯曲部的引入装置6的方法。生物管腔4可以由管腔壁8(例如内膜和/或中膜)包围。管腔壁8可以由周围组织10(例如中膜和/或外膜)包围。
动脉切开装置2可以具有一输送引导件12。输送引导件12可以可滑动地连接到锚固件14。锚固件14可以是刚性的、柔性的或兼具刚性和柔性。锚固件14可以是弹性的、可变形的或兼具弹性和可变形性。锚固件14可以从输送引导件12缩回和伸出。锚固件14可以具有引导眼护套或可连接的导丝。锚固件14可以具有整体的、或多个分开并固定连接的伤口线。锚固件14可以具有线涂层例如光滑涂层和/或由聚氨酯制成的涂层。
锚固件14可以具有锚固件纵向轴线16。引入装置可以具有引入纵向轴线18。锚固件纵向轴线16与引入纵向轴线18的相交可以形成引入角20。锚固件14可以利用Seldinger技术、修改过的Seldinger技术或本领域普通技术人员已知的其它方法插入生物管腔4内。
动脉切开装置2可以构造成以引入角20送入所述引入装置。引入装置6可以具有一引入纵向轴线。引入角20可以是引入纵向轴线18与锚固件纵向轴线16的相交(形成的角)。引入角20的绝对值可以从大约0°到大约30°,范围更窄地从大约0°到大约19°,范围还更窄地从大约0°到大约15°,范围再更窄地从大约5°到大约10°,例如大约10°。
动脉切开装置2或在文中描述的其它装置或设备的任何或所有部件可以例如由下列一种或多种材料制成:不锈钢合金,镍钛合金(例如镍钛诺),钴-铬合金(例如Elgin Specialty Metals,Elgin,IL生产的ELGILOY;Carpenter Metals Corp.,Wyomissing,PA生产的CONICHROME),钼合金(例如钼TZM合金,例如在2003年10月9日公开的国际公开No.WO03/082363 A2公开了该合金,该专利的全文引用在此作为参考),例如国际公开No.WO 03/082363公开的钨-铼合金,聚合物例如聚酯(例如E.I.Du Pont de Nemours and Company,Wilmington,DE生产的DACRON),碳化纤维合成物(例如碳化纤维尼龙合成物如碳化纤维强化尼龙66),聚丙烯,聚四氟乙烯(PTFE),膨体聚四氟乙烯(ePTFE),聚醚酮醚(PEEK),酰胺纤维,聚醚嵌段酰胺共聚物(例如ATOFINA,Paris,France生产的PEBAX),脂族聚醚聚氨酯(例如Thermedics Polymer Products,Wilmington,MA生产的TECOFLEX),聚氯乙烯(PVC),聚亚安酯,热塑性塑料,氟化乙丙烯(FEP),可吸收的或可再吸收的聚合物例如聚乙二醇酸(PGA),聚丙醇酸(PLA),聚对二氧杂环己酮,以及伪聚氨基酪氨酸,压延胶原质,硅树脂,锌,回声的、放射性的、射线透不过的材料或它们的组合物。射线透不过的材料例如是硫酸钡、氧化锌、钛、不锈钢、镍-钛合金、钽和金。
动脉切开装置2的任何或所有构件,包括辅助闭合装置例如填料,或者在文中描述的其它装置或设备,可以是或者具有用于向细胞内生长的基体,或者可以与织物例如用作向细胞内生长的基体的覆盖物(未示出)一起使用。基体和/或织物可以例如是聚脂(例如E.I.du Pont de Nemours andCompany,Wilmington,DE生产的DACRON)、聚丙烯,PTFE、ePTFE、酰胺纤维、压延胶原质、硅树脂或其组合物。
动脉切开装置2的构件和/或填料和/或织物可以填注和/或覆盖本领域普通技术人员已知的药剂输送基体和/或治疗剂和/或诊断剂。这些基体内的药剂可以包括放射性物质;辐射透不过的物质;造细胞剂;细胞毒素剂;细胞(生长)抑制剂;凝血剂,例如聚氨酯、混合有钒酸铋的醋酸纤维素聚合物、乙烯-乙烯醇;润滑的、亲水的物质;胞磷胆碱;抗炎剂,例如非甾体抗炎药(NSAIDs)如环氧合酶-1(COX-1)抑制剂(例如由例如BayerAG,Leverkusen,Germany生产的商标为ASPIRIN的乙酰水杨酸;例如由Wyeth,Collegeville,PA生产的商标为ADVIL的异丁苯丙酸;吲哚美辛;甲芬那酸),COX-2抑制剂(例如Merck & Co.,Inc.,Whitehouse Station,NJ生产的VIOXX;Pharmacia Corp.,Peapack,NJ生产的CELEBREX;COX-1抑制剂);免疫抑制剂,例如西罗莫司(Wyeth,Collegeville,PA生产的RAPAMUNE),或者在有炎症反应的通路内会尽早起作用的基质金属蛋白酶(MMP)抑制剂(例如四环素及其衍生物)。