CN108348253B - 多层外科缝合器支撑物组件 - Google Patents
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Abstract
本发明题为“多层外科缝合器支撑物组件”。本发明提供了一种外科缝合器端部执行器组件,所述端部执行器组件包括钉仓、端部执行器和支撑物组件。所述钉仓包括平台和多个钉。所述钉仓能够操作以驱动所述钉穿过所述平台。所述砧座包括下侧,所述下侧具有钉成形表面,所述钉成形表面被构造成能够接纳被驱动穿过所述平台的钉。所述支撑物组件的尺寸和构造被设置成与所述钉仓的所述平台或所述砧座的所述下侧联接。所述支撑物组件包括支撑物主体、第一粘合剂层和第二粘合剂层。所述第一粘合剂层和第二粘合剂层由不同材料形成。所述第一粘合剂层布设在所述支撑物主体之上。所述第二粘合剂层布设在所述第一粘合剂层之上,使得所述第一粘合剂层插置在所述第二粘合剂层与所述支撑物主体之间。
Description
背景技术
在一些环境下,内窥镜式外科器械相对于传统的开放式外科装置来说是优选的,因为较小的切口可减少术后恢复时间和并发症。因此,一些内窥镜式外科器械可适于通过套管针的插管来将远侧端部执行器放置在期望的外科手术部位。这些远侧端部执行器(例如,内镜切割器、抓紧器、切割器、缝合器、施夹器、进入装置、药物/基因治疗递送装置、以及使用超声波振动、RF、激光等的能量递送装置)可以多种方式接合组织,以实现诊断效果或治疗效果。内窥镜式外科器械可包括位于端部执行器和由临床医生操纵的柄部部分之间的轴。此类轴可使得能够插入到期望的深度并围绕轴的纵向轴线旋转,以由此有利于将端部执行器定位在患者体内。还可通过包括一个或多个关节运动接头或特征部而进一步有利于定位该端部执行器,使得端部执行器能够选择性地进行关节运动或者以其他方式相对于轴的纵向轴线偏转。
内窥镜式外科器械的示例包括外科缝合器。一些此类缝合器能够操作以夹紧组织层,切穿夹持的组织层,并且将钉驱动穿过组织层,以在组织层的切断端部附近将切断的组织层基本上密封在一起。仅示例性外科缝合器被公开于以下专利中:1989年2月21日公布的标题为“Pocket Configuration for Internal Organ Staplers”的美国专利第4,805,823号;1995年5月16日公布的标题为“Surgical Stapler and Staple Cartridge”的美国专利第5,415,334号;1995年11月14日公布的标题为“Surgical Stapler Instrument”的美国专利第5,465,895号;1997年1月28日公布的标题为“Surgical Stapler Instrument”的美国专利第5,597,107号;1997年5月27日公布的标题为“Surgical Instrument”的美国专利第5,632,432号;1997年10月7日公布的标题为“Surgical Instrument”的美国专利第5,673,840号;1998年1月6日公布的标题为“Articulation Assembly for SurgicalInstruments”的美国专利第5,704,534号;1998年9月29日公布的标题为“SurgicalClamping Mechanism”的美国专利第5,814,055号;2005年12月27日公布的标题为“Surgical Stapling Instrument Incorporating an E-Beam Firing Mechanism”的美国专利第6,978,921号;2006年2月21日公布的标题为“Surgical Stapling InstrumentHaving Separate Distinct Closing and Firing Systems”的美国专利第7,000,818号;2006年12月5日公布的标题为“Surgical Stapling Instrument Having a FiringLockout for an Unclosed Anvil”的美国专利第7,143,923号;2007年12月4日公布的标题为“Surgical Stapling Instrument Incorporating a Multi-Stroke Firing Mechanismwith a Flexible Rack”的美国专利第7,303,108号;2008年5月6日公布的标题为“Surgical Stapling Instrument Incorporating a Multistroke Firing MechanismHaving a Rotary Transmission”的美国专利第7,367,485号;2008年6月3日公布的标题为“Surgical Stapling Instrument Having a Single Lockout Mechanism forPrevention of Firing”的美国专利第7,380,695号;2008年6月3日公布的标题为“Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-BeamFiring Mechanism”的美国专利第7,380,696号;2008年7月29日公布的标题为“SurgicalStapling and Cutting Device”的美国专利第7,404,508号;2008年10月14日公布的标题为“Surgical Stapling Instrument Having Multistroke Firing with OpeningLockout”的美国专利第7,434,715号;2010年5月25日公布的标题为“DisposableCartridge with Adhesive for Use with a Stapling Device”的美国专利第7,721,930号;2013年4月2日公布的标题为“Surgical Stapling Instrument with AnArticulatable End Effector”的美国专利第8,408,439号;以及2013年6月4日公布的标题为“Motor-Driven Surgical Cutting Instrument with Electric ActuatorDirectional Control Assembly”的美国专利8,453,914。以上引用的美国专利中的每个的公开内容以引用方式并入本文。
尽管上文所涉及的外科缝合器被描述为用于内窥镜式手术中,但应当理解,此类外科缝合器也可用于开腹手术和/或其他非内窥镜式手术中。仅以举例的方式,在胸廓外科手术中,外科缝合器可通过胸廓切开术被插入并由此位于患者肋骨之间以到达一个或多个器官,所述胸廓外科手术不使用套管针作为缝合器的导管。此类手术可包括使用缝合器来切断和闭合通向肺部的血管。例如,在从胸腔中取出器官之前,可通过缝合器来切断并闭合通向器官的血管。当然,外科缝合器可用于各种其他情况和手术中。
可能特别适合通过胸廓切开术使用的外科缝合器的示例被公开于以下专利中:2014年8月28日公布的标题为“Surgical Instrument End Effector Articulation Drivewith Pinion and Opposing Racks”的美国专利公布第2014/0243801号;2014年8月28日公布的标题为“Lockout Feature for Movable Cutting Member of Surgical Instrument”的美国专利公布第2014/0239041号;2014年8月28日公布的标题为“Integrated TissuePositioning and Jaw Alignment Features for Surgical Stapler”的美国专利公布第2014/0239042号;2014年8月28日公布的标题为“Jaw Closure Feature for End Effectorof Surgical Instrument”的美国专利公布第2014/0239036号;2014年8月28日公布的标题为“Surgical Instrument with Articulation Lock having a Detenting BinarySpring”的美国专利公布第2014/0239040号;2014年8月28日公布的标题为“Distal TipFeatures for End Effector of Surgical Instrument”的美国专利公布第2014/0239043号;2014年8月28日公布的标题为“Staple Forming Features for Surgical StaplingInstrument”的美国专利公布第2014/0239037号;2014年8月28日公布的标题为“SurgicalInstrument with Multi-Diameter Shaft”的美国专利公布第2014/0239038号;以及2014年8月28日公布的标题为“Installation Features for Surgical Instrument EndEffector Cartridge”的美国专利公布第2014/0239044号。以上引用的美国专利公布中的每个的公开内容均以引用方式并入本文。
