CN107405446B - 流体输送和输注装置及其使用方法 - Google Patents
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Abstract
一种包括输注装置的医疗装置,输注装置包括用于容纳治疗流体的流体储存器和流体地联接到流体储存器的经皮接入工具,经皮接入工具构造成将治疗流体输送至患者皮下;其中,在治疗流体被引入到流体储存器之前输注装置以待机模式操作;其中,在用治疗流体将流体储存器填充到预定的填充水平时输注装置操作以在预定的部署时间段内部署经皮接入工具。
Description
相关申请的交叉引用
本申请要求于2015年2月18日提交的美国临时申请第62/117,937号的权益,其全部内容通过引用并入本文。
技术领域
本发明涉及医疗装置,例如用于将治疗液体输送到患者的流体输送装置,更具体地,本发明涉及用于将治疗液体输送到患者的输注泵。
背景技术
流体输送装置具有许多用途,例如将液体药物或其它治疗流体输送到患者皮下。在患有糖尿病的患者中,例如,已经使用便携式输注泵将胰岛素输送到患者。这些便携式输注泵具有提供复杂的流体输送特性的能力,包括可变的基础速率和推注要求。仔细控制药物输送的能力可以使得药物和治疗具有更好的疗效,并且对患者的毒性更小。
一些现有的便携式输注泵包括用于容纳液体药物的储存器,并且使用机电泵送或计量技术将液体药物通过管道输送到***患者皮下的针和/或软套管。这些现有装置允许通过位于装置外壳上的机电按钮或开关进行控制和编程。装置包括通过文本或图形屏幕的视觉反馈,并且可以包括警报或警告灯以及音频或振动信号和报警。这种装置通常被穿戴在线束或口袋中或者绑在患者身上。
已经将一些输注泵设计成相对较小、成本低、重量轻且易于使用。这种泵的一个例子是可从Insulet Corporation获得的胰岛素输注泵。还例如在美国专利号7,128,727;7,018,360;和7,144,384以及美国专利申请公开号2007/0118405、2006/0282290、2005/0238507和2004/0010207中更详细地描述输注泵的示例,这些文献的全部内容通过引用并入本文。这些泵包括***机构,用于使经皮接入工具(例如,针和/或软套管)***患者体内。尽管这样的泵是有效的并且提供了优于其它胰岛素输注泵的显著优点,但是可以改进***机构的设计,例如以减小泵的尺寸和/或提高使用者的舒适度。这些泵还包括流体驱动机构,用于将来自储存器的流体驱动通过经皮接入工具。还可以改进流体驱动机构以便于泵的组装和使用。
发明内容
本公开提供了各种流体输送装置,用于将液体药物或其它治疗流体输送至患者皮下。
在某些实施例中,流体输送装置可以包括向患者施用液体药物或其它治疗流体的便携式输注装置。流体输送装置可以包括用于提供电源的一个或多个电池、用于保持流体的流体储存器、用于将流体驱出储存器的流体驱动机构、用于从储存器接收流体并通过经皮接入工具将流体输送到目的地的流体通道机构、以及用于部署经皮接入工具的经皮接入工具***机构。
在某些实施例中,输注装置可以包括:用于容纳治疗流体的流体储存器;以及流体地联接到流体储存器的经皮接入工具,经皮接入工具可以将治疗流体输送到皮下并且将监测测试条引入皮下。
在某些实施例中,可以提供治疗患者的方法,方法包括提供具有综合监测的输注装置,其中,输注装置包括:用于容纳治疗流体的流体储存器;以及流体地联接到流体储存器的经皮接入工具,经皮接入工具可以将治疗流体输送到皮下并且将监测测试条引入皮下;用经皮接入工具将治疗流体输送到患者皮下,并且用经皮接入工具将监测测试条引入患者皮下。
在某些实施例中,经皮接入工具包括针/套管针,并且经皮接入工具***机构构造成在单次不间断运动中***和缩回针/套管针。以这种方式,患者经历的针/套管针的***和缩回的疼痛可以降低。
在某些实施例中,流体输送装置可以包括:流体储存器;流体地联接到流体储存器的经皮接入工具,经皮接入工具包括针/套管针;以及用于部署经皮接入工具的经皮接入工具***机构,其中,***机构构造成在单次不间断运动中***和缩回针/套管针。
在某些实施例中,流体输送装置可以包括:流体储存器;流体地联接到流体储存器的经皮接入工具,经皮接入工具包括至少一个针/套管针;以及用于部署经皮接入工具的经皮接入工具***机构,其中,***机构构造成当针/套管针沿着***方向移动时利用增加的***力***针/套管针。
