CN107645931B - 具有用于可释放地附接到外科缝合器的一体式粘合剂的外科钉支撑物 - Google Patents
具有用于可释放地附接到外科缝合器的一体式粘合剂的外科钉支撑物 Download PDFInfo
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- CN107645931B CN107645931B CN201680030449.XA CN201680030449A CN107645931B CN 107645931 B CN107645931 B CN 107645931B CN 201680030449 A CN201680030449 A CN 201680030449A CN 107645931 B CN107645931 B CN 107645931B
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Abstract
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、砧座和支撑物组件。所述钉仓包括多个钉和平台。所述钉仓能够操作以驱动所述钉穿过所述平台。所述砧座能够从打开位置朝所述钉仓移动以到达闭合位置。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。所述支撑物组件包括支撑物主体、粘合剂材料和多根加强股线。所述加强股线被构造成能够接合被击发穿过所述支撑物主体的一个或多个钉。
Description
背景技术
在一些设置中,内窥镜式外科器械可优于传统的开放式外科装置,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处。这些远侧端部执行器(例如,直线切割器、抓紧器、切割器、缝合器、施夹器、接入装置、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。这种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,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结构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它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持在组织层上,切穿被夹持的组织层,并且驱动钉穿过组织层,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。仅例示性外科缝合器公开于以下专利:公布于1989年2月21日的名称为“Pocket Configuration for Internal Organ Staplers”的美国专利4,805,823;公布于1995年5月16日的名称为“Surgical Stapler and Staple Cartridge”的美国专利5,415,334;公布于1995年11月14日的名称为“Surgical Stapler Instrument”的美国专利5,465,895;公布于1997年1月28日的名称为“Surgical Stapler Instrument”的美国专利5,597,107;公布于1997年5月27日的名称为“Surgical Instrument”的美国专利5,632,432;公布于1997年10月7日的名称为“Surgical Instrument”的美国专利5,673,840;公布于1998年1月6日的名称为“Articulation Assembly for Surgical Instruments”的美国专利5,704,534;公布于1998年9月29日的名称为“Surgical Clamping Mechanism”的美国专利5,814,055;公布于2005年12月27日的名称为“Surgical Stapling InstrumentIncorporating an E-Beam Firing Mechanism”的美国专利6,978,921;公布于2006年2月21日的名称为“Surgical Stapling Instrument Having Separate Distinct Closingand Firing Systems”的美国专利7,000,818;公布于2006年12月5日的名称为“SurgicalStapling Instrument Having a Firing Lockout for an Unclosed Anvil”的美国专利7,143,923;公布于2007年12月4日的名称为“Surgical Stapling InstrumentIncorporating a Multi-Stroke Firing Mechanism with a Flexible Rack”的美国专利7,303,108;公布于2008年5月6日的名称为“Surgical Stapling InstrumentIncorporating a Multistroke Firing Mechanism Having a Rotary Transmission”的美国专利7,367,485;公布于2008年6月3日的名称为“Surgical Stapling InstrumentHaving a Single Lockout Mechanism for Prevention of Firing”的美国专利7,380,695;公布于2008年6月3日的名称为“Articulating Surgical Stapling InstrumentIncorporating a Two-Piece E-Beam Firing Mechanism”的美国专利7,380,696;公布于2008年7月29日的名称为“Surgical Stapling and Cutting Device”的美国专利7,404,508;公布于2008年10月14日的名称为“Surgical Stapling Instrument HavingMultistroke Firing with Opening Lockout”的美国公布号7,434,715;公布于2010年5月25日的名称为“Disposable Cartridge with Adhesive for Use with a StaplingDevice”的美国专利7,721,930;公布于2013年4月2日的名称为“Surgical StaplingInstrument with An Articulatable End Effector”的美国专利8,408,439;以及公布于2013年6月4日的名称为“Motor-Driven Surgical Cutting Instrument with ElectricActuator Directional Control Assembly”的美国专利8,453,914。上面所引的美国专利申请中的每个专利申请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/或其它非内窥镜式手术中。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插入并由此位于患者肋骨之间以到达一个或多个器官,该胸廓外科手术不使用套管针作为缝合器的导管。此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它设置和手术中。
可能特别适用或通过胸廓切开术使用的外科缝合器的示例公开于以下专利:公布于2014年8月28日的名称为“Surgical Instrument End Effector Articulation Drivewith Pinion and Opposing Racks”的美国专利公布号2014/0243801;公布于2014年8月28日的名称为“Lockout Feature for Movable Cutting Member of Surgical Instrument”的美国专利公布号2014/0239041;公布于2014年8月28日的名称为“Integrated TissuePositioning and Jaw Alignment Features for Surgical Stapler”的美国专利公布号2014/0239042;公布于2014年8月28日的名称为“Jaw Closure Feature for End Effectorof Surgical Instrument”的美国专利公布号2014/0239036;公布于2014年8月28日的名称为“Surgical Instrument with Articulation Lock having a Detenting BinarySpring”的美国专利公布号2014/0239040;公布于2014年8月28日的名称为“Distal TipFeatures for End Effector of Surgical Instrument”的美国专利公布号2014/0239043;公布于2014年8月28日的名称为“Staple Forming Features for SurgicalStapling Instrument”的美国专利公布号2014/0239037;公布于2014年8月28日的名称为“Surgical Instrument with Multi-Diameter Shaft”的美国专利公布号2014/0239038;以及公布于2014年8月28日的名称为“Installation Features for Surgical InstrumentEnd Effector Cartridge”的美国专利公布号2014/0239044。上述美国专利公布中的每个的公开内容以引用方式并入本文。
另外的外科缝合器械公开于以下专利:公布于2012年3月27日的名称为“SurgicalStapler Comprising a Staple Pocket”的美国专利8,141,762;公布于2013年2月12日的名称为“Surgical End Effector Having Buttress Retention Features”的美国专利8,371,491;公布于2014年9月18日的名称为“Method and Apparatus for Sealing End-to-End Anastomosis”的美国公布号2014/0263563;公布于2014年9月4日的名称为“RotaryPowered Surgical Instruments with Multiple Degrees of Freedom”的美国公布号2014/0246473;公布于2013年8月15日的名称为“Linear Stapler”的美国公布号2013/0206813;公布于2008年7月17日的名称为“Buttress Material for Use with a SurgicalStapler”的美国公布号2008/0169328;提交于2014年6月10日的名称为“Woven andFibrous Materials for Reinforcing a Staple Line”的美国专利申请号14/300,804;名称为“Devices and Methods for Sealing Staples in Tissue”的美国专利申请号14/300,811;以及提交于2014年9月26日的名称为“Radically Expandable Staple Line”的美国专利申请号14/498,070。上述美国专利、美国专利公布和美国专利申请中的每一者的公开内容以引用方式并入本文。
在一些情况下中,可能需要为外科缝合器械配备支撑材料以加强钉所提供的对组织的机械紧固。此类支撑物可防止施加的钉牵拉穿过组织并且可在其它情况下降低组织在施加的钉的部位处或附近撕裂的风险。
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示出了示例性关节运动式外科缝合器械的透视图;
图2示出了图1的器械的侧正视图;
图3示出了图1的器械的端部执行器的透视图,其中端部执行器处于闭合构型中;
图4示出了图3的端部执行器的透视图,其中端部执行器处于打开构型中;
图5示出了图3的端部执行器的分解透视图;
图6示出了沿图4的线6-6截取的图3的端部执行器的剖面端视图;
图7A示出了沿图4的线7-7截取的图3的端部执行器的剖面侧视图,其中击发梁处于近侧位置;
图7B示出了沿图4的线7-7截取的图3的端部执行器的剖面侧视图,其中击发梁处于远侧位置;
图8示出了图3的被定位在组织处并已在组织中被致动了一次的端部执行器的透视图;
图9示出了可以与图3的端部执行器一起使用的示例性支撑物组件的剖视图;
图10示出了示例性支撑物和保持器的分解透视图;
图11示出了图10的支撑物和保持器的透视图,其中支撑物固定到保持器的下侧;
图12A示出了被定位成用于与图3的端部执行器接合的图10的支撑物和保持器的侧正视图;
图12B示出了接合图3的端部执行器的图10的支撑物和保持器的侧正视图,其中端部执行器的砧座处于打开位置;
图12C示出了接合图3的端部执行器的图10的支撑物和保持器的侧正视图,其中端部执行器的砧座朝闭合位置移动;
图12D示出了移动远离图3的端部执行器的图10的保持器的侧正视图,其中图10的支撑物留在端部执行器上以形成端部执行器和支撑物组件;
图13A示出了图12D的端部执行器和支撑物组件的一部分的剖视图,其中组织被定位在支撑物与砧座之间,并且其中砧座处于打开位置;
图13B示出了图12D的端部执行器和支撑物组件的一部分的剖视图,其中组织被定位在支撑物与砧座之间,并且其中砧座处于闭合位置;
图13C示出了钉和被图12D的端部执行器固定到组织的图12D的支撑物的剖视图;
图14示出了钉和已被图12D的端部执行器固定到组织的图12D的支撑物的透视图;
图15示出了示例性支撑物和保持器的分解透视图;
图16示出了图15的支撑物和保持器的透视图,其中支撑物固定到保持器的顶侧;
图17A示出了被定位成用于与图3的端部执行器接合的图15的支撑物和保持器的侧正视图;
图17B示出了移动远离图3的端部执行器的图15的保持器的侧正视图,其中图15的支撑物留在端部执行器上以形成端部执行器和支撑物组件;
图18A示出了图17B的端部执行器和支撑物组件的一部分的剖视图,其中组织被定位在支撑物与钉仓之间,并且其中砧座处于打开位置;
