CN102083373A - 具有手动松放装置的自带电源电动手术器械 - Google Patents
具有手动松放装置的自带电源电动手术器械 Download PDFInfo
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Abstract
一种电动手术器械包括具有执行装置的手术端部执行器和手柄,所述手术端部执行器在操纵时实施手术程序,所述手柄连接到端部执行器以操作所述执行装置。所述执行装置的一部件在起始位置和完全执行位置之间移动。手柄有完全置于手柄内的自带电源和驱动装置。驱动装置有电动机和与电源及电动机电气连接的控制器。控制器可选择地操纵电动机。传动装置将电动机机械地连接到移动部件并当电动机运行时选择性地在起始位置和完全伸出位置之间的任何位置移动所述移动部件。手动松放装置机械地联接到传动装置,以便可选择地中止传动,并且在中止期间独立于电动机转动向所述起始位置移动所述移动部件。
Description
技术领域
本发明属于手术器械领域,尤其但不限于是吻合装置。本专利申请所描述的吻合装置是手持式、自带电源全电动和可控制式、手动松放的手术吻合器。
背景技术
在本领域中已经存在医用吻合装置。Ethicon Endo-surgery公司(Johnson & Johnson公司,以下称为“Ethicon”)制造和销售这类吻合装置。Ethicon制造的圆形吻合装置使用PROXIMATEPPH、CDH和ILS商标名称,Ethicon制造的直线吻合装置使用CONTOUR和PROXIMATE商标名称。在这些吻合器中,组织被压缩在钉仓(staple cartridge)和抵钉座(anvil)之间,当击发缝合钉时,同时切下被压缩的组织。根据医生造手术的具体组织,组织能够被压缩得过少(其中仍然能看出组织的血色)、过多(其中组织被压碎)或适度(其中组织的液体被挤出,称为干燥或变白)。
缝合钉有一定的长度,钉仓和抵钉座之间需要有可接受的缝合钉击发距离,以便在击发时缝合钉能正确闭合。因此,这些吻合器有指示装置显示两个平面之间的相对距离和该距离是否在缝合钉长度的击发范围。这种指示器是机械式的,在窗口后面用滑动杆的形式指示安全缝合击发范围。所有这些吻合器都是手动的,换言之,要求使用者或医生用手动相对于被吻合和/或切割的组织放置抵钉座和钉仓、将抵钉座和钉仓相互靠近、向组织击发和固定缝合钉(和/或切割组织)。以前没有电动吻合器进行这些操作的每一项,因为在钉仓必须有大约250磅的纵向力击发缝合钉。另外,这类吻合器没有任何类型的有效的压缩指示器能够使施加到被吻合的组织的力最佳而不发生组织损伤。
转让给Ethicon公司的Main等人的专利号为5,104,025的美国专利例如描述了一种手动管腔内吻合圆形吻合器。Main等人的该专利在此全文引入到本申请中供参考。在Main等人的专利的图7分解图中可以清楚地看到,套管针轴22有一个远端锯齿形凹槽21,用于使套管针轴22对准抵钉座的锯齿29的一些凹进28,从而使缝合钉与抵钉座34对准。套管针尖26受力后能刺入组织。Main等人的专利的图3至图6显示圆形缝合钉10如何将两片组织连接在一起。随着抵钉座30移动到靠近头部20,置于中间的组织被压缩在中间,如图5和图6具体所示。如果组织被过分压缩,手术吻合操作可能不成功。因此,需要不超过组织可接受的最大压缩力。在手术过程中置于中间的组织能承受一定范围的压缩力。这个范围是已知的和称作最佳组织压缩力或OTC,它取决于被吻合的组织类型。在Main等人的专利中,吻合器有一个杆形指示器,所述指示器用于向使用者显示抵钉座与钉仓之间的缝合钉击发安全距离,但它不能向使用者显示吻合前施加到组织的任何压缩力的大小。希望提供这种指示,以便避免过度压缩组织。
发明内容
本发明通过提供自带电源的电动式手术装置,所述手术装置用自带电源实施医疗程序,克服了原有技术的上述缺陷。例如,在直线内切割刀中,自带电源能够针对被吻合和/或切割的组织使抵钉座和吻合器的钉仓的相对位置、击发和在组织上固定缝合钉(和/或切割组织)。而且,自带电源电动式手术装置能够在击发吻合钉之前向使用者指示使用者预先确定的施加到组织的压缩力水平。本发明提供了一种用于在达到最佳组织压缩(OTC)时操作电动外科缝合装置进行缝合的方法。而且提供了手动松放装置,所述手动松放装置允许从部分执行中或卡住状态收回。
抵钉座子组合件和缝合钉击发子组件的偏置轴结构形成一个装置,其尺寸能够舒适地握在使用者的手中。同时由于取消了原先要求的嵌套(同轴)空心轴,减小了制造难度。由于抵钉座子组件的轴线相对于缝合钉击发子组件偏置,伸出和缩回抵钉座的螺纹杆的长度可以减少大约两英寸,从而节省制造成本和缩短纵向尺寸。
使用电动吻合器典型的方法包括一个开机特征,该特征允许为试验目的进入手动模式。在手术操作中,吻合器是单向装置。不过在试验模式,使用者能够根据需要向后和向前移动套管针。试验模式可以被解除,并且将吻合器重新调整到使用模式进行包装和运输。为了包装,最好(不是必须)使抵钉座与钉仓之间有一定距离。因此,在关闭电源进行包装和运输之前,归位顺序可以按程序进行,将抵钉座置于离开钉仓1厘米(例如)的位置。在使用之前,将套管针伸出,将抵钉座取下。如果吻合器用来切除结肠(例如),套管针缩回到手柄内,手柄经肛门插入结肠切除段的下游一侧,同时将抵钉座从腹腔镜切口插入切除段的上游一侧。抵钉座连接到套管针上,两个部件向手柄缩回,直到一个缝合钉达到准备击发状态。可以中断的缝合钉击发顺序起动,以吻合切除段,同时在切除段中心切割组织,在缝合钉圆环的中间清理开口。缝合钉击发顺序包括最佳组织压缩力(OTC)测量和引起缝合钉只在所要求的最佳压缩力范围(称为OTC范围)击发的反馈控制机构。根据在抵钉座和钉仓之间被压缩的组织的特性预先知道这个范围或数值。
可以使用电动吻合器的某些典型的手术包括结肠切除和胃旁路术。电动吻合器在多种不同技术领域有许多其它用途。
为了上述和其它目的,本发明提供了一个电动手术器械,包括手柄和手术端部执行器,所述手术端部执行器具有可操纵成当操作时实施手术程序的执行装置,所述执行装置的一部件可操作成在起始位置与完全执行位置之间移动。为了操纵执行装置,手柄连接到端部执行器。手柄有完全装在手柄内的自带电源、完全设置在手柄内并具有电动机的驱动装置,和与电源和电动机电气连接并有选择地操纵电动机的控制器,手柄具有传动装置,所述传动装置将电动机机械地连接到移动部件并且当操纵电动机时所述传动装置可操作成选择性地把所述移动部件移位到所述起始位置和完全伸出位置之间的任何位置,手动松放装置机械地连接到传动装置,以便有选择地中断传动,并且在中断期间独立于电动机运转向起始位置移动移动部件。
根据本发明的另一个特点,该手术端部执行器是手术线性吻合内切割器,和所述移动部件至少包括吻合执行装置和组织切割滑块。
根据本发明更进一步的特点,驱动装置和传动装置可操纵成执行端部执行器的吻合-切割特征。
根据本发明另外的特点,电源是至少包含一个电池的可拆卸的电池组。
根据本发明另外的特点,电源是串联的四个到六个的CR123或CR2电池。
根据本发明另外的特点,控制器包括多态开关,所述多态开关可操作成当开关在第一状态时引起电动机正转和当开关在第二状态时引起电动机反转。
根据本发明进一步的特点,传动装置有电动机驱动端和执行驱动端,手动松放装置连接到两端之间。
还根据本发明另外的特点,手动松放装置机械地设置在传动装置中。
还根据本发明另外的特点,电动机驱动端有包括最终齿轮的回转减速齿轮系,执行驱动端有至少一个齿轮和连接到所述至少一个齿轮并直接连接到移动部件的至少一部分的齿条-小齿轮总成,和手动松放装置机械地连接在所述至少一个齿轮与最终齿轮之间。
又根据本发明的另一个特点,电动机有一个输出齿轮,齿轮系具有联接到该输出齿轮的第一级。
又根据本发明进一步的特点,齿轮系包括第一级、第二级和第三级,和带有轴的过桥齿轮,所述轴从电动机驱动端跨接到执行驱动端,并且所述过桥齿轮联接到第三级。
又根据本发明进一步的特点,齿轮系有一个带有轴的过桥齿轮,所述轴从电动机驱动端跨接到执行驱动端,过桥齿轮联接到齿轮系,一个堡形齿轮装在过桥轴上,与轴之间不能相对转动而能在轴上纵向移动,堡形齿轮有向执行驱动端伸出的堡形突起,执行驱动端的至少一个齿轮包括具有堡形槽的第一级小齿轮,堡形槽的形状与堡形突起配合,在过桥齿轮和堡形齿轮之间设有偏置装置,所述偏置装置在堡形齿轮上朝向执行驱动端施加偏置力以允许堡形齿轮与第一级小齿轮选择性地结合,并且因此,当如此结合时,引起第一级小齿轮随着轴的旋转而进行相应的旋转,手动松放装置有松放部件,所述松放部件在形状和位置上提供反向力,以克服作用在堡形齿轮上的偏置力和当手动松放装置至少部分地电控操纵时,将堡形齿轮从第一级小齿轮分离。
又根据本发明的另外的特点,执行驱动端的至少一个齿轮包括一个有第二级齿轮轴的第二级小齿轮,第二级小齿轮联接到第一级小齿轮,第二级小齿轮相对于第二级小齿轮轴不能转动,第三级小齿轮可转动地装在第二级小齿轮轴上,第三级小齿轮是齿条-小齿轮总成中的小齿轮,当第三级小齿轮转动时第三级小齿轮纵向移动齿条。
还是根据本发明的另一个特点,手动松放装置有静止状态,在静止状态松放部件提供的反作用力的数值小于对堡形齿轮的偏置力,在第一部分地执行状态中松放部件以大于对堡形齿轮的偏置力提供反作用力,从堡形槽移出堡形突起,在第二部分地执行状态中手动松放装置转动小齿轮,使齿条在退回方向上纵向移动。
仍然根据本发明进一步的特点,执行驱动端的至少一个齿轮包括至少一个松放齿轮,并且第一级小齿轮直接连接到至少一个松放齿轮,以便当第一级小齿轮转动时转动至少一个松放齿轮。
仍然根据本发明补充的特点,执行驱动端的至少一个齿轮包括第一级和第二级松放齿轮,并且第一级小齿轮直接连接到第一级松放齿轮,以便当第一级小齿轮转动时转动第一级和第二级松放齿轮。
根据本发明伴随的特点,手动松放装置包括一根可转动地连接到手柄的手动松放杆,并且具有单向棘轮机构,至少一个松放齿轮有直接连接到棘轮机构的轴,以便当松放杆至少部分地操作时以与松放杆对应的方式转动和当松放杆不操作时独立于松放杆转动。
为了本发明的目的,还提供了一种操作手术器械的方法,包括将手动松放装置机械地联接到具有完全置于手柄内的自带电源的手术器械的传动装置的步骤,传动装置将手柄内的电动机转动转变成连接到手柄的手术端部执行器的一部件的运动,该部件可以操纵成在起始位置与完全执行位置之间的任何位置移动,并且能用手动松放装置选择性地中止传动,以将所述部分独立于电动机的运行朝向起始位置移动。
为了本发明的目的,还提供了一个手术器械,包括用于操作手术器械的方法,包括在手术器械手柄的远端提供手术端部执行器步骤的操纵手术器械的方法,端部执行器具有当操作时可操作成实施手术程序的执行装置,所述执行装置具有可操作成在起始位置和完全执行位置之间移动的部件,设置自带电源,并且电动机完全设置在手柄内并将电动机控制器连接到电动机和将电动机连接到电源以通过控制器选择性地操作电动机,通过传动装置,将电动机机械地连接到移动部件以当电动机运行时选择性地在起始和完全伸出位置之间选择性地移动所述移动部件,和机械地将手动松放装置连接到传动装置以选择性地中止传动,并且在中止的过程中,将移动部件独立于电动机的运行移动所述移动部件。
在附加的权利要求中提出了作为本发明特点的其它特征。
虽然本发明被表达和描述为具有手动松放装置的自带电源的电动手术器械的具体实例,但是本发明不打算限制在所详细表述的例子,因为在不背离本发明的精神和在权利要求相等的范围内,可能进行各种修改和结构改变。
附图说明
结合附图阅读下面的实例的描述将更好地理解本发明的结构和操作方法以及其它目的和优点。
本发明的实例的优点将通过对下列优先选择的实例的详细描述显示出来,这些描述应当结合下列附图考虑:
图1是根据本发明的一个电动吻合器实例的一侧的立体图;
图2是图1的吻合器的局部侧视图,带有右半边柄体和卸掉近端脊梁板;
图3是图1的吻合器的抵钉座控制组件的分解立体图;
图4是图3的抵钉座控制组件的放大局部分解立体图;
图5是图1的吻合器从后面看的缝合钉击发控制组合件的局部立体图;
图6是图1的吻合器的缝合钉击发控制组件的分解立体图;
图7是图6的缝合钉击发控制组件放大的局部分解立体图;
图8是图1的吻合器从柄体部分从下面看抵钉座控制组合件的局部水平断面图;
图9是图8的抵钉座控制组件从近端部分从下面看的局部放大水平断面图;
图10是图8的抵钉座控制组件从中间部分的下面看的局部放大水平断面图;
图11是图8的抵钉座控制组件从远端部分的下面看的局部放大水平断面图;
图12是图1的吻合器的柄体部分从右侧看的局部垂直横断面图;
图13是图12的吻合器的柄体近端部分的右侧的局部放大垂直断面图;
图14是图12的吻合器的柄体中间部分从右侧看的局部放大垂直断面图;
图15是图14的吻合器的柄体中间部分从右侧看的进一步放大局部垂直断面图;
图16是图12的吻合器的远端柄体部分从右侧看的局部放大垂直断面图;
图17是图1的吻合器的抵钉座的一部分的立体图;
图18是图1的吻合器的可拆卸的吻合组件的局部断面图,包括抵钉座、钉仓、力开关(force switch)和可拆卸的钉仓连接组合件;
图19是图1的吻合器从柄体部分上面看的抵钉座控制组件的局部水平断面图,抵钉座杆在完全伸出位置;
图20是图1的吻合器的柄体部分从左侧看的局部正视图,左柄体和电路板卸下,抵钉座杆在完全伸出位置;
图21是图20的吻合器的柄体部分的局部侧视图,抵钉座杆处于1cm抵钉座闭合位置;
图22是图1的吻合器从柄体部分上面看的抵钉座控制组件的局部水平断面图,抵钉座杆处于骑缝合钉安全击发位置;
图23是图1的吻合器从柄体部分的上面看的抵钉座控制组件的局部水平断面图,抵钉座杆处于完全缩回位置;
图24是图1的吻合器从柄体部分上面看的击发控制组件的局部水平断面图;
图25是图24的击发控制组件从近端部分上面看的局部放大的水平断面图;
图26是图24的击发控制组件从中间部分上面看的局部放大的水平断面图;
图27是图24的击发控制组件从远端部分上面看的局部放大的水平断面图;
图28和29是图1的吻合器的钉仓拆卸组件的画阴影线的局部放大的部分透明的立体图;
图30是根据本发明的医疗装置的可换零件的加密电路实例的示意性电路图;
图31是表示小齿轮在不同负荷时推动图32所示的齿条的速度的柱状图;
图32是根据本发明的齿轮箱与齿条之间典型的齿轮系简化示例部分的局部立体图;
图33是端部执行器的一种典型的实例的铰接部分的远端的局部垂直纵向断面图,已卸下内管、推杆-刀片支承、抵钉座、闭合环和将近一半的缝合钉滑轨;
图34是根据本发明的电源的示范开关组件的示意电路图;
图35是根据本发明的控制电动机正转和反转的示范性开关组件的示意电路图;
图36是根据本发明的另一种示例性的电源开关组件和控制电动机正转和反转的开关组件的示意电路图;
图37是本发明的卸掉外壳的装置的左侧视图;
图38是图37的一部分装置卸掉左侧架子的放大的左侧视图;
图39是图37的装置的右侧视图;
图40是图38的一部分装置卸掉右侧架子的右侧放大视图;
图41是图40的装置部分从右后侧看的透视图;
图42是图40的装置部分的后视图;
图43是图40的装置部分卸掉第一和第三级壳体的从左后侧看的透视图;
图44是图40的装置部分卸掉电源后从右侧上方看的透视图;
图45是图44的装置部分在第一个中间位置带有手动松放杆和在分离位置的堡形齿轮的透视图;
图46是图45的装置部分在第二中间位置有手动松放杆的透视图;
图47是图46的装置部分在第三中间位置有手动松放杆的顶视平面图;
图48是手动松放组件卸掉第二级松放齿轮、两个凸轮板和和棘爪弹簧,棘爪在上面脱扣位置时从右侧看放大的透视图;
图49是手动松放杆从右前侧下方看的透视图;
图50是手动松放杆从右后侧下方看的透视图;
图51是手动松放杆从左后侧下方看的透视图;
图52是凸轮板从左侧看的透视图;
图53是堡形齿轮从右侧看的透视图;
图54是第四级小齿轮从左侧看的透视图;
图55是图44的装置部分当棘爪抵住棘爪凸轮时从右前侧上方看的透视图;
图56是图55的装置部分当棘爪离开棘爪凸轮而抵住棘轮齿轮,且堡形齿轮在分离位置时的透视图;
图57是图44的装置部分当手动松放杆在中间位置时从左前侧上方看的透视图;
图58是图57的装置部分当手动松放杆在另一个中间位置时的透视图;
图59是图40的装置的一部分当端部执行器控制手柄在未驱动位置时的右侧放大视图;
图60是图59的装置部分当端部执行器控制手柄在部分地驱动位置时的右侧放大视图;
图61是图37的装置的轴连接器部分带有固定在架子上的可拆卸的端部执行器轴的放大的透视图;
图62是图61的轴连接器部分卸掉轴固定装置,以便能够从架子上卸下端部执行器轴的放大透视图;
图63是图37的装置外壳左半内部的前视图;
图64是图37的装置外壳右半内部的前视图;
图65是图37的装置外壳右半外部的前视图;和
图66是图37的装置外壳左半外部的前视图。
具体实施方式
在涉及本发明的具体实施方案的以下说明和相关附图中将阐明本发明的各个方面。在不脱离本发明的主旨或范围的前提下可以设计替代的实例。另外,本发明的典型实例中众所周知的元件将不再详述或略去,便于突出本发明的相关细节。
在描述本发明之前,应当知道所使用的术语仅仅是为描述实例的目的,没有限定的意图。必须注意,在技术规范和附件的权利要求中,如果没有另外说明,单数不定冠词和定冠词包含复数。
尽管说明书以限定被认为是新颖的本发明特征的权利要求作为结论,但是相信通过结合附图参考下列说明,将能够更好地理解本发明。图不是按比例绘制的。另外,应当说明,图是用计算机辅助设计程序形成的。当从阴影图或彩色图转变成线框图时,这个程序有时去掉某些结构线条和/或面。因此,应当把图看作近似的和用于说明本发明的特点。
