CN102361663B - 具有抽吸能力的导向*** - Google Patents
具有抽吸能力的导向*** Download PDFInfo
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Abstract
本发明提供了一种用于治疗鼻窦的导向导管(601),所述导管包括被构造为围绕球囊导管提供抽吸的导管轴(610)和被成形为可在身体解剖结构中导航的远侧部分。在一个实施例中,所述导向导管包括用于密封所述球囊导管的阀(624)和用于控制抽吸的排气口(628)。
Description
技术领域
本发明整体涉及医疗器件和方法,更具体地讲,涉及用于治疗鼻窦炎的器件、***和方法。
背景技术
慢性鼻窦炎是一种每年影响数百万人的生活的疾病。事实上,据估计,慢性鼻窦炎每年在美国导致1800万至2200万例内科就诊。慢性鼻窦炎是指持续三个月或以上的或频繁发生的副鼻窦炎症。这种疾病会使人非常虚弱,常常会引起头痛、面痛、鼻部分泌物过多、经鼻腔呼吸困难和其他症状,并且常常还会使诸如乘坐飞机之类的活动变得很痛苦。在医疗成本和误工等方面,慢性鼻窦炎的社会总成本非常巨大。
副鼻窦是上面部骨骼后方、双眼之间和前额、鼻部及脸颊后方的空气空间。在面部的每一侧存在一组额窦(在前额内)、上颌窦(在颧骨内)、筛窦(双眼之间)和蝶窦(双眼后方较远处)。额窦、上颌窦和蝶窦均通过称为窦口的开口连接到鼻腔和引流到鼻腔内。鼻腔和副鼻窦由被粘液组织覆盖的骨骼构成,所述粘液组织具有称为纤毛的小的毛发状突起,纤毛一起移动以作为一种过滤器将粘液通过鼻窦扫出。当鼻窦的粘膜组织常常由于感染而发炎时,其有时会肿胀并可能堵塞一个或多个窦口,从而阻止粘液从鼻窦向鼻腔移动,并因此导致阻塞、压力增大和鼻窦炎的症状。这种阻塞有时会持续很长时间或一再复发,从而造成很大的不适感。
治疗鼻窦炎的方法之一是设法恢复粘液经进入鼻腔的开口(窦口)进出鼻窦的流动。典型地,在治疗鼻窦炎方面尝试的最初疗法是药物治疗和鼻喷剂—用于减轻粘膜组织炎症的抗炎剂和用于治疗感染的抗生素。然而,有大批患者对鼻喷剂/药物治疗无反应。对药物治疗无反应或可能无反应的慢性或复发性鼻窦炎患者可能因此决定接受外科手术。
用于治疗慢性鼻窦炎的一种外科手术称为功能性内窥镜鼻窦手术(“FESS”)。在FESS过程中,将刚性内窥镜***鼻内,同时外科医生使用一个或多个刚性器械(诸如刮刀和抓紧器)移除患病的或肥厚的粘膜组织和骨骼,并且在一些情况下扩大鼻窦的窦口以试图“撑开”和恢复鼻窦的正常引流。这些FESS手术在许多情况下是成功的,但的确存在许多明显的缺点。例如,FESS手术需要进行全身麻醉。此外,因为FESS通常会移除大量的软组织和骨骼,所以FESS会引起大量出血和术后疼痛,因此术后康复会很痛苦并需要花费数日甚至数周的时间。因为FESS手术常常伴随大量的术后出血,所以在术后的一段时间内,经常要在患者的鼻腔内放置鼻腔填塞物。此类鼻腔填塞物可能使人感到不适,并可能影响正常的呼吸、进食和饮水等。必须经常移除并更换这种填塞物,该过程会使人感到很不舒服。可能还必须在内科医生的诊所通过称为“清创术”的手术移除瘢痕组织,该手术也会非常痛苦。此外,一些患者甚至在多次FESS手术之后仍有症状。另外,一些FESS手术与医源性眼窝、颅内及鼻腔鼻窦损伤的风险相关。许多耳鼻喉科医师将FESS视为仅用于患有严重鼻窦疾病的患者(如在CT扫描下显示显著异常情况的患者)的选择。因此,病情不太严重的患者可能不会被视为FESS的候选人,他们除了接受药物治疗之外可能别无选择。FESS手术会是流血和疼痛的原因之一与使用具有硬直轴的器械的事实有关。为了使此类硬直器械瞄准解剖结构的深部区域,内科医生需要切除并移除或换句话讲调控任何可以位于器械直接路径中的解剖结构,而不管这些解剖结构是否为病变部分。
作为传统FESS手术的一种替代方式,本专利申请的受让人已经发明了多种侵入性较小/创伤较轻的***、器件和方法,用于通过使用一种可展开的扩张装置来扩大鼻腔和副鼻窦之间的开口来治疗慢性鼻窦炎。在某些情况下,用于治疗鼻窦炎或其他疾病的这些和其他方法可能涉及将一个或多个器件经由导向装置(例如导向导管)推入鼻腔和/或副鼻窦。由于鼻腔、副鼻窦和这二者之间的开口的解剖结构十分复杂、狭小和曲折,并且由于对鼻腔和鼻窦内的粘膜组织的损伤可能引起术后疼痛和出血,故需要在该解剖结构内相对容易使用且尽可能防止损伤的导向装置。本公开解决这些及其他需求。
发明内容
简单而概括地讲,本公开涉及用于治疗副鼻窦的***和方法。在一个具体方面,本发明所公开的***和方法被用来治疗鼻窦炎。
在一个具体的实施例中,用于治疗鼻窦的***包括具有导管轴的导向导管,所述导管轴被构造成可接纳球囊导管并在球囊导管存在于导管轴内时提供抽吸。导向导管还可包括具有第一刚性的近侧部分和具有小于第一刚性的第二刚性的远侧部分。远侧部分可以弯曲并具有小于近侧部分直径的直径。该***可另外包括用于密封球囊导管的阀、以及抽吸口和排气口。
在另外的实施例中,该***被构思为包括导丝,球囊导管可在其上方推进。还可以将导丝设想为发光的。此外,可采用某种方式使导向导管的远尖端成斜面以便于布置在钩突后面,并且远尖端还可实施为挠性材料,从而提供用于接合诸如筛泡之类解剖结构的创伤较轻的接口。远尖端的柔韧性可被选择成使其可扩展以接纳球囊导管。另外,导向导管可以实施为锥形轮廓,使得其远侧部分限定小于近侧部分的尺寸。
导向导管也可包括用来提供与其他器件的连接的面向近侧的凸缘。凸缘可配备有与此类其他器件对准的结构以及操作者抓握表面。还考虑了排气口以提供抽吸控制。
