CN102159276A - 用于治疗耳鼻喉科疾病的方法和设备 - Google Patents
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Abstract
本发明公开了用于扩张人类或动物受试者的鼻旁窦口的器件(400),所述器件(400)可以包括:手柄(402);细长轴(414),所述细长轴(414)具有与所述手柄连接并延伸到远端的近端;导丝(410),所述导丝(410)穿过所述轴内腔的至少一部分设置;扩张器,所述扩张器具有未膨胀构型和膨胀构型;和滑动构件(406),所述滑动构件(406)穿过所述轴的所述纵向开口(408)与所述导丝或所述扩张器中的至少一者连接,以用于使所述导丝和/或所述扩张器相对于所述轴前进。
Description
相关专利申请的交叉引用
本申请为提交于2005年7月29日的美国专利申请序列号11/193,020的部分继续申请,其为提交于2004年4月21日的美国专利申请序列号10/829,917、提交于2004年9月17日的美国专利申请序列号10/944,270、提交于2005年4月26日的美国专利申请序列号11/116,118、提交于2005年6月10日的美国专利申请序列号11/150,847的部分继续申请,这些专利申请各自明确地以引用方式并入本文中。本专利申请要求提交于2008年9月18日的临时申请序列号61/098,157的优先权,该申请的内容以引用方式并入。
技术领域
本发明总体上涉及医疗设备和方法。更具体地讲,本发明涉及用于进入并扩张鼻旁窦的开口的器件和方法。
背景技术
功能性鼻窦内窥镜手术(FESS)是目前用于治疗慢性窦炎的最普通类型的外科手术。在典型的FESS手术中,将内窥镜连同一个或多个外科器械一起***鼻孔中。然后使用这些外科器械来剖切组织和/或骨头、烧灼、抽吸等。在大多数FESS手术中,至少一个鼻旁窦的自然口(如开口)被用外科方法扩大以改善从窦腔的引流。内窥镜提供直接视线观察,外科医生通常由此能够看到外科视场内的一些但不是所有的解剖结构。通过在内窥镜下可视化,外科医生可以移除病变或肥大组织或骨头,并可以扩大窦口以恢复窦的正常引流。FESS手术可有效治疗窦炎和用于从鼻部移除肿瘤、息肉和其它异常生长物。
现有技术的FESS手术中所使用的外科器械包括:涂敷器、凿子、刮匙、起子、钳子、圆凿、吊钩、刮刀、锯、木槌、软骨压碎器、持针器、骨凿、寻口器、探针、穿孔器、缓冲系绳、粗锉、牵开器、修骨钳、剪刀、勒除器、窥器、抽吸插管和套管针。大多数这样的器械为大体刚性的设计。
为了通过内窥镜充分观察手术野和/或允许***和使用刚性器械,许多现有技术的FESS手术包括外科移除或改变正常的解剖结构。例如,在许多现有技术的FESS手术中,在手术开始时进行全钩突切除术(如移除钩突),以允许看到和进入上颌窦口和/或筛泡,并允许后续***刚性的外科器械。实际上,在大多数传统的FESS手术中,如果允许保留钩突,则这样会妨碍上颌窦口和筛泡的内窥镜式可视化以及后续使用可用的刚性器械解剖深层结构。
最近,新型器件、***和方法被设计为能够在最少地移除或不移除、或改变正常的解剖结构的情况下进行FESS手术和其它ENT手术。这样的新方法包括(但不限于)保留钩突Balloon SinuplastyTM手术和使用导管、非刚性器械和先进成像技术的保留钩突筛房切除术(Acclarent,Inc.(MenloPark,California))。这些新器件、***和方法的实例在名称为“Devices,Systems and Methods for Diagnosing and Treating Sinusitis and Other Disorders of the Ears,Nose and/or Throat”(用于诊断和治疗窦炎和其他耳鼻喉科疾病的器件、***和方法)的美国专利申请No.10/829,917;名称为“Apparatus and Methods for Dilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal or Paranasal Structures”(用于扩张和改变鼻旁窦口和其它鼻内结构或鼻旁结构的设备和方法)的美国专利申请No.10/944,270;提交于2005年4月26日、名称为“Methods and Devices for Performing Procedures Within the Ear,Nose,Throat and Paranasal Sinuses”(用于在耳鼻喉和鼻旁窦内进行手术的方法和器件)的美国专利申请No.11/116,118;以及提交于2005年6月10日、名称为“Devices,Systems And Methods Useable For Treating Sinusitus”(可用于治疗窦炎的器件、***和方法)的美国专利申请No.11/150,847中有所描述。
尽管Balloon SinuplastyTM(鼻窦囊扩张术)***在鼻旁窦治疗中已经取得巨大进步,但仍在不断寻求对使用其的***和方法的进一步开发和改良。例如,期望有这样的***,其比当前***更简单,以便于医生使用,特别是不熟悉此***的医生。理想的是,这样的简化***至少在一些情况下可由一个使用者使用和操纵,而不需要助手。同样理想的是,这样的***应当以方便用户的方式简单包装。本发明将满足这些目标中的至少一些。
发明内容
本文所公开的多种实施例提供用于进入和扩张鼻旁窦开口的设备、***和方法。通常,多种实施例中的每一个将两个或更多个外科器械或器械结构组合成能够单手持握的器件(或***),从而帮助解放使用者的另一只手和/或使手术更容易进行。例如,在一个实施例中,导向装置和囊导管可以经手柄连接在一起。在一些实施例中,导丝和/或内窥镜也可以与囊导管和/或手柄连接。这些多种实施例的多种器件和方法可以单独使用或彼此以任何可能和可取的组合方式使用。
根据一个实施例,用于扩张人类或动物受试者的鼻旁窦口的器件包括手柄和细长轴,细长轴具有与手柄连接并延伸到远端的近端。轴包括内腔和纵向开口,纵向开口沿着介于近端和远端之间的长度的至少一部分从内腔延伸到轴的外表面。此实施例也包括导丝和扩张器,导丝穿过轴内腔的至少一部分设置,扩张器具有未膨胀构型和膨胀构型,其中扩张器的至少一部分设置在导丝上和轴内腔内。滑动构件也穿过轴的纵向开口与导丝或扩张器连接,以用于使导丝和/或扩张器相对于轴前进。在一个实施例中,滑动构件能够相对于细长轴进行轴向旋转,以旋转导丝和/或扩张器。另外,在某些实施例中,器件包括与轴的远端连接的穿刺构件,其用于向受试者的鼻旁窦中穿孔,其中轴的远端能够穿过孔***。
在另一个实施例中,器件包括附接到细长轴的流体贮存器,并且流体贮存器与扩张器流体连通。也可以具有与流体贮存器连接的扳机或致动手柄,并且致动扳机引起流体贮存器中的流体将扩张器吹胀成膨胀构型。
根据用于进入人类或动物受试者的鼻旁窦口的器件的另一个实施例,该器件包括手柄和细长轴,细长轴具有与手柄连接并延伸到远端的近端。细长轴包括从近端向远端延伸至少到中途的纵向内腔。也具有器件推进构件,其与手柄或细长轴连接,并被构造成与穿过轴的内腔的一个器件连接并使其至少前进到中途进入鼻旁窦口中。在某些实施例中,导丝穿过细长轴内腔的至少一部分延伸,并且器件推进构件被构造成与穿过内腔的导丝连接并使其前进穿过鼻旁窦口。在一个实施例中,囊扩张导管穿过轴内腔的至少一部分延伸,其中器件推进构件被构造成与穿过内腔的囊扩张导管连接并使其至少前进到中途进入鼻旁窦口中。
根据用于扩张人类或动物受试者的耳部、鼻部或喉部内的解剖结构的***的一个实施例,包括内窥镜以及与内窥镜可拆卸地连接的细长管状导向装置。也具有手柄,其与内窥镜中的至少一个连接,以用于单手抓握内窥镜或细长管状导向装置。在一个实施例中,扩张器可滑动地设置在细长管状导向装置中,其中扩张器具有用于穿过细长管状导向装置的未膨胀构型以及用于扩张解剖结构的膨胀构型。在某些实施例中,第一夹片附接到内窥镜,第二夹片附接到细长管状导向装置。也包括用于连接第一夹片和第二夹片的连接构件。
在一个实施例中,连接在一起的内窥镜和细长管状导向装置的尺寸被设定为穿入受试者的鼻旁窦中所穿刺的孔中。在此实施例中,***还包括与内窥镜或细长管状导向装置中的至少一者连接的穿刺构件,以用于形成孔。
***也可以包括穿过导丝内腔设置的导丝,导丝内腔穿过扩张器的至少一部分延伸,在一个实施例中,也可以包括与细长管状导向装置连接的导丝推进构件,以用于使导丝相对于导向装置前进。在另一个实施例中,***包括与内窥镜连接的内窥镜清洗器。内窥镜清洗器包括设置在内窥镜的至少一部分上的护套以及与护套连接以将护套与清洗流体源连接的管。
根据用于扩张人类或动物受试者的鼻旁窦中的开口的方法的实施例,该方法包括利用手柄单手持握至少部分地刚性的细长管状导向装置,其中囊扩张导管位于导向装置的内腔内并且穿过手柄延伸。另外,该方法包括使导向装置的远端前进到人类或动物受试者的鼻旁窦中的开口附近的位置,其中囊导管在前进过程中位于导向装置的内腔内。一旦就位,该方法还包括使囊扩张导管穿过导向装置前进以将囊扩张导管的囊定位在鼻旁窦开口中。然后,使囊扩张导管的囊膨胀以扩张开口。在一个实施例中,该方法可以包括通过使与手柄和导管连接的前进构件前进来使囊扩张导管前进。另外,在某些实施例中,该方法可以包括使导丝前进穿过导向装置的远端并穿过开口进入鼻旁窦中,其中在导向装置前进到受试者体内过程中,导丝位于囊导管的内腔内,并且其中囊导管在导丝上前进穿过导向装置的远端。
在一个实施例中,该方法也包括在使囊扩张导管前进之前,从导丝的远端发光并从受试者的外部观察所发出的光,以确认导丝的远端位于鼻旁窦中。
在另一个实施例中,导向装置穿过受试者头部犬齿窝中的开口前进到上颌窦中或穿过上颌窦壁中的开口,该方法也包括利用穿刺工具形成犬齿窝开口或上颌窦壁开口。
在另一个实施例中,该方法包括利用手柄持握内窥镜,其中内窥镜和导向装置与手柄连接,并且其中内窥镜和导向装置前进到受试者体内。在另一个实施例中,内窥镜、导向装置和囊导管一起前进到受试者体内。另外,利用内窥镜观察导向装置的远端或囊导管的囊。
将在下面参照附图更详细地描述这些和其他方面和实施例。
附图说明
图1为经历根据本发明的用于治疗窦炎的手术的人类受试者的透视图;
图2A为可用于在耳部、鼻部和喉部内扩张口或鼻旁窦以及其他解剖通道的扩张器件的俯视图;
图2B为图27A的器件的侧视图;
图2C-2D示出使用图27A-27B的扩张器件的方法中的步骤;
图2E为可用于在耳部、鼻部和喉部内扩张鼻旁窦的开口以及其他解剖通道的另一扩张器件的侧视图;
图2F为另一扩张器件的侧视图,其使用压缩吹胀流体吹胀扩张器囊,以在耳部、鼻部和喉部内扩张鼻旁窦开口以及其他解剖通道;
图2G为图27F中所示器件的阀排列的示意图;
图2H为穿过图27A-B的器件的一部分的局部截面图;
图3A为附接到囊导管的把手式吹胀器件的透视图;
图3B为具有把手式吹胀器的囊扩张器件的透视图;
图4A为包括附接到导向导管的内窥镜的集成***的透视图;
图4B为包括与导向导管连接的内窥镜的集成***的另一个实施例的透视图;
图5A为可用于在耳部、鼻部和喉部内扩张口或鼻旁窦以及其他解剖通道的外科手术手持工具的透视图;
图5B为图5A所示的外科手术手持工具的横截面图;
图6A为外科手术手持工具的另一个实施例的透视图;
图6B为图6A所示的外科手术手持工具的横截面图;
