CN103393449A - 用于外科手术中的密封锚定件 - Google Patents

用于外科手术中的密封锚定件 Download PDF

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CN103393449A
CN103393449A CN2013100446380A CN201310044638A CN103393449A CN 103393449 A CN103393449 A CN 103393449A CN 2013100446380 A CN2013100446380 A CN 2013100446380A CN 201310044638 A CN201310044638 A CN 201310044638A CN 103393449 A CN103393449 A CN 103393449A
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CN103393449B (zh
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保罗·D·理查德
鲁塞尔·海因里希
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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
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • 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
    • A61B17/3498—Valves therefor, e.g. flapper valves, slide valves
    • 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
    • A61B17/3431—Cannulas being collapsible, e.g. made of thin flexible material
    • 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
    • A61B2017/3429—Access ports, e.g. toroid shape introducers for instruments or hands having a unitary compressible body, e.g. made of silicone or foam
    • 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
    • A61B17/3417—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
    • A61B2017/3447—Linked multiple cannulas
    • 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
    • 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
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
    • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
    • A61B2017/3486—Balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/0208—Subcutaneous access sites for injecting or removing fluids
    • A61M2039/0223—Subcutaneous access sites for injecting or removing fluids having means for anchoring the subcutaneous access site

Abstract

本发明公开了一种用于外科手术中的密封锚定件，特别是一种能放置在组织管道内的手术设备，其包括：密封锚定部件，其包括近侧部和远侧部以及处于近侧部和远侧部之间的中间部，并且限定了在近侧部和远侧部之间延伸的纵轴，至少一个端口纵向延伸通过所述中间部，其中所述中间部的径向尺寸小于所述近侧部和远侧部的径向尺寸并且沿所述近侧部和远侧部之间的纵向轴变化，从而便于将所述密封锚定部件锚定在组织内。

Description

用于外科手术中的密封锚定件
本申请是申请号为200810176910.X、申请日为2008年10月6日、发明名称为“用于外科手术中的密封锚定件”的专利申请的分案申请。
相关申请的引用
本申请要求于2008年6月26日提交的题目为“用于外科手术中的密封锚定件”的申请号为61/075,867的美国临时申请和于2007年10月5日提交的题目为“用于单个切口手术中的密封锚定件”的申请号为60/997,885的美国临时申请的权益和优先权，其全文被在此引用作为参考。
