CN102112040A - 鼻旁孔口探示器器件和方法 - Google Patents

鼻旁孔口探示器器件和方法 Download PDF

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CN102112040A
CN102112040A CN2009801307175A CN200980130717A CN102112040A CN 102112040 A CN102112040 A CN 102112040A CN 2009801307175 A CN2009801307175 A CN 2009801307175A CN 200980130717 A CN200980130717 A CN 200980130717A CN 102112040 A CN102112040 A CN 102112040A
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J·H·莫里斯
J·马考尔
C·F·费尔南德斯
E·戈德法布
T·詹金斯
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Abstract

本发明提供了用于定位鼻窦口并将导丝设置在所述鼻窦口内的器件和方法。所述主题器件包括：轴，所述轴具有远端、近端、弯曲区域、和内部通道，所述弯曲区域位于远端与近端之间；可伸长和可回缩的导丝，所述可伸长和可回缩的导丝活动安装在所述内部通道内；和探针顶端，所述探针顶端接合到所述导丝。某些器件还包括用于接合并处理人体解剖结构的可膨胀部分。

Description

鼻旁孔口探示器器件和方法
相关专利申请的交叉引用
本专利申请要求2008年7月30日提交的序列号为61/084,965的临时专利申请的优先权，其内容以引用方式并入本文。
技术领域
本发明总体上涉及医疗器件、体系和方法，更具体地讲，涉及用于定位并扩张鼻旁窦口的方法和器件。
背景技术
颅骨包含通过通道连接的被称为鼻旁窦的一系列腔体。鼻旁窦包括额窦、筛窦、蝶窦和上颌窦。鼻旁窦内衬有产生粘液的粘膜组织，并最终通到鼻腔中。通常，由粘膜组织产生的粘液通过被称为孔口的开口缓慢流出每一个鼻窦。如果这些通道之一的粘膜组织因任何原因而发炎，则通过该通道流出的腔体会被阻塞。这种阻塞会是周期性(导致疼痛发作)或慢性的。这种对粘液引流的干涉作用(如鼻窦口的闭合)会导致鼻旁窦内的粘膜充血。鼻窦的慢性粘膜充血会引起对上皮的损害，该损害让鼻窦受随后的较小的氧张力和微生物生长(如鼻窦感染)影响。
术语“鼻窦炎”通常是指由细菌、病毒、真菌(霉菌)、过敏症或其组合形成的鼻旁窦的任何炎症或感染。据估计，慢性鼻窦炎(如持续超过3个月左右)每年在美国导致1800万至2200万例内科就诊。患有鼻窦炎的患者通常经历以下症状中的至少一些：头痛或面部疼痛；鼻充血或鼻后引流；通过单鼻孔或双鼻孔呼吸困难；口臭；和/或上牙疼痛。
治疗鼻窦炎的方法之一是通过恢复损失的粘液流。初步治疗通常是使用抗炎剂来减轻炎症和使用抗生素来治疗感染的药物治疗。大量患者对药物治疗没有反应。目前，针对对药物治疗没有反应的患有慢性鼻窦炎的患者的黄金标准是称为功能性鼻窦内窥镜手术(FESS)的矫正手术。
在FESS期间，将内窥镜插入鼻部中，并在通过内窥镜进行显像的条件下，外科医生可以移除患病或增生的组织或骨骼，并可以扩大鼻窦口，以恢复鼻窦的正常引流。FESS手术通常在患者处于全身麻醉的状况下进行。
尽管FESS仍然是用于严重鼻窦疾病外科治疗的黄金标准疗法，但FESS确实具有若干缺点。例如，FESS可引起严重的术后疼痛。另外，一些FESS手术与严重的术后出血相关，这样，鼻腔填塞物常常在手术后置于患者鼻内一段时间。此类鼻腔填塞物会使患者感到不适，并会干扰正常呼吸、进食、饮水等。另外，一些患者甚至在多次FESS手术后仍有症状。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，可能不将患病不太严重的患者视为有待接受FESS者。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。
正在开发新的器件、体系和技术以用于治疗鼻窦炎以及耳部、鼻部、喉部和鼻旁窦的其他病症。例如，在以下美国专利申请中已描述了各种导管、导丝和其他可用于进行微创、微伤耳部、鼻部和喉部手术的器件：序列号为10/829,917，名称为“Devices，Systems and Methods for Diagnosingand Treating Sinusitis and Other Disorders of the Ears，Nose and/or Throat”(用于诊断及治疗鼻窦炎和耳部、鼻部和/或喉部的其他病症的器件、体系和方法)；序列号为10/912,578，名称为“Implantable Device and Methodsfor Delivering Drugs and Other Substances to Treat Sinusitis and OtherDisorders”(用于递送药物和其他物质以治疗鼻窦炎及其他病症的可植入器件和方法)；序列号为10/944,270，名称为“Apparatus and Methods forDilating and Modifying Ostia of Paranasal Sinuses and Other Intranasal orParanasal Structures”(用于扩张并修改鼻旁窦孔口及其他鼻内或鼻旁结构的设备和方法)；序列号为11/037,548，名称为“Devices，Systems andMethods For Treating Disorders of the Ear，Nose and Throat”(用于治疗耳部、鼻部和喉部病症的器件、体系和方法)；和序列号为11/116,118，名称为“Methods and Devices For Performing Procedures Within the Ear，Nose，Throat and Paranasal Sinuses”(用于进行耳部、鼻部、喉部和鼻旁窦内手术的方法和器件)。这些专利申请中的每一个由此均以全文引用的方式并入本文。这些新器件、体系和技术中的许多可与内窥镜、放射线照相和/或电子/电磁显像辅助器件结合使用，以有利于耳部、鼻部、喉部和鼻旁窦内导管、导丝和其他器件的精确定位和移动，并避免对关键解剖结构(诸如眼部、面部神经和脑部)的不利创伤或损害。
在一项新手术(本文称为“柔性经鼻窦介入”或FTSI或BalloonSinuplastyTM手术)中，在不需要移除或手术改变其他鼻内解剖结构的情况下，扩张导管(如囊导管或其他类型的扩张器)通过鼻部或一些其他进入通道而进入患者头部到达鼻旁窦孔口内的位置或其他部位。扩张导管随后被用来扩张孔口或其他解剖结构(诸如进入鼻旁窦和/或鼻腔内空间的人造开口)，以有利于从鼻窦腔的自然引流。在一些情况下，管状导件初始可以通过鼻部插入并前进到鼻窦口附近的位置，且导丝随后可以通过管状导件前进并进入患病鼻旁窦。扩张导管随后可以沿着导丝前进并通过管状导件到达其扩张器(如囊)设置在鼻窦口内的位置。扩张器(如囊)随后膨胀，从而导致孔口扩张。在一些情况下，此类孔口的扩张可能破碎、移动或重塑围绕或邻近孔口的骨结构。可选地，在一些手术中，冲洗液和/或治疗剂可以通过扩张导管的管腔而注入和/或其他工作器件(如导丝、导管、套管、管、扩张器、囊、物质注射器、针、穿透器、切割器、清创器、微清创器、止血器件、电烙器件、冷冻手术器件、加热器、冷却器、观察镜、内窥镜、光导、光疗器件、钻、锉刀、锯等)可以通过管状导件和/或沿着导丝前进，以在进行FTSI的同一手术期间将其他治疗递送到鼻窦或邻近组织。在FTSI手术中，除鼻窦口之外的结构和通道可以使用上述工具来扩张，组织可以被切除或烧蚀，骨可以被重塑，药物递送体系可以被调配等，如在以引用方式并入本文的文献中所述。
