CN103228219A - 用于超声探测器头的支撑和覆盖结构 - Google Patents
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Abstract
公开了一种用于与超声探测器一起使用的探测器盖体,所述超声探测器包括头部分和声表面。在一个实施方案中,探测器盖体包括本体,所述本体限定这样的腔,所述腔被选定尺寸来将所述探测器的头部分可释放地接纳于所述腔中。探测器盖体的本体进一步限定孔,所述孔邻近所述头部分的声表面。顺从间隔体组件被设置在所述孔中。所述间隔体组件可以包括水凝胶并且在所述声表面和患者的组织表面之间提供声路径。所述间隔体组件包括皮肤接触表面,所述皮肤接触表面限定凹面并且抵靠组织表面是可变形的。附加的实施方案公开用于辅助使用超声探测器并且将针插入患者体内的临床医生的各种探测器盖体以及附带的针导引件设计。
Description
相关申请的交叉引用:本申请为2010年10月8日递交的、题为“用于与超声探测器一起使用的间隔体(Spacers for Use with an Ultrasound Probe)”的美国申请No.12/900,750的部分继续申请。本申请还要求2010年8月9日递交的、题为“用于超声探测器头的支撑和覆盖结构(Support and Cover Structures for an Ultrasound Probe Head)”的美国临时专利申请No.61/372,044的权益。这些申请中的每个通过引用被整体并入本文。
发明内容
简要概述,本发明的实施方案涉及用于与超声探测器一起使用的探测器盖体,所述超声探测器包括头部分和声表面(acoustic surface)。在一个实施方案中,探测器盖体包括本体,所述本体限定这样的腔,所述腔被选定尺寸来将所述探测器的头部分可释放地接纳于其中。探测器盖体本体进一步限定孔,所述孔邻近所述头部分的声表面。顺从间隔体组件(spacer component)被设置在所述孔中。所述间隔体组件可以包括水凝胶并且在所述声表面和患者的组织表面之间提供声路径。间隔体组件还包括皮肤接触表面,所述皮肤接触表面限定凹面(concavity)并且抵靠皮肤是可变形的。所述皮肤接触表面还可以限定靠近所述凹面的一个或更多个间隔体元件,来分散探测器抵靠皮肤进行按压的负载并且防止患者的皮下结构被压迫(compression)。
在另一实施方案中,公开了一种用于对患者的皮下结构进行成像的超声成像系统,并且所述超声成像系统包括显示器、超声探测器以及第一和第二间隔体元件(spacerelements),所述超声探测器包括声表面,超声信号从所述声表面被发射。间隔体元件邻近所述声表面的相对端被安置并且被配置来在声表面和患者的组织表面之间提供间隙。这样配置,间隔体元件防止患者的皮下结构被压迫。
此外,下面将被进一步描述的实施方案公开用于辅助使用超声探测器并且将针插入患者体内的临床医生的各种探测器盖体以及附带的针导引件设计。
本发明实施方案的这些和其他特征将从下面的说明和所附的权利要求书中变得更加完整清晰,或者可以通过对由下文所阐明的本发明实施方案的实践来获悉。
附图说明
将通过参考本发明的具体的实施方案提供对本发明的更加具体的描述,所述的具体实施方案在所附的附图中被图示说明。可以理解,这些附图仅描绘本发明的典型实施方案,因而不能被认为是对本发明范围的限制。将通过使用说明书附图来以附加的特征和细节对本发明的示例性实施方案进行描述和解释,其中:
图1A和图1B分别为包括根据一个实施方案配置的间隔体元件的超声探测器的立体视图和侧视图;
图2为图1A和图1B的超声探测器用于对患者的脉管进行成像的简化剖面视图;
图3为根据一个实施方案的图1A和图1B的超声探测器被封装在套中的侧视图;
图4A和图4B为根据一个实施方案的包括间隔体元件的超声探测器的一部分的侧视图并且进一步示出可能的声表面配置的实施例;
图5为根据一个实施方案的包括间隔体元件的超声探测器的一部分的侧视图;
图6示出根据一个实施方案配置的超声间隔体元件;
图7示出根据一个实施方案配置的超声间隔体元件;
图8示出根据一个实施方案配置的超声间隔体元件;
图9A和图9B示出根据一个实施方案配置的间隔体元件;