图18B示出了图17B的端部执行器和支撑物组件的一部分的剖视图,其中组织被定位在支撑物与钉仓之间,并且其中砧座处于闭合位置;
图18C示出了钉和被图17B的端部执行器固定到组织的图17B的支撑物的剖视图;
图19示出了钉和已被图17B的端部执行器固定到组织的图17B的支撑物的透视图;
图20示出了被驱动穿过组织和支撑物组件的钉的透视剖面图;
图21A示出了在钉已被驱动穿过组织和支撑物组件之后紧接着的阶段被驱动穿过组织和支撑物组件的钉的透视剖面图;
图21B示出了在钉已被迁移到围绕钉腿的间隙中的阶段被驱动穿过组织和支撑物组件的钉的透视剖面图;
图22示出了示例性端部执行器组件、保持器、一对支撑物组件的分解透视剖面图;
图23示出了图22的支撑物组件中的一个支撑物组件的局部透视图;
图24示出了图22的支撑物组件中的一个支撑物组件的一些元件的透视图;
图25示出了图22的支撑物组件中的一个支撑物组件的装配形式的透视图;
图26示出了被驱动穿过组织和图22的支撑物组件的钉的剖视图;
图27示出了示例性另选支撑物组件的透视图;
图28示出了施加到图3的端部执行器的砧座的图27的支撑物组件的剖面端视图;
图29示出了施加到图3端部执行器的钉仓的平台的图27的支撑物组件的局部剖面透视图;
图30示出了示例性另选支撑物组件的透视图;
图31示出了另一个示例性另选支撑物组件的透视图;
图32示出了另一个示例性另选支撑物组件的透视图;并且
图33示出了示例性另选保持器的透视图。
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它方式来执行,包括那些未必在附图中示出的方式。结合在本说明书中并形成本说明书的一部分的附图例示了本发明的若干方面,并与描述一起用于解释本发明的原理;然而,应当理解,本发明不限于所示出的确切布置。
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描述,本发明的其它示例、特征结构、方面、实施方案和优点对于本领域的技术人员而言将是显而易见的,一种最佳方式可被设想用于实施本发明。正如将会意识到的,本发明能够具有其它不同且明显的方面,这些方面均不脱离本发明。因此,图示和描述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示出了包括柄部组件(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定成在图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,此类套管针可被插入患者的腹部中,所述腹部位于患者的两个肋骨之间或其它地方。在一些设置中,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它类型的切口直接插入。应当理解,本文中使用的例如“近侧”和“远侧”的术语是参照临床医生抓握器械(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,本文结图示使用空间用语诸如“竖直”和“水平”。然而,外科器械能够在许多取向和位置中使用,并且这些术语并非限制性的和绝对的。
A.示例性柄部组件和轴组件
如图1至图2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,如将在下文更详细所述。柄部组件(20)还包括砧座释放按钮(25)、击发梁反向开关(27)和可移除电池组(28)。这些部件还将在下文中更详细地进行描述。当然,除任何上述那些之外或作为替代,柄部组件(20)可具有多种其它部件、特征结构和可操作性。参考本文的教导内容,用于柄部组件(20)的其它合适的构型对于本领域的普通技术人员而言将是显而易见的。
如图1至图3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),该闭合环与端部执行器(40)进一步联接。闭合管(32)沿轴组件(30)的长度延伸。闭合环(36)被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结构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)。由此,端部执行器(40)可从所需的角度或由于其它原因到达器官的后面或接近组织。在一些型式中,关节运动节段(34)能够使得端部执行器(40)沿单个平面偏转。在一些其它型式中,关节运动节段(34)能够使得端部执行器沿多于一个平面偏转。在本示例中,关节运动通过位于轴组件(30)的近侧端部处的关节运动控制旋钮(35)而被控制。旋钮(35)能够围绕垂直于轴组件(30)的纵向轴线(LA)的轴线旋转。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。仅以举例的方式,旋钮(35)的顺时针旋转可引起闭合环(36)和端部执行器(40)在关节运动节段(34)处的相应顺时针枢转。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。
在一些型式中,关节运动节段(34)和/或关节运动控制旋钮(35)根据以下专利教导内容中至少一些教导内容进行构造和操作:公布于2014年8月28日的名称为“SurgicalInstrument End Effector Articulation Drive with Pinion and Opposing Racks”的美国公布号2014/0243801,其公开内容以引用方式并入本文。关节运动节段(34)也可根据以下专利教导内容中的至少一些教导内容进行构造和操作:提交于2014年6月25日的名称为“Articulation Drive Features for Surgical Stapler”的美国专利申请号14/314,125,其公开内容以引用方式并入本文;和/或根据以下各种教导内容进行构造的操作。参考本文的教导内容,关节运动节段(34)和关节运动旋钮(35)可采用的其它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。
如图1至图2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。在一些型式中,旋钮(31)能够操作以选择性地锁定轴组件(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)的角度定位。例如,旋钮(31)能够在第一纵向位置与第二纵向位置之间平移,在该第一纵向位置,轴组件(30)和端部执行器(40)能够相对于柄部组件(20)围绕轴组件(30)的纵向轴线(LA)旋转;在该第二纵向位置,轴组件(30)和端部执行器(40)不能够相对于柄部组件(20)围绕轴组件(30)的纵向轴线(LA)旋转。当然,除任何上述那些之外或作为替代,轴组件(30)可具有多种其它部件、特征结构和可操作性。仅以举例的方式,轴组件(30)的至少一部分根据以下专利教导内容中的至少一些教导内容进行构造:公布于2014年8月28日的名称为“Surgical Instrument withMulti-Diameter Shaft”的美国公布号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,用于轴组件(30)的其它合适的构型对于本领域的普通技术人员而言将是显而易见的。
B.示例性端部执行器
同样如图1至图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)的相应弯曲狭槽(54)中的一对一体式向外延伸的销(66)。销(66)和狭槽(54)被示出于图5中。砧座(60)能够朝向和远离下钳口(50)在打开位置(如图2和图4所示)和闭合位置(如图1、图3和图7A至图7B所示)之间枢转。使用术语“能够枢转”(以及与作为基础的“枢转”类似的术语)不应被解读为必须要求围绕固定轴线的枢转移动。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)朝下钳口(50)移动时,这些销沿下钳口(50)的弯曲狭槽(54)滑动。在这种型式中,枢转轴线沿由狭槽(54)限定的路径平移,而砧座(60)同时围绕该轴线枢转。除此之外或另选地,枢转轴线首先可沿狭槽(54)滑动,然后在枢转轴线已沿狭槽(54)滑动特定距离之后,砧座(60)围绕该枢转轴线枢转。应当理解,此类滑动/平移枢转移动被包括在诸如“枢转”(“pivot”,“pivots”,“pivoting”)、“枢转的”(“pivotal”)、“能够枢转的”(“pivotable”)等术语内。当然,一些型式可提供砧座(60)围绕保持固定并且不在狭槽或通道等内平移的轴线的枢转移动。
如在图5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)并利用其它钉仓(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)根据以下专利教导内容中的至少一些教导内容进行构造:公布于2014年8月28日的名称为“Installation Featuresfor Surgical Instrument End Effector Cartridge”的美国公布号2014/0239044,其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)可采用的其它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4至图6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)的上侧存在平台(73),当砧座(60)处于闭合位置时,组织可被压缩贴靠该平台。仓体(71)还限定纵向延伸的通道(72)和多个钉凹坑(74)。钉(77)被定位在每个钉凹坑(74)中。钉驱动器(75)还被定位在位于相应钉(77)下方且位于托盘(76)上方的每个钉凹坑(74)中。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(77)穿过钉凹坑(74)并与砧座(60)接合。钉驱动器(75)由楔形滑动件(78)向上驱动,该楔形滑动件被捕集在仓体(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)处于如图7A所示的近侧位置中时,钉驱动器(75)处于向下位置中并且钉(77)位于钉凹坑(74)中。当通过平移刀构件(80)将楔形滑动件(78)驱动到图7B所示的远侧位置时,楔形滑动件(78)向上驱动钉驱动器(75),由此驱动钉(77)离开钉凹坑(74)并进入在砧座(60)的下侧(65)中形成的钉成形凹坑(64)中。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。
应当理解,钉仓(70)的构型可以多种方式改变。例如,本示例的钉仓(70)包括位于通道(72)的一侧上的两排纵向延伸的钉凹坑(74);以及位于通道(72)的另一侧上的另一组两排纵向延伸的钉凹坑(74)。然而,在一些其它型式中,钉仓(70)在通道(72)的每一侧上包括三个、一个或一些其它数目的钉凹坑(74)。在一些型式中,钉仓(70)根据以下专利的教导内容中至少一些教导内容进行构造和操作:提交于2013年2月28日的名称为“IntegratedTissue Positioning and Jaw Alignment Features for Surgical Stapler”的美国专利申请号13/780,106,其公开内容以引用方式并入本文。除此之外或另选地,钉仓(70)可根据以下专利的教导内容中至少一些教导内容进行构造和操作:公布于2014年8月28日的名称为“Installation Features for Surgical Instrument End Effector Cartridge”的美国公布号2014/0239044,其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)可采用的其它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4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)对准。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)的相应钉凹坑(74)上方。钉成形凹坑(64)被构造成能够当驱动钉(77)穿过组织进入砧座(60)时使钉(77)的腿变形。具体地,钉成形凹坑(64)被构造成能够使钉(77)的腿弯曲,以将成形钉(77)固定在组织中。砧座(60)可根据以下专利教导内容中至少一些教导内容进行构造:公布于2014年8月28日的名称为“Integrated Tissue Positioning and Jaw Alignment Featuresfor Surgical Stapler”的美国公布号2014/0239042;以下专利教导内容中至少一些教导内容:公布于2014年8月28日的名称为“Jaw Closure Feature for End Effector ofSurgical Instrument”的美国公布号2014/0239036;和/或以下专利教导内容中至少一些教导内容:公布于2014年8月28日的名称为“Staple Forming Features for SurgicalStapling Instrument”的美国公布号2014/0239037,其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)可采用的其它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5和图7A至图7B中最佳所见,刀构件(80)被固定到击发梁(82)的远侧端部,该击发梁延伸穿过轴组件(30)的一部分。如在图4和图6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)之间的组织的朝远侧呈现的切割刃(84)。如上所述并如图7A至图7B所示,当刀构件(80)通过端部执行器(40)朝远侧平移时,刀构件(80)也朝远侧驱动楔形滑动件(78),由此驱动钉(77)穿过组织并抵靠砧座(60)成形。可用于通过端部执行器(40)朝远侧驱动刀构件(80)的各种特征结构将在下文中更详细地进行描述。