在某些实施例中,用于部署包括套管和位于套管内部的针/套管针的经皮接入工具的经皮接入工具***机构可以包括:构造成沿着***方向和缩回方向移动针/套管针的第一滑动构件;构造成沿着***方向移动套管的第二滑动构件;扭簧;以及连杆,连杆联接在扭簧和第一滑动构件之间,使得存储在扭簧中的能量使连杆沿着***方向和缩回方向移动第一滑动构件。
在某些实施例中,驱动机构可以包括离合机构。如本文所解释的,通过使用离合机构,可以减少灌注泵的流体路径灌注脉冲的数量,并且可以更好地确保在放置在身体上之前流体路径的充分且适当的灌注。离合机构还可以适合于其它药物应用而不需要显著的重新设计,并且比用于输注装置的常规驱动机构更容易检查。
在某些实施例中,流体输送装置可以包括:流体储存器;流体地联接到流体储存器的经皮接入工具;以及用于从储存器驱动流体的驱动机构。驱动机构可以包括:接收在储存器中的柱塞;从柱塞延伸的丝杠;与丝杠螺纹啮合的螺母;驱动轮;以及联接到驱动轮的离合机构,其中,离合机构构造成在分离时允许螺母穿过离合机构,并且构造成在接合时夹紧螺母,使得驱动轮旋转螺母以将丝杠和柱塞推进到储存器中。
在某些实施例中,流体输送装置可以包括:流体储存器;流体地联接到流体储存器的经皮接入工具;以及用于从储存器驱动流体的驱动机构。驱动机构可以包括:接收在储存器中的柱塞;包括第一伸长构件和第二伸长构件的伸长组件;第一伸长构件从柱塞延伸;第二伸长构件联接到第一伸长构件;驱动轮;以及联接到驱动轮的离合机构,其中,离合机构构造成在分离时允许第二伸长构件穿过,并且构造成在接合时夹紧第二伸长构件,使得驱动轮旋转第二伸长构件以将第一伸长构件和柱塞推进到储存器中。
在某些实施例中,操作前述流体输送装置的方法可以包括:提供流体输送装置;将离合机构保持在分离位置;用流体填充流体储存器;使第二伸长构件穿过离合机构,使得柱塞在储存器内缩回;从分离位置释放离合机构;并且使离合机构与第二伸长构件接合。
在某些实施例中,本公开提供了包括输注装置的医疗装置,输注装置包括用于容纳治疗流体的流体储存器和流体地联接到流体储存器的经皮接入工具,经皮接入工具构造成将治疗流体输送到患者皮下;其中,在治疗流体被引入到流体储存器之前输注装置以待机模式操作;其中,在用治疗流体将流体储存器填充到预定的填充水平时输注装置操作以在预定的部署时间段内部署经皮接入工具。
在某些实施例中,预定的部署时间段可以大于或等于30秒,和/或预定的部署时间段可以小于或等于15分钟。在其它实施例中,经皮接入工具引入时间段可以大于或等于1分钟,和/或小于或等于10分钟。在其它实施例中,经皮接入工具引入时间段可以大于或等于2分钟,和/或小于或等于5分钟。
在某些实施例中,输注装置可以包括非暂时性存储器,非暂时性存储器包括存储的指令,当指令被至少一个处理器执行时,指令使得输注装置在预定的部署时间段内部署经皮接入工具。
在某些实施例中,输注装置可以包括至少一个传感器,其中,当流体储存器中的治疗流体达到预定的填充水平时,所述至少一个传感器可以通过向所述至少一个处理器发送输入信号来操作。
在某些实施例中,所述至少一个处理器可以通过检测来自所述至少一个传感器的输入信号来操作,并且在检测到来自所述至少一个传感器的输入信号时,所述至少一个处理器可以操作以执行指令,指令使得输注装置在预定的部署时间段内部署经皮接入工具。
在某些实施例中,输注装置可以操作以在预定的输注延迟时间段之后将流体储存器中的治疗流体输送通过经皮接入工具。输注装置可以操作以在经皮接入工具被部署时开始预定的输注延迟时间段。预定的输注延迟时间段可以是至少1小时、至少8小时、至少16小时或至少20小时。
在某些实施例中,提供了治疗患者的方法,方法包括:将治疗流体引入到输注装置,其中,输注装置包括容纳治疗流体的流体储存器以及流体地联接到流体储存器的经皮接入工具,经皮接入工具用于将治疗流体输送至患者皮下;将输注装置固定到患者;将经皮接入工具引入到患者;用经皮接入工具将治疗流体输送至患者皮下;其中,在将治疗流体引入到输注装置之后在经皮接入工具引入时间段内将经皮接入工具引入到患者,其中,经皮接入工具引入时间段大于或等于30秒,并且小于或等于15分钟。