图10为包括根据一个实施方案配置的间隔体元件的超声探测器的侧视图;
图11为根据一个实施方案的包括盖体和套的超声探测器的侧视图,所述盖体包括间隔体元件;
图12为根据一个实施方案的间隔体组件的立体视图;
图13A-图13C示出根据一个实施方案的图12的间隔体组件的使用;
图14为根据一个实施方案的间隔体组件的侧视图;
图15A-图15B示出根据一个实施方案的图14的间隔体组件的使用;
图16为根据一个实施方案的超声探测器和探测器盖体的分解立体视图;
图17A-图17D为图16的探测器盖体的各种视图;
图18A和图18B分别为超声探测器/探测器盖体和间隔体组件的分解立体视图和剖面侧视图;
图19为图16的超声探测器的头部分的剖面视图;
图20为图16的探测器盖体的剖面视图;
图21为被接纳在图16的探测器盖体中的图16的超声探测器的头部分的剖面视图;
图22为示出被接纳在图16的探测器盖体中的图16的超声探测器的头部分的另一剖面视图;
图23为图16的超声探测器和探测器盖体的配接结构的立体视图;
图24A和图24B分别为根据一个实施方案的包括顺从(compliant)间隔体组件的超声探测器以及附带的探测器盖体的正视图和侧视图;
图24C为图24A和图24B的探测器盖体的立体视图;
图25A-图25D为根据一个实施方案的探测器盖体的各种视图;
图26A和图26B为根据一个实施方案配置的探测器盖体的各种分解视图;;
图27为图26A和图26B的探测器盖体的侧视图,所述探测器盖体被示出接触在皮下脉管之上的患者皮肤;
图28A和图28B分别为根据一个实施方案的探测器盖体的立体视图和剖面视图;
图29A-图29D为根据一个实施方案的探测器盖体组件的各种视图;
图30A和图30B为根据一个实施方案的探测器盖体的各种立体视图;
图31为图30A和图30B的探测器盖体的剖面侧视图,所述探测器盖体被示出附接到超声探测器;
图32为根据一个实施方案的探测器盖体的立体视图;
图33A和图33B为根据一个实施方案的超声探测器和探测器盖体的部分剖面侧视图;
图34为根据一个实施方案的针导引件的立体视图;以及
图35A和图35B分别为根据一个实施方案的附接到探测器盖体的图34的针导引件的侧视图和立体视图。
具体实施方式
现在将参考附图,其中相似的结构将被提供以相似的参考编号。可以理解,附图为本发明的示例性实施方案的图解的和示意的表征,并且所述附图为非限制性的,也无须按比例绘制。
为清楚起见,将理解到的是,词语“近侧的(proximal)”是指相对地更靠近使用本文将描述的所述设备的临床医生的方向,而词语“远侧的(distal)”是指相对地更远离临床医生的方向。例如,被放置在患者体内的导管的端被认为是所述导管的远侧端,而所述导管仍保留在体外的端为所述导管的近侧端。另外,如本文(包括权利要求书)所使用的词语“包括(including)”、“具有(has)”以及“具有(having)”,应当具有同词语“包括(comprising)”相同的意思。
本发明的实施方案总地涉及在用于对患者的皮下组织进行成像的超声过程期间将超声探测器的声表面与患者的组织表面间隔开的各种部件。例如,结合导管在患者的脉管中的放置,采用这样的超声过程。如将被描述的,在一个实施方案中用于间隔声表面的部件防止皮下脉管(尤其是浅脉管(superficial vessel))的不期望的压迫,这又改善了探测器对这样的脉管的成像。此外,下面将进一步被描述的实施方案公开用于辅助使用超声探测器并且将针插入患者体内的临床医生的各种探测器盖体以及附带的针导引件设计。
首先参照图1A和图1B,图1A和图1B描绘根据一个实施方案的超声成像系统10,超声成像系统10包括超声探测器12和控制台20,控制台20包括显示器30来描绘由探测器产生的图像。在本实施方案中,探测器12经由线缆31被可操作地连接到控制台20,然而在一个实施方案中,探测器可以以无线的方式连接到控制台20。
