CN101856247A - 用于提供进入体腔的通路的方法和装置 - Google Patents

用于提供进入体腔的通路的方法和装置 Download PDF

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CN101856247A
CN101856247A CN201010155990A CN201010155990A CN101856247A CN 101856247 A CN101856247 A CN 101856247A CN 201010155990 A CN201010155990 A CN 201010155990A CN 201010155990 A CN201010155990 A CN 201010155990A CN 101856247 A CN101856247 A CN 101856247A
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retractor
actuation member
diameter
ratchet
tissue
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F·E·谢尔顿四世
C·W·威登豪斯
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Ethicon Endo Surgery Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3439—Cannulas with means for changing the inner diameter of the cannula, e.g. expandable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00407—Ratchet means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B2017/3445—Cannulas used as instrument channel for multiple instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
    • A61B2017/3466—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals for simultaneous sealing of multiple instruments

Abstract

本发明提供了用于提供进入体腔的外科通路的方法和装置。在一个实施例中，提供了包括近侧壳体和远侧牵开器的外科进入装置。至少一个稳定螺纹可围绕所述远侧牵开器的至少一部分的周边延伸。在一些实施例中，所述稳定螺纹可以机械方式进行调节，以改变所述远侧牵开器的直径。

Description

用于提供进入体腔的通路的方法和装置
技术领域
本发明涉及用于提供进入体腔的外科通路的方法和装置。
发明背景
进入口广泛用于进入解剖腔的医疗手术中，该解剖腔的尺寸范围可在腹部至小血管变化，例如静脉和动脉、硬膜外腔、胸膜腔和蛛网膜下腔、心室以及脊髓腔和滑膜腔。由于进入口可为获得多种手术(例如涉及腹腔的手术)的入口提供微创技术，因此进入口的使用变得更加普遍。微创手术公认的优点是缩短术后康复时间、显著减轻术后疼痛和伤口感染以及改善外观效果，这主要是由于外科医生能够利用体腔壁的较小切口实施手术。
在许多外科中，希望提供一个或多个进入体腔的工作通道，穿过这些通道可以通入各种器械，以观察、接合和/或处理组织，从而实现诊断或治疗效果。例如，在腹腔镜手术中，通常向腹腔充入CO2气体，使压力达到约15mm Hg。对腹壁进行穿刺并将一个或多个管状插管插入腹腔，其中每个插管均限定一个工作通道。连接到手术室监视器的腹腔镜可用于使手术野显像并可穿过其中一个工作通道放置。其他腹腔镜手术器械(例如抓紧器、解剖器、手术剪、牵开器等)也可以穿过一个或多个工作通道放置，以有利于外科医生和/或外科助理进行各种操纵。
现有方法和装置的一个问题在于，现有外科进入装置不能将组织的初始切口牵开至任何可观的程度。因此，要将外科进入装置放入切口会比较困难，尤其是在切口相对较小的微创手术中。在紧迫的外科过程中，要首先选择放入切口内的合适尺寸的进入装置会同样困难。
当把进入装置吃紧地放入组织内的切口中时，要取出进入装置也会十分困难，这需要一定的拉力，可能对组织造成损伤和/或延长手术时间。这样用力移出进入装置还会增大切口尺寸，从而降低微创手术在愈合和美观方面的有益效果。
因此，仍然需要用于提供进入体腔的外科通路的方法和装置。
发明内容
本发明总体上涉及用于提供进入体腔的外科通路的方法和装置。在一个实施例中，提供了一种外科进入装置，该装置包括近侧外面部分、具有柔性牵开器的远侧部分、以及螺旋环绕在该牵开器周边的致动构件(如稳定螺纹或致动线缆)，其中柔性牵开器能够设置在人体组织内，以形成进入体腔的通道。该致动构件能够选择性地实现牵开器的直径的改变。
在一些实施例中，该装置可以包括能够改变致动构件张力的致动器，以选择性地实现牵开器的直径的改变。致动器可具有多种构型，例如棘轮机构。棘轮机构可包括棘爪，棘爪能够与多个齿中的至少一个啮合，以及能够运动以选择性地实现牵开器的直径的改变。棘爪能够在第一方向上自由滑动运动以选择性地实现牵开器的直径的改变，而在相反的第二方向不能运动。棘爪能够相对于牵开器向内径向运动，以使棘爪与多个齿中的所述至少一个脱离，从而允许棘爪在第一方向或第二方向运动，以与所述多个齿中的至少另一个啮合。
装置可以任何其他多种方式变化。例如，致动构件的第一末端可以连接到牵开器的远端，而致动构件的第二末端穿过近侧外面部分。又如，选择性地实现牵开器的直径的改变可以基本上不改变牵开器的纵向长度。又如，牵开器可以具有穿过其侧壁的内腔，而致动构件可以设置在该内腔中。又如，牵开器在缺省状态下可以具有第一直径，在牵开器处于缺省状态时致动致动构件可将牵开器运动到第二状态，在第二状态下，牵开器具有小于或大于第一直径的第二直径。
在另一方面，本发明提供了用于提供穿过组织进入体腔的通路的方法，该方法包括：将牵开器设置在组织内的开口中，使得牵开器的工作通道提供穿过组织并进入体腔的通路；以及使围绕该工作通道周边延伸的致动构件运动，以改变围绕工作通道周边延伸的致动构件的长度，并改变牵开器的直径大小。在一些实施例中，该方法可以包括将致动构件相对于牵开器锁定在固定位置，以保持组织内开口的尺寸。该方法可以任何多种其他方式变化。例如，改变围绕工作通道周边延伸的致动构件的长度可包括选择性地增大或减小围绕工作通道周边延伸的致动构件的长度。又如，使围绕工作通道周边延伸的致动构件运动可包括使连接到致动构件的棘爪相对于牵开器在径向上运动。
在另一个实施例中，提供穿过组织进入体腔的通路的方法包括：将具有椭圆形横截面形状的柔性牵开器设置在组织内的开口中，使得牵开器形成穿过组织并进入体腔的通道，并且使得椭圆的长轴大体上平行于组织内的开口的长轴，以及将椭圆的长轴设置为基本上垂直于组织内的开口的长轴，以扩大组织内的开口。该方法可以具有许多变型形式。例如，扩大组织内的开口可以包括将组织内的开口由线性形状变为基本上圆形的形状。又如，将椭圆的长轴设置为基本上垂直于组织内的开口的长轴会使柔性牵开器发生变化，由具有椭圆形横截面形状变为具有圆形横截面形状。又如，将柔性牵开器设置在组织内的开口中可以包括在组织内的开口中对齐围绕牵开器的周边设置的多个环中的至少一个。将椭圆的长轴设置为基本上垂直于组织内的开口的长轴会使多个环中的所述至少一个由椭圆形变为圆形。至少在牵开器处于第一状态且不承受压缩力时，多个环中的每一个均可具有椭圆形形状。