在一些型式中,端部执行器(40)包括闭锁特征结构,该闭锁特征结构被构造成能够当钉仓(70)未插入下钳口(50)中时阻止刀构件(80)朝远侧推进穿过端部执行器(40)。除此之外或另选地,端部执行器(40)可包括闭锁特征结构,该闭锁特征结构被构造成能够当已被致动一次(例如,其中从中布置所有钉(77))的钉仓(70)插入到下钳口(50)中时阻止刀构件(80)通过端部执行器(40)朝远侧推进。仅以举例的方式,这类闭锁特征结构可根据以下专利教导内容中至少一些教导内容进行构造:公布于2014年8月28日的名称为“LockoutFeature for Movable Cutting Member of Surgical Instrument”的美国公布号2014/0239041,其公开内容以引用方式并入本文;和/或以下专利教导内容中至少一些教导内容:提交于2014年6月25日的名称为“Method of Using Lockout Features for SurgicalStapler Cartridge”的美国专利申请号14/314,108,其公开内容以引用方式并入本文。参考本文的教导内容,闭锁特征结构可采用的其它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。另选地,端部执行器(40)可完全省去此类闭锁特征结构。
C.砧座的示例性致动
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)可根据以下专利教导内容中至少一些教导内容进行相互作用:公布于2014年8月28日的名称为“Jaw Closure Feature for EndEffector of Surgical Instrument”的美国公布号2014/0239036,其公开内容以引用方式并入本文;和/或以下专利教导内容中至少一些教导内容:提交于2014年6月25日的名称为“Jaw Opening Feature for Surgical Stapler”美国专利申请号14/314,108,其公开内容以引用方式并入本文。可用于提供闭合环(36)相对于端部执行器(40)的纵向平移的示例性特征结构将在下文中更详细地进行描述。
如上所述,柄部组件(20)包括手枪式握把(22)和闭合触发器(24)。同样如上所述,响应于闭合环(36)的远侧推进,砧座(60)朝下钳口(50)闭合。在本示例中,闭合触发器(24)可朝手枪式握把(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)朝手枪式握把(22)的枢转移动转化成闭合管(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而言将是显而易见的。当闭合触发器(24)达到完全枢转状态使得砧座(60)相对于下钳口(50)处于完全闭合位置时,柄部组件(20)中的锁定特征结构锁定触发器(24)和闭合管(32)的位置,由此将砧座(60)相对于下钳口(50)锁定于完全闭合位置。这些锁定特征结构通过致动砧座释放按钮(25)而释放。砧座释放按钮(25)被构造和定位成能够由抓握手枪式握把(22)的操作者手的拇指致动。换句话讲,操作者可利用一只手来抓握手枪式握把(22),利用同一只手的一个或多个手指来致动闭合触发器(24),并且然后利用同一只手的拇指来致动砧座释放按钮(25),而无需利用同一只来手释放手枪式握把(22)的抓握。参考本文的教导内容,可用于致动砧座(60)的其它合适的特征结构对于本领域的普通技术人员将是显而易见的。
D.击发梁的示例性致动
在本示例中,器械(10)提供击发梁(82)的机动化控制。具体地,器械(10)包括被构造成能够响应于击发触发器(26)朝手枪式握把(22)枢转而朝远侧驱动击发梁(82)的机动化部件。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)接收功率。该马达与传输组件(未示出)联接,该传输组件将马达的驱动轴的旋转运动转换成击发梁(82)的线性平移。在一些这样的型式中,当砧座(60)相对于下钳口(50)处于完全闭合位置时,击发梁(82)可能只能朝远侧推进。在击发梁(82)被朝远侧推进成如上文参照图7A至图7B所述切断组织并驱动钉(77)之后,击发梁(82)的驱动组件可自动地反转以将击发梁(82)朝近侧驱动回到缩回位置(例如,从图7B所示的位置回到图7A所示的位置)。另选地,操作者可致动击发梁反转开关(27),该击发梁反转开关可使击发梁(82)的驱动组件反转,以便将击发梁(82)缩回到近侧位置。本示例的柄部组件(20)还包括应急特征结构(21),该应急特征结构能够操作以提供允许操作者朝近侧手动地缩回击发梁(82)(例如,在击发梁(82)处于远侧位置时的功率损耗等的情况下)的机械应急。
仅以举例的方式,能够操作以提供击发梁(82)的机动化致动的特征结构可根据以下专利教导内容中至少一些教导内容进行构造和操作:公布于2012年7月3日的名称为“Motor-Driven Surgical Instrument”的美国专利8,210,411,其公开内容以引用方式并入本文。作为另一个仅例示性示例,能够操作以提供击发梁(82)的机动化致动的特征结构可根据以下专利教导内容中至少一些教导内容进行构造和操作:公布于2013年6月4日的名称为“Motor-Driven Surgical Cutting Instrument with Electric ActuatorDirectional Control Assembly”的美国专利8,453,914,其公开内容以引用方式并入本文。作为另一个仅例示性示例,能够操作以提供击发梁(82)的机动化致动的特征结构可根据以下专利教导内容中至少一些教导内容进行构造和操作:提交于2014年3月26日的名称为“Surgical Instrument Comprising a Sensor System”的美国专利申请号14/226,142,其公开内容以引用方式并入本文。
参考本文的教导内容,用于提供击发梁(82)的电动化的其它合适的部件、特征结构和构型对本领域的普通技术人员而言将是显而易见的。还应当理解,一些其它型式可提供对击发梁(82)的手动驱动,使得能够省去马达。仅以举例的方式,击发梁(82)可根据本文引用的任何其它参考文献的教导内容中的至少一些教导内容被手动地致动。
图8示出了已通过单个行程被致动穿过组织(90)的端部执行器(40)。如图所示,切割刃(84)(在图8中被遮住)已切穿组织(90),同时钉驱动器(75)已驱动两排交替的钉(77)穿过由切割刃(84)产生的切割线的每一侧上的组织(90)。在此示例中,钉(77)全部与切割线基本上平行地取向,但应当理解,钉(77)可以任何合适的取向定位。在本示例中,在第一行程完成后,端部执行器(40)从套管针取出,利用新钉仓(70)来替换已空钉仓(70),并且然后端部执行器(40)再次插入穿过套管针而到达缝合位点,以用于进行进一步的切割和缝合。这个过程可重复,直到已提供期望量的切口和钉(77)。可能需要将砧座(60)闭合,以有利于通过套管针的插入和取出;并且可能需要将砧座(60)打开以有利于钉仓(70)的替换。
应当理解,在每次致动行程期间,切割刃(84)可基本上与钉(77)被驱动穿过组织同时切断组织。在本示例中,切割刃(84)仅稍微落后于钉(77)的驱动,使得钉(47)刚好在切割刃(84)穿过组织的相同区域之前被驱动穿过组织,但应当理解,这个顺序可颠倒,或者切割刃(84)可直接与相邻的钉同步。虽然图8示出端部执行器(40)在组织(90)的两个层(92,94)中被致动,但应当理解,端部执行器(40)可被致动穿过组织(90)的单个层或组织的多于两个层(92,94)。还应当理解,与切割刃(84)产生的切割线相邻的钉(77)的成形和定位可基本上密封切割线处的组织,由此减少或防止切割线处的出血和/或其它体液的渗漏。此外,尽管图8示出端部执行器(40)在组织的两个基本上平坦的相反平面层(92,94)中致动,但应当理解,端部执行器(40)也可被致动跨过诸如血管、胃肠道的一部分等管状结构。因此,不应将图8视为对端部执行器(40)的设想用途进行任何限制。参考本文的教导内容,其中可使用器械(10)的各种合适的设置和程序对于本领域的普通技术人员将是显而易见的。
还应当理解,器械(10)的任何其它部件或特征结构可根据本文所述的各种参考文献中的任何参考文献进行构造和操作。可提供用于器械(10)的其它示例性修改将在下文中更详细地进行描述。其中下文教导内容可结合到器械(10)的各种合适的方式将对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而言将是显而易见的。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中教导的各种器械。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它种类的器械,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它合适的装置和设置对于本领域的普通技术人员而言将是显而易见的。
II.外科缝合器的示例性支撑物
如上所述,在一些情况下,可能需要为端部执行器(40)配备支撑材料以加强钉(77)所提供的对组织(90)的机械紧固。这种支撑物可防止施加的钉(77)牵拉穿过组织(90)并且可在其它的情况下降低组织(90)在施加的钉(77)的部位处或附近撕裂的风险。除了或代替为一排钉(77)提供结构支撑和完整性,支撑物还可提供各种其它种类的效果,例如间隔或间隙填充、治疗剂施用和/或其它效果。在一些情况下,支撑物可设置在钉仓(70)的平台(73)上。在一些其它情况下,支撑物可设置在面对钉仓(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相同的端部执行器(40)的砧座(60)上。下面将更详细地描述支撑物可以采用的形式的各种示例。下面还将更详细地描述可将支撑物固定到钉仓(70)或砧座(60)的各种方式。
A.用于外科缝合器的支撑物的示例性组成
图9示出了具有基本组成的示例性支撑物组件(100)。本示例的支撑物组件(100)包括支撑物主体(102)、上部粘合剂层(104)和下部粘合剂层(106)。在本示例中,支撑物主体(102)包括被构造成能够在结构上支撑一排钉(77)的强而柔性的材料。除此之外或另选地,支撑物主体(102)可包括包括例如止血剂(诸如血纤维蛋白)的材料,以有助于凝聚血液并减少沿组织(90)的切断和/或缝合的手术部位的出血。
作为另一个仅例示性示例,支撑物主体(102)可包括其它助剂或者可使用止血剂诸如凝血酶,使得支撑物主体(102)可有助于凝聚血液并减少手术部位的出血量。此类助剂的止血能力还可有助于将此类助剂用作粘合剂和密封剂。这些剂可有助于凝聚手术部位的血液,从而允许这些血液周围的组织粘在一起,并可例如防止沿缝合的组织部位的渗漏。可并入支撑物主体(102)的其它助剂或试剂还可包括但不限于医用流体或基质组分。仅以举例方式,支撑物主体(102)可包括天然的或经基因工程改造的可吸收聚合物或合成的可吸收聚合物、或它们的混合物。天然的或经基因工程改造的可吸收性聚合物的仅例示性示例是蛋白质、多糖、以及它们的组合。可使用的蛋白质的仅例示性示例包括前凝血酶、凝血酶、纤维蛋白原、血纤维蛋白、纤粘蛋白、肝素酶、因子X/Xa、因子VII/VIla、因子IX/IXa、因子XI/XIa、因子XII/XIIa、组织因子、巴曲酶、安克洛酶、蛇静脉酶、血管性血友病因子、胶原、弹性蛋白、白蛋白、明胶、血小板表面糖蛋白、加压素、加压素类似物、肾上腺素、选择素、促凝血毒液、纤溶酶原激活物抑制剂、血小板活化剂、具有止血活性的合成肽和/或它们的组合。多糖包括但不限于:纤维素、烷基纤维素例如甲基纤维素、烷基羟烷基纤维素、羟烷基纤维素、纤维素硫酸酯、羧甲基纤维素的盐、羧甲基纤维素、羧乙基纤维素、甲壳质、羧甲基甲壳质、透明质酸、透明质酸的盐、藻酸盐、藻酸、丙二醇藻酸盐、糖原、葡聚糖、硫酸葡聚糖、凝胶多糖、果胶、普鲁兰多糖、黄原胶、软骨素、硫酸软骨素、羧甲基脱乙酰壳多糖、脱乙酰壳多糖、肝素、硫酸肝素、类肝素、硫酸类肝素、硫酸皮肤素、硫酸角质素、角叉菜胶、脱乙酰壳多糖、淀粉、直链淀粉、支链淀粉、聚-N-葡糖胺、聚甘露糖醛酸、聚葡糖醛酸、聚古洛糖醛酸、以及任何上述物质的衍生物。合成的可吸收聚合物的示例是脂族聚酯聚合物、共聚物和/或它们的组合。脂族聚酯通常由单体的开环聚合反应合成,所述单体包括但不限于乳酸、丙交酯(包括L-、D-、内消旋和D、L混合物)、乙醇酸、乙交酯、ε-己内酯、对二氧杂环己酮(1,4-二氧杂环己烷-2-酮)和三亚甲基碳酸酯(1,3-二氧杂环己烷-2-酮)。参考本文的教导内容,可用于医用流体或基质中的其它适合的化合物、材料、物质等对本领域的普通技术人员而言将是显而易见的。
