CN105764568B - 具有压电密封头的超声吻合器械 - Google Patents

具有压电密封头的超声吻合器械 Download PDF

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CN105764568B
CN105764568B CN201480062084.XA CN201480062084A CN105764568B CN 105764568 B CN105764568 B CN 105764568B CN 201480062084 A CN201480062084 A CN 201480062084A CN 105764568 B CN105764568 B CN 105764568B
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ultrasound
distal side
ultrasonic transducer
anvil block
anastomosis apparatus
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CN105764568A (zh
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F·B·斯图伦
T·G·迪茨
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Ethicon Endo Surgery Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A61B17/1155—Circular staplers comprising a plurality of staples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A61B2017/00504—Tissue welding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A61B2017/00513—Tissue soldering
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00184—Moving parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00619—Welding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0043—Ultrasound therapy intra-cavitary

Abstract

本发明提供了一种设备，所述设备包括主体、轴、超声元件和环形夹持垫。所述轴从所述主体朝远侧延伸。所述超声元件位于所述轴的远侧端部处。所述超声元件包括朝远侧呈现的环形面。所述夹持垫能够朝所述超声元件的朝远侧呈现的环形面移动。当组织在所述夹持垫和所述超声元件的朝远侧呈现的环形面之间被压缩时，所述超声元件可利用超声能量被激活。所得的超声振动可切断和密封被捕获在所述朝远侧呈现的环形面与所述夹持垫之间的组织，从而导致吻合。因此，所述设备可用于接合两个中空管状组织结构，诸如胃肠道的部分。

Description

具有压电密封头的超声吻合器械
背景技术
吻合可在患者体内形成以将两个中空组织结构接合在一起，从而在那两个中空组织结构之间提供流体连通。吻合可具有密封的外周边，该外周边阻止从吻合部位的不需要的渗漏。吻合可包括侧对侧吻合(例如，将肠的侧壁接合到胃的侧壁等)或端对端吻合(例如，将两个管状组织结构的自由端接合在一起)。例如，在一些外科手术中，可切割并移除胃肠道的部分以清除不需要的组织，或者出于其他原因而切割和移除。一旦不需要的组织被移除，胃肠道的剩余部分就可以吻合的方式重新联接在一起。可用于实现这些吻合手术的一种器械是圆形缝合器，该圆形缝合器被插入穿过患者体内天然存在的孔和/或穿过外科手术产生的孔。
圆形外科缝合器的示例在以下专利中有所描述：1993年4月27日公布的名称为“Surgical Anastomosis Stapling Instrument”的美国专利No.5,205,459；1993年12月21日公布的名称为“Surgical Anastomosis Stapling Instrument”的美国专利No.5,271,544；1994年1月4日公布的名称为“Surgical Anastomosis Stapling Instrument”的美国专利No.5,275,322；1994年2月15日公布的名称为“Surgical Anastomosis StaplingInstrument”的美国专利No.5,285,945；1994年3月8日公布的名称为“SurgicalAnastomosis Stapling Instrument”的美国专利No.5,292,053；1994年8月2日公布的名称为“Surgical Anastomosis Stapling Instrument”的美国专利No.5,333,773；1994年9月27日公布的名称为“Surgical Anastomosis Stapling Instrument”的美国专利No.5,350,104；1996年7月9日公布的名称为“Surgical Anastomosis Stapling Instrument”的美国专利No.5,533,661；2012年11月22日公布的名称为“Low Cost Anvil Assembly for aCircular Stapler”的美国公布No.2012/0292372；以及2013年9月24日提交的名称为“Surgical Stapler with Rotary Cam Drive and Return”的美国专利申请No.14/033,688，其公开内容以引用方式并入本文。上面所引用的美国专利和美国专利申请公布中的每一个的公开内容以引用方式并入本文。一些此类缝合器能够操作以夹紧组织层，切割穿过被夹紧的组织层，并驱动钉穿过组织层，以在组织层的被切断的端部附近将切断的组织层基本上密封在一起，由此接合管状组织结构的两个被切断的端部。