图7为能够旋转导管和导丝的外科手术手持工具的另一个实施例的透视图;
图8A为外科手术手持工具的另一个实施例的透视图;
图8B为图8A所示的外科手术手持工具的横截面图;
图9A为包括流体贮存器的外科手术手持工具的另一个实施例的透视图;
图9B为图9A所示的外科手术手持工具的横截面图;
图9C至图9E为用于图9A和图9B所示的外科手术手持工具的流体递送***的不同实施例的示意图;
图10A为由导轨支承的外科手术手持工具的另一个实施例的透视图;
图10B为外科手术手持工具的近端的透视图;
图10C为包括掌托的外科手术手持工具的另一个实施例的透视图;
图10D和图10E为包括导向附件的外科手术手持工具的另一个实施例的透视图;
图11为外科手术手持工具的透视图,该外科手术手持工具的主体上安装有注射器以用于流体递送;
图12A为具有侧面切割槽的冲洗导管的透视图;
图12B沿图12A所示的线12B-12B截取的横截面图;
图13为具有侧面切割槽和单内腔的冲洗导管的侧视图;
图14A和图14B为具有侧面切割槽的囊冲洗导管的侧视图;
图15A为穿过囊导管的侧面窗口***的冲洗注射器的侧视图;
图15B为图15A所示的冲洗注射器的远端的侧视图;
图16为治疗窦疾病的方法的流程图,其包括单手持握导向导管和囊导管;
图17为方法流程图,通过结合鼻旁窦开口的扩张来移除或改变解剖或病理结构,该方法可用于治疗窦疾病;
图18为方法流程图,通过结合窦腔的抽吸和/或冲洗来扩张鼻旁窦的开口,该方法可用于治疗窦疾病;
图19为方法流程图,通过在疤痕或附着组织中形成穿刺道,将扩张器***穿刺道中并扩张穿刺道,该方法可用于治疗形成有不需要的疤痕或附着组织的病症;以及
图20为方法流程图,通过结合鼻旁窦中新开口的创建来扩张鼻旁窦的自然开口,该方法可用于治疗窦疾病。
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。提供此详细说明和附图主要是出于示例性目的,而不应被理解为限制由权利要求描述的本发明的范围。尽管在本说明中有时提及Balloon SinuplastyTM鼻旁窦手术,但本发明的许多实施例可以用于执行任何其他鼻旁窦手术。
本文所公开的器件可以单独使用或以各种组合方式使用,以执行各种手术,包括(但不限于)鼻旁窦内和/或鼻旁窦的开口内的各种手术。如本文所用,除非另外指明,否则术语“鼻旁窦的开口”应该包括鼻旁窦或气胞中的任何开口,包括(但不限于):自然口、自然管道、经外科手术改变的自然口、经外科手术创建的开口、窦造口术开口、截骨术开口、打孔、钻孔、穿刺道、筛房切除术开口、开窗术以及其他自然或人造通道。
图1示出经历根据一个实施例的用于治疗窦炎的Balloon SinuplastyTM手术的人类受试者。该人类受试者可以经受一个或多个诊断器件、治疗器件或进入器件,这些器件通过可选的支承器件100引入。在许多情况下,本发明的鼻旁窦手术在不使用任何支承器件100的情况下进行,但在(例如)医生诊所的手术室或其他环境中无助手的情况下进行手术时使用这种支承器件100可能是方便的。本发明的手术中可以使用的治疗器件的一个实例为囊导管,该囊导管用于扩张鼻旁窦的开口或其他鼻内解剖结构。此类手术中可以使用的进入器件的一个实例为导丝,该导丝用于进入鼻旁窦的自然口或进入通向鼻旁窦的自然或人造通道或道。在图1所示的实施例中,支承器件100包括支撑构件,该支撑构件由搁在手术台上的三条或更多条支腿来稳定。该一个或多个诊断器件、治疗器件或进入器件可以利用一个或多个跟踪或导航装置穿过解剖结构来进行跟踪或导航。在图1所示的实施例中,C形臂荧光镜102在手术期间提供解剖区域的荧光镜可视化。也可以提供包括一个或多个功能模块的器械控制台104。器械控制台104可由控制台控制装置(如踏板控制器、远程控制器等)来控制。器械控制台104可以配有轮子,以使手术实施者能够在手术区域内改变器械控制台的位置。器械控制台104可以包括功能模块,功能模块包括(但不限于):
1.抽吸泵,以用于向抽吸器件递送控制的真空量;
2.冲洗泵,以递送盐水或其他合适的冲洗介质;
3.电力模块,以向钻头或其他电器件供电;
4.储存模块,以用于储存器械、药物等;
5.能量递送模块,以向外科手术器件提供射频、激光、超声波或其他治疗能量;
6.荧光镜、MRI、CT、录像机、内窥镜106或相机或其他成像模块,以与各种诊断或治疗手术中所使用的器件连接或交互;
7.显示模块,如LCD、CRT或全息屏,以显示来自诸如内窥镜、荧光镜或其他数据或成像模块的各种模块的数据;
8.远程控制模块,以使手术实施者能够控制一个或多个功能模块的一个或多个参数;和
9.可编程微处理器,其可储存一个或多个功能模块的一个或多个手术设置等。
在图1的实施例中,器械控制台104连接到内窥镜106。内窥镜106可以通过一个或多个引入器件108(诸如导向导管)被引入解剖结构中。医生可以使用手持式引入器110,该手持式引入器包括外科手术导航装置,以将一个或多个诊断器件、治疗器件或进入器件引入解剖结构中。可以设置在引入器110上的外科手术导航装置的实例包括(但不限于)具有反射性无源元件的导航装置、发光二极管、能量(如光能、射频能等)的发送机或接收机、上述导航装置中的两种或更多种的组合等。
从上面的描述可以看出,Balloon SinuplastyTM手术可以涉及使用多个不同的外科手术器械(或“工具”)。例如,医生通常会使用内窥镜、导向装置、导丝、囊导管、用于对囊导管进行吹胀的吹胀器件、以及用于观察手术的至少一部分的C形臂荧光镜器件。在一些情况下,可以使用发光导丝(例如,得自Acclarent,Inc.的Relieva LumaTM Sinus Illumination Guidewire(Relieva LumaTM窦照明导丝)),在这种情况下在手术的至少一部分过程中将光源附接到导丝。可选地,手术也可以包括利用(例如)冲洗导管(诸如得自Acclarent,Inc.的Relieva VortexTM Sinus Irrigation Catheter (Relieva VortexTM窦冲洗导管)对一个或多个鼻旁窦进行冲洗(使用盐水或其他流体清洗),以从窦去除粘液。另外,在一些手术中,可以使用多个导向装置来到达不同的窦,其中每一个导向装置具有不同的角度和/或尺寸。也可以使用不同的囊导管,其中一些囊直径不同,以用于不同尺寸的鼻旁窦开口。另外,在不同的情况下,可以使用其他器械,这些器械中的一些在(例如)Acclarent,Inc.的网站(www.acclarent.com)上有所描述。因此,在某些情况下,期望将两个或更多个器械、结构等连接或换句话讲组合在一起,以便简化手术,允许医生单手持握多个器械,或换句话讲有利于或改善鼻旁窦手术,诸如(但不限于)Balloon SinuplastyTM手术。
现在参见图2A和图2B,以俯视图(图2A)和侧视图(图2B)示出包括囊导管的外科手术手持工具200的一个实施例。在此实施例中,外科手术手持工具200可以包括由生物相容性材料制成的中空近侧主体202,生物相容性材料包括(但不限于)ABS、尼龙、聚氨酯、聚乙烯等。近侧主体202包封囊导管204。囊导管204包括囊吹胀口206,以吹胀囊导管204上的囊。囊吹胀口206穿过贯穿近侧主体202的纵向狭缝208露出近侧主体202外,使得囊导管204可沿着近侧主体202的轴线滑动。囊吹胀口206连接到合适的吹胀器件,以吹胀囊导管204的囊。在此实施例中,囊导管204在导丝210上被引入解剖结构的所需区域中。导丝210的近侧区域可以包括加扭器212。使用者可使用加扭器212来使导丝210旋转、前进、回缩、或扭转。近侧主体202的远侧区域包括允许导向导管214附接到近侧主体202的合适的轮毂。在替代实施例中,导向导管214永久性地附接到近侧主体202。在此实施例中,导向导管214包括由合适的生物相容性材料制成的细长管状元件216,合适的生物相容性材料包括(但不限于)PEEK、Pebax、尼龙、聚酰亚胺、ABS、PVC、聚乙烯等。管状元件216的近侧区域可以被海波管218覆盖,海波管由合适的生物相容性金属或聚合物制成。管状元件216的近端附接到合适的轮毂220。轮毂220允许导向导管214可逆地附接到近侧主体202。在一个实施例中,轮毂220是凹型旋入式锁件,其附接到近侧主体202上的合适的轮毂。因此,各种导向导管可附接到近侧主体202的远侧区域,从而能够进入各种解剖区域。管状元件216的远端可以包括无创顶端222。管状元件216的远端可以包括弯曲、折曲或倾斜区域。图2B示出外科手术手持工具200的侧视图,其示出附接到近侧主体202的手柄224。
图2C至图2D示出利用图2A和图2B所示的外科手术手持工具200扩张解剖区域的方法的各种步骤。在图2C中,外科手术手持工具200被引入解剖结构中。外科手术手持工具200被定位成使得外科手术手持工具200的远侧顶端处于待进入解剖区域附近。随后,导丝210穿过外科手术手持工具200被引入,使得导丝210的远侧顶端处于待进入解剖区域附近。在此步骤期间,可以利用加扭器212穿过解剖结构来导航导丝210。在一个实施例中,导丝210被定位在整个待扩张的鼻旁窦口上。随后,在图2D中,囊导管204在导丝210上前进到解剖结构中。这通过以远侧方向推囊吹胀口206来实现。随后,使用囊导管204来进行诊断或治疗手术。在一个实施例中,囊导管204用于扩张通向鼻旁窦的开口,诸如鼻旁窦口。
图2E示出包括囊导管的第一替代实施例的外科手术手持工具226的侧视图。外科手术手持工具226的设计与外科手术手持工具200的设计类似。外科手术手持工具226包括由生物相容性材料制成的中空细长主体227,生物相容性材料材料包括(但不限于)ABS、尼龙、聚氨酯、聚乙烯等。细长主体227附接到手柄228,以允许使用者抓握外科手术手持工具226。细长主体227包括纵向狭缝229。细长主体227包封囊导管230。囊导管230包括囊吹胀口231,以吹胀囊导管230上的囊。囊吹胀口231穿过纵向狭缝229露出细长主体227之外,使得囊导管230可沿着细长主体227的轴线滑动。囊导管230还连接到扳机232。扳机232在细长主体227上枢转,使得以近侧方向扣动扳机232引起囊导管230以远侧方向移动。相似地,以远侧方向推动扳机232引起囊导管230以近侧方向移动。因此,可通过移动扳机232使囊导管230移动。细长主体227的远侧区域包括允许导向导管233附接到细长主体227的合适的轮毂。在此实施例中,导向导管233包括由合适的生物相容性材料制成的细长管状元件234,合适的生物相容性材料包括(但不限于)PEEK、Pebax、尼龙、聚乙烯等。管状元件234的近侧区域可以被海波管235覆盖,该海波管由合适的生物相容性金属或聚合物制成。管状元件234的近端附接到合适的轮毂236。轮毂236允许导向导管233可逆地附接到细长主体227。在一个实施例中,轮毂236是凹型旋入式锁件,其附接到细长主体227上的合适的轮毂。因此,各种导向导管可附接到细长主体227的远侧区域,从而能够进入各种解剖区域。管状元件234的远端可以包括无创顶端237。管状元件234的远端可以包括弯曲、折曲或倾斜区域。在此实施例中,囊导管230在导丝238上被引入解剖结构的所需区域中。导丝238的近侧区域可以包括加扭器239。使用者可使用加扭器239来使导丝238旋转、前进、回缩、或扭转。外科手术手持工具226可用于将囊导管230引入所需解剖区域中,以在解剖区域中进行诊断或治疗手术。