在下列文献中提供了其它药剂的例子:Walton等人在Circulation(1999年7月6日,48-54)上发表的Inhibition of Prostoglandin E2 Synthesis inAbdominal Aortic Aneurysms;Tambiah等人在Brit.J.Surgery(88(7),935-940)上发表的Provocation of Experimental Aortic InflammationMediators and Chlamydia Pneumoniae;Franklin等人在Brit.J.Surgery(86(6),771-775)上发表的Uptake of Tetracycline by Aortic Aneurysm Walland Its Effect on Inflammation and Proteolysis;Xu等人在J.BiologicalChemistry(275(32)24583-24589)上发表的Sp1 Increases Expression ofCyclooxygenase-2 in Hypoxic Vascular Endothelium;以及Pyo等人在J.Clinical Investigation(105(11),1641-1649)上发表的Targeted GeneDisruption of Matrix Metalloproteinase-9(Gelatinase B)SuppressesDevelopment of Experimental Abdominal Aortic Aneurysms,这些文献的全文引用在此作为参考。
输送引导件12可以布置成穿过周围组织10中并进入管腔壁8和/或管腔4。如美国专利申请No.10/844,247的图45和46所示的肘节式布置装置,动脉切开装置2可以具有一压力检测口。压力检测口可以与动脉切开装置2的手柄上或附近的传感器或孔口流体相通,例如外部管腔中的血流例如可以从外部管子末端或孔口的流动和/或通过一透明或半透明窗口观察到。压力检测口可以有利于将动脉切开装置2布置到一位置,在该位置,例如当压力检测口进入生物管腔4时,压力检测口被引入压力。动脉切开装置2的手柄上或附近的传感器或孔口将发出压力检测口已经置于生物管腔内的信号(例如通过显示少量的血流)。压力检测口可以布置到生物管腔4内,然后从生物管腔4中抽出到一位置,其中管腔壁8恰好挡住压力检测口中的压力。一入口壁保持件孔口可附加地执行文中针对压力检测口描述的功能。
输送引导件12可以形成第一动脉切开部22。当锚固件14适当地定位在管腔4内时,可以从锚固件14和/或输送引导件12布置出管腔保持件24和/或入口壁保持件26。锚固件14和/或管腔保持件24和/或入口壁保持件26可以是金属线、杆、可膨胀气囊、或它们的组合物。锚固件14和/或管腔保持件24和/或入口壁保持件26可以是分开的、一体的或单个部件。
当锚固件14适当地定位在管腔4内时,引入装置6可以如箭头所示地移动。所述引入装置可形成第二动脉切开部28。引入装置6可以在管腔壁8与周围组织10之间产生切缝10。如图2中所示,引入装置6可以在管腔壁8中切开一平面。切缝30和/或切开面可以基本上与管腔壁表面32平行。引入装置6可以邻近血管中的外膜。引入装置6可以沿血管中的内膜下或中膜下的切开面向前移动。
如本领域普通技术人员已知,一旦管腔壁8和/或周围组织10和/或切缝30已经被切分开,可以进行内膜下血管重建。如本领域普通技术人员已知,一旦管腔壁8和/或周围组织10和/或切缝30已经切分开,可以进行远程动脉内膜切除。
引入装置6可以具有一个或多个直线部分和/或弯曲部分。在使用时可以更换不同的弯曲引入装置34和直线引入装置36,以选择性地切分开管腔壁8和/或周围组织10和/或切缝30。工具,例如引导件(例如导丝),可以插入并穿过中空的引入装置6,以选择性地切分。
如图3中所示,当引入装置6中的弯曲部分34移入管腔壁8内时,引入装置6可以如箭头所示地向生物管腔4转动和倾斜。引入装置6中的弯曲部分34可以继续使引入装置6向生物管腔4转动。当引入装置6倾斜时,引入角可以是从大约0°到大约120°,范围更窄地从大约5°到大约45°,范围再窄地从大约10°到大约30°,例如大约15°。
图4示出引入装置6可如箭头所示地进一步移动。引入装置6可进入到管腔4内。
引入装置6可穿过引入长度38和引入高度40。引入长度38可以是引入装置6在管腔壁8中平行于管腔壁8的长度分量。引入长度38可以是第二动脉切开部28在管腔壁8的外侧上的开口与第二动脉切开部28在管腔壁内表面32上的开口之间平行于管腔壁8的长度分量。引入长度38可以从大约0.10cm(0.010in.)到大约3.810cm(1.500in.),例如大约0.64cm(0.25in.)。
引入高度40可以是引入装置6在管腔壁8中垂直于管腔壁8的长度分量。引入高度40可以是第二动脉切开部28在管腔壁8的外侧上的开口与第二动脉切开部28在管腔壁内表面32上的开口之间垂直于管腔壁8的长度分量。引入高度40可以从大约0.51mm(0.020in.)到大约5.08mm(0.200in.),例如大约1.0mm(0.040in.)。
引入斜度可以是引入高度40与引入长度38的比值。引入斜度可以从大约1/2到1/40或更小,例如大约1/6,还例如大约1/3。引入斜度可以例如等于或小于大约1/2或1/3,范围更窄地等于或小于大约1/3或1/4,范围再窄地等于或小于大约1/5或1/6,范围还窄地等于或小于大约1/10。
