CN102389324B - 手持式手术器械 - Google Patents

手持式手术器械 Download PDF

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CN102389324B
CN102389324B CN201110109030.2A CN201110109030A CN102389324B CN 102389324 B CN102389324 B CN 102389324B CN 201110109030 A CN201110109030 A CN 201110109030A CN 102389324 B CN102389324 B CN 102389324B
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load units
theater instruments
drive motors
operating theater
feedback system
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CN102389324A (zh
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戴维·尼古拉斯
唐纳德·马利诺思卡斯
戴维·泽伊奇勒
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Covidien LP
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/70—Manipulators specially adapted for use in surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00473—Distal part, e.g. tip or head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0814—Preventing re-use

Abstract

本发明提供了一种包括手持式手术器械的手术系统，尤其是包括智能手术器械的手术系统，所述智能手术器械具有支撑在外壳中并且与电源电连接的驱动电机；以及控制电路。控制电路包括反馈系统，所述反馈系统用于监控手术器械在使用期间的状态并且用于在监控到的状态发生改变时改变手术器械的操作参数。所述手术系统包括非智能装载单元，其用于选择性地连接到所述手术器械的外壳上并且其可由所述驱动电机致动，所述装载单元具有第一状态和第二状态。在操作中，所述驱动电机致动所述装载单元从所述第一状态到所述第二状态；以及当所述装载单元达到所述第二状态时，在至少一个监控到的状态中发生变化并且改变所述手术器械的操作参数。

