CN102648864A - 受控组织压缩系统及方法 - Google Patents
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Abstract
本公开提供了一种外科装置，尤其提供了一种受控组织压缩系统及方法。所述外科装置包括：末端执行器，其被配置为夹紧、缝合或切割组织；电机，其被配置为驱动所述末端执行器；以及控制系统。该控制系统被配置为接收关于至少一个组织特性的信息并且基于至少一个组织特性来选择组织管理模式，该控制系统基于选择出的组织管理模式来控制电机。
Description
相关申请的交叉引用
本申请要求于2011年2月23日提交的序列号为61/445,700的美国临时专利申请的权益和优先权，该专利申请的全部内容通过引用合并于此。
技术领域
本公开大致地涉及医疗装置。更特别地，本公开大致地涉及用于受控组织压缩的系统和方法。
背景技术
一些外科操作要求对患者组织的压缩，例如夹紧。所述操作可能包括如组织的吻合、缝合和切除。例如，在患者的肠胃道中被判定有癌组织的情况下，该癌组织可能需要被外科去除。例如，在癌组织位于结肠上并且可通过外科器械来接近的情况下，外科医生可以在患者的腹部开一切口从而允许进入肠中。然后外科医生可以利用线性切割和缝合装置在待去除的癌性部分的相反侧切割和缝合结肠组织，该装置如于2008年9月22日提交的序列号为12/235,362的美国专利申请(公开号为2009/0101692的美国专利)中所描述的，该专利申请的全部内容通过引用合并于此。在该操作中，结肠被外部夹紧(例如，在对置钳夹之间)从而压缩组织。当组织被压缩时，切割器和缝合器被用于开一线性切口并且典型地在邻近该切口的区域施加两直排缝合钉。该缝合于是使待去除的肠的部分的两个开口端闭合，并且提供了肠的两个切口端的临时闭合。该闭合限制了使周围组织暴露在肠的内部下，因此限制了感染的风险。在切割和缝合操作之后，可以使组织的癌性部分从患者的身体中去除。
在切除癌组织之后，外科医生可以利用吻合和缝合装置例如圆形缝合器/切割器，如于2004年2月24日提交的序列号为10/785,682的美国专利申请(第7,342,983号美国专利)中所描述的，该专利申请的全部内容通过引用结合于此。在该操作期间，头部定位在邻近其中一个切口端的结肠内并且基座部或轴部定位在邻近另一个切口端的结肠内。该头部和基座部可以经由轴和/或线绳联接，该轴和/或线绳从其中一个切口端延伸出并且进入另一个切口端。经由该联接，外科医生能够致动吻合和缝合装置从而将头部和基座部一起牵引。在结肠的两个切口端相互接触之后，致动继续，使得该结肠的两个部分在环形接触区域被夹紧在一起。在夹紧的同时，吻合和缝合装置可以进一步被致动从而将环形缝合钉施加到压缩组织中。该装置也可以切割布置在结肠内的多余的组织。然后头部和基座部运动分开并且吻合和缝合装置被从患者移开。
为了在上述操作中实现有效的缝合，组织必须被压缩到这样的程度即在工具面之间具有足够小的组织间隙，例如1mm。如果器械的夹紧结构受到过大的力，则横跨待缝合的组织的长度维持均匀的目标组织间隙可能是困难的或者甚至是不可能的。
此外，当执行压缩时，恒定的闭合速度(例如线性缝合器的钳夹之间的闭合速度或者圆形缝合器/切割器的头部和基座部之间的闭合速度)可能将高强度的压力施加在被夹紧组织上。该高强度的压力可能导致额外的组织创伤。因此期望限制这种创伤，例如通过有效地控制施加到组织上的压力来限制。
进一步地，期望确定待夹紧的组织对压缩如何反应并且处理该信息从而确定夹紧压力。于2000年2月22日提交的序列号为09/510,927的美国专利申请(现为第6,716,233号美国专利)描述了使用组织传感器来控制外科缝合器的操作的设备和方法，该专利申请的全部内容通过引用清楚地合并于此。
发明内容
在本公开的一个实施例中，提供了一种外科装置。该外科装置包括：末端执行器，其被配置为夹紧、缝合或切割组织；电机，其被配置为驱动所述末端执行器；以及控制系统。该控制系统接收关于至少一个组织特性的信息并且基于至少一个组织特性来选择组织管理模式。该控制系统基于选择出的组织管理模式来控制电机。