支撑物主体(102)可另选地包括纤维垫、泡沫、网片、织物和/或能够容纳粘合剂和/或其它类型的医用流体的另一结构。除此之外或另选地,支撑物主体(102)可仅包括网片、织物和/或被构造成为一排施加穿过组织(90)的钉(77)提供结构支撑或完整性的某一其它结构。这种材料和结构可能是相对较薄的,并且在一些情况下可能是基本上不可压缩的。仅以进一步举例的方式,支撑物主体(102)可根据以下专利教导内容中至少一些教导内容进行构造:公布于2012年9月27日的名称为“Tissue Thickness CompensatorComprising Controlled Release and Expansion”的美国专利公布号2012/0241493,其公开内容以引用方式并入本文;公布于2013年3月21日的名称为“Surgical Instrument andButtress Material”的美国专利公布号2013/0068816,其公开内容以引用方式并入本文;公布于2013年3月14日的名称为“Surgical Instrument with Fluid Fillable Buttress”的美国专利公布号2013/0062391,其公开内容以引用方式并入本文;公布于2013年3月21日的名称为“Fibrin Pad Matrix with Suspended Heat Activated Beads of Adhesive”的美国专利公布号2013/0068820,其公开内容以引用方式并入本文;公布于2013年4月4日的名称为“Attachment of Surgical Staple Buttress to Cartridge”的美国专利公布号2013/0082086,其公开内容以引用方式并入本文;公布于2013年2月14日的名称为“Devicefor Applying Adjunct in Endoscopic Procedure”的美国专利公布号2013/0037596,其公开内容以引用方式并入本文;公布于2013年3月14日的名称为“Resistive HeatedSurgical Staple Cartridge with Phase Change Sealant”的美国专利公布号2013/0062393,其公开内容以引用方式并入本文;公布于2013年3月28日的名称为“SurgicalStaple Assembly with Hemostatic Feature”的美国专利公布号2013/0075446,其公开内容以引用方式并入本文;公布于2013年3月14日的名称为“Surgical Staple Cartridgewith Self-Dispensing Staple Buttress”的美国专利公布号2013/0062394,其公开内容以引用方式并入本文;公布于2013年3月28日的名称为“Anvil Cartridge for SurgicalFastening Device”的美国专利公布号2013/0075445,其公开内容以引用方式并入本文;公布于2013年3月28日的名称为“Adjunct Therapy for Applying Hemostatic Agent”的美国专利公布号2013/0075447,其公开内容以引用方式并入本文;和/或公布于2013年10月3日的名称为“Tissue Thickness Compensator Comprising a Plurality ofMedicaments”的美国专利公布号2013/0256367,其公开内容以引用方式并入本文。
在本示例中,支撑物主体(102)包括由Ethicon美国公司生产的(聚乳糖910)材料的编织网片。编织网片由分别衍生自乙醇酸和乳酸的乙交酯和丙交酯的合成可吸收共聚物制备而成。这种紧密编织网片由在组成上与在合成可吸收缝合线中所使用的相同的未涂层、未染色纤维制备而成,该纤维被认为是惰性的,非抗原的,非致死的,并且在吸收期间仅引起温和的组织反应。编织网片旨在用作支撑物以在愈合过程中提供临时支撑。另选地,除了或代替材料,可使用任何其它合适的材料或材料组合来形成支撑物主体(102)。
在支撑物主体(102)形成为网片的型式中,应当理解,可使用各种网片几何形状。仅以举例的方式,支撑物主体(102)可形成为编织网片、针织网片或经编针织网片。无论支撑物主体(102)是否形成为网片,在一些示例中,支撑物主体(102)为多孔的。如在下文更详细所述,粘合剂层(104,106)可设置在支撑物主体(102)上,以便将支撑物主体(102)粘附到砧座(60)的下侧(65)或钉仓(70)的平台(73)。在支撑物主体(102)为多孔的一些型式中,形成粘合剂层(104,106)的材料可穿过支撑物主体(102)到达支撑物主体(102)的与粘合剂层(104,106)设置在其上的表面相背对的外表面。
仅以举例的方式,上部粘合剂层(104)可用于将支撑物组件(100)固定到保持器(300)的下侧(304),如将在下文更详细所述;而下部粘合剂层(106)用于将支撑物组件(100)固定到钉仓(70)的平台(73)。在本示例的一些型式中,下部粘合剂层(106)被构造成能够提供比上部粘合剂层(104)更强的附接性。在本示例的一些例示性变型中,保持器(300)的一个或多个特征结构(例如,凸缘、夹具等)被构造成能够选择性地将支撑物组件(100)保持贴靠保持器(300)的下侧(304),使得省略上部粘合剂层(104);而下部粘合剂层(106)用于将支撑物组件(100)固定到钉仓(70)的平台(73)。除此之外或另选地,可向多孔型式的支撑物主体(102)的下表面施加粘合剂材料,以形成下部粘合剂层(106),并且该粘合剂材料中的一些粘合剂材料可穿过支撑物主体(102),以形成上部粘合剂层(104)。在一些这样的型式中,下部粘合剂层(106)最终具有比上部粘合剂层(104)更多的粘合剂材料,使得下部粘合剂层(106)提供比上部粘合剂层(104)更大的粘附力。
在另一个仅例示性示例中,下部粘合剂层(106)可用于将支撑物组件(100)固定到保持器(300)的上侧(302),如将在下文更详细所述;而上部粘合剂层(104)用于将支撑物组件固定到端部执行器(40)的砧座(60)的下侧(65)。在本示例的一些型式中,上部粘合剂层(104)被构造成能够提供比下部粘合剂层(106)更强的附接性。在本示例的一些例示性变型中,保持器(300)的一个或多个特征结构(例如,凸缘、夹具等)被构造成能够选择性地将支撑物组件(100)保持贴靠保持器(300)的上侧(302),省略使得下部粘合剂层(106);而上部粘合剂层(104)用于将支撑物组件(100)固定到砧座(60)的下侧(65)。除此之外或另选地,可向多孔型式的支撑物主体(102)的下表面施加粘合剂材料,以形成上部粘合剂层(104),并且该粘合剂材料中的一些粘合剂材料可穿过支撑物主体(102),以形成下部粘合剂层(106)。在一些这样的型式中,上部粘合剂层(104)最终具有比下部粘合剂层(106)更多的粘合剂材料,使得上部粘合剂层(104)提供比下部粘合剂层(106)更大的粘附力。
下面将更详细地描述可用于形成每个粘合剂层(104,106)的各种合适的组合物以及每个粘合剂层(104,106)可采用的各种形式。
还应当理解,支撑物组件(100)可包括插置在支撑物主体(102)和粘合剂层(102)之间的不可渗透层或半不可渗透层,以防止粘合剂材料从粘合剂层(104,106)迁移到支撑物主体(100)中。仅以举例的方式,主体(102)可由多孔介质(例如,由Codman of Raynham,Massachusetts生产的ETHISORBTM)形成;而半不可渗透层可包含聚二氧六环酮(PDS)。在支撑物组件(100)包括不可渗透层或半不可渗透层以防止或限制粘合剂材料从粘合剂层(104,106)迁移到支撑物主体(100)中的型式中,这种层可被集成到支撑物主体(102)中,使得该层允许粘合剂至少部分地迁移到支撑物主体(102)中而不是跨过支撑物主体(102)的全厚度。参考本文的教导内容,可将不可渗透层或半不可渗透层集成到支撑物组件(100)中以防止或限制粘合剂材料的迁移的各种合适的方式对于本领域的普通技术人员而言将是显而易见的。
B.用于将支撑物固定到钉仓的平台的示例性器械和技术
图10至图12D示出了示例性支撑物(200)与示例性保持器(300)的组合。本示例的支撑物(200)可根据上文关于支撑物组件(100)的教导内容和/或根据本文的其它教导内容进行构造。支撑物(200)包括上侧(202)和下侧(204)。在本示例中,下侧(204)包括粘合剂(例如,类似于下部粘合剂层(106)),以将支撑物(200)固定到钉仓(70)的平台(73),如下文更详细所述。
本示例的保持器(300)包括上侧(302)、下侧(304)、远侧突出的舌状部(306)和一组弹性闩锁(308)。在本示例中,上侧(302)和下侧(304)各自为大致平坦的,但应当理解,上侧(302)和/或下侧(304)可包括本文别处所描述的各种特征结构。舌状部(306)被构造成能够为操作者提供握把,由此有利于在使用期间抓握和操纵保持器(300)。闩锁(308)被构造成能够将保持器(300)可释放地固定到端部执行器(40)的下钳口(50),如将在下文更详细所述。仅以举例的方式,保持器(300)可由模制塑料形成。另选地,保持器(300)可使用任何其它合适的一种或多种材料或技术形成。
在本示例中,支撑物(200)固定到保持器(300)的下侧(304),使得支撑物(200)的上侧(202)与保持器(300)的下侧(304)并列。在一些型式中,粘合剂(诸如上部粘合剂层(104))提供支撑物(200)至保持器(300)的下侧(304)的可释放粘附。在一些其它型式中,保持器(300)包括被构造成能够选择性地将支撑物(200)保持贴靠保持器(300)的下侧(304)的一个或多个特征结构(例如,凸缘、夹具等)。参考本文的教导内容,可将支撑物(200)可释放地固定到保持器(300)下侧(304)的各种合适方式对于本领域的普通技术人员而言将是显而易见的。
如图12A所示,由支撑物(200)和保持器(300)形成的组件可随着砧座(60)处于打开位置而被放置在端部执行器(40)前面。在一些情况下,剥离膜(未示出)被定位在支撑物(200)的下侧(204)上方,以保护支撑物(200)和/或支撑物(200)的下侧(204)上的任何粘合剂材料。在这种型式,该膜在达到图12A所示的阶段之前被剥离以暴露支撑物(200)的下侧(204)。这种膜可包括聚四氟乙烯(PTFE)和/或任何其它合适的一种或多种材料。在达到图12A所示的阶段之后,由支撑物(200)和保持器(300)形成的组件然后可被放置在钉仓(70)上,使得支撑物(200)的下侧(204)并列地接触钉仓(70)的平台(73);并且使得闩锁(308)可释放地固定到下钳口(50),如图12B所示。操作者然后可将砧座(60)朝闭合位置驱动,如图12C所示,从而最终将支撑物(200)压缩贴靠钉仓(70)的平台(73)。这种压缩可促进支撑物(200)的下侧(204)和钉仓(70)的平台(73)之间的粘附。在砧座(60)已用于将支撑物(200)压缩贴靠钉仓(70)的平台(73)之后,砧座(60)可被移回到打开位置,如图12D所示。同样如图12D所示,保持器(300)然后可被拉离端部执行器(40),从而留下粘附到钉仓(70)的平台(73)的支撑物(200)。支撑物(200)的上侧(202)被暴露。端部执行器(40)因此装有支撑物(200)并且准备用于切断和缝合组织(90)。
图13A至图13C示出了用于驱动钉(77)穿过组织(90)的装有支撑物(200)的端部执行器(40)。在图13A中,组织(90)随着砧座(60)处于打开位置而被放置在支撑物(200)上方的砧座(60)和钉仓(70)之间。在图13B中,砧座(60)被驱动到闭合位置,从而将组织(90)压缩贴靠支撑物(200)和钉仓(70)。端部执行器(40)然后被致动,如上所述,从而驱动钉(77)穿过支撑物(200)和组织(90)。如图13C所示,被驱动的钉(77)的冠(210)将支撑物(200)捕获并保持贴靠组织(90)的层(94)。应当理解,一连串的钉(77)将以类似的方式将支撑物(200)捕获并保持贴靠组织(90)的层(94),由此将支撑物(200)固定到组织(90),如图14所示。随着端部执行器(40)在部署钉(77)和支撑物(200)之后被拉离组织(90),支撑物(200)脱离接合钉仓(70)的平台(73),使得支撑物(200)保持由钉(77)固定到组织(90)。支撑物(200)因此为成排的钉(77)提供结构加强。如从图14还可见,刀构件(80)还切穿支撑物(200)的中心线,从而将支撑物(200)分成两个节段(230,240),使得每个节段(230,240)保持固定到组织(90)的相应切断区域。
C.用于将支撑物固定到端部执行器的砧座的示例性器械和技术
图15至图17B示出了示例性支撑物(400)与保持器(300)的组合。本示例的支撑物(400)可根据上文关于支撑物组件(100)的教导内容和/或根据本文的其它教导内容进行构造。支撑物(400)包括上侧(402)和下侧(404)。在本示例中,上侧(402)包括粘合剂(例如,类似于上部粘合剂层(1064)),以将支撑物(200)固定到砧座(60)的下侧(65),如下文更详细所述。
在本示例中,支撑物(400)固定到保持器(300)的上侧(302),使得支撑物(400)的下侧(404)与保持器(300)的上侧(302)并列。在一些型式中,粘合剂(例如下部粘合剂层(106))提供支撑物(400)至保持器(300)的上侧(302)的可释放粘附。在一些其它型式中,保持器(300)包括被构造成能够选择性地将支撑物(400)保持贴靠保持器(300)的上侧(302)的一个或多个特征结构(例如,凸缘、夹具等)。参考本文的教导内容,可将支撑物(200)可释放地固定到保持器(300)的上侧(302)的各种合适的方式对于本领域的普通技术人员而言将是显而易见的。
如图17A所示,由支撑物(400)和保持器(300)形成的组件可随着砧座(60)处于打开位置而被放置在端部执行器(40)前面。在一些情况下,剥离膜(未示出)被定位在支撑物(400)的上侧(402)上方,以保护支撑物(400)和/或支撑物(400)的上侧(402)上的任何粘合剂材料。在这种型式中,该膜在达到图17A所示的阶段之前被剥离以暴露支撑物(400)的上侧(402)。这种膜可包括聚四氟乙烯(PTFE)和/或任何其它合适的一种或多种材料。在达到图17A所示的阶段之后,由支撑物(400)和保持器(300)形成的组件然后可被放置在钉仓(70)上,使得闩锁(308)可释放地固定到下钳口(50),如上所述。操作者然后可将砧座(60)朝闭合位置驱动,如上所述,从而最终将支撑物(400)压缩贴靠砧座(60)的下侧(65)。这种压缩可促进支撑物(400)的上侧(402)和砧座(60)的下侧(65)之间的粘附。在砧座(60)已经用于将支撑物(200)压缩贴靠砧座(60)的下侧(65)之后,砧座(60)可被移回到打开位置,如图17B所示。同样如图17B所示,保持器(300)然后可被拉离端部执行器(40),从而留下粘附到砧座(60)的下侧(65)的支撑物(400)。支撑物(400)的下侧(402)被暴露。端部执行器(40)因此装有支撑物(400)并且准备用于切断和缝合组织(90)。
图18A至图18C示出了用于驱动钉(77)穿过组织(90)的装有支撑物(400)的端部执行器(40)。在图18A中,组织(90)随着砧座(60)处于打开位置而被放置在支撑物(400)下方的砧座(60)和钉仓(70)之间。在图18B中,砧座(60)被驱动到闭合位置,从而将组织(90)压缩贴靠支撑物(400)和钉仓(70)。端部执行器(40)然后被致动,如上所述,从而驱动钉(77)穿过支撑物(400)和组织(90)。如图18C所示,被驱动的钉(77)的弯腿(220)将支撑物(400)捕获并保持贴靠组织(90)的层(92)。应当理解,一连串的钉(77)将以类似的方式将支撑物(400)捕获并保持贴靠组织(90)的层(92),由此将支撑物(400)固定到组织(90),如图19所示。随着砧座(60)在部署钉(77)和支撑物(400)之后返回到打开位置以使端部执行器(40)能够被拉离组织(90),支撑物(400)脱离接合砧座(60)的下侧(65),使得支撑物(400)保持由钉(77)固定到组织(90)。支撑物(400)因此为成排的钉(77)提供结构加强。如从图19还可见,刀构件(80)还切穿支撑物(400)的中心线,从而将支撑物(400)分成两个节段(430,440),使得每个节段(430,440)保持固定到组织(90)的相应切断区域。