Description

手持式手术器械
相关申请的交叉引用
本申请要求于2010年4月16日提交的、序列号为61/324,919的美国临时申请的利益和优先权，将所述申请的全部内容通过引用合并于此。
技术领域
本公开涉及手术器械和/或系统。更特别地，本公开涉及这样一种手持式手术器械和/或系统：其构造为与用来夹紧、切割和/或缝合组织的可拆卸的可置换(disposable)装载单元和/或单次使用装载单元一起使用。
背景技术
许多手术器械生产商已开发了具有用于操作和/或操纵手术器械的专有驱动系统的生产线。在许多情况下，手术器械包括可重复使用的手柄组件，以及可置换装载单元和/或单次使用装载单元等，所述可置换装载单元和/或单次使用装载单元等在使用前选择性地连接到手柄组件上并且之后在使用后从手柄组件分离以便丢弃或在一些情况中被消毒用于重复使用。
在智能手术器械中，智能可置换装载单元和/或单次使用装载单元包括与布置在智能动力手柄组件中的读取元件通信的识别元件。这样，当智能可置换装载单元和/或单次使用装载单元连接到智能手柄组件上时，智能手柄组件的读取元件与智能可置换装载单元和/或单次使用装载单元的识别元件通信，从而向智能手柄组件指示哪个特定的装载单元连接到其上。一旦识别出连接到手柄组件上的特定装载单元，就可以依照预定值设定用于动力手柄组件的操作参数。
存在对如下系统的需要：当非智能(即不包括识别构件)可置换装载单元和/或单次使用装载单元连接到智能手柄组件时，能够检测所述非智能可置换装载单元和/或单次使用装载单元的特定参数(例如，吻合钉钉仓的长度、吻合钉钉仓已被发射的指示)。
发明内容
本公开涉及手持式手术器械和/或系统，其被构造为与用来夹紧、切割和/或缝合组织的可拆卸的可置换装载单元和/或单次使用装载单元一起使用。
根据本公开的一个方案，提供了用于进行手术操作的手术系统。所述手术系统包括智能手术器械，所述智能手术器械具有：外壳；支撑在外壳中的电源；至少一个驱动电机，其支撑在外壳中并且与电源电连接；以及控制电路，其与电源和至少一个驱动电机接合。控制电路包括反馈系统，所述反馈系统用于监控所述手术器械在使用期间的至少一个状态并且用于在至少一个监控到的状态发生改变时改变手术器械的操作参数。手术系统包括至少一个非智能装载单元，其被构造为选择性连接到手术器械的外壳上并且其可由至少一个驱动电机致动，装载单元至少具有第一状态和第二状态。在手术器械的操作过程中，至少一个驱动电机致动装载单元从第一状态到至少第二状态；以及当装载单元达到第二状态时，在至少一个监控到的状态中发生变化并且改变手术器械的操作参数。
由反馈系统监控的至少一个状态可以是被传送到至少一个驱动电机的电压。反馈系统可以包括与传送到至少一个驱动电机的电压相关的已知量值的电阻器。反馈系统可以计算经过电阻器的电流水平。
当反馈系统判定出经过电阻器的电流水平超过阈值电流水平时可以改变手术器械的操作参数。
装载单元的第二状态可以是其发射行程的末端。
当到达装载单元的发射行程的末端时经过电阻器的电流水平可能超过阈值电流水平。
当反馈系统判定经过电阻器的电流水平超过阈值电流水平时改变的手术器械的操作参数可以是传送到至少一个驱动电机的电压。
改变的手术器械的操作参数可以是传送到至少一个驱动电机的电力。
装载单元的所述第二状态可以是其发射行程的末端。
手术系统可以进一步包括多个非智能装载单元，其中每个装载单元包括不同的单一(unique)第二状态。每个装载单元的第二状态可以对应于每个装载单元的发射行程的不同的单一长度。由反馈系统监控的至少一个状态可以是传送到所述至少一个驱动电机的电压，其中反馈系统可以包括与传送到至少一个驱动电机的电压相关的已知量值的电阻器，并且其中反馈系统可以计算经过电阻器的电流水平，并且其中当反馈系统判定经过电阻器的电流水平超过阈值电流水平时可以改变手术器械的操作参数。
当到达多个装载单元中的任一个的发射行程的末端时经过电阻器的电流水平可以超过阈值电流水平。当反馈系统判定经过电阻器的电流水平超过阈值电流水平时改变的所述手术器械的操作参数可以是传送到至少一个驱动电机的电压。
附图说明
在此参考附图对本公开的实施例进行说明，其中：
图1为支撑转接器组件的示例性智能手术器械和/或手柄组件的后视立体图并且图示了支撑在转接器组件的端部上的示例性装载单元；
图2为图1所示的智能手术器械、转接器组件和装载单元的侧视正视图；
图3为图1和图2的智能手术器械的立体图，图示了连接到其上的转接器组件并且图示了与转接器组件分离的装载单元；
图4为图1至图3的智能手术器械的立体图，图示了与其分离的转接器组件并且图示了与转接器组件分离的装载单元；