在某些实施例中,输注装置可以包括非暂时性存储器,非暂时性存储器构造成存储指令,当指令被至少一个处理器执行时,指令使得输注装置在治疗流体被引入到输注装置之后在经皮接入工具引入时间段内将经皮接入工具引入到患者。
在某些实施例中,输注装置可以包括传感器,当容纳在流体储存器中的流体达到预定水平时,传感器发送由所述至少一个处理器检测的输入信号。
在某些实施例中,来自传感器的输入信号可以使得所述至少一个处理器执行指令,指令使得输注装置在治疗流体被引入到输注装置之后在经皮接入工具引入时间段内将经皮接入工具引入到患者。
在某些实施例中,经皮接入工具引入时间段可以大于或等于1分钟,和/或小于或等于10分钟。在某些实施例中,经皮接入工具引入时间段可以大于或等于2分钟,和/或小于或等于5分钟。
在某些实施例中,输注装置可以在经皮接入工具被引入到患者时开始的输注延迟时间段之后用经皮接入工具将治疗流体输送到患者皮下,其中,预定时间段为至少1小时。在某些实施例中,输注延迟时间段可以是至少8小时、至少16小时或至少20小时。
附图说明
通过阅读下面的详细描述以及附图,将更好地理解这些和其它特征和优点,其中:
图1是与本公开一致的流体输送装置的顶部透视图,其中,经皮接入工具***机构处于部署前位置;
图2是缩回到图1所示的处于部署前位置的流体输送装置中的针和套管的底部透视图;
图3是图1所示的流体输送装置的顶部透视图,其中,***机构处于中间位置;
图4是从图3所示的处于中间位置的流体输送装置延伸的针和套管的底部透视图;
图5是图1所示的流体输送装置的顶部透视图,其中,***机构处于部署后位置;
图6是从图5所示的处于部署后位置的流体输送装置延伸的套管的底部透视图;
图7是与本公开一致的处于部署前位置的***机构的另一实施例的侧透视图;
图8是处于中间位置的图7所示的***机构的侧透视图;
图9是处于部署后位置的图7所示的***机构的侧透视图;
图10是锁定在部署前位置和部署后位置的图7所示的***机构的第二滑动构件的顶部透视图;
图11是图1所示的流体输送装置的流体驱动机构在填充之前的顶部透视图,其中,离合机构处于分离位置;
图12是图11所示的流体驱动机构的侧剖视图;
图13是图11所示的流体驱动机构在填充之后的顶部透视图,其中,离合机构处于分离位置;
图14是图11所示的流体驱动机构的顶部透视图,其中,离合机构被释放到接合位置;以及
图15和16是图11所示的流体驱动机构的顶部透视图,其中,离合机构处于接合位置。
图17-23是在图1-6所示的流体输送装置中使用以经皮地***监测测试条的双内腔套管的视图;
图24-29是流体输送装置的另一实施例的视图,其包括具有D形内腔的套管,用于经皮地***监测测试条;
图30-32是在图24-29的流体输送装置中使用的D形内腔套管的视图;
图33和34是与图18-23的流体输送装置中的D形内腔套管一起使用的半圆形套管针的视图;
图35-41是流体输送装置的另一实施例的视图,其包括椭圆形套管针,用于经皮地***监测测试条;
图42是用于在图35-41所示的流体输送装置中使用的椭圆形套管针的侧视图;
图43是用于在图35-41所示的流体输送装置中使用的第二滑动构件的顶部透视图。
具体实施方式
与本公开的实施例一致的流体输送装置可以用于通过经皮接入工具(例如,针/套管针和/或套管)向患者输送治疗流体(例如,液体药物)。可以使用经皮接入工具***机构来部署经皮接入工具,例如,通过在单次不间断运动中***和缩回针/套管针来部署。随着针/套管针沿着***方向移动,***机构还可以提供增加的***力。流体输送装置还可以包括离合机构,以便于填充储存器和接合用于将流体驱出储存器的驱动机构。在某些实施例中,流体输送装置可以包括便携式输注装置。
在其它实施例中,流体输送装置可以用于将治疗流体输送到具有综合监测的患者。在这些实施例中,流体输送装置可以包括经皮接入工具,经皮接入工具构造成例如使用一个或多个针、套管和/或套管针将监测测试条引入穿过患者皮肤。
参考图1-6,示出并描述了流体输送装置100的一个实施例。在示例性实施例中,流体输送装置100用于向人或动物皮下输送诸如液体药物的流体。本领域技术人员将认识到流体输送装置100可以用于输送其它类型的流体。流体输送装置100可以用于以受控的方式(例如,根据实现剂量要求的流体输送特性、连续输注和可变流量输送)输送流体。