在包括将导丝定位到鼻旁窦的FTSI手术中，通常是在使用者用鼻窦探测器发现目标孔口之后，通过鼻窦口放置导丝。使用者或外科医生将鼻窦探测器放置到鼻腔通道，然后通过让鼻窦探测器的远端与目标鼻窦口接触而通过触觉反馈(即通过“感觉”)找到目标孔口。可能需要使用不止一个鼻窦探测器器件来定位目标孔口。外科医生随后将鼻窦探测器从患者移除，并将导向导管引入鼻腔通道中。导丝通过导向导管引入鼻腔通道中，并且外科医生通过触觉记忆将导丝导向或定位到目标孔口。当可使用荧光镜透视检查或其他x射线显像技术时，由于内科医生熟悉使用鼻窦探测器发现目标孔口，内科医生在将导丝插入患者中之前仍可利用鼻窦探测器。
插入或移除孔口定位器件，然后引入导向导管和导丝，导致器件反复侵入患者的鼻旁腔中，并可能相应地导致组织创伤增大、术后恢复时间增加、和/或该手术涉及的手术时间(以及因此费用)增加。现在，没有单个器件能够既找到目标孔口、又将导丝引入鼻旁腔中到达目标孔口，从而允许一步完成两项任务。需要此类在鼻窦手术期间可准确地确定目标鼻旁窦口位置并且也能将导丝提供或定位到目标孔口中的方法和器件。
也需要用于进入并扩张上颌窦口的简化器件和方法。上颌窦口常会难以定位和治疗，并且在很多情况下，可能有利的是，扩张上颌孔口并且也扩张面积或将解剖结构移到鼻窦(在鼻旁腔中)的外部，以有助于治疗鼻窦炎。例如，在一些情况下，可能理想的是，扩张中鼻道或动脉圆锥或移动中鼻道、前筛骨窦或钩突。如果内科医生在没有移除组织的情况下利用相对方便的工具或成套工具能够进行上述操作，则将会是理想的。本发明将解决这些需求中的至少一些。
本公开解决这些及其他需求。
发明内容
本发明提供鼻窦探测器或鼻窦口探示器或探测器器件以及用于使用该鼻窦探测器器件自身来将导丝引入目标鼻窦口中的方法。本公开也提供具有用于定位并扩张上颌窦以及用于扩张上颌窦外部空间的扩张器的探针。
本发明的鼻窦口探示器通常而言包括：轴，其具有远端、近端、位于远端和近端之间的弯曲区域、和内部通道；可伸长和可回缩的导丝，其活动安装在内部通道内；和探针顶端，其接合到导丝。导丝可介于回缩位置和伸长位置之间可逆地活动，其中：在回缩位置中，探针顶端邻近远端；在伸长位置中，探针顶端与远端分离。
具有扩张器器件的探针包括具有刚性近端和不太刚性的弯曲远端的轴，所述远端具有无创伤探针状远侧顶端。器件还可包括一个或多个可扩展的扩张器，其沿着轴附接到(诸如)弯曲远侧部分或其可沿该轴前进。
在某些实施例中，探针顶端为可拆卸并且可互换的。
在某些实施例中，鼻窦口探示器还包括接合到近端的柄部。
在某些实施例中，轴还包括外护套和内部元件，内部通道延伸穿过内部元件。
在某些实施例中，内部元件包含刚性材料，且外护套包含弹性材料。
在某些实施例中，内部元件是可移除且可互换的。
在某些实施例中，鼻窦口探示器还包括机械连接到导丝的致动器元件。致动器元件可以位于柄部上并机械连接到导丝。致动器元件可以以可滑动的方式安装在柄部上的狭槽内。
在某些实施例中，轴还包括管状内护套和管状外护套，内护套设置在外护套内，内部通道延伸穿过内护套。
在某些实施例中，内护套可以相对于外护套伸长和回缩。
在某些实施例中，轴还包括与内部通道连通的狭槽，狭槽被构造并被构型为允许导丝通过该狭槽插入内部通道中以及从内部通道移除。
在某些实施例中，外护套包括第一狭槽，且内护套包括第二狭槽，第一狭槽和第二狭槽被构造并被构型为允许在第一狭槽和第二狭槽彼此对齐时允许导丝通过第一狭槽和第二狭槽插入内部通道中以及从内部通道移除。
在某些实施例中，轴还包括前部和接合到该前部的后部，前部和后部限定管状形状，内部通道位于前部与后部之间。
在某些实施例中，前部还包括狭槽，狭槽与内部通道连通，狭槽被构造并被构型为允许导丝通过该狭槽插入内部通道中以及从内部通道移除。
在许多实施例中，本发明的鼻窦口探示器可以包括：细长轴，其具有远端和近端以及远端和近端之间的弯曲区域；柄部，其接合到近端；纵向内部通道，其延伸穿过轴和柄部；可伸长和可回缩的导丝，其活动安装在内部通道内；探针顶端，其接合到导丝末端；和致动器元件，其与柄部相关并机械连接到导丝，导丝可根据致动器元件的调节而伸长和回缩。
本发明也提供用于定位目标孔口的方法。主题方法通常而言包括：提供鼻窦口探示器，鼻窦口探示器具有轴，轴具有远端、近端、位于远端与近端之间的弯曲区域、和内部通道，可伸长和可回缩的导丝活动安装在内部通道内，且探针顶端接合到导丝；将鼻窦口探示器的轴插入患者的鼻旁腔中；调节轴远端的位置；以及调节导丝和探针顶端的位置，直到目标孔口被定位。
在某些实施例中，该方法还包括将轴从鼻旁腔收回，而让导丝和探针顶端留在调节的位置中。
在某些实施例中，该方法还包括将外科手术器件沿着导丝引到目标孔口。
在某些实施例中，探针可包括用于定位并扩张天然上颌窦口的器件，该器件包括：细长轴，其包括大体刚性近侧部分、弯曲远侧部分、在弯曲远侧部分末端处的无创伤远侧顶端，其中弯曲远侧部分的尺寸和形状适于允许远侧部分通入鼻腔中，以将无创伤远侧顶端设置在上颌窦口内或附近；膨胀管腔，其穿过轴的至少一部分；至少一个可扩展的扩张器，其与轴的远侧部分连接，与膨胀管腔成流体连通。
在其他实施例中，用于定位并扩张天然上颌窦口的器件可包括：细长内轴，其包括大体刚性近侧部分、弯曲远侧部分、和在弯曲远侧部分末端处的无创伤远侧顶端，其中弯曲远侧部分的尺寸和形状适于允许远侧部分通入鼻腔中，以将无创伤远侧顶端设置在上颌窦口内或附近；外轴，其以滑动的方式设置在内轴上并包括膨胀管腔；和至少一个可扩展的扩张器，其与轴的远侧部分连接，与膨胀管腔成流体连通。
在相关方法中，定位和扩张上颌窦口可涉及上颌窦，该方法包括：使上颌窦器件的弯曲远侧部分进入鼻腔中(其中上颌窦器件的近侧部分为大体刚性的)；传递上颌窦器件的无创伤远端穿过天然上颌窦口；使用触觉反馈来确认远端穿过上颌窦口以及扩张至少一个可扩展的扩张器，可扩展的扩张器与上颌窦器件的弯曲远侧部分连接，以扩张天然上颌窦口。
另外，在某些实施例中，器件的远侧顶端可点亮，从而得到透射照明。
在某些实施例中，器件可与各种角度视野的内窥镜连接或一起使用，以用于观察上颌孔口。
在阅读下面更全面描述的器件、方法和体系的细节时，本发明的这些及其他的优点和特征对本领域的技术人员将变得显而易见。
附图说明
图1为正在根据现有技术通过用于基于导管鼻窦手术的现有技术体系治疗的患者的图示。
图2a为示出导丝在回缩位置的根据本发明的鼻窦口探示器的侧正视图。
图2b为示出导丝在伸长位置的图3a的鼻窦口探示器的侧正视图。
图3a和图3b为示出定位左上颌窦口并调配导丝的图2a和图2b的鼻窦口探示器的荧光图像(A-P取向)。
图4a至图4c为示出定位左额窦口并调配导丝的鼻窦口探示器的另一个实施例的荧光图像(A-P取向)。
图5a为示出导丝在回缩位置的根据本发明的鼻窦口探示器的另一个实施例的透视图。
图5b为示出导丝在伸长位置的图4a的鼻窦口探示器的透视图。
图5c为图4a和图4b的鼻窦口探示器沿A-A线截取的横截面图。
图6为根据本发明的鼻窦口探示器的另一个实施例的透视图。
图7为根据本发明的鼻窦口探示器的另一个实施例的远端部分的透视图。
图8a为示出导丝在部分分离位置的根据本发明的鼻窦口探示器的另一个实施例的透视图。
图8b为根据本发明的鼻窦口探示器的另一个实施例的远端部分的透视图。
图9为本发明的鼻窦口探示器的另一个实施例的局部透视图。
图10a为示出没有导丝的情况下本发明另一个实施例的远端部分的前正视图。
图10b为示出导丝设置在内部纵向槽内的图10a的远端部分沿B-B线截取的纵切面视图。
图10c示出图10b的远端部分，导丝从内部纵向槽部分移除。
图11a为示出没有导丝情况下根据本发明的鼻窦口探示器的另一个实施例的远端部分的透视图。
图11b为图11a的远端部分沿C-C线的横截面图。
图12a为示出没有导丝情况下根据本发明的鼻窦口探示器设备的另一个实施例的远端部分的横截面图。
图12b示出具有导丝的图12b的远端部分。