现在来详细看图,首先看图1和2,其中显示出电动手术圆形吻合器1的典型实例。本申请对圆形外科手术吻合头采用电动手柄只是为了容易理解。本发明不限于圆形吻合器,可以应用于任何手术吻合头,例如,尤其是从图37开始描述的典型实例。
电动吻合器1具有手柄10,手柄具有三个开关:抵钉座打开开关20、抵钉座闭合开关21和缝合钉击发开关22。每个开关连接到电路板500(见图12),电路板500有执行吻合器1的吻合功能的程序电路。电路板500连接到包含在手柄10内的电源600。一种典型的实例的电源600用2至6个CR123或CR2锂蓄电池。可以采用其它电源,例如可充电蓄电池或连接供电总线的整流器(对于后一种装置,吻合器不是自供电或自给式装备)。这里,电源600的自供电或自给式装备是可以更换的,意思是电源为完整和独立的单元,用自身的电源可以工作,无须外部电源。例如,具有在使用时被插入到电力主线的电线插头的电源不是自供电或自给式装备。
电路板500上的绝缘导线或导体引线连接吻合器1的所有电子零件,例如通电/断电开关12、组织压缩指示器14、抵钉座和击发开关20、21、22;电路板500、电源600。但是为了容易理解和清楚,这些导线和导体在图上没有画出。
柄体10的远端连接到刚性抵钉座颈部30的近端。在这个连接点的相反一端,在抵钉座颈部30的远端,用联接装置40可拆卸地联接着钉仓50和抵钉座60。另一种方法是钉仓50不可拆卸,吻合器1的结构只有一种用途。这些连接将在下面进一步详述。
图2示出柄体10,柄体10的右半部分13和电路板500已经卸下。如下面将要讨论的,在图2中近端脊梁板70也已卸下,以便能从右侧看到柄体10的内部部件。从图2能够看到的是在柄体10内有两条内部部件轴线。第一条轴线是缝合钉控制轴线80,这条轴线在图2中是相对水平的。缝合钉控制轴线80是中心线,沿这条中心线装有控制缝合钉击发的部件。第二条轴线是抵钉座控制轴线90,这条轴线与缝合钉控制轴线80成一定角度。抵钉座控制轴线90是中心线,沿这条中心线装有控制抵钉座起动的部件。正是轴线80和90的分离,使得电动吻合器1能够用足够小的手柄10供电,使其适合医生的手和不占用过大的空间,避免限制医生在所有必要的方向移动。
柄体10内部显示有电源接通/断开开关12(例如格林纳达(grenade)销),用于控制向所有电气部件和组织压缩指示器14的电源(例如蓄电池电源)。组织压缩指示器14向医生指示被压缩在抵钉座60与钉仓50之间的组织是否被大于预先设定的压缩力压缩,这将在下面进一步详述。指示器14与力开关400连接,力开关已经在2006年5月19日提交的序列号为60/801,989和标题为“力开关”的共同待决美国临时专利申请中描述(在此其全部内容以引用的方式被合并进来)。
沿抵钉座控制轴线90的部件形成抵钉座控制组件100。抵钉座控制架110对准抵钉座控制轴线90,容纳和/或固定抵钉座控制组件100的各种零件。抵钉座控制架110有近端安装座112、中间安装座114和远端安装座116。安装座112、114、116可以连接到控制架110或与其制成一体。在典型的实例中,为了容易制造,近端安装座112分成两半,与控制架110分开,中间安装座114与控制架110分开。
在抵钉座控制组件100的近端有抵钉座马达120。抵钉座马达120包括驱动马达和将固有马达转速转变成要求的输出轴转速所需要的任何齿轮箱。在本案例中,驱动马达的固有转速接近10,000转/分钟,齿轮箱将从抵钉座马达120远端伸出的轴122的转速降低到接近50到70转/分钟。抵钉座马达120在纵向和可转动地固定在近端安装座112内。
马达轴联轴器130可转动地安装在轴122上,以便使轴122的转动转变为马达联轴器130相应的转动。
联轴器130的远端有转动螺母组件140。在本实例中,螺母组件140分成两部分,有近端半螺母141和远端半螺母142,半螺母142可转动地和在纵向固定在半螺母141上。应当说明,半螺母141、142根据需要可以做成一体。这里做成两半,以便于制造。;螺母组件140的近端可转动地安装在联轴器130的远端。这两个互相连接的零件在纵向的转动支承由中间安装座114和远端安装座116加强。
在中间安装座114与近端半螺母141之间安装近端螺母衬套150(见图3),在远端安装座116与远端半螺母142之间安装远端螺母衬套160,使这些零件在柄体10内和抵钉座控制架110内有效和可靠地旋转而不摩擦。衬套150、160可以用任何轴承材料,可以用青铜一类的金属或尼龙一类的聚合物。为了进一步降低转动的螺母组件140与联轴器130之间的纵向摩擦,在近端衬套150与近端半螺母141之间安装推力垫片170。
联轴器130和螺母组件140的转动用于推进或缩回螺纹杆180,通过螺纹杆机构使抵钉座60伸出或缩回。螺纹杆180在图3和图4的分解图中更详细地表示出并将在下面详述。螺纹杆支承190装在抵钉座控制架110的远端,用于延伸螺母组件140内的支承表面,以便保持螺纹杆180沿抵钉座控制轴线90对正。螺纹杆支承190有光滑的内部形状,其与螺纹杆180的通过所述支承的部分的外部形状相对应。这种形状的匹配使螺纹杆180通过支承190向近端和远端无摩擦地可靠移动。为了改善螺纹杆180通过支承190的无摩擦移动,在这个典型的实例中,在支承190与螺纹杆180之间装有圆筒形螺纹杆衬套192。在图2中看不到螺纹杆衬套192,因为它在支承190的内部。不过在图3和图4的分解图中能看到螺纹杆衬套192。安装螺纹杆衬套192之后,支承190的内部形状与螺纹杆衬套192的外部形状相对应;螺纹杆衬套192的内部形状与螺纹杆180的通过支承的部分的外部形状相对应。螺纹杆衬套192可以用青铜一类的金属或尼龙一类的聚合物制造。
沿缝合钉控制轴线80的部件形成吻合控制组件200。吻合控制组件200在图5中被示出,图5是从近端上面和侧面看的透视图。吻合控制组件200的近端包括吻合马达210。吻合马达210包括驱动马达和将固有马达转速转变为要求的转速所需要的任何齿轮箱。在本案例,驱动马达的固有转速接近20,000转/分钟,经过齿轮箱减速,在齿轮箱远端的输出轴212的转速转变接为大约200转/分钟。在图5看不到轴212,但是在图6和图7的分解图中可以看到。
吻合马达210可转动地和在纵向固定在马达安装座220上。马达安装座220的远端有中间连接安装座230。中间连接安装座230有远端板232,如图6所示。远端板232可以从连接安装座230上卸下,从而使旋转螺杆250能保持在中间。正是旋转螺杆250的驱动作用将缝合钉从钉仓50发射出去。轴212的转动转变成螺杆250的转动的效率是显着降低吻合器1输出发射缝合钉必要的250磅纵向力的能力的因素。因此,典型的螺杆250具有爱克米(acme)螺纹。
有两种典型的方法用于有效地将轴212的转动传到螺杆250。第一种方法是吻合马达210可以“宽松地”安装在由柄体10确定的空腔内,从而吻合马达能够稳定地转动,但是在径向有游动间隙、在纵向能够稳定,但是也有游动间隙。在这种结构中,吻合马达210将“自定心”,使轴212的轴线与螺杆250的轴线对准,在典型的实例中,这也是缝合钉控制轴线80。
使轴212与螺杆250对准的第二种典型实施方案表示在图1至图5。在该实施方案中,柔性联轴器240的近端固定在轴212上(可转动的和在纵向方向上)。这个连接是通过将轴212的远端装入柔性联轴器240的近端孔241形成的。见图12。然后将轴212用近端定位螺钉213固定。螺杆250有近端延伸段251,该延伸段插入到柔性联轴器240的远端孔242,并且用远端定位螺钉252固定。应当注意图中所示的柔性联轴器240在中部有隆起。在典型的柔性联轴器240上,零件用铝制或塑料模制,在中心部分圆周有螺旋形切口。在这种结构中,柔性联轴器240的一端能够在任何径向相对于另一端移动(360度)(如同万向接头),这样就提供了所要求的柔性,以有效地将轴212与螺杆250的中心轴线对准。
螺杆250的近端延伸段251的直径小于中间连接安装座230内的孔231的直径。孔231的远端有两个直径增大的台阶。第一个直径增大的台阶的尺寸与螺杆衬套260的近端半径配合,螺杆衬套由比中间连接安装座230的材料软的材料形成。近端半径螺杆衬套260仅仅是保持螺杆250轴向对准,不吸收或传递任何纵向推力。第二个直径增大的台阶的尺寸与螺杆250的近端推力轴承270配合。在一种典型的推力轴承270上,近端板和远端板将轴承球保持板和轴承球夹在中间。当施加高达250磅的纵向力发射钉仓50内的缝合钉时,推力轴承270吸收所有作用在轴212的纵向推力。螺杆250的近端延伸段251有不同尺寸的直径对应于螺杆衬套260和推力轴承270的内部。因此,马达安装座220和连接安装座230形成两个装置,将柔性联轴器240固定在这两个装置之间。
转动螺杆250用远端半径螺杆衬套280保持在远端板232内,螺杆衬套280与近端半径螺杆衬套260相似。因此,螺杆250在远端板232内自由转动。为了将螺杆250的转动转变成远端直线移动,螺杆250在移动螺母290内加工有螺纹。螺母290的移动限制在完成击发缝合钉所需要的移动量,换言之,螺母290移动的距离,只需要在钉仓50与抵钉座60之间足够形成闭合的缝合钉和在钉仓50内伸出刀片(如果有),然后缩回同样的距离。当螺母290在最近端位置时(见图12),缝合钉静止并且准备击发。当螺母290在最远端位置时,缝合钉穿过和包围钉仓50与抵钉座60之间的组织被吻合,刀片(如果有)穿过组织,将组织切割下来。螺母290的最远端位置被远端板232的位置限制。因此,螺杆250的螺纹的纵向长度和远端板232的位置限制螺母290向远端的移动。
螺杆250与螺母290之间的摩擦损失导致通过钉仓柱塞320传递到钉仓50的总力(磅)显着降低。因此,要求以优化法选择螺杆250和螺母290的材料和螺杆250的螺纹螺距。已经发现用低摩擦聚合物制造螺母290将使摩擦力减小到足以传递大约250磅纵向力到钉仓柱塞320的远端,这个力是有效地击发缝合钉的所需要的数值。两种示范性的材料具有所要求的特性,在本领域中被称为DELRINAF Blend Acetal(一种含有均匀地扩散在DELRIN缩醛树脂中的TEFLON纤维的热塑材料)和RULON(一种混合形式的聚四氟乙烯)或其它类似的低摩擦聚合物。
螺母连接支架300纵向固定在螺母290上并且随螺母290一起移动。螺母连接支架300为比较软而光滑的螺母材料提供支撑。在所示的典型装置中,支架300具有形状与螺母290的外形相对应的内腔。因此,螺母290紧贴地固定在连接支架300内,螺母290的移动转化为螺母连接支架300的相应移动。在典型装置中,连接支架300的形状被其周围的部件和所承受的纵向力限定。例如,在螺母290的远端有空腔302,其形状用于容纳远端板232。螺母连接支架300也有远端室304用于容纳一个加强杆310。加强杆310增加纵向支承和形成螺母290与钉仓柱塞320之间的连接部分(见图5),这是手柄10内的元件与钉仓50之间最后一个移动连接。安装在螺母连接支架300与加强杆310之间的击发支架330加强螺母连接支架300与加强杆310之间的连接。
吻合器1的各种部件互相连接,形成脊梁。这根脊梁是一个架子,提供多方向稳定性和由四个主要零件组成(从近端到远端的顺序):抵钉座控制架110、近端脊梁板70(见图3、4、6、7)、远端脊梁板340和抵钉座颈部30。这四个零件中的每一个零件在纵向方向上并可转动地按这个顺序互相固定和形成骨架,手柄的其余部件以某种方式连接到这个骨架上。部件的横向支承由柄体10内表面的形状提供,在典型的装置中柄体10形成两半,左半柄体11和右半柄体13。或者,支承可以是冲压或结合到半个柄体11、13上的单个框架。
抵钉座控制组件100的功能参照图17至27描述。为了用吻合器1进行吻合程序,整个抵钉座60从吻合器1卸下,如图17所示。按下抵钉座打开开关20,伸出套管针尖410的远端,所述套管针尖装在钉仓内和在纵向固定地连接放螺杆250上。套管针尖410的顶点现在能够穿过或刺入被吻合的组织。这时使用者可以将抵钉座60从组织的相反一侧重新装到套管针尖410上(见图18),从而锁定抵钉座60。操作抵钉座闭合开关22,开始对着钉仓50闭合抵钉座60,压紧抵钉座与钉仓之间的空隙62内的组织。
为了描述套管针尖如何控制抵钉座60的移动,参看图8至10、14、15和18。如图15中的虚线所示,杆导销143装在远端半螺母142的中心孔144内。由于螺纹杆180拧入转动螺母140、141、142,销143锁住螺纹182的近端,将销143包围。这样,螺母140连同销143在螺纹182内的转动将根据螺母转动方向导致杆180向近端或远端移动。螺纹182有可变螺距,如图14和15所示,以便以不同的纵向速度移动抵钉座60。当销143在螺距较长的螺纹部分(下部)183时,抵钉座60纵向移动较快。当销在螺距较短的螺纹部分(上部)184时,抵钉座纵向移动较慢。应当注意,在螺距较长的螺纹部分(下部)183,销143是唯一接触螺纹182的部分。因此,销143这时经受作用于杆180的整个纵向力。销143的强度足以承受这种力,但是可能不足以承受抵钉座60对着夹住的组织闭合时产生的所有纵向力。
如图14所示,杆180具有较短螺距的螺纹部分184,与近端半螺母141的中心孔144的近端对应的内螺纹145接合。当较短螺距的螺纹部分184与内螺纹145接合时,螺纹部分184的整个横向表面与内螺纹145接触。这个接触表面比销143与螺纹182的任何部分接触的表面要大得多,因此能承受抵钉座60闭合产生的所有纵向力,尤其是在缝合钉击发状态当抵钉座60闭合时产生的纵向力。例如在典型的装置中,销143最高承受接近30至50磅的纵向力。与能够承受高达400磅纵向力的螺纹比较,几乎有10比1的差距。
抵钉座控制组件100的一种替代实施方案可以取消杆180复杂的螺纹。在这种装置中,杆180有单螺纹螺距,抵钉座马达120根据单螺纹杆180的纵向位置以不同的速度驱动(通过电路板500上的相应的程序)。
在用于驱动马达120、210的任何实施方案中,控制程序可以有许多形式。在一种典型实施方案中,蓄电池供电的电路板500上的微型控制器可以采用脉冲调制(例如脉冲宽度、脉冲频率)控制任何一个或两个马达。而且由于吻合器1是一种低负荷循环装置,或是一种一次使用装置,被驱动的部件可以超过容许的制造技术规范。例如,齿轮箱的扭矩可以超过规定的额定值。另外,例如6伏电压的驱动马达可以超电压,例如用12伏电压。
抵钉座60从延伸位置闭合到没有压缩组织或仅仅轻微压缩组织的位置可以迅速进行而不损坏夹在中间的组织。因此,螺距较长的螺纹部分183允许使用者在组织预压缩状态下较快地使抵钉座60向组织靠近。随后希望较慢地压缩组织,以便使用者能够控制,避免过度压缩组织。为此,在运动的后一阶段使用螺距较短的螺纹部分184,使使用者有更大程度的控制。在这种压缩过程中,可以使用图18中所示和序号为60/801,989的共同待决美国临时专利申请中描述的力开关400,通过组织压缩指示器14向使用者指示(和/或输入到电路板500的控制电路),压缩组织的力大于力开关400内的弹簧420的预负载。应当注意,图18所示的处于正常打开位置的力开关400是序号为60/801,989的美国临时专利申请的第一个实施方案。也可以用应变计测量组织压缩。
图19至23显示杆180从抵钉座延伸位置(见图19、20)到1厘米闭合距离的位置(见图21)、缝合钉准备击发位置(见图22)和最后的抵钉座完全闭合位置(见图23)的移动。杆180的移动由杆180上的凸轮表面推动器185与装在柄体10内的一系列微型开关的推动杆或按钮之间的接触进行电气控制(通过电路板500)。
当杆180(和抵钉座60)在完全伸出位置时,杆全伸开关610处于柄体10远端的(见图19),使推动器185压住全伸开关610的推动杆。1厘米开关612定位于柄体10内的中间位置(见图20和21),防止在杆180(和抵钉座60)在完全闭合位置的1厘米范围内时杆180的1厘米凸轮表面186压住1厘米开关612的推动按钮。在通过1厘米闭合距离后,如图22所示,凸轮表面推动器185与缝合钉准备击发开关614接合。如图22和23所看到的,推动器185的下端在缝合钉准备击发开关按钮614的按钮的前后两侧有一斜角,推动按钮的两个斜角之间的距离(或仅仅它的平坦部分)对应于吻合钉仓50内的缝合钉的吻合形成范围(即安全击发长度)。因此,当缝合钉准备击发开关614的按钮第一次被压下时,抵钉座60与钉仓50之间的距离处于成功击发和闭合缝合钉的最长范围。在按钮被压下时,抵钉座60的分离距离62仍然在安全吻合范围(见图18)。但是,当不再压下缝合钉准备击发开关614的按钮时(因为推动器185靠近按钮),那么缝合钉将不击发,因为对于治疗性吻合来说距离太近。图23显示杆180在最近位置,这由推动器185的顶端接近杆完全缩回开关616的柄指示。当推动开关616时,电路板500上的程序防止马达120向杆缩回方向转动;换言之,开关616是杆180向近端方向缩回的停止开关。
应当注意,图2和3、图11和12和图16显示的杆180的远端没有与其它装置的远端连接(因此应当与力开关400的近端接触)。为了清楚,杆180的远端与力开关400的近端的连接带在图中没有示出。在一个实施方案中,拉带是平的和柔性的,通过抵钉座颈30,横向穿过钉仓柱塞320弯曲的下方,向上到力开关400的近端。当然,如果没有装力开关400,连接带应当连接到套管针尖410的近端,套管针尖可拆卸地连接到抵钉座60的近端。