另外的外科缝合器械被公开于以下专利中:2014年8月12日公布的标题为“Surgical Circular Stapler with Tissue Retention Arrangements”的美国专利第8,801,735号;2012年3月27日公布的标题为“Surgical Stapler Comprising a StaplePocket”的美国专利第8,141,762号;2013年2月12日公布的标题为“Surgical EndEffector Having Buttress Retention Features”的美国专利第8,371,491号;2014年9月18日公布的标题为“Method and Apparatus for Sealing End-to-End Anastomosis”的美国公布第2014/0263563号;2014年9月4日公布的标题为“Rotary Powered SurgicalInstruments with Multiple Degrees of Freedom”的美国公布第2014/0246473号;2013年8月15日公布的标题为“Linear Stapler”的美国公布第2013/0206813号;2008年7月17日公布的标题为“Buttress Material for Use with a Surgical Stapler”的美国公布第2008/0169328号;2014年6月10日提交的标题为“Woven and Fibrous Materials forReinforcing a Staple Line”的美国专利申请第14/300,804号;标题为“Devices andMethods for Sealing Staples in Tissue”的美国专利申请第14/300,811号;以及2014年9月26日提交的标题为“Radically Expandable Staple Line”的美国专利申请第14/498,070号。以上引用的美国专利、美国专利公布和美国专利申请中的每个的公开内容均以引用方式并入本文。
在一些情况下,可能期望为外科缝合器械配备支撑物材料以增强由钉提供的组织的机械紧固。此类支撑物可防止所施用钉牵拉穿过组织并且可以其他方式降低所施用钉的部位处或附近的组织撕裂的风险。
虽然已制造和使用各种外科缝合器械和相关联的部件,但据信在本发明人之前还无人制造或使用在所附权利要求中所描述的发明。
附图说明
并入本说明书中并构成本说明书的一部分的附图示出了本发明的实施方案,并且与上面给出的本发明的一般描述以及下面给出的实施方案的详细描述一起用于解释本发明的原理。
图1示出示例性进行关节运动的外科缝合器械的透视图;
图2示出图1的器械的端部执行器的透视图,其中端部执行器处于打开构型;
图3示出了图2的端部执行器的分解透视图;
图4示出示例性上支撑物和示例性下支撑物的透视图,所述上支撑物和下支撑物中的每个可施用到图2的端部执行器;
图5A示出图2的端部执行器的一部分的剖面端视图,其中由图4的支撑物形成的支撑物组件施用到端部执行器,其中组织定位在端部执行器中的支撑物之间,并且其中砧座处于打开位置;
图5B示出图5A的组合式端部执行器和支撑物组件的剖面端视图,其中组织定位在端部执行器中的支撑物之间,并且其中砧座处于闭合位置;
图5C示出已通过图2的端部执行器固定到组织的钉和图5A的支撑物组件的剖视图;
图6示出已通过图2的端部执行器固定到组织的钉和图5A的支撑物组件的透视图;
图7示出了示例性另选支撑物的透视图;
图8示出了图7的支撑物的剖面端视图;
图9示出了另一个示例性另选支撑物的透视图;并且
图10示出了图8的支撑物的剖面端视图。
附图并非旨在以任何方式进行限制,并且能够设想本发明的各种实施方案可以多种其他方式来执行,包括那些未必在附图中示出的方式。并入本说明书中并构成本说明书的一部分附图示出了本发明的若干方面,并与本说明一起用于解释本发明的原理;然而,应当理解,本发明并不限于所示出的明确布置方式。
具体实施方式
本发明的某些示例的以下说明不应用于限定本发明的范围。根据以举例的方式示出的以下说明,本发明的其他示例、特征、方面、实施方案和优点对于本领域的技术人员将是显而易见的,最佳方式之一被设想用于实施本发明。如将认识到,本发明能够具有其他不同且明显的方面,这些方面均不脱离本发明。因此,附图和说明应被视为实质上是例示性的而非限制性的。
I.示例性外科缝合器
图1示出包括柄部组件(20)、轴组件(30)和端部执行器(40)的示例性外科缝合和切断器械(10)。端部执行器(40)和轴组件(30)的远侧部分的尺寸被设计成用于在图1所示的非关节运动状态中穿过套管针插管插入患者的手术部位,以用于执行外科手术。仅以举例的方式,此类套管针可从患者的两个肋骨之间或其他地方插入患者的腹部中。在一些情况下,在不存在套管针的情况下使用器械(10)。例如,端部执行器(40)和轴组件(30)的远侧部分可通过胸廓切开术或其他类型的切口直接插入。应当理解,本文中使用的术语诸如“近侧”和“远侧”是相对于临床医生抓握器械(10)的柄部组件(20)而言的。因此,端部执行器(40)相对于更近侧的柄部组件(20)而位于远侧。还应当理解,为便利和清楚起见,本文相对于附图使用空间用语诸如“竖直”和“水平”。然而,外科器械能够在许多取向和位置中使用,并且这些术语并非旨在为限制性的和绝对的。
A.示例性柄部组件和轴组件
如图1所示,本示例的柄部组件(20)包括手枪式握把(22)、闭合触发器(24)和击发触发器(26)。每个触发器(24,26)可朝向和远离手枪式握把(22)选择性地枢转,如将在下文中更详细地描述。柄部组件(20)还包括可移除的电池组(28)。这些部件还将在下文中更详细地描述。当然,除了或代替上文所述的那些中的任何一者,柄部组件(20)可具有多种其他部件、特征和可操作性。参考本文的教导内容,柄部组件(20)的其他合适的构型对于本领域的普通技术人员将是显而易见的。
如图1-图2所示,本示例的轴组件(30)包括外部闭合管(32)、关节运动节段(34)和闭合环(36),所述闭合环还与端部执行器(40)联接。闭合管(32)沿轴组件(30)的长度延伸。闭合环(36)定位在关节运动节段(34)的远侧。闭合管(32)和闭合环(36)被构造成能够相对于柄部组件(20)纵向平移。闭合管(32)的纵向平移经由关节运动节段(34)而被传送到闭合环(36)。可用于提供闭合管(32)和闭合环(36)的纵向平移的示例性特征将在下文中更详细地进行描述。
关节运动节段(34)能够操作以侧向偏转闭合环(36)和端部执行器(40),从而以期望的角度(α)侧向远离轴组件(30)的纵向轴线(LA)。在本示例中,关节运动通过位于轴组件(30)的近侧端部的关节运动控制旋钮(35)而被控制。响应于旋钮(35)的旋转,闭合环36和端部执行器(40)围绕垂直于轴组件(30)的纵向轴线(LA)的轴线枢转。关节运动节段(34)被构造成能够将闭合管(32)的纵向平移传送到闭合环(36),而无论关节运动节段(34)是处于笔直构型还是关节运动构型。仅以举例的方式,关节运动节段(34)和/或关节运动控制旋钮(35)可根据以下专利的教导内容中的至少一些来构造和操作:2014年8月28日公布的标题为“Surgical Instrument End Effector Articulation Drive with Pinion andOpposing Racks”的美国公布第2014/0243801号,其公开内容以引用方式并入本文;和/或2014年6月25日提交的标题为“Articulation Drive Features for Surgical Stapler”的美国专利申请第14/314,125号,其公开内容以引用方式并入本文;和/或根据下述各种教导内容来构造和操作。参考本文的教导内容,关节运动节段(34)和关节运动旋钮(35)可采用的其他合适的形式对于本领域的普通技术人员将是显而易见的。
如图1所示,本示例的轴组件(30)还包括旋钮(31)。旋钮(31)能够操作以使整个轴组件(30)和端部执行器(40)相对于柄部组件(20)围绕轴组件(30)的纵向轴线(LA)旋转。当然,除了或替代上文所述那些中任一者,轴组件(30)可具有多种其他部件、特征和可操作性。仅以举例的方式,轴组件(30)的至少一部分根据以下专利的教导内容中的至少一些来构造:2014年8月28日公布的标题为“Surgical Instrument with Multi-Diameter Shaft”的美国公布2014/0239038,其公开内容以引用方式并入本文。参考本文的教导内容,轴组件(30)的其他合适构型对于本领域的普通技术人员将是显而易见的。