技术领域
本公开涉及一种用于外科手术中的密封件。本公开尤其涉及一种密封锚定部件，其适于插入组织内的切口，并适于密封地接收一个或者多个手术实物以使组织和一个或多个手术实物形成充分的流体密封。
背景技术
如今，很多外科手术通过在皮肤上的小切口来执行，与传统的手术中要求典型的较大切口相比，其目的在于减少患者的外伤以及康复时间。这样的手术一般称为“内窥镜式”，除非是在患者的腹部上执行，而这种情况下的手术称为“腹腔镜式”。在本公开中，术语“微创”应当被理解为包括内窥镜式和腹腔镜式。
在典型的微创手术过程中，手术实物，例如手术通路器件，诸如套管针、套管组件或者内窥镜，通过组织内的切口被插入患者的体内。一般地，在向患者体内引入手术实物之前，首先注入气体用来扩大目标手术部位周围的区域以形成一个更大、更易接近的工作区域。因此，为了阻止注入气体的逸出和扩大的手术部位的缩小或塌陷，保持充分地流体的密封是值得的。
为此，各种各样的阀和密封件被用于微创手术过程中，并且广泛地被本领域技术人员所公知。然而，对能在保持注入气体工作空间的完整性的同时可以直接插入组织内的切口并且可以容纳不同的手术实物的密封锚定部件的持续的需求仍然存在。
发明内容
对本领域技术人员而言，这里公开的装置的这些或者其它特征，从下面本公开的不同实施例的详细描述中，将更容易变得明显。因此，一种用于放置在接近下层体腔的组织管道内的手术装置包括包含可压缩材料并适于在易于密封锚定部件在组织管道内固定以及与限定该组织管道的组织表面充分密封的第一扩展状态和易于密封锚定部件至少部分插入到该组织管道内的第二压缩状态之间转变的密封锚定部件。密封锚定部件限定了纵轴，并具有带有在其间延伸的至少一个纵向端口的前端和后端。
该密封锚定部件的前端和后端中的至少一个呈现弓形结构，该弓形结构可以是凹面的或者是凸面的。在一个实施例中，前端和后端中的每一个都呈现弓形结构以便于密封锚定部件插入组织管道内。
所述至少一个纵向端口可以包括多个纵向端口，其关于纵轴对称地配置、相对纵轴等距间隔、相互之间等距间隔，或者上述配置的任意组合。
密封锚定部件可以由泡沫材料形成，泡沫材料至少部分地由选自下列材料集合中的一种材料构成：聚异戊二烯、聚氨酯、硅树脂。作为可选择方案，密封锚定部件也可以由凝胶材料形成。
附图说明
本公开的不同实施例参考附图在下文中进行描述，其中：
图1是示出了相对组织放置的密封锚定部件的被示为处于扩展状态的根据本公开的原理的手术装置的前立体图；
图2是沿图1中的2-2线截取的图1中的密封锚定部件剖视图，示出了贯穿纵向延伸的端口；
图3是手术实物插入其中的图2中的端口中的图；
图4是示出了在插入组织切口之前并处于压缩状态下的图1中的密封锚定部件的立体图；
图5是示出了在插入切口后并且处于扩展状态下的密封锚定部件的前立体图；
图6是用于插入密封锚定部件的纵向延伸的端口内的示例套管的分解立体图；
图7是说明了密封锚定部件和可膨胀流体膜的图1中的手术装置的一个可选实施例的前立体图；
图7A是该流体膜的流体端口的前立体图；
图7B是图7A中的流体端口在阀处于打开位置的前立体图；以及
图8是在插入切口之前处于压缩状态下的外科手术装置的密封锚定部件的前立体图。
图9是具有凹的近端部和远端部的图1中的密封锚定部件的一个可选实施例的俯视立体图。
图10是图9中的密封锚定部件的侧视图；
图11是图9中的密封锚定部件的俯视图；
图12是沿图11中线12-12截取的图9中的密封锚定部件的剖视图，图示了贯穿纵向延伸的端口；
图13是图9中的密封锚定部件沿附图10中的线13-13截取的剖视图；
图14是具有凸起的近端部和远端部的图1中密封锚定部件的另一个实施例的前立体图；
图15是示出了手术实物插入贯穿纵向延伸的端口中的一个的处于的扩展状态下的图1中的密封锚定部件的另一个实施例的俯视立体图；
图16是图15中的密封锚定部件沿线16-16截取的立体剖视图；
图17是示出了手术实物插入贯穿纵向延伸的端口中的一个的处于的扩展状态下的图1中的密封锚定部件的另一实施例的俯视立体图；
图18是图17中的密封锚定部件沿线18-18截取的立体截面图；
图19是包括贯穿纵向延伸的入口和出口的图1中所示的密封锚定部件的另一实施例的俯视立体图；
图20是放置在患者的组织内的图19中的密封锚定部件的侧视立体图；
图21是用于插入图19中的密封锚定部件的一个实施例的入口中的套管组件的侧视立体图；
图22说明了包括图19中的密封锚定部件和放置在多个套管内的多个密闭装置的根据本公开的原理的第一套件；
图23说明了图22中的套件的一个可选实施例；
图24说明了包括密封锚定部件和注入/排出工具的外科手术套件的另一个可选实施例；
图25是图24中的手术套件的密封锚定部件和注入/排出工具的俯视平面图；
图26是密封锚定部件和注入/排出工具沿图25中的线26-26截取的侧视剖视图；
图27说明了并入图24-26中的手术套件内的另外的装置；以及
图28A-28C说明了图24-27中的手术套件的使用方法。
具体实施方式
在下述附图和描述中，如同本领域技术人员所公知的，相同的附图标记标识相似或相同的元件，术语“近端”指的是装置在使用过程中靠近临床医生的端，而术语“远端”指的是远离临床医生的端。