吻合控制组件200的功能对照图12至16和图24至27,尤其是对照图24描述。吻合马达210保持在马达轴承222与马达轴盖224之间。吻合马达210的轴212可转动地连接到柔性联轴器240的近端,柔性联轴器240的远端可转动地连接到螺杆250的近端,它在设置于中间连接安装座230和远端板232内的轴承260、270、280上旋转,纵向传动螺母290拧到中间连接安装座230与远端板232之间的螺杆250上。因此轴212的转动转变为螺杆250相应的转动。
螺母连接支架300纵向固定在螺母290、加强杆310及击发支架330上。击发支架330纵向固定在钉仓柱塞320上,钉仓柱塞向上(通过没有画出的缝合钉驱动器)延伸到钉仓50(或到缝合钉)。用这种连接,螺母290的纵向移动转化为钉仓柱塞320相应的纵向移动。因此,当缝合钉击发开关22被起动时,导致吻合马达210转动足够的时间,以便缝合钉完全从钉仓50击发出(如果装有切割刀片,刀片伸出,完全割下抵钉座60与钉仓50之间的组织)。如下面所述,击发以后,电路中的程序则导致钉仓柱塞320缩回,从抵钉座与钉仓之间的空隙62退出缝合钉击发零件的任何部分和或钉仓内的刀片。
这种吻合运动还通过与电路板500用电连接(例如导线)的微型开关进行。第一个开关(近端吻合开关618)控制所述吻合控制组件200的缩回和限定所述吻合控制组件200的最近端位置。为了起动这个开关,起动板306以可调节的方式连接在螺母接支架300的一侧,见图6和24。这样,当螺母290向近端移动,导致螺母连接支架300上的起动板306起动近端吻合开关618时,切断吻合马达210的电流,停止吻合控制组件200继续向近端方向移动。
控制吻合控制组件200移动的第二个开关位于加强杆310远端横向表面的相反一侧,见图27。在这个表面装有纵向可调节的凸轮312,凸轮与远端吻合开关620接触。在一个实施方案中,凸轮312是一个螺丝,拧入加强杆310的远端孔。因此,当螺母290向远端移动而导致加强杆310上的凸轮312起动远端吻合开关620时,切断吻合马达210的电流,停止吻合控制组件200继续向远端方向移动。
图28和29显示可拆卸的连接组件,以便在抵钉座30的远端更换不同的钉仓60。
柄体10最近端腔室确立了容纳电源600的空腔。电源600通过电路板500连接到马达120、210和吻钉合器1的其它电气部件。
吻合器1的电气部件在通过电路板500的控制方面已经作了一般描述。正如上面实施方案中所描述的,电动吻合器1包括两个驱动马达120、210,所述马达由蓄电池供电和通过按钮20、21和22控制。马达120、210的移动范围由限位开关610、616、618和620控制在行程终点及沿着行程的中间位置612、614。马达120、210的控制逻辑线路可以用几种方法实现。例如可以用继电器或梯形逻辑定义马达120、210和开关610、612、614、616、618和620的控制算法。这种程序是简单但是有局限性的方法。更灵活的方法是采用以微处理器为基础的控制系统进行感知开关的输入信号、锁定开关、接通指示灯、记录数据、发出听觉反馈信号、驱动可视显示屏、询问识别装置(例如射频识别装置(RFID)或密码识别装置)、感知力、与外部装置通信、监测蓄电池寿命等。微处理器可以是为界面连接和控制带有复杂机电控制系统而制造的集成电路的组成部分。这种芯片的例子如由Atmel提供的Mega 128和由PIC提供的PIC 16F684。
这种处理器需要有软件程序提供控制指示。一旦完全开发,可以将程序写入处理器和长期储存。这种系统使控制算法的改变比较简单;对安装到处理器的软件的改变可调整控制和用户界面,无须改变写入程序或装置的机械布局。
对于一次性装置,接通电源只发生一次。在这种情况下,通过拉下接头片或从装置上永久性去除的脱扣装置(release)来完成接通电源,该去除使发生蓄电池接触,即可向装置供电。
在任何实例中,当装置接通电源时,控制程序开始执行,在使用装置之前,进行例行程序,确保知道伸出/缩回和击发子组件的实际位置,叫做复位程序。复位程序可以在制造商向用户发运之前执行。在这种情况下,执行复位程序、设定组件位置、装置在准备好使用状态下向用户发运。一旦接通电源,装置鉴别其位置并准备使用。
用视觉指示器(例如发光二极管)向使用者提供反馈信号。在使用按钮开关20、21、22的情况下,在开关可运行时指示灯亮(或从背后照亮),在开关不能运行时指示灯熄灭。指示灯可以闪烁,向使用者传递另外的信息。按压按钮后如果发生延迟响应,例如,指示灯能够以不断逐渐增加的速度闪烁作为对紧急情况的响应。指示灯还可以用不同颜色指示各种状态。
在吻合器1的不同位置使用凸轮推动限位开关,所述限位开关向处理器提供位置信息。通过使用各种长度的直线凸轮,可以设定位置范围。也可以用编码器代替限位开关(绝对的和递增的定位)。限位开关是二进制的:接通和断开。用编码器(例如光学编码器)可以代替二进制提供位置信息。提供位置反馈信息的另一种方法包括在驱动子组件的马达端部安装脉冲发生器。通过计数脉冲以及了解马达转速与直线行走的比率,可以推导出绝对位置。
用处理器建立储存数据的能力。例如,可以储存重要的预先安装信息,比如可以储存装置序列号和软件版本。使用吻合器1时也可以用存储器纪录数据。每一次按压按钮、每一次限位开关转换、每一次异常中止的击发、每一次完成的击发等都可以储存,供以后检索和诊断。通过程序口或无线地检索数据。在一个实施方案中,通过按压一系列按钮可以把装置设置到诊断模式。在这种诊断模式,技术人员能够向吻合器1询问某些数据或传输/输出某些数据。吻合器1对这种询问的响应可以是发光二极管闪烁,或者如果有显示屏,显示可视字符数据或电子数据。如上所述,可以用应变计模拟输出和提供可接受的应变带。另一种方法是用第二个附加弹簧和支承部件机械地设定应变带。
一个单次击发钉合器1的控制算法的实例可以包括下列步骤:
○接通电源。
○验证原始位置和如果有必要或需意,回到原始位置。
○运行伸出/缩回按钮(灯亮)和使缝合钉击发按钮不能运行(灯不亮)。
○只有在完全伸出(抵钉座卸下)和随后用保持运行的伸出/缩回按钮缩回后才能运行缝合钉击发按钮。
○一旦起动缝合钉击发按钮,抵钉座缩回直到力开关被起动。
○用击发按钮的发光二极管的闪烁开始倒计数和随着击发循环迫近增加闪烁速度。继续监测力开关和缩回抵钉座,以便使力开关保持起动。
○在缝合钉击发循环过程中,任意按钮按压可停止缝合钉击发程序。
○在缝合钉击发马达运行之前如果发生异常中止,击发循环停止,抵钉座伸出到原始位置,缝合钉击发按钮保持可运行和准备再击发。
○另一种情况是如果在击发马达移动过程发生异常中止,击发循环停止,击发马达缩回,抵钉座回到原始位置,击发按钮变得不能运行。因此,吻合器(或钉仓)不能使用。
○完成击发倒计数之后,缝合钉范围限制开关被询问位置。如缝合钉范围限制开关被起动意味着抵钉座在可接受的缝合钉击发范围内则缝合钉击发马达运行,击发循环开始。如缝合钉范围限制开关没有被起动,则击发循环异常中止,抵钉座回到原始位置,缝合钉击发按钮保持运行,准备再击发尝试。
○完成缝合钉击发以后,抵钉座保持在闭合位置和只有伸出按钮保持运行。一旦抵钉座伸出到至少到原始位置,伸出和缩回两个按钮可运行。完成缝合钉击发以后,缝合钉击发按钮保持不能运行。
在上述整个典型循环中,按压按钮、开关状态、异常中止和/或击发可以被记录。
在手术过程中,吻合器是单向装置。但是在试验模式,试验者需要有能力根据需要将套管针410和抵钉座60向后和向前移动。接通电源结构允许使用者为试验目的进入手动模式。这种试验模式可以分离和将吻合器重新设定在使用模式进行包装和发运。
为了包装,希望(但不是必须)将抵钉座60放置在离开钉仓50一定距离。因此,回归原始位置顺序可以编程,在切断电源进行包装和发运之前,将抵钉座60置于离钉仓50一厘米(例如)的位置。
当电动吻合器从包装中取出和准备用于手术时,使用者接通吻合器电源(开关12)。在达到正确的缝合钉击发位置和要求的组织压缩状态之前的任何时间,不应当允许击发缝合钉。因此,抵钉座/套管针的伸出/缩回功能是唯一被运行的功能。在这种状态下,伸出和缩回按钮20、21灯亮,缝合钉击发开关22灯不亮(即不能运行)。
在病人体内使用之前,套管针410伸出,抵钉座60被去掉。如果吻合器用于结肠吻合(例如),套管针410缩回到抵钉座颈30内,钉仓50和抵钉座颈30从肛门插入结肠切开处下游一侧。与此相反,抵钉座60通过上游腹腔镜切口插入并放置在切开处上游一侧。抵钉座60连接到套管针410,两个零件向钉仓50缩回,直到缝合钉进入准备状态。如上所述,抵钉座移动到基本上没有压缩组织、具体说没有使组织脱水的距离。在这个位置,当需要时可以击发缝合钉。
通过起动缝合钉击发开关22开始缝合钉击发程序。在击发程序的任何时间,不论在移动之前(在变白(blanching)循环过程)或移动过程(不论缝合钉是否开始形成),可以停止缝合钉击发。软件编程开始缝合钉击发倒计数顺序,因为程序知道在缝合钉击发之前组织需要压缩和脱水。因此,缝合钉击发开关22被起动之后,抵钉座60向位于中间的组织靠近,开始压缩组织。缝合钉击发程序包括最佳组织压缩(0TC)测量和反馈控制机构,使得只有当压缩在要求的压力范围(叫做OTC范围)和经过足够的时间,使被压缩的组织中脱除液体时,才能击发缝合钉。根据抵钉座60与钉仓50之间被压缩的组织的已知特性,预先知道OTC范围(力开关可以调节,用于不同组织的OTC范围)。正是力开关400提供OTC测量和向微处理器提供信息。所述信息指示该特定组织的OTC已经达到。例如,可以用发光二极管向使用者指示OTC状态。
当击发程序开始时,缝合钉击发开关22的灯以给定速度闪烁,然后闪烁速度越来越快,直到发生击发。如果在这个等待时间没有激发异常中止,在预编程的切开期间将保持OTC状态和在倒计数结束后产生缝合钉击发。在用环形缝合钉吻合结肠的例子中,切开处的吻合与组织切割在切开处中心同时发生。这种切割保证缝合钉圆环中部具有效截面,在手术结束后足够形成用于正常的结肠功能的开口。
随着液体从夹在中间的压缩组织被脱除,组织上的压缩力自然会减小。在某些情况下,可能减小到OTC范围之外。因此,程序中包括取决于力开关400提供的连续测量值的闭环回路抵钉座压缩控制。由于有这种反馈,被压缩的组织在整个过程、甚至在脱水后仍保持在OTC范围内。
在缝合钉击发循环期间,使用者起动任何控制开关都能使缝合钉击发程序异常中止。如果在缝合钉击发马达210起动之前发生异常中止,击发循环停止,抵钉座60缩回到原始位置,缝合钉击发开关22保持可运行,如果需要准备进行再击发尝试。另一种情况是如果在缝合钉击发马达210移动过程发生异常中止,击发循环停止,缝合钉击发马达210导致抵钉座60伸出到原始位置。在这个位置,缝合钉击发开关22变得不能运行。因此,吻合器(或特定的钉仓)不能再使用(除非更换钉仓)。
应当注意,在发生缝合钉击发之前,缝合钉限制开关被询问关于钉仓50和抵钉座60的相对位置。如果缝合钉范围限制开关被起动-意味着抵钉座60处于可接受的缝合钉击发范围-则缝合钉击发马达210可以被起动和允许开始击发循环。如果缝合钉范围限制开关没有被起动,则击发循环异常中止,抵钉座60退回到原始位置,缝合钉击发开关22保持可运行,准备再次击发尝试。
下面描述向马达和/或端部执行器的任何部分(例如抵钉座或吻合器/切割器)的传动系供电。应当知道,这种供电不限于使用者按一次起动按钮,向马达供电也不限于一次供电。对装置中任何马达的控制可以要求使用者按压几次起动按钮,例如,第一次起动按钮使端部执行器的一部分移动第一个三分之一位置,第二次起动按钮移动第二个三分之一,第三次起动按钮移动最后一个三分之一。更准确地说,对于手术吻合器,第一次典型的起动可以移动缝合钉滑架或刀片通过锁定器,第二次典型的起动可以使零件移动到组织,第三次典型的起动可以使滑架通过所有缝合钉到达钉仓端部。与此类似,向马达供电也不需要是持续的,例如从刀片开始移动一直到连续移动到终点时的向马达供电。相反,可以用脉冲模式运行马达,第一种实例包括在驱动端部执行器的功能时定时由电源向马达供电和断电。更准确地说,对于吻合器,当缝合钉/切割刀从近端位置/起动位置到最远端位置,马达每秒钟可以有10次脉冲运转。这种脉冲可以直接控制或通过微处理器控制,两种方法都能可调脉冲频率。作为一种替代方法,或者除此之外,马达可以用脉冲调制操纵(脉冲宽度或脉冲频率),脉冲发生在很短的时间(例如十分之一、百分之一、千分之一或百万分之一秒)。因此,当电源、马达和/或传动系在这里描述为供电时,可以预见和包括上述任何模式和其它可能的运行模式。
在一次完整的缝合钉击发以后,抵钉座60保持在闭合位置,只有伸出开关20保持可运行(所有其它开关被失效)。一旦抵钉座60至少伸出到原始位置,伸出开关20和缩回开关21可运行,但是缩回开关21不允许抵钉座60的闭合超过原始位置。在一次完整的缝合钉击发以后缝合钉击发开关22保持失效。
如上所述,抵钉座颈30内装有与套管针410相连的直线力开关400。开关400校准到当施加给定的拉力时开关起动。给定拉力设定在对应于吻合发生之前施加到特定组织要求的压力。将开关400与处理器界面连接,能够保证击发缝合钉只能发生在OTC范围内。
下面的内容是根据本文描述的发明的一种典型装置执行方法的程序列表。下面的内容只是提供一种范例,熟悉这种技术的人应当知道,根据本发明的编程方法可以采用许多不同的形式达到相同的功能。
′Circular Stapler Program using the rev 3c board(cb280 chipset)V8.03(CS-3c-080306.CUL)
′8-3-06
′Modified program to abort with only fire button,added pbcountvariable
′Added PWM ramping
′7-28-06
′final tweaks-stan is now an integer etc.
′7-17-06 This version written for the 3c board.
′7-14DEBUGGING VERSION
′Program written for 3c board using the Cubloc 280 chipset
′Note:this program is a modified version of the ones noted below.All changes not related to the addition of the E/R limit switches
′apply.The programs below were written to deal with the″graylogic″of the 1 cm switch.This version uses
′a limit switch at either end of the extend/retract stage.
′V6.20 Final Version of Gray Logic program as used in prototype0,serial number 100
′V6.05
′modified the extend to cm 1 and retract to cm 1 routines to makesure that when they are cal led that they move the motor until thecm
′switch is closed;ie:When the anvil is all the way out and theretract button is pressed,retract the anvil until the cm limitswitch
′is closed regardless of whether the retract button is releasedbefore the cm switch is closed.Same change for when the anvil is
′ext ended from the 1 cm position.
′made changes to comments in the extend/retract routines
′
′V6.02
′added loop requiring the release of both buttons to exit jogroutine,and a 1 second delay at the end of jog subroutine before
′going back to main routine
′reformatted datadump labels
′added variables for high and low speed pwm values
′added extend only capability at end of completed fire to preventcrushing stapled tissue
′NOT WORKING-REMOVED added checks To ensure 1 cm switch Is madewhen extending Or retracting from the 1 cm And fully extendedpositions respectively
′V6.01
′All prior versions were made for testing the program on the Cublocdevelopment board.All outputs were pulled LOW.The actual device
′requires all the outputs to be pulled high(+5V).This versionis set-up to run on the actual device.