本发明具体涉及：
(1)一种外科进入装置，包括：
近侧外面部分；
远侧部分，所述远侧部分包括柔性牵开器，所述柔性牵开器能够设置在身体组织中以形成穿过其中进入体腔的通道；和
致动构件，所述致动构件螺旋环绕所述牵开器的周边，所述致动构件能够选择性地实现所述牵开器的直径的改变。
(2)如第(1)项所述的装置，其中所述致动构件的第一末端连接至所述牵开器的远端，并且所述致动构件的第二末端延伸穿过所述近侧外面部分。
(3)如第(1)项所述的装置，还包括致动器，所述致动器能够改变所述致动构件的张力，以选择性地实现所述牵开器的直径的改变。
(4)如第(3)项所述的装置，其中所述致动器包括具有棘爪的棘轮机构，所述棘爪能够与多个齿中的至少一个啮合，所述棘爪能够运动以选择性地实现所述牵开器的直径的改变。
(5)如第(4)项所述的装置，其中所述棘爪能够在第一方向上自由滑动运动，以选择性地实现所述牵开器的直径的改变并防止在相反的第二方向上运动。
(6)如第(5)项所述的装置，其中所述棘爪能够相对于所述牵开器径向向内运动以使所述棘爪与多个齿中的所述至少一个脱离，从而使得所述棘爪能在所述第一方向上或所述第二方向上运动以与所述多个齿中的至少另一个啮合。
(7)如第(1)项所述的装置，其中选择性地实现所述牵开器的直径的改变不会显著影响所述牵开器的纵向长度。
(8)如第(1)项所述的装置，其中所述牵开器具有穿过其侧壁延伸的内腔，所述致动构件设置在所述内腔内。
(9)如第(1)项所述的装置，其中所述牵开器在缺省状态下具有第一直径，并且其中在所述牵开器处于缺省状态的情况下致动所述致动构件是将所述牵开器运动至第二状态，在所述第二状态下，所述牵开器具有小于所述第一直径的第二直径。
(10)如第(1)项所述的装置，其中所述牵开器在缺省状态下具有第一直径，并且其中在所述牵开器处于缺省状态的情况下致动所述致动构件是将所述牵开器运动至第二状态，在所述第二状态下，所述牵开器具有大于所述第一直径的第二直径。
(11)一种提供穿过组织进入体腔的通路的方法，包括：
将牵开器设置到组织内的开口中，使得所述牵开器的工作通道提供穿过所述组织进入体腔的通路；以及
使围绕所述工作通道周边延伸的致动构件运动，以改变围绕所述工作通道的所述周边延伸的所述致动构件的长度，并改变所述牵开器的直径大小。
(12)如第(11)项所述的方法，还包括将所述致动构件相对于所述牵开器锁定在固定位置，以保持所述组织内的开口的尺寸。
(13)如第(11)项所述的方法，其中改变围绕所述工作通道的所述周边延伸的所述致动构件的长度包括选择性地增大或减小围绕所述工作通道的所述周边延伸的所述致动构件的长度。
(14)如第(11)项所述的方法，其中使围绕所述工作通道的所述周边延伸的所述致动构件运动包括相对于所述牵开器在径向方向上运动连接至所述致动构件的棘爪。
(15)一种提供穿过组织进入体腔的通路的方法，包括：
将具有椭圆形横截面形状的柔性牵开器设置在组织内的开口中，使得所述牵开器形成穿过所述组织并进入体腔的通道，并且使得所述椭圆的长轴大体上平行于所述组织内的开口的长轴；以及
将所述椭圆的所述长轴设置为基本上垂直于所述组织内的开口的所述长轴，以扩大所述组织内的开口。
(16)如第(15)项所述的方法，其中扩大所述组织内的开口包括将所述组织内的开口从线性形状移动至基本上圆形的形状。
(17)如第(15)项所述的方法，其中将所述椭圆的所述长轴设置为基本上垂直于所述组织内的开口的所述长轴导致所述柔性牵开器由具有所述椭圆形横截面形状变为具有圆形横截面形状。
(18)如第(15)项所述的方法，其中将所述柔性牵开器设置在所述组织内的开口中包括在所述组织内的开口内对齐围绕所述牵开器的周边设置的多个环中的至少一个。
(19)如第(18)项所述的方法，其中将所述椭圆的所述长轴设置为基本上垂直于所述组织内的开口的所述长轴导致所述多个环中的所述至少一个由椭圆形变为圆形。
(20)如第(18)项所述的方法，其中至少当所述牵开器处于第一状态且不受压缩力时，所述多个环中的每一个都具有椭圆形状。
附图说明
由下文的具体实施方式并结合附图，可更完整地理解本发明，现对各附图说明如下：
图1为外科进入装置的一个实施例的侧视图，该装置具有设置在其牵开器周围的多个环；
图2为图1的装置的侧面剖视图；
图3为图1的装置的侧面局部剖视图，该装置设置在组织内，外科器械穿过其中；
图4为外科进入装置的一个实施例的侧面局部剖视图，该装置具有设置在其牵开器周围的多个倾斜环；
图5为外科进入装置的一个实施例的透视图，该装置包括具有椭圆形横截面形状的牵开器；
图6为图5的装置的侧视图，示出了牵开器的长轴长度；
图7为图5的装置的侧视图，示出了牵开器的短轴长度；
图8为图5的装置的远端视图；
图9为图5的装置的远端视图，该装置设置在组织内的开口中，牵开器的长轴大体上平行于开口的长轴；
图10为图5的装置的远端视图，该装置从其在图9的组织内的位置旋转，使牵开器的短轴大体上平行于组织内的开口的长轴；
图11为外科通路装置的牵开器的一个实施例的局部横截面侧视图，该牵开器具有可机械调节的直径；
图12为外科进入装置的牵开器的另一个实施例的侧面局部剖视图，该牵开器具有可机械调节的直径；
图13为外科进入装置的一个实施例的侧面剖视图，该装置具有可机械调节且可锁定的直径；
图14为图13的装置的壳体的分解剖视图；
图15为图13的装置的局部横截面近端视图；以及
图16为图13的装置的壳体的侧面局部剖视图。
具体实施方式
现在将描述一些示例性实施例以提供对本文所公开的装置和方法的结构、功能、制造和使用原理的全面理解。附图中示出了这些实施例中的一个或多个例子。本领域的技术人员将会理解，本文具体描述并在附图中示出的装置和方法是非限制性的示例性实施例并且本发明的范围仅由权利要求书限定。结合一个示例性实施例示出或描述的特征可以与其他实施例的特征组合。这种修改形式和变型形式旨在包括在本发明的范围内。
本发明提供了用于提供进入体腔的外科通路的多种示例性方法和装置。通常，这些方法和装置允许将外科进入装置牢固地设置在组织内的开口中，以提供进入组织下面的体腔的通路。在一个实施例中，外科进入装置可以包括近侧壳体和远侧牵开器。至少一个稳定螺纹可以围绕远侧牵开器的至少一部分的周边延伸，以使远侧牵开器具有结构完整性，并有助于将装置固定到在组织内形成的开口中。在一些实施例中，该稳定螺纹可以是可机械调节的，以改变远侧牵开器的直径，从而允许装置适应组织内不同尺寸的开口，并可更容易地设置在开口中以及从开口中移出。外科进入装置可使在组织中形成的开口主动收缩，以有助于该装置牢固地设置在组织内。这种牢固的定位可有助于在组织和装置之间形成更好的密封，并且在将装置设置在组织中时有助于将组织保持在更稳定的位置。设置在组织中时，该装置还可以扩张组织，以有助于提高装置和组织之间的密封完整性。这种装置对组织的扩张作用可以增大组织内的开口的尺寸和/或改变开口的形状，以加大穿过组织开口的可用工作空间。具有穿过组织的更大工作空间可有助于减少穿过组织的多个外科器械的相互干扰，和/或允许将更大和/或更多的外科器械穿过组织。
本文所述的多种外科进入装置通常可以被构造成允许穿过在近侧壳体(下文统称为“壳体”)内形成的一个或多个独立的密封口或进入口插入一个或多个外科器械，并进入体腔。每个密封口都可以限定穿过近侧壳体并与远侧牵开器对齐的工作通道。远侧牵开器(下文统称为牵开器)可以被构造为伤口保护器或用于形成穿过组织的通道的其他构件。牵开器可以从装置的近侧壳体伸出，并且可以能够设置在患者体内的开口中，例如肚脐内。本文所述的任何和所有外科进入装置还可以包括多种其他部件，例如一个或多个排气口，以使得能在采用烧灼的手术过程中排出烟，和/或一个或多个充气口，外科医生可通过该充气口向腹腔充入气体以形成气腹，如2006年11月2日提交的名称为“Multi-port Laparoscopic Access Device”(多口腹腔镜进入装置)的美国专利申请No.2006/0247673中的非限制性实例所述，该专利据此全文以引用方式并入本文。本领域的技术人员将会了解到，充气口可以位于装置上的任何位置、可具有任何尺寸并且可以收纳路厄锁或针头。