引入高度40和引入长度38可以是引入矢量的分量。引入长度38可以是引入矢量的平行于管腔壁8的分量。引入高度可以是引入矢量的垂直于管腔壁8的分量。所述引入矢量可以是从外部开口42到内部开口44的矢量。由引入装置6开始移出输送引导件12形成的外部开口42可以是管腔壁8或周围组织10中的临时或永久开口。内开口44可以是管腔壁表面32上的临时或永久开口。
图5示出引入装置6可以用作管腔工具例如导丝46的通道。
一引入件护套(未示出)可以插在导丝46上,和/或插在引入装置6上或穿过引入装置6。引入件护套可以小于22 French(弗伦奇)(直径7.3mm,0.29in)或小于引入件护套要引入的管腔的直径。引入件护套例如可以是大约6 French(直径2.3mm,0.092in.),以及大约8 French(直径2.67mm,0.105in.)。引入件护套可以是本领域内普通技术人员已知的引入件护套,例如授予Dubrul等人的美国专利No.5,183,464中描述的引入件护套等。
引入件护套可以插入第二动脉切开部28。所述引入件护套可以使第二动脉切开部28膨胀到期望的或可操作的尺寸。在布置下文描述的填料和/或使用其它闭合方法或装置之前和/或之后和/或同时,引入件护套可以插入第二动脉切开部28。
图6和图7示出了在动脉切开装置2已经布置到生物管腔4内并从生物管腔4中移除之后的示例性生物管腔4。生物管腔4可以具有第二动脉切开部28。生物管腔4在第二动脉切开部28的一侧可以具有第一管腔瓣(web)48,并且在第二动脉切开部28的相对侧上具有第二管腔瓣50。如箭头所示,作用在第一和第二管腔瓣48、50上的血压52可以自动密封第二动脉切开部28。
第二动脉切开部28可以具有动脉切开部截面,动脉切开部截面可以具有动脉切开部直径54。动脉切开部直径54可以从大约0.5mm(0.020in.)到大约400mm(15in.),更窄的范围从大约1.0mm(0.040in.)到大约10.2mm(0.400in.),例如大约2.54mm(0.100in.)。动脉切开部直径54可以大约是引入装置6的直径。
动脉切开部截面可以是非圆形的。动脉切开部可以具有动脉切开部宽度和动脉切开部高度。动脉切开部宽度可以是动脉切开部周长的大约一半。动脉切开部宽度可以从大约1.0mm(0.040in.)到大约10.2mm(0.400in.),例如大约4.06mm(0.160in.)。
动脉切开部高度152可以小于大约0.51mm(0.020in.),范围更窄地小于0.38mm(0.015in.)。动脉切开部高度可以从大约0.25mm(0.010in.)到大约1.3mm(0.050in.),例如大约0.38mm(0.015in.)。动脉切开部的直径和/或高度和/或宽度可以小得足以越经第二动脉切开部28进行细胞生长、血凝结、声密封、热密封、粘合、加强的自动密封以及这些接合方式的组合。
在使用时,动脉切开装置2的输送引导件12和/或其它部件可以形成输送通道56。在经由皮肤的使用中,该输送通道可以延伸到皮肤138。
第二动脉切开部28可以具有一扁平部58和一斜面60。扁平部58可以是管腔壁8与周围组织之间的切缝30。
图8示出第二动脉切开部28可以具有第一扁平部58、第一斜面64、第二扁平部66和第二斜面68。具有多个扁平部和斜面的第二动脉切开部28可以由一个或多个可具有各种几何结构的引入装置6形成。
图9示出第二动脉切开部28例如在扁平部58和/或斜面60中可以注入填料70。填料70可以是单个固体构件、多个固体构件(例如颗粒)、生物相容的环氧树脂、或它们的组合物。填料70可以完全或部分地是生物可吸收的、生物可再吸收的、生物可吸附的、或它们的组合物。填料70可以由同种移植物、异种移植物、或它们的组合物制成。填料70可以由自体移植物、同种异体移植物、或它们的组合物制成。
填料70可以例如通过经由皮肤注入而穿过周围组织10输入(例如注入和/或植入)到第二动脉切开部28。例如可在引入和/或移除引入装置6期间经由引入装置6通过第二动脉切开部28将填料输入(例如注入和/或植入)第二动脉切开部28。
填料70可以永久地或暂时地布置。在实现止血之后和/或动脉切开部基本上或完全治愈之后,填料70可以进行生物溶解。填料70可以保持大约15分钟到大约24小时或更长,例如大约120分钟。
图10示出填料可以处于切缝30内而不是处于第二动脉切开部28内。填料70可以向第二动脉切开部28,例如向扁平部58和/或斜面60施加填料压力72。第二动脉切开部28可以被血压52和填料压力72压迫。
图11示出填料可以位于切缝30内而不是位于第二动脉切开部28内。填料70可以向第二动脉切开部28的第二扁平部66和/或第一斜面64和/或其它截面施加填料压力72。
填料70可以位于第二动脉切开部28和管腔4(未示出)之间。填料70可以位于周围组织10内。
图12和图13示出动脉切开装置2。动脉切开装置2可以具有一手柄74,该手柄74可以与输送引导延伸件76成一体或固定连接到该输送引导延伸件。输送引导延伸件76可以与输送引导件12成一体或固定连接到该输送引导件。锚固件14可以从输送引导件12延伸出,并且可滑动地和/或固定地连接到输送引导件12或与该输送引导件12成一体。