图12c示出包括润滑剂的图12b的远端部分。
图13为示出本发明方法的一个实施例的流程图。
图14为邻近上颌窦的解剖结构的横截面图。
图15为示出将导件、导丝和囊导管用于处理上颌窦的横截面图。
图16为具有扩张器的探针器件的一个实施例的侧视图。
图17a-d为示出用图16的器件处理上颌窦的横截面图。
图18a-c为示出在成型的轴柄上使用探针的局部横截面图。
图19a-b为具有扩张器的探针器件的另一个方法的透视图。
图20为探针器件的又一实施例的侧视图。
图21为探针器件另一个方法的透视图。
图22为探针器件又一方法的透视图。
图23为示出探针器件的另一个实施例的局部横截面图。
图24为示出探针器件的另一个替代实施例的局部横截面图。
图25为示出包括柄部组件细节的探针器件的透视图。
图26为示出具有探示器顶端的探针的局部横截面图。
图27为用于探针器件的柄部的透视图。
图28a-c示出使用图26的器件的方法中所涉及的步骤。
具体实施方式
本发明不限于所述的具体实施例，因为此类实施例当然可以有差别。另外应当了解，本文所用的术语只是为了描述具体实施例的目的，并非旨在进行限制，因为本发明的范围将仅由所附权利要求书来限定。
在提供数值范围的情况下，应当理解，除非上下文另外清楚决定，否则也明确公开了介于该范围上限和下限之间的每一个居间值，直至下限单位的十分之一。所述范围中任何所述值或居间值与所述范围中任何其它所述值或居间值之间的每一个较小范围涵盖在本发明内。这些较小范围的上限和下限可以独立地包括或不包括在范围中，并且每一个范围也涵盖在本发明内，所述每一个范围中的任一极限值、无一极限值或极限值两者均包括在较小范围中，具体情况受到所述范围中任何具体而言除外的极限值的限制。在所述范围包括极限值之一或极限值两者的情况下，排除这些包括的极限值中的任一者或两者的范围也包括在本发明中。
除非另有定义，否则本文所使用的所有技术术语和科学术语的含义与本发明所属领域的普通技术人员通常理解的含义相同。尽管类似于或等同于本文所述那些的任何方法和材料都可用于本发明的操作或试验，但现在描述的是优选的方法和材料。本文提及的所有专利公开都以引用的方式并入本文，以结合引用的专利公开来公开和描述该方法和/或材料。
应该注意的是，除非上下文清楚决定不是这样，否则本文和所附权利要求中所用的单数形式“一个”和“所述”包括复数指代。因此，例如提及的“管”包括多个此类管，并且提及的“轴”包括提及一个或多个轴及其本领域普通技术人员已知的等同物，等等。
本专利申请提交日之前，仅提供本文所讨论的专利公开，以用于其公开。本文的任何内容不应被理解为承认本发明没有资格依靠现有发明而先于这种专利公开。另外，所提供的专利公开日期可能不同于实际公开日期，实际公开日期可能需要单独证实。
现转到图1，该图示出正在根据现有技术通过用于基于导管的微创鼻窦手术的体系治疗的患者的图示。C型臂荧光镜1000可用于显像导向导管1002、导丝1002和工作器件1006(如囊导管、其他扩张导管、清创器、切割器等)。导向导管1002可以在直接目测、通过荧光镜1000提供的显像下和/或从内窥镜显像下引入，以将导管1002的远端放置在与待治疗的鼻窦口相连的部位处。导丝1004随后穿过导管1002插入，并前进以将导丝1004的远端延伸到待治疗的孔口。正确的放置常常涉及导丝1004远端的前进和回缩，直到已目测确认导丝正确定位。工作器件1006接着经过导丝1004到达将进行外科手术的目标部位。进行外科手术之后，工作器件1006停用并从患者中收回，在此之后，导丝1004和导向导管1002被收回以完成手术。
现在参见图2a和图2b，该图示出根据本发明的鼻窦口探测器、探示器或定位器器件10。本发明的鼻窦探示器10包括具有近端12、远端14和弯曲部分或区域16的轴或主体11。轴11和弯曲部分16限定细长的管状形状，并在延伸穿过轴11和弯曲区域16到达远端14的内部通道或腔体(未示出)内支承导丝18(图2b)。弯曲区域16可以邻近远端14或通过轴或主体11的直的或非弯曲部分与远端14分离。导丝18可通过远端14从轴11伸长和回缩。导丝18上的探针顶端20被构型以用于定位目标孔口。图2a中示出的导丝18在回缩位置中，其中探针顶端20邻近或靠近远端14；图2b中示出的导丝18在伸长位置中，其中探针顶端20远离远端14设置。近端12可以接合到柄部(未示出)。可以通过对导丝18施加适当的力来控制导丝18的伸长和回缩。
轴11和弯曲部分16示出为图2a和图2b实施例中单个零件或单元的集成部分。在某些实施例中，轴11和弯曲部分16可以包括接合在一起的单独元件。所示的弯曲部分16限定大约90度或略大于90度的角度。此角度可以根据需要针对本发明不同用途而变化。优选地，弯曲部分限定介于约0度和约180度之间的角度，且更优选地限定介于约0度与约120度之间的角度，并提供在0度、30度、70度、90度和110度处的若干迭代或根据需要来适应具体的鼻窦手术操作。
弯曲部分16可以从轴11的其余拆卸并可互换以允许曲率的变化。许多实施例中的弯曲部分16和/或主体11为有回弹力的，以有利于定位在患者的鼻旁腔内。在某些实施例中，弯曲部分16和轴11为延展性或弯曲性的。在另外其它的实施例中，弯曲部分16为有回弹力或延展性的，并且轴11实质上为大体刚性的。
探针顶端20被构造并被构型为有利于目标孔口的定位。在许多实施例中，探针顶端20的形状是球形或长方形，但可以根据需要针对本发明的不同用途而变化。探针顶端20和远端14被构造并被构型，从而得到无创伤表面，以将对患者鼻旁腔的创伤或损害降到最低。探针顶端20可以从导丝18拆卸并可互换，以使得不同尺寸和/或形状的探针顶端20可以用于不同鼻窦口的位置。
导丝18可以通过手动、电动或气动机构(未示出)(诸如滑块、可旋转曲柄、绞盘器件、卷轴组件等)来人工伸长或回缩。在某些实施例中，导丝18的延伸和回缩可以通过与导丝18机械连接的电动或气动马达(未示出)来实现。在许多实施例中，导丝18为有回弹力的或柔性的，以允许使用者将探针顶端20易于定位到所需的位置。在某些实施例中，导丝18可以为弯曲性或延展性的，而不是有回弹力的。
在本文所述的若干实施例中，本发明的轴11、弯曲部分16、探针顶端20、导丝18以及元件可以由各种金属或金属合金、或聚合物材料(诸如工程树脂、或其复合材料或这类材料的各种组合)制成。优选地，生物相容性材料或生物相容性材料的涂层被用于轴11、弯曲部分16、探针顶端20和导丝18，以将对接触鼻窦探测器10鼻旁腔组织的创伤最小化。在许多实施例中，轴11和弯曲部分16是单个元件的集成部分。轴11和/或弯曲部分16可以为延展性的，如上所述，使得弯曲部分16的角度可通过弯折而调节，以适应具体用途。在许多实施例中，本发明的轴11、弯曲部分16、探针顶端20和导丝18以及其他元件由可高温高压消毒或换句话讲可灭菌的材料制成，以使得设备10或各个元件可以再利用。在某些实施例中，轴11、弯曲部分16、探针顶端20和导丝18可以由低成本、一次性的材料制成。
在图3a和图3b中，通过荧光镜示出鼻窦口探示器10正用于定位左上颌窦口O1。鼻窦口探示器的主体或轴11被设置在患者的鼻旁腔P内，并且导丝18(图3b)从主体11延伸以定位孔口O1。如上所述，导丝18为有回弹力或延展性的，并可以承受较大角度范围内的挠曲或弯折。如图3b所示，导丝18邻近探针顶端20的部分与导丝18邻近远端14的部分大约平行，表明导丝18在介于远端14和探针顶端20之间的屈曲角度为大约180度。一旦导丝18已设置到上颌窦腔O1中，轴11和弯曲部分16就可以从患者鼻旁腔P移除或收回，同时留下导丝18，从而允许其他工作器件(未示出)沿着导丝18然后进入目标鼻窦中。在某些实施例中，鼻窦口探示器10可以包括轴11上的不透射线标记(未示出)、弯曲部分16、探针顶端20和/或导丝18，以有利于探示器10的荧光镜显像并有助于探示器11在患者鼻腔通道P内的导引。例如，不透射线标记可以包括显示尺寸或距离的梯度标记和标识梯度标记的数字标记。
