CN118078451A - 手术器械与远程操作致动器之间的无菌屏障 - Google Patents

手术器械与远程操作致动器之间的无菌屏障 Download PDF

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CN118078451A
CN118078451A CN202410206298.5A CN202410206298A CN118078451A CN 118078451 A CN118078451 A CN 118078451A CN 202410206298 A CN202410206298 A CN 202410206298A CN 118078451 A CN118078451 A CN 118078451A
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isa
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T·J·莫里赛特
G·W·达克斯二世
B·M·斯凯纳
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Abstract

本申请涉及手术器械与远程操作致动器之间的无菌屏障。一种器械无菌盖布，其包括塑料片和密封到塑料片中的第一开口的袋。袋被成形为围绕包括致动器的滑架安装。器械无菌适配器(ISA)耦接到袋中的第二开口。ISA包括位于袋的相对侧上并且联接在一起的底板和顶板。加强片可围绕第二开口耦接到袋，从而提供对应于保持在底板与顶板之间的袋的一部分的相对无弹性的区域。底板的一部分可突出穿过顶板，从而提供基准面以接收手术器械。ISA可包括松销，当安装手术器械时，松销压下滑架中的感测销。

Description

手术器械与远程操作致动器之间的无菌屏障
本申请是申请日为2015年3月17日、发明名称为“手术器械与远程操作致动器之间的无菌屏障”的分案申请202010087628.5的分案申请。分案申请202010087628.5为中国专利申请201580013292.5(PCT/US2015/020886)的分案申请。
本申请要求以下在先提交的申请的优先权：
2014年3月17日(17-03-2014)提交的US 61/954,497
2014年3月17日(17-03-2014)提交的US 61/954,502
2014年3月17日(17-03-2014)提交的US 61/954,557
2014年3月17日(17-03-2014)提交的US 61/954,571
2014年3月17日(17-03-2014)提交的US 61/954,595
2014年6月30日(30-06-2014)提交的US 62/019,318
2015年1月15日(15-01-2015)提交的US 62/103,991
2015年1月16日(16-01-2015)提交的US 62/104,306，
这些申请中的每个以最大许可程度具体地并入本文。
技术领域
本发明的实施例涉及手术盖布的领域；并且更具体地，涉及用于考虑到附接手术器械的远程操作致动器的手术盖布。
背景技术
微创医疗技术已经用于减少诊断或手术程序期间可被损坏的外部组织的量，从而减少患者恢复时间、减轻患者不适并且减少有害的副作用。微创手术的传统形式包括内窥镜检查。内窥镜检查的更常见形式中的一种为腹腔镜检查，腹腔镜检查为腹腔内的微创检查或微创手术。在传统的腹腔镜检查手术中，患者的腹腔被吹入气体，并且插管套筒穿过患者腹部的肌肉组织中的小(大约12毫米)切口，以提供进入端口，腹腔镜检查手术器械能够以密封的方式穿过该进入端口。