代替具有钉驱动特征部，多种外科器械包括具有刀片元件的端部执行器，该刀片元件以超声频率振动，从而切割和密封组织(例如，通过使组织细胞中的蛋白质变性)或仅仅密封组织。这些器械包括将电力转换成超声振动的压电元件，所述超声振动沿声波导传送到刀片元件。切割和凝固的精度可受外科医生的技术以及对功率电平、刀刃角度、组织牵引力和刀片压力等的调节的控制。
超声外科器械的示例包括HARMONIC
Figure BDA0000988655260000021
超声剪刀、HARMONIC
Figure BDA0000988655260000022
超声剪刀、HARMONIC
Figure BDA0000988655260000023
超声剪刀和HARMONIC
Figure BDA0000988655260000024
超声刀片，它们都购自俄亥俄州辛辛那提市的爱惜康内镜外科公司(Ethicon Endo-Surgery,Inc.of Cincinnati,Ohio)。此类装置的另外示例和相关概念公开于下列专利中：1994年6月21日公布的名称为“ClampCoagulator/Cutting System for Ultrasonic Surgical Instruments”的美国专利No.5,322,055，其公开内容以引用方式并入本文；1999年2月23日公布的名称为“UltrasonicClamp Coagulator Apparatus Having Improved Clamp Mechanism”的美国专利No.5,873,873，其公开内容以引用方式并入本文；1997年10月10日提交的名称为“UltrasonicClamp Coagulator Apparatus Having Improved Clamp Arm Pivot Mount”的美国专利No.5,980,510，其公开内容以引用方式并入本文；2001年12月4日公布的名称为“Bladeswith Functional Balance Asymmetries for use with Ultrasonic SurgicalInstruments”的美国专利No.6,325,811，其公开内容以引用方式并入本文；2004年8月10日公布的名称为“Blades with Functional Balance Asymmetries for use withUltrasonic Surgical Instruments”的美国专利No.6,773,444，其公开内容以引用方式并入本文；以及2004年8月31日公布的名称为“Robotic Surgical Tool with UltrasoundCauterizing and Cutting Instrument”的美国专利No.6,783,524，其公开内容以引用方式并入本文。
超声外科器械的另外示例公开于下列公布中：2006年4月13日公布的名称为“Tissue Pad for Use with an Ultrasonic Surgical Instrument”的美国公布No.2006/0079874，其公开内容以引用方式并入本文；2007年8月16日公布的名称为“UltrasonicDevice for Cutting and Coagulating”的美国公布No.2007/0191713，其公开内容以引用方式并入本文；2007年12月6日公布的名称为“Ultrasonic Waveguide and Blade”的美国公布No.2007/0282333，其公开内容以引用方式并入本文；2008年8月21日公布的名称为“Ultrasonic Device for Cutting and Coagulating”的美国公布No.2008/0200940，其公开内容以引用方式并入本文；2009年4月23日公布的名称为“Ergonomic SurgicalInstruments”的美国公布No.2009/0105750，其公开内容以引用方式并入本文；2010年3月18日公布的名称为“Ultrasonic Device for Fingertip Control”的美国公布No.2010/0069940，其公开内容以引用方式并入本文；2011年1月20日公布的名称为“RotatingTransducer Mount for Ultrasonic Surgical Instruments”的美国公布No.2011/0015660，其公开内容以引用方式并入本文；2012年2月2日公布的名称为“UltrasonicSurgical Instrument Blades”的美国公布No.2012/0029546，其公开内容以引用方式并入本文；以及2013年1月18日提交的名称为“Ultrasonic Surgical Apparatus with SiliconWaveguide”的美国专利申请No.13/745,385，其公开内容以引用方式并入本文；
超声外科器械中的一些可包括无线换能器，诸如在下列美国公布中公开的无线换能器：2012年5月10日公布的名称为“Recharge System for Medical Devices”的美国公布No.2012/0112687，其公开内容以引用方式并入本文；2012年5月10日公布的名称为“Surgical Instrument with Charging Devices”的美国公布No.2012/0116265，其公开内容以引用方式并入本文；和/或2010年11月5日提交的名称为“Energy-Based SurgicalInstruments”的美国专利申请No.61/410,603，其公开内容以引用方式并入本文。