该外科装置还可以包括：指示器，其向临床医师提供末端执行器的组织间隙范围的状况；以及传感器阵列，其被配置为检测至少一个组织特性。该传感器阵列可以通过测量电机上的牵引电流或末端执行器处的驻留效应(dwell effect)来检测组织特性。该传感器阵列还可以通过采取措施如脉搏血氧饱和度、组织氧饱和度或组织阻抗来评估组织特性。当钳夹保持静压力一定时期时，会发生驻留效应并且流体从组织细胞逸出，允许该组织舒张。
外科装置可选择的组织管理模式包括恒定转矩形式、调制转矩形式、最大转矩形式或人控模式。在恒定转矩形式下，控制系统将恒定信号施加于所述电机，或者在调制转矩形式下，控制系统将周期性信号施加于所述电机。在最大转矩形式下，动力外科器械以比在恒定转矩形式、调制转矩形式或人控模式下的发射速度快的速度发射。在人控模式下，用户人工地控制电机。典型地，在组织夹紧期间的压力将是电机转矩的函数。
在本公开的另一个实施例中，提供了一种通过动力外科器械来施加缝合钉的方法。该方法包括如下步骤：提供具有由电机提供动力的末端执行器的外科器械；输入组织类型和/或疾病类型以确定初始夹紧或组织管理模式；使用由电机驱动的末端执行器来夹紧组织；检测被夹紧组织的至少一个组织特性；判定末端执行器是否实现了期望的组织间隙范围；在必要时，选择额外的夹紧模式以反复地调节夹紧从而实现期望的组织间隙；以及在已经实现了期望的组织间隙时，使动力外科器械发射从而将缝合钉施加于被夹紧组织。
该方法还可以进一步包括如下步骤：提供对组织间隙范围的状况的指示。可以通过测量电机上的牵引电流或者测量末端执行器处的驻留效应来检测组织特性。
选择夹紧或者组织管理模式可以是基于检测到的被夹紧组织的组织特性或者可以由临床医师执行。外科装置可以选择的组织管理模式包括恒定转矩形式、调制转矩形式、最大转矩形式或人控模式。人控模式可以允许用户选择组织管理模式。
附图说明
当结合附图时，依据下面详细的描述，本公开的上述和其它的方案、特征和优点将会变得更加显而易见，其中：
图1是根据本公开的一个实施例的动力外科器械的立体图；
图2是根据本公开的一个实施例的动力外科器械的系统框图；
图3是示出根据本公开的一个实施例的动力外科器械的操作的流程图；以及
图4是示出根据本公开的一个实施例的指示器系统的流程图。
具体实施方式
在下文中结合附图对本公开的特定实施例进行描述；然而，应当理解的是，所公开的实施例仅是本公开的示例并且可以以各种形式具体化。不再详细描述已知的功能或构造从而避免不必要的细节使本公开难以理解。这里公开的特定的结构性和功能性细节不被解释为限制，而仅是作为权利要求的基准并且作为用于教导本领域的技术人员将本公开不同地用于实际上任何适当的详细结构中的代表性基准。
在整个附图描述中，相同的附图标记可表示相似或相同的元件。如附图所示以及下面整个描述所述的，当涉及到外科器械上的相对定位时，作为惯例，术语“近侧”是指设备的较接近用户的一端，而术语“远侧”是指设备的较远离用户的一端。术语“临床医师”是指执行包括这里描述的实施例的使用的任何医疗职业(例如，医师、外科医生、护士等)。
根据本公开的动力外科器械如外科缝合器在附图中被称为附图标记100。动力外科器械100仅是利用这里描述的本公开的实施例的外科器械的示例，因此动力外科器械100不旨在将本公开限制于外科器械的这一个特定实施例。
首先结合图1，动力外科器械100包括壳体或手柄110；限定了纵轴线A-A的内窥镜部140，纵轴线A-A延伸通过内窥镜部140；以及限定了纵轴线B-B(在图1中示出为基本上与轴线A-A对齐)的末端执行器160，纵轴线B-B延伸通过末端执行器160。内窥镜部140自壳体110向远侧延伸，并且夹紧机构或末端执行器160邻近内窥镜部140的远侧部142布置。末端执行器160用于夹紧、缝合和/或切割布置在其间的组织。
动力外科器械100可以包括在图2中大体标示为200的控制系统。控制系统200可以被集成在动力外科器械100的壳体110中或者一些部件可以设置在独立单元中。控制系统200包括处理器202、输入装置204、显示器206、存储器208、指示器210、电机212以及传感器阵列214。
处理器202可以是集成电路或者可以包括如下的模拟和/或逻辑电路，该电路可以用于：根据由输入装置204或传感器阵列214提供的输入执行指令；根据存储器208中设置的程序执行指令；和/或控制电机212从而控制末端执行器160以夹紧、缝合和/或切割其间的组织。