根据一个实施例,流体输送装置100可以包括用于提供电源的一个或多个电池110、用于保持流体的流体储存器130、用于将流体驱出储存器130的流体驱动机构150、用于从储存器130接收流体并通过经皮接入工具172将流体输送到目的地的流体通道机构170、以及用于部署经皮接入工具172的经皮接入工具***机构180。流体输送装置100可以包括具有用于控制装置的控制电路的电路板101和在流体输送装置100的部件之间提供机械和/或电气连接的底盘102。流体输送装置100还可以包括壳体104以包封电路板101、底盘102以及部件110、130、150、170、180。
流体输送装置100还可以包括综合监测。联接到装置100中的监视器(未示出)的监测测试条120可以通过经皮接入工具172引入皮下。流体输送装置100可以构造成从监测测试条接收关于患者的一个或多个生理状况的数据。例如,流体输送装置100可以构造成从监测测试条接收关于患者的葡萄糖水平的数据,并且基于葡萄糖水平确定从储存器的流体(诸如,胰岛素)的输出。监测测试条的一个示例是CGM测试条(例如,可从Nova Biomedical获得的类型),其可以被理解为构造成测试患者血液中葡萄糖的浓度水平的葡萄糖传感器。
经皮接入工具172包括引入套管针或针174,引入套管针或针至少部分地定位在套管176(例如,软的柔性套管)的内腔175内,套管的内腔能够将流体输送到患者。特别地,引入针/套管针174可以初始地穿透皮肤,使得引入针/套管针174和套管176二者都被引入(***)到患者,并且引入针/套管针174然后可以缩回到套管内使得套管176保持***。诸如管道178的流体路径将储存器130流体地联接到经皮接入工具172的套管176的内腔175。经皮接入工具172还可以用于将监测测试条引入患者皮下以用于监测目的,如下面更详细描述的那样。
经皮接入工具***机构180联接到经皮接入工具172以部署经皮接入工具172,例如,通过将针/套管针174和套管176***穿过患者皮肤并缩回针/套管针174。在图示的实施例中,***机构180包括弹簧偏压的连杆机构182和分别联接到针/套管针174和套管176的滑动构件184、186,用于沿着***方向移动针/套管针174和套管176并且用于沿着缩回方向移动针/套管针174。在单次不间断运动中,弹簧偏压的连杆机构182从部署前位置(图1)移动到中间位置(图3)并且移动到部署后位置(图5),在部署前位置中,针/套管针174和套管176二者均缩回(图2),在中间位置中,针/套管针174和套管176二者均***(图4),在部署后位置中,针/套管针174缩回并且套管176***(图6)。
弹簧偏压的连杆机构182的一个实施例包括螺旋扭簧181和联接在扭簧181和第一滑动构件184之间的第一连杆183a和第二连杆183b。储存在扭簧181中的能量向连杆183a、183b施加力,连杆向第一滑动构件184施加力以沿着***方向和缩回方向移动第一滑动构件184。在部署前的位置(图1)中,扭簧181被加载,并且滑动构件184、186被锁定并阻止移动。当滑动构件184、186被释放时,存储在扭簧181中的能量使得第一连杆183a旋转(例如,如图所示顺时针),第一连杆通过第二连杆183b向第一滑动构件184施加力,使得带有针/套管针174的第一滑动构件184(与第二滑动构件186一起)沿着***方向移动。在中间位置(图3)中,连杆183a、183b完全伸展,并且针/套管针174和套管176被***,第二滑动构件186被锁定,并且存储在扭簧181中的剩余能量使得第一连杆183a继续旋转,第一连杆通过第二连杆183b向第一滑动构件184施加相反的力,使得带有针/套管针174的第一滑动构件184沿着缩回方向移动到部署后位置(图5)。在所示的实施例中,第二滑动构件186被一个或多个锁止部187锁定以阻止缩回。因此,以上述方式,通过扭簧181的能量的第一连杆183a的连续不间断的顺时针旋转向经皮接入工具***机构180提供在单次不间断运动中***和缩回针/套管针174的能力。