′limi ted the values of the EEPROM data to 255 max
′added delays before changes in motor direct ion,made program runsmoother
′removed pwmoff commands.They were not allowing the motors to stayon when changing subroutines(for some reason)
′V5.27
′added the recording of jog routine button presses
′added the recording of datadump requests
′V5.26
′added the recording of Extend/Retract button presses
′added serial number field in eeprom
′the datadump routine now keeps running total of data as it is readfrom eeprom
′V5.25(circular-stapler-5-25.cul)
′added code to allow storage of data each power on cycle in eeprom
′V5.24 works well,no known bugs(circular-stapler-5-24.cul)
′
′KMS Medical LLC(c)2006
′MAP
′P10 Extend Button
′P11 Retract Button
′P12 Fire Button
′P13 Extend Limit
′P14 Retract Limit
′P15 Fire Forward Limit
′P16 Fire Back Limit
′P17 1 cm Limit Switch
′P18 Staple Range Limit Switch
′P19 Force Switch
′P20 Extend Button LED
′P21 Retract Button LED
′P22 Fire Button LED
′P23 Force LED(blue)
′P24 Not USED
′P25 Not USED
′P26 Not USED
′P27 Not USED
′P28 Not USED
′P29 Staple Range LED(green)
Const Device=cb280′Comfile Tech.Cubloc CB280 chipsetDim ver As String*7
ver=″3C-8.03″′set software version here
Dim extendbutton As Byte
Dim retractbutton As Byte
Dim firebutton As Byte
Dim firs tout As Byte
Dim firstback As Byte
Dim cmstatus As Byte′1cm limit switch status
Dim srstatus As Byte′s taplerange limit switch status
Dim x As Integer
Dim powerons As Byte′s tore in eeprom address 2
Dim cycnumfires As Byte′store in eeprom(powerons*5)
Dim cycabortfires As Byte′s tore in eeprom(powerons*5)+1
Dim cycers As Byte′s tore in eeprom,number of cycle extend/retractpresses
Dim cycjogs As Byte
Dim arm As Byte
Dim completefire As Byte
Dim stapleranges tatus As Byte
Dim bail As Byte
Dim ds As Integer′eeprom data start location for individual cycledata writing
Dim fast As Integer
Dim slow As Integer
Dim extendonly As Byte
Dim extlimit As Byte
Dim retlimit As Byte
Dim speed As Integer
Dim dracula As Byte
′initalize outputs
Out 20,0′extend button LED
Out 21,0′retract button led
Out 22,0′fire button led
Out 23,0′force led
Out 29,0′staple range led
′initialize variables
firstout=0
firstback=0
completefire=0
arm=0
bail=0
cycnumfires=0
cycabortfires=0
cycers=0
cycjogs=0
extendonly=0
′CHANGE PWM VALUES HERE
fast=60000′highspeed pwm value
slow=60000′lowspeed pwm value
speed=0
Output 5′turns on pwm output for PINCH
Output 6′turns on pwm output for FIRE
′read totals from eeprom
powerons=Eeread(2,1)
Incr powerons′increment total power on number
If powerons>=255 Then powerons=255′limit number of recorded
powerons to an integer of one byte max
Eewrite 2,powerons,1′write total power on number to eepromds=powerons*5
′JOG and DATADUMP Check
′push any button within 2(or so)seconds to go to jog routine
′hold all three buttons on at startup to dump the data
For x=1 To 50
If Keyin(10,20)=0 And Keyin(11,20)=0 And Keyin(12,20)=0 Then
datadump ′write all stored data to the debug screen
Exit For
Elseif Keyin(10,20)=0 Or Keyin(11,20)=0 Or Keyin(12,20)=0Then′either e/r button or the fire button pressed
jog
Exit For
End If
Delay 20
Next
′-------------------------------------------------------------
′HOMING SEQUENCES
′-------------------------------------------------------------
cmstatus=Keyin(17,20)′read the status of the 1cm limit switch
If cmstatus=0 Then
homeretract
Elseif cmstatus=1 Then
homeextend
End If
′Return fire motor to back position
homefire′this returns the fire motor to the full retractedcondition(P6 limit switch)
′****************************************************************************************
′Main Loop
′****************************************************************************************
Do
′Debug″Main Loop″,Cr
′Delay 1000
cmstatus=Keyin(17,20)′read the 1cm switch
′staplerangestatus=Keyin(5,20)′read the staplerange limitswitch
extendbutton=Keyin(10,20)
retractbutton=Keyin(11,20)
firebutton=Keyin(12,20)
If cmstatus=0 And Keyin(13,20)<>0 Then
Out 20,1′turn extend led on
Out 21,1′turn retract led on
Elseif cmstatus=0 And Keyin(13,20)=0Then
Out 20,0′turn off extend led because extend limit met
Out 21,1′turn on retract limit
Elseif cmstatus=1 Then
Out 20,1
Out 21,0
End If
′check firebutton led status
If firstout=1 And firstback=1 And arm=1 And completefire<>1 Andcmstatus<>0 Then
Out 22,1′turn on fire button led
Else
Out 22,0′turn off fire led
End If
′check for extend retract button press
If extendbutton=0 And cmstatus=0 Then
extend
Elseif cmstatus=1 And extendbutton=0 Then
extend
End If
If retractbutton=0 And cmstatus=0 Then′And extendonly=0
retract
End If
′check for firebutton press
If firebutton=0 And firstout=1 And firstback=1 And arm=1 Andcompletefire<>1 And cmstatus<>0 Then initialfire
Loop′keep looping til powerdown
End′End of program
′**************************************************************
′
′ SUBROUTINES
′
′**************************************************************
′------------------------------------------------------------------------
′HOME:retract to cm switch=not pressed
′------------------------------------------------------------------------
Sub homeretract()′retract until 1 cm switch is open
′Debug ″Homeretract″,Cr
′Delay 1000
Pwm 0,slow,60000
Do Until Keyin(17,20)=1′retract until 1 cm switch is open
Out 31,1′ER motor reverse
Loop
Out 31,0′er motor off
Out 21,0′turn retract led Off
Out 20,1′turn extend led On
Pwmoff 0′turn pwm off
End Sub
′------------------------------------------------------------------------
′HOME:extend to cm switch=pressed
′------------------------------------------------------------------------
Sub homeextend()′extend until 1 cm switch is closed
′Debug″Homextend″,Cr
′Delay 1000
Pwm 0,slow,60000
If Keyin(17,20)=1 Then
Do Until Keyin(17,20)=0′now the 1 cm switch is pressed
Out 30,1′ER motor forward DDD
Loop
End If
Out 30,0′DDD
Pwmoff 0
Delay 300
homeretract′once the switch is made,call homeretract
End Sub
′----------------------------------------------------------------------------
′Fire motor homing routine
′----------------------------------------------------------------------------
Sub homefire()
′Debug″Homefire″,Cr
′Delay 1000
Pwm 1,slow,60000
Do Until Keyin(16,20)=0′retract firing stage until back switch
is closed
Out 33,1
Loop
Out 33,0
Pwmoff 1
End Sub
′--------------------------------------------------------------------------
′JOG Routine
′--------------------------------------------------------------------------
Sub jog()
Out 20,1
Out 21,1
Do
Delay 25
If Keyin(10,20)=0 And Keyin(11,20)=0 Then Exit Do′if bothbuttons pressed,exit jog routine and start homing routine after1 second delay
If Keyin(10,20)=0 And Keyin(11,20)<>0 And Keyin(12,20)<>0 Then
Pwm 0,slow,60000
′Out 30,1′extend motor forward
Do Until Keyin(10,20)<>0 Or Keyin(13,20)=0
Out 30,1′extend motor on forward DDD
Loop
Out 30,0′extend motor off forward DDD
Pwmoff 0
Incr cycjogs
If cycjogs>=255 Then cycjogs=255
Eewrite ds+3,cycjogs,1
End If
If Keyin(11,20)=0 And Keyin(10,20)<>0 And Keyin(12,20)<>0 Then
Pwm 0,slow,60000
Do Until Keyin(11,20)<>0 Or Keyin(14,20)=0
Out 31,1′extend motor reverse
Loop
Out 31,0′extend motor off reverse
Pwmoff 0
Incr cycjogs
If cycjogs>=255 Then cycjogs=255
Eewrite ds+3,cycjogs,1
End If
If Keyin(12,20)=0 And Keyin(10,20)=0 Then ′jog the fire motorforward
Pwm 1,slow,60000
Do Until Keyin(10,20)<>0 O Keyin(12,20)<>0 OrKeyin(15,20)=0
Out 32,1′fire motor forward
Loop
Out 32,0′fire motor off forward
Pwmoff 1
Incr cycjogs
If cycjogs>=255 Then cycjogs=255
Eewrite ds+3,cycjogs,1
End If
If Keyin(12,20)=0 And Keyin(11,20)=0 Then ′jog the fire motorreverse
Pwm 1,slow,60000
Do Until Keyin(11,20)<>0 Or Keyin(12,20)<>0 OrKeyin(16,20)=0
Out 33,1′fire motor reverse
Loop
Out 33,0′fire motor off reverse
Pwmoff 1
Incr cycjogs
If cycjogs>=255 Then cycjogs=255
Eewrite ds+3,cycjogs,1
End If
Loop
Do Until Keyin(10,20)=1 And Keyin(11,20)=1′let off both buttonsbefore exiting jog routine
Delay 10
Loop
Out 20,0′turn on e/r button leds
Out 21,0
Delay 1000
End Sub
′------------------------------------------------------------------------
′Extend until extend limit is met
′------------------------------------------------------------------------
Sub extend()
Out 22,0′turn off fire button led while extending
Out 21,0′turn off retract button led while extending
Pwm 0,fast,60000
Do Until Keyin(10,20)=1 Or Keyin(13,20)=0′extend until either theextend limit is closed or the extend buttonis released
Out 30,1′ER motor forward DDD
Loop
Out 30,0′DDD
If firstout=0Then ′this will keep the extend motor going on thefirst extension until the anvil is all the way out
Do Until Keyin(13,20)=0
Out 30,1′DDD
Loop
End If
Out 30,0′DDD
Pwmoff 0
Incr cycers
If cycers>=255 Then cycers=255
Eewrite ds+2,cycers,1
If Keyin(13,20)=0 Then
firstout=1′set the firstout flag to enable fire button
Out 20,0′turn off extend led
End If
End Sub
′------------------------------------------------------------------------
′Retract until cm switch is open
′------------------------------------------------------------------------
Sub retract()
Out 22,0′turn off fire button led while retracting
Out 20,0′turn off extend button led while retracting
Pwm 0,fast,60000
Do Until Keyin(11,20)=1 Or Keyin(17,20)=1′retract until eitherthe 1cm switch goes open or the extend button is released
Out 31,1′ER motor reverse
Loop
Out 31,0
Pwmoff 0
Incr cycers
If cycers>=255 Then cycers=255
Eewrite ds+2,cycers,1
If Keyin(17,20)=1 Then
firstback=1
Out 21,0′turn retract led off
End If
If firstout=1 And firstback=1 Then arm=1′set the arm flag to arm
the fire button
End Sub
′------------------------------------------------------------------------
′DATADUMP Routine
′------------------------------------------------------------------------
Sub datadump()
Dim chef As Byte
Dim tf As Byte′total fires
Dim ta As Byte′total aborts
Dim ers As Integer
Dim tj As Byte
Dim tdd As Byte
Dim stan As Integer
Dim kyle As Byte
Dim token As Byte
Dim ike As Byte
Dim kenny As Byte
Dim sn As Byte
tf=0
ta=0
ers=0
tj=0
tdd=0
Eewrite ds+4,1,1′write 1 to the ds+4eeprom register denoting that
datadump was accessed
Delay 1000
sn=Eeread(0,1)
Debug″Circular Stapler Stored Data″,Cr
Debug″Version″,ver,Cr
Debug″KMS Medical LLC″,Cr
Debug″---------------------------------″,Cr
Debug Cr
Debug″Serial Number:″,Dec sn,Cr
powerons=Eeread(2,1)
If powerons>=255 Then powerons=255
Debug″Total Cycles:″,Dec powerons,Cr
Debug Cr
Debug″---------------------------------″,Cr
Debug Cr
For stan=5 To(powerons*5)Step 5
Debug″Cycle″,Dec(stan/5),Cr
Debug″---------------------------------″,Cr
chef=Eeread(stan,1)
tf=chef+tf
Debug″Completed Fires:″,Dec chef,Cr
kyle=Eeread(stan+1,1)
ta=kyle+ta
Debug″Aborted Fires:″,Dec kyle,Cr
token=Eeread(stan+2,1)
ers=token+ers
Debug″E/Rs:″,Dec token,Cr
ike=Eeread(stan+3,1)
tj=ike+tj
Debug″Jogs:″,Dec ike,Cr
kenny=Eeread(stan+4,1)
tdd=kenny+tdd
Debug″Datadumps:″,Dec kenny,Cr
Debug Cr
Next ′stan
Debug″---------------------------------″,Cr
Debug ″Cycle Totals″,Cr
Debug Cr
Debug″Completed Fires:″,Dec tf,Cr
Debug ″Aborted Fires:″,Dec ta,Cr
Debug ″E/R Presses:″,Dec ers,Cr
Debug ″Jog Presses:″,Dec tj,Cr
Debug ″Datadumps:″,Dec tdd,Cr
Debug Cr
Delay 1000
For x=1 To tf′blink the number of completed firing cycles
Out 22,1
Delay 500
Out 22,0
Delay 500
Next ′x
Do Until Adin(0)>800 And Keyin(3,20)=1′wait until datadump
buttons are released
Loop
End Sub
′-------------------------------------------------------------------------
′Initial fire
′-------------------------------------------------------------------------
Sub initialfire()
Dim f As Integer
Dim p As Integer
Dim t As Integer
Dim y As Integer
Dim z As Integer
Dim q As Integer
Dim timmy As Integer
Dim butter As Integer
Dim numblinks As Integer
Dim fbcount As Integer
Debug clr,Cr
′turn off extend and retract buttons to show that they are notactive for abort?