输入装置204可以包括用于控制动力外科器械100的操作的键盘、触摸屏输入装置、开关和/或按钮。输入装置204可以用于：在组织管理模式之间进行选择；控制末端执行器160；施加缝合钉或夹具；以及输入组织特性如组织类型和/疾病。
显示器206可以包括液晶显示器、发光二极管显示器等。显示器206可以输出动力外科器械的状况、测量出的组织特性、施加的缝合钉/夹子的数目等。
控制系统200还可以包括指示器210，指示器210可以包括至少一个发光二极管(LED)，指示器210用于指示是否已经满足在末端执行器160的钳夹之间的组织间隙范围。指示器210可以包括单一的多色LED，或者包括红色、黄色和绿色的单独的LED。红色LED可以指示故障，黄色LED可以指示还未满足组织间隙范围，而绿色LED可以指示已经满足组织间隙范围。另外，LED可以是脉动的以指示额外的信息。例如，脉冲黄色LED能够指示正在执行额外的夹紧周期。
传感器阵列214通过检测电机212上的牵引电流或在末端执行器160处的驻留效应来确定组织特性。检测到的组织特性用于确定夹紧或组织管理模式、组织间隙范围、发射参数、电机速度、电机的调制/脉冲、缝合钉的部署等。组织特性用作对夹紧压力的反复调节和组织管理模式的持续时间的输入。
存储器208可以是易失型存储器(例如随机存取存储器)和/或非易失型存储器(例如，闪存介质、磁盘介质等)，该存储器用于存储动力外科器械100的操作指令的程序或设定。
这些程序包括多种组织管理模式，该组织管理模式可以用于夹紧组织以便将缝合钉或夹子施加于由末端执行器160夹紧的组织。选择组织管理模式从而通过改变组织的压缩来将无损伤的应力或应变施加于组织。组织管理模式包括恒定转矩形式、调制转矩形式、最大转矩形式和人控模式。可以基于检测到的组织参数和/或由临床医师输入的组织类型和疾病类型来自动地选择组织管理模式，或者可以由临床医师来选择组织管理模式。
当选择恒定转矩形式时，动力外科器械100在夹紧、驻留和发射阶段利用受控的组织压缩通过将来自处理器202的恒定信号施加于电机212而在组织发生应变时施加恒定速率，以优化组织间隙和缝合钉成型。在恒定转矩形式下用于控制电机212和/或末端执行器160的参数可以是基于外科器械100的期望的发射速度或由末端执行器160夹持的组织的类型。
调制转矩形式通过将周期性信号施加于电机212从而将脉冲性或周期性的应变能量施加于组织。更特别地，处理器202将脉宽调制(PWM)信号或任何其它的周期性信号施加于电机从而在最小组织损伤(最小应力)的情况下实现优化的压缩形式，即最小组织间隙(最大应变)。优化的压缩形式可以因不同的组织类型和/疾病类型而改变。来自处理器202的信号可以被预先确定并存储在存储器中。可选择地，由处理器202输出的信号可以通过对由电机检测到的电流、初始组织厚度T0、初始被夹紧组织厚度T1以及总应变/能量执行电流梯度分析而被确定。
当为了在最大转矩形式下操作而设定组织管理模式时，外科器械100相对其它操作模式更快地发射。当在最大转矩形式下时，外科器械100在行程开始和结束时相对更快地发射，其中装置应力相对小。当组织管理模式被设定为在人控模式下工作时，临床医师能够人工地控制外科器械100的电机从而实现末端执行器160的期望的组织间隙并且人工地使外科器械100发射。
存储器208还可以存储使组织类型和疾病类型与需要的组织间隙范围和发射参数相关联的相关表，发射参数需要被实现从而成功地将缝合钉或夹子施加于组织。
图3示出了描述动力外科器械100的控制系统200的操作的流程图。如图3所示，在步骤300中，临床医师开始“加电”或“打开”动力外科器械100。在步骤305中，临床医师使用输入装置204来输入组织类型和/或疾病类型。然后，临床医师将末端执行器160定位到期望的组织上并且确定初始夹紧(组织管理)模式。然后，在步骤315中，末端执行器160夹紧期望的组织，并且在步骤320中确定组织特性，如初始厚度、密度、初始夹紧厚度等。然后，在步骤325中，处理器202判定对于特定的组织类型是否满足组织间隙范围。如果满足间隙范围，则控制系统200进行到步骤370。