探测器12包括由纵向长度32A和宽度32B限定的头32。探测器的本体一般地限定正面33A、背面33B以及侧面33C。应当理解的是,前面对探测器的描述并不意图以任何方式限制本文所描述的原理的应用。探测器头32包括沿探测器头的纵向长度32A的至少一部分延伸的声表面34,超声脉冲从该声表面34被发射,从而穿透患者的皮下部分并且对患者的皮下部分进行成像。注意的是,探测器和声表面二者的尺寸、形状和配置可以不同于本文所描述的内容,而仍落入本公开的原理之内。还要注意的是,图1A仅仅示出超声成像系统的一个实施例;包括其他部件的其他系统也可以从本文所公开的原理获益。
如图1A和图1B所描绘的,根据一个实施方案,探测器头32包括两个间隔体元件(一般地以40表示),这两个间隔体元件靠近纵向长度32A的每一端处的探测器声表面34被设置。如下面进一步描述的,当探测器12被放置在患者的皮肤上来用于皮下成像时,每个间隔体元件40用作延伸的表面来在声表面34和皮肤36或患者的其他组织表面之间提供间隙48。
更具体地,在本实施方案中每个间隔体元件40限定片状的延伸表面,该片状的延伸表面包括接触表面42来接触患者的组织/皮肤36。如下面将进一步论述的,接触表面42可以以多种结构中的一种被成形。
现在参照图2。当超声探测器上不存在间隔体时,其声表面在成像期间直接接触患者的皮肤,这会导致足以不合期望地压迫设置在探测器下方的皮下脉管的向下的压力。此外,探测器声表面相对于患者的皮肤的接近度可以导致探测器的焦点处于要被成像的脉管下方,造成浅脉管或者处于相当靠近皮肤表面的其他对象的低于最优的图像分辨率。
与上述相对的,图2示出探测器12包括间隔体元件40,该间隔体元件40设置在探测器头32的每个纵向端处并且靠近声表面34。这样配置,在探测器使用期间声表面34与患者的皮肤36被间隔开,而只有间隔体元件40的接触表面42与患者的皮肤36接触。由此,在声表面34和患者的皮肤36之间限定间隙48,在一个实施方案中,该间隙48可以以超声凝胶84或其他透声物质填充来改善成像。
因为超声探测器头32的声表面34在探测器使用期间不与患者的皮肤36直接接触,所以避免了声表面施加在皮肤上的压力,这又防止探测器12下方的脉管50被探测器在使用期间压迫。取而代之的是,探测器12所提供的任何向下的力被引导通过间隔体元件40。这样,声表面34下方的脉管50仍然是明显的并且可以被准确地成像。另外,由间隙48提供的声表面34和患者的皮肤36之间的增加的距离将探测器12的焦斑移动到相对靠近皮肤表面下方的位置,这使浅脉管和处于紧靠皮肤表面处的其他对象能够更靠近探测器的焦点并且能够被清晰地成像。
注意的是,图1A-图2中所示的间隙48在探测器使用期间被声表面34、皮肤36以及间隔体元件40界定。这样,间隙48在探测器12的正面和背面33A、33B下方保持为敞开的。注意的是,如果期望的话,可以采用附加的间隔体来进一步限定间隙48。
现在参照图3,图3描绘一个实施方案,在该实施方案中套52被放置在探测器12之上,来提供围绕探测器的无菌区域。套52可以围绕探测器12被设置,以致在套和探测器的侧面33C和正面/背面33A、33B之间限定相对的紧配合,从而通过套和间隔体元件40,超声凝胶84可以被包括在间隙48中并且被限制在间隙48内。注意的是,可以使用具有许多不同的类型或结构的套或阻挡物。
图4A和图4B示出声表面34的示例性表面结构。在图4A中,声表面34是平坦的,从而在探测器使用期间与患者的皮肤36基本上平行。在图4B中,声表面34相对于皮肤36限定凹入的形状。这样的配置可以辅助在间隙48中存留一定量的超声凝胶。当然,可以采用其他声表面配置。
图5给出间隔体元件40的接触表面42的可能结构的一个实施例,其中接触表面限定凸出的形状,来接合患者的皮肤或其他组织表面。注意的是,这与例如图4A和图4B中所示的相对平坦的接触表面42是相反的。可以采用其他间隔体接触表面形状,包括笔直的、圆拱的、成角度的等。
图6示出每个间隔体元件40的高度“H”可以根据特定需要或应用被限定,从而在探测器12的使用期间在声表面34和患者的皮肤36之间限定特定间隔。注意的是,在一个实施方案中,间隔体元件与探测器外壳是一体形成的。在另一实施方案中,间隔体元件被可移除地附接到探测器。间隔体元件可以包括与被包括在探测器外壳中的那些材料类似或不同的材料。
现在参照图7和图8,其中图7示出在一个实施方案中,间隔体元件40可以被配置为通过探测器12的侧表面33C纵向延伸一距离“E”。在图8中,每个间隔体元件40从探测器侧表面33C被向内移一距离“I”。