还可以想到各种不同形状的导向导管远端。具体地讲,远尖端可包括旨在减轻创伤的各种形状的凸缘结构。远尖端也可包括在荧光透视下提供可见性的结构。
在相关方法中,鼻窦治疗可包括将导向导管***患者头部内,并穿过导向导管推进柔性器件。在柔性器件周围产生抽吸力,并将柔性器件推进到导向导管的远端之外并进入患者的鼻窦内。在一个具体方面,柔性器件为球囊导管,并且利用该球囊导管来扩张副鼻窦的窦口。该方法还可涉及使用在其上方布置介入器械的导丝。
本公开的其他方面、细节和实施例将在以下的本发明的具体实施方式和附图中示出。
附图说明
图1示出了本发明的用于基于导管的微创性鼻窦手术的***的示意图,该***用来对患者进行鼻窦外科手术。
图1A为图1的“1A”部分的放大视图。
图2A至2D为穿过人体头部的局部矢状剖面图,图中示出了一种方法的各个步骤,该方法用于使用导向器获得进入副鼻窦的通路、然后将窦口扩张或重塑为蝶窦。
图3A至3D为穿过人体头部的冠状剖面图,图中示出了一种方法的各个步骤,该方法用于使用导向器获得进入副鼻窦的通路、然后将窦口扩张或重塑为上颌窦。
图4A至4D为穿过人体头部的局部冠状剖面图,图中示出了一种方法的各个步骤,该方法用于经人工形成的副鼻窦开口进入上颌窦、然后扩张人工形成的开口和/或自然的副鼻窦窦口。
图5A示出了装备成可进行任选的抽吸的管状导向器的透视图。
图5B示出了具有夹管的管状导向器的可供选择的实施例的侧视图。
图6示出了包括球囊导管和抽吸结构的导向导管***的局部剖视图。
图7示出了图6所示导向导管***的远侧部分。
图8至11示出了用导向导管***治疗鼻窦腔。
图12示出了一种可选的导向导管远侧部分。
图13示出了导向导管***的远侧末端部分的横截面。
图14A至C示出了导向导管***的远侧末端部分的各种视图。
图15A和15B示出了一种可选导向导管***的远侧末端部分。
图16示出了导向导管的另一种可选末端部分。
图17A和17B示出了末端部分的另一种方案。
图18A和18B示出了末端的又一种方案。
图19A至D示出了导向导管***的另外的末端部分。
图20A和20B示出了导向导管的远端部分的另一种方案。
图21A至C示出了包括倾斜表面的导向导管***的末端部分的各种视图。
图22A和22B示出了具有椭圆形末端开口的另一种导向导管***。
图23示出了导向导管***的另一种可选末端部分。
图24A至C示出了导向导管的密封结构的各种方案。
图25A和25B为局部剖视图,示出了导向导管毂组件的可选方案。
图26示出了包括抽吸接头的导向导管毂。
图27A和27B示出了与导向导管毂相连的辅助装置的局部剖视图。
具体实施方式
以下详细说明、附图和上述附图说明旨在描述本发明的一些(但并非不可避免地是所有的)实例或实施例。此“具体实施方式”的内容不限制权利要求书中阐述的本发明的范围。
本专利申请的多个附图示出了耳鼻喉的解剖结构。一般地,这些解剖结构用下列参考字母标记:
图1和1A示出了在手术台上的患者,其中微创手术***已就位,用于在一个或多个副鼻窦上进行扩张手术。所示***包括C型臂荧光镜1000、第一导入器件1002(如导向导管或导向管)、第二导入器件1004(如导丝或细长探针)和工作器件1006(如球囊导管、其他扩张导管、清创器、切割器等)。
在一些实施例中,器件1002、1004、1006可以不透过射线和/或可包括不透过射线的标记物,使得C型臂荧光镜1000可用来在手术期间成像并监测器件1002、1004、1006的定位。除了利用放射成像之外或作为另外一种选择,器件1002、1004、1006可装有一个或多个内窥镜器件(例如,耳鼻喉科医师在FESS手术期间使用的通常为刚性的或柔性的内窥镜或立体内窥镜)和/或与这些器件结合使用。此外,除了放射成像和/或内窥镜可视化之外或作为另外一种选择,器件1002、1004、1006的一些实施例可包括能使器件1002、1004、1006与图像引导的手术***或其他电子解剖绘图/引导***结合使用的传感器,这些***包括但不限于:VectorVision(BrainLAB AG);HipNav(CASurgica);CBYON Suite(CBYON);InstaTrak,FluoroTrak,ENTrak(GE Medical);StealthStation Treon,iOn(Medtronic);Medivision;Navitrack(Orthosoft);OTS(Radionics);VISLAN(Siemens);Stryker导航***(Stryker Leibinger);Voyager,Z-Box(Z-Kat Inc.);以及NOGA和CARTO***(Johnson & Johnson)。可商购的介入导航***也可以与这些器件和方法结合使用。更多的非荧光镜介入成像技术也可与这些器件和方法结合使用,这些技术包括但不限于:OrthoPilot(B.BraunAesculap);PoleStar(Odin Medical Technologies,由Medtronic经销);SonoDoppler,SonoWand(MISON);CT Guide,US Guide(UltraGuide)等。如果所述导管被改进为与可与所述***适当地相互作用,那么在磁共振下引导也是可行的。