B.示例性端部执行器
同样如图1-图3所示,本示例的端部执行器(40)包括下钳口(50)和可枢转砧座(60)。砧座(60)包括被设置在下钳口(50)的对应弯曲狭槽(54)中的一对一体的向外延伸的销(66)。砧座(60)能够朝向和远离下钳口(50)在打开位置(如图2所示)和闭合位置(如图1所示)之间枢转。使用术语“能够枢转”(以及以“枢转”为基础的类似术语)不应被解读为必须要求围绕固定轴线进行枢转运动。例如,在本示例中,砧座(60)围绕由销(66)限定的轴线枢转,当砧座(60)朝向下钳口(50)运动时,这些销沿下钳口(50)的弯曲狭槽(54)滑动。在此类型式中,枢轴线沿由狭槽(54)限定的路径平移,而砧座(60)同时围绕所述轴线枢转。除此之外或另选地,枢轴线首先可沿狭槽(54)滑动,然后在枢轴线已沿狭槽(54)滑动特定距离之后,砧座(60)围绕所述枢轴线枢转。应当理解,此类滑动/平移枢转运动被包含在诸如“枢转”、“枢转的”、“可枢转的”等术语内。当然,一些型式可提供砧座(60)围绕保持固定且不在狭槽或通道内平移的轴线的枢转运动等。
如在图3中最佳所见,本示例的下钳口(50)限定被构造成能够接纳钉仓(70)的通道(52)。可将钉仓(70)插入到通道(52)中,可致动端部执行器(40),并且然后可移除钉仓(70)并利用其他钉仓(70)来替换。下钳口(50)因此将钉仓(70)可释放地保持成与砧座(60)对准,以用于致动端部执行器(40)。在一些型式中,下钳口50根据以下专利的教导内容中的至少一些来构造:2014年8月28日公布的标题为“Installation Features for SurgicalInstrument End Effector Cartridge”的美国公布第2014/0239044号,该公布的公开内容以引用方式并入本文。参考本文的教导内容,下钳口(50)可采用的其他合适的形式对于本领域的普通技术人员将是显而易见的。
如在图2-图3中最佳所见,本示例的钉仓(70)包括仓体(71)和被固定到仓体(71)的下侧的托盘(76)。仓体(71)的上侧呈现平台(73),当砧座(60)处于闭合位置时,可将组织按压抵靠在所述平台。仓体(71)还限定纵向延伸通道(72)和多个钉凹坑(74)。钉(90)被定位在每个钉凹坑(74)中。钉驱动器(75)也被定位在每个钉凹坑(74)中,位于对应钉(90)下面以及托盘(76)上方。如将在下文中更详细地描述的,钉驱动器(75)能够操作以在钉凹坑(74)中向上平移,以由此向上驱动钉(90)穿过钉凹坑(74)并与砧座(60)接合。钉驱动器(75)被楔形滑动件(78)向上驱动,所述楔形滑动件被捕获在仓体(71)与托盘(76)之间并纵向平移穿过仓体(71)。
楔形滑动件(78)包括一对倾斜成角的凸轮表面(79),这对倾斜成角的凸轮表面被构造成能够接合钉驱动器(75),并由此当楔形滑动件(78)纵向平移穿过仓(70)时向上驱动钉驱动器(75)。例如,当楔形滑动件(78)处于近侧位置时,钉驱动器(75)处于向下位置并且钉(90)位于钉凹坑(74)中。当通过平移刀构件(80)将楔形滑动件(78)驱动到远侧位置时,楔形滑动件(78)向上驱动钉驱动器(75),由此将钉(90)驱动出钉凹坑(74)并进入形成于砧座(60)的下侧(65)中的钉成形凹坑(64)。因此,当楔形滑动件(78)沿水平维度平移时,钉驱动器(75)沿竖直维度平移。
在一些型式中,钉仓(70)根据以下美国公布的教导内容中的至少一些来构造和操作:2014年8月28日公布的标题为“Integrated Tissue Positioning and Jaw AlignmentFeatures for Surgical Stapler”的美国公布第2014/0239042号,该专利的公开内容以引用方式并入本文。除此之外或另选地,钉仓(70)可根据以下公布的教导内容中的至少一些来构造和操作:2014年8月28日公布的标题为“Installation Features for SurgicalInstrument End Effector Cartridge”的美国公布第2014/0239044号,该公布的公开内容以引用方式并入本文。参考本文的教导内容,钉仓(70)可采用的其他合适的形式对于本领域的普通技术人员而言将是显而易见的。
如在图2中最佳所见,本示例的砧座(60)包括纵向延伸通道(62和多个钉成形凹坑(64)。通道(62)被构造成能够当砧座(60)处于闭合位置时与钉仓(70)的通道(72)对齐。每个钉成形凹坑(64)被定位成当砧座(60)处于闭合位置时位于钉仓(70)的对应钉凹坑(74)上方。钉成形凹坑(64)被构造成能够当驱动钉(90)穿过组织进入砧座(60)时使钉(90)的腿变形。具体地,钉成形凹坑(64)被构造成能够使钉(90)的腿弯曲,以将成形钉(90)固定在组织中。砧座(60)可根据以下来构造:2014年8月28日公布的标题为“Integrated TissuePositioning and Jaw Alignment Features for Surgical Stapler”的美国公布第2014/0239042号;2014年8月28日公布的标题为“Jaw Closure Feature for End Effector ofSurgical Instrument”的美国公布第2014/0239036号的教导内容中的至少一些;和/或2014年8月28日公布的标题为“Staple Forming Features for Surgical StaplingInstrument”的美国公布第2014/0239037号的教导内容中的至少一些,上述公布的公开内容以引用方式并入本文。参考本文的教导内容,砧座(60)可采用的其他合适的形式对于本领域的普通技术人员而言将是显而易见的。
在本示例中,刀构件(80)被构造成能够平移穿过端部执行器(40)。如在图3中最佳所见,刀构件(80)被固定到击发梁(82)的远侧端部,所述击发梁延伸穿过轴组件(30)的一部分。如图2中最佳所见,刀构件(80)被定位在砧座(60)和钉仓(70)的通道(62,72)中。刀构件(80)包括朝远侧呈现的切割刃(84),所述切割刃被构造成能够当刀构件(80)朝远侧平移穿过端部执行器(40)时切断被压缩在砧座(60)和钉仓(70)的平台(73)之间的组织。如上所述,当刀构件(80)朝远侧平移穿过端部执行器(40)时,刀构件(80)也朝远侧驱动楔形滑动件(78),由此驱动钉(90)穿过组织并抵靠砧座(60)成形。
C.端部执行器的示例性致动
在本示例中,通过相对于端部执行器(40)朝远侧推动闭合环(36)而朝向下钳口(50)驱动砧座(60)。响应于闭合环(36)相对于端部执行器(40)的远侧平移,闭合环(36)通过凸轮作用与砧座(60)协作,以朝向下钳口(50)驱动砧座(60)。类似地,响应于闭合环(36)相对于端部执行器(40)的近侧平移,闭合环(36)可与砧座(60)协作,以远离下钳口(50)而打开砧座(60)。仅以举例的方式,闭合环(36)和砧座(60)可根据以下专利的教导内容中的至少一些来相互作用:2014年8月28日公布的标题为“Jaw Closure Feature for EndEffector of Surgical Instrument”的美国公布第2014/0239036号,其公开内容以引用方式并入本文;和/或根据以下专利的教导内容中的至少一些来相互作用:2014年6月25日提交的标题为“Jaw Opening Feature for Surgical Stapler”的美国专利申请第14/314,108号,其公开内容以引用方式并入本文。
如上文所指出,柄部组件(20)包括手枪式握把(22)和闭合触发器(24)。同样如上文所指出,响应于闭合环(36)的远侧推进,砧座(60)朝向下钳口(50)闭合。在本示例中,闭合触发器(24)可朝向手枪式握把(22)枢转以朝远侧驱动闭合管(32)和闭合环(36)。参考本文的教导内容,可用于将闭合触发器(24)朝向手枪式握把(22)的枢转运动转化成闭合管(32)和闭合环(36)相对于柄部组件(20)的远侧平移的各种合适的部件对于本领域的普通技术人员将是显而易见的。
