CN101869495A - 用于控制组织压缩的装置及方法 - Google Patents

用于控制组织压缩的装置及方法 Download PDF

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CN101869495A
CN101869495A CN201010159641A CN201010159641A CN101869495A CN 101869495 A CN101869495 A CN 101869495A CN 201010159641 A CN201010159641 A CN 201010159641A CN 201010159641 A CN201010159641 A CN 201010159641A CN 101869495 A CN101869495 A CN 101869495A
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CN101869495B (zh
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迈克尔·P·惠特曼
唐纳德·马利诺思卡斯
戴维·A·泽伊奇勒
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Abstract

本发明公开了一种用于控制组织的压缩的方法及装置。所述方法及装置包括：通过利用电动机朝向第一夹紧构件与第二夹紧构件之间的预定组织间隙驱动至少一个夹紧构件，夹紧所述第一夹紧构件与所述第二夹紧构件之间的组织；以及在所述夹紧期间，监测所述电动机的指示由所述夹紧构件施加到所述组织上的夹紧力的参数。所述方法及装置包括在所述夹紧期间，基于监测到的所述参数来控制所述电动机，以将所述夹紧力限制到预定最大极限。

Description

用于控制组织压缩的装置及方法
技术领域
本发明通常涉及医疗装置。更具体地，本发明涉及一种用于控制组织压缩的装置及方法。
背景技术
某些手术程序需要压缩例如夹紧患者组织。这种程序可以包括例如组织的吻合、缝合和切除。例如，在患者的胃肠道中确定有癌组织的情况下，可能需要对癌组织进行手术去除。在例如癌组织位于结肠上并且可通过手术器械来接近的情况下，外科医生可以在患者腹部开一切口以允许进入肠。之后，外科医生可以利用诸如在序列号为12/235,362的美国专利申请(其全部内容通过引用合并于此)中描述的线性切割和吻合装置，从而在待去除的癌部分的两侧切割和吻合结肠组织。在所述程序中，在外部(例如，在对置的钳口之间)夹紧结肠以压缩组织。在压缩组织的同时，激活切割器和吻合器以开一线性切口并在邻近切口的区域中典型地施加两直排吻合钉。这样，吻合使待去除的肠部分的两个开口端闭合，并且提供了肠的两个切割端的临时闭合。所述闭合限制了使周围组织暴露在肠的内部下，从而限制了感染的危险。在切割和吻合程序之后，可以使组织的癌部分从患者身体中去除。
在切除癌组织之后，外科医生可以采用吻合和缝合装置，例如，诸如在序列号为10/785,682的美国专利申请(其全部内容通过引用合并于此)中描述的圆形吻合器/切割器。在所述程序期间，头部邻近其中一个切割端位于结肠内并且基座部或轴部位于邻近另一切割端位于结肠内。头部和基座部可以经由从一个切割端延伸出并且延伸入另一切割端中的轴和/或缆索而结合。经由所述结合，外科医生能够致动所述吻合和缝合装置以一起拉动头部和基座部。在结肠的两个切割端彼此接触之后，致动继续，使得结肠的两个部分在环形的接触区域处夹紧在一起。在夹紧的同时，可以进一步致动吻合和缝合装置，以将环形吻合钉施加到压缩组织中。所述装置还可以切割布置在结肠内的多余组织。之后，将头部和基座部移开并且将吻合和缝合装置从患者中去除。
为了在以上程序中实现有效的吻合，必须使组织压缩到这样的程度：在工具的表面之间存在足够小的组织间隙，例如一毫米。如果使器械的夹紧结构受到足够的力，则横跨待吻合的组织长度保持均匀的目标组织间隙可能是困难的以至是不可能的。例如，在夹紧结构为线性吻合器的悬臂式钳口的情况下，钳口可能在高的夹紧力下彼此向外张开。在其中一个或两个钳口均以该方式张开的情况下，组织间隙朝向钳口的远端典型地增大。在所述组织间隙超过可接受范围的情况下，吻合钉可能不足以闭合组织以防止污染。这可能是由例如初始吻合间隙过大引起的，和/或由不适当的成形引起的吻合钉的故障(例如，与经吻合组织的一个或多个部分分离)引起的，所述不适当的成形是由例如吻合钉推动器与闭合吻合钉的砧座之间的间隙过大引起的。