图5为根据本公开的实施例的反馈系统的电路图的示意图；
图6为图示了用于操作智能装载单元的智能手术器械的电流随时间变化的正常的工作分布图的图表；以及
图7为图示了用于操作非智能装载单元的智能手术器械的电流随时间变化的工作分布图的图表。
具体实施方式
参照附图对本公开的手术器械的实施例进行详细描述，其中在几幅附图中的每一个中相同的附图标记代表类似或相同的结构元件。如此处所使用的，术语“远侧”表示手术器械或其部件的较远离用户的一部分，而术语“近侧”表示手术器械或其部件的较靠近用户的一部分。
首先参考图1至图4，示出了依照本公开的实施例的手持式动力手术器械并且通常表示为10。为了对示例性手术器械10的结构和操作进行详细说明，可以参考下述申请：于2008年9月22日提交的、国际申请号为PCT/US2008/077249(国际公布号为WO 2009/039506)的国际申请和于2009年11月20日提交的、序列号为12/622,827的美国专利申请，将所述每个申请的全部内容通过引用合并于此。
手术器械10包括外壳，所述外壳具有形成底座的下部12和中间部14，所述中间部14包括数个手指致动的控制按钮17和18以及摇杆装置(rockerdevice)27。下部12被构造为选择性地存储电池等形式的电源(未示出)。中间部14被构造为且适于容纳由电源供电的至少一个驱动电机(未示出)。手术器械10在其中进一步包括控制电路(未示出)，所述控制电路基于在手术器械10的操作之前、之中或之后获得的用户输入和/或反馈来控制手术器械10的操作。
控制按钮17和18以及摇杆装置27位于手术器械10的中间部14的前面位置。控制按钮17和18以及摇杆装置27中的每一个包括通过用户或操作者的致动而移动的相应的磁铁。此外，布置在手术器械10中的电路板(未示出)包括用于控制按钮17和18以及摇杆装置27中的每一个的相应的霍尔效应开关，所述霍尔效应开关通过控制按钮17和18以及摇杆装置27中的磁铁的运动而致动。霍尔效应开关的致动使得电路板向功能选择模块和致动器或输入驱动部件提供适当的信号以致动或操作装载单元20。
手术器械10可以包括至少一个驱动电机、用于为至少一个驱动电机供电的至少一个电源“PS”(见图5)，以及连接到驱动电机的至少一个可旋转驱动轴。
依照本公开，手术器械10包括第一和第二驱动电机，以及分别连接到第一和第二驱动电机上的第一和第二可旋转驱动构件或轴。使用中，当第一驱动电机被致动时，第一驱动电机将使得第一驱动轴沿其轴线在第一或顺时针方向或在第二或逆时针方向上选择性地旋转。此外，当第二驱动电机被致动时，第二驱动电机将使得第二驱动轴沿其轴线在第一或顺时针方向或在第二或逆时针方向上选择性地旋转。
图1至图4示出了与转接器组件100接合的手术器械10，所述转接器组件100被构造为使手术器械10与可置换装载单元(DLU)和/或单次使用装载单元(SULU)(下文中的“装载单元”)相互连接。为了对示例性转接器组件100的结构和操作进行详细说明，可以参考于2010年2月25日提交的、申请序列号为61/308,045的美国临时申请，该申请的全部内容通过引用合并于此。
如图1至图4所示，转接器组件100被构造为且适于使多个装载单元中的任一个与手术器械10相互连接或联接。例如，转接器组件100被构造为且适于可操作地相互连接和联接包括长度为30mm、45mm或60mm的吻合线的胃肠内吻合(endo-gastrointestinal anastomosis)装载单元20。
为了对胃肠内吻合装载单元20的结构和操作进行详细说明，可以参考于2009年1月14日提交的美国专利公开第2009/0145947号，该申请的全部内容通过引用合并于此。
装载单元20包括包含于其中的至少一个可轴向平移的驱动构件，所述可轴向平移的驱动构件被构造为且适于通过使砧座组件和钉仓组件彼此接近或远离来实现打开其钳夹组件和关闭其钳夹组件中的至少一个，并且启动装载单元以排出包含在钉仓组件中的吻合钉以抵抗着砧座组件而成形，并且可能沿吻合线致动刀片。装载单元可以进一步包括包含于其中的被构造为且适于引起其作关节式运动(articulation)的可轴向平移驱动构件。
装载单元20的非智能性在于装载单元20典型地不包括任何传感器等形式的识别构件，所述识别构件与布置在手术器械10中的读取元件相互作用，以用于对读取元件进行识别并且用于识别读取元件的参数(例如，吻合钉钉仓的长度，该吻合钉钉仓已被发射的指示)。
依照本公开，为了让智能手术器械10识别非智能装载单元20的参数，如图5所示，智能手术器械10包括反馈系统，该反馈系统合并到智能手术器械10的第一驱动电机“M”或第二驱动电机“M”的驱动电路或控制电路“CC”或与所述驱动电路或控制电路“CC”相关联。