同样在本示例中,器械(10)提供对击发梁(82)的机动化控制。具体地,器械(10)包括机动化部件,所述机动化部件被构造成能够响应于击发触发器(26)朝向手枪式握把(22)枢转而朝远侧驱动击发梁(82)。在一些型式中,马达(未示出)容纳在手枪式握把(22)中并且从电池组(28)接收电力。此马达与传输组件(未示出)联接,所述传输组件将马达的驱动轴的旋转动作转换成击发梁(82)的线性平移。仅以举例的方式,能够操作以提供击发梁(82)的机动化致动的这些特征部可根据以下专利的教导内容中的至少一些来构造和操作:2012年7月3日公布的标题为“Motor-Driven Surgical Instrument”的美国专利第8,210,411号,其公开内容以引用方式并入本文;2013年6月4日公布的标题为“Motor-DrivenSurgical Cutting Instrument with Electric Actuator Directional ControlAssembly”的美国专利第8,453,914号,其公开内容以引用方式并入本文;和/或2014年3月26日提交的标题为“Surgical Instrument Comprising a Sensor System”的美国专利申请第14/226,142号,其公开内容以引用方式并入本文。
还应当理解,器械(10)的任何其他部件或特征部可根据本文所述的各种参考文献中的任一者来构造和操作。可提供用于器械(10)的其他示例性修改将在下文中更详细地描述。下述教导内容可并入器械(10)内的各种合适方式对于本领域的普通技术人员将是显而易见的。类似地,可将下述教导内容与本文引用的参考文献的各种教导内容进行组合的各种合适方式对于本领域的普通技术人员将是显而易见的。因此应当理解,下述教导内容可易于并入本文引用的各种参考文献所教导的各种器械内。还应当理解,下述教导内容并不限于本文引用的参考文献中教导的器械(10)或装置。下述教导内容可易于应用到各种其他种类的器械,所述器械包括将不被归类为外科缝合器的器械。参考本文的教导内容,其中可应用下文教导内容的各种其他合适的装置和情况对本领域的普通技术人员将是显而易见的。
II.外科缝合器的示例性支撑物组件
在一些情况下,可能期望为端部执行器(40)配备支撑物材料以增强钉(90)所提供的组织机械紧固。此类支撑物可防止所施用钉(90)牵拉穿过组织并且可以其他方式降低所施用钉(90)的部位处或附近的组织撕裂的风险。除了为一排钉(90)提供结构支撑和完整性之外或者作为另外一种选择,支撑物可提供各种其他种类的效果,诸如间距或间隙填充、治疗剂的给药和/或其他效果。在一些情况下,支撑物可设置在钉仓(70)的平台(73)上。在一些其他情况下,支撑物可设置在面向钉仓(70)的砧座(60)的表面上。还应当理解,第一支撑物可设置在钉仓(70)的平台(73)上,而第二支撑物设置在同一端部执行器(40)的砧座(60)上。支撑物可采用的形式的各种示例将在下文中更详细地描述。支撑物可固定到钉仓(70)或砧座(60)的各种方式也将在下文中更详细地描述。
A.外科缝合器的支撑物组件的示例性组成
图4示出具有基本组成的示例性的一对支撑物组件(100,110)。本示例的支撑物组件(100)包括支撑物主体(102)和上部粘合剂层(104)。类似地,支撑物组件(110)包括支撑物主体(112)和下部粘合剂层(114)。在本示例中,每个支撑物主体(102,112)包括被构造成能够在结构上支撑一排钉(90)的强而柔性的材料。仅以举例的方式,每个支撑物主体(102,112)可包括Ethicon,Inc.,Somerville,New Jersey的polyglactin 910材料的编织网。另选地,除了polyglactin 910材料之外或者作为另外一种选择,可使用任何其他合适的材料或材料组合来形成每个支撑物主体(102,112)。每个支撑物主体(102,112)可采取任何其他合适的形式,并且可由任何其他合适的材料构成。进一步仅以举例的方式,每个支撑物主体(102,112)可包含以下的一个或多个:Gunze Limited,Kyoto,Japan的NEOVEIL可吸收PGA毡;W.L.Gore&Associates,Inc.,Flagstaff,Arizona的SEAMGUARD聚乙醇酸:三亚甲基碳酸酯(PGA:TMC)增强材料;Baxter Healthcare Corporation,Deerfield,Illinois的PERI-STRIPS DRY与VERITAS胶原基质(PSDV)增强材料;Cook Medical,Bloomington,Indiana的BIODESIGN生物移植物;以及/或者Ethicon,Inc.,Somerville,New Jersey的SURGICEL NU-KNIT止血材料。参考本文的教导内容,可用于形成每个支撑物主体(102,112)的另外其他合适的材料对于本领域的普通技术人员而言将显而易见。
除此之外或另选地,每个支撑物主体(102,112)可包括下述材料,所述材料包括例如止血剂诸如血纤维蛋白以有助于凝结血液并且减少沿组织(90)的切断和/或缝合手术部位处的出血。作为另一个仅示例性的示例,每个支撑物主体(102,112)可包括其他助剂或止血剂诸如凝血酶,所述助剂或止血剂可被使用使得每个支撑物主体(102,112)可有助于凝结血液并且减少手术部位处的出血量。可结合到每个支撑物主体(102,112)内的其他助剂或试剂还可包括但不限于医用流体或基质组分。可用于形成每个支撑物主体(102,112)的材料,以及可以其他方式结合到每个支撑物主体(102,112)中的材料的仅示例性的示例在2015年3月25日提交的标题为“Method of Applying a Buttress to a SurgicalStapler”的美国专利申请第14/667,842号,该申请的公开内容以引用方式并入本文。另选地,可使用任何其他合适的材料。
仅以举例的方式,每个支撑物主体(102,112)可根据以下专利公布的教导内容中的至少一些来构造:2012年9月27日公布的标题为“Tissue Thickness CompensatorComprising Controlled Release and Expansion”的美国专利公布第2012/0241493号,其公开内容以引用方式并入本文;2013年3月21日公布的标题为“Surgical Instrument andButtress Material”的美国专利公布第2013/0068816号,其公开内容以引用方式并入本文;2013年3月14日公布的标题为“Surgical Instrument with Fluid FillableButtress”的美国专利公布第2013/0062391号,其公开内容以引用方式并入本文;2013年3月21日公布的标题为“Fibrin Pad Matrix with Suspended Heat Activated Beads ofAdhesive”的美国专利公布第2013/0068820号,其公开内容以引用方式并入本文;2013年4月4日公布的标题为“Attachment of Surgical Staple Buttress to Cartridge”的美国专利公布第2013/0082086号,其公开内容以引用方式并入本文;2013年2月14日公布的标题为“Device for Applying Adjunct in Endoscopic Procedure”的美国专利公布第2013/0037596号,其公开内容以引用方式并入本文;2013年3月14日公布的标题为“ResistiveHeated Surgical Staple Cartridge with Phase Change Sealant”的美国专利公布第2013/0062393号,其公开内容以引用方式并入本文;2013年3月28日公布的标题为“Surgical Staple Assembly with Hemostatic Feature”的美国专利公布第2013/0075446号,其公开内容以引用方式并入本文;2013年3月14日公布的标题为“SurgicalStaple Cartridge with Self-Dispensing Staple Buttress”的美国专利公布第2013/0062394号,其公开内容以引用方式并入本文;2013年3月28日公布的标题为“AnvilCartridge for Surgical Fastening Device”的美国专利公布第2013/0075445号,其公开内容以引用方式并入本文;2013年3月28日公布的标题为“Adjunct Therapy for ApplyingHemostatic Agent”的美国专利公布第2013/0075447号,其公开内容以引用方式并入本文;2013年10月3日公布的标题为“Tissue Thickness Compensator Comprising a Pluralityof Medicaments”的美国专利公布第2013/0256367号,其公开内容以引用方式并入本文;2014年6月10日提交的标题为“Adjunct Materials and Methods of Using Same inSurgical Methods for Tissue Sealing”的美国专利申请第14/300,954号,其公开内容以引用方式并入本文;2015年8月17日提交的标题为“Implantable Layers for a SurgicalInstrument”的美国专利申请第14/827,856号,其公开内容以引用方式并入本文;2015年8月31日提交的标题为“Drug Eluting Adjuncts and Methods of Using Drug ElutingAdjuncts”的美国专利申请第14/840,613号,其公开内容以引用方式并入本文;2015年9月30日提交的标题为“Compressible Adjunct with Crossing Spacer Fibers”的美国专利申请第14/871,071号,其公开内容以引用方式并入本文;和/或2015年9月30日提交的标题为“Method for Applying an Implantable Layer to a Fastener Cartridge”的美国专利申请第14/871,131号,其公开内容以引用方式并入本文。