这些吻合程序的问题可能导致组织的污染(例如，邻近具有肠容量的肠的组织的污染)，这可能促成感染和/或败血症。这些吻合程序的问题还可能导致例如吻合的失败(例如，在吻合组织分离的情况下)和/或由不适当的组织闭合引起的过量出血。而且，这些问题可能需要额外且重复和/或延长的手术并且具有与其相关的任何增大的危险性。如由美国食品和药品管理局所报告的(参见于2004年7月21日最新更新的http://www.fda.gov/cdrh/surgicalstapler/other_data.html的“Surgical StaplerInformation”、“Other Data”)，感染、败血症、吻合失败和出血是吻合程序中出现的主要问题并且可能会导致某些患者重伤以至死亡。因此，希望使这些问题最小化。
而且，当执行压缩时，恒定的闭合速度(例如，线性吻合器的钳口之间或环形吻合器/切割器的头部与基座部之间的闭合速度)可能将高水平的功率(power)施加到受夹组织中。所述高水平的功率可能导致过大的组织外伤。因此，希望例如通过有效地控制施加到组织上的功率来限制所述外伤。此外，希望判定待夹紧的组织是否是可压缩的。
公开号为2009/0057369的美国申请描述了一种通过容纳在砧座颈部中的线性力开关(linear force switch)来应用连续测量的装置。校准所述开关以在施加给定载荷时启动。所述给定载荷设定为对应于在能够发生吻合之前待施加到特定组织上的期望压力。使所述开关与处理器相互配合提供了仅在压缩范围内的吻合钉的发射。这些装置和控制方法不允许连续闭合受压缩组织或对进入受压缩组织的功率进行连续的监测。
此外，希望以简单且可靠的方式来监测和追踪夹紧构件中的结构疲劳。
还希望以简单且可靠地方式来识别适当的吻合钉发射。
发明内容
本发明的示范性实施例提供了一种用于控制组织压缩的装置及方法。
根据本发明的一个示范性实施例，一种方法，包括：通过利用电动机朝向第一夹紧构件与第二夹紧构件之间的预定组织间隙驱动至少一个夹紧构件，夹紧所述第一夹紧构件与所述第二夹紧构件之间的组织。所述方法还包括在所述夹紧期间，监测所述电动机的指示由所述夹紧构件施加到所述组织上的夹紧力的参数。所述方法还包括在所述夹紧期间，基于监测到的所述参数来控制所述电动机，以将所述夹紧力限制到预定最大极限。
可以基于待夹紧的所述组织的预定性质来选择所述预定最大极限。
可以选择所述预定最大极限，以将受夹组织的外伤限制到预定的可接受水平。
所述预定最大极限可以低于所述至少一个夹紧构件的预定挠度极限。
所述控制可以包括调节施加到所述电动机上的电压。所述控制可以包括例如将驱动所述电动机的电流限制到预定最大值。
所述监测可以包括测量驱动所述电动机的电流。
所述方法可以包括：在所述夹紧之前，测量由与移动所述夹紧构件相关的摩擦损耗引起的电流；以及从在所述夹紧期间测量到的电流中减去所述摩擦损耗。
所述方法可以包括在所述夹紧之前，测量电流偏移。
所述方法可以包括从在所述夹紧期间测量到的电流中减去所述电流偏移。
可以选择所述预定最大极限，以防止所述力达到屈服力。
可以选择所述预定最大极限，以防止所述夹紧构件张开。
所述方法可以包括利用监测到的所述参数的分布来监测和追踪至少一个夹紧构件中的结构疲劳。可以将所述分布与正常参数特征相比较。
手术器械可以是手术吻合器并且其中一个夹紧构件是设置为成形手术吻合钉的砧座。
所述方法可以包括利用监测到的所述参数的分布来识别是否已经发射出吻合钉钉仓中的所有吻合钉。
所述方法可以包括利用监测到的所述参数的分布来确定至少一个吻合钉发射失败、吻合钉钉仓中不存在吻合钉和吻合钉卡住中的至少一个。
所述控制可以包括：例如，确定电动机速度；确定电动机位置；以及通过减去电流偏移和由摩擦损耗引起的电流来确定归因于压缩的净电动机电流。所述控制还可以包括：基于确定出的所述速度来确定速度驱动力(velocitydrive)；基于确定出的所述位置来确定位置驱动力(position drive)；以及基于确定出的所述净电动机电流来确定电流驱动力(current drive)。所述控制还可以包括向所述电动机施加所述速度驱动力、所述位置驱动力和所述电流驱动力中最小的一个。
所述方法可以包括基于所述电动机速度来检测不可压缩目标物的存在。