图2F示出包括囊导管的第二替代实施例的外科手术手持工具240的侧视图。外科手术手持工具240的设计与外科手术手持工具226的设计类似。外科手术手持工具240还包括流体递送装置,以递送用于吹胀囊导管230的囊的吹胀流体。流体递送装置包括连接到囊吹胀口231的细长管241。细长管241还连接到流体贮存器242。在一个实施例中,流体贮存器242包括压缩气体,诸如空气、氮、二氧化碳等。从流体贮存器242到囊导管230的流体递送由阀243控制。
图2H示出图2F所示的外科手术手持工具240的局部截面图。细长主体227的近侧区域包括纵向狭缝229。细长主体227包封囊导管230。囊导管230的近端包括Y形轮毂。该Y形轮毂包括囊吹胀口231。囊吹胀口231继而连接到细长管241。导丝238穿过细长主体227的近端中的开口进入细长主体227。
图2G示出图2F所示的器件的阀排列的实施例的透视图。该阀排列包括三通阀243。在一个实施例中,三通阀243为旋入式三通阀。三通阀243的第一臂244通过细长管241连接到流体贮存器242。三通阀243的第二臂245与囊导管230的囊流体连通。三通阀243的第三臂246连接到排放管或通往大气环境。第三臂246可以连接到注射器或真空源,以收缩囊导管230的囊。这种包括连接到第三臂246的注射器或真空源的排列特别可用于收缩非适形囊。三通阀243还包括控制旋钮247。控制旋钮247处于第一位置时,在介于第一臂244与第二臂245之间实现流体连通。控制旋钮247处于第二位置时,在介于第二臂245与第三臂246之间实现流体连通。使用者可将控制旋钮247旋到第一位置,以吹胀囊导管230的囊。然后,使用者可将控制旋钮247旋到第二位置,以收缩囊导管230的囊。除了使用三通阀来可控地吹胀或收缩囊导管230的囊,也可以使用其他合适的阀排列。
图3A示出实施例的手持式囊导管工具250的透视图。囊导管工具250包括近侧区域251。近侧区域251包括手柄252,以使使用者能够持握囊导管工具250。囊导管工具250还包括囊导管轴253。在一个实施例中,囊导管轴253从近侧区域251的远侧区域向远侧延伸。在另一个实施例中,囊导管轴253延伸直至近侧区域251的近端。囊导管轴253还可以包括围绕囊导管轴253的区域的海波管254。囊导管轴253的远侧区域包括填充的囊255,该囊可用于扩张解剖结构的一个或多个区域。囊255通过与手柄252相邻设置的扳机256来吹胀。扳机256连接到柱塞,该柱塞进一步连接到吹胀流体贮存器。扣动扳机256引起储存在吹胀流体贮存器中的吹胀流体被带压递送至囊255。囊导管工具250还可以包括冲刷口257,以冲刷囊导管轴253的内腔。
在手术过程中,使用者利用储存在吹胀流体贮存器中的吹胀流体来将囊255吹胀至所需压力。囊255中的压力可通过与囊255内的吹胀流体流体连通的压力传感器或压力表258来测量。囊导管工具250还可以包括棘轮机构259,以允许使用者以步进增量方式扣动扳机256。这允许使用者以步进增量方式来使囊255膨胀。相似地,囊导管工具250可以包括棘轮机构,以允许使用者在使囊255膨胀之后以步进增量方式释放扳机256。这允许使用者以步进增量方式来使囊255收缩。在一个实施例中,囊导管工具250可在导丝上前进到解剖结构中的所需目标位置。在此实施例中,囊导管工具250还可以包括近侧导丝口260,近侧导丝口260与囊导管轴253中的导丝内腔流体连通。这使得囊导管工具250能够在导丝上被引入解剖结构中。在另一个实施例中,囊导管工具250包括导丝261,导丝261固定在囊导管工具250的远侧顶端处,以穿过解剖结构导航囊导管工具250。在一个实施例中,囊导管工具250包括旋转旋钮262。旋转旋钮262允许使用者旋转囊导管轴253。囊导管工具250还可以包括一个或多个导航装置,包括(但不限于)不透射线的标记物、电磁导航传感器等。囊导管工具250的远侧区域可以通过本文所公开的多种引入器件被引入解剖结构中,包括(但不限于)导向导管。
图3B示出实施例的可拆卸手持式囊导管吹胀工具270的透视图。可拆卸式吹胀工具270包括主体271,主体271包括手柄272,以使使用者能够持握吹胀工具270。可拆卸式吹胀工具270附接到囊导管273。在一个实施例中,向使用者提供套件,该套件包括可拆卸式吹胀工具270和多个囊导管。在图3B所示的实施例中,囊导管273包括细长囊导管轴274。囊导管轴274的远侧区域包括填充的囊275,该囊可用于扩张解剖结构的一个或多个区域。囊导管轴274的近侧区域连接到合适的轮毂276,该轮毂包括用于吹胀囊275的侧口。在一个实施例中,囊导管轴274包括围绕囊导管轴275的区域的海波管277。通过与手柄272相邻设置的扳机278来吹胀囊275。扳机278连接到柱塞,该柱塞进一步连接到吹胀流体贮存器。扣动扳机278引起储存在吹胀流体贮存器中的吹胀流体被带压递送至囊255。吹胀流体通过附接到轮毂276的侧口的流体递送口279来递送。在手术过程中,使用者利用储存在吹胀流体贮存器中的吹胀流体来将囊275吹胀至所需压力。囊275中的压力可通过与囊275内的吹胀流体流体连通的压力传感器或压力表280来测量。可拆卸式吹胀工具270还可以包括棘轮机构281,以允许使用者以步进增量方式扣动扳机278。这允许使用者以步进增量方式来使囊275膨胀。相似地,可拆卸式吹胀工具270可以包括棘轮机构,以允许使用者在使囊275膨胀之后以步进增量方式释放扳机278。这允许使用者以步进增量方式收缩囊275。在一个实施例中,囊导管273与囊导管工具270的组合可在导丝上前进到解剖结构中的所需目标位置。在此实施例中,囊导管工具270还可以包括近侧导丝口282,近侧导丝口282与囊导管轴274中的导丝内腔流体连通。这使得囊导管工具270能够在导丝283上被引入解剖结构中。在另一个实施例中,囊导管273包括导丝,该导丝固定在囊导管273的远侧顶端处,以穿过解剖结构导航囊导管273。在另一个实施例中,囊导管273包括快速交换内腔。该快速交换内腔使囊导管273能够在合适的导丝上被引入。囊导管工具270还可以包括冲刷口284,以冲刷囊导管273的内腔。囊导管工具270还可以包括一个或多个导航装置,包括(但不限于)不透射线的标记物、电磁导航传感器等。囊导管工具273的远侧区域可以通过多种引入器件被引入解剖结构中,包括(但不限于)导向导管。
图3A的囊导管工具250或图3B的可拆卸手持式囊导管吹胀工具270可以被设计成将囊吹胀至固定的压力。作为另外一种选择,它们可以被设计成递送固定体积的吹胀流体以膨胀囊。
本文以及以引用方式并入本文中的专利申请中所述的工具的手柄组件中的任何者可以包括旋转式手柄。此类旋转式手柄可以被设计成将使用者所施加的旋转力的一部分转换为将手柄组件的部件朝彼此拉动的直线力。旋转式手柄的一个实施例在标题为“Pivoted hand tool”(枢转式手持工具)的美国专利No.5,697,159(Lindén)中有所描述,其整个公开内容明确地以引用方式并入本文中。旋转式手柄的此类设计可以用于手柄组件,包括(但不限于)图3A中的手柄252和扳机256、以及图3B中的手柄272和扳机278等。
现在参见图4A,该图示出鼻窦囊扩张和内窥镜集成***300的一个实施例。集成***300包括与导向导管304和囊导管306连接的内窥镜302。手柄308也包括在该***内,该手柄具有轴310,该轴带有贯穿的内腔。示出的内窥镜302在近端314上包括内窥镜手柄312,并且穿过轴310的内腔设置。在一个实施例中,内窥镜护套316连接到轴310的内腔或穿过其设置,以覆盖内窥镜302的细长轴,从而允许用流体清洁内窥镜透镜,而无需将内窥镜从***或其在患者体内的当前位置移除。为了清洁内窥镜302的透镜,流体管线318与内窥镜护套316连通,并且设置在流体管线上的流体阀320允许在任何时间通过打开流体阀来冲刷该护套。内窥镜护套316包括无创顶端321,以防止损伤患者并使内窥镜302的透镜保持清洁。在手柄308上也可以具有摩擦密封件315,摩擦密封件315密封内窥镜护套316的近端,以防止流体穿过手柄往回渗漏。
手柄308包括前部指状切割槽322和后部切割槽324,这允许医生抓握手柄和内窥镜302,并将内窥镜的重量平衡在四个手指上,以卸去拇指上的压力。如图4A所示,在手柄的顶部上也有柱状切割槽326,这允许在使用者需要时内窥镜的灯柱328竖直地退出。作为另外一种选择,内窥镜302的灯柱328可向下笔直悬挂或向侧面挂出,而不受手柄308的约束。
仍参见图4A,集成***300的导向导管304包括海波管330以及从海波管延伸出的细长管状元件332。细长管状元件332也可以包括在导向导管的远端336处的无创顶端334。轮毂338设置在导向导管304的近端340处,该轮毂包括凸缘342并且提供用于使囊导管306进入导向导管304中的开口。轮毂338也与抽吸管线344连通,抽吸管线344在启用时可将流体穿过导向导管304抽吸出目标区域。囊导管306包括囊吹胀口346,以吹胀设置在囊导管上的囊。囊导管306可滑动穿过轮毂338和导向导管304。囊吹胀口346连接到吹胀管349和合适的吹胀器件,以吹胀囊导管306的囊。在一个实施例中,囊导管306在导丝348上被引入解剖结构的所需区域中。导丝348的近侧区域可以包括加扭器350,其可由使用者操纵,以使导丝旋转、前进、回缩或扭转。
为了将内窥镜302与导向导管304连接,在内窥镜护套316上设置内窥镜夹片352,在导向导管304的海波管330上设置导向装置夹片354。在不包括内窥镜护套316的实施例中,内窥镜夹片352可以直接设置在内窥镜的细长轴上。夹片连接器356将内窥镜夹片352和导向装置夹片354连接在一起,以形成集成***。在一个实施例中,内窥镜夹片352和导向装置夹片354分别摩擦配合到护套316和海波管330,夹片352和354可以任何方向旋转和滑动。在另一个实施例中,夹片352和354中的一者或这两者可包括弹簧闩锁或其他锁紧装置,以将夹片沿着器件锁紧在适当位置。还可以想到,夹片352和354可以包括狭缝358,以用于将夹片从内窥镜或导向导管上易于移除。在一个实施例中,夹片连接器356是附接到每一个夹片352和354的可延展线材。可延展线材允许较为容易定位并防止回弹。另外,可延展线材允许导向导管304相对于内窥镜302成角度,以用于目标窦的简单布线。在一些实施例中,夹片连接器356包括用于稳定性的两个连杆机构,然而,也可以使用一个连杆机构。
仍参见图4A,该图示出一个实施例,其中管318、344和349被粘结在一起以防止管缠结。然而,在其他实施例中,管318、344或349中的任何两根可以粘结在一起。在其他实施例中,管318、344和349没有粘结在一起。
图4A所示的集成***300允许单手用内窥镜实现对患者解剖结构(诸如目标鼻旁窦口)的连续可视化,而解放使用者的另一只手,以用于导丝操纵和导管囊前进。该***也允许导向导管304被定位,然后在目标窦处或其附近的设定位置处保持静止,以获得手术过程中的稳定性。手柄还允许使用者持握内窥镜,而无需将内窥镜的整个重量搁在使用者的拇指上,从而有助于防止使用者的手部痉挛。