本发明的器件和方法涉及窦口或耳鼻喉内其他通道的进入和扩张或改变。这些器件和方法可单独使用,或者可以与其他外科手术或非外科手术治疗结合使用,所述治疗包括但不限于在提交于2004年8月4日的共同待审的美国专利申请No.10/912,578中有所描述的递送或植入器件和药物或其他物质,该专利申请的名称为“Implantable Devices and Methods forDelivering Drugs and Other Substances to Treat Sinusitis and Other Disorders”(用于递送治疗鼻窦炎和其他疾病的药物和其他物质的可植入器件和方法),其全部公开内容明确地以引用方式并入本文中。
图2A至2D为穿过人体头部的局部矢状剖面图,图中示出了利用导向导管获得进入副鼻窦的通路并治疗副鼻窦的方法的各个步骤。虽然图2A至2D展示了进入并治疗蝶窦的一种方法,但在可供选择的实施例中,这种或类似的方法和器件可用来进入并治疗其他任何副鼻窦(上颌窦、额窦和/或筛窦)。
在图2A中,将具有导向导管200形式的第一导入器件通过鼻孔并通过鼻腔NC引导至靠近蝶窦SS的窦口SSO的位置。导向导管200可为柔性的。柔性器件被定义为在器件的一英寸长度上具有小于约200磅力/英寸的抗挠刚度的器件。导向导管200可以是直的,或者可以装有一个或多个预成形的弯曲部或弯头。在其中导向导管200为弯曲的实施例中,所述弯曲部或弯头的偏转角可以在135°以下的范围内。由导向导管200的弯曲区域形成的具体偏转角的例子为0°、30°、45°、60°、70°、90°、120°和135°。导向导管200可以由合适的成分构成,例如,PEBAX、聚酰亚胺、编织聚酰亚胺、聚氨酯、尼龙、PVC、Hytrel、HDPE、PEEK、不锈钢之类的金属、以及PTFE、PFA、FEP和EPTFE之类的含氟聚合物。导向导管200可具有多种表面涂层,例如,亲水润滑涂层、疏水润滑涂层、耐磨涂层、耐穿刺涂层、导电或导热涂层、不透射线涂层、回声涂层、降凝血活性涂层和释药涂层。
在图2B中,将包括导丝202的第二导入器件穿过第一导入器件(即导向导管200)引入,使得导丝202经由窦口SSO进入蝶窦SS。导丝202可以如心脏病学领域常见的那样构造和涂布。
在图2C中,将工作器件204(例如球囊导管)套在导丝202上引入蝶窦SS内。其后,在图2D中,工作器件204用于进行诊断或治疗手术。在该具体实例中,从图2D中可清楚地看到,手术是对蝶窦窦口SSO的扩张。然而,本发明还可用于扩张或改变在鼻腔、副鼻窦、鼻咽或相邻区域内的任何其他窦口或其他人造或天然存在的解剖开口或通道,包括但不限于上颌窦、额窦和/或筛窦这些天然副鼻窦窦口。在完成手术后,将导向导管200、导丝202和工作器件204退出并取下。在该手术和本专利申请中所述的任何手术过程中,操作者可以另外推进其他类型的导管或本发明的导管,并且导丝202可以是可操纵(如可扭转、可主动变形)或可成形或可延展的。导丝202可包括嵌入式内窥镜或其他导航或成像形态,包括但不限于荧光镜、X光成像、超声、射频定位、电磁、磁性、自动机械和其他基于辐射能的形态。就此而言,某些附图以虚线示出了可选的检查镜SC。这类可选的检查镜SC可包括任何合适类型的刚性或柔性内窥镜,并且此类可选的检查镜SC可以与本发明的工作器件和/或导入器件分离、或装入本发明的工作器件和/或导入器件内。
任选地,本文所公开的方法也可包括在鼻腔、副鼻窦、鼻咽或附近结构内清洗或灌洗解剖结构的步骤,包括但不限于冲洗和抽吸。清洗目标解剖结构的步骤可以在诊断或治疗手术之前或之后进行。
本发明的方法也可包括用于对鼻腔、副鼻窦、鼻咽或附近结构进行手术前处理的一个或多个准备步骤,例如用引起鼻腔组织收缩的血管收缩剂(如0.025-0.5%的苯肾上腺素或盐酸羟甲唑啉(新福林或阿氟林))和用来清洗组织的抗菌剂(如聚维酮碘(碘伏))等进行喷射或灌洗。
如图3A至3D所示,在一个实施例中,可通过扩张其窦口来处理上颌窦。如图3A所示,可将导向导管290推入患者鼻孔内,以将其远端定位在上颌窦窦口附近。如图3B所示,可接着将导丝294穿过导向导管290和上颌窦窦口推入上颌窦。接着,如图3C所示,可将球囊导管302套在导丝294上穿过导向导管290推进,以将球囊导管302的可扩张球囊304定位在上颌窦窦口内。然后,如图3D所示,可将可扩张球囊304充气,以扩张上颌窦的自然副鼻窦窦口。当扩张手术完成后,可将导向导管290、导丝294和球囊导管302全部从患者体内移除。在可供选择的实施例中,可将导向导管290和/或导丝294留在患者体内,可将球囊导管302移除,并可将另一个柔性器件(图中未示出)套在导向导管和/导丝294上方和/或穿过导向导管和/导丝294推入上颌窦,以进行另外的手术。例如,在一个实施例中,可将冲洗导管穿过导向导管290推进并用来冲洗鼻窦。此类冲洗导管可在不使用导丝294的情况下推进,或者在可供选择的实施例中利用导丝294推进。
图4A至4D为穿过人体头部的局部冠状剖面图,图中示出了一种方法的各个步骤,该方法用来经人工形成的开口进入上颌窦、并扩张人工形成的开口和/或自然副鼻窦窦口。在一些实施例中,不是经由自然窦口进入副鼻窦,而是可制备进入鼻窦的人工开口。在一些实施例中,随后可使用导向器引导球囊导管或其他扩张器(使用或不使用导丝)穿过人工开口进入鼻窦。然后,可将扩张器推进至自然副鼻窦窦口并用来扩张自然窦口,可用扩张器扩张人工开口,或两种情况都有。
在图4A中,将穿刺器300穿过鼻孔,并用来在上颌窦内形成人工开口。此类穿刺器的例子包括但不限于直针、弯针、解剖器、穿孔器、钻头、取芯器、解剖刀、圆头锉、剪刀、钳子和切割器。在图4B中,取出穿刺器300,将工作器件(例如球囊导管302)穿过人工开口引入上颌窦。在图4C中,使用球囊导管302扩张在上颌窦内人工形成的开口。在该步骤之后,取出球囊导管302。在另一个实施例中,如图4D所示,将球囊导管302穿过人工开口推入上颌窦内,然后进一步向上颌窦深处推进,以将导管302的球囊定位在自然副鼻窦窦口内。在一些实施例中,向自然窦口的这种推进可以在扩张人工开口之后进行。作为另外一种选择,在一些实施例中,可以在不扩张人工开口的情况下推进球囊导管302。