图9A和图9B描绘根据一个实施方案的又另一可能的间隔体元件结构,其中每个间隔体元件40被包括在延伸臂48的端处,该延伸臂48从探测器12的正面和背面33A、33B中相应的一个延伸。这样的结构可以是有用的,例如,在沿患者皮肤36以平行于声表面34的纵向长度的方向推进探测器12时是有用的。因此,这些和其他间隔体结构被认为是落入本公开的精神内。
图10示出高度可调节的间隔体元件40,以允许声表面34离开皮肤36的距离上的变化。在图示说明的实施方案中,可滑动地接纳间隔体元件40的支架60被包括在探测器12的侧面33C上并且包括凹陷或孔62。相应的突起64被包括在间隔体元件40上并且被配置来选择性地接纳到孔62中,从而将间隔体元件可移除地锁定在位于指定高度的适合的位置上。突起64沿间隔体元件40的长度分布,以致多个间隔体高度中的一个可以被选择。类似的可调节间隔体元件被包括探测器12的相对侧面上。当然,除了此处明确描述的可调节的间隔体元件结构之外,其他可调节的间隔体元件结构可以被包括在探测器上。
图11示出又另一实施方案的细节,其中间隔体元件40被包括在可移除地可附接到探测器头32的盖体70上。在本实施方案中,盖体通过干涉配合被按扣到探测器头32上,但是在其他实施方案中,可以采用其他附接方案,例如包括探测器和盖体上的互接合表面。套72被附接到盖体70,从而为超声探测器10提供无菌屏障。在一个实施方案中,盖体70和套72是可用后弃置的。
应当理解的是,间隔体元件的数目、尺寸、高度、形状等可以不同于本文所明确描述的内容。例如,一个、三个或更多个间隔体可以被包括。或者,间隔体的相对高度可以彼此不同,从而产生成角度的探测器-到-皮肤配置。探测器可以包括许多不同的形状、设计等中的一个。这些和其他修改由此被考虑作为本公开的一部分。
图12描绘根据一个实施方案的被配置来附接到探测器头32(如图13A所示)的间隔体组件78的细节。间隔体组件78包括顺从材料的本体,例如在一个实施方案中的水凝胶,该包括顺从材料的本体在变形力消除后基本上保持其所预期的形状。顺从材料在一个实施方案中可以包括来自位于新泽西州的费尔菲尔德的帕克实验室公司(Parker Laboratories,Inc.,Fairfield,New Jersey)的超声凝胶。间隔体组件78进一步在其每个纵向端上限定间隔体元件80,其中在间隔体元件之间限定有凹面。要理解的是,对于间隔体组件的顺从材料可以采用其他适合的材料,包括透声的、足够结实的材料,例如软硅有机树脂、橡胶等。在一个实施方案中,顺从材料是可热成形的、可无菌化的并且具有至少一年的保质期。
如在图13A-图13C中所示的,间隔体组件78由于其顺从性质可以变形,从而在探测器12的使用期间与患者的皮肤36表面形状一致。例如,包括间隔体组件78的探测器12可以被放置在患者的手臂上。这样安置的,间隔体组件78的间隔体80可以根据需要变形,以匹配手臂表面的剖面曲率并且保持与其皮肤36接触。图13B和图13C示出针对相对大的手臂的间隔体组件78的这样的变形。因此,间隔体组件78在声表面和皮肤表面之间提供声路径,而无需可流动的超声凝胶。要理解的是,可以与对患者身体的其他部分进行成像结合使用间隔体组件并且间隔体组件可以限定其他形状来接触具有不同形状的身体部分。此外,在一个实施方案中,超声凝胶可以被包括在间隔体组件和皮肤之间,例如在其凹面中。
图14描绘根据另一实施方案的间隔体组件90,如所示的,该间隔体组件90包括可以可操作地附接到探测器头32的柔性壳体92。壳体92包括臂92A,该臂92A包括顺从插入物94,例如在一个实施方案中的水凝胶。如在图15A和图15B中所示的,间隔体组件90被安置在探测器头32上,从而在声表面34和皮肤36的表面或者其他组织表面之间提供间隔和声路径二者,以致无需可流动的超声凝胶。这样配置,其插入物94限定接触表面96来在超声探测器使用期间接触皮肤36的表面。在一个实施方案中,壳体92的臂92A可以被向内按压以改变接触表面96的形状。例如,图15A示出当壳体92的臂92A允许向外折弯时,插入物94的接触表面96限定相对浅的凹面98。然而,如在图15B中的,当臂92A被向内按压时,插入物94被臂压迫并且接触表面96的凹面98变得相对更加显著。这样的接触表面96的配置可以是符合期望的,以稳定皮下脉管的位置,同时防止其塌陷(collapse)。臂92A可以被偏置,以在没有被使用者按压的时候使其自身恢复到给定的位置。