另外，一些超声外科器械可包括关节运动轴节段。此类超声外科器械的示例公开于下列专利中：2012年6月29日提交的名称为“Surgical Instruments with ArticulatingShafts”的美国专利申请No.13/538,588，其公开内容以引用方式并入本文；以及2012年10月22日提交的名称为“Flexible Harmonic Waveguides/Blades for SurgicalInstruments”的美国专利申请No.13/657,553，其公开内容以引用方式并入本文。
尽管已研制出各种器械和技术并用于接合在吻合部位处的中空解剖结构，但据信在本发明人之前还无人研制出或使用所附权利要求中描述的发明。
附图说明
尽管本说明书得出了具体地指出和明确地声明这种技术的权利要求，但是据信从下述的结合附图描述的某些示例将更好地理解这种技术，其中相似的参考数字指示相同的元件，并且其中：
图1示出示例性超声吻合器械的侧正视图，其中砧座与超声头部组件联接；
图2示出图1的器械的侧正视图，其中砧座从超声头部组件脱离；
图3示出图1的器械的砧座的透视图；
图4示出图1的器械的轴组件和超声头部组件的透视图；
图5示出图1的器械的超声头部组件的侧面剖视图；
图6A示出定位在第一管状组织结构中的图5的超声头部组件的侧面剖视图，其中砧座与超声头部组件分开并且定位在第二管状组织结构中；
图6B示出图5的超声头部组件的侧面剖视图，其中第一管状组织结构围绕超声头部组件的套管针缝合，砧座与超声头部组件分开，并且第二管状组织结构围绕砧座的柄部缝合；
图6C示出图5的超声头部组件的侧面剖视图，其中砧座的柄部与超声头部组件的套管针联接；
图6D示出图5的超声头部组件的侧面剖视图，其中砧座的柄部和超声头部组件的套管针回缩到超声头部组件中，以压缩超声头部组件和砧座之间的第一管状结构和第二管状结构的区域；
图6E示出图5的超声头部组件的侧面剖视图，其中超声头部组件的换能器元件被激活以同时横切和密封被压缩的组织；并且
图6F示出在吻合部位处接合在一起的第一管状结构和第二管状结构的侧面剖视图。
附图并非旨在以任何方式进行限制，并且可以预期本技术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。所结合的并且形成说明书的一部分的附图示出了本技术的若干方面，并且与说明书一起用于解释本技术的原理；然而，应当理解，这种技术不局限于所示的精确布置方式。
具体实施方式
下面描述的本技术的某些示例不应当用于限制本技术的范围。从下面的描述而言，本技术的其他示例、特征、方面、实施方案和优点对本领域的技术人员而言将是显而易见的，下面的描述以举例的方式进行，这是为实现本技术所设想的最好的方式之一。正如将意识到的，本文所述技术能够包括其他不同的和明显的方面，这些均不脱离本发明技术。因此，附图和具体实施方式应被视为实质上是例示性的而非限制性的。
还应当理解，本文所述的教导内容、表达方式、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、表达方式、实施方案、示例等中的任何一者或多者相结合。下述教导内容、表达方式、实施方案、示例等不应视为相对于彼此独立。参考本文教导内容，其中本文教导内容可结合的各种合适方式将对本领域的普通技术人员显而易见。此类修改和变型旨在包括在权利要求书的范围内。
为公开的清楚起见，术语“近侧”和“远侧”在本文中是相对于外科器械的人或机器人操作者定义的。术语“近侧”是指更靠近外科器械的人或机器人操作者并且更远离外科器械的外科端部执行器的元件位置。术语“远侧”是指更靠近外科器械的外科端部执行器并且更远离外科器械的人或机器人操作者的元件位置。
I.示例性吻合器械
图1至图2示出示例性吻合器械10，其具有柄部组件20、超声头部组件40、轴组件18和砧座60，其中的每一者将在下面更详细地描述。轴组件18从柄部组件20朝远侧延伸。超声头部组件40位于轴组件18的远侧端部处。砧座60被构造成能够与轴组件18的套管针34可移除地联接，并由此抵靠超声头部组件40压缩组织。然后，柄部组件20能够操作以致动超声头部组件40的换能器元件70，从而横切和密封被捕获在超声头部组件40和砧座60之间的组织。因此，如图6A至图6F所示，吻合器械10可用于在吻合140部位处以密封的方式将两个管状组织结构100、110的自由端接合在一起。下面将更详细地描述器械10的示例性特征部，然而参考本文的教导内容，多个变型对本领域的普通技术人员而言将是显而易见的。
应当理解，除了下面的教导内容之外，器械10的超声特征部中的一个或多个可根据下列专利的教导内容中的至少一些进行构造：美国专利No.5,322,055；美国专利No.5,873,873；美国专利No.5,980,510；美国专利No.6,325,811；美国专利No.6,773,444；美国专利No.6,783,524；美国公布No.2006/0079874；美国公布No.2007/0191713；美国公布No.2007/0282333；美国公布No.2008/0200940；美国公布No.2009/0105750；美国公布No.2010/0069940；美国公布No.2011/0015660；美国公布No.2012/0112687；美国公布No.2012/0116265；美国专利申请No.13/538,588；美国专利申请No.13/657,553；和/或美国专利申请No.61/410,603。前述专利、公布以及申请中的每一个的公开内容均以引用方式并入本文。
A.示例性柄部组件