图4B示出替代实施例的集成***370。在此实施例中,手柄308包括延伸夹片372,延伸夹片372用于附接连接到导向导管304的延伸件374。在此实施例中,延伸件374附接到轮毂338的凸缘342,轮毂338连接到导向导管304。当延伸件374附接到手柄308的延伸夹片372时,内窥镜可拆卸地连接到导向导管304和囊导管306。如图4B所示,延伸件374包括双弯形状,其可由使用者单手持握。可以想到,延伸件374可滑入和滑出延伸夹片372,但在该延伸件被设置在延伸夹片内时不必由使用者持握。
可以与用于扩张解剖区域类似的方式使用图4A和图4B的集成***300和370。应用的集成***300和370被引入解剖结构中。在一个实施例中,内窥镜302和导向导管304穿过患者的鼻孔和/或穿过人造开口被一起引入鼻旁窦中。内窥镜302和导向导管304被定位成使得导向导管304的远侧顶端位于待进入解剖区域附近,并且内窥镜可观察目标解剖区域。随后,导丝348穿过导向导管304被引入,使得导丝的远侧顶端位于目标解剖区域附近。在此步骤过程中,可以利用加扭器350穿过解剖结构导航导丝348。在一个实施例中,导丝348被定位在整个待扩张的鼻旁窦口上。随后,通过以远侧方向推囊导管,使囊导管306在导丝348上前进到解剖结构中。一旦囊导管306的囊被正确定位,就使用囊导管306进行诊断或治疗手术。在一个实施例中,囊导管306用于扩张通向鼻旁窦的开口,诸如鼻旁窦口。一旦手术完成,就从目标解剖区域和患者移除集成***300或370。
现在参见图5A和图5B,该图示出外科手术手持工具400的一个实施例,其包含导向导管和囊导管。外科手术手持工具400包括由生物相容性材料制成的中空近侧主体402,生物相容性材料包括(但不限于)ABS、尼龙、聚氨酯、聚乙烯等。近侧主体402包封囊导管404(见图5B)。囊导管404包括囊吹胀口406,以吹胀囊导管上的囊。囊吹胀口406穿过贯穿近侧主体的纵向开口狭缝408露出近侧主体402之外,使得囊导管404可沿着近侧主体的轴线滑动,如图5B中最佳示出的。囊吹胀口406经吹胀管连接到合适的吹胀器件,以吹胀囊导管404的囊。在此实施例中,囊导管404在导丝410上被引入解剖结构的所需区域中。在图示实施例中,用附接到囊导管近端的线材锁件412将导丝410锁定到囊导管404上。线材锁件412可以一个方向旋转,以将导丝410锁定到囊导管,并可以另一个方向旋转,以将导丝从囊导管解锁。在一些实施例中,导丝410的近侧区域可以包括加扭器(未示出),以使导丝旋转、前进、回缩、或扭转。
近侧主体402的远侧区域包括允许将导向导管414附接到近侧主体402的合适的轮毂413。在替代实施例中,导向导管414永久性地附接到近侧主体202。在此实施例中,导向导管414包括由合适的生物相容性材料制成的细长管状元件416,合适的生物相容性材料包括(但不限于)PEEK、Pebax、尼龙、聚酰亚胺、ABS、PVC、聚乙烯等。管状元件416的近侧区域可以被海波管418覆盖,海波管418由合适的生物相容性金属或聚合物制成。管状元件416的近端附接到轮毂413。轮毂413允许导向导管414可逆地附接到近侧主体402。在一个实施例中,轮毂413是凹型旋入式锁件,其附接到近侧主体402上的合适的轮毂。因此,各种导向导管可附接到近侧主体402的远侧区域,从而能够进入各种解剖区域。管状元件416的远端可以包括无创顶端422。在某些实施例中,管状元件416的远端可以包括弯曲、折曲或倾斜区域。
如图5A至图5B所示,外科手术手持工具400包括部分地设置在近侧主体402内的滑动件或器件推进构件424。滑动件424包括大致圆柱形的主体426,主体426用于固定在吹胀口406处的囊导管404,并且其尺寸被设定为防止滑动件从近侧主体402掉落。当导丝被锁定到囊导管上时,移动滑动件使囊导管404和导丝410一起前进。通过移动外科手术手持工具400来实现囊导管404和/或导丝410的任何操纵。具有第一把手428和第二把手430,以用于手部大小不同的使用者达到并移动滑动件424。后盖432设置在近侧主体402的近端处,以防止滑动件424从近侧主体脱离。在图示实施例中,附接到近侧轴402的手柄434包括手指护栏436,手指护栏436允许使用者的手指可根据需要向前按压以用于额外的控制。
在图5A和图5B中所示实施例的替代实施例中,可以用导轨主体来代替中空近侧主体402。导轨应当提供这样的结构,滑动件424可沿着这种结构滑动,并且导管404和/或导丝410可前进。
图6A和图6B示出外科手术手持工具440的另一个实施例。外科手术手持工具440与图5A和图5B所示的外科手术手持工具400相似,然而,外科手术手持工具440被设计成允许囊导管和导丝利用滑动件旋转。如图6A和图6B所示,外科手术手持工具440包括由生物相容性材料制成的中空近侧主体442,生物相容性材料包括(但不限于)ABS、尼龙、聚氨酯、聚乙烯等。近侧主体442包封囊导管444(见图6B)。囊导管444包括囊吹胀口446,以吹胀囊导管上的囊。囊吹胀口446穿过贯穿近侧主体切割的狭槽或纵向开口448露出近侧主体442之外,使得囊导管444可沿着近侧主体的轴线滑动,如图5B中最佳示出的。囊吹胀口446经吹胀管连接到合适的吹胀器件,以吹胀囊导管444的囊。在此实施例中,囊导管404在导丝450上被引入解剖结构的所需区域中。在图示实施例中,用附接到囊导管近端的线材锁件452将导丝450锁定到囊导管404。线材锁件452可以一个方向旋转,以将导丝450锁定到囊导管,并可以另一个方向旋转,以将导丝从囊导管解锁。在一些实施例中,导丝450的近侧区域可以包括加扭器(未示出),以使导丝旋转、前进、回缩、或扭转。
近侧主体442的远侧区域包括允许将导向导管454连接到近侧主体442的合适的轮毂453。在替代实施例中,导向导管454永久性地附接到近侧主体442。在此实施例中,导向导管454包括由合适的生物相容性材料制成的细长管状元件456,合适的生物相容性材料包括(但不限于)PEEK、Pebax、尼龙、聚酰亚胺、ABS、PVC、聚乙烯等。管状元件456的近侧区域可以被海波管458覆盖,海波管458由合适的生物相容性金属或聚合物制成。管状元件456的近端附接到轮毂453。轮毂453允许导向导管454可逆地附接到近侧主体442。在一个实施例中,轮毂453是凹型旋入式锁件,其附接到近侧主体442上的合适的轮毂。因此,各种导向导管可附接到近侧主体442的远侧区域,从而能够进入各种解剖区域。管状元件456的远端可以包括无创顶端462。在某些实施例中,管状元件456的远端可以包括弯曲、折曲或倾斜区域。
如图6A和图6B所示,外科手术手持工具440包括在近侧主体442内移动的滑动件或器件推进构件464。滑动件464包括大致圆柱形的底部466,底部466用于固定在吹胀口446处的囊导管444,并且其尺寸被设定为防止滑动件从近侧主体442掉落。当导丝被锁定到囊导管上时,移动滑动件使囊导管444和导丝450一起前进。在此实施例中,狭槽或纵向开口448的尺寸允许使用者旋转、并因此操纵囊导管和导丝,其中滑动件在两个方向均介于约30度至60度之间,以用于介于约60度和120度之间的总旋转自由度。然而,滑动件的旋转可在两个方向上均从约零度至约90度,以用于介于约零度和约180度之间的总旋转自由度。也可以通过移动外科手术手持工具440来实现操纵。在此实施例中,在任一侧或两侧上均具有从滑动件464延伸的多个把手468,以用于手部大小不同的使用者达到并移动滑动件424。滑动件464的安装座469将把手468一起附接。在另一个实施例中,可用在近侧主体442上延伸的套环来代替把手468。后盖472设置在近侧主体442的近端处,以防止滑动件464从近侧主体脱离。在图示实施例中,附接到近侧轴442的手柄474包括手指护栏476,其允许使用者的手指可根据需要向前按压以用于额外的控制。
在图6A和图6B所示的此实施例中,外科手术手持工具也包括朝滑动件464的近端附接的安装底座478,以允许囊导管444沿着近侧主体442行进可能的最长行程。在近侧主体442上也具有切割槽480,切割槽480允许滑动件464被额外旋转几度,以允许将囊导管移除并用另一根囊导管代替。当滑动件464旋转到切割槽480中时,可从滑动件的圆柱形底部466将囊导管移除。在滑动件仍处于此位置的情况下,可以将另一根囊导管***滑动件的圆柱形底部466中,以用于与外科手术手持工具一起使用。
图7示出外科手术手持工具490的另一个实施例,其与图6A和图6B中所示的实施例类似。在此实施例中,近侧主体被导轨492代替,导轨492允许滑动件494更大程度的旋转。滑动件494的总旋转自由度可在约150度至约280度的范围内。滑动件494包括架空套环496,架空套环496将滑动件约束到导轨494并为使用者提供把手以使滑动件沿着导轨移动,该滑动件继而使通过线材锁件502锁定的囊导管498和导丝500移动。
图8A和图8B示出外科手术手持工具510的另一个实施例,其允许单手控制鼻窦囊扩张器件。外科手术手持工具510包括由生物相容性材料制成的中空近侧主体512,生物相容性材料包括(但不限于)ABS、尼龙、聚氨酯、聚乙烯等。近侧主体512包封囊导管514(见图8B)。囊导管514包括囊吹胀口516,以吹胀设置在囊导管上的囊。囊吹胀口516穿过贯穿近侧主体的纵向狭缝或开口518露出近侧主体512之外,使得囊导管404可沿着近侧主体的轴线滑动。囊吹胀口516经吹胀管连接到合适的吹胀器件,以吹胀囊导管514的囊。在此实施例中,囊导管514在导丝520上被引入解剖结构的所需区域中。
导丝520穿过附接到近侧主体512的近端的近侧套环522、经线材滑道524被送入近侧主体的线材狭槽526中。导丝520被定位在近侧主体512上方,从而允许使用者利用拇指和食指在导向导管后面控制导丝。近侧套环522防止导丝左右偏移,并且可围绕近侧主体512旋转。线材滑道524保持导丝520的位置,并用于在囊导管前进过程中固定导丝。穿过线材狭槽526,导丝520穿过囊导管侧面上的开口528进入囊导管514。此导管的类型(诸如快速交换导管)是本领域所已知的。
近侧主体512的远侧区域包括允许将导向导管532附接到近侧主体512的合适的轮毂530。在替代实施例中,导向导管532永久性地附接到近侧主体512。在此实施例中,导向导管532包括由合适的生物相容性材料制成的细长管状元件534,合适的生物相容性材料包括(但不限于)PEEK、Pebax、尼龙、聚酰亚胺、ABS、PVC、聚乙烯等。管状元件534的近侧区域可以被海波管536覆盖,海波管536由合适的生物相容性金属或聚合物制成。管状元件534的近端附接到轮毂530。轮毂530允许导向导管532可逆地附接到近侧主体512。在一个实施例中,轮毂530是凹型旋入式锁件,其附接到近侧主体512上的合适的轮毂。因此,各种导向导管可附接到近侧主体512的远侧区域,从而能够进入各种解剖区域。管状元件534的远端可以包括无创顶端538。在某些实施例中,管状元件534的远端可以包括弯曲、折曲或倾斜区域。还可以想到,导向导管532摩擦配合到轮毂530中,使得导向导管能够在轮毂内旋转,但在该机构中仍具有足够的摩擦,以允许其一旦被正确调节就停在适当的位置。
如图8A和图8B所示,外科手术手持工具510包括囊驱动器540,囊驱动器540部分地设置在近侧主体512内并穿过纵向狭缝或开口518伸出。囊驱动器540包括囊驱动器闩锁542(图8B),囊驱动器闩锁542固定吹胀口516处的囊导管514。以远侧方向移动囊驱动器540使囊导管514向前前进。当使囊导管向前前进时,导丝520可抵靠滑道524固定。囊导管和/或导丝的任何操纵通过移动外科手术手持工具510来实现。在图示实施例中,附接到近侧轴512的手柄544包括前部546,前部546优选地由使用者的第四和第五根手指抓握,以用于稳定化。当持握器件时,使用者的手掌优选地压贴手柄的后部548上,以用于稳定化。