外科进入装置的任何和全部实施例还可以包括一个或多个防护罩，这些防护罩设置为穿过任何部件和/或组织、位于这些部件和/或组织中和围绕这些部件和/或组织，以保护这些部件不被插入穿过装置的外科器械刺穿或撕裂。防护罩的示例性实施例在下列专利中有更详细的描述：提交于2006年11月2日的名称为“Multi-portLaparoscopic Access Device”(多口腹腔镜进入装置)的美国专利公布No.2006/0247673，提交于2009年3月6日的名称为“Methodsand Devices for Providing Access to a Body Cavity”(用于提供进入体腔的通路的方法和装置)的美国专利申请No.12/399,625，提交于2009年3月6日的名称为“Methods and Devices forProviding Access to a Body Cavity”(用于提供进入体腔的通路的方法和装置)的美国专利申请No.12/399,482，以及提交于2008年9月30日的名称为“Surgical Access Device”(外科进入装置)的美国专利申请No.12/242,765，藉此将这些专利全文以引用方式并入本文。
在本文所公开的任何和全部外科进入装置实施例中，均可包括接合和/或释放机构，以允许外科进入装置的某些部件在需要时可移除。本领域已知的任何接合和释放机构(如弹簧锁机构、对应螺纹等)都可以用来以可脱开的方式与装置的部件配合。接合和释放机构的示例性实施例在上文提及的下列专利中有更详细的描述：提交于2008年9月30日的名称为“Surgical Access Device”(外科进入装置)的美国专利申请No.12/242,765、提交于2009年3月6日的名称为“Methods and Devices for Providing Access to a Body Cavity”(用于提供进入体腔的通路的方法和装置)的美国专利申请No.12/399,625，和提交于2009年3月6日的名称为“Methods andDevices for Providing Access to a Body Cavity”(用于提供进入体腔的通路的方法和装置)的美国专利申请No.12/399,482；另外也在下列专利中有更详细的描述：提交于2008年5月13日的名称为“Trocar Seal Assembly”(套管针密封组件)的美国专利No.7,371,227和提交于2007年5月13日的名称为“Trocar WithImproved Universal Seal”(具有改进的通用密封件的套管针)的美国专利No.5,628,732，藉此将这些专利全文以引用方式并入本文。
在使用时，如下文将进一步讨论的，本文所公开的外科进入装置可用于提供进入患者体腔的通路。装置的牵开器可以定位在患者身体的开口中，使得牵开器远侧部分伸入患者体腔，近侧部分则能够连接到设置在患者体外靠近患者皮肤的装置壳体上。牵开器的内腔可以形成穿过患者身体开口的通道，从而使得外科器械可从体外插入内部体腔。患者皮肤的弹性可有助于将牵开器保持在身体开口或在体内形成的切口中。可将牵开器放置在患者体内的任何开口中，不管是天然孔口还是切开而成的开口。作为非限制性实例，可以将牵开器穿过肚脐进行设置。在一个实施例中，牵开器可以是基本上柔性的，以使得可易于根据需要对其进行调整而放入组织内并处于组织内。在其他实施例中，牵开器可以是基本上刚性的或基本上半刚性的。牵开器可由本领域已知的任何合适材料形成，如硅胶、氨基甲酸酯、热塑性弹性体以及橡胶。
在体腔(例如腹部)外科过程中，通常通过外科进入装置进行充气使体腔扩大，以便于开展外科。因此，为了保持体腔内的充气，大部分外科进入装置都包括至少一个设置在其中的密封件，当穿过此密封件插入外科器械时，密封件可以防止空气和/或气体逸出。多种密封元件在本领域中是已知的，但通常外科进入装置可以包括至少一个器械密封件，其能够在穿过其设置的器械周围形成密封，但在没有器械穿过其设置时不会形成密封；至少一个通道密封件或零闭合密封件，当没有器械穿过其设置时，此类密封件将密封口形成的工作通道封闭；或者器械密封件和通道密封件的组合，其既能够在穿过其设置的器械周围形成密封，又能够在没有器械穿过其设置时在工作通道中形成密封。本领域的技术人员将会知道，可以使用本领域已知的多种密封件，包括(例如)鸭嘴密封、锥密封、挡板阀、凝胶密封、隔膜密封、唇形密封、虹膜式密封等。本领域的技术人员还会知道，在本文所述的任何实施例中可以包括密封的任意组合，而不论特定实施例的对应描述中是否具体讨论了该密封组合。各种密封保护器的示例性实施例在下列专利中有更详细的描述：提交于1994年8月30日的名称为“Trocar Seal/Protector Assemblies”(套筒针密封件/保护器组件)的美国专利No.5,342,315和提交于2007年1月16日的名称为“Duckbill Seal Protector”(鸭嘴密封保护器)的美国专利No.7,163,525，藉此将这些专利全文以引用方式并入本文。
在图1和图2所示的示例性实施例中，提供了具有壳体12的外科进入装置10，该壳体能够具有一个或多个穿过其插入的外科器械。虽然壳体12可以具有任何构型，但在该示例性实施例中，壳体12包括密封基座14，密封基座用来支撑至少一个密封口或进入口，并能够在基座14和装置10的远侧部分(如牵开器18)之间形成支座和密封。壳体12可以固定地或可拆卸地连接至牵开器18，牵开器能够从壳体12向远侧延伸，并提供穿过组织进入体腔的通道。在该实施例中，牵开器18包括连接到远侧牵开器部分22的近侧牵开器部分或近侧牵开器基座20。如该实施例所示，壳体12可以通过搭扣配合可拆卸地连接至牵开器18。壳体12可以如该实施例所示相对于牵开器18处于固定位置，或者壳体12也可以相对于牵开器18活动。多种壳体的示例性实施例在上文提及的下列专利中有更详细的描述：提交于2006年11月2日的名称为“Multi-port Laparoscopic Access Device”(多口腹腔镜进入装置)的美国专利公布No.2006/0247673，提交于2009年3月6日的名称为“Methods and Devices for Providing Access toa Body Cavity”(用于提供进入体腔的通路的方法和装置)的美国专利申请No.12/399,625，提交于2009年3月6日的名称为“Methodsand Devices for Providing Access to a Body Cavity”(用于提供进入体腔的通路的方法和装置)的美国专利申请No.12/399,482，以及提交于2008年9月30日的名称为“Surgical Access Device”(外科进入装置)的美国专利申请No.12/242,765，另外在提交于2009年3月6日的名称为“Surgical Access Devices And MethodsProviding Seal Movement In Predefined Paths”(在预定路径内提供密封移动的外科进入装置和方法)的美国专利申请No.12/399,547中也有更详细的描述，藉此将这些专利全文以引用方式并入本文。