本发明实施例的柄部组件20包括手枪式握把22、触发器组件24、旋钮26和套管针致动组件30。应当理解，手枪式握把22仅仅是任选的，由此使得柄部组件20可提供任何其他合适种类的抓持特征部。线缆14从手枪式握把22延伸，并且进一步与发生器12联接。发生器12能够操作以选择性地向超声头部组件40的换能器元件70提供电力。仅以举例的方式，发生器12可包括俄亥俄州辛辛那提市的爱惜康内镜外科公司(Ethicon Endo-Surgery,Inc.of Cincinnati,Ohio)出售的GEN 300。除此之外或另选地，发生器12可根据2011年4月14日公布的名称为“Surgical Generator for Ultrasonic and ElectrosurgicalDevices”的美国公布No.2011/0087212的教导内容中的至少一些进行构造，该公布的公开内容以引用方式并入本文。还应当理解，发生器12的功能性中的至少一些可整合进柄部组件20，并且柄部组件20甚至可包括电池或其他板载电源，由此使得线缆14被省略。参考本文的教导内容，发生器12可采用的其他合适的形式，以及发生器12可提供的各种特征部和操作性对于本领域普通技术人员而言是显而易见的。
触发器组件24可朝手枪式握把22枢转以选择性地将发生器12与超声头部组件40的换能器元件70联接，从而选择性地激活换能器元件70。在一些型式中，触发器组件24包括阻止触发器组件24意外致动的安全特征部。在一些此类型式中，当砧座60在距超声头部组件40的预定距离范围之外时，安全特征部有效地禁用触发器组件24，或者以其他方式阻止触发器组件24的致动。一旦砧座60到达其在距超声头部组件40的预定距离范围之内的位置，安全特征部就可启用触发器组件24的致动。仅以举例的方式，此种安全特征部可根据2013年9月24日提交的名称为“Control Features for Motorized Surgical StaplingInstrument”的美国专利申请No.14/033,751的教导内容中的至少一些进行构造，该专利的公开内容以引用方式并入本文。参考本文中的教导内容，其中触发器组件24的安全特征部可被构造的其他合适方式将对本领域的普通技术人员而言是显而易见的。相似地，参考本文的教导内容，用于触发器组件24的各种其他合适的特征部和构型对于本领域普通技术人员而言将是显而易见的。
旋钮26能够旋转以选择性地致动套管针致动组件30。如下面将更详细地描述的，套管针致动组件30能够操作以选择性地平移套管针34，从而选择性地调节砧座60相对于超声头部组件40的位置。具体地，旋钮26在一个方向上的旋转致使砧座60朝向超声头部组件400朝近侧回缩；而旋钮26在另一个方向上的旋转致使砧座60朝向超声头部组件400朝远侧推进。因此，套管针致动组件30能够操作以将旋钮26的旋转运动转换成套管针34和砧座60的线性运动。仅以举例的方式，套管针致动组件30可根据下列专利的教导内容中的至少一些进行构造：美国专利No.5,205,459；美国专利No.5,271,544；美国专利No.5,275,322；美国专利No.5,285,945；美国专利No.5,292,053；美国专利No.5,333,773；美国专利No.5,350,104；美国专利No.5,533,661；美国公布No.2012/0292372；和/或美国专利申请No.14/033,688，这些专利的公开内容均以引用方式并入本文。参考本文的教导内容，其中套管针致动组件30可被构造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。
B.示例性轴组件
在本发明实施例中，轴组件18具有刚性弯曲的构型，其可有利于超声头部组件40从直肠途径定位在患者结肠中。在一些其他型式中，轴组件18是刚性直的。在一些其他型式中，轴组件18是柔性的。作为另一个仅仅例示性的替代形式，轴组件18能够操作以在柔性构型和刚性构型之间选择性地转变。仅以举例的方式，此种选择性的转变可根据2012年12月17日提交的名称为“Motor Driven Rotary Input Circular Stapler with LockableFlexible Shaft”的美国专利申请No.13/716,323的教导内容中的至少一些进行设置，所述专利申请的公开内容以引用方式并入本文。
如图4中最佳所见，本发明实施例的轴组件18包括套管针致动轴32，其能够操作以在轴组件18内平移。套管针34固定到套管针致动轴32的远侧端部，由此使得套管针34与套管针致动轴32一体地平移。套管针致动轴32与套管针致动组件30联接，由此使得套管针致动组件30能够操作以经由套管针致动轴32平移套管针34。参考本文的教导内容，其中套管针致动轴32可与套管针致动组件30联接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。
套管针34被构造成能够用于选择性地插入砧座60的柄部66中，其将在下面更详细地进行描述。本发明实施例的套管针34包括锥形远侧末端36。此种末端36能够刺穿组织并且/或者有助于砧座60的柄部66定位在套管针34上，但是末端36的锥形构型仅仅是任选的。例如，在其他型式中，套管针34可具有钝的末端36。除此之外或另选地，套管针34可包括磁性部分(未示出)，其可吸引砧座60朝向套管针34。参考本文的教导内容，对套管针34的其他构型和布置方式对于本领域的普通技术人员而言将是显而易见的。
C.示例性超声头部组件