现在参见图4a至图4c，该图示出根据本发明的另一个实施例的鼻窦口探示器21，图中相同的附图标记用于代表相同的零件。通过荧光镜示出鼻窦口探示器21正用于定位左额窦口O2。在图4a至图4c的实施例中，鼻窦口探示器21的弯曲区域16限定大约150度曲率的角度。比较而言，图3a和图3b的鼻窦口探示器10具有限定大约110度角的弯曲区域16。在其他方面，鼻窦口探示器21与鼻窦口探示器10相同。
在图4a中，示出鼻窦口探示器21插入鼻旁腔P中，导丝(未示出)在完全回缩位置，使得探针顶端20邻近远端14而设置。在图4b中，示出导丝18从远端14部分延伸。在图4c中，导丝更完全地延伸，使得在导丝18末端的探针顶端20能够定位孔口O2。
图5a、图5b和图5c示出根据本发明的鼻窦探测器或探示器22的又一实施例，图中相同的附图标记用于代表相同的零件。鼻窦探测器22包括分别具有远端部分26和近端部分28的柄部24(仅示出近端部分28的部分)。在图5a-5c的实施例中，柄部24为细长圆柱形构型，并被构型为允许使用者手动调节鼻旁腔内的轴11和弯曲部分16的位置。柄部24使用内螺纹(未示出)、按扣配合或其他适合的附接元件而在接头30处接合到主体或轴11的近端12，并可以从轴11拆卸且可互换。作为另外一种选择，柄部24可以与轴11一体制成。弯曲部分16使用内螺纹(未示出)、按扣配合或其他适合的附接元件而在接合点32处接合到主体或轴11，并如上所述可以从轴11拆卸。作为另外一种选择，弯曲部分16可以与轴11一体制成。
内部开口或通道34纵向延伸穿过柄部24、轴11和弯曲部分16，通道34被构型成以可滑动或可移动的方式容纳导丝18。通常，根据与本发明一起使用的导丝18的尺寸，纵向槽34的内径范围是从约0.5mm至约5mm，且更优选地从约1mm至约3mm。
更具体地参见图5c，鼻窦探测器22的弯曲部分16还可以包括柔性或有回弹力的外护套36和护套36内的内部元件38。在图5c的实施例中，外护套36为圆形横截面形状，而内部元件38为“U”形或“C”形横截面形状，使得纵向槽34和导丝18定位在部分或末端40、42之间。内部元件38可以从护套36移除并可互换。内部元件38可以为比护套36具有更高弹性模量的材料，使得内部元件38的大致曲线形状和挠性性质被赋予到弯曲部分16。可以选择内部元件38的材料，以用于所需的挠性或延展性能。在许多实施例中，内部元件也可以延伸穿过轴11、或通过轴11和柄部。在某些实施例中，外护套36可以包括比内部元件38具有更高弹性模量的材料，使得弯曲区域的形状和挠性性能衍生自护套36而非内部元件38。在许多实施例中，内部元件38也可以延伸穿过轴11、或通过轴11和柄部24。
现在参见图6，该图示出根据本发明的鼻窦口探示器或探测器44的另一个实施例，图中相同的附图标记用于代表相同的零件。鼻窦探测器44的柄部24为细长圆柱形形状，并包括与内部通道34连通的纵向狭槽46。旋钮或致动器元件48以可滑动的方式安装在狭槽46内。旋钮48机械连接到导丝18，使得当致动器48邻近狭槽46的远端设置时，旋钮朝柄部24的远端26的移动使导丝18和探针顶端20从远端14前进，如图6所示。致动器48滑动到狭槽46的近端导致导丝18和探针顶端20对应的回缩，如虚线所示。
接着参见图7，该图示出根据本发明的鼻窦口探示器50的另一个实施例的一部分。鼻窦探测器50包括大致管状形状的外护套52和设置在外护套52内的内护套54。内护套54也为大致管状形状。纵向槽34延伸穿过内护套54，并被构造并被构型为以可滑动的方式容纳导丝18。在图7的实施例中，纵向槽34为大致圆形横截面形状。
外护套52可以沿着包括弯曲区域(未示出)在内的轴11的一部分、或整个长度延伸。内护套54可以同样沿着弯曲部分和轴的一部分、或整个长度延伸。内护套54可以相对于外护套52以可滑动的方式伸长和回缩，使得在延伸期间，内护套54的远端56移动离开外护套的远端58，并在回缩期间，内护套54的远端56接近外护套52的远端58。内护套54相对于外护套52的伸长和回缩可以由致动器旋钮(诸如图6中的旋钮48)来控制。
内护套54可以为比外护套52具有更高弹性模量的材料，使得内护套的形状和机械性能被赋予到鼻窦探测器50的弯曲部分和/或轴(未示出)。在其他实施例中，外护套52可以包括比内护套具有更高弹性模量的材料。可以根据本发明的所需用途来选择内护套52和/或外护套的材料的具体挠性或延展性质。
图8a示出鼻窦探测器60的又一实施例，其中相同的附图标记代表相同的零件。鼻窦探测器60的远端14包括与内部纵向槽34连通的纵向狭槽62。狭槽62可以沿着弯曲区域16和轴11的全部或部分的长度延伸。旋钮48以上述方式致动允许导丝18相对于远端14前进或回缩。图8a示出邻近柄部24的近端28设置的旋钮48，与用于导丝18的回缩位置对应。
狭槽62允许导丝18穿过狭槽62从通道34移除以及通过延伸从远端14移除。就这一点而言，曲线部16可以由弹性材料制成，使得导丝18在正常情况下保留在通道34内，但可在对导丝18施加横向力时“快速脱离”狭槽62，以从通道34脱离。如图8a所示，导丝18从通道34和狭槽62部分脱离。由鼻窦探测器60提供的让导丝18穿过狭槽62脱离有利于导丝18和探针顶端20的移除和互换，并有利于轴11、弯曲部分16和远端14从目标鼻窦或鼻旁腔的邻近区域移除，而让导丝18和探针顶端20留在适当的位置。工作器件(未示出)随后可以沿着导丝18导向到目标鼻窦，以进行外科手术。
在图8a的实施例中，轴11可相对于柄部24伸长和回缩。套管或套环64支承轴11，并可以使用螺丝或螺纹零件(未示出)张紧，以将轴固定在适当的位置。套环64旋松允许轴11从套环64和柄部24伸长或回缩，以向鼻窦探测器60提供不同的长度和构型。一旦轴11已通过从柄部24伸长或回缩而调节到所需长度，套环64就可以张紧，以保持轴11的调节的位置。
图8b示出根据本发明的鼻窦口探示器68的另一个实施例的远侧部分。设备68包括大致圆柱形或管状形状的外护套70以及设置在外护套70内的大致圆柱形或管状形状的内护套72。纵向槽34延伸穿过内护套72，并被构造和构型用于以可滑动的方式容纳导丝18。在图8b的实施例中，纵向槽34为大致圆形横截面形状。
纵向狭槽74延伸穿过内护套72，并与纵向槽34连通。狭槽74允许在对导丝18施加横向力时导丝18从通道34以横向方向移除导丝18。外护套70还可以包括纵向狭槽76，纵向狭槽76延伸穿过外护套72以与纵向狭槽74连通，并因此与纵向槽34连通。因此，可以在对导丝18施加适当的横向力时经由狭槽74、72从内护套72、外护套70横向移除导丝18。
在图8b的实施例中，纵向狭槽74、76被对齐，以使得狭槽74、76均与内部通道34连通，以允许导丝18从通道插入和释放。在某些实施例中，内护套72和外护套70之一或两者可以沿着轴的纵轴A和设备68的弯曲区域(未示出)相对于彼此为可旋转的。内护套72、外护套70或这两者均可以机械连接到设备68的柄部(未示出)上的旋转调节机构，以使得可旋转地调节护套70和/或护套72的旋转位置，以控制狭槽74、76的对齐。因此，当护套70、72之一相对于另一者旋转时，狭槽74、76可以移动出对齐位置，以使得导丝18不能穿过狭槽74、76移除，或可以如图8b所示对齐，以使得导丝18可穿过狭槽74、76从通道34移除。
外护套70可以沿着鼻窦探测器设备68的弯曲部分和轴(未在图8b中示出)的一部分、或整个长度延伸。内护套72可以相似地沿着弯曲部分和轴的一部分、或整个长度延伸。内护套72可以相对于外护套70以可滑动的方式伸长和回缩，在延伸期间，内护套72的远端78从外护套70的远端80移出，而在延伸期间，远端78朝远端80移动。