虽然密封基座14中可形成任意数目的密封口，但在该示出的实施例中，第一密封口16a和第二密封口16b延伸穿过密封基座14。该示出的实施例中的密封口16a和16b均具有基本上垂直于密封基座14的近侧表面14a延伸的中心轴，并且密封口16a和16b均相对于壳体12处于固定位置，但任何一个或多个密封口都可相对于密封基座14倾斜，和/或可相对于密封基座14和/或壳体12的其他部分旋转或以其他方式运动。除此之外或作为一种选择，密封口16a和16b中的任何一个或多个均能够相对于牵开器18的任何一个或多个部分和/或密封口16a和16b中的任何其他部分运动。密封口16a和16b可以使用本领域已知的任何连接或配合机构连接或配合到密封基座14上，但在所示实施例中，密封口16a和16b均可以通过过盈配合与密封基座14配合。通常，密封口16a和16b均可以包括可直接或间接地安放在密封基座14内的开口中的开口壳体和可设置在相关开口壳体内的密封元件。密封元件可以包括至少一个器械密封件和/或至少一个通道密封件，并且通常能够与穿过该密封元件的相关密封口插入的器械相接触。多种密封口的示例性实施例在上文提及的下列专利中有更详细的描述：提交于2006年11月2日的名称为“Multi-port LaparoscopicAccess Device”(多口腹腔镜进入装置)的美国专利公布No.2006/0247673，提交于2009年3月6日的名称为“Methods andDevices for Providing Access to a Body Cavity”(用于提供进入体腔的通路的方法和装置)的美国专利申请No.12/399,625，提交于2009年3月6日的名称为“Methods and Devices for ProvidingAccess to a Body Cavity”(用于提供进入体腔的通路的方法和装置)的美国专利申请No.12/399,482，以及提交于2008年9月30日的名称为“Surgical Access Device”(外科进入装置)的美国专利申请No.12/242,765。
如上文所述，牵开器18可从壳体12向远侧延伸，并且可使其能够位于组织中形成的开口内。如该示例性实施例所示，牵开器18可以包括基本上柔性的远侧部分22，其具有近侧凸缘24和远侧凸缘26以及在两者间延伸的内部细长部分28。近侧牵开器基座20和柔性远侧部分22之间可以设置牵开器保持带44(如O形环)，以有助于在两者间形成牢固密封。内部细长部分28的直径可以比近侧凸缘24和远侧凸缘26的直径小，而近侧凸缘24和远侧凸缘26的直径可以相同或不同，内部细长部分28能够设置在组织内。近侧凸缘24能够安放在近侧牵开器基座20内，或者如该实施例所示，近侧牵开器基座20能够安放在近侧凸缘24内。本领域的技术人员将会知道，近侧牵开器基座20可任选地使用粘合剂、密封剂、互补螺纹或任何其他连接机构连接到近侧凸缘24上。可任选将近侧O形环(未示出)设置在近侧凸缘24内，以便在近侧凸缘24安放在近侧牵开器基座20内时，有助于为牵开器18提供结构支承。远侧O形环30可任选设置在远侧凸缘26内，以便在患者体内为牵开器18提供结构支承。近侧和远侧O形环可以根据需要为基本上柔性或基本上刚性的，并且可以彼此相同或不同，以应用于具体用途。
如该实施例所示，装置10可包括一个或多个稳定螺纹，其为围绕牵开器18的周边设置的一个或多个环的形式，例如，纵向等间距或以任何其他间距隔开并围绕牵开器18的内部细长部分28的周边延伸的三个环32。通常，环32可以至少在牵开器18的内部细长部分28中围绕牵开器18的周边设置，以有助于为牵开器18提供结构完整性。
环32可以具有任何尺寸、形状和构型，并且可以与任何其他环32相同或不同。环32可以具有与其各自配合的牵开器18的某一部分相对应的尺寸和形状。该所示实施例中的牵开器18至少在其内部细长部分28具有大致圆形的横截面形状，因此环32可以具有相似的基本上圆形的形状，并围绕内部细长部分28的周围设置，使得环32围绕贯穿牵开器18的通道34的至少一部分。如该实施例所示，环32可以围绕牵开器18的周边设置，让每个环32均位于与其他环32的平面平行的平面内，使得至少当装置10处于图1和图2所示的缺省初始位置时，每个环32的中点可以彼此轴向对齐，并与装置10的中心纵向轴线A轴向对齐。环32的平面也可以平行于壳体12的近侧表面(如密封基座14的近侧表面14a)，使得插入通道34的外科器械可在与环32的平面成非零角度的方向延伸。
如图所示，环32可以设置在内部细长部分28的侧壁内，使得环32可以包含在牵开器18内，并且不会阻塞内部细长部分28的内表面28I(例如，至少部分地限定穿过牵开器18的通道34的表面)，使得环32不伸入通道34内。但在一些实施例中，环32可以连接到内部细长部分28的内表面28I和/或外表面28O。因此，环32的直径32D可以基本上等于与环32相连的牵开器18的某些部分的直径，但取决于环32与内部细长部分28配合的位置，环32的直径32D可以与内部细长部分28的内径28D略有不同。在该所示实施例中，内部细长部分28具有内径28D基本上不变的大体上圆柱形的形状，并且环32相应地具有略大于内部细长部分28的内径28D的基本上相等的直径32D，因为环32设置在内部细长部分28内，使得不会伸入内部细长部分28。
环32可以根据需要为基本上柔性或基本上刚性的并可以彼此相同或不同，以便用于具体的应用。环32可由比用来形成牵开器18的材料更具刚性的材料制成，这可有助于为牵开器18提供结构支承，并且在包括环32的牵开器18部分(如内部细长部分28)中提供额外的环向强度，以有助于扩张其中设置有装置10的组织开口，和/或在将装置10设置在开口中后使开口保持基本上不变的尺寸和形状。
如该实施例所示，当环32围绕牵开器18的周边设置，并在纵向上以非零距离分开时，环32可在牵开器18的外表面(例如内部细长部分28的外表面28O)上形成脊36。脊36通常能够有利于通过夹住组织而将装置10设置在组织中，从而有助于稳定装置10并防止其纵向运动。脊36也能够迫使其中设置有装置10的组织形成环32的形状，从而有助于将组织内的开口扩张或伸展至更有效穿过外科器械的尺寸和形状。
使用时，如图3所示，可以将装置10设置在组织38内，以提供进入组织38下面的体腔42内的通路。装置10可以多种方式设置在组织38内。在一个实施例中，装置10可以在完全组装后以图1和图2所示的缺省状态设置在组织中。在另一个实施例中，可以将装置10部分组装后设置在组织38中，然后与设置在组织38中的装置10的一部分进行完全组装，例如，可以首先将牵开器18设置在组织38内，随后将壳体12连接到该牵开器上。如果组织38和/或牵开器18足够柔韧，那么可以将牵开器18倾斜或枢转到所需的位置，以便于将壳体12连接到牵开器18上。
然而，如该实施例所示，当设置在组织38中时，可以将完全组装的牵开器18设置在形成于组织38中(如肚脐中)的开口或切口内，使牵开器18的近侧凸缘24和远侧凸缘26设置在组织38的相对侧上。牵开器18的近侧部分中的近侧凸缘24可以设置在组织38的一侧上，使近侧凸缘24的远侧表面设置在组织38的近侧表面38P上和/或在其近侧。牵开器18的远侧凸缘26可以设置在体腔42中的组织38远侧表面38D上和/或在其远侧。因此，牵开器18的内部细长部分28可以设置在组织38内，使牵开器18的工作通道或通路34贯穿组织38，以提供进入体腔42的通路。如上所述并如图3所示，由环32形成的脊36可在开口内将组织38夹紧，并迫使开口适形于环32的形状，例如，如图所示的基本上圆形。