参考图1-3，说明了用于例如微创手术的外科手术中的手术装置10。手术装置10包括密封锚定部件100，其限定了纵轴“A”并具有后端（或者近端）102和前端（或者远端）104，以及布置在后端102和前端104之间的中间部106。密封锚定部件100包括一个或多个在后端102和前端104之间纵向延伸并通过密封锚定部件100的端口108。
密封锚定部件100优选为由合适的泡沫材料形成，其具有充分的适应性以关于一般示出为手术实物“I”（见图3）的一个或者多个手术实物形成密封，并且同时建立与组织相关的密封。该泡沫优选具有充分的适应性以容纳手术实物“I”的远离轴线运动。在一个实施例中，泡沫材料包括聚异戊二烯材料。
密封锚定部件的近端102限定了第一直径D1，而远端104限定了第二直径D2。在密封锚定部件100的一个实施例中，近端102的第一直径D1和远端104的第二直径D2大体相等，参见图1，尽管直径D1和D2不同的密封锚定部件100的实施例也在本公开的范围之内。如图1所描述的，近端102和远端104限定了大体平面的表面。然而，这里还考虑的实施例为，近端102和远端104中的任意一个或者两个限定了大体弓形的表面以帮助密封锚定部件100插入由组织表面14所限定并在组织“T”中形成的组织管道12内的实施例，例如，如下面更详细地讨论的切口。
中间部106限定了径向尺寸“R”，并在近端102和远端104之间纵向延伸以限定轴向尺寸或者长度“L”。中间部106的径向尺寸“R”沿轴向尺寸或者长度“L”变化。因此，如在下面更详细地讨论的，密封锚定部件100限定了便于密封锚定部件100锚定在组织“T”内的沿其长度“L”变化的横截面的尺寸。然而，径向尺寸R沿轴向尺寸“L”保持大体一致的密封锚定部件100的实施例也在本公开的范围内。
如在下面更详细地讨论的，中间部106的径向尺寸“R”优选小于近端102和远端104的相应的直径D1和D2以使密封锚定部件100限定“沙漏形状”或者结构以帮助密封锚定部件100锚定在组织“T”内。然而，在一个可选实施例中，中间部106的径向尺寸“R”可以与近端102的直径D1以及远端104的D2大体相同。在横截面中，中间部106可展示为任意合适的结构，例如，大体圆形的、椭圆形的或长方形的。
每个端口108配置为可移动地接收手术实物“I”。在插入手术实物“I”之前，端口108处于第一状态，在此状态下，端口108限定了第一或者初始尺寸DP1。DP1一般大约为0mm以使在手术实物“I”不存在的情况下充分阻止注入气体（未示出）通过密封锚定部件100的端口108而逸出。例如，端口108可以是穿过近端102和远端104沿密封锚定部件100的纵向长度延伸的裂缝。可选择地，端口108可以限定具有初始的打开状态的密封锚定部件100内的开口。引入手术实物“I”后，端口108转变为第二状态，在此第二状态下，端口108限定了更大的第二尺寸DP2，其大体接近手术实物“I”的直径DI以使在其中形成充分地流体的密封，从而充分阻止注入气体（未示出）在手术实物“I”存在的情况下通过密封锚定部件100的端口108而逸出。DI和DP2一般在大约5mm到大约12mm的范围内，因为这些尺寸是在微创手术的过程中所使用的手术实物的典型尺寸。然而，包括可以在其第二状态下呈现充分更大或充分更小的尺寸的端口108的密封锚定部件100，也没有超过本公开的范围。另外，密封锚定部件100也可以不具有端口108。在此布置下，在手术实物“I”的插入过程中端口108在密封锚定部件100内形成。根据该实施例，密封锚定部件100由易流动的材料形成或者由具有充分适应的材料形成，例如泡沫材料，诸如开孔聚氨酯泡沫、热塑性弹性体（TPE）或者凝胶。密封锚定部件100的形成可以包括例如CO2或者氮的惰性气体由此注入到材料中以形成泡沫结构的过程。为了便于工具和/或套管的贯穿插入，密封锚定部件100还可以涂上例如聚对二甲苯或者聚氯代对二甲苯的光滑的涂层。
现在参考图1和4，密封锚定部件100适于从扩展状态（图1）转变为压缩状态（图4）以便于其在组织“T”中的组织管道12内的插入以及稳定性。在扩展状态下，密封锚定部件100静止并且密封锚定部件100的近端102的直径D1和远端104的直径D2以及中间部106的径向尺寸R使得密封锚定部件100不能够插入到组织管道12内。然而，参见图4，在压缩状态下，密封锚定部件100的近端102和远端104以及中间部106被确定尺寸以使其能够插入组织管道12内。
密封锚定部件100由生物相容的可压缩材料形成，以便于密封锚定件100在扩展状态和压缩状态之间实现相应的、弹性的转变。在一个实施例中，可压缩材料是“记忆”泡沫。外部力“F”施加到密封锚定部件100以使得密封锚定部件100呈现为压缩状态。外部力“F”指向内并且当作用于密封锚定部件100例如当挤压密封锚定部件100时，密封锚定部件100经受明显的形变程度，从而转变为压缩状态。
如图4所描述的，由于密封锚定部件100在外部力“F”的影响下被压缩，因此在密封锚定部件100的内部产生了与力“F”相反的朝向外的内部偏向力“FB1”。内部偏向力“FB1”尽力扩展密封锚定部件100从而使密封锚定部件100恢复到其扩展状态。因此，只要外部力“F”作用于密封锚定部件100，密封锚定部件100将保持压缩状态。然而，撤去外部力“F”之后，偏向力“FB1”使得密封锚定部件100恢复到扩展状态。