图16示出根据一个实施方案的用于与探测器12一起使用的探测器盖体110的细节。盖体110被配置来将探测器12的头32接纳到其中并且提供间隔体组件118来在探测器头32的声表面34和皮肤36之间提供预期的间隔。
如在图17A-图17D中所示的,盖体110限定这样的腔112,该腔112被选定尺寸来将探测器12的头32接纳到其中。接合构件114与盖体110一起被包括来可释放地且机械地将盖体附接到探测器12,然而要理解的是,可以采用各种设计来实现相同的功能。盖体110进一步包括针导引件基座116,可拆卸的针导引件可以被放置在该针导引件基座116上,从而在通过使用超声系统10(图1A)已经对脉管进行定位后辅助临床医生将针放置通过皮肤36。
继续参照图17A-图17D,现参照图18A和图18B,图18A和图18B描绘间隔体组件118的各种细节,该间隔体组件118被设置在如在图17A和图17C中最佳可见的、限定于盖体110中的孔130中。如所示的,间隔体组件118包括限定两个间隔体元件120以及设置于其间的凹面122的皮肤接触表面126。间隔体组件118包括顺从材料,例如在一个实施方案中的水凝胶,然而要理解的是,还可以采用其他适合的材料。间隔体组件118由此不要求使用可流动的超声凝胶来施用到皮肤36以提供声表面134和患者的皮肤之间的声路径。如在图18B中可见的,间隔体组件118进一步限定围绕其周边的缘128,以辅助其在盖体110的孔130中的固位。如所示的,在本实施方案中,缘128被这样成形,从而被夹在盖体110和探测器头32之间,由此防止其从盖体的意外移除。
图19示出在本实施方案中探测器头32的声表面134限定一凸出形状。相应地,图20示出顺从间隔体组件118的探测器接触表面136也限定凸出表面。图21示出当探测器头32被接纳到盖体110的腔112中时,间隔体组件118的凸出成形的探测器接触表面136可变形地接合探测器头32的凸出成形的声表面134,从而确保其间的适当接触并且提供通过间隔体组件的适合的声路径。当然,在声表面和间隔体组件的探测器接触表面上可以采用其他互补的形状。
图22示出根据本实施方案的探测器头32和盖体110之间的接合的另一视图。凹陷138被包括在盖体110上,用于将探测器头32上的定向块140接纳在其中,该定向块提供方位标记来利用在被临床医生握持时的探测器12的定向在显示器30(图1A)上定向超声图像。图23示出被可移除地附接到探测器12的盖体110,该盖体110包括间隔体组件118。注意的是,在一个实施方案中,盖体为探测器头提供无菌屏障并且是可用后弃置的。
图24A-图24C描绘根据一个实施方案的探测器盖体110和凸入成形的顺从间隔体组件118,以及超声探测器12。如所示的,还包括以适合的方式成形的覆盖物148来覆盖间隔体组件118,以防止其受到污染并且防止间隔体组件在使用前变干燥。当期望使用探测器盖体时,通过摩擦或其他适合的配合被装配到探测器盖体110的覆盖物148可以被临床医生简单地移除并且丢弃。
如在图24C中最佳可见的,盖体110在本实施方案中包括支架144,针导引件可以被可移除地附接到支架144,从而使针朝向由超声探测器12成像的期望脉管的导引得以进行。关于可以被附接到支架144的针导引件的一个非限制性实施例的其他细节可以参见例如2010年12月22日递交的、题为“可选择角度针导引件(Selectable Angle Needle Guide)”的美国临时申请No.61/426,297,该申请通过引用被整体并入本文。注意的是,针导引件和支架可以不同于本文所示出并描述的内容。
下面的讨论结合导管和其他医疗设备在患者身体中的放置论述用于促进超声探测器的使用的进一步其他的结构。事实上,当患者身体的超声成像部分做好设备被放置于其中的准备时,本文所描述的实施方案提供便利。这样的放置情况的实施例包括临床医生将针、PICC导管、PIV导管、中线导管等通过经皮插入部位插入患者身体。