腹腔镜检查手术器械通常包括用于观察手术区域的腹腔镜，以及具有端部执行器的手术器械。典型的手术端部执行器包括，例如夹钳、抓紧器、剪刀、缝合器和持针器。手术器械类似于常规(开放式)手术中使用的器械，除了每个手术器械的工作端或端部执行器通过例如大约30厘米长的延伸管与其柄部分开，以便允许操作者将端部执行器引入到手术部位，并且从患者身体外部控制端部执行器相对于手术部位的移动。
为提供端部执行器的改进的控制，可期望使用远程操作致动器来控制手术器械。外科医生可在控制台上操作控制装置，从而间接地操纵连接到远程操作致动器的器械。手术器械可拆卸地耦接到远程操作致动器，使得手术器械能够被单独消毒，并且被选择用作用于要执行的手术程序的所需要的器械。在手术过程中可改变手术器械。
使用远程操作手术器械执行手术产生新的挑战。一个挑战是需要将与患者相邻的区域保持在无菌条件下。然而，控制手术器械所必需的马达、传感器、编码器和电连接件通常不能使用常规方法例如蒸汽、热、压力或化学品进行消毒，因为它们在消毒过程中可被损坏或破坏。
使用远程操作手术系统的另一个挑战在于手术器械与远程操作致动器及其控制器之间需要许多连接件。需要连接件以传输致动力、电信号和数据。这使手术器械附接到远程操作致动器，并且使其控制器变得复杂。
使用伺服致动的远程操作手术系统的另一个挑战在于手术室并非用于准备精密机械组件的理想环境。
可期望在手术系统的远程操作致动器与由致动器控制的手术器械之间提供有效的无菌屏障接口。尽管已知的无菌屏障接口已经有效，但是改进患者侧手术人员的工作流程以及适应远程操作手术器械设计和能力发展的需要要求改进的无菌接口。在所要求的改进中有将无菌屏障接口(与其相关联的无菌屏障盖布一起)快速地、容易地并且可靠地安装到致动器的机械驱动元件，以及手术系统的信息通信接口点的能力；将手术器械快速地、容易地并且可靠地安装到接口的能力，使得致动器的机械驱动功能部和系统的信息通信功能部被有效地耦接到手术器械；将手术器械从接口快速地、容易地脱离和拆下的能力，使得另一个手术器械能够安装和接合在其位置中；以及将接口从致动器快速地且容易地脱离和拆下的能力。另外，此类改进的接口必须是机械坚固的，并且制造起来既容易又便宜。
发明内容
一种器械无菌盖布包括塑料片和密封到塑料片中的第一开口的袋。袋被成形为围绕包括致动器的滑架安装。器械无菌盖布(ISA)耦接到袋中的第二开口。ISA包括位于袋的相对侧上并且联接在一起的底板和顶板。加强片可围绕第二开口耦接到袋，以提供相对无弹性的区域，该相对无弹性的区域对应于保持在底板与顶板之间的袋的一部分。底板的一部分可突出穿过顶板，从而提供基准面以接收手术器械。ISA可包括松销，当手术器械被安装时，松销压下滑架中的感测销。
从下面的附图和详细描述，本发明的其他特征和优点将显而易见。
附图说明
通过参考用于以举例方式而非限制方式说明本发明实施例的以下描述和附图，可最佳地理解本发明。在附图中，其中类似的参考标号指示类似的元件：
图1为远程操作手术系统的例示性患者侧部分100的视图。
图2为与远程操作致动器一起使用的手术器械的侧视图。
图3为装配接头/组合接头(setup joint)的透视图。
图4为图3所示的安装接头的支柱部分的透视图。
图5为无菌盖布的一部分的透视图。
图6为滑架、器械无菌适配器(ISA)以及手术器械的控制表面的透视图。
图7为ISA的分解透视图。
图8为ISA的袋部分的透视图。
图9为沿图7中的线7A--7A截取的剖视图。
图10为沿图7中的线7B--7B截取的ISA的底板的剖视图。
图11为沿图7中的线7C--7C截取的ISA的一部分和存在(presence)销的剖视图。
图12为在图11中圈住的ISA的一部分和存在销的透视图。
具体实施方式