所述控制可以包括调节所述电动机的驱动速度，以将所述夹紧力限制到所述预定最大极限。
根据本发明的一个示范性实施例，一种手术装置，包括：第一夹紧构件；第二夹紧构件；电动机，其构造为朝向所述夹紧构件之间的预定组织间隙驱动所述第一夹紧构件和所述第二夹紧构件中的至少一个夹紧构件。所述装置还包括控制系统，所述控制系统构造为监测所述电动机的指示由所述夹紧构件施加到所述组织上的夹紧力的参数，以及基于监测到的所述参数来控制所述电动机，以将所述夹紧力限制到预定最大极限。
可以基于待夹紧的所述组织的预定性质来选择所述预定最大极限。
可以选择所述预定最大极限，以将受夹组织的外伤限制到预定的可接受水平。
所述预定最大极限可以低于所述至少一个夹紧构件的预定挠度极限。
所述手术装置可以设置为(a)线性手术吻合器、(b)圆形手术吻合器和(c)直角线性切割器中的至少一个。应当意识到的是，所述手术装置可以设置为包括夹紧部件的手术装置，所述夹紧部件包括吻合钉、结扎器等。
所述手术装置可以包括：电流传感器，其确定驱动所述电动机的电流；速度传感器，其确定所述电动机的转速；以及位置传感器，其确定所述电动机的输出位置和所述第一夹紧构件与所述第二夹紧构件的相对位置中的至少一个。
所述控制系统可以适于通过调节所述电动机的驱动速度来控制所述电动机，以将所述夹紧力限制到所述预定最大极限。
根据本发明的一个示范性实施例，一种手术装置，其构造为监测电动机的指示施加到正被夹紧的组织上的夹紧力的参数，控制所述电动机以判定夹紧力是否达到了预定最大极限并且限制所述电动机的所述参数，以及监测所述夹紧力以判定所述夹紧力的变化并且允许在施加到组织上的所述夹紧力已经下降到所述预定最大极限以下时重新激活所述电动机。
根据本发明的一个示范性实施例，一种手术装置，其构造为控制第一夹紧构件和第二夹紧构件朝向预定组织间隙的压缩力，并且当达到所述组织间隙时，配置(deploy)组织紧固件、能量和粘性流体中的至少一个，使得所述组织将在愈合过程期间保持接近。
根据本发明的一个示范性实施例，一种手术装置，包括：夹紧机构，其构造为夹紧组织；电动机，其构造为驱动所述夹紧机构；以及控制系统。所述控制系统构造为：监测所述电动机的指示施加到正被夹紧的组织上的夹紧力的参数，控制所述电动机以判定所述夹紧力是否达到了预定最大极限并且限制所述电动机的所述参数，以及监测所述夹紧力以判定所述夹紧力的变化并且允许在施加到组织上的所述夹紧力已经下降到所述预定最大极限以下时重新激活所述电动机。
根据本发明的一个示范性实施例，一种手术装置，包括：第一夹紧构件；第二夹紧构件；以及控制系统。所述控制系统构造为：控制所述第一夹紧构件和所述第二夹紧构件朝向所述第一夹紧构件与所述第二夹紧构件之间的预定组织间隙的压缩力，并且当达到所述组织间隙时，配置组织紧固件、能量和粘性流体中的至少一个，使得所述组织将在愈合过程期间保持接近。
根据本发明的一种用于控制组织压缩的示范性方法，包括：将组织置于组织压缩机构例如线性切割和吻合装置的钳口或圆形切割和吻合装置的砧座和基座中。所述方法还包括根据闭合速度来压缩所述组织。
所述方法还包括确定在压缩期间施加到所述组织上的瞬时能量或功率，和/或累积的能量或功率。所述方法进一步包括例如在所施加的功率增加时使闭合速度降低到预定的水平。所述测量可以包括测量施加到直流电动机上的电流。在压缩的过程中，可以例如以固定时间间隔连续地测量所述电流。可以调节所述闭合速度，使得施加到组织中的功率在部分压缩期间保持恒定。
根据本发明的一种用于控制组织压缩的示范性装置可以包括夹紧或压缩机构。压缩机构可以是任何适当机构，例如转动或平行的钳口、圆形吻合和切割机构的砧座和基座等。所述压缩机构由致动器致动，所述致动器可以包括可以布置在远程控制台和/或所述装置的壳体中的一个或多个电动机。可以通过任何适当的结构例如设置为传输转动力的一个或多个转动轴而将功率从致动器传递给压缩机构。在致动器包括直流电动机的情况下，控制系统例如数字和/或模拟控制系统可以通过改变施加到致动器上的电压来控制进入致动器中的电流。可以对所述控制系统进行构造和/或编程，以限制进入电动机中的电流。可以对所述控制系统进行编程，以基于如由电流传感器所指示的测量到的进入电动机中的电流来计算施加到组织上的功率。可以对所述控制系统进行编程，以基于电压输入来计算压缩机构的闭合速度。
而且，可以对所述控制器进行编程，以通过改变例如降低输入到致动器中的电压来降低闭合速度，以便限制进入组织中的功率和/或使进入组织中的功率保持在恒定的水平。