包括密封锚定部件100的可压缩材料同样便于端口108在其第一闭合状态（图1-2）和其第二状态（图3）之间的弹性转变。如之前所讨论的，在插入手术实物“I”之前，端口108处于其第一状态，在此状态下，端口108限定了第一或者初始尺寸DP1。端口108可以合并沿密封锚定部件100的纵向长度延伸的裂缝。在此第一状态下，端口108处于静止并且没有受到任何外力的作用。然而，如图3所描述的，通过端口108引入手术实物“I”后，手术实物“I”在端口108上施加沿径向向外的力“FI”。力“FI”作用旨在扩大端口108的尺寸，从而使端口108转变为其第二状态，在第二状态下，端口108限定了较大的第二尺寸DP2，其充分接近手术实物“I”的直径DI。因此，产生了与力“FI”相反的沿径向向内的内部偏向力“FB2”。内部偏向力“FB2”尽力恢复端口108以减小端口108的内部尺寸，从而使得端口108恢复到其第一状态。内部偏向力“FB2”施加到手术实物“I”，并旨在于此创建充分地流体的密封。力“FB1”和力“FB2”的重要性将在下面进行更详细的讨论。
再次参考图1，一个或者多个定位部件114可以与密封锚定部件100的后端（或者近端）102和远端（或者前端）104中的一个或者两个结合。定位部件114可以由任何合适的至少半弹性的生物相容的材料组成以使该定位部件114可以弹性变形并且可以呈现为任意合适的结构，例如，大体上的环形或者椭圆形。在插入密封锚定部件100之前，定位部件114连同密封锚定部件100的近端102和远端104一起变形以便于更好地通过组织管道12而推进（图4）。在密封锚定部件100插入组织管道12内之后，定位部件114的弹性本质允许定位部件114恢复到其正常的、大体上的环形的结构，从而协助近端102和远端104中的至少一个或两个的扩展以及便于密封锚定部件100从其压缩状态转变为其扩展状态。定位部件114还接合限定了体腔的壁以进一步便于密封锚定部件100在人体组织内的稳定性。例如，前端104处的定位部件114可以接合内部腹膜壁而邻近后端102的定位部件114可以接合邻近组织“T”内的切口12的外部外部表皮的组织。在密封锚定部件100的另一个实施例中，可以有一个或者多个另外的定位部件114与中间部106结合。
密封锚定部件100的使用和功能将在典型的微创手术过程中加以讨论。开始，腹膜腔（未示出）被注入合适的生物相容的气体，例如CO2气体，使得内腔壁被升起并脱离内部器官和其覆盖的组织以便更好地接入。注入气体的过程可以用注入针或者在本领域中传统使用的相似器件来实现。组织管道12在注入前或注入后在组织“T”内被创建，其尺寸根据手术的实际需求而变化。
在向组织管道12内插入密封锚定部件100之前，密封锚定部件100处于其扩展状态，在此状态下，其尺寸阻止密封锚定部件100插入组织管道12。为便于插入，临床医生通过在其上施加力“F”，例如挤压密封锚定部件100，使得密封锚定部件100转变为压缩状态。力“F”旨在分别将近端102的包括定位部件114（如果设置的话）的径向尺寸减小至D1’和将远端104的包括定位部件114（如果设置的话）的径向尺寸减小至D2’(图4)以将中间部106的径向尺寸减小至R’，以使密封锚定部件100可以插入组织管道12。如图5中最佳描述的，在其插入之后，远端104、定位部件114（如果提供的话），以及中间部106的至少一部分112布置在组织“T”之下。密封锚定部件100通过从此去除力“F”从压缩状态转变为扩展状态。
在从压缩状态转变为扩展状态的过程中，密封锚定部件100的尺寸，即近端102的径向尺寸D1’（图4）和远端104的径向尺寸D2’（图4）相应增加到D1和D2（图5），而径向尺寸R’增加到R。在组织“T”下布置的远端104的扩展没有被相对地限制，因此，在没有完全展开的情况下，允许远端104大体展开。然而，参考图5，限定组织管道12的组织表面14（图1）限制了中间部106的一部分112的扩展，从而向中间部106施加方向向内的外部力“F”。如以上所讨论的，这将导致产生内部偏向力“FB1”，其方向指向外并且施加到组织表面14上，从而产生密封锚定部件100和组织表面14之间充分地流体的密封并且充分阻止注入气体在密封锚定部件100周围通过组织管道12而逸出。
在扩展状态下，近端102的径向尺寸D1和远端104的径向尺寸D2充分大于中间部106的径向尺寸R，从而使得密封锚定部件100具有前述的“沙漏”结构。在插入之后，远端104的径向尺寸D2和定位部件114同样充分大于组织管道12的尺寸。因此，在扩展状态下，密封锚定部件100可以不从组织管道12中移除，这样，密封锚定部件100将一直保持锚定在组织“T”内，直到其恢复到其压缩状态。
在密封锚定部件100成功锚定在患者的组织“T”内后，一个或者多个手术实物“I”可通过端口108而插入。图5说明了手术实物“I”通过端口108中的一个端口而引入。如同上文所描述的，在插入手术实物“I”之前，端口108处于其第一状态，在此状态下，端口108限定了在该端口108内可以忽略的初始尺寸DP1，在一个实施例中，其是纵向裂缝。因此，在注入气体通过端口108逸出之前，在没有手术实物“I”存在的情况下，是最小的，从而保持注入气体的工作空间的完整性。