本发明实施例的超声头部组件40包括罩42，其限定经设定尺寸以接收换能器元件70的承窝。仅以举例的方式，罩42可包括铝和/或任何其他合适的材料。换能器元件70由压电材料形成，由此使得换能器元件70被构造成能够将来自发生器12的电力转换成超声振动。如在图4至图5中最佳所见，本发明实施例的换能器元件70由限定孔71的压电材料的单个整体件组成，由此使得换能器元件70具有中空的、细长的、圆筒状构型。因此，换能器元件70包括远侧面72、近侧面74、内径表面76和外径表面78。作为一个仅仅例示性的替代形式，换能器元件70可由在叠堆中同轴布置的多个压电盘元件形成。参考本文的教导内容，换能器元件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。
在一些型式中，换能器元件70通过过盈配合被接收在罩42中，由此使得罩42使沿径向向内指向的压缩力施加在外径表面78上。在一些型式中，声音绝缘体插置在换能器元件70和罩40的相对表面之间。作为另一个仅仅例示性的实施例，罩42可包括向内指向的环形突起，该环形突起使向内指向的压缩在纵向位置处施加在换能器元件70上，所述纵向位置对应于与通过换能器元件70传送的共振超声振动相关联的波节。还应当理解，一个或多个特征部可定位在远侧面72之上。例如，金属垫圈可定位在远侧面72之上以提供保护，同时也提供声透射性。仅以举例的方式，此种垫圈可包含钛(Ti6Al4V)和/或任何其他合适的材料。套管针34同轴地定位在孔71内。如图5至图6B所示，孔71的直径足够大以允许套管针34相对于换能器元件70朝远侧和朝近侧自由地平移。如图6C至图6E所示，孔71的尺寸也经设定以容纳砧座60的柄部66，由此使得柄部66在不接触内径表面76的情况下可进入孔71。
面72、74是电绝缘的(例如，通过涂层、膜、其他特征部等)；而表面76、78是导电的(例如，利用金属镀层等)。当将电压施加到表面76、78时(例如，其中表面76充当接地或中性路径)，换能器元件70被构造成能够将电力转换成超声振动。仅以举例的方式，换能器元件70可根据2013年1月18日提交的名称为“Ultrasonic Surgical Apparatus with SiliconWaveguide”的美国专利申请No.13/745,385的教导内容中的至少一些进行构造，该专利申请的公开内容以引用方式并入本文。
来自发生器12的电力经由线材80到达换能器元件70，线材80设置在通过超声头部组件40和柄部组件18形成的通道44中。基于触发器组件24的致动，线材80与线缆14选择性地电通信，并且因此与发生器12选择性地电通信。线材80可以各种方式与换能器元件70联接。仅以举例的方式，线材80可根据2013年9月20日提交的名称为“Transducer Featuresfor Ultrasonic Surgical Instrument”的美国专利申请No.14/032,842的教导内容中的至少一些与换能器元件70联接，该专利申请的公开内容以引用方式并入本文。应当理解，线材80仅仅是例示性的，并且可使用任何其他合适种类的电导体。参考本文的教导内容，其中换能器元件70可接收电力的其他合适的方式对本领域的普通技术人员而言将是显而易见的。
在本发明实施例中，换能器元件70的远侧面72位于这样的位置，该位置对应于与通过换能器元件70传送的共振超声振动相关联的波腹。当换能器元件70通电时，远侧面72被构造成能够在例如大约10至500微米峰间范围内，并且在一些情况下在约20至约200微米的范围内以例如55.5kHz的预定的振动共振频率fo轴向地/纵向地和/或径向地移动。当本发明实施例的换能器元件70被激活时，远侧面72因此以共振超声频率轴向地/纵向地和/或径向地振动。因此，如下面将更详细地描述的，当组织被夹持在换能器元件70的远侧面72和砧座60的夹持垫64之间时，换能器元件70在轴向方向/纵向方向上和/或在径向方向上的超声振荡可同时切断组织，并且使相邻组织细胞中的蛋白质变性，从而提供具有相对小的热扩散的促凝效果。在一些型式中，也可通过换能器元件70和/或夹持垫64提供电流以另外烧灼组织。
在本发明实施例中，换能器元件70的远侧面72与罩42的远侧边缘48齐平。在一些其他的型式中，换能器元件70的远侧面72朝远侧突出经过罩42的远侧边缘48。在其他型式中，换能器元件70的远侧面72相对于罩42的远侧边缘48朝近侧凹陷。在其中换能器元件70的远侧面72相对于罩42的远侧边缘48朝近侧凹陷的型式中，当砧座60相对于超声头部组件40在完全回缩的位置中时，夹持垫64可被构造成能够朝近侧突出经过罩42的远侧边缘48。参考本文的教导内容，这些结构特征部之间的其他合适的关系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，换能器元件70可以多种方式改变。仅以举例的方式，换能器元件70可包括同轴布置的压电环结构的叠堆，其类似于如在本文所引用的各种参考文献中所教导的压电布置。还应当理解，端部质量块可纵向地插置在换能器元件70的近侧面74和超声头部组件40的罩42内面朝远侧的表面46之间。此种端部质量块可以是盘和/或任何其他合适种类的结构的形式。在一些其他型式中，换能器组件定位在柄部组件20中(例如，在手枪式握把22内等)，并且声波导延伸穿过轴组件18以到达位于超声头部组件40中的圆筒状刀片，由此使得由换能器组件生成的超声振动传送到圆筒状刀片。此种圆筒状刀片可具有基本上类似于换能器元件70的构型的构型，由此使得圆筒状刀片就像换能器元件70一样与砧座60配合。在其中轴组件18具有弯曲构型或者波导以其他方式需要沿弯曲路径弯曲的此类型式中，波导可根据美国专利申请No.13/538,588和/或美国专利申请No.13/657,553的教导内容中的至少一些进行构造，这些专利的公开内容以引用方式并入本文。参考本文的教导内容，其他合适的变型对于本领域普通技术人员而言将是显而易见的。
D.示例性砧座