以下，结合附图来详细地描述本发明的示范性实施例的进一步的细节和方案。
附图说明
图1为图示了在压缩期间以恒定的砧座闭合速度施加到组织上的功率的曲线图。
图2为图示了根据本发明的一个示范性实施例的在压缩期间施加到组织上的功率的曲线图。
图3为图1和图2的曲线图的叠加。
图4为根据本发明的一个示范性实施例的控制系统的示意图。
图5为图示了根据本发明的一个示范性实施例的方法的流程图。
图6a和图6b示意性地图示了吻合装置的钳口的张开效果。
图7a至图7d图示了与不同的吻合事件相关的电流分布。
具体实施方式
在患者组织的压缩期间，由于组织的成分(例如，流体的存在等)而存在液压效应。在这点上，可以测量液压阻力并将其用作对夹紧元件闭合的反馈。
当夹紧患者组织时，通过夹紧装置例如线性吻合器施加到组织上的力可能达到不可接受的高水平。例如，当采用恒定的闭合速度时，所述力可能变得足够高而造成受夹组织的过大外伤，并且可能导致夹紧装置的变形而使得可接受组织间隙不被保持在吻合路径上。例如，可接受组织间隙可以在以下范围内：例如1mm±0.4mm、
Figure GSA00000083660800071
(0.7mm至1.4mm)等。
参考图6a和图6b，示意性地图示了在将夹紧力施加到一部分组织上时的线性手术吻合器1000和1100。
如图所示，由吻合器1000和1100的钳口施加的高水平力导致了张开效果，为了图示目的，在图6a和图6b中对所述张开效果进行了夸张。参考图6a，一对对置的钳口1005和1010仅在近侧部处形成了目标组织间隙1020，而钳口1005和1010的远端离开彼此向外张开，导致了在远侧部处扩大的组织间隙1025。所述张开导致了钳口1005和1010偏离平行对齐，这会导致在朝向钳口1005和1010的远端施加吻合钉的情况下不可接受的大组织间隙，依次会导致诸如泄漏、污染和失败的吻合钉连接的上述困难。所述张开是由超过导致钳口相对于彼此偏离平行对齐的屈服力而引起的。
图6b示出了可比较的效果，而其中张开首先发生在与第二钳口1110相比结构上较脆弱的第一钳口1105中。这又导致了显著超过目标组织间隙1120的不可接收的大组织间隙1125。
图1为图示了在压缩期间以恒定的砧座闭合速度施加到组织上的功率的曲线图。在初始打开状态时开始压缩，其中，夹紧构件或元件在压缩其间的组织之前移动一定距离。区域A表示夹紧元件从初始打开状态移动到组织压缩开始所持续的时间，而区域B表示组织从初始厚度被压缩到目标厚度所持续的时间段，在本例中，目标厚度为1mm组织厚度(对应于夹紧元件之间的1mm组织间隙)。区域A′和B′由表示在组织处于其初始厚度的情况下压缩开始的“拐点”来描绘。在到达峰值之前，施加到组织中的功率以及力随着时间急剧升高。线10表示夹紧元件的闭合速度(在图1中表示为砧座闭合速度)，在初始打开状态与1mm的目标组织间隙之间，所述闭合速度是恒定的。功率曲线下方的阴影区域表示在夹紧程序期间施加的总能量。
图2为图示了根据本发明的一个示范性实施例的在压缩期间施加到组织上的功率的曲线图。如同对应于图1的曲线图的装置及方法的情况，如图2所示的在初始打开状态时开始压缩，其中，夹紧构件或元件在压缩其间的组织之前移动一定距离。区域A′表示夹紧元件从初始打开状态移动到组织压缩开始所持续的时间，而区域B′表示组织从初始厚度被压缩到目标厚度所持续的时间段，在本例中，目标厚度为1mm组织厚度(对应于夹紧元件之间的1mm组织间隙)。A′和B′由表示在组织处于其初始厚度的情况下压缩开始的“拐点”来描绘。在A′所描绘的期间，夹紧元件以例如13mm/s的恒定速度闭合。然而，应当意识到的是，可以采用任何适当的速度并且速度在整个期间A′内无需是恒定的。功率曲线下方的阴影区域表示在夹紧程序期间施加的总能量。
与图1相比，图2图示了确定出施加到组织上的功率正在增加并且处于特定水平的闭合速度正在降低，在本示例中，从13mm/s到1mm/s，这有效地增加了压缩组织所需的时间并且降低了施加到组织上的功率。在图2中，所述闭合速度图示为线100。在本示例中，使施加到组织上的功率保持恒定，但是应当意识到的是，根据特定的示范性实施例，功率是可以波动的。