手术实物“I”可以是任何合适的手术工具，因此可具有不同的尺寸。在一个或者多个端口108内引入的合适的手术实物包括微创手术抓紧器工具、手术钳、夹-填充器、吻合器等等。进一步可以预期，手术实物还包括如图6所描述的传统套管1000。套管1000配置为可移动地插入端口108中并包括近端1002、远端1004、在近端1002和远端1004之间布置的轴或者伸长部件1006，以及密封壳体1008。伸长部件1006限定了贯穿纵向延伸的开口1010，开口1010的尺寸允许其作为例如密闭装置的手术设备（未示出）的通道。在密封壳体1008内布置有工具密封件1012，其适于接收插入纵向开口1010的手术设备以便与其形成充分地流体的密封。套管1000进一步包括关闭阀1014，关闭阀1014偏向闭合的位置，但是在手术设备插入纵向开口1010时适于打开以允许手术设备贯穿通过。在闭合位置中，例如，在不存在手术设备时，闭合阀1014阻止注入气体的连通。
引入例如套管1000的手术实物“I”后，端口108被扩大，从而转变为其第二状态，在此第二状态下，端口108限定了第二尺寸DP2（图3），第二尺寸DP2充分接近手术实物“I”的直径DI，从而与手术实物“I”创建充分地流体的密封并且充分阻止注入气体（未示出）在手术实物“I”存在的情况下通过密封锚定部件100的端口108而逸出，如前面所讨论的。
参考图7-8，公开了密封锚定部件200的一个可选实施例。密封锚定部件200包括合适的弹性材料，例如泡沫材料，或可选择的，例如凝胶材料。密封锚定部件200、近端202、远端204以及布置在近端和远端之间的中间部206。密封锚定部件200进一步包括限定了内腔210的可扩展膜208。膜208可以是例如大体环形或者圆环形结构，虽然任何想得到的形状都可以使用，并可以被固定、连接或嵌入到密封锚定部件200的泡沫材料或者凝胶材料上。在一个实施例中，膜208包围泡沫或者凝胶部分212，从而限定了密封锚定部件200的外围。一个或者多个流体端口214与膜208的内腔210连通，并且一个或多个纵向端口216通过密封锚定部件200的泡沫部分212而延伸。
由膜208限定的内腔210配置为将流体保持在其中。膜208可以由任何具有充分弹性的合适的生物相容的材料形成以允许流体的流入或者流出内腔210，从而引起其扩展和收缩。另外，组成膜208的材料关于流体大体是不渗透的以确保流体仅仅通过流体端口214流入和流出内腔。
流体端口214适于连接到流体源218。流体端口214可以是适合预期目的的任何部件或结构。虽然上述描述中仅包含了单个的流体端口214，但在一个可选实施例中，密封锚定部件200可以例如在近端202和远端204的每一个上分别包括另外的流体端口。流体端口214同样可以包括阀220，阀220选择地可放置在打开位置（图7A）和闭合位置（附图7B）之间以调节流体通过流体端口214流入或者流出内腔210的流动。
如同上述关于图1-6对密封锚定部件100的论述，密封锚定部件200适于从扩展状态（图7）转变为压缩状态（图8）。在压缩状态下（图8），密封锚定部件200配置为以与如上讨论的关于密封锚定部件100（附图1-5）的类似的方式，插入到组织“T”中的组织管道12内。密封锚定部件200凭借密封锚定部件200的泡沫部212放置在组织“T”内，并呈现扩展状态。流体端口214可以连接到流体源216（图7），并且流体流通到由膜208限定的内腔210。由于内腔210充满流体，因此内腔210的尺寸和膜208的尺寸被扩大，从而促使密封锚定部件200的外表面向外展并且在切口“I”内建立密封。
现在参考图9-13，公开了密封锚定部件300的另一个实施例。密封锚定部件300沿通过其中点“C”的纵轴“A”而延伸。密封锚定部件300限定了沿着纵轴“A”测量的总轴向尺寸“H”。该总轴向尺寸“H”一般将大体位于大约25mm至大约75mm的范围之内，并且理想地近似等于50mm。然而，本公开同样预期了限定了充分更大或者充分更小的总轴向尺寸“H”的密封锚定部件300。
如同前述实施例中的每一个，组成密封锚定件300的材料是充分适应的以容纳贯穿插入的一个或多个手术实物“I”的远离轴线运动，其在使用密封锚定部件300的微创手术过程中可能是必要的。在一个实施例中，密封锚定部件300由合适的泡沫材料形成，该泡沫材料至少部分地由聚异戊二烯、聚氨酯或硅树脂之类物质构成。可选择地，密封锚定部件300可以由生物相容的凝胶形成。
如同前述实施例，密封锚定部件300包括后端（或近端）302、前端（或远端）304、布置在近端302和远端304之间的中间部306以及一个或者多个在后端302和前端304之间纵向延伸并通过密封锚定部件300的端口308。
密封锚定部件300的近端302限定了第一径向尺寸D1和第一轴向尺寸H1，而远端304限定了第二径向尺寸D2和第二轴向尺寸H2。本公开预期分别具有限定了一般大体位于大约25mm至大约75mm的范围之内的径向尺寸D1、D2和一般大体位于大约6mm至大约11mm的范围之内的轴向尺寸H1、H2的近端302和远端304的密封锚定部件300。然而，理想地，密封锚定部件300包括分别具有大约等于50mm的径向尺寸D1、D2和大约等于8.5mm的轴向尺寸H1、H2的近端302和远端304。具有限定了充分更大或者充分更小的径向尺寸以及轴向尺寸近端102和远端104的密封锚定部件300同样在本公开的范围之内。