图9示出根据本发明的鼻窦口探测器82的又一实施例，其中相同的附图标记代表相同的零件。设备82包括从远端14延伸到柄部24的远端26的纵向狭槽84。纵向狭槽84与延伸穿过柄部24、轴11和弯曲区域16到达远端14的纵向槽34连通。狭槽84包括横向弯曲区域86，使得邻近柄部远端26的狭槽84的末端88相对于轴11和弯曲区域16具有与邻近远端14的狭槽84的末端90不同的角取向(相对于穿过轴11的中心轴)，使得狭槽84随着其从其远端遍历到其近端而相对于轴11“扭转”。因此，在图9中，狭槽84邻近狭槽末端88的部分相对于由轴11和弯曲部分16限定的纵轴(未示出)从狭槽84邻近末端90的部分旋转。狭槽84的横向弯曲区域86有利于导丝18插入内部纵向槽34中和从内部纵向槽34移除导丝18。
现在参见图10a至图10c，该图示出根据本发明的鼻窦口探示器92的另一个实施例的远侧部分，图中相同的附图标记用于代表相同的零件。设备92包括从远端14在整个弯曲部分16上纵向延伸到轴11的开口94。开口94与内部纵向槽34连通。开口94被构造并被构型为允许使用者利用手指、镊子或其他抓握工具(未示出)穿过开口94来抓住导丝18。开口94有利于将导丝18从通道34和设备92移除。这样，导丝的近端(未示出)可加载到轴11的远端14中，其中尽管有弯曲顶端的锐弯角，但弯头中的切口94有助于将导丝的刚性近端穿入导向导管的主体中。因此，导丝在加载期间不会太急剧弯曲。一旦加载，体系就如图10B所示地被构型。在体系被用以将导丝的顶端放置到鼻窦中后，导向导管可拉回离开导丝的近端。
图11a和图11b示出根据本发明的鼻窦口探示器96的另一个实施例的远侧部分，图中相同的附图标记用于代表相同的零件。设备96包括通过粘合剂、热焊接或其他粘结部件沿着接缝102、104接合在一起的细长后部98和细长前部100。后部98和前部100一起限定管状形状，使后部98和前部100之间具有管状横截面形状的内部通道34。后部98和前部100沿着弯曲区域16和轴(未示出)从远端14延伸，并一起限定设备96的弯曲区域16和轴(未示出)。前部100中的纵向狭槽106与内部通道34连通。在图11a和图11b的实施例中，后部98和前部100的横截面形状各为半圆形，并将圆形横截面形状赋予内部通道34。
在许多实施例中，后部98由刚性或大体刚性的弹性模量较高的材料制成，而前部100包括弹性模量较低的弹性材料。前部100的弹性性质允许导丝(未示出)穿过末端108、110(图11b)之间的狭槽106而“按扣配合”。由此可通过对前部100施加适当的力以迫使或移动导丝穿过狭槽106，使导丝易于插入通道34中或从通道34移除。在某些实施例中，前部和后部均可以包含挠性材料。
图12a至图12c提供根据本发明的又一鼻窦口探示器112的一部分的横截面图，图中相同的数字用于代表相同的零件。设备112包括外护套114和设置在外护套114内的内段或内部116。护套114为细长管状构型，并限定纵向延伸穿过设备112的弯曲区域和轴(未示出)的内部通道34。内段116装配在通道34内，并沿着轴和弯曲区域的全部或一部分延伸。狭槽118沿着护套114纵向延伸，并与内部通道34连通。在图12a至图12c所示的实施例中，护套114为圆形横截面形状，且内段116为弓形或半圆形横截面形状，使得内段116的横截面形状适应于护套114的横截面形状。导丝18(图12b和图12c)装配在通道34内。
护套114由弹性材料制成，使得导丝18可被迫在末端或部分120、122之间穿过狭槽188并进入通道34中。导丝18随后保留在通道34内，直到适当的力施加到导丝，以使导丝穿过末端120、122之间的狭槽118并穿出通道34。在许多实施例中，内段116由刚性或大体刚性的材料或比护套114具有更高弹性模量的材料制成。
生物相容性低摩擦系数材料(诸如TEFLONTM)的涂层124(图12c)可以包括在导丝18上，以有利于导丝18在通道34内的滑动运动并减少或最小化可能对患者鼻旁腔的创伤。润滑油或凝胶126(图12c)可以包括在通道34内，以有利于导丝34在通道34内的移动。
通过结合图13的流程图以及图2-图12，将更全面地理解本发明的方法。下述事件的序列可以有差别，且不应视为限制性的。并非所有描述的事件都可以在本发明的具体用途中进行，且在某些实施例中，可以进行图13未中示出的另外事件。
在事件200中，本发明鼻窦口探示器的轴11被插入患者的鼻旁腔中。如图3和图4所示，该事件通过将远端14插入、然后将弯曲区域16和轴11插入鼻旁腔P中而进行。可以由外科医生或其他医护人员进行插入，并可以通过荧光镜和/或内窥镜监视、或可以在没有显像工具的情况下进行插入。
在事件210中，调节远端14的位置。在许多实施例中，手动进行调节，从而通过柄部24的适当手动定位来定位远端14。在许多实施例中，远端14的定位通过荧光镜来监视，以使得远端14以及轴11和弯曲区域14可以显现。应当认识到，作为另外一种选择，此类定位可只通过内窥镜显像来显现。在下面的事件中，远端14位置的调节以定位目标鼻窦口为目标而进行。在某些实施例中，不透射线标记或由视觉对比色提供的标记可以包括在远端14、轴11和/或弯曲区域16上，以有助于定位目标孔口。
在事件220中，通过从远端14延伸导丝18来调节导丝18和探针顶端11的位置，直到探针顶端20接近或到达目标孔口。导丝18和探针顶端20的定位通常通过荧光镜监视，以使得探针顶端20相对于目标孔口的位置可以显现。在某些实施例中，不透射线和透射线的标记可以包括在探针顶端20和/或导丝20上，以有助于定位目标孔口。
在事件230中，测定目标孔口是否已定位。通过目测诸如通过内窥镜、荧光镜或使用发光透射照明来观察探针顶端20相对于目标孔口的位置或定位来进行测定。在许多实施例中，探针顶端20被选定具有匹配目标孔口直径的直径，并且目标孔口的位置通过将探针顶端20刚好配合到目标孔口中来确定。如果目标孔口已定位，则进行事件240。
如果在事件230中确定目标孔口尚未定位，则可以通过再次调节导丝18和探针顶端20的位置来重复事件220。这可以通过以下方法进行：将导丝18朝远端14回缩，然后从远端14再延伸导丝18，以调节导丝18和探针顶端20的位置，并将探针顶端20朝目标孔口导向。
在事件230中已确定目标孔口尚未定位的某些情形下，事件210和220均重复。因此，导丝18回缩，远端14的位置或取向通过手动定位鼻窦口探示器设备来调节，然后导丝18再次前进，以调节导丝18和探针顶端20的位置。
在事件230中已确定目标孔口尚未定位的另外情形下，事件200至220可以重复。在此类情形下，导丝18将回缩，并且鼻窦口探示器将从鼻旁腔收回。然后，更合适构型的不同鼻窦口探示器将重新插入鼻旁腔中，并且事件210至230被重复。作为另外一种选择，探针顶端20可以从导丝移除，并且不同尺寸或形状的探针顶端20可以引入到导丝，之后事件210至230被重复。
在事件240中，轴11(包括弯曲区域16和远端14)从鼻旁腔移除，而让导丝18和探针顶端20留在其调节的适当位置中。在其中轴11包括狭槽的本发明实施例中，导丝18可以在从轴11移除之前与狭槽脱离。
在事件250中，外科手术或工作器件沿着导丝18引入，并沿着导丝18朝目标孔口导向。例如，此类器件可以包括导管、套管、管、扩张器、囊、物质注射器、针、穿透器、切割器、清创器、微清创器、止血器件、电烙器件、冷冻手术器件、加热器、冷却器、观察镜、内窥镜、光导、光疗器件、钻、锉刀、锯等等。
在事件260中，使用在事件250中引入的工作器件来进行外科手术或其他手术。
在事件270中，工作器件和导丝从鼻旁腔收回。
现在参见图14和图15，在相关方法中，各种实施例可以为扩张和/或重塑鼻窦腔和/或通向孔口的过渡空间作准备。具体地讲，下面所述的器件、体系和方法涉及重塑上颌窦口和/或通向上颌孔口的过渡空间。在可供选择的实施例中，其他鼻旁窦的孔口和/或过渡空间可以被扩张。扩张或重塑过渡空间会意味着扩张孔口附近的总体解剖区域和/或移动在该总体解剖区域中的一个或多个解剖结构。在一些情况下，此类扩张或重塑可以有利于或促进空气、粘液和/或其他物质流入和/或流出上颌窦。