图3为图1和图2的曲线图的叠加。与图1所反映的系统及方法相比，根据图2的施加到组织中的峰值功率低得多。基于所施加的功率，可以计算出由手术装置施加的力(或与所述力有关或成比例的参数)。在这点上，可以限制功率，使得通过手术装置例如通过线性吻合器的钳口所施加的力不超过屈服力或压力，该屈服力或压力导致钳口张开使得在处于完全闭合位置时组织间隙沿整个吻合长度均不在可接受的范围内。例如，钳口应当平行或足够平行地接近，使得对于沿钳口整个长度的所有的吻合钉位置，组织间隙保持在可接受的范围或目标范围内。此外，对所施加的功率的限制避免或者至少最小化了组织的外伤或损害。
在本示例中，在图1的方法中施加的总能量与在图2的方法中施加的总能量相同，即，图1和图2的功率曲线下方的区域相同或基本相同。然而，所使用的功率分布的区别是很大的，因为与图1相比，图2的示例中的峰值功率低得多。
在图2的示例中，如由线100所图示的，通过降低闭合速度实现了对功率的限制。应当注意到的是，压缩时间B′比闭合时间B长。如图1至图3所图示的，设置了恒定闭合速度的装置及方法在1mm组织间隙处实现了50lb的相同压缩力，与关于图2所反映的装置及方法相同。虽然例如由图1所图示，设置为恒定闭合速度的装置及方法(图1)与图2相比可以以较短的时间段在期望组织间隔处实现压缩力，但是这导致了施加到组织上的功率的尖峰。相比之下，例如关于图2所图示的示范性实施例开始降低闭合速度，以将施加到组织上的功率量限制到某一水平以下。相比于图1所反映的系统及方法，可以通过限制施加到组织上的功率来最小化组织外伤。
根据示范性实施例，由于电流与电动机的转矩输出是成比例的，因此可以通过测量施加到致动器上的电流而确定施加到组织上的功率或力来实施所述装置及方法。在这点上，可以从施加到驱动电动机上的功率中减去例如由运动部件之间的摩擦等引起的基于器械的损耗，从而更精确地确定出正施加到组织中的功率。这些待除去的损耗可以以任何合适的方式来确定，例如利用器械或器械的部件的已知性质来测试器械或器械的部件，和/或基于测试和/或已知性质来执行计算。例如，可以在未负载的情况下驱动器械，以获得对驱动器械及其相关部件所需的功率或电流的基线测量。此后，超过基线的功率或电流对应于在压缩期间施加到组织上的功率。
在例如致动器为直流电动机的情况下，可以基于对驱动电动机所需的电流的测量来确定施加到电动机上的功率。之后，除去由器械引起的损耗，以确定在压缩期间施加到组织中的功率。当压缩组织时，所述测量允许反馈源。可以利用正连续执行的计算来连续地监测施加到电动机上的功率。例如，这允许例如通过调节进入电动机中的电压来精确地控制施加到组织上的功率或力。在所述示范性反馈控制系统中，在调节电压以实现期望电流的情况下，所消耗的电流将是反馈。当确定出的功率达到特定水平(例如为防止不可接受水平的组织外伤而选择出的预定功率水平)时，图2的曲线图中所图示的示例利用所述控制系统来降低闭合速度。
图4为根据本发明的一个示范性实施例的控制系统的示意图。控制器400控制电动机410，电动机410驱动夹紧操作，例如夹紧线性手术吻合器的钳口。例如通过特定控制程序和/或通过外科医生或操作者手动输入而将目标位置、目标电流和目标速度输入控制器400中。控制器400接收电动机位置信号、电动机速度信号和电动机电流信号，作为反馈以控制电动机410。如以下更详细讨论的，根据本示例的控制器400选择最小输入来控制电动机410。
图5为图示了根据本发明的一个示范性实施例的方法的流程图。系统启动在500处发生。在系统启动之后，测量电流偏移并将测量到的电流偏移设定为从所有的电流读数中减去，使得所有的读数从零或近零基线起读取。校准在510处发生，校准包括测量由摩擦损耗例如电动机和驱动部件中的摩擦引起的电流，驱动部件将电动机的转动力转换为通过器械施加的夹紧力，例如通过线性吻合器的钳口施加的力。在未负载的情况下，即在非干扰运动期间，可以通过测量与不同电动机速度相对应的电流来执行校准。应当意识到的是，每当系统启动时可以执行偏移测量和校准，和/或可以存储获得的值以用于利用同一设备的随后的程序中。例如，在给定的时间段、使用次数和/或系统启动次数之后，控制系统可能需要对这些值进行重新测量。
在校准之后，夹紧程序可以开始。当待夹紧的组织布置在手术器械的夹紧部分中时，在515处开始移动。之后，所述示范性方法执行电流回路、速度回路和位置回路。这些回路无需按特定顺序来执行，并且在某些示例中，其中两个回路或所有的三个回路可以同时或基本同时地执行。