在以下描述中，阐述了许多具体细节。然而，应当理解，可在没有这些具体细节的情况下实践本发明的实施例。在其他情况下，未详细示出已知的电路、结构和技术，以便不模糊对本说明书的理解。
在以下描述中，参考说明本发明的若干实施例的附图。应当理解，可利用其他实施例，并且在不偏离本公开的精神和范围的情况下，可做出机械、组分、结构、电气以及操作的改变。以下详细描述不应被视为具有限制意义，并且本发明实施例的范围由授权专利的权利要求唯一限定。
本文所用的专有名词仅是为了描述具体实施例的目的，而并非旨在限制本发明。为便于描述，本文可使用空间相关术语，诸如“在……之下”、“下面”、“下部”、“上面”、“上部”等等，以描述如图所示的一个元件或特征部与另一或另一些元件或特征部的关系。应当理解，空间相关术语旨在涵盖除附图中示出的取向之外的在使用或操作中的设备的不同取向。例如，如果附图中的设备被翻转，则被描述为在其他元件或特征部“下面”或“之下”的元件将被定向在其他元件或特征部“之上”。因此，示例性术语“下面”能够涵盖上面和下面的取向两者。设备可以其他方式进行定向(例如，旋转90度或在其他取向上)，并且本文使用的空间相关描述符进行相应地解释。
如本文所用，除非上下文另外指明，否则单数形式“一种/个”和“该”旨在包括复数形式。应当进一步理解，“包括”和/或“包含”指定所述特征、步骤、操作、元件和/或部件的存在，但不排除其一个或多个其他特征、步骤、操作、元件、部件和/或其集合的存在或添加。
图1为根据本发明实施例的远程操作手术系统的例示性患者侧部分100的视图。患者侧部分100包括支撑组件110，以及在每个支撑组件的端部处的一个或多个手术器械操纵器112。支撑组件任选地包括一个或多个无动力的、可锁定安装接头，该接头用于相对于进行手术的患者定位一个或多个手术器械操纵器112。如图所示，患者侧部分100搁置在地板上。在其他实施例中，患者侧部分可安装到墙壁、天花板、手术台126(其也支撑患者的身体122)或者其他手术室器材。进一步地，虽然患者侧部分100被示为包括四个操纵器112，但可使用更多或更少的操纵器112。更进一步地，患者侧部分100可由如图所示的单个组件组成，或者其可包括两个或更多个单独的组件，每个组件以各种可能的方式任选地安装。
每个手术器械操纵器112支撑在患者身体122内的手术部位处操作的一个或多个手术器械120。每个操纵器112可以各种形式被提供，所述形式允许相关联的手术器械以一个或多个机械自由度(例如，全部六个笛卡尔自由度，五个或更少的笛卡尔自由度等等)移动。通常，机械约束或控制约束限制每个操纵器112围绕相对于患者保持静止的器械上的运动中心移动其相关联的手术器械，并且该运动中心通常位于器械进入身体的位置处。
术语“手术器械”在本文用于描述医疗设备，该医疗设备被配置成插入患者身体中，并且用于进行手术或诊断程序。手术器械通常包括与一个或多个手术任务相关联的端部执行器，诸如镊子、针驱动器、大剪刀、双极烧灼器、组织稳定器或牵开器、施夹器、吻合设备、成像设备(例如，内窥镜或超声波探头)等等。与本发明实施例一起使用的一些手术器械进一步提供用于端部执行器的铰接式支撑(有时被称为“腕部”)，使得可相对于器械的轴以一个或多个机械自由度操纵端部执行器的位置和取向。进一步地，许多手术端部执行器包括功能性机械自由度，诸如打开或关闭的钳口，或沿路径平移的刀。手术器械也可包含存储(例如，在器械内部的半导体存储器上)的信息，信息可以为永久的，或者可通过手术系统更新。因此，系统可在器械与一个或多个系统部件之间提供单向信息通信或双向信息通信。