在一些实施例中,可将球囊导管302套在导丝上推进至自然副鼻窦窦口。作为另外一种选择,在其他实施例中,可在不使用导丝的情况下推进球囊导管302。在一些实施例中,穿刺器300可具有内腔,导入器件(如导丝或其他细长探针或构件)可穿过该内腔***上颌窦内,然后可以移除穿刺器300,从而将此类导入器件(如导丝或其他细长探针或构件)留在原位。在这类情况下,工作器件(如球囊导管302)可包括内腔或其他结构,以允许将工作器件(如球囊导管300)套在此前***的导入器件(如导丝或其他细长探针或构件)上推进。在一些实施例中,穿刺器可包括内腔,并且在各个实施例中,可以在使用或不使用导丝的情况下将球囊导管302穿过穿刺器推入上颌窦。同样,在可供选择的实施例中,可利用类似的方法和器件来进入并治疗其他副鼻窦。
在另一个可供选择的实施例(在图4A至4D中未示出)中,可利用穿刺器在不同位置处形成进入上颌窦的开口,并且可使用导向导管经开口进入鼻窦。例如,在一个实施例中,可制备穿过犬齿窝进入上颌窦的人工开口。在另一个实施例中,可制备进入额窦的环钻切口。在其他实施例中,可以形成进入筛窦或蝶窦的人工开口。在一些实施例中,可以接着穿过人工开口布置导向器,并用它来进入自然副鼻窦窦口。在其他实施例中,导向导管可保留在鼻窦外面的人工开口附近,并用来将导丝和/或其他一个或多个器件导入鼻窦内。在可供选择的实施例中,可将人工开口扩张,可将自然副鼻窦窦口扩张,或将两者都扩张。这些方法可应用于任何副鼻窦。如下文将更详细描述的,不论是用于经自然开口还是经人工开口进入副鼻窦,根据本发明各个实施例的任何这种导向导管都可具有抽吸能力。
本文所公开的任何导向导管或其他腔内器件可具有抽吸能力,从而可包括用于经导向导管或器件的远端抽吸解剖部位的构造。在一些实施例中,导向导管可与用来将其附接到抽吸源的适配器一起提供。在另一个实施例中,导向导管可具有一体的或内置的抽吸附件,使得适配器不是必需的。目前,当在鼻腔和副鼻窦内使用手术器械时,内科医生使用传统的抽吸器来清理手术部位。这需要外科医生频繁更换器件,从而需要在每次手术时多次拾起和放下传统的抽吸器。使外科医生可以在将导丝、球囊、冲洗导管和/或类似器件穿过导向导管的同时通过导向导管进行抽吸,这样能够简化外科手术。抽吸适配器可附接在导向导管的近端。抽吸适配器可包括与导向导管轴的轴线一致的阀,该阀使导丝、球囊和冲洗导管之类的器件能够穿过抽吸适配器和导向导管,同时维持通过导向导管内腔的抽吸。延长管可被构造成偏离抽吸适配器的主体而延伸。延长管可以端接于阶梯适配器和/或开关阀,以方便使用。
为了连接到导向导管,可使用滑配合的公鲁尔接头。该接头提供了机械固定和气密密封,同时考虑到相对于抽吸适配器容易地旋转调节导向导管。此外,穿过抽吸适配器主体的孔便于容易地控制经导向导管的抽吸量。当孔未被封闭时,在导向导管的远端处很少或没有真空。外科医生可以用手指部分或完全地封闭孔,以增加导向导管顶端处的真空。还可以提供双位开关来控制对抽吸的启动。将开关置于“开”位置,从而封闭孔以开始抽吸。此外,可利用有机硅或聚异戊二烯阀来保持导丝、球囊或冲洗导管周围的密封。当不存在器件时,阀完全关闭。可利用具有轻质管材形式的延长管将抽吸适配器连接到手术室中常用的较重的仪表管线。管材具有足够的壁厚,以免在真空下扁瘪,但不会增加导向导管的质量或带来工效学方面的问题。
例如,图5A示出了具有用于附接到抽吸器的近侧适配器的导向器。更具体地讲,导向导管500可包括细长管502,细长管可由合适的生物相容性材料制成,所述材料包括但不限于:金属,例如不锈钢、钛、镍钛合金(如镍钛诺)等;塑料,例如PEBAX、PEEK、尼龙、聚乙烯等。细长管502的远侧区域可包括弯曲或倾斜的区域。在一些实施例中,细长管502的远端可具有无损伤顶端504。虽然可使用各种形式的构造,但在图示的实例中,在细长管502的外表面上设置有细长的海波管506,并且导向导管500的近端具有分叉或Y型的连接器508。Y型连接器508的近侧区域具有直臂510和侧臂512。直臂510的近端具有合适的毂514。在一个实施例中,毂514为母鲁尔接头毂。在另一个实施例中,毂514包括旋转的止血阀,例如Touhy-Borst适配器。侧臂512的近端具有合适的毂516。在一个实施例中,毂516包括用来调节抽吸量的旋转的止血阀,例如Touhy-Borst适配器。毂516连接到给导向导管500提供抽吸力的抽吸管518。因此,导向导管500可用来提供抽吸力并将一个或多个诊断、治疗或进入器件引入解剖结构。
在一个可选方案中,所述导向导管还可配有夹管550(参见图5B)。夹管连接在Y型连接器508的近端,可由有机硅或另一种柔性材料形成。此外,细长管502的近端可被构造为具有母鲁尔接头552,其与附接到Y型连接器508的公鲁尔接头554紧密配合。使用时,内科医生将夹管550在导丝551或其他器件周围夹紧和封闭,以封闭延伸穿过导向器的内腔,从而便于抽吸。如上所述,通过侧臂512施加抽吸力。
现在参见图6和图7,在一个实施例中,导向导管***600可包括具有轴610的导向导管601和设置在轴610近端处的毂组件604。轴610可包括具有第一直径的近侧部分603、具有较小的第二直径的末端部分602、在两者之间的渐缩过渡段614、以及延伸穿过轴610的长度和毂组件604的内腔608。(毂组件604的内部可以是与导管轴610的内腔608流体连通的内腔、室等)。在一些实施例中,导向导管***600还可包括导丝612和/或球囊导管606,如图6所示。在一些实施例中,导向导管***600还可包括抽吸器,例如抽吸管633。