在本示例中,粘合剂层(104)设置在支撑物主体(102)上以便将支撑物主体(102)粘附到砧座(60)的下侧(65)。类似地,粘合剂层(114)设置在支撑物主体(112)上以便将支撑物主体(112)粘附到钉仓(70)的平台(73)。将支撑物主体(102)粘附到砧座(60)的下侧(65)或粘附到钉仓(70)的平台(73)可以通过各种机构进行,包括但不限于压敏粘合剂。在一些型式中,每个粘合剂层(104,114)包括压敏粘合剂材料。可用于形成粘合剂层(104,114)的各种合适材料的示例在2015年3月25日提交的标题为“Method of Applying aButtress to a Surgical Stapler”的美国专利申请第14/667,842号,该申请的公开内容以引用方式并入本文。另选地,可使用任何其他合适的材料。应当理解,本文所使用的术语“粘合剂”可包括(但不限于)粘性材料以及柔韧或蜡状并且经由变形和贴合粘附到复杂几何形状的材料。一些合适的粘合剂可提供此类柔韧性以经由变形和贴合粘附到复杂几何形状,而不必提供高的初始粘性。在一些情况下,粘性较低的粘合剂可从表面更干净地去除。参考本文的教导内容,可用于形成粘合剂层(104,114)的各种合适材料对于本领域的普通技术人员将是显而易见的。
B.用于提供支撑物到外科缝合器的粘附的示例性材料和技术
如上文所指出,支撑物组件(100,110)可包括粘合剂材料的层(104,114)(或粘合剂材料的其他形式),该层将支撑物主体(102,112)粘附到砧座(60)的下侧(65)或钉仓(70)的平台(73)。此类粘合剂材料可在端部执行器(40)的致动之前和期间提供支撑物主体(102,112)的适当定位;然后在端部执行器(40)已被致动之后允许支撑物主体(102,112)与端部执行器(40)分离,而不会对支撑物主体(102,112)造成损坏,该损坏足以损害支撑物主体(102,112)的适当后续功能。
图5A-图5C示出已经装载有支撑物组件(100,110)的端部执行器(40)被致动以驱动钉(90)通过组织(T1,T2)的两个并列层的序列,其中支撑物组件(100,110)通过钉(90)固定到组织(T1,T2)的同一层。具体地讲,图5A示出定位在砧座(60)和钉仓(70)之间的组织(T1,T2)的层,其中砧座(60)处于打开位置。支撑物组件(100)经由粘合剂层(104)粘附到砧座(60)的下侧(65);而支撑物组件(110)经由粘合剂层(114)粘附到钉仓(70)的平台(73)。因此组织(T1,T2)的层被插置在支撑物组件(100,110)之间。接下来,触发器(24)朝向手枪式握把(22)枢转以朝远侧驱动闭合管(32)和闭合环(36)。这样将砧座(60)驱动到如图5B所示的闭合位置。在该阶段处,组织(T1,T2)的层被压缩在砧座(60)和钉仓(70)之间,其中支撑物组件(100,110)接合组织(T1,T2)层的相对表面。端部执行器(40)随后如上所述被致动,由此驱动钉(90)穿过支撑物组件(100,110)和组织(90)。如图5C所示,被驱动钉(90)的冠部(92)将支撑物组件(110)捕获和保持抵靠在组织(T2)的层。钉(90)的变形腿(94)将支撑物组件(100)捕获和保持抵靠在组织(T1)的层。
应当理解,一系列钉(90)将类似地将支撑物组件(100,110)捕获和保持抵靠在组织(T1,T2)的层,由此将支撑物组件(100,110)固定到组织(T1,T2),如图6所示。因为在部署钉(90)和支撑物组件(100,110)之后端部执行器(40)被拉离组织(90),所以支撑物组件(100,110)与端部执行器脱离接合,使得支撑物组件(100,110)保持用钉(90)固定到组织(T1,T2)。支撑物组织(T1,T2)因此为成排的钉90提供结构增强。另外如图6可见,刀构件(80)还切穿支撑物组织组件(100,110)的中心线,从而将每个支撑物组件(100,110)分成对应对的节段,使得每个节段保持固定到组织(T1,T2)的相应切断区域。
在上述示例中,支撑物组件(100)的尺寸被设计成横跨下侧(65)的全部宽度,使得支撑物组件(100)横跨通道(62)。因此,如上所述,刀构件(80)在端部执行器(40)的致动期间切穿支撑物组件(100)。在一些其他示例中,诸如以下所述的那些示例,支撑物组件(100)设置在两个分开的侧向间隔开的部分中,其中一个部分设置在通道(62)一侧的下侧(65)上,而另一部分设置在通道(62)另一侧的下侧(65)上。在此类型式中,支撑物组件(100)不横跨通道(62),使得在端部执行器(40)的致动期间,刀构件(80)不切穿支撑物组件(100)。
同样,如上所述,支撑物组件(110)的尺寸可被设计成横跨平台(73)的全部宽度,使得支撑物组件(110)横跨通道(72),并且使得刀构件(80)在端部执行器(40)的致动期间切穿支撑物组件(110)。另选地,支撑物组件(110)可被提供成两个分开的侧向间隔开的部分,其中一个部分设置在通道(72)的一侧上的平台(73)上,而另一部分设置在通道(72)的另一侧上的平台(73)上,使得支撑物组件(110)不横跨通道(72),并且使得刀构件(80)在端部执行器(40)的致动期间不切穿支撑物组件(110)。
III.支撑物组件的示例性多层粘合剂布置
在一些情况下,可能需要提供一种型式的支撑物组件(100,110),其中粘合剂层(104,114)包括具有不同性质的两种或更多种不同种类的粘合剂材料。例如,图7-图8示出了包括支撑物主体(202)、布设在支撑物主体(202)之上的第一粘合剂层(204)和布设在第一粘合剂层(204)之上的第二粘合剂层(206)的示例性支撑物组件(200)。应当理解,在支撑物主体(202)位于支撑物组件(200)的底部时,支撑物组件(200)类似于上述支撑物组件(100),并且可类似地固定到砧座(60)的下侧(65)。或者,支撑物组件(200)可以颠倒至倒置,以用于将支撑物组件(200)固定到钉仓(70)的平台(73)的布置。在此类型式中,第二粘合剂层(206)将位于底部,第一粘合剂层(204)将被布设在第二粘合剂层(206)之上,并且支撑物主体(202)将被布设在第一粘合剂层(204)之上。
支撑物主体(202)可以仅类似于上述支撑物主体(102,112)的方式来构造和操作。此外,支撑物主体(202)可根据以下美国专利申请的教导内容中的至少一些教导内容进行构造和操作:2015年3月25日提交的标题为“Method of Applying a Buttress to aSurgical Stapler”的美国专利申请第14/667,842号,该申请的公开内容以引用方式并入本文。参考本文的教导内容,支撑物主体(202)可采用的其他合适形式对于本领域的普通技术人员将是显而易见的。
第一粘合剂层(204)由不同于形成第二粘合剂层(206)的粘合剂材料形成。在一些型式中,第一粘合剂层(204)由具有比形成第二粘合剂层(206)的材料更大的柔韧性和粘性的材料形成。在一些此类型式中,第二粘合剂层(206)用作第一粘合剂层(204)的保护剂。例如,第二粘合剂层(206)可保护第一粘合剂层(204)不受在支撑物组件(200)的运输和/或储存期间可能遇到的湿度、温度波动和/或其他环境条件的影响。换句话讲,第二粘合剂层(206)可比第一粘合剂层(206)更耐湿度和/或温度影响。在一些其他变型中,第二粘合剂层(206)被非粘合剂保护层代替。仅以举例的方式,第二粘合剂层(206)可以被生物相容性和可生物吸收的、可溶解的膜或其他结构代替,或者可被能够以其方式限制形成第一粘合剂层(204)的材料的膜或其他结构代替(例如,以防止第一粘合剂层在储存、运输、手术前处理等期间渗漏、迁移或以其他方式流出支撑物组件(200))。当将砧座(60)按压抵靠在支撑物组件(200)时,两个粘合剂层(204,206)可以配合以将支撑物组件(200)粘附至砧座(60)的下侧(65)。