在步骤325中，如果未满足间隙范围，则通过处理器202来评估组织间隙和组织特性从而判定额外的夹紧是否是有利的。如果判定出是有利的，则在步骤327中使用间隙范围和组织特性以确定新的夹紧模式。然后，反复的夹紧和评估处理返回到步骤315并且一直进行直到满足优化的间隙范围，或者判定出组织不适合于选择的范围，在该情况下，动力外科器械100向临床医师提出这样的建议：是否应该使用不同的重装物(reload)或末端执行器(装载有不同尺寸的缝合钉)。如果临床医师选择不同的重装物或末端执行器，则随后在步骤340中重新装载动力外科器械100并且进行到步骤315而夹紧组织。
如果临床医师未选择不同的重装物或末端执行器，则临床医师可以在步骤345中选择人控模式。如果用户选择人控模式，则在步骤350中将动力外科器械100置于人控模式下。
可选择地，处理进行到步骤355以选择组织管理模式。可以由处理器202基于输入的组织类型、疾病类型和/或组织特性自动地选择组织管理模式，或者可以由临床医师来选择组织管理模式。基于组织管理模式的选择，动力外科器械100可以输入步骤362的恒定转矩形式、步骤364的调制转矩形式或步骤366的最大转矩形式。然后控制系统200进行到步骤370，其中，进行关于是否应该施加缝合钉的判定。该判定可以由处理器202或者临床医师做出。如果应该施加缝合钉，则随后在步骤375中，控制系统200控制动力外科器械100以施加缝合钉。如果不施加缝合钉，则控制系统200结束操作(步骤380)或者重新开始施加下一个缝合钉(步骤300)。
图4示出了描述动力外科器械100的指示器系统的操作的流程图。在步骤400中动力外科器械100被启动，并且在步骤405中输入组织类型和/或疾病类型。然后处理器202使用存储在存储器208中的其中一个相关表从而确定用于红黄绿指示器210的组织间隙范围。在步骤415中测量组织间隙范围。如果判定出有错误或者组织间隙范围超出上限，则处理进行到步骤430并且红色指示器发亮。如果没有错误或者组织间隙范围未超出上限，则处理进行到步骤435。如果组织间隙范围不在可接受的范围内但是并未超出上限，则在步骤440中黄色指示器发亮。如果满足组织间隙范围，则处理进行到步骤445并且绿色指示器发亮。
应当理解的是，前面的描述只是本公开的示例。本领域的技术人员能够在不偏离本公开的情况下设想出各种替代方案和改进。因此，本公开意图包含所有的这些替代方案、改进和变化。结合附图所描述的实施例仅用于举例说明本公开的特定示例。与上文和/或在附属权利要求中描述的元件、步骤、方法和技术无实质不同的其它的元件、步骤、方法和技术也被意图包含在本公开的范围内。
Claims (18)
1.一种外科装置，包括：
末端执行器，其被配置为夹紧、缝合或切割组织；
电机，其被配置为驱动所述末端执行器；以及
控制系统，其被配置为：
接收关于至少一个组织特性的信息；
基于所述至少一个组织特性来选择组织管理模式；以及
基于选择出的组织管理模式来控制电机。
2.根据权利要求1所述的外科装置，其中，所述控制系统进一步包括指示器，所述指示器向临床医师提供所述末端执行器的组织间隙范围的状况。
3.根据权利要求1所述的外科装置，其中，所述控制系统进一步包括传感器阵列，所述传感器阵列被配置为检测至少一个组织特性。
4.根据权利要求3所述的外科装置，其中，所述传感器阵列通过测量电机上的牵引电流来检测组织特性。
5.根据权利要求3所述的外科装置，其中，所述传感器阵列通过测量所述末端执行器处的驻留效应来检测组织特性。
6.根据权利要求1所述的外科装置，其中，所述组织管理模式是恒定转矩形式、调制转矩形式、最大转矩形式或人控模式。
7.根据权利要求6所述的外科装置，其中，在所述恒定转矩形式下，所述控制系统将恒定信号施加于所述电机。
8.根据权利要求6所述的外科装置，其中，在所述调制转矩形式下，所述控制系统将周期性信号施加于所述电机。
9.根据权利要求6所述的外科装置，其中，当动力外科器械使用最大转矩形式时，所述动力外科器械以比在所述恒定转矩形式、所述调制转矩形式或所述人控模式下的发射速度快的速度发射。
10.根据权利要求6所述的外科装置，其中，在所述人控模式下，用户人工地控制所述电机。
11.一种通过动力外科器械来施加缝合钉的方法，所述方法包括如下步骤：
提供具有由电机提供动力的末端执行器的外科器械；
输入组织类型和/或疾病类型；