结合图14，在上颌窦外部的鼻腔/鼻旁腔具有包括称为漏斗I、钩状突U、筛泡B、中鼻甲骨MT和中鼻道的解剖结构及空间且由其形成的过渡空间。在各种实施例中，这些结构中的任何者都可以移动和/或这些区域中的任何者都可以扩张。
现在参见图15，类似于鼻旁腔和鼻窦本身的解剖结构，上颌窦过渡空间的解剖结构由骨和粘膜组成。可以设想用柔性和刚性器械来移除过渡空间中的阻塞物。如图15所示，一个柔性的实施例可以涉及囊导管300。可以使用导件302和导丝304进入该区域，并且囊导管300可以被设置在过渡空间中并被填充。然而，该方法需要协调使用若干器件。该方法还可以需要多个导件302来适当地定位囊300。
现在参见图16，简化的探针器件310可包括从柄部314延伸的延展性或半刚性区域312。探针顶端316可为弯曲的，并设想为包括诸如囊之类的扩张器318。柄部314的近端装备锁紧接口320，以用于接受可操作用于扩展扩张器318的填充器件。在此构型中，可以调节探针顶端316的弯曲，以优化钩突后面和通向上颌窦的过渡空间中的通路。当附接填充器件(未示出)时，囊可被填充，从而产生过渡区域中的空间以及扩张上颌窦口。该器件可以在直视、荧光镜和/或图像导引下用作单手器械。导件和导丝可以适于与其一起使用，但可能不是必要的。
探针器件310的囊扩张器318可以具有各种属性和构型。例如，囊318可以为非适形、半适形或适形的。另外，可能有一个或若干囊，并且囊可以为同心或不同心的。此外，设想的囊318可以具有多种直径和长度、多种锥形几何形状，并且它可以在探针远侧顶端处或其之前终止，或延伸超过探针。囊318也可以具有改进的摩擦性能，以释放或获得在解剖结构上的牵引，诸如防滑面。在各种实施例中，囊318可以具有圆形或非圆形横截面几何形状，以有助于重新包裹和分布。
在一个设想的方法中，如图17a-d所示，囊318可以为不同心的，并且可以取向，以在探针310的弯曲部316的外部填充。囊318可以相对较长，从而从中间轴320延伸至超过探针顶端316。当填充时，囊318不会推动钩突U。然而，囊可被构型为在中间推动中鼻甲骨MT并在后推动筛泡B，从而打开过渡空间(见图17c和图17d)。囊318也可以延伸超过探针顶端316，以确保漏斗已被重塑并对中鼻甲骨MT施加中间力。
又如，同心且相对较短的囊(未示出)可以在前推动钩突U，并会对筛泡B产生一定的在后冲击。对中鼻甲骨MT不一定有冲击。在可供选择的实施例中，相同或类似器件可以用来移除或减少额窦和蝶窦过渡空间中的阻塞。当与观察器件结合使用时，内科医生可以能够打开用于上颌窦的过渡空间，并目测确认孔口是打开还是关闭的。如果孔口是关闭的，则外科医生会选择使用传统鼻窦道整形器件或其他方法。如果孔口是打开的，则移除过渡空间中的阻塞可能是足够的治疗。
如图18a-c所示，该图示出用于扩张漏斗、筛泡、和/或中鼻甲骨、以及上颌孔口的另一个探针器件330。具体地讲，探针器件330被构型为通过触感首先进入上颌孔口。其次，构件前进穿过上颌孔口，然后用来扩张该区域中的解剖结构。这里，探针器件300包括构型有球形顶端334的囊332。器件330还被构型为接纳内腔338内的成型的轴柄336。
如图18b所示，囊部分332在轴柄336上前进，轴柄336横向地引导囊332。通过使用该结构，囊332穿过上颌孔口O。然后，囊332被扩张，因此在中间推动中鼻甲骨MT并在后推动筛泡B。扩张也打开孔口O和漏斗，然而在前推动钩突。在没有使用导丝的情况下，轴柄336使得探针器件330能够经受用来扩展囊332的扩张压力。
内腔338或探针器件330被构型为允许在没有纽结的情况下在轴柄336上回缩。轴柄336本身可为回火的或延展性的弹簧。轴柄336也可以具有短盘卷或软顶端，以减少囊回缩期间的内构件的纽结。轴柄336还可以由应当与填充时囊336的几何形状适形的形状记忆合金构造。这也可以有助于减少内腔338上的应力以及囊回缩期间的纽结。
在可供选择的实施例中，探针器件320可以改进，以通过使用大体直线或不太急剧弯曲的轴柄分别应对蝶骨或额部鼻旁窦。在一些实施例中，可选护套(未示出)可以整合到探针的轴上，以在扩张和放气后有助于重新包裹囊并因此减小囊的总体外形。
在一些实施例中，探针器件320有利于利用触感和囊前进来确认孔口进入。这在将器件用于上颌窦和蝶窦和/或其过渡区域时通常是期望的，但其可能不如在额窦中工作良好。若干另外的确认手段也可以是适合的。例如，流体可以流动通过探针器件336的管腔。如果在鼻腔中通过荧光镜看见流体，则可认为器件尚未进入鼻窦。作为另外一种选择，可以将光纤添加到器件的顶端，以透射照明鼻窦。这种光纤和透射照明的添加可以用于上颌窦、蝶窦或额窦中。
在另一个实施例中，图像导引传感器可以固定到探针器件320的顶端并用电磁体系跟踪。这将为鼻窦中的每一个提供确认。荧光镜还可用来确认进入。同样，如果器件320的顶端已进入目标鼻窦，则可沿着探针器件320的中心传递柔性纤维镜，以显像该区域。
现在参见图19a和图19b，该图示出探针器件350的可供选择的方法。器件350包括端接有钩状钩354的刚性或延展性轴构件352。囊356被构型在钩354周围，从而得到旨在维持钩周围进入转向的支承形状。扩张时，囊356形成C状形状，并且在介入部位处的解剖结构被移动。例如，当放置到鼻窦中时，器件350的末端358打开漏斗，邻近末端358的区域360打开在前囊空间，中段362打开中鼻道，且囊的最近侧部分364移动中鼻甲骨。因此，器件350可极大程度地且均匀地打开鼻道和漏斗，以使得更易于随后进入额窦、上颌窦或筛窦。
在相关器件370中，并且现在结合图20，囊部分372离心定位在钩部分374上。钩部分374可为刚性或延展性的。轴376邻近囊部分372被构型，并且器件370还可包括延伸到器件末端的管376，管376包括用于导丝(未示出)的出口。
探针器件的另外其他方法在图21和图22中示出。在一个实施例中，如图21所示，探针器件380可包括轴382，弯曲中鼻道/上颌囊384附接到轴382上。囊384包括形成上颌区域386的远侧部分和限定中鼻道区域388的近侧部分。囊384被构型成具有内置式弯曲，以绕患者的钩突转动。
在另一个实施例中，如图22所示，探针器件390可以包括轴396和具有上颌区域392的囊391，上颌区域包括在鼻窦区域394远侧且在鼻窦区域394弯曲附近构型的增大的直径。在这一实施例或前一实施例中，囊391的上颌区域392和鼻道区域394可以由不同囊材料形成，使(例如)上颌区域392更为适形。两个区域392、394还可包括不同形状，诸如限定狗骨构型的上颌侧。这样，使用探针器件380、390实现了上颌区域和中鼻道区域两者的同时扩张，同时保护钩突不受创伤。另外，这些器件的鼻道囊区域388、394可起作用以锚定上颌囊区域386、392预防突然移动。
现在参见图23，在另一个实施例中，过渡空间扩张工具400可以包括附接在半刚性、刚性或延展性轴404远侧部分附近的囊402。轴404的远端可装备球状无创伤顶端406。囊402可被球-轴交界面408机械捕获，由此使囊402的颈部区域最小化。此外，轴404可以包括用于扩展囊402的可膨胀管腔出口410，其可以预成型为吊钩。还可以包括填充插孔411，从而得到扩张手段。
该探针器件400的囊402通常包括三个区域：漏斗囊区域412、筛泡囊区域414、和中鼻道囊区域416。漏斗区域412被构型为扩张漏斗过渡空间，筛泡区域414压紧筛泡，以为观察镜或其他器件腾出空间，并且中鼻道区域416打开鼻道空间，以减轻来自后续器件插入的潜在创伤。每一个区域可以具有不同直径或厚度，并可限定无数的形状、角度和弯曲。另外，轴404可为单腔或多腔的，并且囊可为适形、半适形或非适形的。
现在结合图24，漏斗鼻道或凹口过渡空间扩张器420可以包括具有球状顶端424的轴422和被囊426围绕的弯曲远侧部分。填充开口428设置在被囊426围绕的轴422区域中，并且要注意的是，球状顶端424被囊426包封。囊426还包括中鼻甲骨区域430、筛泡区域432和漏斗区域434。囊可用闭端模制，或可传统地模制，然后顶端模制完成并关闭。如前所述，囊材料可为非弹性、局部弹性、适形、非适形或局部适形的。