尽管上述示例提供保持器(300)的下侧(304)上的支撑物(200)或保持器(300)的上侧(302)上的支撑物(400),但应当理解,如果需要,这两个保持器(200,400)可设置在相同的保持器(300)上。具体地,保持器(200)可设置在保持器(300)的下侧(304)上,而支撑物(400)设置在保持器(300)的上侧(302)上。这可导致支撑物(200)设置在钉仓(70)的平台(73)上,而支撑物(400)设置在相同的端部执行器(400)中的砧座(60)的下侧(65)上。这可最终导致支撑物(200)由钉(77)的冠(210)固定贴靠组织(90)的层(94),而支撑物(400)由相同的钉(77)的弯腿(220)固定贴靠组织(90)的层(92)。
III.用于提供支撑物至外科缝合器的粘附的示例性材料和技术
如上所述,支撑物组件(100)可包括粘合剂材料(或其它形式的粘合剂材料)的至少一个层(104,106),所述至少一个层将支撑物主体(102)粘附到砧座(60)的下侧(65)或钉仓(70)的平台(73)。这种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)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)与端部执行器(40)分离,而不会对支撑物主体(102)产生足以损害支撑物主体(102)的适当后续运行的损坏。可能需要使这种粘合剂材料对击发梁(82)楔形滑动件(78)和钉驱动器(75)的运行的影响最小化。例如,可能需要防止粘合剂材料阻塞或以其它方式提供对击发梁(82)楔形滑动件(78)和钉驱动器(75)的移动的显着阻力。此外,粘合剂材料应允许支撑物主体(102)足够易于与被致动的端部执行器(40)分离,以免在钉(77)已被击发穿过组织且砧座(60)被移动到打开位置之后撕裂组织(90)。
在一些情况下,可能理想的是,粘合剂材料提供额外的效果,而不仅仅是将支撑物主体(102)粘附到砧座(60)的下侧(65)或钉仓(70)的平台(73)。例如,粘合剂材料可包括提供对组织(90)的治疗效果、止血效果或其它期望的效果的一种或多种成分。作为另一个仅例示性示例,粘合剂材料可填充由被驱动穿过组织(90)和支撑物主体(102)的钉(77)的腿(220)形成穿过组织(90)和/或支撑物主体(102)的路径的至少一部分。
在一些情况下,用于支撑物主体(102)的粘合剂材料可为压敏材料。除此之外或另选地,粘合剂材料可被构造成能够采用支撑物主体(102)的表面不规则的形式;除了或代替采用砧座(60)的下侧(65)和/或钉仓(70)的平台(73)中的表面不规则的形式。
用于支撑物主体(102)的粘合剂材料的上述特性是仅例示性示例。除了或代替上述那些,合适的粘合剂材料可以具有各种其它特性。合适的粘合剂材料也可以各种不同种类的组合物提供。下面更详细地描述可用于形成并提供用于支撑物主体(102)的粘合剂材料的各种合适的组合物和构型的示例,以及这种粘合剂材料可具有的各种示例性特性。
A.具有合成基的示例性聚合物粘合剂材料
在一些情况下,粘合剂材料(例如,支撑物主体(102)的层(104,106)中的一个或多个)包括可吸收合成基聚合物。可改变合成基聚合物的各种物理力学性质,以提供不同的粘合剂性质。各种可变特性包括但不限于共聚物组成、玻璃化转变温度(Tg)、分子量、固有粘度(IV)、结晶度、序列分布、共聚物链组成、熔融温度(Tm)、以及表面张力。下面将提供这些变数的几个示例性组合,但应当理解,这些示例是仅例示性的。还应当理解,粘合剂材料的这些示例可设置在上部粘合剂层(104)中。除此之外或另选地,粘合剂材料的这些示例可设置在下部粘合剂层(106)中。除此之外或另选地,粘合剂材料的这些示例可以其它方式集成到支撑物主体(102)中。因此应当理解,粘合剂材料不一定构成可离散地识别为与由支撑物主体(102)限定的层不同的单独层。
在一些示例中,粘合剂材料由丙交酯和己内酯(PLA/PCL)共聚物形成。该组合物可按在20/80至60/40范围内,或更具体地在35/65至50/50范围内的比率提供。该组合物可具有低于4℃,或更具体地低于-10℃的玻璃化转变温度(Tg)。该组合物可具有在10,000g/mol至145,000g/mol范围内,或更具体地低于200,000g/mol的分子量。该组合物可具有在1.0dL/g至2.0dL/g范围内的固有粘度(IV)。
在一些其它示例中,粘合剂材料由丙交酯和三甲基碳酸酯(PLA/TMC)共聚物形成。该组合物可按在20/80至50/50范围内的比率提供。其它特性可在上文关于示例性PLA/PCL组合物所列出的相同参数内。另选地,PLA/TMC组合物可具有任何其它合适的特性。
在一些其它示例中,粘合剂材料由三甲基碳酸酯和己内酯(TMC/PCL)共聚物形成。该组合物可按在20/80至80/20范围内,或更具体地在50/50至60/40范围内的比率提供。该组合物可具有在0.3dL/g至3.0dL/g范围内,或更具体地在0.5dL/g至1.0dL/g范围内的固有粘度(IV)。该组合物可具有低于20%,或更具体地低于5%,或更具体地等于0%(即,完全无定形的聚合物)的结晶度。该组合物可具有低于0℃,或更具体地低于-20℃的玻璃化转变温度(Tg)。
在一些其它示例中,粘合剂材料由己内酯和乙交酯(PCL/PGA)共聚物形成。该组合物可按在45/55至85/15范围内,或更具体地在40/60至65/35范围内,或更具体地在50/50至65/35范围内的比率提供。该组合物可具有在0.2dL/g至3.0dL/g范围内,或更具体地在1.0dL/g至2.0dL/g范围内的固有粘度(IV)。该组合物可具有在100,000g/mol至200,000g/mol范围内的分子量。该组合物可具有低于20%,或更具体地低于5%,或更具体地等于0%(即,完全无定形的聚合物)的结晶度。该组合物可具有低于0℃,或更具体地低于-20℃的玻璃化转变温度(Tg)。该组合物的一个特定示例具有50/50PCL/PGA的比率、0.2的固有粘度(IV)、83,000g/mol的分子量、以及-19.4°的玻璃化转变温度(Tg)。该组合物的另一个特定示例具有65/35PCL/PGA的比率、1.04至1.07的固有粘度(IV)、110,000g/mol至118,000g/mol的分子量、以及在-37.3°至-38.6°范围内的玻璃化转变温度(Tg)。
可用于形成粘合剂材料的其它示例性合成基聚合物组合物包括如下:丙二醇和己内酯(PDO/PCL);结晶度非常低至无且玻璃化转变温度(Tg)低于0℃的丙二醇、己内酯和三亚甲基碳酸酯(PDO/PCL/TMC)的组合;以及固有粘度(IV)为约0.5dL/g的均聚物聚(TMC)。参考本文的教导内容,其它合适的合成基聚合物组合物对于本领域的普通技术人员而言将是显而易见的。
粘合剂材料可包括嵌段共聚物。例如,可用于粘合剂材料的嵌段共聚物的一个示例包括具有低玻璃化转变温度(Tg)的嵌段聚(TMC)。在一些情况下,嵌段共聚物可以是随机的。在一些其它情况下,例如当共聚物是无定形的(例如,0%结晶度)时,嵌段共聚物可以是有序的。
粘合剂材料可包括各种共聚物链组合物。例如,共聚物链组合物可以相对短的片段分支。这可进一步增强柔韧性体验。另选地,共聚物链可以是直链的。作为另一种选择,共聚物可以是交联的或星形的。然而,在共聚物是交联的型式中,可能理想的是,基共聚物链片段越是无定形,这些链段越是交联。
如上所述,熔融温度(Tm)是可以选择以提供所需粘合特性的聚合物的物理力学性质。在一些情况下,单体组分的较低熔融温度(Tm)可限制产生所需粘合效果所需的共聚单体的量。仅以举例的方式,聚二氧六环酮(PDS)具有大约110℃左右的熔融温度(Tm)和大约-10℃左右的玻璃化转变温度(Tg)。因此,聚二氧六环酮(PDS)可能需要较少的己内酯(PCL)以制备合适的压敏粘合剂(PSA)共聚物。还应当理解,具有聚乙交酯(PGA)或丙交酯(PLA)的聚二氧六环酮(PDS)共聚物可以提供期望的粘合效果。可能理想的是,这种共聚物具有低于室温的玻璃化转变温度(Tg)、等于或低于室温的熔融温度(Tm)、在10%至0%范围内的结晶度、以及小于2.0dL/g,更具体地小于1.0dL/g的固有粘度(IV)。
在一些示例中,粘合剂材料可包括共混共聚物。例如,相同的压敏粘合剂(PSA)共聚物的高分子量和低分子量可允许调节降解速率而不调节聚合物化学性质。当低分子量型式分解时,其酸副产物会改变pH并影响高分子量部分的分解。共聚物的优选共混物将包括不影响共聚物的结晶度、低熔点温度(Tm)和低玻璃化转变温度(Tg)的共混物。
粘合剂材料的一些示例可包括聚氨酯。例如,聚氨酯可以压敏粘合剂的形式提供。仅以举例的方式,聚氨酯基压敏粘合剂(PSA)可由异氰酸酯、多元醇和扩链剂制备而成。压敏粘合剂(PSA)也可由100%固体、水性或溶剂型体系制备而成。聚氨酯基压敏粘合剂(PSA)的性质可通过改变异氰酸酯与多元醇和扩链剂的比率来加以控制。作为另一个仅例示性示例,聚氨酯可以可流动形式提供。例如,可流动聚氨酯基粘合剂材料可具有小于1.0dL/g,或更具体地小于0.5dL/g的固有粘度(IV);在-10℃和10℃的范围内,或更具体地更接近于-10℃的玻璃化转变温度(Tg);以及类似于蜂蜜或油的稠度,如果需要,具有适当的固有粘度(IV)。
提供可吸收合成基聚合物的上述示例仅用于例示目的。参考本文的教导内容,其它合适的示例对于本领域的普通技术人员而言将是显而易见的。还应当理解,可吸收合成基聚合物的上述示例可易于并入下文所提供的各种教导内容和示例。换句话讲,可吸收合成基聚合物的上述示例可易于并入本文中涉及粘合剂材料的任何示例。
B.具有天然基的示例性聚合物粘合剂材料
虽然上述讨论提供了可用作支撑物主体(102)的粘合剂材料(例如,层(104,106)中的一个或多个)的合成基聚合物的各种示例,但还应当理解,天然基聚合物可用作粘合剂材料。下面将更详细地描述可用作粘合剂材料的天然基聚合物的几个仅例示性示例。还应当理解,粘合剂材料的这些示例可设置在上部粘合剂层(104)中。除此之外或另选地,粘合剂材料的这些示例可设置在下部粘合剂层(106)中。除此之外或另选地,粘合剂材料的这些示例可以其它方式集成到支撑物主体(102)中。因此应当理解,粘合剂材料不一定构成能够离散地识别为与由支撑物主体(102)限定的层不同的单独层。
在一些情况下,粘合剂材料包括水凝胶。水凝胶通常可包括能够吸收和/或保留流体的亲水性聚合物网络。示例性水凝胶材料为乙二醇甲醚。仅以进一步举例的方式,合适的水凝胶材料可包括均聚物水凝胶、共聚物水凝胶、多元聚合物水凝胶、互穿聚合物水凝胶、以及它们的组合。在其它示例中,水凝胶可包括微凝胶、纳米凝胶、以及它们的组合。水凝胶还可包括非交联的水凝胶、交联的水凝胶、以及它们的组合。水凝胶可包括化学交联剂、物理交联剂、疏水片段和/或水不溶解的片段。水凝胶可通过聚合反应、小分子交联和/或聚合物-聚合物交联来化学地交联。水凝胶可通过离子相互作用、疏水相互作用、氢键结合相互作用、立体络合和/或超分子化学来物理地交联。水凝胶可因交联剂、疏水片段和/或水不溶解的片段而为基本上不溶解的,但由于吸收和/或保留流体而为可扩展和/或可溶胀的。在一些型式中,前体可与内源性材料和/或组织交联。
可使用的水凝胶的其它示例包括多官能丙烯酸酯、甲基丙烯酸羟乙酯(HEMA)、以及丙烯酸弹性体。除此之外或另选地,水凝胶粘合剂材料可根据以下专利教导内容中至少一些教导内容进行构造:公布于2012年9月27日的名称为“Tissue Thickness CompensatorComprising at Least One Medicament”的美国专利公布号2012/0241492,其公开内容以引用方式并入本文。参考本文的教导内容,可为粘合剂材料提供水凝胶的其它合适的方式对于本领域的普通技术人员而言将是显而易见的。
可用于形成粘合剂材料的天然基聚合物的其它示例包括藻酸盐(例如,海藻酸钙、藻酸钠等)、透明质酸、胶原(包括明胶)和多糖。在包括多糖的型式中,多糖可包括纤维素、壳多糖、果胶或阿拉伯木聚糖。在包括纤维素的型式中,纤维素可包括氧化再生纤维素、羧甲基纤维素、羧乙基纤维素、羟丙基纤维素、羟乙基纤维素或氧化纤维素。在包括几丁质的型式中,壳多糖可包括壳聚糖(例如,脱乙酰壳多糖)或壳聚糖盐。
可用于形成粘合剂材料的天然基聚合物的一些型式可包括油灰或蜡状材料。一些这样的型式可以是不可吸收的,并且可以类似于常规的骨蜡。例如,该材料可包括具有石蜡、凡士林、棕榈酸异丙酯、芝麻油、碳酸或任何其它常规骨蜡组合物中的一者或多者的蜂蜡。可用于形成用于支撑物主体(102)的粘合剂材料的油灰或蜡状材料的一些其它型式可以是可吸收的或可再吸收的。例如,一些这样的型式可包括由Abyrx,Ink,Irvington,NewYork生产的油灰、水溶性亚烷基共聚物(例如,Baxter HealthcareCorporation,Deerfield,Illinois生产的OSTENE)、甘油、1-丙交酯、乙交酯、聚乙二醇(PEG)、聚环氧乙烷(PEO)或聚烯烃弹性体(POE)。以进一步举例的方式,粘合剂材料可包括分子量小于20,000g/mol的聚乙二醇(PEG)或聚乙二醇(PEG)共聚物。使分子量在这样的范围内可促进溶解形式的粘合剂通过肾脏。参见,例如,Webster等人的“PEGylatedProteins:Evaluation of Their Safety in the Absence of Definitive MetabolismStudies,”(《药物代谢与处置》,2007年,第1期,第35卷,第9页至第16页),其公开内容以引用方式并入本文。作为另一个仅例示性示例,粘合剂材料可根据以下专利教导内容中至少一些教导内容进行构造:公布于1953年6月16日的名称为“Hemostatic Compositions”的美国专利2,642,375,其公开内容以引用方式并入本文。
一些聚合物粘合剂(包括但不限于上文所提及的油灰或蜡状组合物)可包括作为止血剂的氧化再生纤维素(ORC)。例如,油灰或蜡状组合物可用作氧化再生纤维素(ORC)的载体。公布于2012年9月27日的名称为“Tissue Thickness Compensator ComprisingControlled Release and Expansion”的美国专利公布号2012/0241493讨论了可将氧化再生纤维素(ORC)并入各种组合物的各种方式,该公布的公开内容以引用方式并入本文。应当理解,美国专利公布号2012/0241493的这些教导内容可在将氧化再生纤维素(ORC)并入聚合物粘合剂(包括但不限于上文所提及的油灰或蜡状组合物)的上下文中易于应用于本文。