在一些型式中,第二粘合剂层(206)被喷涂到第一粘合剂层(204)上,同时第一粘合剂层被保持在使第一粘合剂层(204)保持固体的温度和湿度水平。应当理解,不同粘合剂层(204,206)的组合仅比单个粘合剂层(204)抵靠砧座(60)更易溶解,并且/或者抵靠砧座(60)的粘性更小。当在外科手术过程中将一系列支撑物组件(200)施加到下侧(65)以激活一系列端部执行器(40)时,这可以防止在砧座(60)的下侧(65)上的不期望的粘合剂材料累积。还应当理解,粘合剂层(204,206)可以在不同层(204,206)中提供不同比率的两种分子量的共混物。另外,粘合剂层(204,206)可以具有交联差异,并且/或者来自不同族的粘合剂。仅以举例的方式,由较高分子量泊洛沙姆形成的粘合剂层(204,206)可更硬且更不易于随着温度波动而流动。因此,即使粘合剂层(204)随着温度波动而变为流体,使用具有较高分子量的泊洛沙姆共混物的粘合剂层(206)可以容纳形成粘合剂层(204)的较低分子量材料。具有较高交联度的材料可具有较高的转变温度,因此在极端温度下流动较小。不同族的示例可以是粘合剂层(204)中的泊洛沙姆共混物,其具有喷涂在粘合剂层(204)上以形成粘合剂层(206)的PCL/PGA共聚物薄层。
参考本文的教导内容,可用于形成第二粘合剂层(206)的各种合适材料和第二粘合剂层的非粘合替代物对于本领域的普通技术人员将是显而易见的。仅以举例的方式,第一粘合剂层(204)可根据下列美国专利申请的教导内容中的至少一些来构造和操作:美国专利申请与本发明于同一日期提交的标题为“Surgical Stapler Buttress Assemblywith Humidity Tolerant Adhesive”的美国专利申请No.[代理人案卷号END7809USNP.0630312],其公开内容以引用方式并入本文;与本发明于同一日期提交的标题为“Surgical Stapler Buttress Assembly with Adhesion to Wet End Effector”的美国专利申请No.[代理人案卷号END7810USNP.0630307],其公开内容以引用方式并入本文;以及/或者本文引用的任何其他参考文献。
在支撑物组件(200)中,第一粘合剂层(204)的外边缘由第二粘合剂层(206)保持暴露。图9-图10示出了示例性的另选支撑物组件(300),其中第一粘合剂层(304)的外边缘被第二粘合剂层(306)的向下突出区域(308)覆盖。在该示例中,向下突出区域(308)沿着第一粘合剂层(304)的全部宽度和全部长度延伸。向下突出区域(308)也向下延伸至与支撑物主体(302)的上表面接触。因此,支撑物主体(302)和第二粘合剂层(306)配合以完全包封第一粘合剂层(304)。如上所述,支撑物主体(302)、第一粘合剂层(304)和第二粘合剂层(306)可以以其他方式与支撑物主体(202)、第一粘合剂层(204)和第二粘合剂层(206)相同。参考本文的教导内容,粘合剂层(304,306)可相对于支撑物主体(302)构造和布置的其他合适方式对于本领域的普通技术人员将是显而易见的。
除了上述内容以外,还应当理解,本文所述的各种支撑物组件中的任何一种可进一步根据以下专利的教导内容中的至少一些来构造和操作:2015年3月25日提交的标题为“Method of Applying a Buttress to a Surgical Stapler”的美国专利申请第14/667,842号,该申请的公开内容以引用方式并入本文。
IV.示例性组合
下述实施例涉及本文的教导内容可被组合或应用的各种非穷尽性方式。应当理解,下述实施例并非旨在限制可在本专利申请或本专利申请的后续提交文件中的任何时间提供的任何权利要求的覆盖范围。不旨在进行免责声明。提供以下实施例仅仅是出于例示性目的。设想到,本文的各种教导内容可按多种其他方式进行布置和应用。还设想到,一些变型可省略在以下实施例中所提及的某些特征。因此,下文提及的方面或特征中的任一者均不应被视为决定性的,除非另外例如由发明人或关注发明人的继承者在稍后日期明确指明如此。如果本专利申请或与本专利申请相关的后续提交文件中提出的任何权利要求包括下文提及的那些特征之外的附加特征,则这些附加特征不应被假定为因与专利性相关的任何原因而被添加。
实施例1
一种外科缝合器端部执行器组件,该端部执行器组件包括:(a)钉仓,其中该钉仓包括:(i)多个钉,和(ii)平台,其中该钉仓能够操作以驱动钉穿过平台;(b)砧座,其中该砧座能够从打开位置朝向钉仓运动以到达闭合位置,其中砧座包括下侧,下侧具有被构造成能够接纳驱动穿过平台的钉的钉成形表面;以及(c)支撑物组件,其中该支撑物组件的尺寸和构造被设置成与钉仓的平台或砧座的下侧联接,其中该支撑物组件包括:(i)支撑物主体,(ii)布设在支撑物主体之上的第一粘合剂层,其中该第一粘合剂层由第一粘合剂材料形成,以及(iii)布设在第一粘合剂层之上的第二粘合剂层,使得第一粘合剂层插置在第二粘合剂层与支撑物主体之间,其中第二粘合剂层由第二粘合剂材料形成,其中第二粘合剂材料不同于第一粘合剂材料。
实施例2
根据实施例1所述的端部执行器组件,其中该第二粘合剂层被定位成面向砧座的下侧。
实施例3
根据实施例1至2中任一项或多项所述的端部执行器组件,其中该第二粘合剂层被定位成面向钉仓的平台。
实施例4
根据实施例1至3中任一项或多项所述的端部执行器组件,其中第一粘合剂材料具有比第二粘合剂材料大的柔韧性。
实施例5
根据实施例1至4中任一项或多项所述的端部执行器组件,其中第一粘合剂材料具有比第二粘合剂材料大的粘性。
实施例6
根据实施例1至5中任一项或多项所述的端部执行器组件,其中第二粘合剂材料比第一粘合剂材料更耐湿度。
实施例7
根据实施例1至6中任一项或多项所述的端部执行器组件,其中第二粘合剂材料比第一粘合剂材料更耐温度。
实施例8
根据实施例1至7中任一项或多项所述的端部执行器组件,其中第一粘合剂层和第二粘合剂层被构造成能够配合以将支撑物主体粘附至钉仓的平台或砧座的下侧。
实施例9
根据实施例1至8中任一项或多项所述的端部执行器组件,其中第一粘合剂材料和第二粘合剂材料具有不同分子量的共混物。
实施例10
根据实施例1至9中任一项或多项所述的端部执行器组件,其中第一粘合剂材料和第二粘合剂材料具有不同的交联属性。
实施例11
根据实施例1至10中任一项或多项所述的端部执行器组件,其中第一粘合剂材料和第二粘合剂材料选自不同的粘合剂材料族。
实施例12
根据实施例1至11中任一项或多项所述的端部执行器组件,其中第二粘合剂材料包括接触支撑物主体的区域。
实施例13
根据实施例12所述的端部执行器组件,其中支撑物主体和第二粘合剂材料的接触该支撑物主体的区域配合以包封第一粘合剂材料。
实施例14
根据实施例12至13中任一项或多项所述的端部执行器组件,其中第一粘合剂层具有长度,其中第二粘合剂材料的接触支撑物主体的区域沿着第一粘合剂层的全部长度延伸。
实施例15
根据实施例12至14中任一项或多项所述的端部执行器组件,其中第一粘合剂层具有宽度,其中第二粘合剂材料的接触支撑物主体的区域沿着第一粘合剂层的全部宽度延伸。
实施例16
根据实施例1至15中任一项或多项所述的端部执行器组件,其中该支撑物组件粘附至砧座的下侧,其中钉被定位成驱动穿过支撑物组件。
实施例17
外科缝合器端部执行器组件,该端部执行器组件包括:(a)下钳口;(b)砧座,其中该砧座能够从打开位置朝向下钳口运动以到达闭合位置,其中砧座包括具有钉成形表面的下侧;和(c)支撑物组件,该支撑物组件固定至砧座的下侧,其中该支撑物组件包括:(i)支撑物主体,(ii)布设在支撑物主体之上的第一粘合剂层,其中该第一粘合剂层由第一粘合剂材料形成,以及(iii)布设在第一粘合剂层之上的第二粘合剂层,使得第一粘合剂层插置在第二粘合剂层与支撑物主体之间,其中第二粘合剂层由第二粘合剂材料形成,其中第二粘合剂材料不同于第一粘合剂材料。
实施例19
一种制造与外科缝合器端部执行器一起使用的支撑物组件的方法,其中该端部执行器包括钉仓和砧座,其中钉仓包括平台和多个钉,其中该钉仓能够操作以驱动钉穿过平台,其中砧座能够从打开位置朝向钉仓运动以到达闭合位置,其中砧座包括下侧,该下侧具有被构造成能够接纳驱动穿过平台的钉的钉成形表面,该方法包括:(a)将第一粘合剂层施加到支撑物主体,其中支撑物主体的尺寸和构造被设置成配合在钉仓的平台或砧座的下侧上,其中第一粘合剂层包括第一粘合剂材料;以及(b)将第二粘合剂层施加到第一粘合剂层,使得第一粘合剂层插置在第二粘合剂层与支撑物主体之间,其中第二粘合剂层由第二粘合剂材料形成,其中第二粘合剂材料不同于第一粘合剂材料。
实施例19
根据实施例18所述的方法,其中将第二粘合剂层施加到第一粘合剂层的动作包括将第二粘合剂层喷涂在第一粘合剂层之上。
实施例20
根据实施例18至19中任一项或多项所述的方法,还包括将支撑物组件按压抵靠在砧座的下侧,其中响应于将支撑物组件按压抵靠在砧座的下侧,第一粘合剂材料或第二粘合剂材料中的一者或两者将支撑物组件固定至砧座的下侧。