对于600处的电流回路，例如，根据电流传感器的信号来读取电动机电流，电流传感器设置为感知驱动电动机的电流。去除或减去在505和510处确定出的偏移和摩擦损耗。以该方式，确定出响应于组织夹紧而施加的电流部分。在605处，利用电流驱动力公式来计算电流驱动力。例如，可以通过K1x(目标电流-电动机电流)来确定电流驱动力，其中，基于用于控制电动机电流的期望控制性能来选择K1。
对于700处的速度回路，确定电动机速度。通过读取来自速度信号的信号或任何其它适当的方式例如通过位置和时间数据来确定所述速度。在705处，利用速度驱动力公式来计算速度驱动力。例如，可以通过K2x(目标速度-电动机速度)来确定速度驱动力，其中，基于用于控制电动机速度的期望控制性能来选择K2。在710处，判定是否已经碰到了不可动目标物。在这点上，速度值为零指示夹紧装置碰到了不可动目标物或障碍物。如果碰到了障碍物，则之后在A处停止电动机的驱动。否则，控制继续。应当意识到的是，可以在计算速度驱动力之前、之后和/或在计算速度驱动力的同时进行所述判定。
对于800处的位置回路，读取电动机位置。可以例如通过耦合到电动机的输出端上的编码器或分解器或者任何其它适当的方式来确定电动机位置。在805处，利用位置驱动力公式来计算位置驱动力。例如，可以通过K3x(目标位置-电动机位置)来确定位置驱动力，其中，基于用于控制电动机位置的期望控制性能来选择K3。
在810处，判定是否已经到达目标位置。如果已经到达目标位置，则控制回路在B处继续存在。在B处，可以停止对电动机的输出(例如，在利用不能逆向驱动的驱动器，通过由受夹组织施加的剩余压力或通过正被驱动并且形成在夹紧构件之间的吻合钉的力来夹紧组织的情况下)和/或可以控制电动机以输出使电动机保持在目标位置处所需的力的量，在上述示例中，目标位置通常对应于目标组织间隙。如果还未达到目标位置，则控制继续。应当意识到的是，可以在计算位置驱动力之前、之后和/或在计算位置驱动力的同时进行所述判定。此外，应当意识到的是，可以将夹紧元件例如钳口或任何中间部件例如驱动器的相对位置用作位置输入。
在所述三个控制回路之后，比较计算出的电流驱动力、速度驱动力和位置驱动力，并且在900处将最小的驱动力施加到电动机上。在905处，报告在减去偏移和摩擦损耗之后与电动机电流成比例且通过电动机电流确定出的所施加的转矩。在910处，累积所施加的转矩以计算施加到组织上的能量。
图表950图示了三种不同情形的控制优化。在第一种情形中，电动机速度和电动机电流低于它们各自的目标值，而电动机位置不低于其目标值。在这种情形中，位置回路控制，同时将速度回路和电流回路设定为最大值。在第二种情形中，速度回路和位置回路低于它们各自的目标值，而电流回路不低于其目标值。在这种情形中，电流回路控制输出，同时将速度回路和位置回路设定为最大值。在第三种情形中，电流回路和位置回路低于它们各自的目标值，而速度不低于其目标值。在这种情形中，速度回路控制，同时将电流回路和位置回路设定为最大值。
在915处判定是否需要过长的时间来达到目标位置。可以通过检查在判定915之前经过的时间量、基于经过的时间和控制分布(例如，电流、速度和位置)的预测的总时间量和/或任何其它适当的方式来进行所述判定。如果判定出所需时间过长，则所述示范性控制方法在C处继续存在。在C处，可以停止对电动机的控制输出，或者可以采用其它控制方法，例如，以使电动机的位置反转。例如，可以驱动电动机以将线性吻合器的钳口移动到打开位置，从而外科医生或操作者可以将手术装置移走或将钳口移动到可易于夹紧的不同的组织部分。换句话说，在C处，可以触发请求或要求用户介入。
如果判定出无需过长的时间，则控制系统再次分别执行600、700、800处的电流回路、速度回路和位置回路。所述回路继续，直到事件A、B和/或C出现而使回路中断。然而，应当意识到的是，可以实施其它条件例如手动超越控制、传感器错误等以使回路中断。
如上所述，在B处到达目标位置之后，可以控制电动机以维持保持目标位置所需的力。为了多个目的，可以暂时监测驱动电动机的电流。例如，在所述装置为例如手术吻合器的情况下，测量到的电流的分布可以用于识别是否已经发射出吻合钉钉仓中的所有吻合钉。图7a图示了在吻合程序期间当驱动器例如楔形物按顺序驱动五个吻合钉时的期望电流分布。应当理解的是，可以设置任意数量的吻合钉，并且发射五个吻合钉是为了图示的目的。电流测量中的尖峰对应于在夹紧元件例如线性吻合器的钳口之间推动吻合钉的情况下保持组织间隙所需的大的力或功率。如果发射被初始化并且产生近似于图7a的电流分布，则可以判定出所有的吻合钉被适当地驱动或发射出。