弹簧偏压的连杆机构182允许单个弹簧和单次运动来实现***和缩回并且具有相对较小的尺寸。由于连杆183a、183b引导(vector)施加到滑动构件184、186的力的方式,弹簧偏压的连杆机构182还减少了由锁定和阻止(holding back)滑动构件184、186而引起的静态应力,并且提供了更平顺且更舒适的针/套管针***。当连杆183a、183b完全缩回时,在部署前位置中,滑动构件184、186上的静态力相对较小。当部署开始并且连杆183a、183b开始变得伸展时,因为随着连杆183a、183b伸展,力矢量在***方向上增加,所以***力增加,直到在完全伸展的中间位置处达到最大***力。通过逐渐增加***力,针/套管针***和缩回更平顺、更安静且更少疼痛。
在图7-10中更详细地示出了***机构280的另一实施例。滑动构件284、286可滑动地接收在框架290中,并且由包括扭簧281和连杆283a、283b的弹簧偏压的连杆机构282移动。在该实施例中,抵靠(cam)指部292(例如,从框架290延伸)接合在滑动构件284、286中的一个或两个的下方,以将滑动构件锁定在缩回或部署前位置(图7)。在该部署前的位置中,抵靠指部292通过释放杆296保持抵靠滑动构件284、286,释放杆可以被移动(旋转)以允许抵靠指部292移动并释放滑动构件284、286(图8)。抵靠指部292可以沿向下方向偏压和/或第二滑动构件286可以包括抵靠(cam)表面287,以有助于在致动时在锁定机构293上沿着抵靠指部292移动。
释放杆296包括杆297,用于使释放杆296在抵靠抵靠指部292的接合位置(图7)和释放抵靠指部292的分离位置(图8)之间枢转。释放杆296可以朝向分离位置偏置并且在接合位置中保持抵靠抵靠指部292,直到杆297被释放,从而允许释放杆296移动到分离位置。在所示的实施例中,杆297接合流体驱动机构150的驱动轮256的旋转表面257,使得在部分旋转时杆297被保持在接合位置,并且在旋转期间的某一时刻杆被释放(例如,当旋转表面257的平坦部分允许杆297移动时)。
如图9和10所示,抵靠指部292还可以用于将第二滑动构件286锁定在***位置。当连杆机构282在中间位置完全伸展并且防止第二滑动构件286缩回而使得套管保持***时,第二滑动构件286的锁定部分288接合抵靠指部292的锁定部分293。如上所述,第二滑动构件286还可以由从框架290的顶部延伸的一个或多个锁止部(未示出)锁定。
参考图11-16,流体驱动机构150的一个实施例使用离合机构160来促进填充储存器130和接合用于将流体驱出储存器130的流体驱动机构150。流体驱动机构150包括呈伸长轴形式的第一螺纹构件(例如,螺纹驱动杆或丝杠152),其具有从柱塞136延伸的外螺纹,柱塞接收在储存器130中并且用O形环137相对于储存器130的内表面密封。丝杠152和柱塞136可以是不可分离的***模制的组件。呈伸长轴形式的第二螺纹构件(例如,具有内螺纹的管螺母154)螺纹啮合丝杠152,并且可以通过离合机构160由驱动轮156驱动。
当储存器130为空时(图11和12),柱塞136定位在储存器130的一端处,使得柱塞136伸展并且离合机构160分离。在某些实施例中,储存器130可以通过打开通向储存器130的入口端口并在足够的液压压力下泵入流体以使柱塞136在储存器130内缩回来填充流体。之后,入口端口可以关闭。当储存器130被填充并且柱塞136移动到储存器130的相对(缩回)端时(图13),离合机构160保持分离,以允许管螺母154进入驱动轮156的毂的伸长圆柱形孔(沿着驱动轴线)。然后,离合机构160可以接合(图14-16),使得驱动轮156的旋转致使离合机构160旋转管螺母154,这导致丝杠152将柱塞推进到储存器130中以从储存器130输送流体。在替代实施例中,可以在柱塞136已经缩回时填充储存器130。
在所示的实施例中,离合机构160包括离合弹簧162(例如,螺旋扭簧),离合弹簧位于驱动轮156的与储存器130相邻的一端处的沉头孔中。当离合弹簧162被加载时,离合弹簧的内径162大于管螺母154的外径,从而使离合弹簧162与管螺母154分离,并且允许管螺母154穿过弹簧162的中心孔并进入驱动轮156的伸长孔中。替代地,当离合弹簧162卸载时,离合弹簧162的内径小于管螺母154的外径,从而接合或夹紧管螺母154并允许驱动轮156旋转管螺母154。在图示的实施例中,在填充储存器130之前,离合弹簧162通过与驱动轮156接合的弹簧闩164保持在加载的分离位置(图11-13)。在储存器130已经被填充之后,因此可以通过旋转驱动轮156直到弹簧闩164释放离合弹簧162而使离合弹簧162接合(图14),从而允许离合弹簧162卸载并夹紧管螺母154(图15和16),此时可以通过驱动轮156的持续旋转从储存器130分配流体。