在又一方法中，并且现在结合图25，探针器件440包括分开的内部元件442，内部元件442可前进和回缩以给予触觉反馈来找到上颌孔口。一旦已发现上颌孔口，使用者就可独立地使囊部分444前进经过海波管部分446。内部元件442可为线材或一些其他挠性元件，线材或一些其他挠性元件可延伸出成型的海波管446到达用于鼻窦的探针。在某些方法中，内部元件442可为缠绕在镍钛诺芯上的线材、实心柔性线材或塑料构件、轻质线材、或其他挠性元件。成型的海波管446可由具有弯曲以引导内部挠性构件442和外部囊444的钢管或塑料管形成。在各种实施例中，针对具体鼻窦，管可为预成型的或延展性的，以允许使用者针对目标轨线定形器件。
囊444构型在成型的海波管446的外部附近，并可独立于内部元件442而前进。囊轴448设置有一个或两个管腔，以允许囊444前进并用于填充。轴448可以延伸经过海波管弯曲446周围或可邻近弯曲开始。还提供囊推杆450来将力从囊驱动器452平移到囊444。此结构还可以充当流体的歧管，以用于囊的填充/增压。
探针柄部454可成型以形成细长结构，并且可为细长的，以便于握持和控制。柄部454还可包括用于通过牵引有助于握持或推进元件的指状抓取器。柄部454也包括在柄部454内滑动并允许使用者控制推进/拉回内部元件422以及从内部元件442接纳触觉反馈的内部元件控制器455。柄部也包括在柄部454内滑动并允许使用者推进/拉回囊的囊驱动器456。还提供导轨457以用于引导内部控制元件455和将囊驱动器连接到囊推杆的推杆(未示出)的移动。在各种可供选择的实施例中，如果导轨为管，则囊填充流体可以穿过导轨457之一或两者，或作为另外一种选择，探针器件440可以包括一个或多个用于将流体/压力递送到囊的分开的膨胀管腔。
在某些实施例中，当尝试用包括成型轴柄的探针器件进入上颌窦开口时，让具有非常紧凑半径的轴柄将顶端的探测末端送到正确位置中会是可用的。让起始顶端长度本身相对较短也可以是可用的。顶端可能需要在前部具有更精细的选择末端。如果囊导管管腔本身太大、太笨重和/或太硬，则当囊导管前进时可从孔口旁边通过而不进入开口，这是因为开口可更像壁侧中的孔，且不一定在漏斗袋的末端处。另外，即使顶端确实暂时接合孔口，囊导管的硬度也会将其压倒，并且一旦囊尝试前进，囊就不会进入开口。因此，在一些实施例中，可以使用支承囊硬度过渡到开口中的更柔性的引入段。
现在参见图26，图中描述了在存在解剖结构时让短小有角顶端选择侧孔孔口的探针器件460。该器件包括也具有允许向前前进到孔口中以支承过渡到较硬囊的良好柱强度的松软引入导管段。可提供镍钛诺超弹性轴柄来形成非常紧凑的初始半径，该初始半径随松软引入导管前进而维持其形状，但随较硬囊前进而展开其形状。
如图所示，探针器件460包括探示器顶端462，探示器顶端是可成型的，或可固定或朝外取向的，以找到“壁”或漏斗中的开口。顶端462可由聚合物制成，或可为针头。探针器件460也可包括由形状记忆超弹性弹簧钢或其他半刚性材料形成的轴柄464。这在只选择柔性导管时有助于保持角度非常紧凑。此外，探针器件460可以包括柔性探示器导管主体464，柔性探示器导管主体464像导丝一样用来跟在顶端462后面，并起到通过无阻力前进来确认进入鼻窦。
现在参见图27，在一个实施例中，用于探针器件460的柄部470可以包括可操作连接到囊部分474的拇指推杆472，以使得推杆472的操纵使囊474前进和/或回缩。柄部470还可以包括其尺寸和形状适于接纳操作者手指的稳定化下部结构473。
现在结合图28a-28c，在用于使用探针器件460方法的一个实施例中，探针器件460可以放置在预调配构型(图28a)中，使轴柄464加载在柔性导管主体466内。在中部调配(图28b)期间，轴柄464近侧地收回，但让其延伸超过囊部分474。接着，轴柄464还邻近囊474(图28c)收回，以实现完整的调配。囊474随后可扩展以产生空间或完成所需的组织操纵。
上面的描述常常集中在用于上颌鼻旁窦的器件、体系和方法的实施例。然而，在一些情况下，上述实施例可以用于涉及额窦、蝶窦和/或筛窦的手术中。在一些情况下，这些实施例可以如在这些其他鼻窦中所述地使用，而在其他情况下，可以对器件、体系或方法进行微量修改，以让其更顺从于在额窦、蝶窦或筛窦中使用。在任何情况下，上面与上颌窦中使用有关的描述不应解释为将本发明限制到仅在该鼻窦中的应用。
尽管已结合本发明的具体实施例描述了本发明，但在不脱离本发明真实精神和范围的前提下，可以进行各种改变并且可以替代等同形式。另外，可以进行许多修改来使具体环境、材料、物质组成、方法、工序适应本发明的目的、精神和范围。所有此类修改旨在落入本文所附权利要求书的范围内。

Claims (56)

1.一种鼻窦口探示器，包括：
轴，所述轴具有远端、近端、弯曲区域、和内部通道，所述弯曲区域位于所述远端与所述近端之间；
可伸长和可回缩的导丝，所述可伸长和可回缩的导丝活动安装在所述内部通道内；和
探针顶端，所述探针顶端接合到所述导丝。
2.根据权利要求1所述的鼻窦口探示器，其中所述导丝可在介于回缩位置与伸长位置之间可逆地活动，所述探针顶端在所述回缩位置中为邻近所述远端，所述探针顶端在所述伸长位置中与所述远端分离。
3.根据权利要求1所述的鼻窦口探示器，其中所述探针顶端为可拆卸并且可互换的。
4.根据权利要求1所述的鼻窦口探示器，还包括可膨胀式囊，所述可膨胀式囊与所述轴或所述导丝中的至少一个连接。
5.根据权利要求1所述的鼻窦口探示器，还包括柄部，所述柄部接合到所述轴的近端。
6.根据权利要求1所述的鼻窦口探示器，其中所述轴还包括外护套和内部元件，所述内部通道延伸穿过所述内部元件。
7.根据权利要求6所述的鼻窦口探示器，其中所述内部元件包括刚性材料，并且所述外护套包括弹性材料。
8.根据权利要求6所述的鼻窦口探示器，其中所述内部元件为可移除的并且可互换的。
9.根据权利要求1所述的鼻窦口探示器，还包括致动器元件，所述致动器元件机械连接到所述导丝。
10.根据权利要求1所述的鼻窦口探示器，还包括：
柄部，所述柄部与所述轴的近端连接；和
致动器元件，所述致动器元件位于所述柄部上并机械连接到所述导丝。
11.根据权利要求10所述的鼻窦口探示器，其中所述致动器元件为以可滑动的方式安装在所述柄部上的狭槽内。
12.根据权利要求10所述的鼻窦口探示器，其中所述轴还包括管状内护套和管状外护套，所述内护套设置在所述外护套内，所述内部通道延伸穿过所述内护套。
13.根据权利要求12所述的鼻窦口探示器，其中所述内护套相对于所述外护套为可伸长和可回缩的。
14.根据权利要求1所述的鼻窦口探示器，其中所述轴还包括与所述内部通道连通的狭槽，所述狭槽被构造并被构型为允许所述导丝穿过所述狭槽插入所述内部通道中以及从所述内部通道移除。
15.根据权利要求14所述的鼻窦口探示器，其中所述外护套包括第一狭槽，并且所述内护套包括第二狭槽，所述第一狭槽和所述第二狭槽被构造并被构型为在所述第一狭槽和所述第二狭槽彼此对齐时允许所述导丝穿过所述第一狭槽和所述第二狭槽插入所述内部通道中以及从所述内部通道移除。
16.根据权利要求1所述的鼻窦口探示器，其中所述轴还包括前部和接合到所述前部的后部，所述前部和所述后部限定管状形状，所述内部通道位于所述前部与所述后部之间。
17.根据权利要求16所述的鼻窦口探示器，其中所述前部还包括狭槽，所述狭槽与所述内部通道连通，所述狭槽被构造并被构型为允许所述导丝穿过所述狭槽插入所述内部通道中以及从所述内部通道移除。
18.一种鼻窦口探示器，包括：
细长轴，所述细长轴具有远端、近端、和弯曲区域，所述弯曲区域介于所述近端与所述远端之间；
柄部，所述柄部接合到所述近端；
纵向内部通道，所述纵向内部通道延伸穿过所述轴和所述柄部；
可伸长和可回缩的导丝，所述可伸长和可回缩的导丝活动安装在所述内部通道内；
探针顶端，所述探针顶端接合到所述导丝的末端；和