功能性远程操作手术系统将通常包括视觉系统部分(未示出)，视觉系统部分使操作者能够从患者身体122外部观察手术部位。视觉系统通常包括手术器械，手术器械具有视频图像捕获功能部128(“相机器械”)，以及用于显示所捕获图像的一个或多个视频显示器。在一些手术系统配置中，相机器械128包括光学器件，光学器件将来自相机器械128的远侧端部的图像传输到在患者身体122外部的一个或多个成像传感器(例如，CCD或CMOS传感器)。另选地，一个或多个成像传感器可定位在相机器械128的远侧端部处，并且由一个或多个传感器产生的信号可沿引线传输或者无线地传输用于进行处理，并且在视频显示器上显示。例示性视频显示器为由加利福利亚州森尼维耳市的直观外科公司(IntuitiveSurgical,Inc.)商业化的手术系统中的外科医生控制台上的立体显示器。
功能性远程操作手术系统将进一步包括控制系统部分(未示出)，用于当器械在患者体内时控制手术器械120的运动。控制系统部分可在手术系统中的单个位置处，或者其可分布在系统中的两个或更多个位置(例如，控制系统部分部件可在系统的患者侧部分100中，在专用的系统控制台中，或者在单独的器材架中)处。根据期望的控制程度、被控制的手术组件的尺寸以及其他因素，可以各种方式完成远程操作的主/从控制。在一些实施例中，控制系统部分包括一个或多个手动操作的输入设备，诸如操纵杆、骨骼式手套、动力的和重力补偿的操纵器等等。这些输入设备控制远程操作的马达，远程操作的马达进而控制手术器械的运动。
通过远程操作的马达产生的力经由传动系机构传递，传动系机构将来自远程操作马达的力传输到手术器械120。在一些远程手术实施例中，控制一个或多个操纵器的输入设备可在远离患者的位置处提供，患者在放置患者的房间内部或外部。然后，将来自输入设备的输入信号传输到控制系统部分。熟悉远程操纵、远程操作以及远程呈现手术的人员将了解这些系统以及它们的部件，诸如由直观外科公司(Intuitive Surgical,Inc.)商业化的da手术系统，和最初由计算机动态公司(Computer Motion,Inc.)制造的手术系统，以及此类系统的各种例示性部件。
如图所示，手术器械120和任选的进入引导件124(例如，患者腹部中的插管)二者均可移除地耦接到操纵器112的远侧端部，其中手术器械120插入穿过进入引导件124。操纵器112中的远程操作致动器移动作为整体的手术器械120。操纵器112进一步包括器械滑架130。手术器械120可拆卸地连接到滑架130。容纳在滑架130中的远程操作致动器提供许多控制器运动，手术器械120将控制器运动转化成手术器械上的端部执行器的各种运动。因此，滑架130中的远程操作致动器仅移动手术器械120的一个或多个部件，而不是移动作为整体的器械。控制作为整体的器械或器械的部件的输入是使得由外科医生提供到控制系统部分的输入(“主”命令)通过手术器械转化成对应的动作(“从”响应)。
图2为手术器械120的例示性实施例的侧视图，手术器械120包括远侧部分250和通过细长管210耦接的近侧控制机构240。手术器械120的远侧部分250可提供多种端部执行器中的任何一种，诸如所示的镊子254、针驱动器、烧灼设备、切削工具、成像设备(例如，内窥镜或超声波探头)或者包括两个或更多个多种工具和成像设备的组合的组合设备。在所示的实施例中，端部执行器254通过“腕部”252耦接到细长管210，“腕部”252允许相对于器械管210操纵端部执行器的取向。
图3为从安装接头110延伸的臂部的透视图。臂部支撑滑架130，滑架130进而支撑支柱310上的手术器械120。在手术的准备中，安装接头覆盖有无菌盖布300。无菌盖布保护臂部免受污染，并且围绕臂部提供无菌表面。大部分无菌盖布300为塑料片，塑料片可以为覆盖臂部的管或袋子的形式。例如，单层热塑性聚氨酯(TPU)或其他合适的材料可用于塑料片。可将润滑剂复合在其中以降低塑料的粘着性。片材可以为大约100微米(0.004英寸)厚。