轴610的外部轮廓被构造成适于推入鼻腔内,使得可将一个或多个器件穿过内腔608而推入副鼻窦。渐缩过渡段614设置在轴的近侧部分603和远侧部分602之间,使得远侧部分602具有比近侧部分603小的横截面。这样,在抽吸力穿过内腔608并围绕球囊导管606结构的同时,球囊导管606可存在于近侧部分603内。该构型可用于(例如)使用预装到导向器内腔608的球囊导管606将导向导管***600推入患者鼻孔内,并便于在推进和定位导向导管601的过程中进行抽吸。在推进和定位导向导管601的过程中进行抽吸是有利的,因为这样便于从外科医生操作的区域移除血液和粘液,从而有助于该区域的可视化和进入副鼻窦。
导向导管601的轴远侧末端部分602限定特有的弯曲轮廓,该弯曲轮廓旨在将穿过内腔608推进的一个或多个器件导入副鼻窦的自然或人造开口。在一个实施例中,末端部分602的最远尖端616比轴610的其余部分更为柔韧。因此,PEBAX是一种预期的用于远尖端616的材料。轴610的中间部分618可包括渐缩过渡段614,也可由柔性材料制成,但在一个实施例中,该材料的柔性可低于用来形成远尖端616的材料的柔性。例如,在一个实施例中,中间部分618可由尼龙材料形成。邻近该中间部分618的轴610的近侧部分603可由更刚性的材料形成,例如但不限于更刚性的聚合物和/或不锈钢海波管619。
柔性远尖端616的一个优点是,当推进、操纵和收回导向导管601时,远尖端616在鼻腔内部柔软的粘膜组织上产生较少的创伤。例如,当把导向导管601推入鼻腔时,远尖端616常常会接触筛泡,柔性的尖端616产生的创伤将会小于刚性的尖端。在一些实施例中,在球囊扩张手术完成之后,当把泄气的球囊导管606拉回导向导管内时,远尖端616也可以扩张。这种扩张(或“扩展性”)可以减少手术后将球囊导管606拉回导向导管601内所需的力的大小,从而使球囊导管606/导向导管601***更易于使用。这也使远尖端616的直径比原本的更小,从而进一步减轻使用过程中的创伤,还有利于将远尖端616定位在解剖结构内所需的位置处。远尖端616还可设置有可扩展的射线不透带,以帮助在介入手术期间跟踪定位和保持无损伤轮廓。
此外,PEBAX远尖端616相对于相邻的近侧部分618成形,用于穿过并围绕鼻腔结构导航。例如,在一个实施例中,尖端部分616的弯曲形状有利于在钩突周围导航,使得可以将一个或多个器件导航到上颌窦内。在一个实施例中,远尖端616和相邻的中间部分618之间的接合部是倾斜的。这种倾斜的连接增大了远尖端616部分相对于中间部分618的面积,从而增大了轴610的最柔韧部分的面积,这有助于防止软组织创伤。末端部分602成角度的形状部分地由于更刚性的尼龙中间部分618及其与远尖端部分616的倾斜接合而得以维持。
在各个可供选择的实施例中,如上文和下文描述的导向装置可具有任何合适的成角度构型。例如,实施例中的角度可设置得不同,以有助于进入上颌窦、额窦、蝶窦和筛窦。在各个实施例中,远尖端616可相对于轴610的剩余部分成大约0°至大约180°的角度。在一些实施例中,可以提供具有不同成角度构型的导向导管601的组合,例如,具有0°、30°、70°和110°的角度的一组导向导管601。然后,外科医生可选择具有用于进入给定副鼻窦的理想角度的导向导管601。在各个实施例中,可以设置任何角度或具有任何角度组合的导向器。
在各个实施例中,包括末端部分602、渐缩过渡段614和近侧部分603在内的轴610的外径和内径可具有多种不同的尺寸,只要轴610被构造成适于推入鼻腔即可。末端部分602和远尖端部分616尤其可以被确定为合适的尺寸,以有助于定位在副鼻窦的开口附近。在一个实施例中,例如,远尖端616可具有大约0.093英寸的内径。该直径的结构可以从尖端616纵向延伸至渐缩部分614远侧的导管部分,并可限定相对较长的尺寸。然而,末端部分602的尖端环绕部620可呈现相对较短的尺寸,使得其可以更容易地穿过鼻腔解剖结构,从而在***(例如)中鼻甲时可能受到较少的结构约束。就本专利申请而言,“尖端环绕部”被定义为从远尖端616的最远端到末端部分602的直部分的相对的表面垂直画出的线的长度,如图7所示。
如图6和图7所示,在一个实施例中,远尖端616的最远端可具有斜面形状。斜面形状还有助于***和相对于鼻腔解剖结构定位,例如在钩突周围引导导向导管601,以获得进入上颌窦窦口的通路。此外,斜尖端616的这种特定构型使操作者可以在将器件放入鼻孔内时看到尖端的开口。这是因为斜面结构的开口向后对着操作者。这样对尖端616的开口直接观察,有助于器件的操纵和定位。
在一些实施例中,末端部分602内的内腔608的内径,可被确定成使得当在该部分内腔608中推进球囊导管606时不能再进行抽吸,因为在远侧末端部分602的内腔608的内壁与球囊外表面之间形成过盈配合。在一个可供选择的实施例中,即使在该推进位置处,仍然可以通过内腔608并在球囊导管606周围进行抽吸,然而当球囊存在于末端部分602中时,抽吸力将比球囊存在于近侧轴部分603中时的小。当把球囊导管606向远侧推进到尖端612之外时,可以再次恢复抽吸力以进行介入手术,然后,在一些情况下,抽吸的首次使用可能在将导向导管***600初次推进并定位在鼻腔内期间。