如果吻合钉驱动程序被初始化并且导致如图7b所图示的电流分布，则可以通过尖峰的不足判定出：例如由于发射失败或漏掉吻合钉钉仓中的吻合钉，第二个吻合钉位置未被适当地驱动或发射出。发射失败可能类似于例如当电流尖峰存在但是基本上低于期望时示出的情形。
如果吻合钉驱动程序被初始化并且导致如图7c所图示的电流分布，则可以判定出第三个吻合钉位置中的吻合钉以某种方式被卡住，导致了较高的峰值电流测量。
如果吻合钉驱动程序被初始化并且导致如图7d所图示的电流分布，则可以判定出吻合钉钉仓是空的或者吻合钉钉仓不存在。
如果发生了这些非期望事件中的任意一个，则控制系统可以例如通过发出声音报和/或在计算机屏幕上显示错误信息来告用户。控制系统还可以使吻合钉发射中止，或者输入不同的控制算法。
而且，电流测量的分布可以用于例如通过与正常电流特征或电动机特征相比较来监测和追踪至少一个夹紧构件中的结构疲劳。在这点上，电流分布可以指示例如由疲劳破坏导致的塑性变形而引起的挠曲。此外，电流分布可以用于通过确定由夹紧元件施加的力的量和循环的数量来追踪累积的疲劳。
应当意识到的是，根据本发明的示范性方法可以利用可集成到医疗装置中或者可以位于远处的任何适当的控制系统例如数字和/或模拟控制系统来实施，由此控制信号和反馈信号经由例如无线或有线的接口来进行通信。所述控制系统可以具有显示输出端(例如监测器)和/或输入端以与例如外科医生进行通信。显示输出端可以显示与程序相关的数据，例如包括当前闭合速度、压缩力和/或组织间隙。控制系统可以运行可预先选择出以用于特定装置的预定控制程序或算法。控制系统还可以额外地或可选择地可以要求来自操作者的输入，以限定组织压缩控制的参数。
此外，可以通过与闭合速度相比检查施加到电动机上的电流来确定组织的可压缩性。例如，如果在使用低的闭合速度时测量到的电流很高，则与较高的闭合速度而电流低的情形相比，组织的可压缩性较低。
虽然以上描述了1mm的组织间隙作为适于组织吻合的期望组织间隙的示例，但是应当意识到的是，代替对间隙的绝对距离测量，可以设置可选间隙参数。例如，可以设置一个或多个光学传感器，以测量在一个或多个吻合线上流动的血流量，作为对期望组织间隙的测量。此外，关于期望组织间隙的确定，可以使用氧饱和度。而且，例如基于在图1和图2的曲线图中在拐点处施加到组织上的功率，受压缩与未压缩组织之比可以形成期望组织间隙的基准。

Claims (33)

1.一种方法，包括：
通过利用电动机朝向第一夹紧构件与第二夹紧构件之间的预定组织间隙驱动至少一个夹紧构件，夹紧所述第一夹紧构件与所述第二夹紧构件之间的组织；
在所述夹紧期间，监测所述电动机的指示由所述夹紧构件施加到所述组织上的夹紧力的参数；以及
在所述夹紧期间，基于监测到的所述参数来控制所述电动机，以将所述夹紧力限制到预定最大极限。
2.根据权利要求1所述的方法，其中，基于待夹紧的所述组织的预定性质来选择所述预定最大极限。
3.根据权利要求2所述的方法，其中，选择所述预定最大极限，以将受夹组织的外伤限制到预定的可接受水平。
4.根据权利要求1所述的方法，其中，所述预定最大极限低于所述至少一个夹紧构件的预定挠度极限。
5.根据权利要求1所述的方法，其中，所述控制包括调节施加到所述电动机上的电压。
6.根据权利要求1所述的方法，其中，所述控制包括限制驱动所述电动机的电流。
7.根据权利要求1所述的方法，其中，所述监测包括测量驱动所述电动机的电流。
8.根据权利要求7所述的方法，进一步包括：
在所述夹紧之前，测量由与移动所述夹紧构件相关的摩擦损耗引起的电流；以及
从在所述夹紧期间测量到的电流中减去所述摩擦损耗。
9.根据权利要求7所述的方法，进一步包括在所述夹紧之前，测量电流偏移。
10.根据权利要求9所述的方法，进一步包括从在所述夹紧期间测量到的电流中减去所述电流偏移。
11.根据权利要求1所述的方法，其中，选择所述预定最大极限，以防止所述力达到屈服力。
12.根据权利要求1所述的方法，其中，选择所述预定最大极限，以防止所述夹紧构件张开。
13.根据权利要求1所述的方法，进一步包括利用监测到的所述参数的分布来监测和追踪至少一个夹紧构件中的结构疲劳。
14.根据权利要求13所述的方法，其中，将所述分布与正常参数特征相比较。
15.根据权利要求1所述的方法，其中，手术器械是手术吻合器并且其中一个夹紧构件是构造成成形手术吻合钉的砧座。