使用由所述电机驱动的所述末端执行器来夹紧组织；
检测被夹紧组织的至少一个组织特性；
判定所述末端执行器是否实现了期望的组织间隙范围；
选择组织管理模式以夹紧组织从而实现期望的组织间隙；以及
在选择出的管理模式下使所述动力外科器械发射，从而将缝合钉施加于被夹紧组织。
12.根据权利要求11所述的方法，所述方法进一步包括如下步骤：提供对组织间隙范围的状况的指示。
13.根据权利要求11所述的方法，其中，检测至少一个组织特性的步骤进一步包括测量电机上的牵引电流。
14.根据权利要求11所述的方法，其中，检测至少一个组织特性的步骤进一步包括测量所述末端执行器处的驻留效应。
15.根据权利要求11所述的方法，其中，选择组织管理模式的步骤是基于检测到的被夹紧组织的至少一个组织特性。
16.根据权利要求11所述的方法，其中，选择组织管理模式的步骤由临床医师执行。
17.根据权利要求11所述的方法，其中，所述组织管理模式是恒定转矩形式、调制转矩形式、最大转矩形式或人控模式。
18.根据权利要求11所述的方法，进一步包括如下步骤：当未实现用于所述末端执行器的期望的组织间隙范围时，所述动力外科器械建议不同的重载物。
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- 2012-02-22 CN CN2012100420634A patent/CN102648864A/zh active Pending
- 2012-02-22 EP EP12156454A patent/EP2491872A1/en not_active Withdrawn
-
2017
- 2017-12-01 US US15/828,895 patent/US10278698B2/en active Active
-
2019
- 2019-05-06 US US16/403,700 patent/US11399830B2/en active Active
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| US11141152B2 (en) | 2012-10-18 | 2021-10-12 | Covidien Lp | Loading unit velocity and position feedback |
| CN103767748B (zh) * | 2012-10-18 | 2017-12-22 | 柯惠Lp公司 | 装载单元速度和位置反馈 |
| US10201347B2 (en) | 2012-10-18 | 2019-02-12 | Covidien Lp | Loading unit velocity and position feedback |
| CN103767748A (zh) * | 2012-10-18 | 2014-05-07 | 柯惠Lp公司 | 装载单元速度和位置反馈 |
| CN110063795A (zh) * | 2014-02-14 | 2019-07-30 | 柯惠Lp公司 | 止端检测 |
| CN110063795B (zh) * | 2014-02-14 | 2022-05-31 | 柯惠Lp公司 | 止端检测 |
| CN107530077A (zh) * | 2015-03-06 | 2018-01-02 | 伊西康有限责任公司 | 用于调整多种组织类型的闭合速率的自适应组织压缩技术 |
| CN107530077B (zh) * | 2015-03-06 | 2020-12-18 | 伊西康有限责任公司 | 用于调整多种组织类型的闭合速率的自适应组织压缩技术 |
| CN109310424B (zh) * | 2016-04-15 | 2021-11-19 | 伊西康有限责任公司 | 具有可配置操作模式的模块化外科器械 |
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| US12029422B2 (en) | 2018-11-28 | 2024-07-09 | Covidien Lp | Surgical stapler adapter with flexible cable assembly, flexible fingers, and contact clips |