如图所示,弹簧闩164可以被离合弹簧162偏压,使得随着驱动轮156旋转,弹簧闩164抵靠储存器盖132的表面旋转地移动,直到离合弹簧162将弹簧闩164偏移到储存器盖132中的窗部133中。当弹簧闩164移动到窗部133中时,离合弹簧162的由弹簧闩164保持的端部被释放,从而使离合机构160接合。当离合弹簧162接合时,驱动轮156接触离合弹簧162的端部163,以在离合弹簧162上产生推力,推力致使离合弹簧162旋转管螺母154。流体驱动机构150还可以使用能够允许管螺母154或其它类型的螺母或螺纹构件穿过离合机构然后被激活以接合螺母或螺纹构件的其它离合机构。
在所示的实施例中,驱动轮156包括棘轮157,棘轮由致动器158接合以递增地驱动轮156并将柱塞136推进到储存器130中。该致动机构的示例在美国专利申请公开号2005/0238507中更详细地描述,其全部内容通过引用并入本文。
通过使用离合机构,在组装时发生丝杠和螺母之间的啮合,因此不需要螺母旋转以通过装置的操作来啮合丝杠。这减少了灌注泵的流体通道灌注脉冲的数量,并且确保了在放置在身体上之前流体路径的充分且适当的灌注。离合机构还使得能够改变螺距以用于其它药物应用,而不需要重新设计在其它现有泵中的流体驱动机构中使用的倾斜螺母。离合机构的部件也比倾斜螺母组件更容易检查。
根据一个实施例,如图17-23所示,提供用于输送流体的经皮接入的套管176还可以用于引入监测测试条120。在该实施例中,套管176包括用于接收针/套管针174的第一内腔175和用于接收测试条120的第二内腔177。如图所示,第一内腔175具有圆形(圆柱形)轮廓,第二内腔177具有矩形轮廓。套管176还可以包括一个或多个窗部179a、179b,其提供通向测试条120上的一个或多个传感器122a、122b的通道。如图所示,套管176的所述多个窗部179a、179b可以布置在套管176的侧壁的同一侧上,其中,所布置的第一窗部179a与套管176的远端尖端的距离小于第二窗部179b与套管176的远端尖端的距离。
为了将测试条120***第二内腔177中,测试条120在套管176的头部178处进入第二内腔177并延伸到窗部179a、179b。因此,至少一个窗部179a、179b暴露监测测试条120的传感器122a、122b。在示例性实施例中,设置有两个窗部179a、179b,其中,最靠近套管176的尖端的窗部179a提供通向主传感器区域的通道,距离尖端最远的窗部179b提供基准。尽管示出了双内腔套管的具体形状和构造,但是也可以使用其它构造的具有第一内腔和第二内腔的套管来输送治疗流体和将测试条引入皮下。
根据另一实施例,如图24-34所示,流体输送装置300可以包括经皮接入工具372,其具有用于输送流体的第一套管376和用于引入测试条320的第二套管377。第一套管376接收第一针/套管针374(示出为圆形针),以便于***第一套管376,并且第二套管377接收第二针/套管针375(示出为半圆形套管针),以便于***第二套管377。流体输送装置300包括与上述第一实施例类似的***机构380,但是其中滑动构件384、386联接到针374和套管针375二者以及套管376、377二者。***机构380以与上述方式相同的方式***第二套管377和套管针375,然后缩回套管针375。在套管针375缩回之后,测试条320保持***。因此,第一针/套管针374和第二针/套管针375二者可以同时引入到患者,特别是为了减少顺序***的疼痛。