图4为支撑滑架130的臂部的支柱310部分的透视图。翼梁402将滑架130定位在支柱310上。未示出无菌盖布，以允许更清楚地看到滑架130。滑架的表面400提供许多机械接口和电接口，以在控制系统、致动器和手术器械之间传送机械运动和数据信号。应当理解，到手术器械的连接件可需要穿透通过无菌盖布。难以提供穿透通过与滑架130和手术器械之间的连接件兼容的塑料片。进一步地，滑架130被成形为允许手术器械120的细长管210(图2)沿滑架的侧面穿过缺口410。由于滑架的形状，并且因为其从支柱310突出，所以难以使用塑料覆盖滑架。
图5为无菌盖布的一部分的透视图，其被构造成围绕滑架130放置。无菌盖布包括三个部分。第一部分为上述的塑料片300。第二部分为袋500，其被成形为围绕滑架130安装。第三部分为高度刚性的器械无菌适配器(ISA)510，其接合滑架130的控制特征部400，并且提供用于连接到手术器械的控制特征部的无菌对应部。无菌盖布的三个部分中的每个抵靠着相邻部分重叠和密封，使得三个部分形成连续的屏障。无菌盖布为一次性组件。
袋500可由诸如低密度聚乙烯(LDPE)、乙烯-乙酸乙烯酯共聚物(EVA)和/或热塑性聚氨酯(TPU)的材料制成，该材料可以为用于塑料片300的相同材料但具有更大的厚度。其他合适的材料可用于袋。袋500可通过合适的工艺诸如热成形、热电成形或真空成形由适当厚度的塑料片制造而成。袋500可以为柔性的，但是其应在未经受应力时恢复到其初始形状。袋500提供盖布的一部分，该部分为围绕滑架130的松散形式安装，以为致动器和手术器械提供无障碍的工作空间。可存在其中袋500更紧密地安装到滑架130的某些区域，诸如其中手术器械的轴通过滑架的区域410。可期望由透明或半透明材料形成袋500，使得能够通过袋看见滑架130的特征部，诸如指示灯。在一些实施例中，袋可由两个或更多个部分形成。例如，袋的部分可由更加刚性的材料形成，并且袋的部分可由更加柔性的材料形成。
孔520在塑料片300中形成，其中袋500联接到塑料片。可期望在袋定位在孔520上方而不是延伸穿过孔的情况下将袋500联接到塑料片300。塑料片可通过与片材和袋的材料兼容的任何工艺联接到袋，诸如通过热焊接或压敏粘合剂(PSA)。孔520可在袋500联接到塑料片之前或之后形成于塑料片300中。
图6为滑架、ISA510(没有袋或无菌盖布的塑料片部分)的控制表面400，以及已经被旋转以示出器械控制表面242的手术器械的近侧控制机构240的透视图。如附图所暗示的，ISA510耦接到滑架的控制表面400。ISA 510提供控制表面，该控制表面将滑架的控制表面400的所有控制特征部延伸成为无菌的、一次性表面，其能够接收远程操作手术器械的近侧控制机构240，并且接合手术控制表面242的控制特征部。
图7为ISA510的分解透视图。通过将耦接器盘724插入ISA的底板710中的开口722来组装ISA。通过使盘上的突出部穿过底板中的键槽，并且然后使盘转动以使突出部和键槽错开，耦接器盘724可保持在开口中。存在销600可插入ISA的底板710中的凹坑712中。通量耦接器704可耦接在ISA的顶板700中的开口702上方。
图8为袋500的透视图。袋提供开口802，控制特征部，诸如耦接器盘724、存在销600和通量耦接器704通过开口802在底板710与顶板700之间连通。组装的底板710与开口802相邻放置在袋500的第一侧面上，即在面对袋腔内部的袋的侧面上。组装的顶板700与开口802相邻放置在袋的相对第二侧面上，即在背离袋腔内部的袋的侧面上。袋500可被捕获在顶板700和底板710之间，顶板700和底板710可通过各种方法联接在一起。联接顶板700和底板710的一个方法为使销穿过顶板与底板之间，并且通过袋，然后将销热铆接，从而形成永久组件。联接顶板和底板的其他合适的方法包括超声波焊接、压敏粘合剂(PSA)、液体粘合剂和扣合安装。