| US11723664B2 (en) | 2019-02-04 | 2023-08-15 | Covidien Lp | Programmable distal tilt position of end effector for powered surgical devices |
| US11202635B2 (en) | 2019-02-04 | 2021-12-21 | Covidien Lp | Programmable distal tilt position of end effector for powered surgical devices |
| US11950783B2 (en) | 2019-02-06 | 2024-04-09 | Covidien Lp | End effector force measurement with digital drive circuit |
| US11376006B2 (en) | 2019-02-06 | 2022-07-05 | Covidien Lp | End effector force measurement with digital drive circuit |
| US11219461B2 (en) | 2019-03-08 | 2022-01-11 | Covidien Lp | Strain gauge stabilization in a surgical device |
| WO2021078196A1 (zh) * | 2019-10-23 | 2021-04-29 | 苏州英途康医疗科技有限公司 | 外科手术装置及其检测方法 |
| US11458244B2 (en) | 2020-02-07 | 2022-10-04 | Covidien Lp | Irrigating surgical apparatus with positive pressure fluid |
| US11553913B2 (en) | 2020-02-11 | 2023-01-17 | Covidien Lp | Electrically-determining tissue cut with surgical stapling apparatus |
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| US11622768B2 (en) | 2020-07-13 | 2023-04-11 | Covidien Lp | Methods and structure for confirming proper assembly of powered surgical stapling systems |
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| US11832823B2 (en) | 2022-02-08 | 2023-12-05 | Covidien Lp | Determination of anvil release during anastomosis |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2012170820A (ja) | 2012-09-10 |
| US20180085121A1 (en) | 2018-03-29 |
| US20120211542A1 (en) | 2012-08-23 |
| US20190254663A1 (en) | 2019-08-22 |
| AU2012200317A1 (en) | 2012-09-06 |
| US11399830B2 (en) | 2022-08-02 |
| CA2765623A1 (en) | 2012-08-23 |
| US10278698B2 (en) | 2019-05-07 |
| EP2491872A1 (en) | 2012-08-29 |
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