提供天然基聚合物的上述示例仅用于例示目的。参考本文的教导内容,其它合适的示例对于本领域的普通技术人员而言将是显而易见的。还应当理解,天然基聚合物的上述示例可易于并入下文所提供的各种教导内容和示例。换句话讲,天然基聚合物的上述示例可易于并入本文中涉及粘合剂材料的任何示例。
C.具有一体式附接和加强特征结构的示例性外科钉支撑物
在一些情况下,除了或代替在支撑物主体(102)的上表面或下表面上具有一个或多个粘合剂层(104,106),可能需要将附接和加强特征结构集成到支撑物主体(102)中。这种一体式附接和加强特征结构可增强支撑物主体(102)相对于组织(90)、相对于钉仓(70)的平台(73)和/或相对于砧座(60)的下侧(65)的附接和加强。下述示例包括可通过其将一个或多个附接和加强特征结构与支撑物主体(102)进行组合以增强支撑物主体(102)相对于组织(90)、相对于钉仓(70)的平台(73)和/或相对于砧座(60)的下侧(65)的附接和加强的各种示例性构型。在本示例中,可以设想,粘合剂材料包括合成基聚合物,例如本文所提及的那些。仅以举例的方式,可用于下述示例中的粘合剂材料组合物可包括具有低固有粘度(IV)和低结晶度的己内酯和乙交酯(PCL/PGA)的65/35共聚物。参考本文的教导内容,其它合适的组合物对于本领域的普通技术人员而言将是显而易见的。还应当理解,天然基聚合物可与下述教导内容结合。
1.具有缝合后粘合剂流的示例性支撑物组件
图20至图21B示出了示例性支撑物组件(2900),该支撑物组件包括容纳粘合剂辅助材料(2904)的支撑物主体(2902)。粘合剂辅助材料(2904)可具有使得粘合剂辅助材料(2904)能够在支撑物主体(2902)被压缩时流出支撑物主体(2902)的低粘度。参考本文的教导内容,可用于提供粘合剂辅助材料(2904)的各种合适的组合物对于本领域普通技术人员而言将是显而易见的。支撑物主体(2902)可具有纤维结构、多孔结构和/或被构造成能够吸收或以其它方式容纳粘合剂辅助材料(2904)的任何其它合适类型的结构。参考本文的教导内容,可用于提供支撑物主体(2902)的各种合适材料和结构对于本领域的普通技术人员而言将是显而易见的。
压敏、不可渗透粘合剂膜(2910)固定到支撑物主体(2902)的一个表面。作为不可渗透的,粘合剂膜(2910)被构造成能够防止粘合剂辅助材料(2904)流出支撑物主体(2902)的该表面。粘合剂膜(2910)还被构造成能够将支撑物主体(2900)可移除地固定到砧座(60)的下侧(65)或钉仓(70)的平台(73)。具体地,粘合剂膜(2910)包括压敏粘合剂,该压敏粘合剂提供足够的粘合强度以将支撑物组件(2900)暂时固定到砧座(60)的下侧(65)或钉仓(70)的平台(73);然而压敏粘合剂还允许在端部执行器(40)已被致动且钉(77)已被驱动穿过支撑物组件(2900)之后将粘合剂膜(2910)从砧座(60)的下侧(65)或钉仓(70)的平台(73)扯下。参考本文的教导内容,可用于形成粘合剂膜(2910)的各种合适的材料对于本领域的普通技术人员而言将是显而易见的。类似地,参考本文的教导内容,可用于在粘合剂膜(2910)上或中提供压敏粘合剂的各种合适的材料对于本领域的普通技术人员而言将是显而易见的。
应当理解,当支撑物组件(2900)装载在保持器(300)上时,上侧(302)或下侧(304)(取决于支撑物组件(2900)装载到哪一侧上)的表面可防止粘合剂辅助材料(2904)流出支撑物主体(2902)的与粘合剂膜(2910)相背对的表面。图20至图21B示出了两个支撑物组件(2900),使得一个支撑物组件(2900)将被装载到保持器(300)的上侧(302)上,而另一个支撑物组件(2900)将被装载到保持器(300)的下侧(304)上。图20具体示出了当端部执行器(40)被致动时驱动钉(77)穿过组织(90)并且穿过这两个支撑物组件(2900)的缝合器驱动器(75)。如图21A所示,当钉(77)最初被驱动穿过组织(90)和支撑物组件(2900)时,钉(77)的腿(220)撕裂膜(2910),从而在冠(210)和钉腿(220)周围形成间隙(2920)。这些间隙(2920)提供粘合剂辅助材料(2904)流出支撑物主体(2902)的路径。此外,该一连串的施加的钉(77)将支撑物组件(2900)压缩贴靠组织(90),由此将粘合剂辅助材料(2904)推出支撑物主体(2902)并进入间隙(2920),如图21B所示。该排出的粘合剂辅助材料(2904)流动到冠(210)和将以其它方式暴露的腿(220)的区域上。排出的粘合剂辅助材料(2904)可最终固化且由此进一步加强施加的支撑物组件(2900)的结构完整性;并且/或者进一步加强钉(77)至支撑物组件(2900)的附接。排出的粘合剂辅助材料(2904)还可通过阻断原本可能通过间隙(2920)发生的血液流动来提供止血效果。
在支撑物组件(2900)的一些型式中,粘合剂辅助材料(2904)设置在覆盖支撑物主体(2902)上方的层中(除了或代替被吸收或以其它方式容纳在支撑物主体(2902)中)。例如,粘合剂辅助材料(2904)可设置在用于替换不可渗透粘合剂膜(2910)的层中或设置在插置在支撑物主体(2902)和不可渗透粘合剂膜(2910)之间的层中。参考本文的教导内容,其它合适的构型对于本领域的普通技术人员而言将是显而易见的。
2.具有一体式紧固股线的示例性支撑物组件
图22至图26示出了具有示例性另选保持器(3100)的另一个示例性支撑物组件(3000)。图中示出了两个支撑物组件(3000),包括被定位成附接到砧座(60)的下侧(65)的一个支撑物组件(3000)和被定位成附接到钉仓(3270)的平台(3273)的另一个支撑物组件(300)。如在图23中最佳所见,本示例的每个支撑物组件(3000)包括支撑物主体(3002),该支撑物主体具有被编织在其中的一组紧固股线(3010)。支撑物主体(3002)可根据本文所提及的各种支撑物主体中的任何支撑物主体进行构造和操作。仅以举例的方式,紧固股线(3010)可包括由Ethicon US公司生产的(聚乳糖910)股线材料。另选地,可使用任何其它合适的材料。在本示例中,股线(3010)仅设置在一连串的小的离散编织区域(3012)中。换句话讲,在本示例中,股线(3010)未被编织遍及整个支撑物主体(3002)。股线(3010)的离散编织区域(3012)被定位在钉(77)将被驱动穿过支撑物组件(3000)的位置处,如将在下文更详细所述。在一些其它型式中,股线(3010)被编织遍及整个支撑物主体(3002)或呈某一其它布局。
同样如图23所示,支撑物组件(3000)还包括一组加强构件(3020,3022)。加强构件(3020,3022)还可包括(聚乳糖910)股线材料和/或任何其它合适的一种或多种材料。每个加强构件(3020)沿支撑物主体(3002)的全长纵向延伸。加强构件(3022)横向延伸跨过支撑物主体(3002)的全长。加强构件(3022)还跨越限定在一对支撑物主体(3002)之间的间隙(3004),从而提供支撑物主体(3002)跨过间隙(3004)的连接。在一些型式中,加强构件(3020,3022)穿过股线(3010)的离散编织区域(3012),使得加强构件(3020,3022)包括在一些离散编织区域(3012)处的织物中。除此之外或另选地,加强构件(3020,3022)本身可至少部分地被编织在支撑物主体(3002)中。
如在图24中最佳所见,支撑物组件(3000)还包括覆盖在支撑物主体(3002)上方的不可渗透层(3030)。在本示例中,股线(3010)和加强构件(3022)部分地被编织在不可渗透层(3030)中;而加强构件(3022)被定位在不可渗透层(3030)上方。在一些其它型式中,不可渗透层(3030)由半不可渗透层(诸如聚二氧六环酮(PDS)和/或某些其它材料的层)替代。参考本文的教导内容,可用于形成不可渗透层(3030)(或其半不可渗透替代物)的各种合适的材料对于本领域的普通技术人员而言将是显而易见的。
如在图25中最佳所见,支撑物组件(3000)还包括覆盖在不可渗透层(3030)上方的不可渗透剥离膜(3040)。剥离膜(3040)限定多个凹坑(3042),所述多个凹坑被构造成能够将可流动粘合剂材料(3050)(如图26所示)在不可渗透层(3030)上保持成一系列离散形成的液滴。剥离膜(3040)被构造成能够在支撑物组件(3000)的储存和运输期间粘附到不可渗透层(3030),但可就在支撑物组件(3000)安装在端部执行器(40)上之前剥离以暴露凹坑(3042)下方的可流动粘合剂材料(3050)。粘合剂材料(3050)的离散液滴的尺寸和位置被设计成与砧座(60)的钉成形凹坑(64)的定位对应。因此,粘合剂材料(3050)的离散液滴和凹坑(3042)被布置成三个纵向延伸的线性阵列。另选地,可使用任何其它合适的布局。参考本文的教导内容,可用于形成剥离膜(3040)的各种合适的材料对于本领域的普通技术人员而言将是显而易见的。
重新参见图22,保持器(3100)具有上表面(3110)和下表面(3120)。第一对支撑物组件(3000)被定位在上表面(3110)上,以将那些支撑物组件(3000)粘附到砧座(60)的下侧(65)。第二对支撑物组件(3000)被定位在下表面(3120)上,以将那些支撑物组件(3000)粘附到钉仓(3270)的平台(3273)。上表面(3110)包括向上突出的纵向延伸的肋(3114)。肋(3114)的尺寸被设计成与砧座(60)的通道(62)互补。下表面(3120)还包括向下突出的纵向延伸的肋(3124),该肋的尺寸被设计成与钉仓(3270)的通道(3272)互补。当砧座(60)被移动到闭合位置以将保持器(3100)和支撑物组件(3000)压缩在砧座(60)与钉仓(3270)之间时,肋(3114,3124)进入相应通道(62,3472)并且阻止可流动粘合剂材料(3050)进入通道(62,3472)。肋(3114,3124)还可确保保持器(3100)和支撑物主体(3000)与砧座(60)和钉仓(3270)的适当侧向对齐。
本示例的上表面(3110)包括多个向上延伸的突出部(3112)。虽然突出部(3112)仅示出在肋(3114)的一侧上,但应当理解,突出部(3112)也可位于肋(3114)的另一侧上。突出部(3112)被构造和定位成能够与砧座(60)的下侧(65)上的钉成形凹坑(64)和剥离膜(3040)的凹坑(3042)对应。当砧座(60)被移动到闭合位置以将保持器(3100)和支撑物组件(3000)压缩在砧座(60)与钉仓(3270)之间时,突出部(3112)被构造成能够在对应于钉成形凹坑(64)和由凹坑(3042)形成的粘合剂材料(3050)的液滴的区域处对支撑物主体(3002)的区域提供集中压力。虽然图中未示出,但应当理解,下表面(3120)还可包括类似于突出部(3112)的向下延伸的突出部,以对支撑物主体(3002)的选定区域提供集中压力。
同样如图22所示,本示例的钉仓(3270)基本上类似于钉仓(70),因为本示例的钉仓(3270)包括通道(3272)和钉凹坑(3274)。然而,本示例的钉仓(3270)不同于钉仓(70),因为本示例的钉仓(3270)包括向上延伸的壁(3280),该向上延伸的壁环绕每个钉凹坑(3274)、平台(3273)的外边缘、以及平台(3273)邻近通道(3272)的边缘。壁(3280)因此限定槽(3290),这些槽被构造成能够防止粘合剂材料(3050)在平台(3273)的外边缘上方流入钉凹坑(3274)并进入通道(3272)。在一些其它变型中,钉仓(3270)完全由钉仓(70)或某一其它类型的钉仓替代。
图26示出了在由砧座(60)和钉仓(3270)形成的端部执行器已被致动穿过组织(90)之后的组织(90)。如图所示,钉(77)将支撑物组件(3000)固定到组织(90)。每个钉(77)的冠(210)和腿(220)捕获股线(3010)和加强构件(3022),从而提供可能比假如支撑物主体(3002)缺乏股线(3010)和加强构件(3022)原本可能提供的更牢固的附接。应当理解,当在端部执行器的致动期间击发梁(82)被朝远侧推进时,刀构件(80)切断加强构件(3022)横跨间隙(3004)的部分。
同样如图26所示,一些粘合剂材料(3050)保留在不可渗透层(3030)上。在一些情况下,该粘合剂材料(3050)可流入原本可能邻近冠(210)和/或腿(220)存在的间隙。粘合剂材料(3050)因此进一步加强可最终固化且由此进一步加强施加的支撑物组件(3000)的结构完整性;并且/或者进一步加强钉(77)至支撑物组件(3000)的附接。粘合剂材料(3050)还可通过阻断原本可能通过原本可能邻近冠(210)和/或腿(220)存在的间隙发生的血液流动来提供止血效果。在一些其它变型中,支撑物组件(3000)被构造成使得在钉(77)被击发之后不可渗透层(3030)上不再存在大量的粘合剂材料(3000)。参考本文的教导内容,其它合适的布局和组合物对于本领域的普通技术人员而言将是显而易见的。
3.具有热敏股线的示例性支撑物组件
图27至图29示出了另一个示例性支撑物组件(3300)。本示例的支撑物组件(3300)包括支撑物主体(3302),该支撑物主体具有一对被编织在支撑物主体(3302)中的热敏股线(3310)。支撑物主体(3302)可根据本文所提及的任何支撑物主体进行构造。每根热敏股线(3310)被编织在支撑物主体(3302)中,使得热敏股线(3310)沿支撑物主体(3302)的全长延伸。热敏股线(3310)彼此平行并且以与通道(62,72)的侧向宽度互补的距离间隔开。热敏股线(3310)由将在相对低的温度下熔融并且当其熔融和冷却时粘附到与其接触的表面的材料形成。热敏股线(3310)的熔融温度(Tm)低于支撑物主体(3302)的熔融温度(Tm)。
仅以举例的方式,热敏股线(3310)可包括聚二氧六环酮(PDS)。在一些这样的型式中,支撑物主体(3302)包括由Ethicon US公司生产的(聚乳糖910)材料,热敏股线(3310)包括聚二氧六环酮(PDS),并且支撑物组件(3300)形成为PDS的7:1共混物制成,该共混物被热处理以使聚二氧六环酮(PDS)收缩并将羊毛中的单个纤维粘结在一起。另选地,可使用任何其它合适的共混比。在支撑物组件(3300)包括由材料和聚二氧六环酮(PDS)的共混物制成的编织羊毛材料的一些型式中,该羊毛可附接到聚二氧六环酮(PDS)膜,以将支撑物组件(3300)固定到砧座(60)的下侧(65)或钉仓(70)的平台(73)。