预期的是，依照本公开的实施例，反馈系统合并了具有约0.05欧姆的非常低的电阻的高容差电阻器(highly toleranced resistor)“R”，该电阻器添加到负责驱动第一驱动电机或第二驱动电机的H电桥的低端(low side)。在操作中，反馈系统测量经过电阻器“R”的电压“V”。通过测量经过电阻器“R”的电压“V”的下降，反馈系统可以使用欧姆定律计算流经电阻器“R”的电流“I”的量：
V＝IR
在诸如第一驱动电机或第二驱动电机的DC电动机中，电流“I”与通过使用例如扭矩常数(Km)的关系式得到的扭矩“τ”的量直接相关。因此，反馈系统根据以下公式计算施加到第一驱动电机或第二驱动电机的扭矩“τ”的量。
τ＝(Km)(I)
通过使手术器械10的传送装置和手术器械10的螺杆传动的缩减量乘以一个系数(factoring)，反馈系统可以确定施加到装载单元20中的发射杆的线性力的量。此外，反馈系统需要确定装载单元20的发射杆的线性位置以便最终确定施加到第一驱动电机或第二驱动电机的扭矩是否对应于装载单元20中装载的吻合钉钉仓的特定长度。预期的是，可以使用光学或磁性编码器、线性可变差动变压器(LVDT)或其它方法来确定发射杆的线性位置。
在手术器械10的正常操作状态中，期望在手术器械10的控制电路中的反馈系统看到特定或预定的力的分布图(profile)，例如电流随时间的分布图(见图6)或电流随距离的分布图(未示出)。在操作中，随着控制电路监控电流“I”，当手术器械10的发射杆位于对应于特定吻合钉钉仓长度(即，30mm、45mm或60mm)的行程末端的线性位置并且控制电路的反馈系统确定了高于预期的电流“I”或电流波峰时(如图7所示)，控制电路可以合理地假定装载单元20的发射滑轨(firing sled)到达了吻合钉钉仓和/或装载单元20的末端或止点。
如图7所示，在装载单元20的发射滑轨到达对应于大约30mm的吻合钉钉仓和/或装载单元20的末端或止点时的位置说明了第一电流波峰“I1”。同样如图7所示，在装载单元20的发射滑轨到达对应于大约45mm的吻合钉钉仓和/或装载单元20的末端或止点时的位置说明了第二电流波峰“I2”。
每个电流波峰“I1”或“I2”超过了电流“I”的预定阈值水平“IT”。电流“I”的预定阈值水平“IT”被选择为使得如果在发射序列期间在30mm的吻合钉钉仓的30mm之前的位置、在45mm的吻合钉钉仓的45mm之前的位置、在60mm的吻合钉钉仓的60mm之前的位置处存在电流“I”的增加，则手术器械10将继续发射直至如上所述达到吻合钉钉仓和/或装载单元20的末端或止点。如果通过装载单元20所作用的组织的路径包括较厚组织的片段、组织类型的变化、之前部署的紧固器等，则在手术器械10的发射过程中可以感觉到电流“I”的过早增加。
附加地或选择性地，手术器械10的控制电路也可以监控电流随时间变化的斜率(dI/dt)或电流随距离变化的斜率(dI/dx)以确定是否已经到达吻合钉钉仓的末端。例如，如果反馈系统判定斜率的上升变得过大，则控制电路也可合理地假定装载单元20的发射滑轨已经到达了吻合钉钉仓和/或装载单元20的末端或止点。
依照本公开，手术器械的控制电路10包括装载单元锁定识别系统，所述装载单元锁定识别系统依照与上述反馈系统相同或相似的原理工作和/或运行。装载单元锁定识别系统用作判定是否已启动或还未启动装载在装载单元20中的吻合钉钉仓的机械锁定。
在使用中，当吻合钉钉仓首次载入装载单元20并且装载单元20首次由手术器械10夹紧时，手术器械10继续向前驱动到比装载单元20的夹紧位置稍微远的位置。如果装载单元锁定识别系统测量到对应于扭矩“τ”的快速增加的电流“I”中的突变峰值，则控制电路的装载单元锁定识别系统判定出到达了装载单元20中的吻合钉钉仓的机械锁定的立即停止点。之后手术器械10可以将信息转发给用户并且控制电路将不允许手术器械10被发射。
如果装载单元锁定识别系统没有测量到电流“I”中的突变峰值，则控制电路的装载单元锁定识别系统推定装载单元20中的吻合钉钉仓的机械锁定还没有被启动。如果装载单元锁定识别系统推定装载单元20中的吻合钉钉仓的机械锁定还没有被启动，则控制电路向手术器械10指示存在未发射的吻合钉钉仓并且手术器械10的操作可以正常继续以发射装载单元20。
应该理解的是，可对本公开的转接器的实施例做出多种改进。因此，上述说明不应理解为限制性的，而仅仅作为实施例的示例。本领域技术人员将预想到在本公开的范围和精神内的其它改进。