如在图3中最佳所见，本发明实施例的砧座60包括头部62和柄部66。头部62包括面向近侧的环形夹持垫64。在一些型式中，夹持垫64包含聚四氟乙烯(PTFE)。例如，夹持垫64可包含涂覆有PTFE或一些其他低摩擦材料的钢。作为另一个仅仅例示性的实施例，夹持垫64可包括聚酰亚胺、石墨和PTFE的组合。参考本文中的教导内容，可以用于形成夹持垫64的其他合适材料(以及其组合)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，夹持垫64可基本上是平坦的，或者可包括各种种类的表面特征部。例如，夹持垫64可包括压花纹、以角度间隔的一系列径向延伸的脊(例如，呈星放射状的图案等)、一系列同心的环形脊、十字形交叉的脊和/或各种其他种类的表面特征部。夹持垫64也可以是锥形的。例如，夹持垫64的暴露表面可以是锥形的，由此使得夹持垫64在夹持垫64的内径处具有的厚度大于在夹持垫64的外径处的厚度。作为另一个仅仅例示性的实施例，夹持垫64可以是锥形的，由此使得夹持垫64具有带圆角的等边三角形的横截面轮廓，其中当砧座60与套管针34联接时，峰朝换能器元件70的远侧面72取向。
夹持垫64可根据美国公布No.2006/0079874的一个或多个教导内容进行构造，该公布的公开内容以引用方式并入本文。夹持垫64和/或砧座60的一些其他部分也可包括生物制剂、药剂和/或增加组织的止血和/或愈合的其他物质。参考本文的教导内容，增加组织的止血和/或愈合的各种合适的生物制剂、药剂和/或其他物质对于本领域普通技术人员而言将是显而易见的。相似地，参考本文的教导内容，用于夹持垫64的其他合适的特征部和构型对于本领域普通技术人员而言将是显而易见的。
头部62也包括限定在柄部66和夹持垫64之间的凹陷部68。凹陷部68被构造成能够容纳多余组织，如将在下文中更详细地描述。如在图6A至图6E中最佳所见，柄部66限定经设定尺寸以接收套管针34的孔69。柄部66也包括延伸到柄部66的自由端的多个叶67。叶67被弹性偏压以限定圆筒状构型；但是可向外变形以允许套管针34的插入。一旦套管针34被插入柄部66的孔69中至一定的深度，叶67向内扣合以捕获套管针34，从而在柄部66和套管针34之间提供扣合接合。在一些其他型式中，柄部66包括弹性偏压的保持夹具，其选择性地将柄部66固定到套管针34。在其他型式中，柄部66和/或套管针34可包括倒钩、单向按扣、筒夹、衬圈、突片、带和/或任何其他合适的特征部，其在砧座60和套管针34之间提供可移除的或单向联接。通过进一步的说明，砧座60可根据下列专利的教导内容中的至少一些来与套管针34进行联接：美国专利No.5,205,459；美国专利No.5,271,544；美国专利No.5,275,322；美国专利No.5,285,945；美国专利No.5,292,053；美国专利No.5,333,773；美国专利No.5,350,104；美国专利No.5,533,661；美国公布No.2012/0292372；和/或美国专利申请No.14/033,688，这些专利的公开内容以引用方式并入本文。作为另一个仅仅例示性的实施例，砧座60可经由双头螺栓与套管针34联接。还应当理解，套管针34可包括类似于孔69的特征部，同时柄部66包括类似于末端36的闭合末端。参考本文的教导内容，其中砧座60可与套管针34联接的其他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。
当砧座60与套管针34联接时，夹持垫64的面向近侧的表面和换能器元件70的远侧面72之间的距离限定间隙距离d。如上所述，旋钮26可用于致动套管针致动组件30，其将基于旋钮26旋转的方向调节间隙距离d。一旦间隙距离d置于预定范围之内，触发器组件24可被致动以激活换能器元件70，从而横切和密封被捕获在夹持垫64和换能器元件70的远侧面72之间的组织。为了向操作者提供与间隙距离d相关的视觉反馈，本发明实施例的柄部组件20包括具有特征部的指示器窗口38，所述特征部能够操作以向使用者提供间隙距离d是否在预定范围之内的视觉指示。仅以举例的方式，指示器窗口38可包括相对于固定的标记移动的条(例如，根据美国专利No.5,533,661的教导内容，该专利的公开内容以引用方式并入本文)。另选地，指示器窗口38可包括一个或多个LED、LED屏幕和/或任何其他合适的特征部，其向操作者提供间隙距离d是否在预定范围之内的视觉指示。除此之外或另选地，柄部组件20可包括一个或多个特征部，其提供间隙距离d是否在预定范围之内的可听指示。例如，当间隙距离d在预定范围之内时，声反馈特征部可提供特定音调，音调模式或一些其他可听指示。参考本文的教导内容，其中器械10可向操作者指示间隙距离d在预定范围之内的其他合适的方式对于本领域普通技术人员而言将是显而易见的。
应当理解，对插置在换能器元件70的远侧面72和砧座60的夹持垫64之间的组织进行适当的超声切割和密封可取决于通过远侧面72和夹持垫64作用于该组织上的压力或压缩力的量。应当理解，间隙距离d可与优选的压缩力相关联。另选地，套管针致动轴32的致动可更多地集中于实际的压缩力且更少地集中于距离d。仅以举例的方式，在一些型式中，套管针致动轴32是纵向顺应性的(例如，沿其长度可弹性变形)。套管针致动轴32的顺应性可被选择，以允许通过远侧面72和夹持垫64作用于组织上的压缩力在套管针致动轴32开始拉伸之前达到近似的预定值。一旦压缩力达到近似的预定值，套管针致动轴32就可开始拉伸，由此使得套管针致动轴32通过旋钮26的进一步致动将不显著地增加压缩力。在一些此类型式中，指示器窗口38可提供套管针致动轴32已经拉伸的程度的视觉指示，其可指示通过远侧面72和夹持垫64作用于组织上的压缩力。作为另一个仅仅例示性的实施例，弹性构件(例如，卷簧、弹簧叠堆等)可插置在套管针致动轴32和旋钮26之间。一旦压缩力达到近似的预定值，此种弹性构件就可相似地提供某种程度的拉伸。参考本文的教导内容，其中响应于近似的预定压缩力的实现，器械10可提供一个或多个部件的顺应性的其他合适方法对于本领域普通技术人员而言将是显而易见的。
II.超声吻合器械的示例性操作