与上述实施例类似,第一套管376包括圆形(圆柱形)内腔376a。如图30-32中更详细所示,第二套管377包括半圆形(D形)内腔377a,以允许监测条在套管377内安置得相对平坦。第二套管377还包括一个或多个窗部379a、379b,其提供通向测试条320上的一个或多个传感器320a、320b的通道(参见图27和29)。如图所示,类似于先前的实施例,套管377的所述多个窗部379a、379b可以布置在套管377的侧壁的同一侧上,其中,所布置的第一窗部379a与套管377的远端尖端的距离小于第二窗部379b与套管377的远端尖端的距离。因此,至少一个窗部379a、379b暴露监测测试条320的传感器320a、320b。在示例性实施例中,设置有两个窗部379a、379b,其中,最靠近套管377的尖端的窗部379a提供通向主传感器区域的通道,并且距离尖端最远的窗部379b提供基准。如图33和34中更详细所示,套管针375具有对应于D形内腔377a的形状,以允许套管针375缩回并且保持测试条320***(参见图29)。如图所示,套管针包括对应于平面测试条320的平面侧表面373,使得当组装时,平面测试条320可以位于第二套管377中的套管针375的平面侧表面373附近。
根据另一实施例,如图35-43所示,流体输送装置400可以包括经皮接入工具472,其具有用于输送流体的套管476和用于引入测试条420的针或套管针475(示出为半圆形套管针)。套管476接收针/套管针474(示出为圆形针)以便于套管476的***,并且套管针475与测试条420一起***。流体输送装置400包括类似于上述第一实施例的***机构480,但是其中滑动构件484、468联接到针474和套管针475二者。***机构480以与上述针/套管针相同的方式***套管针475(图37和38),然后缩回套管针475(图39和40)。在套管针475缩回之后,测试条420保持***(图41)。与先前的实施例不同,针/套管针475仅将监测测试条420引入皮下(即,不利用套管来引入监测测试条420)。
在图42中更详细地示出了套管针475。在图43中更详细地示出了第二滑动构件486。在该实施例中,第二滑动构件486设计成捕获套管476,并且设计成接收套管针475并允许其穿过。
因此,流体输送装置的各种实施例可以使用经皮接入工具来输送流体和将测试条引入皮下以提供综合监测。
在某些实施例中,本公开的流体输送装置100(或300或400)的操作序列可以基于用流体将流体储存器130填充到预定的填充水平而自动地触发或以其它方式开始。例如,流体储存器130可以包括提供流体填充水平的反馈的流体填充传感器,流体填充水平的反馈可以作为存储在非暂时性存储器中并由计算机处理器运行的计算机指令程序的输入,计算机处理器随着流体输送装置100的电路板101储放和定位。
在流体储存器130被填充流体之前,流体输送装置100(更具体地,计算机处理器)可以处于待机(例如,睡眠)模式。一旦计算机处理器检测到来自流体填充传感器的输入信号(流体储存器130中的流体已经达到预定的填充水平),则计算机处理器可以执行计算机程序,计算机程序包括指令以在经皮接入工具引入时间段内自动地操作经皮接入工具***机构180,经皮接入工具引入时间段也可以被理解为预定的部署时间段,即,填充流体储存器130与针/套管针174和套管176穿过患者皮肤之间的时间段。
例如,临床医生可以在诊所处用治疗流体填充流体储存器130,这导致流体填充传感器发送由计算机处理器检测的关于流体储存器130的填充状态的输入信号。在接收到来自流体填充传感器的输入信号时,正由计算机处理器运行的用于流体输送装置100的操作计算机程序可以指示流体输送装置100在经皮接入工具引入时间段内操作经皮接入工具***机构180。在经皮接入工具引入时间段期间,临床医生可以将流体输送装置100适当地放置和定位在患者上。经皮接入工具引入时间段应该足够长以将流体输送装置100适当地安装在患者上,但不要太长以至于临床医生和患者必须等待相当长的时间以便经皮接入工具***机构180操作。
在某些实施例中,经皮接入工具引入时间段可以大于或等于30秒,并且小于或等于15分钟。更具体地,经皮接入工具引入时间段可以大于或等于1分钟,并且小于或等于10分钟。更具体地,经皮接入工具引入时间段可以大于或等于2分钟,并且小于或等于5分钟。
还可以期望在将针/套管针174和套管176***穿过患者皮肤之后对输注的开始延迟输注延迟时间段。例如,如果来自流体储存器130的流体可能与已经存在于患者体内的第一组合物(例如,另一种治疗组合物,其也可以是治疗流体)不利地反应或因其而导致不太有效,则可以期望延迟输注这样的流体。
在这种情况下,可以期望自动地延迟输注来自流体储存器130的流体,直到与第一治疗组合物引入到患者时患者体内的浓度水平相比,患者体内的第一治疗组合物降低至所述浓度水平的小于20%(并且更特别地小于10%,甚至更特别地小于5%)的水平。