在图9-13所说明的实施例中，密封锚定部件300包括分别具有大体相等的第一径向尺寸D1和第二径向尺寸D2的近端302和远端304。然而，这里同样可以预期包括分别具有第一径向尺寸D1和第二径向尺寸D2的近端302和远端304的密封锚定件300的实施例。
密封锚定部件300的中间部306限定了一般大体位于大约20mm至大约50mm的范围内的径向尺寸“R”和一般大体位于大约10mm至40mm的范围内的轴向尺寸“L”。而中间部306的径向尺寸“R”和轴向尺寸“L”分别近似等于35mm和25mm是理想的，具有限定了充分大或者充分小的径向尺寸“R”和轴向尺寸“L”的中间部306的密封锚定部件300没有超出本公开的范围。中间部306的径向尺寸“R”沿其纵向尺寸“L”方向可以大体一致或者发生变化，并且可以分别略微小于、大于或者等于前述的近端302的径向尺寸D1和远端304的径向尺寸D2。
如同前述实施例中的每一个，一个或者多个端口308配置来可移动地接收手术实物“I”（未示出），并且在手术实物“I”插入之前，每一个端口308限定了初始尺寸DP1。初始尺寸DP1一般大体位于近似0mm至近似13mm的范围内，理想地是近似等于6.5mm。然而，具有限定了充分更大的初始尺寸DP1的端口308的密封锚定部件300也没有超出本公开的范围。在利用限定了近似等于0mm的初始尺寸DP1的端口308的密封锚定部件300的那些实施例中，在手术实物“I”不存在时，可以充分阻止注入气体（未示出）通过端口而逸出。
密封锚定部件300可以包括多个关于纵轴“A”对称排列的端口308。进一步可以预期，每个端口308可以相对纵轴“A”等距地布置。在一个实施例中，每个端口308布置在相距纵轴“A一般大体位于近似6mm至近似11mm的范围内并且理想地近似等于8.5mm的距离D处。然而，在一个可选实施例中，密封锚定部件300可以包括布置在相距纵轴“A”更远或者更近的端口308。端口308可以排列成彼此等距的，或可选择的，相邻的端口308之间的距离也是可以变化的。
密封锚定部件300的近端302和远端304中的任意一个或者两个限定了例如参见图9-13所示的凹面的大体弓形的表面以便于密封锚定部件300插入由组织表面14限定并在组织“T”内形成的组织管道12（图1），例如，如上文所讨论的切口。例如，所述凹面的方向可以帮助引导手术工具朝向端口308中的一个端口并同时对存在于密封锚定部件300的近端302的外边界中的工具的尖端进行限制。在一个可选方案中，近端302和远端304中的任意一个或者两个可以是凸面的，参见图14。
现在参考图15-16，公开了密封锚定部件400的另一个实施例。密封锚定部件400包括近端402、远端404、布置在近端402和远端404之间的中间部406，以及一个或者多个一般为管状的端口段408，端口段408限定了通过密封锚定部件400纵向延伸并且位于近端402和远端404之间的端口408a。密封锚定部件400与图1-5中所说明的密封锚定部件100大体类似，因此，这里只讨论两者之间的不同之处。
在一个实施例中，参见图15-16，密封锚定部件400限定了相应的近端边缘410和远端边缘412。近端边缘410和远端边缘412便于密封锚定部件400从扩展状态（图15-16）变形为压缩状态（未示出），以及便于密封锚定部件400在组织内的锚定，如同前文参考图1-5中说明的有关密封锚定部件100的讨论。
管状端口段408通过连接部件414固定到中间部406使得端口段408的纵向位置在插入或者移出手术实物“I”的过程中关于近端边缘410和远端边缘412保持大体一致。在图15-16所说明的实施例中，连接部件414从中间部406向内延伸并在其中点“M”处连接到端口408，中点“M”相对近端边缘410和远端边缘412是等距的。在不同的实施例中，连接部件414可以由与组成密封锚定件400的材料相同的材料组成，或者可选择的，连接部件414可以由充分地更加刚性的材料组成以抑制手术实物“I”在插入端口408中一个端口后的远离轴线运动，或者由充分地更小刚性的材料组成以便于手术实物“I”的远离轴线运动。
在图15-16所说明的实施例中，端口408沿密封锚定部件400限定的纵轴“A”纵向延伸使得端口408的近端416与近端边缘402共面以及端口408的远端418与远端边缘404共面。然而，于此同样可以预期的是，端口408的近端416和远端418分别超过近端边缘402和远端边缘404延伸使得近端416和远端418至少部分地从中间部406处起延伸的实施例，以及端口408的近端416和远端418被完全限定在中间部406的范围内的实施例。
现在参考图17-18，在一个可选的实施例中，连接部件414从远端边缘412处起向内延伸，并在其末端418处连接到端口408。为进一步限制手术实物“I”插入后的远离轴线运动，连接部件414可以沿着端口408的长度充分延伸，如图所示。例如，端口408的近端416和远端418中的任意一个或两个可以是倾斜的以便于手术实物“I”的插入和移除。
图19-20说明了一般由附图标记500涉及的密封锚定部件的一个可选实施例。密封锚定部件500与以上关于图9-14所讨论的密封锚定部件300大体相似，因此，这里仅仅讨论两者的不同之处。