Out 20,0′extend button
Out 21,0′retract button
bail=0
t=15′total blink time
p=3′number of blink periods
Pwm 0,fast,60000
′start blink and adjust pinch motor to force
f=(t*1000)/p
fbcount=0
If Keyin(12,20)=1 Then fbcount=1
For y=1 To p
numblinks=(t*y)/p
For z=1 To numblinks
timmy=f/numblinks
butter=timmy/50 ′calibrate this to seconds
If timmy=0 Then timmy=1
If Keyin(12,20)=0 And fbcount=1 Then
bail=1′set abortfire flag
Exit For
End If
If Keyin(12,20)=1 Then fbcount=1
Do Until Keyin(19,20)=0 Or Keyin(14,20)=0′retract
until force switch met or retract limit met
Out 31,1
If Keyin(12,20)=0 And fbcount=1 Then
bail=1′set abortfire flag
Exit Do
End If
If Keyin(12,20)=1 Then fbcount=1
Loop
If bail=1 Then Exit For
Out 31,0
Out 23,1′force led
Out 22,1′fire button led
For q=0 To butter
Delay 10
If Keyin(12,20)=0 And fbcount=1 Then
bail=1′set abortfire flag
Exit For
End If
If Keyin(12,20)=1 Then fbcount=1
If Keyin(19,20)=1 Then Out 23,0
Next ′q
If bail=1 Then Exit For
Do Until Keyin(19,20)=0 Or Keyin(14,20)=0′retract untilforce switch met or retract limit met
Out 31,1
If Keyin(12,20)=0 And fbcount=1 Then
bail=1′set abortfire flag
Exit Do
End If
If Keyin(12,20)=1 Then fbcount=1
Loop
Out 31,0
Out 23,1
If Keyin(12,20)=0 And fbcount=1 Then
bail=1′set abortfire flag
Exit For
End If
If Keyin(12,20)=1 Then fbcount=1
Out 22,0
For q=0 To butter
Delay 10
If Keyin(12,20)=0 And fbcount=1 Then
bail=1′set abortfire flag
Exit For
End If
If Keyin(12,20)=1 Then fbcount=1
If Keyin(19,20)=1 Then Out 23,0
Next′q
If bail=1Then Exit For
Next ′z
′Debug Dec?fbcount,Cr
If bail=1Then Exit For
Next ′y
Pwmoff 0
If bail=1 Then
abortfire
Else
′staplerangecheck
finalfire
End If
End Sub
′----------------------------------------------------------------------
′Staple Range Check Routine
′----------------------------------------------------------------------
Sub staplerangecheck()
srstatus=Keyin(29,20)′read the staplerange limit switch
If srstatus=0 Then
finalfire
Else
abortfire
End If
End Sub
′---------------------------------------------------------------------
′Final Fire Rout ine
′---------------------------------------------------------------------
Sub finalfire()
Out 23,0′turn force led off
Out 20,0′turn extend led off
Out 21,0′turn retract led off
Out 22,1′Turn on fire led to signify final fire abort ready
Pwmoff 1
′Pwm 1,fast,60000
′Out 32,1′fire mot or forward DDD
completefire=1
Do Until Keyin(15,20)=0′fire forwa rd until forward limit is met
If speed>=60000 Then speed=60000
If speed<60000 Then
speed=speed+10000
End If
Pwm 1,speed,60000
Out 32,1
Delay 50
If Keyin(12,20)=0 Then′Or Keyin(10,20)=0 Or Keyin(11,20)=0
bail=1
Exit Do
End If
Loop
Out 32,0′fire motor fwd off DDD
speed=0
Delay 250
Do Until Keyin(16,20)=0′retract fire motor
If speed>=60000 Then speed=60000
If speed<60000 Then
speed=speed+10000
End If
Pwm 1,speed,60000
Out 33,1
Delay 50
Loop
speed=0
Out 33,0
Pwmoff 1
Out 22,0′turn fire led off
Out 21,0′turn off retract led
extendonly=1
Incr cycnumfires
If cycnumfires>=255Then cycnumfires=255
Eewrite ds,cycnumfires,1′write the current cycle number of firesto the eeprom
Delay 200
End Sub ′return to the main routine
′-------------------------------------------------------------------
′Abort fire
′-------------------------------------------------------------------------
Sub abortfire()
′Debug ″Fire aborted before firing!!″,Cr
Out 31,0′turn retract motor off
Out 32,0′turn fire forward off DDD
Out 23,0′turn force led off
Pwm 1,fast,60000
Delay 250
Do Until Keyin(16,20)=0′retract fire motor
Out 33,1
Loop
Out 33,0
Pwmoff 1
Out 22,0′turn fire led off
Incr cycabortfires
If cycabortfires>=255Then cycabortfires=255
Eewrite ds+1,cycabortfires,1′write the current cycle abortfiresto the eeprom
Delay 200
homeextend ′extend to 1cm
End Sub
上面还提到使用带有可拆卸和/或可更换部分的端部执行器的识别装置的可能性。这种识别装置可以用于跟踪使用和库存。
一种典型的识别装置采用射频,被称作RFID。在一种典型的实例中,医疗吻合器采用可再装、可更换的钉仓,如本文描述的吻合器1,RFID可以装在钉仓内,以保证与特定的吻合器相适合,用于感知适合的钉仓的RFID阅读器可以与柄体联系。在这种结构中,阅读器询问装载钉仓内的RFID。RFID用吻合器验证的独特编码回答。如果钉仓如所验证的那样标记,则吻合器变得可运行,准备使用。如果钉仓被拒绝,则吻合器发出拒绝指示(例如发光二极管闪烁、听觉信号、视觉信号)。为了避免意外或不正确的阅读附近的钉仓,可以建造RFID阅读器的天线,当钉仓安装在吻钉合器内或非常靠近(最佳的位置在装置的远端)时只阅读该RFID。使用RFID可以结合机械锁止装置,以保证每一个钉仓只允许一个击发循环。RFIDs具有缺点,因为阅读器成本高,要求天线比较大,阅读距离比较近,一般以厘米计量。
可以采取其它无线电鉴别措施。可以用活动的RFIDs。同样,可以使用红外线(IR)传输装置。但是这两种方法要求在接受端产生动力,有成本高和尺寸大的缺点。
另一种典型的识别装置采用加密。加密后需要有处理号码,与这种计算先联系的是使用处理芯片(例如微处理器),其中一种是装在可更换的零件上,例如钉仓或可更换的端部执行器轴。这种加密芯片具有一定特性,能够为本发明的手术器械的最佳化进行分析。首先,可更换的零件用单独的电源是不合乎要求的。这种电源不仅增加成本,而且增加重量和占用其它结构的位置或不能获得位置。因此,该零件的电源应当来自柄体内已有的电源。而且应当确保任何时间都能供电。因为可更换的零件比较小,加密芯片应当相应地小。另外,手柄和可更换零件形成可废弃的零件,因此,两个加密处理器的成本应当允许废弃。最后,可更换零件的加密装置与柄体的相应的加密装置之间的连接应当最少。正如下面将要讨论的,根据本发明的加密装置提供所有这些要求的特性,限制不需要的特性。
用来加密识别的装置在市场上可以买到。其中一种用于加密的装置是达拉斯半导体公司生产的,叫做DS 2432芯片。DS 2432芯片不仅提供阅读器与应答器之间的加密识别,而且还有存储器,可以储存装置特有的信息,这种信息及其使用将在下面详述。DS 2432的一个有利特性是这是一个单线装置。这意味着电源和输入及输出信号通过同一条线。用DS2432这样的单线装置,为了连接柄体和端部执行器,只需要单根线通过柄体10到抵钉座颈30的距离到达可更换的钉仓50。这种结构满足电气连接数量最少和降低制造成本的特点。DS 2432蕊片需要接地线也是事实,不过金属的抵钉座颈30是导电体,能连接到吻合装置1的接地线,因此,DS 2432芯片接地的典型的实例是通过导体直接与钉座颈30电气接触,或将芯片的接地线直接与钉座颈30连接。
一种典型的加密电路是在可更换的零件上(例如钉仓)装第一加密芯片。第一加密芯片的接地是电气连接到可更换零件的金属部分,这个金属部分再电气连接到装置的接地线,例如抵钉座颈30。DS 2432芯片的单线连接电气连接到可更换零件上某个位置的接触焊点,但是与接地线没有连接。例如,如果可更换的零件是线状60毫米钉仓,DS 2432可以附在或嵌入到最后的缝合钉组的电气绝缘的钉仓远端。加密芯片可以嵌入到与缝合钉发射面相反的钉仓侧面,以便在使用时芯片既不暴露于工作表面,也不暴露于暴露的组织。DS 2432芯片的接地导线可以电气连接到钉仓的金属外框架,金属外框架电气连接到吻合器的接地线。单线引线电气连接到与钉仓金属框架绝缘的第一个导电装置(例如焊点、引线或凸台)。单根有绝缘皮的导线在近端连接到电路板或连接到在吻钉合装置的柄体内在适当的控制电子器件上。这根导线与吻合器的其它部分绝缘,尤其是与接地的框架绝缘,从柄体延伸,通过抵钉座颈,到达可更换零件的接受室。在远端,绝缘的导线暴露出来,电气连接到第二个导电装置(例如焊点、引线或凸台),第二个导电体的形状保证当钉仓锁定在端部执行器时能可靠地接触钉仓上的第一个导电装置。在这种结构中,每当可更换零件(例如钉仓)被插入端部执行器,两个导电装置始终形成直接电气连接;在一种特定实例中,只有正确插入零件可能接触。
DS 2432芯片只有几平方毫米的面积,使芯片很容易安装到小的可更换零件上,例如钉仓,同时满足尺寸最小化的要求,例如小于50mm2。值得指出,DS 2432芯片比较便宜。为了保持与不能从外部检验的DS2432芯片的全部通信,可以用DS 2460(也是由达拉斯半导体公司制造)将从DS 2432接受的加密传输信息与内部计算的预期结果进行比较。这两个芯片的特性由达拉斯半导体公司的操作说明书3675解释,本文将其全部内容作为参考。DS 2460芯片比DS 2432芯片贵得多,但是DS2432还没有便宜到与与柄体一起废弃的程度。应当注意,医疗装置(例如本发明的手术器械)的可更换的废弃零件数量通常远远超过安装可更换零件的柄体数量。因此,如果DS 2432芯片装在可更换的零件上,DS 2460芯片装在柄体上,符合低成本加密的特性。也满足所需要的小尺寸,因为DS2460芯片所占的面积大约是31mm2。在操作说明书3675的图2,解释了使用DS 2432芯片的另一种替代的电路结构,这种电路取消了比较贵的DS 2460芯片,用局部微处理器(例如微处理器2000)进行比较。在这种结构中,吻合装置1增加加密的成本被降低,但是正如所解释的,这种结构放弃了安全的某些方面,可以检查被比较的两个数字。
在医疗装置上用加密进行电子验证可更换零件相同的过程用具有一个DS 2432芯片和一个DS 2460芯片的典型实例描述。加密装置典型的控制电路表示在图30。这个典型实例采用在柄体内含有微处理器2000的电路板上的直线吻合器描述。微处理器2000的一个自由I/O引脚2010连接到DS 2460的第一个引线2110,另一个I/O引脚2020连接到第二个引线2120。每个可更换零件2200具有DS 2432芯片和单线引线连接到微处理器2000的第三个I/O引脚。
为了启动程序,将可更换的零件2200连接到装置,与接地线和单线引线接触。当微处理器2000检测到新零件2200已经连接到装置1时,微处理器运行鉴别例程。首先,微处理器2000启动随机数,通过第一个通信引脚2012请求DS 2460。DS 2460有预编程的密码,与储存在可更换零件2200上的每一片DS 2432芯片的预编程的密码相同。因此,当相同的随机数提供给DS 2432芯片和DS 2460芯片时,两片芯片的输出结果相同。DS 2460产生一个随机数,通过第二个引脚2020提供给微处理器2000,微处理器通过引脚2030和单线引线转发给DS 2432芯片。当DS 2432收到随机数时,应用其SHA-1算法(由国家工业技术标准协会开发)加密地生成一个散列编码回答。这个散列编码回答通过单线引线传回微处理器2000和经过引脚2010或2020转发到DS 2460。在此期间,DS 2460也在计算自己的散列编码回答。首先,DS 2460在内部将与发到DS 2432相同的随机数应用到自己的SHA-1算法和在内部储存生成的散列编码回答。DS 2460还储存着由微处理器2000传来的DS 2432传输的散列编码回答。两个散列编码回答进行比较,如果相同,则可更换零件2200经过鉴别被确认。如果散列编码回答之间有区别,则零件2200被拒绝,装置或者处于零件2200不能使用的状态,或者处于只有在满足一定保护后才能使用的状态。例如,关于时间、日期、环境等数据和未被确认的零件的特性可以被储存,供以后或同时传给制造商或代理,告知制造商关于用户在装置上打算使用或已经使用未被授权的零件2200。如果信息没有加密,则鉴别信息可能被截获和伪造、非法拷贝,或未授权的零件2200可能被使用,而不是从授权经销商购买零件2200。在本文描述的典型的加密实例中,通过线路传送的能够检验的唯一信息是单随机数和单散列编码回答。众所周知,解密SHA-1生成的回答需要几百年,因此减少了对逆向工程的动机。
因为在这个例子中使用的每一片芯片有安全存储器,安全存储器只有在鉴别以后才能访问,安全存储器的编程可以对每次存入采用多秘密密钥。例如,如果DS 2460存储有多个密钥,每一个零件2200只有一个从这些储存的密钥中选择的密钥,则DS 2460可以对零件2200的“一般密钥”起“主密钥”的作用。
通过鉴别本发明的手术器械的可更换零件,可以得到许多积极的结果。首先,器械制造商能够防止用户使用未经授权的零件,保证只能使用授权的零件。这不仅保证制造商从销售可更换零件中获得专利权使用费,而且制造商能保证手术零件保持高质量。由于加密电路有存储器,本发明提供了巨大的利益。例如,如果一个直线吻合器的单端部执行器能够装30mm、60mm和120mm钉仓,每个尺寸的钉仓可以具有个性化的密钥,柄体的编程可以储存和使用这三个密钥。一旦接受到对应于一个密钥的散列编码回答,而不是另外两个内部计算的散列编码回答,柄体将知道哪一种钉仓已经插入吻合器。每个钉仓还可以在其存储器中包含钉仓特有的参数,例如不同尺寸的钉仓的缝合钉滑架的不同移动长度,因此,根据检测到的钉仓,导致柄体的作用不同。检验出的参数还能说明特定零件的修正等级。例如1级修正的钉仓可能有某些参数使用,通过检测这个特定的钉仓,程序可能导致柄体不允许使用1级修正的钉仓,而允许使用2级修正的钉仓,或反之亦然。
加密芯片有存储器还允许钉仓保持跟踪其它类型数据。例如,钉仓能够储存其所连接的每一个柄体的身份、击发过钉仓的柄体的身份、使用和/或连接的时间、日期和其它时态数据、击发钉仓用多长时间、在击发缝合钉过程启动几次以及许多其它类似的参数。当钉仓错误击发时可能储存一个特别的参数,这使制造商能确定是否是钉仓出错或是用户的错误,例如,后者可以进行调查,帮助用户纠正或进行其它培训。通过在柄体上提供存储器,可以储存其它与柄体有关的参数,例如每个程序的延续时间、每次击发缝合钉的速度、每次击发产生的扭矩和/或每次击发所承受的负荷。存储器可以只用已经装在柄体内的锂基蓄电池供电数年。因此能保证柄体数据的长期性。存储器能够用来储存特定柄体的全部使用情况和相关的日历数据。例如,如果只批准柄体在一次手术过程使用,但是柄体数据显示钉仓击发间隔几天或几周,当柄体为重复利用最后返回制造商时,制造商能够检测出用户(医院、医生、诊所等)不正确和可能不安全地使用柄体。加密鉴别也可以用于可拆卸蓄电池。而且可以在装置的任何部分增加传感器,用于加密芯片存储器内部储存的信息通信。例如温度传感器能够传送钉仓被击发时操作室的温度。这个温度读数可以用于确定如果后来的感染是否是由于操作过程不正确的温度控制(例如在没有空调的农村)。