图6A至图6F示出其中器械10用于将一个管状组织结构100与另一个管状组织结构110接合的过程。仅以举例的方式，组织结构100、110可包括患者肠道的部分(例如，在结肠内等等)，其中肠道已经被切断以移除肠道的节段，从而使自由端104、114打开。如图6A所示，超声头部组件40已经被插入穿过下部管状组织结构110，由此使得套管针34从管状组织结构110的打开的自由端114突出。砧座60已经被插入穿过上部管状组织结构100，由此使得柄部66从管状组织结构100的打开的自由端104突出。参考本文的教导内容，其中超声头部组件40和砧座60可放置在图6A所示的位置中的各种合适的方式对于本领域普通技术人员而言将是显而易见的。
在超声头部组件40和砧座60已经放置在图6A所示的位置中之后，上部管状组织结构100的打开的自由端104被拉到砧座60的柄部66的一部分之上，如图6B所示。相似地，下部管状组织结构110的打开的自由端114被拉到套管针34的一部分之上，也如图6B所示。然后，缝合线120穿过处于荷包构型的上部管状组织结构100，其中缝合线120被牵拉以抵靠柄部66大体绷紧上部管状组织结构100。缝合线140也穿过处于荷包构型的下部管状组织结构110，其中缝合线140被牵拉以抵靠柄部66大体绷紧下部管状组织结构110。应当理解，该技术仅仅是任选的。参考本文的教导内容，其中上部管状组织结构100可固定到砧座60的各种其他合适的方式，以及其中下部管状组织结构110可固定到超声头部组件40的其他合适的方式对本领域的普通技术人员而言将是显而易见的。
一旦管状组织结构100、110已经分别固定到砧座60和超声头部组件40，套管针34就被插入柄部66的孔69中，直到叶67扣合到套管针34上，如图6C所示。仅以举例的方式，这可通过借助一组常规的组织抓紧器抓持柄部66的暴露部分并且朝套管针34拉动柄部66实现。参考本文中的教导内容，可用于将柄部66和套管针34如图6C所示固定在一起的其他适合技术和器械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，砧座60朝超声头部组件40的移动将朝管状组织结构110拉动管状组织结构100。
在柄部66和套管针34固定在一起的情况下，然后操作者可旋转旋钮26以相对于超声头部组件40使砧座60朝近侧回缩，从而减小夹持垫64和换能器元件70的远侧面72之间的间隙距离d，如图6D所示。如上所述，旋钮26的此旋转经由套管针致动组件30和套管针致动轴32转换成套管针34的回缩。操作者可通过观察指示器窗口38来监视间隙距离d。应当理解，当已经实现期望的间隙距离d时，被捕获在夹持垫64和换能器元件70的远侧面72之间的组织可以处于基本上压缩的状态。如上所述，一旦夹持垫64和换能器元件70的远侧面72之间合适的压缩力已经实现，套管针致动轴32的顺应性特征部(和/或与套管针致动轴32联接的顺应性特征部)就可开始弹性变形。换能器元件70在该阶段也可经受纵向指向的压缩力。还应当理解，位于夹持垫64的内径内部的组织在该阶段可在凹陷部68内聚集。
一旦已经实现期望的间隙距离d和/或压缩力，操作者就可致动触发器组件24，从而利用超声能量激活换能器元件70，如图6E所示。由换能器元件70生成的超声振动将横切和密封被捕获在夹持垫64和远侧面72之间的组织。具体地，在凹陷部68内聚集的组织将从剩下的管状组织结构100、110被横切；并且管状组织结构100、110的相邻的并列组织区域将被密封在一起，从而获得密封的组织层的大体上环形构型。然后操作者可从患者身上移除器械10(例如，经由管状组织结构110的管腔112)，从而留下如图6F所示的密封吻合140。在凹陷部68中横切的组织可借助器械10移除。应当理解，所得的吻合140可为在第一管状组织结构100的管腔102和第二管状组织结构110的管腔112之间的流体连通提供清除路径。还应当理解，在正常的生物过程期间，吻合140可具有足够的结构完整性以耐受将在管状组织结构100、110上/沿管状组织结构100、110/通过管状组织结构100、110传送的力，由此使得穿过管腔102、112和吻合140的内容物将不在吻合140的部位处渗漏。
应当理解，如从图6E到图6F的转变所示，当器械10从患者身上移除时，砧座60可保持与套管针34联接。在一些情况下，在完成图6E所示的阶段之后并且在如图6F所示的移除器械10之前，操作者可在相对的方向上旋转旋钮26，以增加在夹持垫64和换能器元件70的远侧面72之间的间隙距离d。这可有助于在吻合处的组织的释放，其可有利于在不损坏吻合140的情况下移除器械10。
在一些情况下，换能器组件70可在相同的吻合140部位被重复地激活，而无需在激活之间从患者身上移除超声头部组件40。此外，换能器组件70可在患者体内的各种部位被激活，而无需在激活之间从患者身上移除超声头部组件40。因此，应当理解，器械10可比常规的圆形缝合器器械更适合于重复的焙烧。此外，在吻合140完成之后，本发明实施例的器械10不在患者体内留下像缝合器的人造部件。
虽然在图6A至图6F中描绘的并且在上文描述的实施例关于端对端吻合，但是应当理解，器械10也可容易地用于执行侧对侧吻合。参考本文的教导内容，器械10可使用的其他合适方式对于本领域普通技术人员而言将是显而易见的。
III.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、示例等不应视为相对于彼此独立。根据本文的教导内容，其中本文教导内容可进行组合的各种合适的方式将对本领域的普通技术人员是显而易见的。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，据称以引用方式并入本文中的任何专利、出版物或其他公开材料，无论是全文或部分，仅在所并入的材料与本公开中给出的定义、陈述或者其他公开材料不冲突的范围内并入本文。同样地并且在必要的程度下，本申请明确阐述的公开内容取代了以引证方式并入本申请的任何冲突材料。据称以引用方式并入本文但与本文所述的现有定义、陈述或其他公开材料相冲突的任何材料或其部分，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本文。