假设可能不能准确地预测患者体内的治疗组合物的浓度降低速率,则可以期望对来自流体储存器130的流体的输注延迟预定的输注延迟时间段。
例如,将针/套管针174和套管176***穿过患者皮肤和输注来自流体储存器的流体之间的输注延迟时间段可以是至少1小时。在其它实施例中,输注延迟时间段可以是至少2小时、至少4小时、至少8小时、至少12小时、至少16小时、至少20小时、至少24小时、至少28小时、至少32小时、至少36小时、至少40小时、至少44小时、至少48小时、至少52小时、至少56小时、至少60小时、至少64小时、至少68小时或至少72小时。
虽然本文已经描述了本发明的原理,但是本领域技术人员应当理解,该描述仅通过示例作出而不是作为对本发明的范围的限制。除了本文所示和描述的示例性实施例之外,还考虑了本发明的范围内的其它实施例。本领域普通技术人员进行的修改和替换被认为是在本发明的范围内,除了所附权利要求之外,范围不受限制。
Claims (14)
1.一种医疗装置,包括:
输注装置,输注装置包括用于容纳治疗流体的流体储存器和流体地联接到流体储存器的经皮接入工具,经皮接入工具构造成将治疗流体输送至患者皮下;
其中,在治疗流体被引入到流体储存器之前输注装置以待机模式操作;
其中,输注装置包括流体填充传感器,当治疗流体被引入到流体储存器中并且治疗流体达到预定的填充水平时,所述流体填充传感器提供信号;并且
其中,在用治疗流体将流体储存器填充到预定的填充水平时开始的预定的部署时间段结束之后,输注装置操作以部署经皮接入工具。
2.根据权利要求1所述的医疗装置,其中:
预定的部署时间段大于或等于30秒。
3.根据权利要求1所述的医疗装置,其中:
预定的部署时间段小于或等于15分钟。
4.根据权利要求1所述的医疗装置,其中:
预定的部署时间段大于或等于1分钟,并且小于或等于10分钟。
5.根据权利要求1所述的医疗装置,其中:
预定的部署时间段大于或等于2分钟,并且小于或等于5分钟。
6.根据权利要求1所述的医疗装置,其中:
输注装置包括非暂时性存储器,非暂时性存储器包括存储的指令,当指令被至少一个处理器执行时,指令使得输注装置在预定的部署时间段结束之后部署经皮接入工具。
7.根据权利要求6所述的医疗装置,其中:
当流体储存器中的治疗流体达到预定的填充水平时,至少一个传感器通过向所述至少一个处理器发送输入信号来操作。
8.根据权利要求7所述的医疗装置,其中:
所述至少一个处理器通过检测来自所述至少一个传感器的输入信号来操作;并且
在检测到来自所述至少一个传感器的输入信号时,所述至少一个处理器操作以执行指令,指令使得输注装置部署经皮接入工具。
9.根据权利要求1所述的医疗装置,其中:
输注装置操作以在预定的输注延迟时间段之后将流体储存器中的治疗流体输送通过经皮接入工具。
10.根据权利要求1所述的医疗装置,其中:
输注装置操作以在经皮接入工具被部署时开始预定的输注延迟时间段。
11.根据权利要求10所述的医疗装置,其中:
预定的输注延迟时间段为至少1小时。
12.根据权利要求10所述的医疗装置,其中:
预定的输注延迟时间段为至少8小时。
13.根据权利要求10所述的医疗装置,其中:
预定的输注延迟时间段为至少16小时。
14.根据权利要求10所述的医疗装置,其中:
预定的输注延迟时间段为至少20小时。
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CN107405446A (zh) | 2017-11-28 |
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CN111905188A (zh) | 2020-11-10 |
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US20200306448A1 (en) | 2020-10-01 |
CA2977053C (en) | 2023-08-01 |
US20230218823A1 (en) | 2023-07-13 |
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