V.杂项
应当理解,本文所述的教导内容、表达、实施方案、示例等中的任何一者或多者可与本文所述的其他教导内容、表达、实施方案、示例等中的任何一者或多者进行组合。因此,上述教导内容、表达、实施方案、示例等不应视为彼此孤立。参考本文的教导内容,本文的教导内容可进行组合的各种合适方式对于本领域的普通技术人员而言将显而易见。此类修改和变型旨在包括在权利要求书的范围内。
除了上述内容以外,还应当理解,本文所述的各种支撑物组件中的任何一种可进一步根据以下专利的教导内容中的至少一些来构造和操作:2015年3月25日提交的标题为“Method of Applying a Buttress to a Surgical Stapler”的美国专利申请第14/667,842号,其公开内容以引用方式并入本文;2015年8月17日提交的标题为“ImplantableLayers for a Surgical Instrument”的美国专利申请第14/827,856号,其公开内容以引用方式并入本文;2015年9月30日提交的标题为“Compressible Adjunct with CrossingSpacer Fibers”的美国专利申请第14/871,071号,其公开内容以引用方式并入本文;以及2015年9月30日提交的标题为“Method for Applying an Implantable Layer to aFastener Cartridge”的美国专利申请第14/871,131号,其公开内容以引用方式并入本文。此外,除了本文所述的方法以外,本文所述的各种支撑物组件中的任何一种可根据以下专利的教导内容中的至少一些应用于端部执行器(40):2015年8月24日提交的标题为“Methodand Apparatus for Applying a Buttress to End Effector of a Surgical Stapler”的美国临时专利申请第62/209,041号,其公开内容以引用方式并入本文;和/或2015年9月30日提交的标题为“Method for Applying an Implantable Layer to a FastenerCartridge”的美国专利申请第14/871,131号,其公开内容以引用方式并入本文。可将本文的教导内容与上面所引的参考文献的各种教导内容进行组合的各种合适的方式对于本领域的普通技术人员将是显而易见的。
应当理解,据称以引用的方式并入本文的任何专利、专利公布或其他公开材料,无论是全文或部分,仅在所并入的材料与本公开中所述的现有定义、陈述或者其他公开材料不冲突的范围内并入本文。因此,并且在必要的程度下,本文明确列出的公开内容代替以引用方式并入本文的任何冲突材料。据称以引用方式并入本文但与本文列出的现有定义、陈述或其他公开材料相冲突的任何材料或其部分,将仅在所并入的材料与现有的公开材料之间不产生冲突的程度下并入。
上述装置的型式可应用于由医疗专业人员进行的传统医学治疗和手术、以及机器人辅助的医学治疗和手术中。仅以举例的方式,本文的各种教导内容可易于并入机器人外科系统,诸如Intuitive Surgical,Inc.(Sunnyvale,California)的DAVINCITM系统。类似地,本领域的普通技术人员将认识到本文中的各种教导内容可容易地与以下专利中的任一个的各种教导内容进行结合:1998年8月11日公布的标题为“Articulated SurgicalInstrument For Performing Minimally Invasive Surgery With Enhanced Dexterityand Sensitivity”的美国专利第5,792,135号,其公开内容以引用方式并入本文;1998年10月6日公布的标题为“Remote Center Positioning Device with Flexible Drive”的美国专利第5,817,084号,其公开内容以引用方式并入本文;1999年3月2日公布的标题为“Automated Endoscope System for Optimal Positioning”的美国专利第5,878,193号,其公开内容以引用方式并入本文;2001年5月15日公布的标题为“Robotic Arm DLUS forPerforming Surgical Tasks”的美国专利第6,231,565号,其公开内容以引用方式并入本文;2004年8月31日公布的标题为“Robotic Surgical Tool with UltrasoundCauterizing and Cutting Instrument”的美国专利第6,783,524号,其公开内容以引用方式并入本文;2002年4月2日公布的标题为“Alignment of Master and Slave in aMinimally Invasive Surgical Apparatus”的美国专利第6,364,888号,其公开内容以引用方式并入本文;2009年4月28日公布的标题为“Mechanical Actuator Interface Systemfor Robotic Surgical Tools”的美国专利第7,524,320号,其公开内容以引用方式并入本文;2010年4月6日公布的标题为“Platform Link Wrist Mechanism”的美国专利第7,691,098号,其公开内容以引用方式并入本文;2010年10月5日公布的标题为“Repositioningand Reorientation of Master/Slave Relationship in Minimally InvasiveTelesurgery”的美国专利第7,806,891号,其公开内容以引用方式并入本文;2013年1月10日公布的标题为“Automated End Effector Component Reloading System for Use witha Robotic System”的美国公布第2013/0012957号,其公开内容以引用方式并入本文;2012年8月9日公布的标题为“Robotically-Controlled Surgical Instrument with Force-Feedback Capabilities”的美国公布第2012/0199630号,其公开内容以引用方式并入本文;2012年5月31日公布的标题为“Shiftable Drive Interface for Robotically-Controlled Surgical Tool”的美国公布第2012/0132450号,其公开内容以引用方式并入本文;2012年8月9日公布的标题为“Surgical Stapling Instruments with Cam-DrivenStaple Deployment Arrangements”的美国公布第2012/0199633号,其公开内容以引用方式并入本文;2012年8月9日公布的标题为“Robotically-Controlled Motorized SurgicalEnd Effector System with Rotary Actuated Closure Systems Having VariableActuation Speeds”的美国公布第2012/0199631号,其公开内容以引用方式并入本文;2012年8月9日公布的标题为“Robotically-Controlled Surgical Instrument withSelectively Articulatable End Effector”的美国公布第2012/0199632号,其公开内容以引用方式并入本文;2012年8月9日公布的标题为“Robotically-Controlled SurgicalEnd Effector System”的美国公布第2012/0203247号,其公开内容以引用方式并入本文;2012年8月23日公布的标题为“Drive Interface for Operably Coupling aManipulatable Surgical Tool to a Robot”的美国公布第2012/0211546号,其公开内容以引用方式并入本文;2012年6月7日公布的标题为“Robotically-Controlled Cable-Based Surgical End Effectors”的美国公布第2012/0138660号,其公开内容以引用方式并入本文;和/或2012年8月16日公布的标题为“Robotically-Controlled Surgical EndEffector System with Rotary Actuated Closure Systems”的美国公布2012/0205421,其公开内容以引用方式并入本文。