再次参考图6和图7，顶板700可包括竖直壁部分612，其基本上垂直于滑架的控制表面，并且基本上平行于支撑滑架130的支柱310(图4)。ISA的竖直壁部分612可提供刚性表面，刚性表面协助引导手术器械与ISA接合，并且在该过程期间保护无菌盖布的柔软表面。竖直壁部分612可包括肋状件614，肋状件614接合手术器械的近侧控制机构240中的对应凹陷部616。肋状件614可以是渐缩的，以提供与近侧控制机构240的耐受的初始接合，然后当器械处于适当位置以接合ISA时，近侧控制机构240将器械引导至更精确的位置。
再次参考图8，保持在底板710与顶板700之间的一些区域804是窄的。如果柔性材料用于形成袋500，则由于袋材料的柔性和弹性，材料可以不充分地保持在底板710与顶板700之间。加强片800可耦接到袋500，以提供对应于保持在底板710与顶板700之间的一部分袋的相对无弹性的区域。无弹性区域可通过共挤出具有一层改性的聚对苯二甲酸乙二醇酯(PETG)和一层热塑性聚氨酯(TPU)的片材而形成。加强片800可被切下用于共挤的片材。可通过将TPU表面热焊接到袋而使加强片800耦接到袋500，袋500也可由TPU形成。也可使用提供具有无弹性区域800的柔性袋500的其他组件，无弹性区域800保持在ISA的底板710与顶板700之间。其他实施例可使用压敏粘合剂(PSA)或液体粘合剂，以将袋500粘结到底板710和顶板700中的一者或两者，从而将袋保持在板之间。
图9为沿图7中的线7A--7A截取的ISA510剖视图。参考图6，滑架可提供传感器604，用于读取包括在手术器械中的射频识别(RFID)设备。由于附近存在金属部件，所以RFID设备可需要传感器604非常靠近RFID设备。ISA的底板710可提供通道900，通道900允许传感器604穿过底板、加强片800以及袋500，从而与ISA的顶板700相邻放置。进一步地，可使顶板700的将与传感器604相邻的区域902变薄，以允许传感器仍然更靠近手术器械中的RFID设备。
再次参考图6，滑架可提供通量连接件606，通量连接件606提供用于电信号和/或光信号的连接。在所示实施例中，弹簧(pogo)销606(弹簧加载的导电销)提供电信号以被连接到手术器械。ISA的底板710可提供通道910，通道910允许通量连接件606穿过经过底板、加强片800以及袋500，从而与ISA的顶板700相邻放置。顶板700的将与通量连接件相邻的区域可提供用于通量连接器904的开口912，通量连接器904使顶板中的开口闭合以提供连续的屏障，同时在通量连接件与手术器械之间提供用于电信号和/或光信号的路径。
图10为沿图7中的线7B--7B截取的ISA的底板710的剖视图。可期望将手术器械定位在距滑架130的控制表面400(图4)已知的距离处。如果手术器械相对于ISA的顶板700定位，则顶板710、加强片800、袋500以及顶板的尺寸公差均将影响手术器械的位置，这可以不提供期望的位置精度。底板710可包括着陆垫602，着陆垫602为手术器械提供基准面。着陆垫602从底板710延伸穿过加强片800、袋500以及顶板700。底板710可进一步包括安装表面1000，安装表面1000为ISA在滑架130的控制表面400上的安装提供基准面。由于着陆垫602和安装表面1000为实心底板710上相对的平行表面，所以可相当精确地控制着陆垫与安装表面之间的距离。因此，ISA能够将手术器械精确地定位在距滑架130的控制表面400已知的距离处。