组装好外科进入装置10并设置在组织中后，可将一个或多个外科器械通过其插入体腔42，在体腔中外科器械可有助于实施任何形式的外科。一个或多个外科器械可穿过密封口16a和16b中的任何一个插入装置10并进入体腔42，例如将一对可活动的夹钳40插入第一密封口16a，以有助于实施至少一部分外科。如果组织38和/或牵开器18足够柔韧，那么在使用装置10的过程中，可以通过可活动夹钳40和/或其他穿入其中的外科工具将牵开器18倾斜或枢转。虽然图中所示是将一对可活动夹钳40插入装置10，但可以将诸如抓紧器、镜头装置(如内窥镜、腹腔镜和结肠镜)、切割器械等任何外科装置插入装置10。本领域的技术人员将会知道，如本文所用的术语“抓紧器”旨在涵盖能够抓紧和/或连接到组织上从而操纵组织的任何外科器械，例如，镊子、牵开器、可活动夹钳、磁铁、粘合剂、支座缝合夹等。本领域的技术人员还会知道，如本文所用的术语“切割器械”旨在涵盖能够切割组织的任何外科器械，例如，手术刀、超声刀、钝头分离器、能够切割组织的烧灼工具、手术剪、内窥镜线性切割器、外科吻合器等。
在外科之前、期间和之后的任何时间，都可以将壳体12从牵开器18上整体或部分移除，并且可从组织38中移出牵开器18。装置10的壳体12脱离牵开器18后，牵开器18的通道34仍可提供进入组织38下方的体腔42的通路。可将一个或多个外科器械推进穿过通道34，例如能够容纳来自体腔42的废物(如切取的组织、过多的体液等)的废物清除袋。可以通过牵开器的通道34或其他进入口将袋放入体腔42中。本领域的技术人员将会知道，在将壳体12连接到牵开器18上之前和/或之后，可将一个或多个外科器械推进穿过牵开器的通道34。
图4示出了外科进入装置100的另一个实施例，该装置包括至少一个环132形式的至少一个稳定螺纹，该环132能够在装置外表面上形成至少一个脊136。外科进入装置100可以具有类似于上述外科进入装置10的构造和用途，并且可以包括类似于上述壳体12的壳体112，壳体112能够在其中容纳一个或多个密封口116。壳体112也能够以可脱开的方式或固定的方式与牵开器118配合。牵开器118和环132可与上述牵开器18和环32类似，但与上述装置10中不同，在该实施例中，与牵开器118配合的环132相对于穿过牵开器118的通道134倾斜。换句话讲，每个环132的平面可以彼此平行，但至少当装置100处于图4所示的缺省初始位置时，可以相对于装置100的中心纵向轴线A2成0°至+/-90°之间的任何角度a。对于如图所示的每个环132，角a可以基本上相等，或者角a也可以在一个或多个环132之间变化。倾斜的环132可有助于通过增加装置相对于组织纵向运动的难度而将装置100保持在组织内。倾斜的环132可被构造为如该实施例所示的分立、独立构件，或者倾斜的环132也可以被构造为以螺旋形式围绕牵开器118周边的至少一部分的连续螺纹。
图5-8示出了外科进入装置300的又一个实施例，该装置包括至少一个环形式的至少一个稳定螺纹(由图5-8可模糊看出)，该环能够在装置的外表面上形成至少一个脊336。外科进入装置300可以具有类似于上述外科进入装置10、100的构造和用途，并且可包括类似于上述壳体12的壳体312，壳体312被构造成在其中设置有一个或多个密封口，例如，位于在壳体312的密封基座314内形成的三个密封口开口317中的三个密封口(未示出)。壳体312也能够以可脱开的方式或固定的方式与牵开器318配合。牵开器318和环可以类似于上述牵开器18、118及环32、132，但与上述装置10和100中不同，在该实施例中，牵开器318可具有椭圆形式的非圆形横截面形状，其具有长轴M1和短轴M2。因此，穿过牵开器318的工作通道或通路334也可以为椭圆形，并且环和脊336也为椭圆形。虽然该实施例所示环和脊336连续螺旋环绕在牵开器318的内部细长部分328周围，但如上所述，环和脊336可设置在牵开器318的任何部分周围和/或被构造为分立构件。在一个示例性实施例中，牵开器318可以是基本上柔性的，以使得将装置300设置在组织中时，至少牵开器318的内部细长部分328可以变形，下文将对此进行进一步论述。连接到牵开器318的壳体312可具有任何形状，例如，如图所示的基本上圆形。
分别沿着牵开器318的长轴M1和短轴M2的通道334的长轴宽度L1和短轴宽度L2可以具有任何长度。在一个示例性实施例中，短轴宽度L2可以为约15mm，长轴宽度L1可以为约25mm，这使得牵开器318可以设置在纵向长度为约1英寸(25.4mm)的组织开口内。
使用时，如图9所示，可以将牵开器318设置到在组织338内形成的开口350中(类似于上述装置10中的情形)，使牵开器318处于其长轴M1大体上平行于开口350的长轴M1′的第一位置。由于在组织内形成的开口常常具有线性形状，例如，组织内的人造线性切口，因此比起具有基本相等的长轴和短轴长度的圆形牵开器，可更容易将短轴长度小于长轴长度的椭圆形牵开器设置在开口中。当将牵开器318设置在组织350中的第一位置后，开口350可适形于牵开器318的形状，例如，从线性形状扩张或变形为椭圆形状，该椭圆形状具有基本上等于牵开器318的长轴宽度L1和短轴宽度L2的长轴和短轴长度。
通过(例如)在体外抓住并旋转近侧牵开器基座320，可以将牵开器318在组织338内顺时针和/或逆时针旋转任意角度，以将牵开器318移至第二位置，在第二位置下，牵开器318的长轴M1可以与开口350的长轴M1′成非零角，使得长轴M1和M1′不再基本上平行。如图10中的一个实施例所示，牵开器318可以在开口350内旋转约+/-90°，使得牵开器318的长轴M1可以基本上垂直于开口350的长轴M1′，而牵开器M2的短轴M2可以大体上平行于开口350的长轴M1′。将牵开器318从第一位置移至第二位置可以进一步扩大开口350或使其变形。在第二开口内的牵开器318会试图迫使开口350变为椭圆形，但组织338施加在牵开器318上的压缩力可以超过牵开器318施加在组织338上的力。装置300的环可有助于抵消组织施加在牵开器318上的压缩力，因此，如图10所示，设置在组织338内的包括环和脊336的牵开器318可以扩大或变形，以在第二位置具有基本上为圆形的横截面形状。通常适形于牵开器318的形状的开口350因此也可具有基本上圆形的形状，相对于线性或椭圆开口来说，这可有助于最大限度扩大穿过组织338的可用工作空间。
虽然图9和图10所示牵开器318设置在组织338中，并且在壳体312未连接到牵开器318的情况下相对于组织旋转，但当牵开器318设置在组织338中和/或相对于组织338旋转时，壳体312可以任选地连接到牵开器318上。
在外科进入装置的另一个实施例中，围绕装置的牵开器周边设置的稳定螺纹能够机械调节，使得可选择性地改变牵开器的横截面尺寸和/或形状。这样，可选择性地扩大装置(例如，增大装置的牵开器的直径)和收缩装置(例如，减小牵开器的直径)。当将装置设置在患者组织中时，可机械调节的稳定螺纹能够从患者体外进行调整。因此，其中设置有装置的组织的横截面尺寸和/或形状也可以大致与装置的机械调整成比例地以机械方式进行调整。扩大牵开器可允许装置牵开组织并提供更大的穿过组织的进入开口，而收缩牵开器则可以允许开始时更容易地将牵开器定位在组织中，并且更容易地从组织中移出牵开器。
在具有可机械调节的牵开器直径的外科进入装置的一个实施例中，如图11所示，装置可具有类似于上述外科进入装置10、100和300的构造和用途，并且可包括类似于上述壳体12、112、312的壳体(未示出)，该壳体能够在其中安装一个或多个密封口，并且能够以可脱开的方式或固定的方式与牵开器218配合。与上述牵开器18、118和318类似，牵开器218可具有圆形、椭圆形或其他横截面形状，并且包括连接到基本上柔性的远侧部分222的近侧牵开器基座220，远侧部分222具有近侧凸缘224和远侧凸缘226，以及在近侧凸缘和远侧凸缘之间延伸的内部细长部分228。如上文结合图1和图2的装置10所述，在近侧牵开器基座220和柔性远侧部分222之间可设置牵开器保持带244，以有助于在两者之间形成牢固密封。