近侧阀624设置在导向器内腔608(或毂604的室)内。在一个实施例中,阀624在球囊导管606周围形成密封,从而有利于在内腔608内施加抽吸力。在一个实施例中,该阀可被构造成使其也可以在导丝612周围形成密封。然而,在一个可供选择的实施例中,阀并未在导丝612周围形成密封,使得当直径比导丝612大的球囊导管606或另一个柔性器件被设置在内腔608内时才形成抽吸。
导向导管601的毂604还包括排气口628和抽吸口630。最近侧的部分配备有成形为方便操作者抓握的凸缘631。在一个实施例中,例如,凸缘631可被外科医生用来抓住导向导管601,就如抓捏注射器那样,并用同一只手将球囊导管606推过导向导管601。在可供选择的实施例中,可将标准的或定制的抽吸管632附接到抽吸口630上,以形成所需的抽吸力。此外,抽吸口630向近侧倾斜,使得穿过毂604推进的导丝612不会退出抽吸口630。
排气口628的尺寸和位置被确定成可接纳操作者的手指,以使得通过抽吸口630提供的抽吸力可被加在导向导管601的远尖端616处。在一些实施例中,排气口628可以限定从毂604的外表面到毂604的内壁的较短管状路径,并且可采用类似于抽吸口630的方式向近侧定向,以防止导丝612穿过排气口628。在一个可供选择的实施例中,排气口628也可以或替代地被格栅状结构覆盖,以防导丝612穿过其中。
现在参见图8至11,描述一种使用导向导管***600的方法。虽然图8至11示出了使用导向导管***600进入并治疗额窦,但该实施例或其他实施例也可用来进入并治疗包括上颌窦、蝶窦和筛窦在内的任何其他副鼻窦。
参见图8,在该方法的一个实施例中,首先将导向导管601推入鼻腔内并定位,使得导向导管601的末端部分602位于进入副鼻窦的开口处或附近。在图8所示的实例中,末端部分602安置在额隐窝附近,额隐窝是通向额窦窦口(进入额窦的自然开口)的通道。可使用观察用的内窥镜和/或荧光透视将导向导管601安置在所需位置,然而在大多数情况下,仅使用内窥镜就足够了。在一些实施例中,在将导丝612和/或球囊导管606预装入导向导管内腔608的情况下,将导向导管601推入鼻腔内。在推进和/或安置导向导管601的过程中,可通过连接于毂装置604的抽吸管施加抽吸力并将拇指或其他手指放在排气口628上方来施加抽吸,以从末端部分602的区域移除血液、粘液和/或其他流体。利用这种抽吸通常将提高外科医生使用内窥镜观察鼻腔的能力,从而有助于定位目标副鼻窦窦口。
仍然参见图8,在将导向导管601安置在鼻腔内的所需位置之后,外科医生随后将导丝612推出导管601的远侧开口并穿过副鼻窦的自然窦口650进入鼻窦腔652。在一些实施例中,导丝612可以是发光的导丝。这种发光的导丝可用来在推进导丝612的过程中或之后在患者的外表面上形成透照点,以确认导丝612的远端已进入并存在于所需副鼻窦内。(参见例如美国专利申请No.11/522,497和11/803,695,这两份申请的全部公开内容均据此以引用方式并入本文中。)在其他实施例中,可以使用不发光的导丝612。无论发光还是不发光的导丝的实施例,都可以用荧光透视观察在副鼻窦内的导丝612,以进一步确认其位置。
接着,如图9所示,将球囊导管606套在导丝612上推进并定位,然后使其在副鼻窦窦口650内扩张。(就额窦而言,如这些图中所示,球囊导管606的球囊可以定位在窦口和/或额窦流出道内并充气膨胀。)设有充气装置(未示出)来对球囊充气。之后,将球囊导管放气并退出远侧末端部分602。在一个实施例中,不是立即退出球囊导管606,而是可将球囊重新定位并再次充气,以进一步扩张窦口和/或扩张额窦流出道的一部分等。任选地,可将球囊导管606进一步撤出到导向导管601内,并可施加抽吸力,以从副鼻窦腔或流出道或鼻腔移除物质。
现在参见图10,在一可选步骤中,在一些实施例中,可经由导向导管从患者体内取出球囊导管606,然后可将柔性冲洗导管654穿过导向导管601(套在导丝612上,或在可供选择的实施例中不使用导丝)进入副鼻窦。然后,可从冲洗导管654流出冲洗流体652(例如盐水溶液)以冲刷或冲洗鼻窦。在一些实施例中,可以仅仅让冲洗流体652流出鼻窦,而不施加抽吸力。在其他实施例中,可经由抽吸导向导管601施加抽吸力,以有助于移除冲洗流体652。
在手术结束时,如图11所示,从患者体内取出导向导管601和任何剩余器件。窦口650保持扩张状态,这样将理想地促成鼻窦的正常引流,并有助于治疗患者的鼻窦炎。
如图12所示,导向导管700的一种可选方案可包括具有多个转弯或弯头的远侧末端部分702。第一弯头704可设置在相对于第二弯头706的远侧,在此处第一弯头704限定比第二弯头706更小的角度。这种“双弯头”构型可有利于将导向导管700以尖端朝下的取向***鼻孔内,然后允许导管700旋转,以将其远尖端716定位在上颌窦窦口处或附近。
在其他可供选择的实施例中,导向导管700的末端部分702可被构造成可有助于在鼻腔内进行其他过程或操作。例如,在一个实施例中,末端部分702可被构造成可有助于在介入手术期间将钩突(或其他解剖结构)推到一边,与此同时根据需要相对于治疗部位布置远尖端716。图12中所示的“双弯头”方案可以有助于降低通过导向器700推进和收回球囊导管所需的***力和回拉力。例如,50度和60度的双弯头承受的这两种力可小于单个110度的弯头。
现在转到图13至23,图中示出了导向导管的远端构型的多个可供选择的实施例。各个实施例可能具有其优点,便于在鼻腔内推进和/或定位导向导管和/或在将球囊导管或一个或多个其他器件推入和撤出导向导管远端。如图13所示,在一个实施例中,导向导管的末端尖端750可具体表现为包括圆内径754的眼形突出或造型752。设有形成为一体的翼756,以有助于进入并横跨鼻腔解剖结构。例如,翼756可以便于将导向导管的远端定位在钩突后面,以进入上颌窦窦口。翼756可允许外科医生向前拨动钩突,从而暴露用于导入上颌窦窦口的开放通道。