致动器元件，所述致动器元件与所述柄部相连并机械连接到所述导丝，所述导丝根据所述致动器元件的调节而可伸长和回缩。
19.根据权利要求18所述的鼻窦口探示器，其中所述导丝可在介于回缩位置与伸长位置之间可逆地活动，所述探针顶端在所述回缩位置中为邻近所述远端，所述探针顶端在所述伸长位置中与所述远端分离。
20.根据权利要求18所述的鼻窦口探示器，其中所述探针顶端为可拆卸并且可互换的。
21.根据权利要求20所述的鼻窦口探示器，其中所述轴还包括细长外护套和细长内部元件，所述纵向内部通道延伸穿过所述内部元件。
22.根据权利要求21所述的鼻窦口探示器，其中所述内部元件包含刚性材料，并且所述外护套包含弹性材料。
23.根据权利要求21所述的鼻窦口探示器，其中所述内部元件为可移除的并且可互换的。
24.根据权利要求18所述的鼻窦口探示器，其中所述致动器元件为以可滑动的方式安装在所述柄部上的狭槽内。
25.根据权利要求24所述的鼻窦口探示器，其中所述轴还包括细长管状内护套和细长管状外护套，所述内护套设置在所述外护套内，所述纵向内部通道延伸穿过所述内护套。
26.根据权利要求25所述的鼻窦口探示器，其中所述内护套相对于所述外护套为可伸长和可回缩的。
27.根据权利要求25所述的鼻窦口探示器，其中所述外护套包括第一狭槽，并且所述内护套包括第二狭槽，所述第一狭槽和所述第二狭槽被构造并被构型为在所述第一狭槽和所述第二狭槽彼此对齐时允许所述导丝穿过所述第一狭槽和所述第二狭槽插入所述内部通道中以及从所述内部通道移除。
28.根据权利要求18所述的鼻窦口探示器，其中所述轴还包括与所述纵向内部通道连通的纵向狭槽，所述纵向狭槽被构造并被构型为允许所述导丝穿过所述狭槽插入所述内部通道中以及从所述内部通道移除。
29.根据权利要求28所述的鼻窦口探示器，其中所述纵向狭槽包括侧面区域。
30.根据权利要求18所述的鼻窦口探示器，其中所述轴还包括前部和接合到所述前部的后部，所述前部和所述后部限定管状形状，所述内部通道位于所述前部与所述后部之间。
31.根据权利要求30所述的鼻窦口探示器，其中所述前部还包括狭槽，所述狭槽与所述内部通道连通，所述狭槽被构造并被构型为允许所述导丝穿过所述狭槽插入所述内部通道中以及从所述内部通道移除。
32.一种定位鼻窦口的方法，所述方法包括：
提供鼻窦口探示器，所述鼻窦口探示器具有轴，所述轴具有远端、近端、弯曲区域、和内部通道，所述弯曲区域位于所述远端与所述近端之间，可伸长和可回缩的导丝活动安装在所述内部通道内，并且探针顶端接合到所述导丝；
将所述鼻窦口探示器的所述轴插入患者的鼻旁腔中；
调节所述轴的远端的位置；以及
调节所述导丝和所述探针顶端的位置，直到目标孔口被定位。
33.根据权利要求32所述的方法，还包括将所述轴从所述鼻旁腔收回，同时让所述导丝和所述探针顶端留在所述调节的位置中。
34.根据权利要求33所述的方法，还包括将外科手术器件沿着所述导丝引入所述目标孔口。
35.一种用于定位并扩张天然上颌窦口的器件，所述器件包括：
细长轴，所述细长轴包括：
大体刚性的近侧部分；
弯曲远侧部分；
无创伤远侧顶端，所述无创伤远侧顶端在所述弯曲远侧部分的末端处，其中所述弯曲远侧部分的尺寸和形状适于允许所述远侧部分通入鼻腔中，以将所述无创伤远侧顶端设置在上颌窦口内或附近；和
膨胀管腔，所述膨胀管腔穿过所述轴的至少一部分；
至少一个可扩展的扩张器，所述至少一个可扩展的扩张器与所述轴的远侧部分连接，与所述膨胀管腔成流体连通。
36.根据权利要求35所述的器件，其中所述可扩展的扩张器包括可膨胀式囊。
37.根据权利要求36所述的器件，其中所述囊的至少一部分为邻近所述轴的远侧部分中的弯曲部设置。
38.根据权利要求37所述的器件，其中所述囊沿着所述轴从邻近所述弯曲部延伸到远离所述弯曲部。
39.根据权利要求36所述的器件，其中所述扩张器包括两个囊，一个邻近所述轴的远侧部分的弯曲部设置，而另一个远离所述弯曲部设置。
40.根据权利要求36所述的器件，其中所述囊远离所述轴的弯曲远侧部分的内曲率半径不对称地向外扩展。
41.根据权利要求35所述的器件，还包括柄部，所述柄部具有致动器，其中所述扩张器使用所述致动器沿着所述轴为可前进和可回缩的。
42.根据权利要求35所述的器件，其中所述无创伤远侧顶端包括球形顶端，所述球形顶端用于在定位所述上颌窦口时增强触觉反馈。
43.一种用于定位并扩张天然上颌窦口的器件，所述器件包括：
细长内轴，所述细长内轴包括：
大体刚性的近侧部分；
弯曲远侧部分；和
无创伤远侧顶端，所述无创伤远侧顶端在所述弯曲远侧部分的末端处，其中所述弯曲远侧部分的尺寸和形状适于允许所述远侧部分通入鼻腔中，以将所述无创伤远侧顶端设置在上颌窦口内或附近；和
外轴，所述外轴以可滑动的方式设置在所述内轴上，并包括膨胀管腔；和
至少一个可扩展的扩张器，所述至少一个可扩展的扩张器与所述轴的远侧部分连接，与所述膨胀管腔成流体连通。
44.根据权利要求43所述的器件，还包括柄部，所述柄部具有致动器，所述致动器用于使所述外轴沿着所述内轴前进和回缩。
45.根据权利要求43所述的器件，其中所述扩张器包括可膨胀式囊。
46.根据权利要求43所述的器件，其中所述无创伤远侧顶端包括球形顶端，所述球形顶端用于在定位所述上颌窦口时增强触觉反馈。
47.一种用于定位并扩张天然上颌窦口的方法，所述方法包括：
使上颌窦器件的弯曲远侧部分前进到鼻腔中，其中所述上颌窦器件的近侧部分为大体刚性的；
传递所述远侧部分的无创伤远端穿过所述天然上颌窦口，利用触觉反馈来确认所述远端穿过所述天然上颌窦口；以及
扩张至少一个可扩展的扩张器，所述至少一个可扩展的扩张器与所述上颌窦器件的弯曲远侧部分连接，以扩张所述天然上颌窦口。
48.根据权利要求47所述的方法，其中传递所述无创伤远端和利用触觉反馈的步骤包括用所述器件的球形远侧顶端来感觉。
49.根据权利要求47所述的方法，还包括在所述扩张步骤之前使所述上颌窦器件的外轴沿所述器件的内轴前进，其中所述可扩展的扩张器与所述外轴连接。
50.根据权利要求47所述的方法，其中扩张所述可扩展的扩张器的步骤包括使至少一个可膨胀式囊膨胀。
51.根据权利要求47所述的方法，其中扩张所述至少一个囊的步骤包括：
扩张第一囊，所述第一囊位于所述上颌窦口内；以及
扩张第二囊，所述第二囊位于所述上颌窦的外部，所述上颌窦在所述鼻旁腔内。
52.根据权利要求47所述的方法，其中扩张所述可扩展的扩张器的步骤引起骨的重塑或破裂，所述骨在粘膜的下面，形成所述天然上颌窦口。
53.根据权利要求47所述的方法，其中扩张所述可扩展的扩张器的步骤引起所述上颌窦口附近的鼻旁腔中解剖区域的扩张或解剖结构的移动中的至少一者。
54.根据权利要求53所述的方法，其中所述解剖区域选自由漏斗和中鼻道组成的组。
55.根据权利要求53所述的方法，其中所述解剖结构选自由钩突、中鼻甲骨和前筛骨窦组成的组。
56.根据权利要求47所述的方法，还包括，在所述扩张步骤之前，拉回所述上颌窦器件，以使所述鼻旁腔的钩突回缩。
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CN105163677A (zh) * 2012-12-21 2015-12-16 美敦力施美德公司 窦扩张系统和方法
CN106488736A (zh) * 2014-07-09 2017-03-08 阿克拉伦特公司 用于鼻窦扩张术的导丝操纵
CN106535745A (zh) * 2014-07-09 2017-03-22 阿克拉伦特公司 用于鼻窦扩张术的导丝导航
CN107529997A (zh) * 2015-04-22 2018-01-02 阿克拉伦特公司 标测鼻腔结构的系统和方法
CN109600988A (zh) * 2016-06-15 2019-04-09 阿里内克斯股份有限公司 用于治疗鼻腔外侧表面的装置和方法
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