在不多见的情况下发生吻合器在使用过程不能操作,提供有机械代用装置或应急装置(bail-out),允许手动将装置从病人体内取出。所有应急装置使用能够用这些加密芯片上的存储器记录。而且能够储存指出为什么需要使有应急的数据供以后检查。为了保证质量,当检测到应急时,柄体可以编程,指示应将证明函发给客户/用户,告知他们关于应急使用。
如上所述,本发明不限于以上作为典型实例的环形吻合器,可以应用于任何手术吻合头,例如直线吻合装置。因此,在后面的各种典型实例内容中使用直线吻合器。但是在这部分内容中使用直线吻合器不应当被认为只限于使用直线吻合器。
以上描述的是沿直线吻合器和环形吻合器吻合控制轴线80存在的部件,这些部件形成吻合控制组合件200。如前面所述,适当弹射缝合钉和切割组织所需要的力可能超过200磅,很可能达到250磅。已经确定,用直线电动手术吻合器对人体组织(例如结肠组织)进行有效的吻合和切割功能所需要的最小力是:
1)在大约3秒钟内通过大约60mm行程输送大约54.5kg(120磅)力;或
2)在大约8秒钟内通过大约60mm行程输送大约82kg(180磅)力。
本发明的电动手持式直线手术吻合装置能够满足这种要求,因为如下所述,它以新颖的方法达到优化。
为了产生符合上述要求的必要的力,机械组合件的最大功率(瓦)需要根据这些要求的最大极限计算:在3秒钟内通过60mm行程输送82kg力。通过数学转换,这些数字在传动系的输出端需要最大约16瓦的机械功率。电功率转换成机械功率不是1比1,因为马达的效率低于100%,传动系的效率也低于100%。这两个效率的乘积形成总效率。产生16瓦机械功率乘以总效率的倒数,所需要的电功率大于16瓦。一旦确定了所需要的电功率,可以检验电源是否满足最低功率要求。因此,可以进行不同电源的检验和优化。下面将详述这项分析。
电源与马达的匹配或优化包括调查二者的各个特性。当检验电动马达特性时,较大的马达相对于较小的马达能以较高的效率执行给定的工作量。另外,带稀土磁体或无心结构的马达能够以较小的尺寸输出相同的功率,但是价格较高。一般来说,如果马达的设计在给定时间内输出相同的功率,大马达比小马达成本低。但是用于手术吻合装置中,大马达有不理想的特性,因为安装马达的柄体尺寸受操作者手的限制。医生希望使用较小和较轻的装置,而不是较大和较重的装置。基于这些考虑,在本发明的手术吻合器中使用马达的成本、尺寸和重量是能够优化的因素。
可以在医生手中使用的马达包括具有比较便宜的陶瓷磁体的马达和具有比较贵的稀土(即钕)磁体的马达。但是后者与前者比较,功率的增加没有成本的增加多。因此,可以选择陶瓷磁体马达在柄体中使用。例如典型马达的标准尺寸(直径)是27.5mm和24mm。这些马达的额定效率大约60%(根据负荷的大小减小到30%或更低)。这种马达无负荷转速大约30,000转/分钟(20,000转/分钟和40,000转/分钟之间)。
即使这种传统的马达能够使用,也希望进一步减小尺寸。为此目的,发明者发现了,无蕊、电刷型、直流马达能产生类似的功率输出,但是尺寸显着减小。例如直径17mm的无蕊马达的输出功率几乎与直径24mm的标准马达的输出功率相同。与标准马达不同,无蕊马达的效率高达80%。无蕊马达几乎都用稀土磁体。
鉴于这种有限制的体积和需要的机械功率,要求选择具有最高效率的机械齿轮系。用齿条和小齿轮组合件作传动系的最后一控制级,比螺杆传动相比在驱动系中设置了一高效最后一级,因为一般来说齿条和小齿轮传动效率接近95%,而螺杆传动的最高效率大约是80%。对于直线电动吻合器来说,当装有60mm钉仓时(可以使用的钉仓尺寸从30mm到100mm,但是为了举例说明,在本实例中用60mm),吻合/切割机构有60mm移动距离。以这个移动距离,3秒钟的总移动时间,使齿条和小齿轮的延伸速度为每秒0.8英寸。为了以合理尺寸的齿条和小齿轮组合件实现这个速度,齿轮系应当将马达转速减速到接近60转/分钟。由于马达输出转速接近30,000转/分钟,传动系的减速比接近500比1。为了达到这个减速比,选择5级传动系。已知这种传动系每一级的效率接近97%。因此,与齿条和小齿轮的效率95%组合,传动系的总效率是(0.95)(0.97)5或82%。将马达效率60%与传动系总效率82%组合,得出总电动效率对最终机械效率比接近49.2%。知道这个总效率评分之后,在测定按要求操作吻合器所需要的电功率时,实际需要的电功率几乎是为产生吻合/切割力计算的电功率的两倍。
为了产生满足上述要求所必要的力,机械组合件的功率(瓦)可以根据在3秒钟内移动60mm需要82kg力计算,结果接近16瓦。已知总机械效率是49.2%,因此电源需要提供32.5瓦功率(16瓦机械功率≈32.5瓦×0.492总效率)。有了这个所需要的最小电功率,就可以确定驱动吻合器的蓄电池类型,其中包括高能量锂蓄电池。已知的高能量锂蓄电池特性(例如CR123或CR2蓄电池)是每个蓄电池产生5瓦峰值功率。因此,至少需要六个蓄电池串联才能产生所要求的32.5瓦电功率,再转变成16瓦机械功率。这一步并没有结束优化过程,因为制造的每一种型号高能量锂蓄电池对于发出峰值功率有不同的特性,这些特性对于施加的负荷是不同的。
不同的蓄电池特性能够区分第一个制造商的一种蓄电池与第二个制造商的另一种蓄电池。用来进行比较的重要蓄电池特性是那些限制蓄电池发出的功率的特性,其中包括:
●蓄电池内电解液的类型;
●电解液的浓度和化学性质;
●阳极极板和阴极极板是如何制造的(化学成分和机械构造);以及
●电阻正温度系数(PTC)装置的类型和结构。
试验一项或多项这些特性能得到用于选择吻合装置的最合乎要求的蓄电池的有价值信息。已经发现,检验最后一项特性-PTC装置特性-能够优化用于执行要求的工作的蓄电池类型。
大多数电源需要在长期比较确定和有效地执行许多次工作。当设计和制造电源时,为短时间使用与使用次数少组合选择电源不具有代表性。但是电动吻合装置的电源只在短时间使用和使用次数少。在每一次使用中,马达需要承受峰值负荷和需要不出错地工作。这就是说,对于手术吻合器,吻合/切割只在一次治疗过程中执行,最多循环10到20次,每一次使用需要承受装置可能的峰值负荷。在一个程序之后,装置退出使用和被废弃。因此,本发明的电源需要制造得与任何其它传统电源不同。
与不用于吻合装置的蓄电池的预期有用寿命比较,本发明的装置被制造成具有有限的蓄电池有用寿命。当这样制造后,装置在确定的“寿命跨度”预期工作很少次数。众所周知,自带电源(例如蓄电池)在某些使用之后有恢复能力。为了使本发明优化,装置在一定参数之内制造,相应地执行确定的程序,但是如果使用时间超过该程序,将限制或不能继续执行。虽然装置可能恢复和有可能重新用于不同的程序,但是装置被设计成使用蓄电池,使得它们很可能不能在超出预期的单次使用时间范围的有用寿命或临床寿命是确定的,这个寿命也可以描述为预期使用。应当知道,这个有用寿命或临床寿命不包括为确认装置能按要求工作在试验期内的使用时间。寿命也不包括装置在预期的程序以外被启动的其它时间,即不是根据手术程序被启动。
市场上提供的普通蓄电池是为两种使用方法设计的:(1)在短时间内提供较大的功率(例如像摄像机这样的高耗电数字装置)或(2)长期提供小功率(例如电脑的时钟备份)。如果不遵守任何一种使用方法,蓄电池将发热。如果对发热蓄电池不进行检查,可能发热到化学物质导致重大损坏的温度,例如爆炸。很显然,应当避免蓄电池爆炸。在普通蓄电池这些极端状态用PTC装置预防,这是一种当蓄电池温度增加时(即电阻正温度系数)为限制蓄电池导电而制造的装置。PTC装置在过电流和高温状况保护蓄电池和/或电路。有重要意义的是,PRC装置在外电路短路时保护蓄电池,在短路消除之后蓄电池能继续工作。某些蓄电池用一次性保险丝提供短路和/或过热保护。但是这种保险丝蓄电池的事故短路导致保险丝断开,使蓄电池变得不能使用。PTC保护的蓄电池比保险丝保护的蓄电池有优点,因为当短路消除后能自动“复位”,使蓄电池恢复正常工作。了解本发明中PTC装置的特性尤其重要,因为马达将输出比在典型高耗电应用中所见到的高几倍的电流。
PTC装置与阳极极板和阴极极板串联,在两个导电层之间形成一个部分导电层。在正常工作温度时(根据使用PTC装置的电路状况,例如从室温到40℃)PTC装置处于低电阻状态。当由于形成短路或过度放电导致异常大电流而产生高温时(根据使用PTC装置的电路状况,例如从60℃到130℃),PTC装置切换到极高电阻模式。简言之,当电路中包括PTC装置和异常电流通过电路时,该PTC装置进入较高温度状态,从而切换到较高电阻状态,将通过电路的电流降低到最低水平,因此保护电路中的电气元件和蓄电池。在最低电流水平(例如大约峰值电流的20%),蓄电池可以冷却到“安全”程度,这时可以输出较大的功率。PTC装置的部分导电层是碳粉和聚烯烃塑料的复合材料。由于这些装置在技术上已被描述和众所周知,不再赘述。
由于不同制造商的PTC装置电路以不同的特性行为工作,本发明利用这一特点,为优化选择与特定的马达和特定的用途匹配的特定的蓄电池提供一种方法。检验PTC装置切换到较高电阻状态的时间可以作为特定的马达和传动系与蓄电池的优化的指示。知道PTC装置切换的时间是合乎要求的,以致在吻合器正常使用时,PTC装置不发生切换。
典型的蓄电池充电至各种程度,从接近3安培到接近8安培。在高电流时,PTC装置立即改变到高电阻状态,使得对于标准的CR123蓄电池这个电流过高。已经确定,对于4到6安培电流,一个制造商的蓄电池比另一个制造商的蓄电池正温度系数装置启动较快。第二个制造商的最长的PTC装置切换延长时间对于4安培大于3分钟,对于5安培接近2分钟,对于6安培几乎是50秒。这些持续时间显着大于峰值负荷所要求的8秒。因此,可以确定与第一个制造商的蓄电池相比,第二个制造商的蓄电池是在峰值电流使用的最佳选择。
最初推断较高的电流和较低的或恒定的电压应当使蓄电池输出较大的功率。根据6个蓄电池串联的形式,峰值电源可以达到18伏,峰值电流只有6安培。将蓄电池并联,理论上应当有较大的峰值电流,3×2形式(两个并联的三个串联蓄电池)应当由9伏峰值电压和最大12安培峰值电流。
调查了不同的单个蓄电池,证实较低的电压(大约1.5至2伏)和接近4至6安培电流产生最大的功率瓦数。检验了两组6个蓄电池的形式:一组6×1形式串联和一组3×2并联。3×2形式产生最大峰值电流接近10安培。6×1形式产生6安培峰值电流,单个蓄电池在PTC装置转变状态之前能够产生5-6安培峰值电流。该信息指出,在串联组内任何单个蓄电池能够启动PTC装置,从而限制通过整个电池组的电流。因此,维持了用3×2形式在低电压获得峰值电流的推测性结论。
对三个不同的CR123蓄电池形式进行了试验:4×1、6×1和3×2,对于120#和180#负荷和给定的典型齿轮装置,以了解小齿轮推动齿条有多快(每秒英寸(“IPS”))。这项实际动态负荷试验结果显示在图3的表中,对于120#负荷:
●4×1蓄电池组在接近2.5安培电流和接近8伏电压时能够以大约每秒钟0.6IPS移动负荷;
●6×1蓄电池组在接近2.5安培电流和接近13伏电压时能够以大约每秒钟0.9IPS移动负荷;
●3×2蓄电池组在接近2.5安培电流和接近6伏电压时能够以大约每秒钟0.4IPS移动负荷。
对于180#负荷:
●4×1蓄电池组在接近4安培电流和接近7.5伏电压时能够以大约每秒钟0.65IPS移动负荷;
●6×1蓄电池组在接近4安培电流和接近12伏电压时能够以大约每秒钟0.9IPS移动负荷;以及
●3×2蓄电池组在接近4安培电流和接近7伏电压时能够以大约每秒钟0.4IPS移动负荷。
很清楚,峰值电流被限制,该限制取决于负荷。这个试验揭示出对于给定的负荷不论电源,马达输入较小的电流,但是电压根据电池形式变化。对于两种负荷,如预期的那样,6×1的形式功率输出最大,而不是3×2形式。由此确定电池组的总功率由电压决定,而不是由电流决定,因此并联形式(3×2)不是优化电源的途径。
按照传统,当设计马达的技术性能时,马达的绕组与马达预期的运行电压匹配。这种匹配考虑每次循环的持续时间和希望的产品总寿命。对于电动吻合装置,马达只使用很短的循环和只有很短的寿命,传统的匹配方法得出的结果低于最佳值。马达制造商给出的马达额定电压对应于绕组圈数。圈数越少,额定电压越低。在给定的马达绕组尺寸范围内,较少的圈数能够使用较粗的导线,因此较少的圈数导致较低的绕组电阻,较多的圈数导致较高的电阻。这种特性限制了马达流出的最大电流,这种最大电流在马达过载时产生大多数的热和破坏。对于本发明,合乎要求的形式将具有最低的绕组电阻,从电源(即蓄电池组)输出最大电流。通过以远远高于马达额定电压运转马达,尺寸类似的马达能输出显着增大的功率。用接近相同而只是绕组电阻不同(因此圈数不同)的无蕊马达试验验证了这个特性。例如,用6个蓄电池(即19.2伏电压)运转额定电压12伏和6伏的马达。额定电压12伏的马达输出峰值功率4瓦,在蓄电池输出0.7安培电流时电压只降低到18伏。相比之下,额定电压6伏的马达输出峰值功率15瓦,电压降低到15伏,但是输出2安培电流。因此,选择电阻较低的绕组能从蓄电池输出足够的功率。应当注意,马达绕组应当与特定的蓄电池组平衡,以便在失速状态马达不能从蓄电池输入足以启动PTC装置的电流,这种状况将在手术中延迟使用电动手术吻合器,这是不允许的。
6×1电池组看起来超出足够满足电动吻合装置要求。尽管如此,这时可以进一步对蓄电池进行优化,以确定是否必须有6个蓄电池执行所要求的工作。为此进行了4个蓄电池的试验,确定了在120#负荷下马达/传动系在3秒钟内不能将齿条移动60mm距离。对6个蓄电池进行了试验,确定了在120#负荷下马达/传动系能够在2.1秒钟内将齿条移动60mm距离,比要求的3秒钟快得多。还进一步确定了在180#负荷下马达/传动系能够在2.5秒钟内将齿条移动60mm距离,比要求的8秒钟快得多。此时,需要优化电源和机械布局,以确保没有“失控”的吻合/切割;换言之,如果负荷显着小于180#最大负荷或甚至小于120#最大负荷,则齿条移动太快是不符合要求的。
齿轮减速比和传动系统需要优化,以便在击发行程保持马达接近峰值效率。要求的在3秒钟内移动60mm行程意味着齿条最低速度为20mm/sec(0.8英寸/秒)。为了减少优化过程的变量数量,设定齿轮箱的减速比为333比1。最后的减速比由齿轮箱的输出轴214和齿条217之间的齿轮完成,其中该齿轮包括锥形齿轮215和小齿轮216(用于驱动齿条),简化的例子如图32所示。
这些变量可以与333比1的齿轮箱的输出轴214每一转齿条移动的英寸数结合。如果齿轮箱输出(rpm)始终不变,使输出轴每一转齿条移动的英寸数(“IPR”)与输出rpm匹配,以获得所要求的速度是很简单的功能:
(60rpm→1转/秒(rps);1rps @ 0.8IPR→0.8in/sec)。
在这种理想情况,如果根据速度标绘出IPR的典线,将产生一条直线。在一段固定距离的速度可以进一步简化为击发时间。因此,在这种理想状况,击发时间与IPR的曲线也是一条直线。但是马达输出(转/分钟)和因此齿轮箱输出转速不是固定的,因为这个转速随负荷而改变。负荷的大小决定马达能够输出功率的大小。随着负荷增加,rpm降低和效率改变。根据不同负荷下对效率的检验,已经确定效率峰值只有60%。但是在这个效率峰值对应的电压和电流与在功率峰值点的电压和电流不同。随着负荷增加,功率继续增加,直至效率的降低比功率增加快。随着IPR增加,预计速度将会增加,但是相应的IPR的增加降低机械效益,从而增加负荷。由于逐渐增大负荷效率相应地降低,这个增大的负荷意味着存在一个点,在这一点更高的齿条速度将不可能有更高的IPR。这种特性反映为在击发时间(秒)对IPR的曲线图上偏离预计的直线。本发明的系统的实验揭示出不必要的机械效益与不足的机械效益之间的边界线发生在接近0.4IPR。
从这个IPR数值,现在有可能选择锥形齿轮215的最终齿数比为输出轴的齿轮的齿数大约多三倍(3比1)。这个传动比转换成大约0.4的IPR。
既然锥形齿轮215已经优化,可以再检验电池组,确定是否能将6个蓄电池减少到5个或甚至4个蓄电池,这将降低成本和显着减小柄体内电源所需要的体积。大约120#的恒定负荷月于优化的马达、传动系、锥形齿轮、齿条和小齿轮,发现用4个蓄电池使齿条移动60mm用几乎5秒钟时间。用5个蓄电池时间减少到接近3.5秒。用6个蓄电池,时间是2.5秒。因此,插入这条曲线得出最少蓄电池形式是5.5个蓄电池。由于蓄电池数量只能是整数,需要用6个蓄电池满足电动吻合装置的要求。
据此,最小电源数量能够作为一个固定值计算,除非能够用提供相同电功率特性的不同规格的蓄电池。型号为CR2的锂电池具有与CR123相似的电功率特性,但是较小。因此,用6个CR2蓄电池电源,所需空间减少17%以上。
如上所述,为完成手术程序在要求的时间窗口内提供出合乎要求的输出力的总效率,电源(即蓄电池)、传动系和马达被优化。每一种电源、传动系和马达的效率经过检验,然后根据检验选择电源、传动系和马达的类型,以便在要求的时间内输出最大功率。换言之,检验在给定的时间内存在最大功率条件(电压和电流)而不启动PTC装置(例如大约15秒)。本发明确定电压-电流-功率值,所述值优化蓄电池向马达输出功率的方法。即使在这种优化以后,还可以进行其它改变,以改善电动吻合器的特性。
可以用另一类电源,叫做“混合”蓄电池。在这种形式中,可充电的锂-离子电池或锂-聚合物电池联接到一个或多个前面提到的优化蓄电池上(或者也许是另一个尺寸较小但是具有相似或较高电压的一级蓄电池)。在这种形式中,锂-离子电池向吻合/切割马达供电,因为在一个CR2蓄电池内含有的能量足够对锂离子蓄电池进行许多次充电,但是一次电池的输出是有限的。锂-离子电池和锂-聚合物电池内电阻很小,在短时间内能够输出很高的电流。为了利用这种有利的特性,一次电池(例如CR123、CR2或其它蓄电池)可以用10到30秒向二次蓄电池充电,二次蓄电池在击发过程形成马达的附加电源。锂-离子蓄电池的替代实例是使用电容器;但是电容器的体积效率低。即使如此,在马达供电系统可以装超级电容器;在操作者决定需要附加电源之前可以不联接。在需要附加电源时操作者将联接电容器,作为能量的附加“助力”。
如上面所提到的,如果马达负荷的增加通过给定点,效率开始降低。在这种情况下,可以使用多速比变速器,以便改变在要求的时间内输出的功率。当负荷过大使效率降低时,可以用多速比变速器切换齿轮速比,使马达回到较高效率点,在较高效率点至少能够提供例如180#力。但是应当注意,本发明的马达需要正转和反转。在反转模式,马达必须能够从“卡紧”的组织分离吻合/切割器械。因此,反转比正转产生更大的力是有利的。
由于显着变化的负荷,例如从很小的磅数到高达180磅,在负荷范围的低端传动组合件可能力量过大。因此本发明可以包括调速装置。可能的调速装置包括消耗性(主动)调速器和被动调速器。一种典型的被动调速器是飞轮,例如授予Palmer等人的美国2005/0277955号专利申请中披露的能量储存元件56,456。可以使用的另一种被动调速器是“飞”桨轮。这种装置用风阻力调速,因为随着转动加快,能吸收更多的力,从而当马达转动过快时提供调速功能。另一类调速器可以是压缩弹簧,马达将弹簧缓慢地压到压缩状态。当需要起动时,松开被压缩的弹簧,允许全部能量在较短时间内传递到传动系。另一个典型调速器实例包括多极开关,各级开关分别联接到不同的分电池组。当需要小力时,可以起动第一个或第一部分开关,在电源电路只接入少数蓄电池。随着需要的功率增大,使用者(或自动计算装置)可以在电源电路增加接入的蓄电池。例如在6个蓄电池形式中,前4个蓄电池在第一个开关位置连接电源电路,第五个蓄电池与在第二个开关位置连接,第六个蓄电池与第三个开关位置连接。