远侧O形环230可任选地设置在位于远侧凸缘226内的鞘231中，以为患者体内的牵开器218提供结构支承。如图11中的实施例所示，远侧O形环230可以为基本上刚性的(如金属丝)，以允许远侧凸缘226具有基本上固定的直径。换句话讲，牵开器218的远侧凸缘226可不受牵开器直径调整的影响。当远侧凸缘226具有基本上固定的直径时，牵开器218能够更有效地抓紧其中设置有牵开器218的组织的远侧表面，从而在将牵开器218设置在组织中时可有助于将其保持在更稳定的位置。
与上述装置10、100和300不同，在该实施例中，牵开器218可包括致动构件260形式的可调式稳定螺纹，其中致动构件260围绕牵开器218的周边设置。通常，致动构件260能够选择性地实现牵开器218的直径的改变，使得牵开器218改变横截面形状和/或尺寸。
致动构件260可具有多种形状、尺寸和构型。致动构件260可具有如图所示的圆形横截面形状，以有助于致动构件260围绕牵开器218的周边平滑运动，但致动构件260也可以具有任何横截面形状。致动构件260还可以具有能够允许致动构件260螺旋环绕牵开器218周边的任何纵向长度，下文将对此进行进一步论述。本领域的技术人员将会知道，致动构件260可用任何一种或多种材料形成，例如，编织弹簧钢、诸如镍钛诺(Nitinol)等之类的形状记忆材料，在示例性实施例中致动构件260为柔性生物相容线缆。
与上述环32、132和332类似，如该实施例所示的致动构件260能够以(例如)螺旋构型沿着并围绕牵开器218的周边的至少一部分延伸的连续螺纹。在一个示例性实施例中，致动构件260可螺旋环绕牵开器的内部细长部分228的整个纵向长度，以使得能调整内部细长部分228的直径228D，该直径可对应于穿过牵开器218的内部通道或工作通道234的直径。致动构件260可围绕牵开器218的周边环绕任何圈数(包括少于一圈)，例如，如图11所示的至少两圈，使各圈纵向间距相等或相隔任何其他距离并围绕牵开器218的周边延伸。
致动构件260可以多种方式连接到牵开器218。与上述环32、132和332类似，致动构件260可连接到内部细长部分228的内表面228I上、内部细长部分228的外表面228O上和/或设置在内部细长部分228的侧壁内。在如图11所示的示例性实施例中，通过穿过围绕外表面228O延伸的内腔262，致动构件260可连接到内部细长部分228的外表面228O上。内腔262可与牵开器218整体地成形，例如在内部细长部分228的侧壁内形成，或者如该实施例中所示，内腔262可在连接到内部细长部分228的外表面228O的腔鞘264内形成。因此，围绕内部细长部分228的周边延伸的腔鞘264可在内部细长部分的外表面228O上形成至少一个脊，可以将该脊与上述脊36、136和336进行类似构造。致动构件260的纵向长度可贯穿内腔262，并且致动构件260的第一末端260a和第二末端260b可分别连接到牵开器218的近侧部分内的致动器266以及牵开器218的远侧部分内的联接机构268。虽然在该实施例中致动器266连接到牵开器218，但致动器266可以连接到能够连接到牵开器218的壳体的任何部分上。此外，在一些实施例中，致动器266可设置在牵开器218的远侧部分，使致动构件的第二末端260b连接到致动器266，致动构件的第一末端260a连接到牵开器218的近侧部分或位于能够连接至牵开器218的壳体的任何部分内。
连接到致动构件260的第一末端260a的致动器266可具有多种形状、尺寸和构型。通常，致动器266能够至少部分地位于设置有牵开器218的患者体外并在体外进行操纵，以实现致动构件260的运动从而调整牵开器的内部细长部分228的直径228D。如图11所示，致动器266可包括设置在牵开器218外面的柄部。如图11所示，柄部可包括指环，但本领域的技术人员将会知道，柄部可具有多种形状、尺寸和构型，例如旋钮、丁字梁等。柄部能够相对于牵开器218运动以致动致动构件260。
连接到致动构件260的第二末端260b的联接机构268也可具有多种形状、尺寸和构型。通常，联接机构268能够将致动构件260固定到牵开器218的相反端(致动构件260从此处开始设置)，以使得致动构件260能沿牵开器的内部细长部分228的至少一部分纵向长度延伸。如该图示实施例所示，联接机构268可包括固定连接至远侧O形环230的块体。块体可以具有任何形状，例如，如图所示的矩形。在一些实施例中，致动构件260可直接连接至远侧凸缘226内的远侧O形环230或包封远侧O形环230的鞘231。
使用时，与上文结合装置10所论述的那样相似，可将牵开器218设置到在组织内形成的开口中。在将牵开器218设置在组织内之前和/或之后，可在第一方向运动致动器266，例如在远离牵开器218的方向，以拉动致动构件260，从而增大致动构件260的张力并收缩内部细长部分228的直径228D，使得牵开器218可处于收缩状态，如图11中的内部细长部分228的实线所示。当致动构件260固定连接到联接机构268后，致动构件260可提供足够大的张力，以使得致动构件260能穿过内腔262滑动，并改变内部细长部分228的直径228D。致动器266可在与第一方向相反的第二方向运动，例如朝向牵开器218的方向，以减小致动构件260的张力，从而松开致动构件260并扩大内部细长部分228的直径228D，使得牵开器218可处于伸展状态，如图11中的内部细长部分228的虚线所示。如图11所示，牵开器218能够使得改变牵开器218的直径228D不会显著改变牵开器218的纵向长度，这可有助于使牵开器218与其中设置有牵开器218的组织的近侧表面和远侧表面保持牢固接合。
虽然牵开器218能够具有任何缺省状态，但在该所示实施例中，牵开器218能够处于伸展状态的缺省状态。以该方式，可通过(例如)拉动柄部而拉紧致动构件260以将牵开器218设置在组织内，从而将牵开器218运动至具有较小直径的第二状态。在将牵开器218设置在组织内的开口中之后，例如，使近侧凸缘224和远侧凸缘226设置在组织的相对侧后，可通过(例如)释放柄部松开致动构件260，以使得牵开器218能向第一状态运动。因此，牵开器218可动态调整到开口的尺寸，并通过对组织施加向外的力来扩大开口。取决于其中设置了牵开器218的组织的弹性，当柄部释放后，牵开器218可完全或部分地运动到其缺省状态。要从组织中移除牵开器218，可致动致动器262，例如可拉动柄部，以减小内部细长部分的直径228D，这可更容易地在组织开口内运动牵开器218并将其运动出开口。
在具有可机械调节的牵开器直径的外科进入装置的另一个实施例中，如图12所示，该装置可具有与上述外科进入装置类似的构造和用途，并且可包括类似于上述壳体的壳体(未示出)，该壳体能够在其中安装一个或多个密封口，并能够以可脱开的方式或固定的方式与牵开器518配合。与上述牵开器18、118、218和318类似，牵开器518可具有圆形、椭圆形或其他横截面形状，并且包括连接到基本上柔性的远侧部分522的近侧牵开器基座520，远侧部分522具有近侧凸缘524和远侧凸缘526，以及在近侧凸缘和远侧凸缘之间延伸的内部细长部分528。如上文结合图1和图2的装置10所论述的那样，在近侧牵开器基座520和柔性远侧部分522之间可设置牵开器保持带544，以有助于在两者之间形成牢固密封。该装置还可包括致动构件560形式的可调式稳定螺纹，其中致动构件560围绕牵开器518的周边设置。