密封锚定部件500包括通过密封锚定部件500纵向延伸的入口502和出口504。入口502便于流体通过密封锚定部件500以及进入位于患者的组织“T”下的手术部位“W”的流通。在一个实施例中，入口502被配置和设定尺寸为可移出地接收管组件600（图21）以便于手术部位“W”的气体注入。相比之下，出口504便于例如烟尘的流体通过密封锚定部件500以及离开手术部位“W”的流通。为了充分限制流体进出手术部位“W”，入口502和出口504可以分别包括单向阀（未示出），例如鸭嘴阀或者零闭合阀（zero closure valves）。可选择的，入口502和出口504可以通常偏向闭合状态。
现在参考图22-23，根据本公开的套件包括密封锚定部件、一个或者多个套管、一个或者多个密闭装置连同其使用说明“IFU”。在一个实施例中，公开了包括关于图19-20所讨论的密封锚定部件500、各自限定5mm的外径“DA”的三个套管800A以及配置为可移动地插入套管800A的三个密闭装置900A的第一套件700A。在另一个实施例中，公开了第二套件700B，其包括关于图22-23所讨论的密封锚定部件500、各自限定5mm的外径“DB1”的两个套管800B1、配置为可移动地插入套管800B1的两个密闭装置900B1、限定一个12mm的外径“DB2”的单个套管800B2以及配置为可移动地插入套管800B2的单个密闭装置900B2。
套件部件可以典型地保持在消过毒的包装内，单组件可以放置在一起，也可以分别地放置在不同的消过毒的容器中。通常，即便当放置在分离的消过毒的容器中时，套件中的所有组件也都放置在同一个包装中。使用说明“IFU”可以以单个印刷单的形式提供，例如传统的包装插入物，或者可以整个或部分地印刷在包装或器件的其它部分。
虽然套件700A、700B被描述为包括密封锚定部件500和三个具有相应特定尺寸的密闭装置的套管，但是应当可以理解，根据本公开的套件可以可选择地包括以上讨论的任意密封锚定部件与任意理想数量的套管以及任意合适尺寸的密闭装置的组合。
图24-26说明了手术套件的另一个实施例，手术套件1000包括密封锚定部件1100和例如注气工具/排气工具的流体输送工具1200，流体输送工具1200放置在密封锚定部件1100内。密封锚定部件1100包括多个通过密封锚定部件1100延伸的通道1102（例如示出的四个）。通道1102可以关于纵轴“k”大体平行地延伸。在一个可选的方案中，通道1102可以关于纵轴“k”倾斜以便为密封锚定部件1100提供特定方向上的能力，由此工具可以相对纵轴“k”在预定角度的方向上被推进。通道1102可以关于密封锚定部件1100相对纵轴“k”而径向放置。一方面，通道1102相隔预定的距离放置，该预定的距离足以相应地隔开被引入密封锚定部件1100内的工具。这种间隔可以充分最小化插入工具之间接合的潜在可能性和加强在上述可操作区域运动的自由度。通道1102可以是限定在密封锚定部件1100内的纵向孔。纵向孔可以在初始状态或者静止状态下打开。在可选择的方案中，通道1102可以限定裂缝或者单个阀，例如零闭合阀（zero closure valves），其在不存在插入实物时的正常状态下关闭。在此实施例中，通道1102可以打开以允许手术实物的通道。在其它情况下，一旦手术实物或者工具被引入，限定通道1102的内表面关于手术实物建立充分地流体的密封。
密封锚定部件1100限定了大体上沙漏状的结构并且结合扩大的前端凸缘段1104和后端凸缘段1106以帮助保持在体腔中。前端面1108和后端面1110可以如图所示是凹入的并且/或可以具有任意数量或者形状以提供密封锚定部件1100的可压缩性或者任何插入其中的工具的移动的自由度的提高。密封锚定部件1100可以由包括泡沫、凝胶之类的任何前文所提及的材料制成。
注入/排气工具1200适于放置在通道1102中的至少一个内。注入/排气工具1200可以是任何合适的工具，该工具适于输送流体或者注入例如CO2的气体至腹膜腔内，并且/或者从腔排出烟尘。在此描述的实施例中，注入工具1200包括壳体1202和从壳体1202延伸的伸长部件1204。壳体1202可以由任何合适的材料制成并且结合活栓阀1206以允许例如贯穿通过的注入气体或者烟尘的流体可选择地通过和中断。壳体1202包括邻近活栓阀1204的第一和第二端口或者露尔（Luer）连接器1208、1210。第一露尔（Luer）连接器1208可适于到例如用于吹入人体腹腔的CO2的注入气体源1212的连接。第二露尔（Luer）连接器1210可适于与抽吸装置或者气体（例如烟尘）排出装置1214建立流体连接。活栓阀1206可以限定开口1216，开口1216通过选择地旋转活栓阀1206与端口或露尔（Luer）连接器1208、1210中的任意一个对齐，从而选择地流体地连接气体注入源1212或排出装置1214。第一露尔（Luer）连接器1208和第二露尔（Luer）连接器1210可以围绕大体互相垂直的轴线排列。其它方向也是可以考虑。
伸长部件1204包括连接到壳体1202的第一延长段1216和从第一延长段1216继续延伸的第二延长段1218。第一延长段1216和第二延长段1218可以大体上相互对齐。在可选择方案中，第一延长段1216和第二延长段1218可以相对彼此成一个预定的角度。在一个实施例中，第一延长段1216和第二延长段1218大体成直角或者相互垂直排列。此排列可以便于从手术区域转移壳体1202和第一延长段1216，从而减小密封锚定部件1100和注入/排出工具1200的整体轮廓。伸长部件1204限定了通过第一延长段1216和第二延长段1218而延伸并与活栓阀1206连通的流体管道。第一延长段1216和第二延长段1218之间可拆开地装接在一起。