电动马达和相关的齿轮箱在使用时产生一定的噪音。本发明的吻合器将马达和/或马达传动系与柄体隔离,以便降低声音和振动特性,从而降低操作过程产生的总噪音。在第一种实例中,减振材料装在柄体与马达和传递系之间。材料可以是泡沫,例如乳胶、聚酯、植物型材料、聚醚、聚醚酰亚胺、聚酰亚胺、聚烯烃、聚丙烯、酚醛、聚异氰酸酯、聚氨酯、聚硅氧烷、尼龙、乙烯基树脂、乙烯共聚物、膨胀聚乙烯、含氟聚合物、或泡沫聚苯乙烯。材料可以是弹性体,例如聚硅氧烷、聚氨酯、氯丁二烯、丁基橡胶、聚丁二烯、氯丁橡胶、天然橡胶、或异戊二烯橡胶。泡沫可以是封闭蜂窝状、敞开蜂窝状、柔性的、网眼状、或复合泡沫塑料。材料可以装在柄体与马达/齿轮箱之间给定的位置或填满整个马达/齿轮箱周围的空腔。在第二种实例中,马达和传动系用另一个巢状箱箱结构内隔离,有时叫做“中国箱”或“俄罗斯筑巢洋娃娃”。在这种结构中,在马达/齿轮箱周围包裹上减振材料,然后将马达/齿轮箱装在第一个箱中,使齿轮箱轴从第一个箱中伸出。然后将第一个箱装在“第二个箱”内--手柄体-减振材料装在第一个箱与手柄内部之间。
本发明的电动吻合器可以用于手术。大多数吻合装置是一次性的,在一次医疗过程之后可以处理掉,因为成本相对比较低。但是电动手术吻合器成本较高,至少柄体需要在多于一次医疗过程使用。因此,使用后对柄体部件的灭菌成为一个问题。使用之前的灭菌也很重要。因为电动吻合器包含的电子部件没有经过标准的灭菌过程(即蒸汽或伽马射线),吻合器需要用其它方法灭菌(很可能费用更高),例如环氧乙烷气体。不过用伽马射线对吻合器灭菌比用气体灭菌成本低,是合乎需要的。已经知道电子部件在空间能够使用,空间是使电子部件暴露于伽马射线的环境。但是在这种应用中,电子部件需要在暴露状态下工作。与此相反,电动吻合器在暴露于伽马灭菌射线时不需要工作。当采用半导体时,即使切断电子部件的电源,伽马射线对储存的记忆也有不利影响。这些部件只需要经受这种辐射和只有终止暴露于辐射之后才准备使用。知道这一点,可以采取许多措施伽马硬化柄体内的电子部件。首先,代替使用MOSEFT储存器,比如可以熔性连接的储存器。对于这种存储器,一旦熔丝被编入程序(即烧断),存储器就成为永久性的和防伽马射线灭菌。第二种措施,存储器可以是掩码编程的。如果存储器是用掩码硬编程的,医疗灭菌伽马射线强度对程序没有不利影响。第三种措施,在易失存储器空载时进行灭菌,灭菌后可以通过各种措施对存储器编程,例如可以用无线电线路,包括红外线、无线电、超声波或蓝牙通信。另外一种方法是在清洁环境接触外部电极,这种导体可以对存储器编程。最后一种措施,在对伽马射线敏感的部件周围提供不透射线的屏蔽(例如用钼或钨制造),防止这些部件暴露在有潜在损害性的辐射中。
如上所述,蓄电池、传动系和马达的特性被检验和优化。用于电动吻合器。蓄电池的特定设计(即化学性质和正温度系数PTC)将决定能够提供的电流和/或一定时间内能够产生的功率。已经确定标准的碱性蓄电池不能在短时间内产生所需要的高功率,以便有效地驱动电动吻合装置。还确定了某些锂-二氧化锰蓄电池也不能满足驱动电动吻合装置的需要。因此,需要检验某些锂-二氧化锰蓄电池的构造特征,例如电解液和正温度系统数装置。
我们知道,传统的锂-二氧化锰蓄电池(例如CR123和CR2)是为长时间负荷设计的。例如SUREFIRE出售闪光灯和这种蓄电池,规定蓄电池在在闪光灯的最大输出流明时持续20分钟到几个小时(3到6小时)。在这个期间蓄电池的负荷没有接近蓄电池的功率容量。因此没有达到蓄电池的临界电流率,从而没有因过热爆炸的危险。如果这种使用不是连续的,蓄电池以同样的全功率输出能够经受许多循环(即几百次)。
简言之,这种蓄电池不是为10秒钟或更短,例如5秒钟的负荷设计的,也不是为使用次数很少,例如十次到十五次设计的。本发明所做的工作是配置电源、传动系和马达,优化用于使用次数少、每次使用经过的时间少于10秒和显着高于额定负荷的电源(即蓄电池)。
所有被检验的一次锂蓄电池都具有由各自的正温度系数(PTC)和/或化学性质及内部构造确定的临界电流率。如果在临界电流率以上使用一段时间,蓄电池将过热和可能爆炸。当遇到很高的功率要求(接近PTC阈值)而循环次数少,电压和电流特性曲线与原有技术标准使用的表现不同。已经发现某些蓄电池有正温度系数(PTC)装置,防止产生本发明的吻合器所要求的功率,但是其它蓄电池能够为驱动电动吻合装置产生所希望的功率(能够提供电流一个电压)。这意味着根据蓄电池的具体化学性质、构造和/或正温度系数(PTC),临界电流率不同。
本发明设计电源在临界电流率范围以上操作,在本文中称作“超临界电流率”。应当注意,在超临界电流率定义内也是一个由超过临界电流率的电源提供的经过调制的平均电流。由于蓄电池以超临界电流率供电不能长时间持续,所以蓄电池的使用时间缩短。蓄电池的这种以超临界电流率缩短的使用时间在本文被叫做“超临界脉冲放电期”,而电源使用的整个时间叫做“脉冲放电期”。换言之,超临界脉冲放电期小于或等于脉冲放电期,在这个期间电流率高于蓄电池的临界电流率。本发明的超临界脉冲放电期小于大约6秒,换言之,大约在半秒到15秒的范围内,例如,在2到4秒之间,更具体地说,大约3秒。在吻合装置的寿命期内,电源在临床过程中可能在脉冲放电期经受超临界电流率至少一次和少于二十次,例如,大约在五次至十五次之间,尤其在五分钟内在十次至十五次之间。因此,与电源的标准用途几个小时供电比较,本发明具有至多大约200至300秒,尤其大约225秒的合计使用,叫做“合计脉冲时间”。应当注意,在起动过程中,吻合装置可能不需要在一定的程序中始终超过或始终超过超临界电流率,因为装置所遇到的负荷取决于具体的临床应用(即某些组织比另一些组织密度高,高密度将增加装置的负荷)。但是,吻合器的设计在预期的手术使用中能够有一定次数超过超临界电流率。在这种超临界脉冲放电期工作时,装置能够操作足够的时间,以完成要求的手术程序,但是时间不能很长,因为要求电源以加大的电流供电。
当在增大的电流范围进行操作时,由装置(例如电动吻合器1)产生的力比原有的手动吻合器显着增大。事实上力大到能够损坏吻合器本身。在一种典型使用中,马达和传动组合件可以操作至损坏刀片锁定装置-在没有钉仓或钉仓座1030中的钉仓已经击发时防止刀片1060前进的安全装置。这个结构显示在图33。正如所讨论过的,只有当缝合钉滑架102出现在准备击发位置,即当滑架102处于图33的位置,才允许刀片106向远端移动。如果滑架102不在这个位置,这意味着两种情况之一,或者在钉仓座1030中没有钉仓,或者滑架102已经向远端移动-换言之,装载的钉仓已经发生部分地或完全击发。这样,不应当允许刀片1060移动,或应当限制其移动。因此,为了保证在击发状态滑架102支撑刀片1060,滑架102有锁定接触面104,刀片1060有相应形状的接触头1069。在此应当注意,在刀片1060向远端移动通过边缘1035之前,下导翼1065没有靠紧钉仓座1030的底板1034。由于这种结构,如果滑架102不在刀片1060的远端支撑接触头1069,那么下导翼1065不是在底板1034上前移,而是沿着接近边缘1035的凹槽1037移动和碰到边缘1035,防止刀片1060继续向前移动。为了在滑架102不存在(被称为“锁止”)时帮助这种接触,钉仓1030有板弹簧1090(由至少1个铆钉1036安装)用于偏移刀片1060。由于板弹簧1090向上弯曲和向下压住法兰盘1067(至少直到法兰盘1067远离板弹簧1069的远端),向下的力施加到刀片1060,将下导翼1065向下压入凹槽1037。因此,当刀片1060向远端移动而滑架102不存在时,下导翼1065沿着凹槽1037的下曲线移动,当下导翼1065的远端边缘碰到边缘1035时,停止继续向远端移动。
只要刀片1062传递到刀片1060的力没有大到足够从刀片1060撕下下导翼1065,这个安全装置就按照描述起作用。用本发明的电源、马达和传动系能够产生的力,刀片1060能够被向远端有力地推动,以致将下导翼1065撕开。如果发生这种情况,就不能防止刀片1060或滑架102向远端移动。因此,本发明提供一种方法,在下导翼1065通过边缘1035之前降低能够施加到下导翼1065的力。换言之,在刀片行程的第一部分(通过边缘1035)能够施加到刀片1060的力的上限减小,当下导翼1065离开边缘1035和靠在底板1034上之后能够施加到刀片1060的力增大。更准确地说,这种两部分力的发生限制器的第一个典型实例采用一种电路形式,在吻合/切割行程的第一部分,电源中的一个或几个蓄电池联接到马达,在吻合/切割行程的第二部分,电源中多数或全部蓄电池联接到马达。这种电路的第一种典型形式如图34所示。在这个实例中,当开关在“A”位置时,电源仅有一个蓄电池602(在本实例中可能有四个蓄电池)向马达(例如吻合马达210)供电。然而,当开关在位置“B”时,电源600所有4个蓄电池602向马达供电,因此提供给刀片1060的力增大。开关1100在位置“A”和“B”之间的控制可以用沿刀片控制组合件或沿滑架102某个位置安装的第二个开关进行,当下导翼1065通过边缘1035之后,第二个开关向控制器发出信号。应当注意,控制电路的第一个实例仅仅是范例,任何类似的执行组合件都能为装置提供锁定保护,例如图36所示的第二个典型实例。
马达正转和反转控制电路的第一个典型形式表示在图35。第一个典型实例用双投双刀开关1200。开关1200在正常情况下用弹簧偏置到中间位置,使双刀断开。图示的马达M可以代表本发明的吻合马达210。从图中可以看到,启动装置必须接通电源开关1210。当然这个开关是可选件。当希望马达M正转时,开关1200置于右侧位置,如图35所示,向马达供电,使其向第一个方向转动,被定义为正转,因为蓄电池的正极“+”联接到马达M的正极“+”。开关在正转位置时马达M驱动刀片1060向远端移动。安装适当的传感器或开关指示刀片1060或滑架102合乎需要的最前端位置可用于控制向前行程开关1220,开关1220中断向马达M供电,至少只要开关1220保持打开,就能防止继续向前移动。电路可以编程,绝不允许开关1220闭合和形成回路,或只有当装上新钉仓时才允许开关1220复位。
当需要马达M反转时,开关1200置于左侧位置,如同35所示,向马达供电,使其向第二个方向转动,被定义为反转,因为蓄电池的负极“-”联接到马达M的正极“+”。开关在反转位置时马达M驱动刀片1060向近端移动。安装适当的传感器或开关指示刀片1060或滑架102合乎需要的最后端位置能够用于控制向后行程开关1230,开关1230中断向马达M供电,至少只要开关1230保持打开,就能防止继续向后移动。应当注意,在电路中可以提供其它开关(用虚线箭头指示),以便独立于行程开关1220、1230可选择地防止向两个方向转动。
应当注意,马达能够用很大的力驱动齿轮系,驱动力转变成高的转动惯性。因此,当用图34和35中提到的任何开关停止马达转动时,齿轮可能不停止转动。相反,在马达断电时转动惯性继续驱动齿条217向移动的方向移动。这种移动在很多方面是不利的。通过适当配置供电和马达,形成能绝对消除这种断电后移动的电路,从而使用户能更好地控制移动。
图36显示一种典型的实例,当正转/反转控制终止时,马达(例如吻合马达210)被阻止继续转动。图36还显示另一种正转/反转控制和多级电源实例。图36的电路有一个采用马达短路特性的马达制动分电路。更准确地说,马达M被短路,以便使建立的电磁场与永久磁场相反,因此以显着防止惯性诱导的超过行程的速度减慢仍然转动的马达。为了解释图36的电路如何能制动马达M,提供了对正反转开关1300的解释。可以看到,正反转开关1300有三个位置,正像图35的开关1200一样。当置于右侧位置时,马达M正转,当置于左侧位置时,马达M反转。当开关1300不操作时(如图36所示),马达M被短路。短路线路表示在开关1300的上面部分。应当注意,制动开关的切换过程希望以延时的方式发生,称为先断后合切换形式。当从马达M转动切换到马达M制动时,在马达短路生效之前双刀双投正反转开关1300打开。反过来,当从马达M制动切换到马达M转动时,在开关1300启动马达之前短路打开。因此,在操作时,当使用者从正转或反转位置断开三向开关1300,马达M很快被短路和制动。
电路36的其它装置已经在图35解释。例如,有一个电源开关1210。还有一个电源锁止开关1100,在给定的移动部分(在行程开始或行程的任何其它需要的部分)只用一个蓄电池602向马达供电,在行程的其它部分用全部蓄电池602(例如6个蓄电池)向马达M供电。
一种正反转新的限制开关1320、1330防止马达M在正转限制开关1320动作以后继续正转。当达到限制位置时,正转限制开关1320起动,开关移动到第二个位置。在这种状态,马达没有正转电源,但是能够供给马达反转电源。正转限制开关可以是程序化的肘节开关或钉仓的一次性使用开关。更准确地说,开关1320将保持在第二个位置,直到用更换新钉仓产生开关复位。因此,在更换新钉仓之前,只能向马达M反转供电。如果开关仅仅是一个触发器,则只有当后退到离开操作开关1320时,电源才能够恢复,进行继续移动。
反转限制开关1330可以用类似方法形成。当达到反转限制位置时,开关1330移动到第二个位置和停在那里,直到产生复位。应当注意,在这个位置,马达M被短路,防止马达向任一个方向转动。由于这种形式,吻合器的操作被限制在单行程最远到前限制位置,单次后退最远到后限制位置。当两种情况都发生时,马达不能转动,直到两个开关1320复位。
现在来详细谈图,首先具体谈其中的图37到40,这些图展示本发明的电动手术装置1000的典型实例,在这些实例中,是一个电动手术直线吻合器。图37显示卸掉手柄外壳1001和1002的装置1000的左侧。与此类似,图39显示卸掉手柄外壳的装置1000的右侧。外壳1001和1002的两半只显示在图63至66,以便能够清楚地看到内部组件。端部执行器也没有在这些图和随后的图中显示出来。直线吻合端部执行器的典型实例在共有的和共同待决的专利申请族中详细描述,包括2005年7月26日提出的60/702,643号、2006年1月18日提出的申请号为60/760,000号和2006年6月8日提出的申请号为60/811,950的美国临时专利申请及2006年7月24日提出的序列号11/491,626和2006年9月29日日提出的序列号11/540,255和11/541,105,以及2007年8月24日提出的序列号11/844,406的美国专利申请。在此所述专利申请族全部被以引用的方式合并进来。
图38示出了装置1000卸掉左侧架子1010后的机械组件。图40用比较地示出了卸掉左侧和右侧架子1010、1020后的机械组件。
图37显示齿轮盖板1105,在其下面是马达变速器组件的第一级、第二级和第三级齿轮1110、1120、1130。在图37中还显示端部执行器闭合组件1400。将对照图59至60更详细地解释这个端部执行器闭合组件1400。
图37至38还显示电源和电源控制组件。在这个实例中电源组件1500是可卸下的蓄电池组,包含一个或几个蓄电池1510。如上所述,一种典型的电源是串联的四个和六个CR123或CR2电池。在这里是六个电池1510。在图37中位于左侧上面的一个电池1510a安放成能断开的状态,以便电源能够选择通过单个电池1510a或全部六个电池1510供给马达1520。这对只需要小电源的场合或希望禁止最大扭矩的场合有好处。前面提到的这种禁止最大扭矩的一种情形是关于移动缝合钉滑架或刀片通过锁定器。在缝合/切割行程的第一部分,典型的电路只连接这一个电池1510a到马达1520,在缝合/切割行程的第二部分,电源中的所有电池1510、1510a连接到马达1520。见图34。
在典型实例中电源控制组件1600采用摇臂开关1610的形式。向一个方向推动摇臂开关1610,马达1520向第一个方向转动,例如前进,向另一个方向推动摇臂开关1610,马达1520向相反的第二个方向转动,例如后退。
在典型实例中用电动传动系操纵直线切割器/吻合器的一个装置。在这里,用传动系驱动缝合/切割装置。为此,传动系连接到直线推动器1700,在此实例中,推动器形成一个齿条,该齿条沿导轨1720在远端和近端之间移动。如图38所示,齿条1700处于相对靠近近端位置。为了使外壳1001、1002在近端的尺寸最小(图38右侧),齿条1700有枢轴部分1710,当枢轴部分1710不包含在齿条导轨1720内时,枢轴部分自由向下转动(如图38所示)。随着齿条1700向远端移动(在图38向左),枢轴部分1710的底部接触齿条导轨1720的近端,并引起向上转动,由于齿条导轨1720的形状而转动到与齿条1700的剩余部分完全同轴线的位置。齿条导轨1720的近端在图41中能看到。
齿条1700的齿1702的形状能够与传动系的最后一级以齿条与小齿轮结构互相作用。由于传动系各种装置实际上都在图37至47,因此具体参照图43和46很容易看到对传动系的解释。在此应当注意,在许多图中某些变速级并没有画出齿。这是因为齿轮仅仅是特定典型实例的示意性表示形式。因此,没有齿或甚至没有表示出齿数或尺寸,不应当作为限制条件或固定条件。另外,图示的许多齿轮在齿内侧有中央光带。这条光带不能看作装置1000的部分,仅仅是用于建立瞬时应用数字的软件极限。
对传动系的解释从马达1520开始。马达1520的输出齿轮1522连接到变速器的第一级、第二级和第三级齿轮1110、1120、1130。第三级齿轮1130用联轴器连接到表示在装置1000左侧的最终齿轮。这个连接在所有图中很难看到,因为它位于内部。但是图55至56显示出第三级齿轮1130连接到第四级齿轮,即过桥齿轮1140。如前面提到的,第三级齿轮1130的输出端只是示意图-没有齿的圆筒。继续参照图46,过桥齿轮1140与第四级轴1142转动联接,轴1142从装置1000的左侧向右侧跨过齿条1700。轴1142的右侧没有以转动的方式在右侧直接联接到任何齿轮。而是转动内侧的轴承1144,轴承1144装在架子1020右侧内的对应的套内,架子1020从图46取消,以便能看清传动系右侧。
堡形齿轮1146(如图53所示)装在过桥轴1142上,与轴不能相对转动,但是能纵向移动。为了实现这种联接,轴1142有一条未画出的内槽,槽内装入一个未画出的销,此销穿过堡形齿轮1146的两个相对的口11462。将销固定在堡形齿轮1146上,轴1142的转动导致堡形齿轮1146相应转动,同时仍然允许堡形齿轮1146沿轴1142的纵向轴线至少移动到轴1142的槽的程度。如图46所示,堡形齿轮1146的右侧堡形突起11464的形状与第四级小齿轮1148左侧对应的堡形槽11482配合,如图54所示。由于要求堡形齿轮1146与第四级小齿轮1148可靠地啮合,需要一个右侧偏压力F。为了提供这个偏压力,可以提供一个弹簧一类的装置(未画出),使弹簧一端接触过桥齿轮1140的右面,另一端接触中央法兰盘11468的左面,该法兰盘从堡形齿轮1146的外圆柱表面向外沿径向突出,(法兰盘11468将在下面关于装置1000的手动松放装置中详细描述)。除了有代表性的弹簧以外,可以用任何类似的有偏压力功能的装置。这种结构使堡形齿轮1146有选择地与第四级小齿轮1148转动联接。更具体地说,当只有偏压力F作用到堡形齿轮1146而无其它力作用时,堡形突起11464将与堡形槽11482啮合,因此轴1142的任何转动将引起第四级小齿轮1148相应的转动。当施加与偏压力F相反的力并且克服偏压力,堡形突起11464从堡形槽11482退出,轴1142的任何转动对第四级小齿轮1148没有影响。正是这种可选择的接合允许进行手动松放。在解释这种松放之前,先描述右侧传动系。