图8A和图8B所示的外科手术手持工具510允许使用者将器件持握在手掌中,优选地用第四和第五根手指来保持器件平衡,并用食指和拇指使导丝520前进。这样,用同一只手持握外科手术手持工具510和控制导丝520。使用者还可直接触及导丝,从而在使导丝前进和操纵过程中获得全面触感。然后,拇指向后移,将囊驱动器540向前(向远侧)推,从而实现囊导管514的前进。然后,可利用食指和拇指使导丝回缩,并通过以近侧方向拉囊驱动器540使囊导管514回缩。
另外,图9A和图9B示出外科手术手持工具550的另一个实施例,外科手术手持工具550允许单手控制鼻窦囊扩张器件以及向吹胀器件递送流体。外科手术手持工具550包括由生物相容性材料制成的中空近侧主体552,生物相容性材料包括(但不限于)ABS、尼龙、聚氨酯、聚乙烯等。近侧主体552包封囊导管554(见图9B)。囊导管554包括囊吹胀口556,以吹胀设置在囊导管上的囊。囊吹胀口556穿过近侧主体中的纵向狭缝或开口558露出近侧主体552之外,使得囊导管554可沿着近侧主体的轴线滑动。囊吹胀口556还延伸穿过囊驱动器或器件推进构件560并由其固定,器件推进构件560用于使囊导管以远侧方向和近侧方向两者移动。囊驱动器560的手柄562可根据使用者的需要转向外科手术手持工具550的任一侧,并且当流体管线附接到囊导管554的吹胀口556时可被夹紧在适当位置。在此实施例中,囊导管554在导丝558上被引入解剖结构的所需区域中。
设置在囊导管554的远侧区域的膨胀囊(未示出)可用于扩张解剖结构的一个或多个区域。通过附接到近侧主体552的致动手柄或扳机560来将囊从未膨胀构型吹胀至膨胀构型。致动手柄560连接到柱塞562,柱塞562进一步连接到包括吹胀流体贮存器566的流体圆筒564。储存在吹胀流体贮存器566中的流体(水、盐水等)可用于吹胀囊导管的囊、冲刷涡旋、或向任何需要的地方提供流体。在手术过程中,使用者利用储存在吹胀流体贮存器566中的流体将囊导管的囊吹胀至所需压力。囊中的压力可通过与囊内的吹胀流体流体连通的压力传感器或压力表(未示出)来测量。在一个实施例中,外科手术手持工具550被设计成将囊导管的囊吹胀至固定压力。作为另外一种选择,该工具可以被设计成递送固定体积的吹胀流体以膨胀囊。
流体圆筒564包括圆筒口568,圆筒口568提供用于将流体管线570从流体圆筒附接至囊导管554以及吹胀囊结构。在其他实施例中,圆筒口568可以成一角度以及从流体圆筒上的任何位置延伸。在此实施例中,流体管线570从圆筒口568延伸到囊导管的吹胀口556。
致动手柄560被设计成根据使用者的舒适度和手部大小适应使用者的一至三根手指。除了致动此器件的流体机构之外,致动手柄还起到在导丝设置、囊部署、涡旋部署、或其他器件的部署过程中稳定器件的作用。如图9A和图9B所示,手柄包括指状外凸缘572,从而使手部更大的使用者得到稳定器件的结构。如果需要的话,指状外凸缘也可允许使用者提供额外的扭矩,以用于致动流体机构。在介于致动手柄560和柱塞562之间附接的旋转铰链574将致动手柄的运动以及所施加的力递送到柱塞。在其他实施例中,旋转铰链可被弯曲,以在手柄560致动过程中更易于深入到流体圆筒564中并避免约束。还可以想到,铰链574、致动手柄560、和柱塞562上的枢转点可根据柱塞行进的距离对所需要的手柄旋转及施加的扭矩来更靠近或更远离。致动手柄枢转点575将手柄附接到近侧主体552。为了使柱塞行进的距离以及通过手柄施加的扭矩量最大化,手柄枢转点被设置为与介于旋转铰链574和柱塞562之间的连线的中心齐平。
在一个实施例中,弹簧(未示出)可以被嵌入器件的近侧主体552中,以在扣紧手柄以吹胀囊导管的囊之后,使致动手柄560偏置返回到远离流体圆筒564的伸展或打开位置中。该弹簧可以是设置在手柄枢转点575周围或手柄/铰链枢轴577周围的扭转弹簧。作为另外一种选择,该弹簧可以是设置在介于器件的两个构件或点(诸如点575和577)之间的片簧。在其他实施例中,该弹簧可以是卷簧(拉伸或压缩)。
如图9A和图9B所示,外科手术手持工具550也包括倚靠使用者的手掌的背部手柄576。与其他实施例的手柄不同,背部手柄576在底部处是开放式的,这允许使用者更自由地调控器件。
在图9A和图9B所示的实施例中,导丝558穿过附接到近侧主体552的近端的近侧套环580、经线材滑道582上被送入近侧主体的线材狭槽584中。导丝558被定位在近侧主体552上方,从而允许使用者在导向导管后面控制导丝。近侧套环580防止导丝左右偏移,并且可围绕近侧主体552旋转。线材滑道582保持导丝582的位置,并用于在囊导管前进过程中固定导丝。穿过线材狭槽584,导丝558穿过囊导管侧面上的开口586进入囊导管554。此导管的类型(诸如快速交换导管)是本领域所已知的。
近侧主体552的远侧区域包括允许将导向导管592附接到近侧主体552的合适的轮毂590。在一个实施例中,导向导管592永久性地附接到近侧主体552。与上述实施例类似,导向导管592包括由合适的生物相容性材料制成的细长管状元件,合适的生物相容性材料包括(但不限于)PEEK、Pebax、尼龙、聚酰亚胺、ABS、PVC、聚乙烯等。管状元件的近侧区域可以被海波管覆盖,该海波管由合适的生物相容性金属或聚合物制成。管状元件的近端附接到轮毂590。轮毂590允许导向导管592可逆地附接到近侧主体552。在一个实施例中,轮毂590是凹型旋入式锁件,其附接到近侧主体552上的合适的轮毂。因此,各种导向导管可附接到近侧主体552的远侧区域,从而能够进入各种解剖区域。管状元件的远端可以包括无创顶端。在某些实施例中,管状元件的远端可以包括弯曲、折曲或倾斜区域。还可以想到,导向导管592摩擦配合到轮毂590中,使得导向导管能够在轮毂内旋转,但在该机构中仍具有足够的摩擦,以允许其一旦被正确调节就停在适当的位置。
图9A和图9B所示的外科手术手持工具550允许使用者将器件持握在手掌中,优选地用第四和第五根手指来保持器件平衡,并用食指和拇指使导丝558前进。这样,用同一只手持握外科手术手持工具550和控制导丝558。使用者还可直接触及导丝,从而在前进和操纵过程中获得完全触感。然后,拇指向后移,将囊驱动器560朝着近侧主体552的远端推,从而实现囊导管554的前进。然后,可利用食指和拇指使导丝558回缩,并通过以近侧方向拉囊驱动器560使囊导管554回缩。
如图9A所示,通向囊吹胀口556的流体管线570是简单的封闭***。当致动手柄560被扣紧或向近侧移动时,柱塞562迫使流体从贮存器566穿过流体管线进入囊导管554中。以远侧方向移动致动手柄560建立真空,以使囊导管544的囊收缩。作为另外一种选择,在一些实施例中,设置在柱塞562之中或之上的弹簧可起到收缩导管544的作用。
在多种实施例中,致动手柄560可以具有任何合适的构型,并且可以在任何距离处与手持工具550的其他部件间隔开,以向柱塞562提供所需量的杠杆作用。在一些实施例中,柱塞562可以是可移除的/可互换的。例如,在一个实施例中,第一尺寸的柱塞562可以用于提供高压,以吹胀囊导管544,第二尺寸的柱塞562可以用于提供高流量的冲洗流体,以冲洗与手持工具550连接的导管。在一些实施例中,器件550可以包括压力指示器以监测柱塞562中的压力。作为另外一种选择或除此之外,柱塞562可以包括硬障碍物,以防止施加超过某一点的压力。
在图9C所示的另一个实施例中,流体递送***包括两个阀。为了易于参见,图9C中已移除了器件的近侧主体552。在此实施例中,囊导管已被末端开放的器件600(在远端处开放)代替,末端开放的器件600包括吹胀口602。器件600可用于形成涡旋或向特定区域递送流体。流体管线604在介于流体圆筒564和吹胀口602之间连接,并且也与单独的流体槽606连通。流体管线包括邻近流体槽606的第一阀608和邻近器件600的第二阀610。在一个实施例中,第一阀和第二阀均为单向阀。通过扣紧手柄从而迫使柱塞562向近侧移动,流体圆筒564中的流体被推动穿过流体管线604、穿过第二阀610、并进入末端开放的器件600(涡旋形成器件或其他流体递送器件)中。第一单向阀608防止流体流出到流体槽606中。以远侧方向移动柱塞562引起流体从流体槽606中被抽出并穿过第一单向阀608。第二单向阀610防止空气、流体等从器件600中被抽到流体管线中。在此***中,通过前后(或向近侧和向远侧)移动柱塞,流体圆筒564可“连续地”从流体槽606填充以及通过器件600排空。
图9D示出流体递送***的另一个实施例。在此实施例中,流体管线604未附接到末端开放的器件600,而连接到流体圆筒562和单独的流体槽606。起初,流体管线604附接到第二单向阀610,而未附接到器件600,通过以远侧方向移动柱塞562来从流体槽606中抽出流体。通过以近侧方向推动柱塞562,可通过第二单向阀610排出空气。一旦***中的所有空气均被排出,流体管线604就可与第二单向阀610分离以及附接到器件600上。一旦附接到器件600上,就可以向近侧移动柱塞562,以将流体传送到器件中并穿过器件。第二单向阀610防止流体流出到流体槽606中。还可以想到,可使用三通阀来代替第一单向阀,从而无需使流体管线与器件600分离。
图9E示出流体递送***的另一个实施例,并且该流体递送***连接到包括填充的囊622和吹胀口624的囊导管620。如图9E所示,流体管线604连接到三通阀626,三通阀626具有第一阀628、第二阀630和第三阀632。为了填充流体圆筒564,向远侧移动柱塞562,以将流体从流体槽606穿过第一单向阀608抽到流体管线604中。为了排出流体管线604中的空气,打开第一阀628,关闭第二阀630,并且打开三通阀626的第三阀632,并且使其通向充当排气口的第二单向阀610。在此种构型的情况下,向近侧移动柱塞562,以迫使流体管线604中的空气穿过第二单向阀610排出。一旦***中的空气被排出,就可通过首先打开第二阀630,然后关闭第三阀632来吹胀囊622。第一阀628一直打开。在此种构型的情况下,向近侧移动柱塞,以迫使流体穿过三通阀626并进入囊导管620中,以吹胀囊622。***可以其他构型布置,使用其他阀来通过前后运动(向近侧和向远侧)移动柱塞562来使流体圆筒654填充流体以及从***排出空气。
现在参见图10A-10E,该图示出替代实施例的外科手术手持工具700,外科手术手持工具700允许单手控制鼻窦囊扩张器件。外科手术手持工具700包括代替上述外科手术手持工具的近侧主体的第一导轨和第二导轨702。这些导轨702可以由生物相容性材料制成,生物相容性材料包括(但不限于)ABS、尼龙、聚氨酯、聚乙烯等。在手持工具700的近端处使用导轨702可减小手持工具700的外形,从而赋予使用者的食指和拇指更多的自由,以使导丝703前进。囊导管704被定位成平行于导轨702,并且囊导管704的囊吹胀口706通过外科手术手持工具700的囊驱动器708来固定。具体地讲,囊吹胀口706被固定在囊驱动器708的摩擦配合狭槽709内,如图10A所示。在另一个实施例中,囊吹胀口706被固定在囊驱动器708的闩锁711内,如图10B所示。囊驱动器708沿着导轨702行进,以使囊导管704前进或回缩,这会形成相对低的摩擦。如图10A所示,囊驱动器708包括T形杆710,T形杆710可由使用者的食指和拇指抓握,以使囊导管前进或后退。图10B示出囊驱动器708的另一个实施例,囊驱动器708包括环712,以用于使用者抓握并使囊导管704前进或后退。囊吹胀口706经吹胀管连接到合适的吹胀器件(未示出),以吹胀囊导管704的囊。在此实施例中,囊导管704在导丝703上被引入解剖结构的所需区域中。