注入/排出工具1200可以是放置在通道1102中一个通道内的分离的工具。在可选方案中，密封锚定部件1100和注入/排出工具1100可以预先组装在一起，由此注入/排出工具1100可以永久地连接在密封锚定部件1100。在一个实施例中，注入/排出工具1200的第二延长段1218包括围绕第二延长段1218的外围安装的外部的锚定件1220a、1220b。锚定件1220a、1220b可以便于注入/排出工具1200的第二延长段1218保持在密封锚定部件1110内。锚定件1220a、1220b在结构上可以大致呈环形，或者可以由从第二延长段1218向外伸展的多个单独的叉组成。锚定件1220a、1220b的尺寸设计为嵌入到限定了容纳注入/排出工具的通道1102的内表面。在邻近其近端处，后端锚定件1220a可以限定扩大的尺寸以防止注入/排出工具1200的移出或者后退。在邻近其远端处，前端锚定件1220b可以限定扩大的尺寸以阻止注入/排出工具1200的过分插入。
现在参考图27，其说明了可以结合到手术套件1000内的另外的设备。手术套件1000可以进一步包括第一套管1300和第二套管1302以及分别与第一套管1300和第二套管1302一起使用的第一密闭装置1304和第二密闭装置1306。第一套管1300可以是5mm的套管，其适于接收直径不超过5mm的设备。第一密闭装置1304放置在第一套管1300内以便于推进第一套管1300通过密封锚定部件1100的通道1102中的一个通道。第二套管1302可以是12mm的套管，其适于接纳直径不超过12mm的设备，并通过同等尺寸设计的第二密闭装置1306的使用，在密封锚定部件1100内被推进。第二锚定件可以结合密封机构，例如共同转让给Racenet的公开号为2007/0197972的美国专利中所公开的密封系统，其全部内容在此合并引入作为参考。手术套件1000可以结合三个或者更多个带有相应密闭装置的套管。任何大小的套管和密闭装置的组合是可以考虑的。
图28A-28C公开了手术套件的一种使用方法。在例如腹部组织的组织内作出切口，以及通过公知方法来实现通过筋膜和腹部的钝器解剖。密封锚定部件1100的前端凸缘1104和端表面1108可以在手术夹1400的帮助下，在切口内被操作（图28A）。当密封锚定部件1100适当地放置在切口内时，其贴身地接合切口的内表面，同时，前端凸缘1104邻接腹膜的内层皮肤组织，而后端凸缘1106邻接腹膜的外层皮肤组织（图28B）。其后，套管1300和套管1302的任意组合可以通过相应的密闭装置1304和1306的使用而被引入密封锚定部件1100的通道1102内。（图28C）放置之后，密闭装置被移走，从而提供通过合适的套管1300、1302的通路，作为手术设备的通道以执行手术过程。套管1300和套管1302相对密封锚定部件1100可以是相互交错的以便于在手术区域内自由运动。可以容易地实现移出套管1300和套管1302中的一个，并且以另一个尺寸的套管1300、1302替换。结果，密封锚定部件1100的通道1102在初始状态下是打开的（例如在不存在手术设备时），外科医生可以放置手指以覆盖移除套管后的通道，并且当向通道中引入第二个套管时再移开手指。通过使用活栓阀1204，在手术全过程中，注入和/或排出装置可以持续有效。
虽然已经参照附图描述了本公开的示例性的实施例，但是以上说明、公开和附图不应被理解为用于限制，而是仅仅是特定实施例的示例性说明。因此，能够理解，本公开不限于那些明确的实施例，并且由本领域的技术人员在不背离本公开的范围或精神的情况下对其作出的各种其它的改变或修改也是有效的。

Claims (10)

1.一种能放置在组织管道内的手术设备，其包括：
密封锚定部件，其包括近侧部和远侧部以及处于近侧部和远侧部之间的中间部，并且限定了在近侧部和远侧部之间延伸的纵轴，至少一个端口纵向延伸通过所述中间部，其中所述中间部的径向尺寸小于所述近侧部和远侧部的径向尺寸并且沿所述近侧部和远侧部之间的纵向轴变化，从而便于将所述密封锚定部件锚定在组织内。
2.根据权利要求1所述的手术设备，其中所述密封锚定部件能在限定了第一结构的第一状态和限定了不同于所述第一结构的第二结构的第二状态之间转变，所述密封锚定部件在处于所述第一状态时适于插入到所述组织管道内并且当所述密封锚定部件朝所述第二状态弹性地转变时与所述组织管道形成充分的密封关系。
3.根据权利要求1所述的手术设备，其中当将实物通过所述至少一个端口转移时所述至少一个端口弹性变形以与其形成充分的密封关系。
4.根据权利要求1所述的手术设备，其中所述至少一个端口径向地偏离所述纵轴。
5.根据权利要求1所述的手术设备，其中所述近侧部和远侧部相同。
6.根据权利要求1所述的手术设备，其中所述近侧部和远侧部不同。
7.根据权利要求1所述的手术设备，其中所述近侧部和远侧部中的至少一个是平面的。
8.根据权利要求1所述的手术设备，其中所述近侧部和远侧部中的至少一个是弓形的。
9.根据权利要求1所述的手术设备，其中所述密封锚定部件由泡沫材料形成。
10.根据权利要求1所述的手术设备，其中所述密封锚定部件由凝胶材料形成。
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