图11为沿图7中的线7C--7C截取的ISA的顶板700和底板710的一部分以及存在销600的剖视图。控制系统可需要指示手术器械何时已经耦接到ISA510的信号。滑架可提供弹簧加载的柱塞608(图6)，柱塞608能够被压下，以将信号提供到控制系统。ISA的底板710可提供凹坑1104，以接收存在销600。在底板710中提供开口1102，使得弹簧加载的柱塞608能够进入底板中的凹坑1104中，并且提升存在销600通过顶板710中的开口。存在销600允许手术器械压下滑架中的弹簧加载的柱塞608，同时保持手术器械与滑架之间的无菌屏障。当手术器械耦接到ISA时，存在销600被压下，也许被压下至图11中示出的位置，并且弹簧加载的柱塞608同样被压下以向控制系统提供指示手术器械耦接到ISA的信号。
图12为在图11中圈住12的ISA的一部分以及存在销的透视图。如图12最佳所见，底板710中的凹坑1104可从底板的下表面1000突出。容纳凹坑的突起1106可延伸到滑架中，其为弹簧加载的柱塞608周围的空间。这允许弹簧加载的柱塞位于滑架的表面的下面，该表面接收ISA以保护弹簧加载的柱塞免受可损坏柱塞的侧向力。
突起1106在端部可以为倒角的，倒角端部进入滑架以协助将ISA定位在滑架上。参考图6，滑架的控制表面400上的导销610可接合ISA上的接收器，从而当其定位在滑架上时侧向地定位ISA的那个端部。突起116，尤其是距竖直壁部分708最远的突起可与导销610接合部合作，从而侧向地定位ISA的相对端部，并且将其对准用于与滑架的控制表面400接合。
虽然已经描述并且在附图中示出某些示例性实施例，但是应当理解，此类实施例仅仅是例示性的，而非对广义的本发明的限制，并且本发明并非限于所示和所述的具体构造与布置，因为本领域技术人员可想到各种其他修改。因此，本说明书应被视为例示性而非限制性的。

Claims (10)

1.一种用于组装器械无菌盖布的方法，所述方法包括：
在塑料片中创建第一开口；
形成袋，以围绕包括致动器的滑架安装；
在所述塑料片中的所述第一开口上方将所述袋附接到所述塑料片；
在所述袋中创建第二开口；并且
通过将器械无菌适配器即ISA的底板和所述ISA的顶板联接在一起将所述ISA在所述袋中的所述第二开口上方附接到所述袋，其中所述袋的一部分被保持在所述底板和所述顶板之间。
2.根据权利要求1所述的方法，其中所述塑料片具有第一厚度并且所述袋具有大于所述第一厚度的第二厚度。。
3.根据权利要求1所述的方法，进一步包括，在将所述底板联接到所述顶板之前，将加强片围绕所述袋中的所述第二开口联接到所述袋。
4.根据权利要求1所述的方法，其中将所述ISA附接到所述袋进一步包括：
将所述底板放置在所述袋的第一侧面上的所述第二开口上方；
将所述顶板放置在与所述第一侧面相对的所述袋的第二侧面上的所述第二开口上方。
5.根据权利要求4所述的方法，进一步包括：
使销穿过所述顶板和所述底板和所述袋；以及
将所述销热铆接以将所述顶板和所述底板联接到一起。
6.根据权利要求4或5所述的方法，进一步包括使用粘合剂将所述袋保持在所述顶板与所述底板之间。
7.根据权利要求1所述的方法，其中将所述袋附接到所述塑料片包括将所述袋密封到所述塑料片。
8.根据权利要求1至7中任一项所述的方法，其中所述塑料片是以管为形式的大约100微米厚的单层热塑性聚氨酯。
9.根据权利要求1至7中任一项所述的方法，其中所述塑料片是以管为形式的大约0.004英寸厚的单层热塑性聚氨酯。
10.根据权利要求1至9中任一项所述的方法，其中所述塑料片包括润滑剂。
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