锚固件14可以具有从输送引导件12延伸出的锚固件第一伸长部78。锚固件14可以在锚固件第一伸长部78远离输送引导件12的末端具有锚固件第一弯曲部80。锚固件第二伸长部82的第一末端可以从锚固件第一弯曲部80延伸出。锚固件第二伸长部82的第二末端可以具有锚固件第二弯曲部84。锚固件第三伸长部86可以从锚固件第二弯曲部84延伸出。锚固件第三伸长部86可以形成末尾。锚固件14可以具有伸长部和弯曲部的任何组合。
锚固件弯曲部80和84的曲率半径可以从大约0.1mm(0.004in.)到大约2.0mm(0.079in.)。任何锚固件弯曲部两侧的锚固件伸长部可以形成锚固角。锚固角可以从大约90°到大约160°,范围更窄地从大约120°到大约150°,例如大约135°。锚固件14的截面的直径为约0.38mm(0.015in.)到约1.0mm(0.039in.),例如大约0.71mm(0.028in.)。
锚固件第三伸长部86可以具有锚固件顶端88。锚固件顶端88可以变窄、变宽、变尖、变钝、或以其它方式构造,以有助于锐器解剖或钝器解剖。锚固件顶端88可以具有锚固件端部孔口90。锚固件端部孔口90可以与锚固件导丝管腔(未示出)相通。该锚固件导丝管腔可以与输送引导延伸件76和/或手柄74和/或第三控制件94中的引导管腔92相通。引导管腔92沿输送引导件76和/或沿手柄74和/或沿第三控制件94可以具有打开的通道(如图所示)。
手柄74可以具有第一控制件96。第一控制件96可以可滑动地连接到控制滑道98。第一控制件96可以构造成在人体工程学上能由手指和/或手掌致动。
手柄74可以具有第二控制件100。第二控制件100可以例如在控制枢转点102可转动地连接到手柄74。第二控制件100可以具有一突出部104。突出部104可以构造成在人体工程学上能由手指和/或手掌致动。
手柄74可以具有第三控制件94。第三控制件可以可滑动地连接到手柄74。第三控制件94可以具有或是柱塞。第三控制件94可以具有按压部106。按压部106可以构造成在人体工程学上能由手指和/或手掌致动。手柄74可以具有一个或多个夹持部108。夹持部108可以构造成在人体工程学上可由手指和/或手掌保持。
第一、第二或第三控制件96、100和94中的任一控制件可以具有任何构造(例如第一控制件可以具有第二控制件100的可转动控制杆)。
导丝46可以接近锚固件顶端88。
图14和15示出导丝46可以插入锚固件端部孔口90,如箭头所示。导丝46可以穿过锚固件导丝管腔和引导管腔92。导丝46可以通过引导管腔92的敞开部分引出。
导丝46可以用于将所述动脉切开装置布置在管腔内的希望位置。动脉切开装置2可以例如经由皮肤地在导丝46上并沿导丝46移动。如果导丝46在管腔内,则动脉切开装置2可以沿导丝46移动,例如直到压力测试口出现血流。
图16示出第一控制件96可以如箭头所示地进行致动。第一控制件96可以沿控制滑道98移动。如图17中的箭头所示,第一控制件96的致动可以移动地和/或转动地布置管腔保持件24。
管腔保持件24可以是金属线、例如由可变形的或弹性的材料如形状记忆合金制成的支架、可膨胀气囊、或它们的组合物。管腔内可膨胀的气囊例如利用生理盐水或二氧化碳膨胀的气囊,对于本领域普通技术人员是已知的。管腔保持件24可以伸入输送引导件12。
图17示出例如由于致动第一控制件96,管腔保持件24可以如箭头所示地布置。管腔保持件24可以具有第一受力构型。管腔保持件24可以具有第二松弛构型。管腔保持件24在布置之前可以处于松弛或受力构型。管腔保持件24在布置之后可以处于松弛或受力构型。管腔保持件24的松弛构型可以是管腔保持件24的布置好的构型。
管腔保持件24可以构造成在使用时压靠管腔4。该管腔保持件可以通过相对于锚固件14移动、转动、或它们的组合运动而被布置。
管腔保持件24可以从锚固件14布置。管腔保持件24可以从管腔保持口(未示出)布置。管腔保持件24可以具有管腔保持件的布置直径。管腔保持件的布置直径可以从大约2.54mm(0.100in.)到大约10.2mm(0.400in.),例如大约6.35mm(0.250in.)。
图18示出第二控制件100可以如箭头所示地被致动。第二控制件100可以绕控制枢转点102转动。第二控制件的致动可以如图19中的箭头所示地移动地和/或转动地缩回锚固件14。
图19示出锚固件14可以平行或垂直于输送引导件12移动。
锚固件第一伸长部78可以具有锚固件偏移部110或小的变形。如图19中所见,锚固件偏移部110可以构造成使得其中锚固件第一伸长部78垂直于输送引导件12的纵向轴线进行移位。例如在锚固件缩回到输送引导件12之前,引入管腔出口112可以被锚固件第一伸长部78覆盖。
当所述锚固件缩回到输送引导件12内时,可以露出引入管腔出口112。当所述锚固件缩回到输送引导件12内时,相比锚固件第一伸长部78的其余部分侧向定位的锚固件偏移部110可以使引入管腔出口112露出。当锚固件缩回到输送引导件12内,相比锚固件第一伸长部78的其余部分侧向定位的锚固件偏移部110可以迫使整个锚固件14侧向移动,因而露出引入管腔出口112。
图20示出了第三控制件94可以如箭头所示地被致动。第三控制件94可以相对于手柄74移动。第三控制件的致动可以如图21中的箭头所示地可移动地布置引入装置6。