在图13至23中,一些导向导管的远端还具有椭圆形横截面。这种椭圆形可以有助于最小化导向器在受解剖结构限制的取向下的尺寸。因为钩突常常会紧贴筛泡(在前后方向上),所以将导向器加工成椭圆形,使得较小的尺寸可取向在钩突和筛泡之间。各个实施例可包括这种具有或不具有翼756的椭圆形横截面。导向导管的一些实施例的柔软的远尖端材料,使得导向器尖端的横截面形状能够相对于其遇到的力改变。因此,具有圆形横截面的柔软尖端在被置于钩突后面时可以变成椭圆形,从而减小到达理想位置所需的力。
在其他方案中,导向导管的远侧末端部分可包括各种构型的带凸缘翼。翼可以布置在尖端的顶部、中间或底部,并且可以是短的、长的、平的或弯曲的。此外,翼可以向外张开而形成为单片材料,并且在各个实施例中可由任何合适的柔性或非柔性材料制成,例如但不限于多种金属或聚合物,例如铝箔、不锈钢、硬塑料或软塑料。在一种特定方案(图14A至C)中,导向导管的远侧末端部分750可包括由铝箔形成的翼756。此类翼同样用来促成通过鼻窦解剖结构的导航,例如以便在钩突后面滑动。由PEBAX形成的类似构型的翼在图15A和15B中示出。可促进导航的另一种方案在图16中示出,该图示出了成形于导向导管的远侧末端750周围的硬塑料覆盖物758。
此外,如图17A至B所示,导航翼757也可由不锈钢条形成,该不锈钢条被构造成横跨大致垂直于在其内形成的远侧开口的末端。PEBAX翼结构756的另一种方案在图18A和18B中示出。更多不同的方案分别在图19A至D、20A至B、21A至C、22A至B和23中示出。尤其值得指出的是图19A中所示具有下侧翼756的倾斜尖端方案和图21A至C的倾斜切割尖端。还可以想到在导向器末端处的多种形状的开口,例如在图21A至C、22A至B和23中所示的那些。
如图24A至C所示,可以想到用于将球囊导管606密封在导向导管***内的阀624的各种不同的方案。在第一方案中,平的圆形垫圈800具有中央密封通孔802(图24A)。作为另外一种选择,可以在导向导管***内采用由具有双锥形812的通孔限定的阀810。此外,如图24C所示,阀624可实施为具有内部活门结构822的单向阀820。
现在转到图25A和25B,图中示出了导向导管***600的毂组件604的可选方案。通过将毂分成第一部分830和第二部分840,构思出将阀密封件624附接到导管轴610的改进方案。在第一方案中,将阀624固定到轴610上,并将其两部分设置在毂604的第二部分内。然后将毂的第一部分830***第二部分内,以完成毂组件。在一可选方案(图25B)中,阀624被约束在毂组件的第二部分840和导管轴610的末端内。毂的第一部分830被构造为具有将阀624固定就位的凸缘842。这些方案的目的是为了方便组装。
如图26所示,毂组件604还可包括具有倒钩850的抽吸口630。抽吸管的附接须为考虑到易于附接和移除的结构,并且还形成气密密封,以便在很少或没有渗漏的情况下提供足够的抽吸速率。倒钩850有助于这种理想的连接,还限定了在使用过程中不妨碍操作者的外形,不管抽吸部件是否使用。
另外,如图27A和27B所示,毂组件604可包括近侧开口860,该开口可用来将毂604连接到其他器件。脊862可以在开口860内形成,并且其尺寸和形状可被确定为适于锁紧地接合到在辅助装置866的末端上形成的开孔内。这样,可通过脊862的接合产生可听见的“咔哒”声,从而确认毂604与辅助装置正确对准。从而用开孔864确认开口是否完全接合。另外,还在开口之间提供了一定阻力,以有助于避免意外释放。
虽然已经结合若干优选实施例示出和描述了本发明,但在不脱离本发明的精神和范围的前提下,可以在本发明中对其形式和细节进行各种修改、删减和增补。
Claims (26)
1.一种导向导管,用于将一个或多个柔性器件导入患者的副鼻窦内,并可以用于通过所述导向导管进行抽吸,所述导向导管包括:
细长导管轴,所述细长导管轴的尺寸被定成可将其推入患者的鼻孔内,所述导管轴包括:
近侧部分;
弯曲的远侧部分,所述弯曲的远侧部分比所述近侧部分更为柔韧;和
内腔,所述内腔穿过所述近侧部分和所述远侧部分纵向延伸;以及
毂组件,所述毂组件与所述导管轴的所述近侧部分相联接,所述毂组件包括:
内室,所述内室与所述导管轴内腔流体连通;
单向阀,所述单向阀设置在所述内室内部,所述阀具有其尺寸定成可在被推进而通过所述阀的器件周围形成密封的开口;
抽吸口,所述抽吸口用于将抽吸源与所述毂相联接;以及
排气口;
其中,所述内腔具有在所述轴的所述近侧部分内的第一内径,其中所述第一内径足以允许在球囊导管留存于所述近侧部分内腔内的同时通过所述导管轴向近侧抽吸。
2.根据权利要求1所述的导向导管,其中所述内腔具有:
在所述远侧部分内的第二内径,所述第二内径小于所述第一内径。
3.根据权利要求1所述的导向导管,其中所述导管的近侧外轮廓大于远侧外轮廓。
4.根据权利要求3所述的导向导管,其中所述导管包括介于所述近侧外轮廓和所述远侧外轮廓之间的渐缩过渡段。
5.根据权利要求1所述的导向导管,其中所述近侧部分的一段由不锈钢形成。
6.根据权利要求1所述的导向导管,其中所述弯曲的远侧部分的末端部分具有柔韧性,从而允许所述末端部分在柔性器件穿过其中推进时扩展。
7.根据权利要求6所述的导向导管,其中所述弯曲的远侧部分的所述末端部分由PEBAX形成。
8.根据权利要求6所述的导向导管,其中所述导管包括尼龙段,所述尼龙段被构造为邻近由PEBAX形成的所述弯曲的远侧部分的所述末端部分。