16.根据权利要求15所述的方法，进一步包括利用监测到的所述参数的分布来识别是否已经发射出吻合钉钉仓中的所有吻合钉。
17.根据权利要求15所述的方法，进一步包括利用监测到的所述参数的分布来识别至少一个吻合钉发射失败、吻合钉钉仓中不存在吻合钉和吻合钉卡住中的至少一个。
18.根据权利要求1所述的方法，其中，所述控制包括：
确定电动机速度；
确定电动机位置；以及
通过减去电流偏移和由摩擦损耗引起的电流来确定归因于压缩的净电动机电流。
19.根据权利要求18所述的方法，其中，所述控制进一步包括：
基于确定出的所述速度来确定速度驱动力；
基于确定出的所述位置来确定位置驱动力；以及
基于确定出的所述净电动机电流来确定电流驱动力。
20.根据权利要求19所述的方法，其中，所述控制进一步包括向所述电动机施加所述速度驱动力、所述位置驱动力和所述电流驱动力中最小的一个。
21.根据权利要求18所述的方法，进一步包括基于所述电动机速度来检测不可压缩目标物的存在。
22.根据权利要求1所述的方法，其中，所述控制包括调节所述电动机的驱动速度，以将所述夹紧力限制到所述预定最大极限。
23.一种手术装置，包括：
第一夹紧构件；
第二夹紧构件；
电动机，其构造为朝向所述夹紧构件之间的预定组织间隙驱动所述第一夹紧构件和所述第二夹紧构件中的至少一个夹紧构件；
控制系统，其构造为监测所述电动机的指示由所述夹紧构件施加到所述组织上的夹紧力的参数，以及基于监测到的所述参数来控制所述电动机，以将所述夹紧力限制到预定最大极限。
24.根据权利要求23所述的手术装置，其中，基于待夹紧的所述组织的预定性质来选择所述预定最大极限。
25.根据权利要求24所述的手术装置，其中，选择所述预定最大极限，以将受夹组织的外伤限制到预定的可接受水平。
26.根据权利要求23所述的手术装置，其中，所述预定最大极限低于所述至少一个夹紧构件的预定挠度极限。
27.根据权利要求23所述的手术装置，其中，所述手术装置设置为(a)线性手术吻合器、(b)圆形手术吻合器和(c)直角式线性切割器中的至少一个。
28.根据权利要求23所述的手术装置，进一步包括：
电流传感器，其构造为确定驱动所述电动机的电流；
速度传感器，其构造为确定所述电动机的转速；以及
位置传感器，其构造为确定所述电动机的输出位置和所述第一夹紧构件与所述第二夹紧构件的相对位置中的至少一个。
29.根据权利要求23所述的手术装置，其中，所述控制系统适于通过调节所述电动机的驱动速度来控制所述电动机，以将所述夹紧力限制到所述预定最大极限。
30.一种手术装置，其构造为监测电动机的指示施加到正被夹紧的组织上的夹紧力的参数，控制所述电动机以判定夹紧力是否达到了预定最大极限并且限制所述电动机的所述参数，以及监测所述夹紧力以判定所述夹紧力的变化并且允许在施加到组织上的所述夹紧力已经下降到所述预定最大极限以下时重新激活所述电动机。
31.一种手术装置，其构造为控制第一夹紧构件和第二夹紧构件朝向预定组织间隙的压缩力，并且当达到所述组织间隙时，配置组织紧固件、能量和粘性流体中的至少一个，使得所述组织将在愈合过程期间保持接近。
32.一种手术装置，包括：
夹紧机构，其构造为夹紧组织；
电动机，其构造为驱动所述夹紧机构；以及
控制系统，其构造为
监测所述电动机的指示施加到正被夹紧的组织上的夹紧力的参数，
控制所述电动机以判定所述夹紧力是否达到了预定最大极限并且限制所述电动机的所述参数，以及
监测所述夹紧力以判定所述夹紧力的变化并且允许在施加到组织上的所述夹紧力已经下降到所述预定最大极限以下时重新激活所述电动机。
33.一种手术装置，包括：
第一夹紧构件；
第二夹紧构件；以及
控制系统，其构造为
控制所述第一夹紧构件和所述第二夹紧构件朝向所述第一夹紧构件与所述第二夹紧构件之间的预定组织间隙的压缩力，并且
当达到所述组织间隙时，配置组织紧固件、能量和粘性流体中的至少一个，使得所述组织将在愈合过程期间保持接近。
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AU2017202913B2 (en) 2018-11-15
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EP2245994B1 (en) 2019-08-21

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