引入装置6可以具有引入装置直径。引入装置直径可以从大约0.25mm(0.010in.)到大约1.0mm(0.039in.),例如大约0.56mm(0.022in.)。
动脉切开装置2可以构造成从锚固件14和/或输送引导件12布置引入装置6(如图示出)。锚固件14和/或输送引导件12可以具有引入管腔出口112。引入装置6可以通过引入管腔出口112布置。引入装置6可以是实心针或空心针或它们的组合物。
图22示出在引入管腔出口112到锚固件第一伸长部78之间垂直于引入装置6的距离可以基本上和/或完全等于引入高度40。锚固件14可以具有一个或多个辐射透不过的标记。例如,锚固件第一伸长部78可以具有第一辐射透不过的标记114。第一辐射透不过的标记114沿锚固件第一伸长部78的长度显著地大于第一辐射透不过的标记114的高度或宽度。输送引导件12可以具有第二辐射透不过的标记116。第二辐射透不过的标记116可以与引入装置6离开引入管腔出口112的路径平行和对齐。用户可以观察射线照片以帮助放置动脉切开装置2。
图23示出动脉切开装置可以具有第一、第二和第三辐射透不过的标记114、116和118。第一辐射透不过的标记114可以在手柄上。第二辐射透不过的标记116可以在输送引导延伸部76上。第三辐射透不过的标记118可以在锚固件14上。直的对齐轴线120可以穿过第一、第二和第三辐射透不过的标记114、116和118。例如在观察射线照片时,用户可以利用对齐轴线120来帮助放置动脉切开装置2。
辐射透不过的标记可以是用于任何医学影像的标记。例如,标记可以是与声谱仪一起使用的不透声的和/或声反射的标记。
图24示出例如通过将第三控制件94如箭头所示继续向手柄74移动,可以进一步致动第三控制件94。第三控制件的致动或重新致动可以如图25中的箭头所示移动地布置引入装置6。
引入装置6可以具有弯曲部34。弯曲部34可以处于引入装置6的松弛构型。如果引入装置6被布置得足够远,则弯曲部34可以使引入装置6向管腔4转动。
第一、第二和第三控制件96、100和94可以具有闭锁,以防止控制件96、100和94被不正确地致动(例如防止以错误顺序使用)。
图26示出管腔保持件24可以形成圆形、椭圆形或螺旋形构造。图27示出锚固件14可以具有管腔保持件出口122。
图28到32示出管腔保持件24在布置之前在锚固件14中的各种构型。图28示出管腔保持件的一端可以固定地或可转动地连接到锚固件14。管腔保持件24可以具有球部124,并且锚固件14可以具有凹窝126。球部124可以过盈配合在凹窝126中。当施加如箭头所示的布置力时,如果管腔保持件24被施加过预应力(例如热处理成特定形状),则管腔保持件24可以松弛和/或被迫弯曲穿出管腔保持件出口122。
图29示出管腔保持件24可以以环或螺旋构型装载在锚固件14中。当如箭头所示施加布置力时,环128将自然地膨胀并从管腔保持件出口122退出。
图30示出管腔保持件可以预先形成有弯曲部130。当施加如箭头所示的布置力时,如果管腔保持件24被施加过预应力(例如热处理成特定形状),则管腔保持件24可以松弛和/或在锚固件14内的管腔保持件出口122对面被迫弯曲。然后,管腔保持件24可以沿长度在最薄弱位置例如弯曲部130弯曲和/或扭曲。然后管腔保持件24可以从管腔保持件出口122退出。
图31示出管腔保持件24可以例如在固定区域132(例如经由焊接、胶接、搭扣配合等)固定到锚固件14。图32示出管腔保持件可以相对于动脉切开装置2的其它部分在方向上颠倒的实施例。
图33和34示出管腔保持件24可以布置成环形或螺旋形。管腔保持件24可以布置在管腔保持件出口122外部并位于锚固件(如图所示)和/或输送引导件12上。
图35和36示出动脉切开装置2可以足够深地移动到管腔4内,以使所布置的管腔保持件24接触与动脉切开部134相对的管腔壁8。图37和38示出手柄74可以如图37中的箭头所示地移出管腔4。管腔保持件24可以如图38中的箭头所示地移动到最接近动脉切开部134的管腔壁8。管腔保持件24可以邻接管腔壁8,以起例如入口壁保持件26的作用。输送引导延伸件76可以例如通过铰链136可转动地连接到输送引导件12。
图39示出手柄74和输送引导延伸件76可以相对于输送引导件12、锚固件14和管腔保持件24如箭头所示地绕铰链转动。手柄74和输送引导延伸件的转动构型以虚线示出。在使用时,可以操作手柄74和输送引导延伸件76,而减小对输送引导件12、锚固件14和管腔保持件24的影响。
图40示出输送引导延伸件可以是柔性的。手柄74和输送引导延伸件76可以相对于输送引导件12、锚固件14和管腔保持件24如箭头所示地绕柔性输送引导延伸件76转动。手柄74和输送引导延伸件的转动构型以虚线示出。
图41示出输送引导件12的第一纵向部分140。图42示出输送引导件12的第二纵向部分142。第一纵向部分140可以完全或基本上是第二纵向部分142的镜像。
延伸件连接部144可以构造成固定地连接到输送引导延伸件76。延伸件邻接部146可以构造成邻接和/或固定地连接到输送引导延伸件76。延伸件连接部144和/或延伸件邻接部146可以与输送引导延伸件76形成流密密封和/或气密密封。