外科手术手持工具700也包括具有套环716的导丝保持元件714,以用于保持导丝703。另外,导轨702的近端附接到导丝保持元件714,以防止导轨702移动或扭曲。应用的导丝703穿过套环716经线材滑道718上被送入囊导管704中。导丝703被定位在手持工具700的导轨702的上方,从而允许使用者利用拇指和食指在导向导管后面控制导丝703。套环716防止导丝703左右偏移,线材滑道718保持导丝703的位置,并用于在囊导管前进过程中固定导丝703。导丝703穿过囊导管704侧面上的开口720进入囊导管704中。此导管的类型(诸如快速交换导管)是本领域所已知的。
导轨702的远端连接到允许将导向导管724附接到外科手术手持工具700的合适的轮毂722。在此实施例中,导向导管724包括由合适的生物相容性材料制成的细长管状元件726,合适的生物相容性材料包括(但不限于)PEEK、Pebax、尼龙、聚酰亚胺、ABS、PVC、聚乙烯等。管状元件726的近侧区域可以被海波管覆盖,该海波管由合适的生物相容性金属或聚合物制成。管状元件726的近端附接到轮毂722。轮毂722允许导向导管724可逆地附接到外科手术手持工具700。管状元件726的远端可以包括无创顶端728。在某些实施例中,管状元件726的远端可以包括弯曲、折曲或倾斜区域。
如图10A所示,手柄730可以附接到外科手术手持工具700的导轨702。手柄730优选地由使用者的第四和第五根手指抓握,以用于稳定化。当持握器件时,使用者的手掌优选地压贴手柄730的后部上,以用于稳定化。在图10C所示的一个实施例中,连接构件732附接到手柄730,连接构件732为可延展的或包括弹簧元件。掌托734附接到连接构件的另一端,并用于在使导丝703或囊导管704前进时将外科手术手持工具700托在使用者手掌上,以用于支承。使用者可将连接构件732弯曲成任何形状或将其移动到所需的任何位置中,以适应取向偏好。在此实施例中,持握掌托允许使用者轻轻地将一根或两根手指放在手柄730中,以固定外科手术手持工具700。另外,连接构件732的弹簧结构帮助吸收在对窦进行布线时外科手术手持工具700将经历的震动和运动中的一些。
图10A或图10C所示的外科手术手持工具700允许使用者将器件持握在手掌中,优选地用第四和第五根手指来保持器件平衡,并用食指和拇指使导丝703前进。这样,用同一只手持握外科手术手持工具700和控制导丝703。使用者还可直接触及导丝703,从而在使导丝前进和转向过程中获得完全触感。然后,拇指向后移,将囊驱动器708向前(向远侧)推,从而实现囊导管704的前进。然后,可利用食指和拇指使导丝703回缩,并通过以近侧方向拉囊驱动器708使囊导管704回缩。
图10D和图10E示出外科手术手持工具700的另一个实施例。在此实施例中,导向导管724附接到导向附件736,导向附件736搭扣配合到具有第一凸缘740和第二凸缘742的引导按扣738中。凸缘740和742之间的距离小于导向附件736的直径。凸缘740和742挠曲,以让导向附件736进入引导按扣738中,然后向回挠曲,以抓住导向附件736。另外,如图10E中最佳示出的,邻近凸缘740和742设置凹槽744,以接纳导向附件736的近侧盘746。此实施例能够更牢固地固定导向导管724。
如图10E所示,在此实施例中,囊驱动器708包括可移动的手柄748。可移动的手柄748通过轴750附接到囊驱动器708,轴750允许可移动的手柄748从一侧摆动到另一侧。当可移动的手柄748从一侧移动到另一侧时,位于囊驱动器708上的弹簧销轴752按扣到位于可移动的手柄748上的孔754中。
另外,如图10D和图10E所示,在此实施例中,外科手术手持工具700包括线材滑道756,线材滑道756由附接到手柄730的线材或塑料形成。此实施例的第一导轨和第二导轨702也更靠近地一起移动,并且甚至可以彼此接触。使两个导轨702一起靠近可防止囊驱动器708的旋转并减小外科手术手持工具700的外形。
现在参见图11,该图示出外科手术手持工具780的另一个实施例,外科手术手持工具780包括前流体递送***,以用于递送流体,以吹胀囊导管(未示出)的囊。在此实施例中,外科手术手持工具780包括连接到安装座784的注射器圆筒782,安装座784在轴788上附接到外科手术手持工具780的近侧主体786的远端。随着安装座784绕轴788旋转,注射器圆筒782被向上朝着柱塞790驱动,柱塞790在轴792上附接到近侧主体786。在连同允许柱塞790绕轴792旋转的情况下,轴792沿着在近侧主体786中形成的狭槽794滑动。当轴792向远侧滑动时,轴792和788更靠近地一起移动,并且柱塞790和注射器圆筒782***的机械效益增大,但“投程”(即圆筒782沿着柱塞790向上的动程)减小。相反,当轴792沿着狭槽794向近侧移动时,轴792和788更远地相隔移动,机械效益减小,而投程增大。在操作中,使用者可以逆时针方向旋转旋转注射器圆筒782,以朝着柱塞790移动圆筒782,并迫使流体流出圆筒782并穿过附接到圆筒782的出口797的细长管796。细长管796在另一端处也附接到囊导管的囊吹胀口798。在柱塞790下方的注射器圆筒782中具有弹簧(未示出),该弹簧在注射器被释放时驱动***回到起始位置。
现在参见图12A和图12B,该图示出侧面加载的冲洗导管820,冲洗导管820与上述外科手术手持工具400、440、490、510、550、700或780中的任何者一起使用。冲洗导管820包括侧面切割槽或窗口822,以用于导丝进入。冲洗导管820的远侧部分824可以包括在远端处带有侧孔826的单内腔。在远侧部分的远端处也可以设置有标记828,诸如射线不可透标记或任何其他类型的标记。标记828告知使用者冲洗导管820的远端的位置。远侧部分824的长度在约1至4英寸之间变化。
双内腔挤出件830附接到冲洗导管820的远侧部分824的近端。图12B示出双内腔挤出件830的横截面图,双内腔挤出件830包括用于导丝的第一圆形内腔832和用于流体或盐水流动的第二月牙形内腔834。在介于双内腔挤出件830和远侧部分824之间的过渡处,冲洗导管820从双内腔过渡到单内腔。双内腔挤出件830的两个内腔均通往远侧部分824的单内腔,以允许导丝进入和流体流到远侧部分的远端。双内腔挤出件830延伸到冲洗导管820的近端,并至少部分地被支承海波管836覆盖。海波管836可以与囊导管上的海波管类似,以允许穿过上述外科手术手持工具顺利前进。如图12A所示,侧面切割槽822贯穿支承海波管836的壁,并贯穿双内腔挤出件830的壁,以使得导丝可延伸到冲洗导管820和第一圆形内腔832中。也可以在支承海波管836上距冲洗导管的远端这样的距离设置标记带838,该距离告知使用者远端正在离开导向导管在支承海波管836的近端处具有轮毂840,以用于将注射器连接到冲洗导管820,以冲刷流体穿过导管。在此实施例中,仅需要一个口,并且该口可处于任何取向。
在冲洗导管820的另一个实施例中,可以在远侧部分824的单内腔的内部设置瓣膜或阀(未示出),以防止流体向近侧流回到双内腔挤出件830的第一圆形内腔832中。
现在参见图13,该图示出侧面加载的冲洗导管850,冲洗导管850与上述外科手术手持工具400、440、490、510、550、700或780中的任何者一起使用。在一个实施例中,冲洗导管850包括一个内腔,以用于更大的流体流量。在冲洗导管上设置有侧面切割槽、窗口或开放槽852。冲洗导管850的远侧部分854可以包括在远端处带有侧孔856的单内腔。可在远端处设置任何数量的侧孔。在远侧部分的远端处也可以设置有标记858,诸如射线不可透标记或任何其他类型的标记。远侧部分854的长度可从约1英寸变化到4英寸。
单内腔挤出件860附接到冲洗导管850的远侧部分854的近端。单内腔挤出件860延伸到冲洗导管850的近端,并至少部分地被支承海波管866覆盖。海波管866可以与囊导管上的海波管类似,以允许穿过上述外科手术手持工具顺利前进。如图13所示,侧面切割槽852贯穿支承海波管866的壁,并贯穿单内腔挤出件860的壁,以使得导丝可延伸到冲洗导管850中。冲洗注射器868也可穿过切割槽852延伸到冲洗导管850中,以冲刷流体穿过导管。也可以在支承海波管866上距冲洗导管的远端这样的距离设置标记带,该距离告知使用者远端正在离开导向导管。在支承海波管866的近端处有轮毂870,以用于将注射器连接到冲洗导管820,以冲刷流体穿过导管。在此实施例中,仅需要一个口,并且该口可处于任何取向。在另一个实施例中,远侧部分854的细长管可以延伸到冲洗导管的近端,而没有单内腔挤出件或支承海波管。在此实施例中,切割槽852将在其近端附近贯穿细长管延伸。
代替图12A和图13所示的单独的器件,冲洗导管的远侧部分可设置在囊导管的远端上。图14A和图14B示出带有冲洗远端880的囊导管,并且其允许医生在扩张之后冲刷窦,而无需移除囊导管。囊冲洗导管880用于与上述外科手术手持工具400、440、490、510、550、700或780中的任何者一起使用。在囊冲洗导管880上设置有侧面切割槽、窗口或开放槽882。远侧冲洗部分884可附接到囊导管885的远端,并且包括带有侧孔886的单内腔,如图14B中最佳示出的。可在远侧冲洗部分884上设置任何数量的侧孔。在远侧冲洗部分的远端处也可以设置有标记888,诸如射线不可透标记或任何其他类型的标记。远侧冲洗部分884的长度可从约1英寸变化到4英寸。
囊导管885附接到远侧冲洗部分884的近端,囊导管885包括膨胀构件889。囊导管885包括双内腔管890,双内腔管890的横截面类似于图12B所示的横截面,具有第一圆形内腔和第二月牙形内腔。在此实施例中,第一圆形内腔可容纳导丝和/或注射器,以将流体冲刷到目标区域中。第二月牙形内腔可为吹胀内腔,以吹胀膨胀构件或囊889。双内腔管890延伸到囊冲洗导管880的近端,并且甚至可以包括至少部分地覆盖双内腔管890的支承海波管896。海波管896允许穿过上述外科手术手持工具顺利前进。侧面切割槽882贯穿支承海波管896的壁,并贯穿双内腔管890的壁,以使得导丝可延伸到囊冲洗导管880中。冲洗注射器898也可穿过切割槽852延伸到冲洗导管850中,以冲刷流体穿过导管。冲洗注射器898可以包括折曲的钢海波管或柔性聚合物挤出件。冲洗注射器的外径应该足够小,以配合在囊冲洗导管880的侧面切割槽882内。另外,冲洗注射器898包括钝的远侧顶端(未示出),远侧顶端是钝的,以避免切伤或刮伤囊冲洗导管880的内腔。
也可以在支承海波管896上距囊冲洗导管880的远端这样的距离设置标记带,该距离告知使用者该远端正在离开导向导管。另外,可以距囊冲洗导管的远端这样的距离设置第二标记带,该距离指示膨胀构件889已经离开导向导管。在支承海波管896的近端处有轮毂900,以用于将注射器连接到囊冲洗导管880,以冲刷流体穿过导管。