上文所述装置的型式可应用在由医疗专业人员进行的传统医疗处理和手术中、以及可应用在机器人辅助的医疗处理和手术中。仅以举例的方式，本文的各种教导内容可易于结合到机器人外科系统诸如购自加利福尼亚州桑尼维尔市的直觉外科公司(IntuitiveSurgical,Inc.,of Sunnyvale,California)的DAVINCITM系统中。
上文所述型式可被设计成在单次使用后废弃，或者其可被设计成能够使用多次。在任一种情况下或两种情况下，可修复型式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，然后清洁或更换特定零件以及随后进行重新组装。具体地，可拆卸一些型式的所述装置，并且可选择性地以任何组合型式来更换或移除所述装置的任意数量的特定零件或部分。在清洁和/或更换特定部分时，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前由使用者重新组装以供随后使用。本领域的技术人员将会知道，装置的修复可以利用多种技术进行拆卸、清洁/更换以及重新组装。这些技术的使用和所得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/或之后进行消毒。在一种消毒技术中，将装置放置在闭合且密封的容器中，诸如塑料袋或TYVEK袋。然后可将容器和装置放置在可穿透所述容器的辐射场中，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。经消毒的装置随后可储存在无菌容器中，以供以后使用。还可使用本领域已知的任何其他技术对装置消毒，所述技术包括但不限于β辐射或γ辐射、环氧乙烷或蒸汽。
已经示出和描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，并且其他修改将对本领域的技术人员显而易见。例如，上文所讨论的示例、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所要求的。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细节。

Claims (16)

1.一种超声吻合设备，包括：
(a)主体；
(b)从所述主体朝远侧延伸的轴，其中所述轴具有远侧端部，其中所述轴的所述远侧端部包括罩，其中所述罩包括朝远侧呈现的面；
(c)设置在所述罩内的超声换能器，其中所述超声换能器包括朝远侧呈现的环形面和朝近侧呈现的环形面，其中所述超声换能器的所述朝近侧呈现的环形面抵靠所述罩的所述朝远侧呈现的面，其中所述超声换能器限定中心孔；以及
(d)环形夹持垫，其中所述夹持垫能够朝所述超声换能器的所述朝远侧呈现的环形面移动。
2.根据权利要求1所述的超声吻合设备，其中所述主体包括柄部组件。
3.根据权利要求1所述的超声吻合设备，其中所述轴是弯曲的。
4.根据权利要求1所述的超声吻合设备，其中所述超声换能器具有圆筒状构型。
5.根据权利要求1所述的超声吻合设备，还包括从所述主体通过所述轴延伸到所述超声换能器的一个或多个电导体。
6.根据权利要求1所述的超声吻合设备，其中所述中心孔延伸穿过所述朝远侧呈现的面。
7.根据权利要求6所述的超声吻合设备，还包括延伸穿过所述超声换能器的所述中心孔的细长构件，其中所述细长构件能够操作以选择性地使所述夹持垫朝向和远离所述超声换能器的所述朝远侧呈现的环形面移动。
8.根据权利要求7所述的超声吻合设备，其中所述细长构件包括套管针。
9.根据权利要求7所述的超声吻合设备，还包括砧座，其中所述砧座包括：
(i)头部，其中所述夹持垫固定到所述头部，以及
(ii)从所述头部延伸的柄部，其中所述柄部被构造成能够与所述细长构件联接。
10.根据权利要求9所述的超声吻合设备，其中所述头部限定所述夹持垫内部的凹陷部。
11.根据权利要求1所述的超声吻合设备，其中所述罩被构造成能够使向内指向的压缩作用于所述超声换能器的外部区域上。
12.根据权利要求1所述的超声吻合设备，其中所述罩包括远侧边缘，其中所述朝远侧呈现的环形面与所述远侧边缘齐平。
13.根据权利要求1所述的超声吻合设备，其中所述超声换能器被构造成能够以纵向运动和以径向运动超声地振动。
14.根据权利要求1所述的超声吻合设备，其中所述夹持垫包含被构造成能够增强组织的止血或愈合的物质。
15.根据权利要求1所述的超声吻合设备，还包括能够操作以向所述超声换能器提供电力的发生器，其中所述发生器经由线缆与所述主体联接。
16.一种超声吻合设备，包括：
(a)主体；
(b)从所述主体朝远侧延伸的轴，其中所述轴具有限定内表面的中空远侧端部；
(c)位于所述轴的所述远侧端部处的圆筒状超声换能器，其中所述圆筒状超声换能器包括朝远侧呈现的平坦的环形面；
(d)砧座联接特征部，其中所述砧座联接特征部能够相对于所述圆筒状超声换能器平移；以及
(e)砧座，其中所述砧座被构造成能够与所述砧座联接特征部联接，其中所述砧座包括环形夹持垫，其中所述夹持垫能够朝所述圆筒状超声换能器的所述朝远侧呈现的平坦的环形面移动，以捕获所述夹持垫与所述圆筒状超声换能器的所述朝远侧呈现的平坦的环形面之间的两个解剖结构的组织；
其中所述圆筒状超声换能器被构造成能够切断并固定捕获在所述圆筒状超声换能器的所述朝远侧呈现的平坦的环形面与所述砧座的所述环形夹持垫之间的两个解剖结构之间的吻合。
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