锚固件管腔148可以构造成接纳和布置锚固件出口150外的锚固件14。引入件管腔152可以构造成接纳和布置引入管腔出口112外的引入装置6。锚固件管腔148、引入件管腔152、锚固件出口150和引入管腔出口112的相对几何形状可以改变,以改变引入角20、引入长度38、引入高度40、以及动脉切开部134的几何形状——包括动脉切开部134的斜面60和扁平部58。
输送引导件的半连接件154可以例如通过可转动地连接到螺钉而使第一纵向部分140连接到第二纵向部分142。第一纵向部分140的接合面156可以与第二纵向部分142的接合面156形成流密密封和/或气密密封。输送引导顶端158可以是尖锐的、钝的或以其它方式构造,以有助于锐器解剖或钝器解剖。
图43到46示出可以各具有引入装置轴杆160的实心引入装置6,该引入装置轴杆可以终止于引入装置顶端162。如图43中示出,引入装置顶端162可以具有中心针尖。引入装置顶端162可以具有引入装置顶端截面164。引入装置顶端截面164可以是圆形的或方形的或它们的组合形状。引入装置顶端可以是弯曲的(未示出)。
图44示出引入装置顶端162可以具有偏心针尖。引入装置顶端截面164可以是圆形或方形或它们的组合形状。引入装置6可以构造成具有沿引入装置轴杆160和沿引入装置顶端162的平面侧。
图45示出引入装置顶端162可以具有中心凿形部。引入装置顶端截面164可以是卵形的、矩形的、椭圆形的或它们的组合形状。
图46示出引入装置顶端162可以具有偏心凿形部。引入装置顶端截面164可以是卵形的、矩形的、椭圆形的或它们的组合形状。引入装置6可以构造成具有沿引入装置轴杆160和沿引入装置顶端162的平面侧。
图47到53示出各具有引入装置轴杆160空心引入装置6,该引入装置轴杆终止于引入装置顶端162。引入装置轴杆160可以具有延伸到引入装置顶端162或引入装置轴杆160侧面的空心引导管腔92。引导管腔92可以终止于引导口166。引导件(例如导丝或其它工具)可以可滑动地连接到引导管腔92内的引入装置6。该引导管腔可以具有可终止于引导顶端170的引导轴杆168。引导件172可以在从引导口166退出引入装置。
如图47中示出,引入装置顶端162可以是位于中心的空心针尖。引导顶端170可以是中心针尖。引导顶端170可以对齐所述引入装置顶端,以形成基本上平滑的组合顶端。
如图48中示出,引入装置顶端162可以是偏心的空心针尖。引导顶端170可以是中心针尖。
图49示出引导轴杆168可以具有键174和/或槽176(未示出)。引入装置轴杆160可以具有槽176和/或键174(未示出)。引导轴杆168上的键174可以可滑动地连接到引入装置轴杆160中的槽176。键174和槽176的可滑动连接可以防止引导轴杆168相对于引入装置轴杆160绕纵向轴线转动。
图50示出引导管腔92和引导轴杆168可以是椭圆形。引导管腔92和引导轴杆168的椭圆形构型可以防止引导轴杆168相对于引入装置轴杆160绕纵向轴线转动。
图51示出引入装置顶端162可以具有弧形末端178。弧形末端178可以构造成配合到引导件172中的凹槽180中。凹槽180可以具有钩状部分182。弧形末端178可以具有凹口184。钩状部分182可以与凹口184形成过盈配合和/或搭扣配合。
图52示出引导管腔92可以是弧形的。引导管腔92可以终止于位于引入装置轴杆160侧面上的引导口166。
图53示出引入装置顶端162和/或引入装置轴杆(未示出)可以是弧形的。引导件172或引导件172的伸长部在松弛构型中是弧形的。由于引入装置6的弯曲,引导件172或引导件172的伸长部在受力构型中可以是弧形的。
图43到图46中示出的任何一种引入装置6可以是空心的,并且构造成与图47到图53中示出的引入装置相同或类似。图47到图53中示出的任何一种引入装置6可以没有引导管腔,并且构造成与图43到图46中示出的引入装置相同或类似。
引导件172和/或引导管腔92和/或引入装置6可以具有光滑涂层或被浸渍以洗提光滑材料。
图54示出引入装置6的松弛构型具有一扁平部58,该扁平部58在一端可以具有一弯曲部34。从弯曲部34可以延伸出斜面。在从输送引导件12布置引入装置6的过程中,引入装置6的松弛构型可以形成例如如图7和9中示出的动脉切开构型。
图55示出引入装置6的松弛构型具有第一扁平部62,第一扁平部62在一端可以具有第一弯曲部186。第一斜面64可以在第一末端从第一弯曲部186延伸出。第一斜面64可以在第二末端具有第二弯曲部188。第二扁平部66可以在第一末端从第二弯曲部188延伸出。第二扁平部66可以在第二末端具有第三弯曲部190。第二斜面68可以从第三弯曲部190延伸出。在从输送引导件12布置引入装置6的过程中,引入装置6的松弛构型可以形成例如如图8、10、11中示出的动脉切开构型。
引入装置6例如空心的引入装置6可以用作要布置到管腔4内的管腔工具例如导丝46的的通道。引入装置6例如实心引入装置6可以从第二动脉切开部28移除,并且可以通过例如引入管腔出口112和第二动脉切开部28布置管腔工具。引入装置6或其一部分可以是管腔工具,例如引导件172。在穿过管腔壁8之后,引入装置6还可以被布置和用作管腔工具。