第四级小齿轮1148与传动系的第五级1150直接接合,第五级由轴1152、固定在第五级州1152上不能转动的第五级输入齿轮1154和同样固定在第五级州1152上不能转动的第五级小齿轮1156。第五级小齿轮1156的齿直接与齿条1700的齿1702啮合。因此,第五级输入齿轮1154的任何转动引起第五级小齿轮相应的转动齿条1700的纵向移动。如图46的典型实例所示,第五级输入齿轮1154顺时针转动导致齿条1700向近端移动(退回),第五级输入齿轮1154逆时针转动导致齿条1700向远端移动(伸出)。
根据上述传动系第五级的联接,马达轴向一个方向转动将导致齿条1700纵向移动,但是只有当堡形齿轮1146与第四级小齿轮1148接合时齿条才能移动。当堡形齿轮1146与第四级小齿轮1148没有接合时,马达的转动对齿条没有影响。正是这两个齿轮1146、1148有不啮合状态,才有可能使齿条1700用手动松放。
在操作装置1000时,齿条1700向远端移动(伸出),推动端部执行器移动一定距离。在直线手术吻合/切割装置实例中,当齿条1700向远端移动时,发生吻合和切割的滑架(带有吻合传动装置和切割刀片)向远端移动,执行吻合和切割。由于实际上很难在每一个手术程序中将组织置于端部执行器的颚之间,医生不能预测滑架因任何原因被卡住的次数。在被卡住的情况下,滑架需要不使用马达而向远端退回。还有可能失去电源或者电动机严重不能使得输出轴固定的可能性。如果滑架在远端时失去电源,端部执行器的颚将闭合在组织之间,因此,在颚张开和释放组织之前必须向近端移动滑架。在这种情况下,齿条1700需要不使用马达而向近端移动。为了执行这种所希望的功能,本发明提供了手动松放组件1800。
在图37至44、55、59至62中,手动松放杆1810在未推动位置(例如向下)。在图45和57中,手动松放杆1810在中间位置。在图46、47、56和58中,手动松放杆1810在接近全推动位置(例如向上)。
当手动松放杆1810在未推动位置时,如图44所示,堡形齿轮1146与第四级小齿轮1148接合。因此,马达1520的输出齿轮1522的任何转动导致齿条1700的移动。但是第四级小齿轮1148不仅仅直接与第五级输入齿轮1154联接,还直接联接第一级松放齿轮1820,该齿轮又直接联接到第二级松放齿轮1830。因此,第四级小齿轮1148的任何转动必然导致第二级松放齿轮1830转动(转动方向取决于它们之间的齿轮数量)。如果齿轮1830的轴直接连接到手动松放杆1810,则第四级小齿轮1148每次转动时手动松放杆1810也转动。并且如果第四级小齿轮1148转动超过一转,则有可能导致手动松放杆1810转动360度。正如所预料的,这种情况不会发生,因为有单向齿轮组件将手动松放杆1810联接到第二级松放齿轮1830(见下面图48的解释)。应当注意,第一级松放齿轮1820有与齿轮同轴线伸出的带齿的轴1822。这根带齿的轴1822直接联接到指示轮1840。在指示轮1840的右表面可以看到,围绕指示轮轴线有一个曲线形状的线性展开,并且有与表面的其余部分不同的颜色。当与外壳1002右侧的窗口1004联接时(见图64至65),彩色的形状以线性方式变得越来越明显-对应于齿条1700从完全的近端位置(例如缩回)移动的距离。
图48示出了单向齿轮组件将手动松放杆1810联接到第二级松放齿轮1830。这个组件是通过提供棘轮齿轮1850形成的,棘轮齿轮1850的中心在杆1810的枢轴点,棘轮齿轮的轴1852伸到第二级松放齿轮1830的中心孔1832内。由于轴1852固定在第二级松放齿轮1830的中心孔1832内,这样,第二级松放齿轮1830的任何转动导致棘轮齿轮1850相应地转动。但是,当马达1520没有驱动传动系时,仅仅使棘轮齿轮1850随第二级松放齿轮1830转动本身并不能帮助手动松放齿条1700。
有两个手动松放项目建立手动松放功能。第一个是从左侧齿轮系和马达脱开右侧齿轮系的装置。这样就避免在推动手动松放时必须克服马达1520和左侧齿轮系产生的阻力。当堡形齿轮1146从第四级小齿轮1148分离时脱开联接。为了导致这种脱开,在棘轮齿轮1850与第二级松放齿轮1830之间安装一个凸轮板1860,该凸轮板固定在轴1852上不能转动,如图52所示。凸轮板1860有斜面1862,斜面的位置使其与堡形齿轮1146的中央法兰盘11468相互作用。凸轮板1860与中央法兰盘11468的相互作用可以从图44至47和图57至58的进展中看到。
在图44中,手动松放杆1810在未推动位置,这意味着堡形齿轮1146可转动地联接到第四级小齿轮1148是合乎需要的。这样,马达1520的任何转动将转变成第四级小齿轮1148的转动和齿条1700的移动。在图45至47和57至58中,手动松放杆1810处于几个推动位置之一,每个推动位置表示为充分转动凸轮板1860,使凸轮斜面1862接触堡形齿轮1146的中央法兰盘11468,并迫使堡形齿轮1146充分向左侧移动,使堡形突起11464从第四级小齿轮1148的堡形槽11482中分离。在这个位置,堡形齿轮1146从第四级小齿轮1148可转动地脱开。因此,马达1520(或左侧齿轮系的齿轮)的任何转动完全独立于右侧齿轮系,从而防止齿条1700随马达1520的转动有任何移动。
在右侧齿轮系从右侧马达和齿轮系的转动独立以后,为了有手动松放齿条的功能,齿条1700需要向近端方向移动。为了提供这种移动,设有前面提到的两个手动松放装置的第二个。第二个项目与棘轮齿轮1850的齿1832互相作用,以便使手动松放杆1810的逆时针转动(从装置1000的右侧看)导致棘轮齿轮1850逆时针方向旋转-在图示实例中这个方向是合乎需要的,因为这个方向导致第五级小齿轮1156顺时针转动-此转动对应于齿条1700向近端移动(例如缩回)。为了用松放杆1810逆时针移动控制棘轮齿轮1850,本发明提供一个棘轮爪1870,此棘轮爪转动地安装在松放杆1810的锁定凸台1814上。这种结构在图48最好地表示出来。一个未画出的片弹簧固定在松放杆1810的弹簧槽1816内,在朝向棘轮齿轮1850的方向D向棘轮爪1870施加片呀。但是应当注意,如果不用某种方式限制棘轮爪1870,棘轮爪1870将始终接触棘轮齿轮1850的齿1852和防止棘轮齿轮1850有任何顺时针转动-在现在的实例中当堡形齿轮1146与第四级小齿轮1148互相啮合(见图44)并一起转动时发生这种情况。为了防止这种状态,如图44和55所示,棘爪1870的远端有加宽部分1872,此加宽部分从棘爪槽1818向第二级松放齿轮1830伸出。由于在第二级松放齿轮1830与凸轮板1870之间有第二凸轮板1880,当松放杆1810在原始位置或未推动时,棘爪凸轮1882能够位于与加宽部分1872的底表面接触并将棘爪1870保持在棘爪槽1818内(通过在方向D的相反方向提供一个力,克服片弹簧的偏压力)。棘爪1870与棘爪凸轮1882之间的这种接触显示在图44和55。因此,当不推动松放杆1810时,棘爪1870不与棘轮齿轮1850的齿1852接触。反之,当手动松放杆转动通过足以从第四级小齿轮1148分离棘轮齿轮1850的位置时,棘爪1870的底表面不再接触不转动的第二凸轮板1880的棘爪凸轮1882,因此,当逆时针转动时,在方向D自由移动(有片弹簧的偏压力引起)接合棘轮齿轮1850的齿1852。这样,当顺时针转动时,棘爪1870顶住齿1852的顶表面。
例如在松放杆1810移动大约15度以后棘爪1870不再与棘爪凸轮1882接触,且堡形齿轮1146的堡形突起11464不再与第四级小齿轮1148的堡形槽接合。在这个位置,棘爪1870能够向轴1852移动并接合棘轮齿轮1850的一个齿1852。松放杆1810进一步逆时针移动相应地转动棘轮齿轮1850,这导致第二级松放齿轮1830相应地逆时针转动。随之,第二级松放齿轮1830的转动分别导致第一级松放齿轮1820顺时针转动、第四级小齿轮1148逆时针转动和第五级输入齿轮1154顺时针转动。如上面所指出的,第五级输入齿轮1154导致齿条1700向近端移动在连接到齿条1700的端部执行器装置的手动松放过程合乎需要的移动方向。由于松放杆1810被松放,回位偏压力装置1890迫使松放杆1810回到未推动位置(见图44),这导致棘爪凸轮1882推动棘爪1870回到其在棘爪槽1818的上部位置,与棘轮齿轮1850的齿1852分离。应当注意,通过棘爪凸轮1882的顶部前表面和顶部后表面及加宽部分的底部前表面和底部后表面各自的形状加工,使棘爪凸轮1882与加宽部分1872的下表面之间的接触光滑。还应当注意,在图46、57和58所示的回位偏压力装置1890,例如用螺旋弹簧,其一端绕在固定在松放杆1810的螺栓上,在图63-66示出了相反端是固定在外壳1001、1002部分的固定柱。螺旋弹簧1890的相反端固定柱在图中移动只是因为画图的限制。在本发明中不发生这种移动。
如上面所讨论的,本发明的装置1000的端部执行器的一个典型实例包括一组夹住组织闭合的颚和将被切割的组织两侧固定在一起的吻合器/切割器。上面描述的手动松放能够联接到吻合器/切割器,端部执行器闭合组件1400能够联接到颚,当操作时将颚闭合在一起。图59至60显示颚与端部执行器闭合组件1400之间联接的一个典型实例。在这里,端部执行器闭合组件1400由具有杆支承1412并且绕手柄枢轴1414转动的手柄1410组成。杆支承1412用枢轴连接到连杆1420的第一端。连杆1420的另一端用枢轴连接到滑块轴1430。端部执行器轴组件1900包括内轴1910和外轴1920。内轴1910纵向固定在架子1010、1020和端部执行器的下颚上,因此是端部执行器的纵向固定部件。外轴1920围绕内轴1910连接和在内轴上纵向移动。端部执行器的上颚相对于下颚绕枢轴转动。为了产生绕枢轴转动,外轴1920从图59所示的近端位置伸到图60所示的远端位置。因为外轴1920围绕内轴,一部分(例如上面部分)接触张开的上部颚的近端,上颚处在上颚枢轴的近端位置。随着外轴1920进一步向远端移动,上颚不能向远端移动,因为枢轴位置是固定的,但是能够绕枢轴转动。因此,上颚向纵向固定的下颚闭合。简言之,从图59至图60的进展中看到,当手柄1410向电动组件1500移动时,滑块1430从图59的近端位置向图60的远端位置纵向移动。这种原有技术的颚组件出现在由Ethicon Endo-Surgery制造的直线吻合器中,使用的商标名称为Echelon EC60。
应当注意,端部执行器轴组件1900的这种典型结构是与前面提到的共有待决专利申请族中的端部执行器的驱动相反的,包括2007年8月24日提出的序列号11/844,406申请。如图39和40所示,在这项申请中,随着下颚/钉仓座1030向近端移动越过空隙1031,导致上抵钉座1020绕枢轴向下转动,因为上抵钉座1020的近端上边缘被压向纵向固定的筒形套1040。
各种原有技术的直线吻合器,如前面提到的Echelon EC60一种,使用相同的端部执行器和轴。因此,使那些原有技术的端部执行器轴组件能够装配到本发明的装置1000的内部是合乎需要的。这是通过左侧和右侧架子1010、1020的成形实现的,例如图61至62所示。架子1010、1020的成形使一侧(上侧)敞开,如图62所示。在这种结构中,原有技术的端部执行器轴组件内轴1910的近端能够简单地装到各自的管子1012、1022之间,将内轴1910(因而整个组件)纵向固定在这里,并且除了在内轴1910插入架子1010、1020之间的开口的方向之外,在所有径向方向将内轴1910横向固定在管子之间。为了关闭这个开口,将一个轴塞1930固定在管子1012、1022之间,例如用螺栓固定,如图61所示。在另一个不同实例中,通过延伸左、右架子1010、1020的远端并设计成蚌壳形状,当装到一起时围绕内轴1910固定,可以完全不用轴塞1930。
以上描述和附图说明了本发明的原理、优先的实例和操作模式。更准确地说,本发明已经描述了关于手术吻合器优化的电源、马达和传动系。但是本发明不应当被解释为限制在上面讨论的个别实例。对于本领域以及与手术装置无关、但需要先进的电源或电流输出,在短时间和有限制的时间内用有限的功率或电流输出的蓄电池供电的其它领域的技术人员,可以认识到上述实施方案的其它变型。正如图示和描述,在根据本发明优化的条件下,有限的电源能够产生提升力、推力、拉力、拖力、保持力和其它类型的力,足以移动相当大的重量,例如超过82kg。
上面描述的实例应当作为说明性的,而不是限制性的。另外,应当理解,熟悉此项技术者在不脱离下列权利要求所确定的本发明的范围的前提下可以对那些实例可以进行改变。
Claims (19)
1.一种电动手术器械,由下列部分组成:
具有执行装置的手术端部执行器,所述执行装置可操作成当操作时实施手术程序,所述执行装置的一部件可操纵地在起始位置与完全执行位置之间移动;和
连接到所述端部执行器的手柄,所述手柄用于操作所述执行装置,所述手柄有:
完全装在手柄内的自带电源;
完全装在手柄内的驱动装置,所述驱动装置具有:
电动机;和
与所述电源和电动机电气连接和选择地操纵所述电动机的控制器;
传动装置,所述传动装置将电动机机械地连接到所述移动部件和当所述电动机运行时可操作成选择性地在所述起始位置和完全伸出位置之间的任何位置移动所述移动部件;
手动松放装置,所述手动松放装置机械地联接到传动装置,以有选择地中止传动和在中止期间独立于电动机的转动将所述移动部件朝向所述起始位置移动。
2.根据权利要求1所述的电动手术器械,其中:
手术端部执行器是直线吻合内切割器;和
所述移动部件至少包括吻合执行装置和组织切割滑块。
3.根据权利要求2所述的电动手术器械,其特征在于,所述驱动装置和传动装置可操纵成执行所述端部执行器的吻合-切割特征。
4.根据权利要求1所述的电动手术器械,其特征在于,所述电源是包含至少一个电池的可拆卸电池组。
5.根据权利要求1所述的电动手术器械,其特征在于,所述电源是串联的四到六个的CR123或CR2电池。
6.根据权利要求1所述的电动手术器械,其特征在于,
所述控制器包括多态开关,所述多态开关可操作成当所述开关在第一状态时引起电动机正转和当开关在第二状态时引起电动机反转。
7.根据权利要求1所述的电动手术器械,其特征在于,所述传动装置具有电动机驱动端和执行驱动端,和所述手动松放装置连接到所述电动机驱动端和执行驱动端之间。
8.根据权利要求1的所述电动手术器械,其特征在于,所述手动松放装置设置在传动装置中。
9.根据权利要求7所述的电动手术器械,其特征在于,
所述电动机驱动端有包括最终齿轮的转动减速齿轮系;
所述执行驱动端有:
至少一个齿轮;和
齿条-小齿轮总成,所述齿条-小齿轮总成连接到所述至少一个齿轮并直接连接到所述移动部件的至少一部分;和
手动松放装置,所述手动松放装置机械地联接在至少一个齿轮与所述最终齿轮之间。
10.根据权利要求9所述的电动手术器械,其特征在于,
所述电动机有输出齿轮;和
所述齿轮系具有联接到所述输出齿轮的第一级。
11.根据权利要求10所述的电动手术器械,其特征在于,
所述齿轮系包括第一级、第二级和第三级齿轮,和带有从电动机驱动端跨接到所述执行驱动端的轴的过桥齿轮;和
所述过桥齿轮联接到所述第三级。
12.根据权利要求9所述的电动手术器械,其特征在于,
所述齿轮系有带跨接轴的过桥齿轮,所述跨接轴从电动机驱动端跨接到执行驱动端;
所述过桥齿轮联接到所述齿轮系;
一个堡形齿轮联接到跨接轴上,相对于轴不能转动,能在所述轴上纵向滑动,所述堡形齿轮有向执行驱动端伸出的堡形突起;
执行驱动端的至少一个齿轮包括具有形状与堡形突起配合的堡形槽的第一级小齿轮;
偏置装置,所述偏置装置设在过桥齿轮与堡形齿轮之间,所述偏置装置对堡形齿轮向执行驱动端施加偏置力,以允许堡形齿轮与第一级小齿轮选择地结合,并且因此,当如此结合时,引起所述第一级小齿轮相应于轴的转动而一起转动;和
所述手动松放装置有松放部件,所述松放部件在形状和位置上提供反作用力以克服对堡形齿轮的偏置力,和当手动松放装置至少部分地操作时从第一级小齿轮分离堡形齿轮。
13.根据权利要求12所述的电动手术器械,其特征在于,所述执行驱动端的至少一个齿轮包括具有下列装置的第二小齿轮级:
第二级小齿轮轴;
第二级小齿轮,所述第二级小齿轮联接到第一级小齿轮并且相对于第二级小齿轮轴不能转动;和
第三级小齿轮,所述第三级小齿轮相对于所述第二级小齿轮轴不能转动,所述第三级小齿轮是齿条-小齿轮总成的小齿轮,当第三级小齿轮转动时纵向移动齿条。
14.根据权利要求12所述的电动手动器械,其特征在于,所述手动松放装置有:
静止状态,在静止状态松放部件提供小于施加到堡形齿轮的偏置力的反作力;
第一部分地操作状态,在所述第一部分地操作状态中,所述松放部件施加的反作用力大于作用到所述堡形齿轮的偏置力,和从所述堡形槽移出所述堡形齿轮;和
第二部分地操作状态,在所述第二部分地操作状态中,所述手动松放装置转动小齿轮,使齿条在退回方向上纵向移动。
15.根据权利要求12所述的电动手术器械,其特征在于,
所述执行驱动端的至少一个齿轮包括至少一个松放齿轮;和所述第一小齿轮直接连到所述至少一个松放齿轮,以便在转动时转动所述至少一个松放齿轮。
16.根据权利要求12所述的电动手术器械,其特征在于,
所述执行驱动端的至少一个齿轮包括第一级和第二级松放齿轮;第一级小齿轮直接连接到所述第一级松放齿轮,以便当第一级小齿轮转动时转动第一级和第二级松放齿轮。
17.根据权利要求15所述的电动手术器械,其特征在于,
所述手动松放装置包括手动松放杆:
转动地连接到所述手柄;和
具有单向棘轮机构;和
所述的至少一个松放齿轮具有直接连接到该棘轮机构的轴,以便当松放杆至少部分地操纵时以与所述松放杆相应的方式转动,和当不操纵松放杆时独立于所述松放杆转动。
18.一种操作手术器械的方法包括:
机械地将手动松放装置联接到具有完全设置在手柄内的自带电源的手术器械的传动装置,所述传动装置将手柄内的电动机的运动转变成连接到手柄的手术端部执行器的一部件的移动,所述部件可操作成在起始位置和完全执行位置之间的任何位置移动;和
通过所述手动松放装置选择性地中止所述传动以独立于电动机运行朝向起始位置移动所述部件。
19.一种用于操作手术器械的方法,所述方法包括:
在手术器械手柄的远端提供手术端部执行器,所述端部执行器具有当操作时实施手术程序的执行装置,所述执行装置具有可操作成在起始位置和完全执行位置之间移动的部分;完全在手柄内设置自带电源和电动机和将电动机控制器连接到电动机和电源以选择性地通过所述控制器操作所述电动机;
机械地将电动机通过传动装置连接到移动部件,所述传动装置可操作成当电动机运行时选择性地在起始位置和完全伸出位置之间的任何位置移动所述移动部件;和
机械地将手动松放装置连接到所述传动装置以选择性地中止所述传输,和在所述中止过程中,独立于电动机运行朝向所述起始位置移动所述移动部件。
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