通常，致动构件560可具有与图11的致动构件260类似的构造和用途，并利用类似于上述致动器266的致动器566来致动。然而，在该所示实施例中，除了调整牵开器的内部细长部分528的直径之外，致动构件560还能够调整牵开器的远侧凸缘526的直径。如图所示，致动构件560在其中延伸的牵开器518的内腔可穿过连接到内部细长部分228的腔鞘564，并且穿过设置在远侧凸缘526中的鞘531。以这种方式，致动构件560能够穿过内腔运动并选择性地实现牵开器518在内部细长部分528和远侧凸缘526的直径的改变，使得牵开器518可在第一伸展状态(如图12中内部细长部分528和远侧凸缘526的虚线所示)和第二收缩状态(如内部细长部分528和远侧凸缘526的实线所示)之间运动。具有可选择性调整的远侧凸缘可进一步有利于将牵开器518设置在组织内，并有利于从组织中移出牵开器518。与上述腔鞘264类似，围绕内部细长部分528的周边延伸的腔鞘564可在内部细长部分528的外表面上形成至少一个脊。
具有围绕装置的牵开器的周边设置的可机械调节的稳定螺纹的外科进入装置可任选包括锁紧装置，锁紧装置能够将牵开器保持在具有固定直径的固定状态。锁紧装置可具有多种形状、尺寸和构型。在具有与图11的牵开器218和致动构件260类似的牵开器和致动构件的外科装置的一个实施例中，致动器可包括类似于致动器262的柄部，但该柄部没有被构造为可自由滑动来使致动构件自由滑动，而是被构造为可以锁定，如带螺纹的柄部，其能够与牵开器218上的对应螺纹啮合，并且可旋转以调整连接到其上的致动构件的张力。
在具有可调且可锁定的牵开器直径的外科进入装置600的另一个实施例中，如图13-16所示，装置600可具有与上述外科进入装置类似的构造和用途，并且可包括类似于上述壳体的壳体612，该壳体能够在其中安装一个或多个密封口616，并以固定方式与牵开器618配合，但在一些实施例中，具有可调的和可锁定的牵开器直径的装置的壳体能够可拆卸地与牵开器配合。与上述牵开器类似，牵开器618可具有圆形、椭圆形或其他横截面形状，并且包括具有远侧凸缘626的基本上柔性的远侧部分，内部细长部分628从远侧凸缘626上向近侧延伸。该装置还可包括致动构件660形式的可调式稳定螺纹，其中致动构件660围绕牵开器618的周边设置。
该所示实施例中的壳体612包括密封基座614，密封基座614用来支承在其中形成的一个或多个密封口开口617内的至少一个密封或进入口616，它们与图1和图2的密封基座14和密封口16a、16b类似。壳体612还包括棘轮环619、内环615以及近侧牵开器耦合器621和远侧牵开器耦合器623，其中棘轮环619能够连接到致动构件660，内环615能够将棘轮环619与密封基座614配合，近侧牵开器耦合器621和远侧牵开器耦合器623能够与牵开器618接合并将牵开器618安放在两者之间，以及能够与密封基座614配合。
通常，致动构件660可具有类似于上述致动构件260和560的构造和用途，并且利用与上述致动器266和566类似的致动器666致动。该所示实施例中的致动器666能够除了牵开器的内部细长部分628之外还调整牵开器的远侧凸缘626的直径，并且也可被构造为下文将进一步论述的锁紧装置，以将牵开器618保持在具有固定直径的固定状态。如图所示，致动构件660在其中延伸的牵开器618的内腔可穿过连接到内部细长部分628的腔鞘664，并且穿过设置在远侧凸缘626内的鞘631。以该方式，致动构件660能够穿过内腔运动并选择性地实现牵开器618在内部细长部分628和远侧凸缘626的直径的改变，使得牵开器618可在第一伸展状态(如图13中内部细长部分628和远侧凸缘626的虚线所示)和第二收缩状态(如内部细长部分628和远侧凸缘626的实线所示)之间移动。与上述腔鞘264和564类似，围绕内部细长部分628的周边延伸的腔鞘664可在内部细长部分628的外表面上形成至少一个脊。
致动器666可具有多种形状、尺寸和构型。如该实施例所示，致动器666可被构造为棘轮机构，其能够致动致动构件660。致动器666可包括如图13和图15所示的棘爪670，棘爪能够至少部分地设置到在棘轮环618内形成的槽672中，并且可在槽内滑动。旋钮668可固定地或可拆卸地连接到棘爪670上，但本领域的技术人员将会知道，旋钮668可具有多种形状、尺寸和构型，例如指环、丁字梁等。旋钮668可从设置在槽672内的棘爪670伸出并穿过内环615和棘轮环619的近侧表面限定的滑动狭槽674，从而使得能从壳体612外部通过旋钮668操纵棘爪670。虽然在该实施例中旋钮668从棘爪670向近侧延伸，但旋钮668可从棘爪670向任何方向延伸，例如径向向外穿过壳体612的侧壁。滑动狭槽674可围绕装置600的周围延伸任何距离，例如，如图15所示围绕装置约345°。虽然致动器666在该实施例中连接到壳体612，但致动器666可连接到壳体612的任何部分。此外，在一些实施例中，致动器666可连接到外科进入装置的牵开器(如近侧牵开器基座)，而不是装置的壳体，这样可更容易地将壳体可拆卸地连接到牵开器。
棘爪670可包括齿670a，齿670a能够与围绕壳体612的棘轮环619周围至少一部分形成的对应齿619a啮合。该实施例所示棘爪670具有能够与三个壳体齿619a同时啮合的三个齿670a，但棘爪670可包括能够与任何数量的壳体齿619a啮合的任何数量的齿670a。致动器666也可包括在棘爪670的一侧连接到棘爪670的锁紧弹簧676，该侧与棘爪670上形成有齿670a的一侧相对。锁紧弹簧676能够在槽672的壁和棘爪670之间提供偏置力，以迫使棘爪670向壳体齿619a运动，从而将棘爪670相对于壳体612和牵开器618保持在锁紧的固定位置，直到致动致动器666，下文将对此进行进一步论述。虽然在该实施例中与棘爪670和齿619a(能够与棘爪齿670a啮合)啮合的槽672在棘轮环619内部或上面形成，但棘爪670可以可滑动地与壳体612或牵开器618的任何部分啮合，并且与棘爪670啮合的齿可在壳体612或牵开器618的任何部分上形成。本领域的技术人员将会知道，互补齿670a和619a可具有能够彼此对应啮合的任何尺寸和形状。棘爪齿670a能够相对于壳体齿619a选择性地运动，以通过使旋钮668运动选择性地调整致动构件660的张力。
致动器666可以任何方式连接至致动构件660，例如通过将致动构件660的第一末端660a连接至棘爪670。旋钮668能够至少部分地在其中设置有装置600的患者体外设置和操纵，而棘爪670则能够至少部分地设置在装置600内并与致动构件660连接，以响应旋钮668的动作(如运动、推动、拉动等)调整致动构件660的张力。
致动构件660可以从致动器666向远侧延伸，并围绕牵开器618以螺旋方式向远侧延伸，并且壳体612和/或牵开器618的一个或多个部件具有在其中或穿过其形成的、用于容纳致动构件660的开口或腔管。如图所示，致动构件660可以从棘爪670延伸，并穿过分别在棘轮环619、密封基座614和近侧牵开器耦合器621内形成的开口619b、614b和621b，然后进入可以从内部细长部分628延伸并进入近侧牵开器耦合器621的腔鞘664的内腔。