在移除动脉切开装置2之后,引导件172可以基本上保持就位。引导件172的一部分可以在管腔4外部,引导件172的另一部分可以在管腔4内部。然后引导件近端可以连接到其它装置以及植入物,以将所述装置和植入物引导到管腔内。在完成其它过程并且移除引导件172之后,可以添加填料70;或者在移除引导件172之前,利用引导件172将动脉切开装置2重新布置到动脉切开部134,以输送填料70。
制造方法
例如通过熔化、螺纹连接、胶接、焊接、或者采用过盈配合或压力配合例如压接、咬接或它们的组合方法,动脉切开装置2的元件以及文中公开的任何其它装置和构件的元件可以直接连接。例如通过从单件或单一材料浇铸、冲切、激光切割、电火花加工(EDM)或冲压,元件可以成为一体。可以采用本领域普通技术人员已知的任何其它方法。
在动脉切开装置2的任何元件以及文中公开的任何其它装置和构件的元件包括辅助闭合装置组装后,可以将其作为整体利用本领域普通技术人员已知的浸渍涂敷、刷涂或喷涂的方法进行涂层。
在Ding等人的美国专利No.6,358,556中提供了涂覆用于脉管的医疗设备的方法的一个例子,该专利的全文引用在此作为参考。本领域普通技术人员已知的延时释放涂层方法也可以用于使涂层例如辅助闭合装置上的涂层中的制剂延迟释放。
文中的所有元件可以覆盖有织物例如聚脂(例如E.I.du Pont deNemours and Company,Wilmington,DE公司的DACRON)、聚丙烯,PTFE、ePTFE、酰胺纤维、压延胶原质、硅树脂或其组合物。用织物覆盖可植入装置的方法对本领域普通技术人员是已知的。
如图13、41和42示出,例如通过焊接、整体结构(例如通过铸造)、搭扣配合部件、螺钉192或它们的组合方式,输送引导件12可以固定地组合成。例如通过将螺钉拧过输送引导件和/或将输送引导件挤压到输送引导延伸件上,螺钉192可以将输送引导件12连接到输送引导延伸件76。
辐射透不过的标记可以连接到构件上和/或覆盖在构件的表面上和/或一体地制造在构件中。
通过采用本领域普通技术人员已知的方法,引入装置6、引导件172、锚固件14、管腔保持件24、入口壁保持件26、任何其它构件或它们的组合件可以被热定形成松弛构型。
对于本领域普通技术人员显然的是,可以对本公开内容进行各种改变和修改并使用其等效形式,而不会脱离本发明的范围。任一实施例示出的构件对于特定实施例是示例性的,并且可以用于本公开内的其它实施例。
Claims (28)
1.一种用于穿刺生物管腔的穿刺装置,包括:
输送引导件;
锚固件,所述锚固件从所述输送引导件的末端延伸出,并包括在其间限定形成锚固件弯曲部的第一部分和第二部分;和
具有松弛构型的引入装置,该引入装置可滑动地接纳在所述输送引导件中,并能经由位于所述锚固件的末端附近的开口从所述输送引导件伸出,所述引入装置包括第一扁平部、位于第一扁平部末端的第一弯曲部、以及在第一末端从第一弯曲部延伸出的第一斜面。
2.如权利要求1所述的装置,其特征在于,引入装置的松弛构型还包括位于第一斜面的第二末端的第二弯曲部、在第一末端从第二弯曲部延伸出的第二扁平部、位于第二扁平部的第二末端的第三弯曲部、以及从第三弯曲部延伸出的第二斜面。
3.如权利要求1所述的装置,其特征在于,所述锚固件连接到所述输送引导件。
4.如权利要求1所述的装置,其特征在于,所述锚固件构造成使穿刺装置相对于管腔稳定。
5.一种用于形成穿过组织的管路的装置,包括:
输送引导件;
锚固件,所述锚固件连接到所述输送引导件并从所述输送引导件的末端延伸出,所述锚固件包括第一、第二和第三伸长部,位于所述第一和第二伸长部之间的第一弯取部,以及位于所述第二和第三伸长部之间的第二弯曲部;以及
引入装置,所述引入装置可滑动地接纳在所述输送引导件中,并能经由所述输送引导件中的开口从所述输送引导件伸出。
6.如权利要求5所述的装置,其特征在于,所述锚固件固定地连接到所述输送引导件。
7.如权利要求6所述的装置,其特征在于,还包括能从所述锚固件伸出的保持件。
8.如权利要求7所述的装置,其特征在于,所述引入装置包括一个针。
9.如权利要求8所述的装置,其特征在于,所述针是空心的。
10.如权利要求5所述的装置,其特征在于,所述锚固件与所述输送引导件一体形成。
11.如权利要求5所述的装置,其特征在于,所述第一弯取部具有从约0.1mm到约2.0mm的曲率半径。
12.如权利要求11所述的装置,其特征在于,所述第二弯曲部具有从约0.1mm到约2.0mm的曲率半径。
13.如权利要求5所述的装置,其特征在于,所述第一和第二伸长部之间形成从约90°到约160°的锚固角。
14.如权利要求13所述的装置,其特征在于,所述锚固角为从约120°到约150°。
15.如权利要求14所述的装置,其特征在于,所述锚固角为约135°。
16.如权利要求13所述的装置,其特征在于,所述第二和第三伸长部之间形成从约90°到约160°的锚固角。
17.如权利要求16所述的装置,其特征在于,所述锚固角为从约120°到约150°。
18.如权利要求17所述的装置,其特征在于,所述锚固角为约135°。
19.如权利要求5所述的装置,其特征在于,所述锚固件的截面的直径为从约0.38mm到约1.0mm。