在操作中,使用者可以沿着导丝将囊冲洗导管880***窦中。囊冲洗导管的膨胀构件889一旦处于正确的位置就可被吹胀,以扩张窦。在扩张之后,可从囊冲洗导管移除导丝,并可将冲洗注射器898***侧面切割槽882中。冲洗注射器898在囊冲洗导管880中向远侧滑动,以使得其末端处于导管880内的内腔的封闭部分内。一旦正确地***囊冲洗导管880中,就可利用冲洗注射器898穿过囊冲洗导管注入流体(诸如盐水),以使得流体将从远侧冲洗部分884的侧孔886流出。
在另一个实施例中,冲洗导管的尺寸可被设定为使得其穿过囊导管的切割槽配合到囊导管的导丝内腔中。图15A和图15B示出囊导管910和冲洗注射器912,冲洗注射器912用于在扩张之后冲刷窦。侧面切割槽、窗口或开放槽914设置在囊导管910上,并提供用于***冲洗注射器912的开口。冲洗注射器包括折曲的钢海波管或柔性聚合物挤出件916,其中多孔囊918安装在海波管916的远端处。当流体被注入冲洗注射器912中时,多孔囊918伸展以打开孔919,然后流体从孔流出。一旦来自流体的压力被移除,多孔囊918就收缩,以使得可从囊导管910移除冲洗注射器912。
如图15A所示,囊导管910包括膨胀构件920。囊导管910也包括双内腔管922,双内腔管922的横截面类似于图12B所示的横截面,并具有第一圆形内腔和第二月牙形内腔。在此实施例中,第一圆形内腔可容纳导丝和/或冲洗注射器912,以将流体冲刷到窦中。第二月牙形内腔可为吹胀内腔,以吹胀膨胀构件或囊920。双内腔管922延伸到囊导管910的近端,并且甚至可以包括至少部分地覆盖双内腔管922的支承海波管924。海波管924允许穿过上述外科手术手持工具顺利前进。侧面切割槽914贯穿支承海波管924的壁,并贯穿双内腔管922的壁,以使得导丝和/或冲洗注射器912可延伸到囊导管910中。冲洗注射器912的外径应该足够小,以配合在囊导管910的侧面切割槽914内。另外,冲洗注射器912包括钝的远侧顶端926,远侧顶端926是钝的,以避免切伤或刮伤囊冲洗导管910的内腔。
上述外科手术手持工具400、440、490、510、550、700或780可各自以相似的方式使用,以用于扩张解剖区域。应用的外科手术手持工具通常穿过鼻孔(但在替代实施例中,穿过诸如犬齿窝穿刺的另一个开口)被引入患者头部内。在一个实施例中,可以首先穿过患者的鼻孔***内窥镜,然后***导向导管。在其他实施例中,内窥镜和导向导管可一起***。内窥镜和导向导管被定位成使得导向导管的远侧顶端位于待进入解剖区域附近,并且内窥镜可观察到目标解剖区域。随后,穿过导向导管引入导丝,使得导丝的远侧顶端位于目标解剖区域处或附近。在此步骤过程中,可以利用导丝的加扭器穿过解剖结构来导航导丝。在一个实施例中,导丝被定位在整个待扩张的鼻旁窦口上。随后,通过将滑动件或囊导管驱动器以远侧方向推动,囊导管在导丝上前进到解剖结构中。一旦囊导管的囊被正确定位,就使用囊导管进行诊断或治疗手术。在一个实施例中,囊导管用于扩张通向鼻旁窦的开口,诸如鼻旁窦口。一旦手术完成,就从目标解剖区域和患者移除内窥镜和外科手术手持工具400、440、490、510、550、700或780。
图16示出用于使用(诸如)如上所述的那些手持工具400、440、490、510、550、700或780的方法的一个实施例。作为第一步骤,经手柄单手持握在其内腔中设置有囊导管的导向装置。然后,内部带有囊导管的导向装置前进到人类或动物受试者体内。可以前进到鼻孔中,或穿过一些其他进入通道(诸如穿过犬齿窝穿刺)进入上颌窦。在一些实施例中,在前进步骤之前,此方法可以包括在鼻旁窦中形成人造开口,诸如犬齿窝穿刺。在多种实施例中,导向装置/导管组合可以在内窥镜前进到受试者体内之前、过程中或之后通过相同或不同的进入路径前进。
当导向装置被定位在受试者体内的所需位置处,诸如其远端在鼻旁窦口附近时,在一些实施例中,囊导管可以前进到导向装置之外,以将导管的囊定位在窦开口中。一些实施例可以任选地包括以下附加步骤:使导丝前进到导向装置之外,然后使囊导管在导丝上前进到导向装置之外。一旦囊导管的囊相对于鼻旁窦口的开口处于所需位置,囊就可以膨胀,以扩张开口。然后,可以从受试者移除导向装置和囊导管。
可以对上述多种实施例中的方法进行多种不同的变型。例如,如上文进一步所述,在一些实施例中,内窥镜也可以附接到手柄,使得导向装置、囊导管和内窥镜可同时前进到受试者体内。在一些实施例中,作为另外一种选择,仅导向装置与手柄连接,囊导管被预先加载在导向装置和手柄中,导丝被预先加载在囊导管中。在一些实施例中,可以使用发光导丝,在这种情况下,在手术的任何合适的部分期间,导丝可以被照亮。此方法的一些实施例也可以包括冲洗程序,其中冲洗导管前进到鼻旁窦中并用于将粘液和/或其他物质冲刷到窦之外。因此,如上面更详细描述的,在各种替代实施例中,本发明的方法可以包括多种不同的步骤和变型。
在上面所有实施例中,使用的导丝可为任何常规的导丝。还可以想到,也可使用照明导丝器件,诸如美国专利申请No.11/522,497中所公开的器件,其以引用的方式并入本文。照明导丝器件连接到光源,并在远端处包括用于照明的照明部分。照明导丝器件的照明可用于在视觉上确认放置在患者体内的照明器件的远端部分的定位。应用的照明器件的远端部分被***患者体内,并从照明器件的远端部分发光。然后,医生可观察由于照明器件的远端部分所发出的光而在患者外表面上发生的透照,其将患者外表面上所观察到的透照位置与所观察到的透照位置下方的患者体内位置相关联。这可确认照明器件的远端部分的定位。
鼻窦扩张器件和***200、250、300、370、400、440、490、510、550、700、780、820、850、880、910和912中的任何者都可被封装或制成套件,以随时使用。在此实施例中,此器件或***应当被放置在单个包装中,以用于医生刚好在该手术或外科手术之前打开。在某些实施例中,不同类型的套件可与各种器械(例如笔直和/或弯曲的导向导管)包裹在一起。这样,可针对特定手术预备套件,诸如用于上颌窦或用于额窦。可以提供各种套件,诸如(但不限于)“完整”和“部分”套件。例如,在一个实施例中,完整套件可以包括导向导管、照明导丝、囊导管和集成的吹胀器件。可选地,可以包括冲洗导管、额外或不同的导丝、额外或不同的囊导管和/或等等。在一个实施例中,部分套件可以包括与手柄和吹胀器件集成的囊导管。导向导管、照明导丝、冲洗导管和/或等等可以作为单独的包等提供。当然,在各种替代实施例中,本专利申请中所描述的多种器件和元件的任何组合可以配备成套。在一些实施例中,套件也可以包括内窥镜,诸如摆动棱镜内窥镜。此类摆动棱镜内窥镜在美国专利申请No.61/084,949(名称为Swing Prism Endoscope(摆动棱镜内窥镜),提交于3008年7月30日)中有更详细的描述,其全部公开内容以引用方式并入本文。
此器件也可以与集成在一起的***的多种器件封装在一起,并且一旦从包装中取出器件或***就随时可以使用。例如,囊导管可被定位在导向导管内。另外,在某些实施例中,在包装中吹胀器件可能已经附接到囊导管,除非其便于流体预备而未附接吹胀器件。在包括与器件或***封装在一起的内窥镜的实施例中,抽吸内腔也可附接到导向导管,并且流体内腔可附接到内窥镜。另外,导向导管可连接到器件200、250、400、440、490、510、550、700和780的近侧主体。对于鼻窦囊扩张和内窥镜集成***300和370,内窥镜可预先附接到导向导管。在其他实施例中,内窥镜可以不与器件或集成***封装在一起。这应当允许医生在该手术或外科手术过程中选择偏好的内窥镜来使用。
将器件和***封装在一起,以用于立即使用可节省医生准备和设置器件和200、250、300、370、400、440、490、510、550、700、780、820、850、880、910和912的时间。器件和***可在封装之前消毒,并且无需在准备手术时冲洗。医生应当仅需在使用成套***之前***流体内腔并将光缆附接到内窥镜。对于包括外科手术手持工具200、250、400、440、490、510、550、700或780的包装,如果套件内未提供内窥镜,医生也可能需要选择并准备用于手术的内窥镜。另外,在某些实施例中,导丝可包括在套件内,甚至被定位在器件或***的囊导管和导向导管内。然而,在其他实施例中,封装的套件内不包括导丝,医生可以选择偏好的导丝来执行手术。
本文所公开的刚性或柔性的内窥镜可以具有0度至145度的观察范围。包括弯曲、折曲或倾斜区域的内窥镜的实施例可以通过在熔融光纤之前弯曲或折曲光纤来制造。可以通过(例如)将光纤加热到500℃至700℃的温度或通过使用合适的环氧树脂粘合剂将光纤附接到彼此来熔融光纤。可以利用包层厚度减小的光纤来制造内窥镜,以允许弯曲、折曲或倾斜区域带有大角度或曲率,而曲率半径较小。也可以利用玻璃/玻璃/聚合物(GGP)多模光纤(诸如由3M制造的那些)来制造内窥镜,以允许弯曲、折曲或倾斜区域带有大角度或曲率,而曲率半径较小。例如,在内窥镜具有包围90度或更大的角度的弯曲、折曲或倾斜区域的情况下,弯曲、折曲或倾斜区域的曲率半径可优选地小于或等于1.5cm。此类包括带有大角度或曲率,而曲率半径较小的弯曲、折曲或倾斜区域的内窥镜特别适用于使使用者能够进入上颌窦。
已经主要结合微创手术描述了本文的实施例,但其也可有利地用于现有开放式外科手术或腹腔镜式外科手术技术。例如,本文所公开的方法和器件可与功能性鼻窦内窥镜手术(FESS)的一种或多种技术结合。在FESS中,外科医生可以移除病变或肥大组织或骨头,并可以扩大鼻旁窦口以恢复窦的正常引流。这通常利用内窥镜可视化在患者全身麻醉的情况下进行。
尽管FESS仍然是严重窦炎的黄金标准疗法,但其存在若干缺陷,诸如术后疼痛以及手术相关的出血、对于相当多的患者而言无法缓解症状、造成眼窝、颅内和鼻腔鼻窦损伤的风险等。替换FESS的一个或多个步骤可减少与传统FESS相关的缺陷。以下是涉及FESS与本专利申请以及以引用方式并入本文的专利申请中所公开的手术的组合的手术的一些实例。
1.在一种组合手术中,在全部或部分移除钩突或没有全部或部分移除钩突的情况下,通过囊扩张治疗上颌窦。全部或部分移除钩突可以使一些医生能够更容易或更快速地看见并进入上颌窦。
2.在另一种组合手术中,结合鼻甲的移除通过囊扩张来治疗上颌窦。在此组合手术中,可以移除部分或整个鼻甲(如中鼻甲)。移除部分或整个鼻甲为器械在钩突中间的区域中提供了额外的空间。这可以潜在地使组合手术更容易或更快速。
3.在另一种组合手术中,结合筛房切除术通过囊扩张来治疗蝶窦口。筛房切除术的步骤可以使医生能够将导向导管穿过中鼻道引入蝶窦口。这可以潜在地允许容易地进入蝶窦口。
4.在另一种组合手术中,结合中鼻甲切除和/或筛房切除术通过囊扩张来治疗额窦。此组合手术可以使医生一旦类似筛泡、鼻甲等的解剖结构被移除或减小就能够更容易地找到、看到或进入额窦。
5.在另一种类型的组合手术中,在没有或极少组织或骨移除的情况下,通过囊扩张来治疗多种窦。然后通过标准技术来治疗窦疾病。此类组合手术包括:
5A.通过囊扩张来治疗额窦、上颌窦或蝶窦。另外,在保留钩突的同时进行筛房切除术。钩突的存在可保留钩突的天然功能。这继而可以降低窦中类似感染等并发症的发生率。
5B.可以结合第二手术通过囊扩张来治疗任何鼻旁窦,包括(但不限于)筛房切除术、鼻中隔成型术、鼻甲(如鼻甲、中鼻甲等)切除、等。