作为另一个仅例示性示例,支撑物组件(3300)可根据以下专利的教导内容中的至少一些进行构造:公布于1997年11月11日的名称为“Multi-Layered Implant”的美国专利5,686,090,其公开内容以引用方式并入本文。参考本文的教导内容,可用于形成热敏股线(3310)的各种其它合适的材料对于本领域的普通技术人员而言将是显而易见的。虽然在所示示例中支撑物组件(3300)只包括两根热敏股线(3310),但应当理解,如果需要,任何其它合适数量的热敏股线(3310)可并入支撑物组件(3300)。
图28示出了施加到砧座(60)的下侧(65)的支撑物组件(3300)。如图所示,热敏股线(3310)被定位在下侧(65)的邻近通道(62)的相应区域上。当支撑物组件(3300)如此定位时,热敏股线(3310)可被加热到其熔点;然后被允许冷却,由此将支撑物组件(3300)粘附到下侧(65)。仅以举例的方式,支撑物组件(3300)可使用保持器(300)的经修改型式施加到下侧(65)。例如,保持器(300)的这种经修改型式可在上侧(302)处或下方包括加热元件。当砧座(60)夹持在支撑物组件(3300)上时,加热元件可被激活。保持器(300)的这种经修改型式还可包括诸如聚四氟乙烯(PTFE)的涂层,以防止热敏股线(3310)粘附到上侧(302)。除此之外或另选地,保持器(300)可包括被构造成能够防止热敏股线(3310)粘附到上侧(302)的表面特征。还应当理解,热敏股线(3310)可被编织在支撑物主体(3302)中,以使得热敏股线(3310)不会接触经修改保持器(300)的上侧(302)。参考本文的教导内容,可用于向热敏股线(3310)提供热量的各种合适的结构和技术对于本领域的普通技术人员而言将是显而易见的。
图29示出了施加到钉仓(70)的平台(73)的支撑物组件(3300)。如图所示,热敏股线(3310)被定位在平台(73)的邻近通道(72)的相应区域上。当支撑物组件(3300)如此定位时,热敏股线(3310)可被加热到其熔点;然后被允许冷却,由此将支撑物组件(3300)粘附到平台(73)。仅以举例的方式,支撑物组件(3300)可使用如上所述的保持器(300)的经修改型式或使用任何其它合适的结构或技术施加到平台(73),参考本文的教导内容,这对于本领域的普通技术人员而言将是显而易见的。
4.其它示例性支撑物组件
应当理解,将支撑物主体(102)可移除地固定到砧座(60)的下侧(65)或钉仓(70)的平台(73)的粘合剂材料可具有各种性质,包括提供至砧座(60)的下侧(65)或钉仓(70)的平台(73)的自动附接的延展性和粘着性。换句话讲,粘合剂材料可变形为由下侧(65)或平台(73)的相应接触区域呈现的形状。还应当理解,粘合剂材料可在支撑物主体(102)上被设置成各种形状和构型。例如,粘合剂材料可被设置成包括选择性粘附区的图案,以使最小化。以使对其性能可能受到粘合剂材料流入的不利影响的区域(诸如钉凹坑(74))造成附带损害的可能性最小化。粘合剂材料的图案还可使粘合剂与下侧(65)或平台(73)的接触次数和尺寸最小化,由此使在端部执行器(40)已被致动之后将支撑物组件(100)从下侧(65)或平台(73)扯下所需的力最小化。粘合剂材料的几何形状可提供均匀的厚度或可变的厚度。粘合剂材料还可提供可变的刚度。提供可变的厚度和/或可变的刚度可提供可变的压力分布。
图30示出了包括一对支撑物主体(3402)和沿每个支撑物主体(3402)的上表面(3404)的外周边定位的粘合剂材料(3410)的示例性另选支撑物组件(3400)。支撑物主体(3402)由与砧座(60)的通道(62)和钉仓(70)的通道(72)对应的间隙(3406)分隔开。一组栓系件(3420)横向延伸跨过间隙(3406),从而连接支撑物主体(3402)。如上文关于其它栓系件所述,当击发梁(82)在端部执行器(40)的致动期间被朝远侧推进时,本示例的栓系件(3420)将被刀构件(80)切断。由于粘合剂材料(3410)的构型和布局,支撑物组件(3400)仅沿支撑物主体(3402)的外周边粘附到下侧(65)或平台(73),这可使在端部执行器(40)已被致动之后将支撑物组件(3400)从下侧(65)或平台(73)扯下所需的力最小化。参考本文的教导内容,可用于形成支撑物主体(3402)、粘合剂材料(3410)和栓系件(3420)的各种合适的材料对于本领域的普通技术人员而言将是显而易见的。
图31示出了包括支撑物主体(3502)和沿支撑物主体(3502)的上表面(3504)的外周边被定位在离散区域中的粘合剂材料(3510)的另一个示例性另选支撑物组件(3500)。支撑物主体(3502)限定与砧座(60)的通道(62)和钉仓(70)的通道(72)对应的一系列纵向延伸的间隙(3506)。支撑物主体(3502)还限定一组分开间隙(3506)的横向延伸的桥接区域(3520)。如上文关于栓系件所述,当击发梁(82)在端部执行器(40)的致动期间被朝远侧推进时,本示例的桥接区域(3520)将被刀构件(80)切断。由于粘合剂材料(3510)的构型和布局,支撑物组件(3400)仅沿支撑物主体(3502)的外周边在离散区域处粘附到下侧(65)或平台(73),这可进一步使在端部执行器(40)已被致动之后将支撑物组件(3500)从下侧(65)或平台(73)扯下所需的力最小化。由于在支撑物组件(3500)中使用较少的粘合剂材料(3510),该拉离力可能对于支撑物组件(3500)比对于支撑物组件(3400)更低。参考本文的教导内容,可用于形成支撑物主体(3502)和粘合剂材料(3510)的各种合适的材料对于本领域的普通技术人员而言将是显而易见的。
图32示出了包括具有多个一体式加强构件(3610)的支撑物主体(3602)的另一个示例性另选支撑物组件(3600)。支撑物主体(3602)可根据本文所述的各种支撑物主体中的任何支撑物主体进行构造和操作。粘合剂材料(未示出)并入支撑物主体(3602),以便提供支撑物组件(3600)至砧座(60)的下侧(65)或钉仓(70)的平台(73)的可移除附接。参考本文的教导内容,可用于提供粘合剂材料的各种合适的组合物和可将这种粘合剂材料并入支撑物主体(3602)的各种合适的方式对于本领域的普通技术人员而言将是显而易见的。
加强构件(3610)被构造成能够提供对支撑物主体(3602)和/或被驱动穿过支撑物组件(3600)的钉(77)的附接的结构加强。仅以举例的方式,在一些型式中,支撑物主体(3602)由多孔海绵状材料形成,而加强构件(3610)由具有比形成支撑物主体(3602)的材料更大的拉伸强度的紧密纤维织物形成。参考本文的教导内容,可用于形成加强构件(3610)的各种合适材料和结构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,加强构件(3610)中的两个具有大致“S”形构型,而加强构件(3610)中的另外两个具有大致“L”形构型。这些形状被构造成使得每个加强构件(3610)能够从不同行和列的钉仓(70)接纳若干个钉(77)。通过横跨来自不同行和列的钉仓(70)的若干组离散的钉(77),加强构件(3610)可提供比假如加强构件(3610)横跨整个阵列的钉(77)或仅单个的钉(77)原本可能提供的更强的加强。参考本文的教导内容,加强构件(3610)的其它合适的形状和布局对于本领域的普通技术人员而言将是显而易见的。还应当理解,加强构件(3610)可以任何合适的方式集成到支撑物主体(3602)中,包括但不限于在支撑物主体(3602)的并列层之间提供加强构件(3610)或围绕加强构件(3610)形成支撑物主体(3602)。
5.示例性另选保持器
图33示出了可与本文所述的各种支撑物组件中的任何支撑物组件一起使用的示例性另选保持器(3700)。本示例的保持器(3700)包括具有上表面(3754)的基座构件(3752)、多个闩锁(3756)、以及被构造成能够有利于抓握和操纵保持器(3750)的远侧突出舌状部(3758)。保持器(3700)还包括通过活铰链(3770)固定到基座构件(3752)的上部构件(3760)。上部构件(3760)具有被构造成能够接合支撑物主体(3702)的上表面(3762)。上部构件(3760)包括从上表面(3762)向上延伸的多个突出部(3764)和沿上表面(3762)的侧向中心区域向上且纵向延伸的中心肋(3766)、以及一对沿上表面(3762)的外边缘向上且纵向延伸的外肋(3768)。虽然突出部(3764)被示出为沿上表面(3762)的长度的仅一部分跨越,但应当理解,突出部(3764)可沿上表面的整个长度跨越。还应当理解,突出部(3764)可沿中心肋(3766)的每一侧上的对应于砧座(60)的下侧(65)上的三行钉成形凹坑(64)的三行跨越。
应当理解,保持器(3700)可通过可释放地接合下钳口(50)的闩锁(3756)以类似于上文所述的保持器(300)的方式可移除地固定到端部执行器(40)。在这样一个阶段,因于活铰链(3770)所施加的弹性偏压,上部构件(3760)与基座构件(3752)的上表面(3754)隔开。活铰链(3770)所提供的弹性偏压可确保在砧座(60)到达完全闭合位置之前支撑物组件(100)的覆盖在上表面(3762)上方的上部粘合剂层(104)将接触砧座(60)的下侧(65)的适当区域。活铰链(3770)所提供的弹性偏压还可在砧座(60)的闭合期间提供并维持最小的一致压力,以增强上部粘合剂层(104)至砧座(60)的下侧(65)的附接。
当砧座(60)被进一步朝闭合位置推进时,砧座(60)压向上部粘合剂层(104)和上部构件(3760),由此使上部构件(3760)朝基座构件(3752)枢转。粘合剂层(104)压缩在砧座(60)的下侧(65)和突出部(3764)之间。突出部(3764)在对应于钉成形凹坑(64)的区域处(和/或到下侧(65)的其它表面特征中)对支撑物组件(100)的区域提供集中压力,由此进一步促进粘合剂层(104)和下侧(65)之间的粘附。肋(3766,3768)可确保在砧座(60)的闭合期间保持器(3700)和支撑物组件(100)与砧座(60)的适当侧向对齐。肋(3766,3768)还防止粘合剂材料在砧座(60)的闭合期间进入通道(62)或从砧座(60)的侧面逸出。当砧座(60)到达闭合位置时,保持器(3700)的闩锁(3768)可将上部构件(3760)固定成与基座构件(3752)并列,从而有利于从端部执行器(40)移除保持器(3750)。支撑物组件(100)然后可保持粘附到砧座(60)的下侧(65),使得端部执行器(40)然后准备使用。
虽然保持器(3700)被描述为与支撑物组件(100)结合使用,但应当理解,保持器(3700)可与本文所提及的任何其它支撑物组件结合使用。
IV.示例性组合
下述示例涉及其中可组合或应用本文教导内容的各种不完全方式。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。提供下述示例仅用于例示目的。可设想到,本文的各种教导内容可按多种其它方式进行布置和应用。还可设想到,某些变型可省去下述示例所提及的某些特征结构。因此,下文提及的方面或特征中的任一个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结构之外的附加特征结构,则这些附加特征结构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,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;(b)砧座,其中所述砧座能够从打开位置朝所述钉仓移动以到达闭合位置,其中所述砧座包括下侧,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;和(c)支撑物组件,其中所述支撑物组件包括:(i)支撑物主体、(ii)粘合剂材料,其中所述粘合剂材料被构造成能够将所述支撑物主体可移除地固定到所述钉仓的所述平台或所述砧座的所述下侧、和(iii)多根加强股线,所述多根加强股线延伸穿过所述支撑物主体,其中所述加强股线被构造成能够接合被击发穿过所述支撑物主体的一个或多个钉。
实施例2
根据实施例1和下述实施例中任一项所述的外科缝合器端部执行器组件,其中所述粘合剂材料包括压敏粘合剂。
实施例3
根据上述或下述实施例中任一项所述的外科缝合器端部执行器组件,其中所述加强股线包含聚乳糖910。
实施例4
根据上述或下述实施例中任一项所述的外科缝合器端部执行器组件,其中所述加强股线中的至少一些加强股线被编织在所述支撑物主体中。
实施例5
根据上述或下述实施例中任一项所述的外科缝合器端部执行器组件,其中所述加强股线中的至少一些加强股线在离散编织区域中被编织在所述支撑物主体中。
实施例6
根据实施例5所述的外科缝合器端部执行器组件,其中所述钉仓能够操作以在对应于所述离散编织区域的区域处驱动所述钉穿过所述支撑物主体。
实施例7
根据上述或下述实施例中任一项所述的外科缝合器端部执行器组件,其中所述支撑物主体限定一段长度,其中所述加强股线中的至少一根加强股线沿所述支撑物主体的这个长度延伸。
实施例8
根据上述或下述实施例中任一项所述的外科缝合器端部执行器组件,其中所述支撑物主体限定一段长度,其中所述加强股线中的至少一根加强股线相对于所述支撑物主体的这个长度横向延伸。
实施例9
根据上述或下述实施例中任一项所述的外科缝合器端部执行器组件,其中所述支撑物主体包括一对彼此由间隙侧向间隔开的部分。
实施例10
根据实施例9所述的外科缝合器端部执行器组件,其中所述加强股线中的至少一根加强股线延伸跨过所述间隙。
实施例11
根据上述或下述实施例中任一项所述的外科缝合器端部执行器组件,其中所述支撑物组件还包括中间层,所述中间层被定位在所述支撑物主体与所述粘合剂材料之间,其中所述中间层是不可渗透的或半不可渗透的。
实施例12
根据实施例11所述的外科缝合器端部执行器组件,其中所述加强股线中的至少一根加强股线被定位在所述中间层上或穿过所述中间层。
实施例13
根据上述或下述实施例中任一项所述的外科缝合器端部执行器组件,其中所述支撑物组件还包括膜层,所述膜层被定位在所述粘合剂材料上方,其中所述膜层是不可渗透的。
实施例14
根据实施例13所述的外科缝合器端部执行器组件,其中所述膜层被定位在所述多根加强股线上方。
实施例15
根据实施例13所述的外科缝合器端部执行器组件,其中所述膜层限定多个凹坑,其中所述多个凹坑被构造成能够将所述粘合剂材料容纳在多个离散区域中。