20.如权利要求5所述的装置,其特征在于,所述锚固件是柔性的。
21.如权利要求5所述的装置,其特征在于,所述锚固件还包括引导眼护套。
22.如权利要求5所述的装置,其特征在于,所述锚固件还包括可连接的导丝。
23.如权利要求5所述的装置,其特征在于,所述引入装置包括一个针。
24.如权利要求23所述的装置,其特征在于,所述针是空心的。
25.如权利要求5所述的装置,其特征在于,所述输送引导件中的所述开口位于所述锚固件的末端的附近。
26.如权利要求5所述的装置,其特征在于,还包括与所述输送引导件成一体的输送引导延伸件。
27.如权利要求26所述的装置,其特征在于,所述输送引导延伸件是柔性的。
28.如权利要求5所述的装置,其特征在于,还包括能从所述锚固件伸出的保持件。
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- 2006-05-12 EP EP20060770440 patent/EP1885260A4/en not_active Withdrawn
- 2006-05-12 JP JP2008511478A patent/JP5140800B2/ja not_active Expired - Fee Related
- 2006-05-12 US US11/432,982 patent/US8241325B2/en not_active Expired - Fee Related
- 2006-05-12 CN CN2013100756940A patent/CN103190942A/zh active Pending
- 2006-05-12 CA CA2607387A patent/CA2607387C/en not_active Expired - Fee Related
- 2006-05-12 AU AU2006247355A patent/AU2006247355B2/en not_active Ceased
- 2006-10-06 US US11/544,317 patent/US8083767B2/en not_active Expired - Fee Related
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2007
- 2007-04-19 US US11/788,509 patent/US8002794B2/en not_active Expired - Fee Related
- 2007-11-01 IL IL187109A patent/IL187109A0/en unknown
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2009
- 2009-05-15 US US12/467,251 patent/US20090318889A1/en not_active Abandoned
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2010
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US20070255313A1 (en) | 2007-11-01 |
AU2006247355A1 (en) | 2006-11-23 |
JP2008539989A (ja) | 2008-11-20 |
JP2010184124A (ja) | 2010-08-26 |
IL187109A0 (en) | 2008-02-09 |
AU2006247355B2 (en) | 2013-01-10 |
US20070106246A1 (en) | 2007-05-10 |
JP5341816B2 (ja) | 2013-11-13 |
CA2607387A1 (en) | 2006-11-23 |
US8241325B2 (en) | 2012-08-14 |
WO2006124896A2 (en) | 2006-11-23 |
CN103190942A (zh) | 2013-07-10 |
CA2607387C (en) | 2014-12-23 |
EP1885260A2 (en) | 2008-02-13 |
WO2006124896A3 (en) | 2007-10-11 |
EP1885260A4 (en) | 2015-01-21 |
CN101217916A (zh) | 2008-07-09 |
US8083767B2 (en) | 2011-12-27 |
US20090318889A1 (en) | 2009-12-24 |
JP5140800B2 (ja) | 2013-02-13 |
US20060271078A1 (en) | 2006-11-30 |
US8002794B2 (en) | 2011-08-23 |
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