上文所述的型式的装置可被设计为单次使用后丢弃,或者它们可被设计为可多次使用。在任一种情况下或两种情况下,可对这些型式进行修复以在至少一次使用之后重复使用。修复可包括以下步骤的任意组合:拆卸装置,然后清洁或替换特定零件以及随后进行重新组装。具体地,可拆卸一些型式的装置,并且可以任何组合来选择性地替换或移除装置的任意数量的特定零件或部分。在清洁和/或更换特定部件时,所述装置的一些型式可在修复设施处重新组装或者在即将进行手术之前由用户重新组装以供随后使用。本领域的技术人员将会了解,装置的修复可利用多种技术进行拆卸、清洁/更换、以及重新组装。此类技术的使用以及所得的修复装置均在本申请的范围内。
仅以举例的方式,本文描述的型式可在手术之前和/或之后消毒。在一种消毒技术中,将所述装置放置在闭合且密封的容器诸如塑料袋或TYVEK袋中。然后可将容器和装置放置在可穿透容器的辐射场中,诸如γ辐射、x射线、或高能电子。辐射可杀死装置上和容器中的细菌。经消毒的装置随后可存储在无菌容器中,以供以后使用。还可使用本领域已知的任何其他技术对装置进行消毒,所述技术包括但不限于β辐射或γ辐射、环氧乙烷或蒸汽。
已经示出和阐述了本发明的各种实施方案,可在不脱离本发明的范围的情况下由本领域的普通技术人员进行适当修改来实现本文所述的方法和系统的进一步改进。已经提及了若干此类可能的修改,并且其他修改对于本领域的技术人员而言将显而易见。例如,上文所讨论的实施例、实施方案、几何形状、材料、尺寸、比率、步骤等均是例示性的而非必需的。因此,本发明的范围应根据以下权利要求书来考虑,并且应理解为不限于说明书和附图中示出和描述的结构和操作的细节。
Claims (17)
1.一种外科缝合器端部执行器组件,所述端部执行器组件包括:
(a)钉仓,其中所述钉仓包括:
(i)多个钉,和
(ii)平台,其中所述钉仓能够操作以驱动所述钉穿过所述平台并进入组织;
(b)砧座,其中所述砧座能够从打开位置朝向所述钉仓运动以到达闭合位置以用于抵靠所述平台而夹持所述组织,其中所述砧座包括下侧,所述下侧具有被构造成能够接纳驱动穿过所述平台和被夹持的组织的钉的钉成形表面;以及
(c)支撑物组件,其中所述支撑物组件的尺寸和构造被设置成与所述钉仓的所述平台或所述砧座的所述下侧联接,其中所述支撑物组件包括:
(i)支撑物主体,
(ii)第一粘合剂层,所述第一粘合剂层布设在所述支撑物主体之上并与所述支撑物主体粘结,其中所述第一粘合剂层由可流动的第一粘合剂材料形成,以及
(iii)第二粘合剂层,所述第二粘合剂层布设在所述第一粘合剂层之上并和所述第一粘合剂层粘结,使得所述第一粘合剂层被构造为在所述支撑物主体与所述钉仓或所述砧座联接之前插置在所述第二粘合剂层与所述支撑物主体之间,其中所述第二粘合剂层由第二粘合剂材料形成,其中所述第二粘合剂材料具有不同于所述第一粘合剂材料的特性,
其中所述支撑物主体被相对于所述钉仓和所述砧座定位,使得当所述支撑物主体被定位为和被夹持在所述钉仓和所述砧座之间的组织直接接触时,所述第二粘合剂层和所述钉仓的所述平台直接接触并粘合至所述平台,或者所述第二粘合剂层和所述砧座的所述下侧直接接触并粘合至所述下侧。
2.根据权利要求1所述的端部执行器组件,其中所述第二粘合剂层被定位成面向所述砧座的所述下侧。
3.根据权利要求1所述的端部执行器组件,其中所述第二粘合剂层被定位成面向所述钉仓的所述平台。
4.根据权利要求1所述的端部执行器组件,其中所述第一粘合剂材料具有比所述第二粘合剂材料大的柔韧性。
5.根据权利要求1所述的端部执行器组件,其中所述第一粘合剂材料具有比所述第二粘合剂材料大的粘性。
6.根据权利要求1所述的端部执行器组件,其中所述第二粘合剂材料被构造为当所述支撑物主体被暴露至潮湿时具有和所述第一粘合剂材料不同的反应。
7.根据权利要求1所述的端部执行器组件,其中所述第二粘合剂材料被构造为当所述支撑物主体被暴露至温度变化时具有和所述第一粘合剂材料不同的反应。
8.根据权利要求1所述的端部执行器组件,其中所述第一粘合剂层和所述第二粘合剂层被构造成能够配合以将所述支撑物主体粘附至所述钉仓的所述平台或所述砧座的所述下侧。
9.根据权利要求1所述的端部执行器组件,其中所述第一粘合剂材料和所述第二粘合剂材料具有不同分子量的共混物。
10.根据权利要求1所述的端部执行器组件,其中所述第一粘合剂材料和所述第二粘合剂材料具有不同的交联属性。
11.根据权利要求1所述的端部执行器组件,其中所述第一粘合剂材料和所述第二粘合剂材料选自不同的粘合剂材料族。
12.根据权利要求1所述的端部执行器组件,其中所述第二粘合剂材料包括接触所述支撑物主体的区域。
13.根据权利要求12所述的端部执行器组件,其中所述支撑物主体和所述第二粘合剂材料的接触所述支撑物主体的所述区域配合以包封所述第一粘合剂材料。
14.根据权利要求12所述的端部执行器组件,其中所述第一粘合剂层具有长度,其中所述第二粘合剂材料的接触所述支撑物主体的所述区域沿着所述第一粘合剂层的全部长度延伸。
15.根据权利要求12所述的端部执行器组件,其中所述第一粘合剂层具有宽度,其中所述第二粘合剂材料的接触所述支撑物主体的所述区域沿着所述第一粘合剂层的全部宽度延伸。
16.根据权利要求1所述的端部执行器组件,其中所述支撑物组件粘附至所述砧座的所述下侧,其中所述钉被定位成驱动穿过所述支撑物组件。
17.一种外科缝合器端部执行器组件,所述端部执行器组件包括:
(a)下钳口;
(b)砧座,其中所述砧座能够从打开位置朝向所述下钳口运动以到达闭合位置,其中所述砧座包括具有钉成形表面的下侧;和
(c)支撑物组件,所述支撑物组件被构造为固定至所述砧座的所述下侧,其中所述支撑物组件包括:
(i)支撑物主体,
(ii)第一粘合剂层,所述第一粘合剂层布设在所述支撑物主体之上并和所述支撑物主体粘结,其中所述第一粘合剂层由可流动的第一粘合剂材料形成,以及
(iii)第二粘合剂层,所述第二粘合剂层布设在所述第一粘合剂层之上并和所述支撑物主体粘结,使得在所述支撑物组件固定至所述砧座之前所述第一粘合剂层插置在所述第二粘合剂层与所述支撑物主体之间,其中所述第二粘合剂层由第二粘合剂材料形成,其中所述第二粘合剂材料具有不同于所述第一粘合剂材料的特性,
其中所述支撑物主体能够被固定至所述砧座的下侧,使得当所述支撑物主体被定位为和被夹持在所述下钳口和所述砧座之间的组织直接接触时,所述第二粘合剂层和所述砧座的所述下侧直接接触并粘合至所述下侧。
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PCT/US2016/058398 WO2017074844A1 (en) | 2015-10-29 | 2016-10-24 | Surgical stapler buttress assembly with multi-layer adhesive |
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- 2016-10-24 BR BR112018008559-6A patent/BR112018008559B1/pt active IP Right Grant
- 2016-10-24 JP JP2018522073A patent/JP6926076B2/ja active Active
- 2016-10-24 WO PCT/US2016/058398 patent/WO2017074844A1/en active Application Filing
- 2016-10-28 EP EP19195235.7A patent/EP3616627B1/en active Active
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JP2018536467A (ja) | 2018-12-13 |
US10441286B2 (en) | 2019-10-15 |
EP3616627A1 (en) | 2020-03-04 |
EP3162302A1 (en) | 2017-05-03 |
BR112018008559B1 (pt) | 2022-10-11 |
US20170119392A1 (en) | 2017-05-04 |
EP3616627C0 (en) | 2024-06-26 |
JP6926076B2 (ja) | 2021-08-25 |
BR112018008559A2 (pt) | 2018-11-21 |
EP3616627B1 (en) | 2024-06-26 |
CN108348253A (zh) | 2018-07-31 |
EP3162302B1 (en) | 2019-09-04 |
WO2017074844A1 (en) | 2017-05-04 |
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