6.可以结合用柔性导管或刚性器械冲洗和抽吸一个或多个鼻旁窦,执行本文所公开的手术中的任何者。柔性导管尤其可用于触及刚性器械难以进入的区域。此类区域可位于额窦的侧方、上颌窦的下方或中间、等。
7.本文所公开的手术中的任何者还可以包括移除一个或多个息肉。通过标准技术(诸如使用剃刀)的息肉移除可与各种鼻旁窦口的囊扩张相结合。一旦一个或多个息肉被移除,就可以通过囊扩张来扩张一个或多个鼻旁窦口。
8.在另一种类型的手术中,可以执行一个或多个鼻旁窦口的囊扩张以改变先前执行的外科手术或结合标准内窥镜窦外科技术。此类手术的实例包括:
8A.治疗额隐窝上方的疤痕形成:在此组合手术中,尝试用导丝进入额隐窝。然后,囊导管在导丝上穿过。如果导丝由于疤痕或由于额窦口太小而无法进入额窦口,则可以使用(例如)刮匙或导引头的外科器械来打开或穿刺疤痕组织或附着物或额窦口。此类疤痕组织或附着物可能由于(例如)感染、先前的外科手术等而引起。随后,可以通过囊扩张来扩张额窦口。
8B.可以执行与前述组合手术类似的组合手术以治疗蝶窦和上颌窦附近的疤痕。
9.在另一种类型的手术中,可以通过通向窦的人工创建的开口来进入一个或多个鼻旁窦(如上颌窦)。随后,可以执行本文所公开的或在以引用方式并入本文的专利文献中所公开的诊断或治疗手术。人工创建的开口可以用于通过内窥镜可视化诸如囊导管、导丝或其他器件的器件穿过鼻旁窦的自然口的放置。人工创建的开口也可以用于进入一个或多个诊断、治疗或进入器件。人工创建的开口可以用于引入液体,包括(但不限于)抗生素溶液、抗炎剂溶液等。人工创建的开口可以利用合适的器件形成,包括(但不限于)钻孔器件、切削器件、穿刺器件等。
在图17-20的流程图示出本发明的混合手术的一些具体实例。
图17示出一种方法的步骤,其中移除或显著改变解剖或病理结构(诸如钩突、鼻甲、筛骨气胞壁、息肉等),并且扩张器(如囊导管的囊)被定位在鼻旁窦的开口内并用于扩张该开口。在手术期间或术后检查及后续程序期间,解剖或病理结构的移除或改变可提供更清晰的进入和/或某些解剖结构的可视化。
图18示出一种方法的步骤,其中扩张器(诸如囊导管的囊)被定位在鼻旁窦的开口中并用于扩张该开口,并且在这种扩张之前或之后,抽吸或冲洗鼻旁窦腔。在带有贯通内腔的囊导管或其他扩张器件用于实现扩张步骤的情况下,可以通过使流体或负压穿过扩张导管的所述贯通内腔来执行冲洗和/或抽吸步骤。或者,在扩张步骤中可使导丝前进到窦腔中或附近,随后可使抽吸和/或冲洗器件经此类导丝上前进并用于执行抽吸和/或冲洗步骤。
图19示出一种方法的步骤,其中在阻塞内腔、孔口或通道的位置中形成了疤痕或附着组织(如阻塞鼻旁窦开口的疤痕组织),并且初始地在疤痕或附着组织中形成穿刺道。这可以通过将针、导引头、探针、导丝或其他穿入物推动穿过组织来实现。随后,使扩张器(如囊导管)前进到穿刺道中并用于扩张该穿刺道,从而缓解由畸变疤痕或附着组织引起的阻塞。
图20示出一种方法的步骤,其中扩张器(如囊导管的囊)被置于鼻旁窦预先存在的开口中,诸如窦的自然口(或先前外科手术改变的口),并用于扩张该开口。另外,从鼻腔或穿过面外部在该鼻旁窦中创建单独的开口(如骨孔、窦造口术、环钻术等)。这可以改善窦腔的通气和/或引流。可选地,两个开口然后可以用于执行其他手术。例如,可以通过使冲洗溶液穿过一个开口并从另一开口流出来进行“直通”冲洗。或者,可以穿过一个开口***器件,而留下另一开口未堵塞。或者,医生可以在治疗预先存在的开口或执行窦的其他诊断或治疗的同时,通过新创建的开口进行观察(如通过内窥镜)。
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。这些器件和方法可以单独使用,或可以结合其他外科手术或非外科手术处理一起使用,包括(但不限于)器件和药物或其他物质的递送或植入,如共同待审的美国专利申请No.10/912,578(名称为“Implantable Devices and Methods for Delivering Drugs and Other Substances to Treat Sinusitis and Other Disorders”(用于递送药物和其他物质以治疗窦炎和其他疾病的可植入器件和方法),提交于2004年8月4日)中所述,其全部公开内容明确地以引用方式并入本文中。
已经结合某些实例或实施例对本发明进行了描述,但在不脱离本发明的预期精神和范围的前提下,可以对这些实例和实施例进行各种添加、删除、更改和修改。例如,可以将一个实施例或实例的任何元件或属性整合到另一个实施例或实例中或与另一个实施例或实例一起使用,除非这样做将会使得实施例或实例不适合于其要达到的目的用途。所有适当的添加、删除、修改和更改应视为所述实例和实施例的等同形式,并应包括在以下权利要求书的范围内。
Claims (20)
1.一种用于扩张人类或动物受试者的鼻旁窦口的器件,所述器件包括:
手柄;
细长轴,所述细长轴具有与所述手柄连接并延伸到远端的近端,其中所述轴包括内腔和纵向开口,所述纵向开口沿着介于所述近端和所述远端之间的长度的至少一部分从所述内腔延伸到所述轴的外表面;
导丝,所述导丝穿过所述轴内腔的至少一部分设置;
扩张器,所述扩张器具有未膨胀构型和膨胀构型,其中所述扩张器的至少一部分被设置在所述导丝上和所述轴内腔内;和
滑动构件,所述滑动构件穿过所述轴的所述纵向开口与所述导丝或所述扩张器中的至少一者连接,以用于使所述导丝和/或所述扩张器相对于所述轴前进。
2.根据权利要求1所述的器件,其中所述细长轴的所述远端包括与所述细长轴连接的细长管状元件。
3.根据权利要求1所述的器件,其中所述滑动构件能够相对于所述细长轴进行轴向旋转,以旋转所述导丝和/或所述扩张器。
4.根据权利要求1所述的器件,其中所述轴的所述远端能够穿过所述受试者的鼻部的鼻孔***。
5.根据权利要求1所述的器件,还包括与所述轴的所述远端连接的穿刺构件,以用于向所述受试者的鼻旁窦中穿孔,其中所述轴的所述远端能够穿过所述孔***。
6.根据权利要求1所述的器件,还包括附接到所述细长轴的流体贮存器,其中所述流体贮存器与所述扩张器流体连通。
7.根据权利要求6所述的器件,还包括与所述流体贮存器连接的扳机,其中致动所述扳机引起所述流体贮存器中的流体将所述扩张器吹胀成所述膨胀构型。
8.一种用于进入人类或动物受试者的鼻旁窦口的器件,所述器件包括:
手柄;
细长轴,所述细长轴具有与所述手柄连接并延伸到远端的近端以及从所述近端向所述远端延伸至少到中途的纵向内腔;
器件推进构件,所述器件推进构件与所述手柄或所述细长轴中的至少一者连接,并被构造成与穿过所述轴的所述内腔的至少一个器件连接并使其至少前进到中途进入鼻旁窦口中。
9.根据权利要求8所述的器件,还包括穿过所述轴内腔的至少一部分延伸的导丝,其中所述器件推进构件被构造成与穿过所述内腔的所述导丝连接并使其前进穿过所述鼻旁窦口。
10.根据权利要求8所述的器件,还包括穿过所述轴内腔的至少一部分延伸的囊扩张导管,其中所述器件推进构件被构造成与穿过所述内腔的所述囊扩张导管连接并使其至少前进到中途进入所述鼻旁窦口中。
11.根据权利要求8所述的器件,其中所述器件推进构件包括滑动构件。
12.根据权利要求8所述的器件,其中所述器件推进构件包括:
两个辊,所述两个辊被构造成保持所述器件并使其前进;和
致动器,所述致动器与所述两个辊连接以移动所述辊。
13.一种用于扩张人类或动物受试者的耳部、鼻部或喉部内的解剖结构的***,所述***包括:
内窥镜;
细长管状导向装置,所述细长管状导向装置与所述内窥镜可拆卸地连接;
手柄,所述手柄与所述内窥镜或所述细长管状导向装置中的至少一者连接,以用于单手抓握与所述细长管状导向装置连接的所述内窥镜;和
扩张器,所述扩张器可滑动地设置在所述细长管状导向装置中,其中所述扩张器具有用于穿过所述细长管状导向装置的未膨胀构型以及用于扩张所述解剖结构的膨胀构型。
14.根据权利要求13所述的***,还包括:
第一夹片,所述第一夹片附接到所述内窥镜;
第二夹片,所述第二夹片附接到所述细长管状导向装置;和
连接构件,所述连接构件用于连接所述第一夹片和所述第二夹片。
15.根据权利要求13所述的***,其中连接在一起的所述内窥镜和所述细长管状导向装置的尺寸被设定为能够进入所述受试者的鼻部的鼻孔中。
16.根据权利要求13所述的***,其中连接在一起的所述内窥镜和所述细长管状导向装置的尺寸被设定为穿入所述受试者的鼻旁窦中所穿刺的孔中,所述***还包括与所述内窥镜或所述细长管状导向装置中的至少一者连接的穿刺构件,以用于形成所述孔。
17.根据权利要求13所述的***,还包括穿过导丝内腔设置的导丝,所述导丝内腔穿过所述扩张器的至少一部分延伸。
18.根据权利要求17所述的***,还包括与所述细长管状导向装置连接的导丝推进构件,以用于使所述导丝相对于所述细长管状导向装置前进。
19.根据权利要求13所述的***,还包括与所述内窥镜连接的内窥镜清洗器,所述内窥镜清洗器包括:
护套,所述护套设置在所述内窥镜的至少一部分上;和
管,所述管与所述护套连接,以将所述护套与清洗流体源连接。
20.根据权利要求13所述的***,其中所述内窥镜包括刚性的摆动棱镜内窥镜。
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Also Published As
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US20100099946A1 (en) | 2010-04-22 |
RU2011115098A (ru) | 2012-10-27 |
WO2010033629A8 (en) | 2010-05-27 |
US10702295B2 (en) | 2020-07-07 |
US9826999B2 (en) | 2017-11-28 |
JP5584687B2 (ja) | 2014-09-03 |
US8414473B2 (en) | 2013-04-09 |
MX2011003025A (es) | 2011-04-21 |
CN102159276B (zh) | 2014-01-15 |
US20180125515A1 (en) | 2018-05-10 |
CN103623498A (zh) | 2014-03-12 |
JP5837152B2 (ja) | 2015-12-24 |
BRPI0919195A2 (pt) | 2019-09-24 |
AU2009293312A1 (en) | 2010-03-25 |
KR101643907B1 (ko) | 2016-07-29 |
JP2015037540A (ja) | 2015-02-26 |
KR20110056409A (ko) | 2011-05-27 |
JP2012502749A (ja) | 2012-02-02 |
US20130261388A1 (en) | 2013-10-03 |
CN103623498B (zh) | 2015-12-30 |
AU2009293312B2 (en) | 2015-07-09 |
CA2737804A1 (en) | 2010-03-25 |
EP2323724A1 (en) | 2011-05-25 |
WO2010033629A1 (en) | 2010-03-25 |
RU2506056C2 (ru) | 2014-02-10 |
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