在使用时，与上文结合装置10所述类似，牵开器618可设置在组织内形成的开口中。致动器666可选择性地机械致动，以选择性地增大和/或减小致动构件660的张力，从而在将牵开器618设置在组织内之前和/或之后选择性地增大和/或减小牵开器618的直径。可以将旋钮668相对于牵开器618和/或壳体612径向向内推入，以抵消锁紧弹簧676提供的偏置力，并使棘爪670的齿670a运动，使其与棘轮环619的齿619a脱离。当互补齿619a和670a脱离后，可以将棘爪670在顺时针和/或逆时针方向穿过槽672自由滑动任何距离。使旋钮668在第一方向(如逆时针)运动进而使棘爪670在第一方向运动，可以减小致动构件660的张力，而使旋钮668和棘爪670在相反的第二方向(如顺时针)运动，则可以增大致动构件660的张力。换句话讲，使棘爪670在第一方向运动可以将致动构件660从槽672内运动一定长度，使得致动构件660可以围绕牵开器618的周边延伸更长的长度，从而允许内部细长部分628伸展。同样地，使棘爪670在第二方向运动可以将致动构件660向槽672内运动一定长度，使得致动构件660可围绕牵开器618的周边延伸更短的长度，从而收缩内部细长部分628。旋钮668可相对于牵开器618和/或壳体612径向向外运动，以重新啮合锁紧弹簧676以及重新啮合互补齿619a和670a，使得可防止棘爪670运动，使棘爪670和连接到其上的致动构件660相对于牵开器618处于固定位置，从而可将牵开器618的直径锁定在固定状态，直到随后致动致动器666以增大和/或减小牵开器618的直径。
本领域的技术人员将会知道，本文公开的任何和全部实施例都可以根据需要彼此互换。例如，示例性外科进入装置组件可包括具有一个或多个牵开器的多个壳体和密封基座。每个密封基座和壳体组合可以具有不同的活动密封口构型，从而能够根据具体应用的需要实现活动密封口运动的多种组合。可以使用本领域已知的多种释放机构以可脱开的方式将多个基座构件和壳体连接到牵开器上。
本文所公开的任何和全部外科进入装置实施例可任选地包含多种特征。例如，装置的组件(如密封基座、壳体、牵开器等)可以具有一个或多个在其上或围绕其周边形成的灯，以在插入患者体内时能够具有更佳的可视化效果。可以知道的是，可将任何波长的光用于多种应用，无论是可见光还是不可见光。在外科进入装置上或穿过其中可以包括任何数量的端口，以根据具体手术的需要使用多种外科技术和装置。例如，通过开口和端口可以引入压缩气体、真空系统、能源(如射频和超声)、冲洗、成像等。本领域的技术人员将会知道，可将任何这些技术和装置可拆卸地连接到外科进入装置上，并可以根据需要进行更换和操作。
本领域的技术人员将会知道，本文所述的实施例可以用于任何已知的和将来的外科和方法。例如，本文所公开的任何实施例可用于进行袖状胃切除术和/或胃成形术，如以下文献所述：2008年9月30日提交的、名称为“Surgical Access Device”(外科进入装置)的美国专利申请No.12/242,765；2008年9月30日提交的、名称为“Surgical Access Device with Protective Element”(具有保护元件的外科进入装置)的美国专利申请No.12/242,711；2008年9月30日提交的、名称为“Multiple Port Surgical Access Device”(多端口外科进入装置)的美国专利申请No.12/242,721；2008年9月30日提交的、名称为“Variable Surgical Access Device”(可变式外科进入装置)的美国专利申请No.12/242,726；2008年9月30日提交的、名称为“Methods and Devices for PerformingGastrectomies and Gastroplasties”(进行胃切除术和胃成形术的方法和装置)的美国专利申请No.12/242,333；2008年9月30日提交的、名称为“Methods and Devices for PerformingGastrectomies and Gastroplasties”(进行胃切除术和胃成形术的方法和装置)的美国专利申请No.12/242,353；以及2008年9月30日提交的、名称为“Methods and Devices for PerformingGastroplasties Using a Multiple Port Access Device”(使用多端口进入装置进行胃成形术的方法和装置)的美国专利申请No.12/242,381，藉此将以上所有专利申请全文以引用方式并入本文。
本文所公开的器械可被设计为单次使用后丢弃，或者它们可被设计为可使用多次。然而无论是哪种情况，该器械都可在至少使用一次后经过修复再行使用。修复可包括以下步骤的任何组合：拆卸器械，然后清洗或更换特定零件，以及重新组装。具体地讲，可拆卸装置，然后可以任何组合选择性地更换或移除任何数量的特定零件或部件，例如密封基座、壳体、近侧牵开器基座等。在清洗和/或更换特定部件后，可在修复设备上或由手术小组在紧接外科前重新组装装置，以供后续使用。本领域的技术人员将会知道，修复装置时可利用多种技术进行拆卸、清洗/更换和重新组装。这些技术的使用以及所得的经修复的装置均在本发明的范围内。
优选的是，本文所述的发明将在外科前进行处理。首先，获取新的或用过的器械，并根据需要进行清洗。然后对器械进行消毒。在一种消毒技术中，将器械置于闭合并密封的容器中，例如塑料或TYVEK袋中。然后将容器和器械置于可穿透该容器的辐射场中，例如γ辐射、X射线或高能电子。辐射将杀死器械上和容器中的细菌。然后可将消毒后的器械保存在消毒容器中。该密封容器将器械保持在无菌状态，直到在医疗设备中打开该容器。
优选对装置进行消毒。这可以通过本领域技术人员已知的多种方法来完成，包括β或γ辐射、环氧乙烷、蒸汽以及液浴(如冷浸)。
本领域技术人员根据上述各实施例，会认识到本发明的更多特征和优点。因此，本发明不受已具体示出和描述的内容所限制，而是由所附权利要求书限定。本文引述的所有出版物和参考文献都明确地以引用方式全文并入本文中。

Claims (10)

1.一种外科进入装置，包括：
近侧外面部分；
远侧部分，所述远侧部分包括柔性牵开器，所述柔性牵开器能够设置在身体组织中以形成穿过其中进入体腔的通道；和
致动构件，所述致动构件螺旋环绕所述牵开器的周边，所述致动构件能够选择性地实现所述牵开器的直径的改变。
2.根据权利要求1所述的装置，其中所述致动构件的第一末端连接至所述牵开器的远端，并且所述致动构件的第二末端延伸穿过所述近侧外面部分。
3.根据权利要求1所述的装置，还包括致动器，所述致动器能够改变所述致动构件的张力，以选择性地实现所述牵开器的直径的改变。
4.根据权利要求3所述的装置，其中所述致动器包括具有棘爪的棘轮机构，所述棘爪能够与多个齿中的至少一个啮合，所述棘爪能够运动以选择性地实现所述牵开器的直径的改变。
5.根据权利要求4所述的装置，其中所述棘爪能够在第一方向上自由滑动运动，以选择性地实现所述牵开器的直径的改变并防止在相反的第二方向上运动。
6.根据权利要求5所述的装置，其中所述棘爪能够相对于所述牵开器径向向内运动以使所述棘爪与多个齿中的所述至少一个脱离，从而使得所述棘爪能在所述第一方向上或所述第二方向上运动以与所述多个齿中的至少另一个啮合。
7.根据权利要求1所述的装置，其中选择性地实现所述牵开器的直径的改变不会显著影响所述牵开器的纵向长度。
8.根据权利要求1所述的装置，其中所述牵开器具有穿过其侧壁延伸的内腔，所述致动构件设置在所述内腔内。
9.根据权利要求1所述的装置，其中所述牵开器在缺省状态下具有第一直径，并且其中在所述牵开器处于缺省状态的情况下致动所述致动构件是将所述牵开器运动至第二状态，在所述第二状态下，所述牵开器具有小于所述第一直径的第二直径。
10.根据权利要求1所述的装置，其中所述牵开器在缺省状态下具有第一直径，并且其中在所述牵开器处于缺省状态的情况下致动所述致动构件是将所述牵开器运动至第二状态，在所述第二状态下，所述牵开器具有大于所述第一直径的第二直径。
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US8257251B2 (en) 2012-09-04

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