Claims (7)

1.一种用于执行手术操作的手术系统，所述手术系统包括：
智能手术器械，其包括：
外壳；
支撑在所述外壳中的电源；
至少一个驱动电机，其支撑在所述外壳中并且与所述电源电连接；以及
控制电路，其与所述电源和所述至少一个驱动电机接合，其中所述控制电路包括反馈系统，所述反馈系统用于监控所述手术器械在使用期间的至少一个状态并且用于在至少一个监控到的状态发生改变时改变所述手术器械的操作参数；以及
多个非智能装载单元，其被构造为选择性地连接到所述手术器械的外壳上并且其分别可由所述至少一个驱动电机致动，其中每个装载单元至少包括第一状态和不同的单一第二状态，每个装载单元的第二状态对应于每个装载单元的发射行程的不同的单一长度；
其中，在所述手术器械的操作过程中，所述至少一个驱动电机致动多个装载单元的被选择装载单元从所述第一状态到至少所述第二状态；以及
其中，当所述被选择的装载单元达到所述第二状态时，在至少一个监控到的状态中发生变化并且改变所述手术器械的操作参数。
2.根据权利要求1所述的手术系统，其中由所述反馈系统监控的至少一个状态是被传送到所述至少一个驱动电机的电压。
3.根据权利要求2所述的手术系统，其中所述反馈系统包括与传送到所述至少一个驱动电机的电压相关的已知量值的电阻器，并且其中所述反馈系统计算经过所述电阻器的电流水平。
4.根据权利要求3所述的手术系统，其中当所述反馈系统判定经过所述电阻器的电流水平超过阈值电流水平时改变所述手术器械的操作参数。
5.根据权利要求1所述的手术系统，其中改变的所述手术器械的所述操作参数是传送到所述至少一个驱动电机的电力。
6.根据权利要求4所述的手术系统，其中在到达多个装载单元中的任一个的发射行程的末端时，经过所述电阻器的所述电流水平超过所述阈值电流水平。
7.根据权利要求6所述的手术系统，其中当所述反馈系统判定出经过所述电阻器的电流水平超过阈值电流水平时所改变的所述手术器械的操作参数是传送到所述至少一个驱动电机的电压。
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US9706981B2 (en) 2017-07-18
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AU2018200975A1 (en) 2018-03-01
AU2016204387A1 (en) 2016-07-14
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EP3058879B1 (en) 2018-09-05
EP2377472A1 (en) 2011-10-19
US20130317486A1 (en) 2013-11-28
CN102389324A (zh) 2012-03-28
AU2011201182B2 (en) 2014-04-24
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US20110253765A1 (en) 2011-10-20
US20200253591A1 (en) 2020-08-13
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US8517241B2 (en) 2013-08-27
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AU2014204542B2 (en) 2016-05-19
JP2011224368A (ja) 2011-11-10

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