实施例16
根据实施例15所述的外科缝合器端部执行器组件,还包括保持器组件,所述保持器组件被构造成能够可释放地保持所述支撑物组件,其中所述保持器组件包括多个突起部,所述多个突起部被构造成能够在对应于粘合剂材料的所述离散区域的位置处接合所述支撑物组件。
实施例17
根据上述或下述实施例中任一项所述的外科缝合器端部执行器组件,其中每个钉包括冠和一对腿,其中所述加强股线中的至少一根加强股线被构造成能够接合所述钉的所述冠或所述腿中的至少一个腿。
实施例18
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;(b)砧座,其中所述砧座能够从打开位置朝所述钉仓移动以到达闭合位置,其中所述砧座包括下侧,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;和(c)支撑物组件,其中所述支撑物组件包括:(i)支撑物主体;和(ii)被编织在所述支撑物主体中的热敏股线,其中所述热敏股线被构造成能够响应于热量而熔融并由此将所述支撑物主体固定到所述砧座的所述下侧或所述钉仓的所述平台。
实施例19
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,其中所述钉被布置成多个行和多个列,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;(b)砧座,其中所述砧座能够从打开位置朝所述钉仓移动以到达闭合位置,其中所述砧座包括下侧,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;和(c)支撑物组件,其中所述支撑物组件包括:(i)支撑物主体,其中所述支撑物主体包括多孔材料、和(ii)粘合剂材料,其中所述粘合剂材料被构造成能够将所述支撑物主体可移除地固定到所述钉仓的所述平台或所述砧座的所述下侧、和(iii)多个加强构件,所述多个加强构件被定位在所述支撑物主体上或所述支撑物主体中,其中所述加强构件包括纤维材料,其中每个加强构件被构造成能够接合相应的一组被击发穿过所述支撑物主体的钉,其中每组钉横跨相应的多个行和列。
实施例20
根据实施例19所述的外科缝合器端部执行器组件,其中所述加强构件中的至少一个加强构件具有“L”形或“S”形。
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它教导内容、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。
应当理解,据称以引用的方式并入本文的任何专利、专利公布或其它公开材料,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、陈述或者其它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,本文明确阐述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、陈述或其它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和现有的公开材料之间不产生冲突的程度下并入。
上述型式的装置可应用于由医疗专业人员进行的常规医学治疗和规程、以及机器人辅助的医学治疗和规程。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易于结合以下美国专利申请中的任何申请专利的各种教导内容:公布于1998年8月11日的名称为“Articulated SurgicalInstrument For Performing Minimally Invasive Surgery With Enhanced Dexterityand Sensitivity”的美国专利5,792,135,其公开内容以引用方式并入本文;公布于1998年10月6日的名称为“Remote Center Positioning Device with Flexible Drive”美国专利5,817,084,其公开内容以引用方式并入本文;公布于1999年3月2日的名称为“AutomatedEndoscope System for Optimal Positioning”的美国专利5,878,193,其公开内容以引用方式并入本文;公布于2001年5月15日的名称为“Robotic Arm DLUS for PerformingSurgical Tasks”的美国专利6,231,565,其公开内容以引用方式并入本文;公布于2004年8月31日的名称为“Robotic Surgical Tool with Ultrasound Cauterizing and CuttingInstrument”的美国专利6,783,524中,其公开内容以引用方式并入本文;公布于2002年4月2日的名称为“Alignment of Master and Slave in a Minimally Invasive SurgicalApparatus”的美国专利6,364,888,其公开内容以引用方式并入本文;公布于2009年4月28日的名称为“Mechanical Actuator Interface System for Robotic Surgical Tools”的美国专利7,524,320,其公开内容以引用方式并入本文;公布于2010年4月6日的名称为“Platform Link Wrist Mechanism”的美国专利7,691,098,其公开内容以引用方式并入本文;公布于2010年10月5日的名称为“Repositioning and Reorientation of Master/Slave Relationship in Minimally Invasive Telesurgery”的美国专利7,806,891,其公开内容以引用方式并入本文;公布于2013年1月10日的名称为“Automated End EffectorComponent Reloading System for Use with a Robotic System”的美国公布号2013/0012957,其公开内容以引用方式并入本文;公布于2012年8月9日的名称为“Robotically-Controlled Surgical Instrument with Force-Feedback Capabilities”的美国公布号2012/0199630,其公开内容以引用方式并入本文;公布于2012年5月31日的名称为“Shiftable Drive Interface for Robotically-Controlled Surgical Tool”的美国公布号2012/0132450,其公开内容以引用方式并入本文;公布于2012年8月9日的名称为“Surgical Stapling Instruments with Cam-Driven Staple DeploymentArrangements”的美国公布号2012/0199633,其公开内容以引用方式并入本文;公布于2012年8月9日的名称为“Robotically-Controlled Motorized Surgical End EffectorSystem with Rotary Actuated Closure Systems Having Variable Actuation Speeds”的美国公布号2012/0199631,其公开内容以引用方式并入本文;公布于2012年8月9日的名称为“Robotically-Controlled Surgical Instrument with SelectivelyArticulatable End Effector”的美国公布号2012/0199632,其公开内容以引用方式并入本文;公布于2012年8月9日的名称为“Robotically-Controlled Surgical End EffectorSystem”的美国公布号2012/0203247,其公开内容以引用方式并入本文;公布于2012年8月23日的名称为“Drive Interface for Operably Coupling a Manipulatable SurgicalTool to a Robot”的美国公布号2012/0211546,其公开内容以引用方式并入本文;公布于2012年6月7日的名称为“Robotically-Controlled Cable-Based Surgical EndEffectors”的美国公布号2012/0138660,其公开内容以引用方式并入本文;和/或公布于2012年8月16日的名称为“Robotically-Controlled Surgical End Effector Systemwith Rotary Actuated Closure Systems”的美国公布号2012/0205421,其公开内容以引用方式并入本文。
上文所述的型式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,可对这些形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,可拆卸一些形式的装置,并且可选择性地以任何组合来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,该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。此类技术的使用和所得的修复装置均在本专利申请的范围内。
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,将该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。辐射可将装置上和容器中的细菌杀死。然后将经杀菌的装置储存在无菌容器中,以供以后使用。还可使用本领域已知的任何其它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潜在修改,并且其它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、步骤等均是示例性的而非必需的。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 (16)
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;
(b)砧座,其中所述砧座能够从打开位置朝所述钉仓移动以到达闭合位置,其中所述砧座包括下侧,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;和
(c)支撑物组件,其中所述支撑物组件包括:
(i)支撑物主体,
(ii)粘合剂材料,其中所述粘合剂材料被构造成能够将所述支撑物主体可移除地固定到所述钉仓的所述平台或所述砧座的所述下侧,
(iii)多根加强股线,所述多根加强股线延伸穿过所述支撑物主体,其中所述加强股线被构造成能够接合被击发穿过所述支撑物主体的一个或多个钉,其中所述加强股线中的至少一些加强股线在离散编织区域中被编织在所述支撑物主体中,以及
(iv)中间层,所述中间层被定位在所述支撑物主体和所述粘合剂材料之间,其中所述中间层是不可渗透的或半不可渗透的,
其中,所述钉仓能够操作以在对应于所述离散编织区域的区域驱动所述钉穿过所述支撑物主体。
2.根据权利要求1所述的外科缝合器端部执行器组件,其中,所述粘合剂材料包括压敏粘合剂。
3.根据权利要求1所述的外科缝合器端部执行器组件,其中,所述加强股线包含聚乳糖910。
4.根据权利要求1所述的外科缝合器端部执行器组件,其中,所述加强股线中的至少一些加强股线被编织在所述支撑物主体中。
5.根据权利要求1所述的外科缝合器端部执行器组件,其中,所述支撑物主体限定一段长度,其中所述加强股线中的至少一根加强股线沿所述支撑物主体的这个长度延伸。
6.根据权利要求1所述的外科缝合器端部执行器组件,其中,所述支撑物主体限定一段长度,其中所述加强股线中的至少一根加强股线相对于所述支撑物主体的这个长度横向延伸。
7.根据权利要求1所述的外科缝合器端部执行器组件,其中,所述支撑物主体包括一对彼此由间隙侧向间隔开的部分。
8.根据权利要求7所述的外科缝合器端部执行器组件,其中,所述加强股线中的至少一根加强股线延伸跨过所述间隙。
9.根据权利要求1所述的外科缝合器端部执行器组件,其中,所述加强股线中的至少一根加强股线被定位在所述中间层上或穿过所述中间层。
10.根据权利要求1所述的外科缝合器端部执行器组件,其中,所述支撑物组件还包括膜层,所述膜层被定位在所述粘合剂材料上方,其中所述膜层是不可渗透的。
11.根据权利要求10所述的外科缝合器端部执行器组件,其中,所述膜层被定位在所述多根加强股线上方。
12.根据权利要求10所述的外科缝合器端部执行器组件,其中,所述膜层限定多个凹坑,所述多个凹坑被构造成能够将所述粘合剂材料容纳在多个离散区域中。
13.根据权利要求12所述的外科缝合器端部执行器组件,还包括保持器组件,所述保持器组件被构造成能够可释放地保持所述支撑物组件,其中所述保持器组件包括多个突起部,所述多个突起部被构造成能够在对应于粘合剂材料的所述离散区域的位置处接合所述支撑物组件。
14.根据权利要求1所述的外科缝合器端部执行器组件,其中,每个钉包括冠和一对腿,其中所述加强股线中的至少一根加强股线被构造成能够接合所述钉的所述冠或所述腿中的至少一个腿。
15.根据权利要求1所述的外科缝合器端部执行器组件,其中,所述钉在所述钉仓内被布置成多个行和多个列,所述支撑物主体包括多孔材料,所述加强股线形成多个加强构件,所述多个加强构件被定位在所述支撑物主体上或所述支撑物主体中,其中所述加强构件包括纤维材料,其中每个加强构件被构造成能够接合相应的一组被击发穿过所述支撑物主体的钉,其中每组钉横跨相应的多个行和列。
16.根据权利要求15所述的外科缝合器端部执行器组件,其中,所述加强构件中的至少一个加强构件具有“L”形或“S”形。
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EP3970628A1 (en) | 2022-03-23 |
WO2016153904A2 (en) | 2016-09-29 |
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