9.根据权利要求1所述的导向导管,还包括有斜面的末端。
10.根据权利要求1所述的导向导管,还包括具有翼的末端。
11.根据权利要求1所述的导向导管,其中所述阀围绕穿过所述导向导管推进的柔性球囊导管形成密封。
12.根据权利要求1所述的导向导管,其中所述毂组件包括抓握表面,以允许外科医生用单手的手指抓捏所述毂组件并遮盖所述排气口。
13.根据权利要求1所述的导向导管,其中所述排气口包括从所述毂的外表面到所述毂的内表面的通道,并且其中所述通道相对于所述导向导管的所述纵向轴线从所述内表面到所述外表面向近侧成角度。
14.根据权利要求1所述的导向导管,其中所述抽吸口相对于所述导向导管的纵向轴线向近侧成角度。
15.一种导向导管,用于将一个或多个柔性器件导入患者的副鼻窦内,并可以用于通过所述导向导管进行抽吸,所述导向导管包括:
细长导管轴,所述细长导管轴的尺寸被定成可将其推入患者的鼻孔内,所述导管轴包括:
近侧部分;
弯曲的远侧部分,所述弯曲的远侧部分比所述近侧部分更为柔韧;和
内腔,所述内腔穿过所述近侧部分和所述远侧部分纵向延伸;
单向阀,所述单向阀设置在所述近侧部分中的所述内腔内部,所述阀具有其尺寸定成可在被推进而通过所述阀的器件周围形成密封的开口;
抽吸口,所述抽吸口沿所述轴的近侧部分设置,用于将抽吸源与所述导向导管相联接;以及
排气口,所述排气口沿所述轴的近侧部分设置;
其中所述内腔具有在所述轴的所述近侧部分内的第一内径,其中所述第一内径足以允许在球囊导管留存于所述近侧部分内腔内的同时通过所述导管轴向近侧抽吸。
16.根据权利要求15所述的导向导管,其中所述内腔具有:
在所述远侧部分内的第二内径,所述第二内径小于所述第一内径。
17.一种用于在副鼻窦上面或内部进行手术的***,所述***包括:
导向导管,所述导向导管包括:
细长导管轴,所述细长导管轴的尺寸被定成可将其推入患者的鼻孔内,所述导管轴包括:
近侧部分;
弯曲的远侧部分,所述弯曲的远侧部分比所述近侧部分更为柔韧;和
内腔,所述内腔穿过所述近侧部分和所述远侧部分纵向延伸;以及
毂组件,所述毂组件与所述导管轴的所述近侧部分相联接,所述毂组件包括:
内室,所述内室与所述导管轴内腔流体连通;
单向阀,所述单向阀设置在所述内室内部,所述阀具有其尺寸定成可在被推进而通过所述阀的器件周围形成密封的开口;
抽吸口,所述抽吸口用于将抽吸源与所述毂相联接;以及
排气口;以及
柔性器件,所述柔性器件被构造为穿过所述导向导管进入副鼻窦,以在所述鼻窦上面或内部进行手术;
其中所述导向导管的所述内腔具有在所述轴的所述近侧部分内的第一内径,其中所述第一内径足以允许在球囊导管留存于所述近侧部分内腔内的同时通过所述导管轴向近侧抽吸。
18.根据权利要求17所述的***,其中所述柔性器件包括用于扩张进入所述副鼻窦的开口的柔性球囊导管。
19.根据权利要求18所述的***,还包括导丝,所述球囊导管套在所述导丝上推进。
20.根据权利要求19所述的***,其中所述导丝包括能够透照副鼻窦的发光导丝。
21.根据权利要求18所述的***,还包括用于对所述球囊导管充气的充气装置。
22.根据权利要求18所述的***,还包括冲洗导管,所述冲洗导管用于在所述扩张之后穿过所述导向导管以冲洗所述副鼻窦。
23.根据权利要求15所述的***,其中所述导向导管的所述内腔具有:
在所述远侧部分内的第二内径,所述第二内径小于所述第一内径。
24.根据权利要求15所述的***,其中所述导向导管的所述弯曲的远侧部分的末端部分具有柔韧性,从而允许所述末端部分在柔性器件穿过其中推进时扩展。
25.根据权利要求15所述的***,其中所述导向导管还包括有斜面的末端。
26.根据权利要求15所述的***,其中所述导向导管的所述阀围绕穿过所述导向导管推进的所述柔性球囊导管形成密封。
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JP5855562B2 (ja) | 2016-02-09 |
US20220142663A1 (en) | 2022-05-12 |
KR20120012796A (ko) | 2012-02-10 |
US20100241155A1 (en) | 2010-09-23 |
US20160324535A1 (en) | 2016-11-10 |
RU2538237C2 (ru) | 2015-01-10 |
EP2408505A1 (en) | 2012-01-25 |
CA2755321A1 (en) | 2010-09-23 |
AU2010226594A1 (en) | 2011-10-20 |
MX2011009837A (es) | 2011-10-19 |
RU2011142301A (ru) | 2013-04-27 |
US11207087B2 (en) | 2021-12-28 |
CN102361663A (zh) | 2012-02-22 |
JP2012520749A (ja) | 2012-09-10 |
BRPI1012540A2 (pt) | 2016-03-29 |
US10524814B2 (en) | 2020-01-07 |
AU2010226594B2 (en) | 2015-12-03 |
US20200046392A1 (en) | 2020-02-13 |
WO2010108017A1 (en) | 2010-09-23 |
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