图25A-图25D示出根据一个实施方案的探测器盖体160的细节,探测器盖体160限定腔162和接合构件164,该腔162用来将探测器12的头32接纳到其中,该接合构件164用来使盖体到探测器头的可移除接合得以进行。固定装置166被包括在盖体160的侧边上并且被配置来在其上可移除地接纳针导引件192。在另一实施方案中,本文所公开的这种和其他针导引件可以被永久性地附接到盖体。注意的是,尽管在此没有示出,与已示出并结合图24A-图24C描述的那些间隔体组件类似的间隔体组件被设置在盖体160的孔径130中,以提供从探测器头32到患者的皮肤的声通路。
如在图25D中最佳可见的,针导引件192限定通道194,要被插入患者体内的针的套管的一部分可以被暂时接纳到通道194中。注意的是,如本文的,通道的尺寸可以适应具有各种尺寸/直径的针套管,或者可以被配置来接受具有预先确定的尺寸的针。端接表面(abutment surface)196被包括在通道194的远侧端处,针围绕该端接表面196可以枢转从而在针插入过程期间相对于患者的皮肤连续限定不同的攻角。这样,针导引件192能够以各种各样的攻角中的任一个朝向患者的皮肤导引针而同时保持针与被探测器12成像的皮下脉管对齐。
注意的是,本文所论述的探测器盖体160和其他盖体可以被配置来以各种各样的方式配接超声探测器的头部分,包括摩擦配合、夹-袋(clip-pocket)接合、粘合方式、钩和环等。探测器盖体的盖体部分还可以在设计上不同于本文所示出和描述的内容。
盖体160还包括从盖体本体的远侧部分延伸的稳定臂200。稳定臂200被配置来,在超声成像过程期间当装配有盖体的探测器被垂直握持并且抵靠患者的皮肤被放置时,倚靠患者的皮肤,由此使探测器在垂直位置上稳定。此外,稳定臂200可以辅助通过例如使用围绕患者的手臂并且在稳定臂之上延伸的绳缆或橡皮筋将装配有盖体的探测器固定到患者的皮肤,由此在使用期间保持超声探测器在直立位置而不需临床医生的手动接触,并且在成像过程期间为临床医生提供更多的自由。在一个实施方案中,还在稳定臂200中限定孔202,以使临床医生能够通过其中按压患者的皮肤,从而定位/封闭(occlude)皮下脉管。邻近孔202的周边的区域在本实施方案中是轮廓化的(contoured),以辅助临床医生的手指放置。图26A和图26B示出根据另一实施方案的探测器盖体210的各种细节,包括由盖体本体限定的腔212,该腔212被配置来通过按扣配合或其他适合的方式将超声探测器12的头32可支撑地接纳在其中。在盖体本体上还包括用于在其上接纳针导引件的固定装置216。
围绕其周边限定缘218A的顺从膜218被包括来附接到盖体本体。具体地,盖体本体在本体的远侧端处围绕孔径230限定脊219。膜218的缘218A被配置来弹性地附接到脊219,从而当盖体210被附接到探测器12时将膜接合到盖体本体并且覆盖探测器头32的超声换能器。膜218由此在换能器和患者的皮肤之间提供声通路。注意的是,在超声成像期间患者的皮肤上的超声凝胶可以,但无需,与盖体210一起使用。还要注意的是,膜218在一个实施方案中包括硅有机树脂,然而也可以采用其他适合的顺从材料。
更具体地,如在图26A和图27中最佳可见的,脊219包括凹入成形的凹面222,以致其在两端限定两个托脚(standoff)或间隔体220。膜218的顺从本质使其在超声过程期间当膜抵靠患者的皮肤被放置时能够针对脊219的凹面222变形。因此,膜218可以在超声成像期间与患者的皮肤36一致而无需对膜218提供不希望的压力,从而使皮下结构(例如图27中可见的浅脉管50)的成像得以进行。
图28A和图28B描绘根据一个实施方案的探测器盖体260,其中盖体的本体限定腔262和用于在其上接纳针导引件的固定装置266。透超声的膜268邻近孔径280被包括在盖体本体的远侧端,以覆盖插入其中的超声探测器的头的换能器。超声透射介质(例如超声凝胶269)可以被放置在膜268的内部表面上,以确保换能器和患者的皮肤之间的声耦合。如本文描述的其他盖体实施方案,探测器盖体260可以被配置为无菌盖体来为超声探测器提供无菌性或隔离性。间隔体270还可以被包括在膜268的两侧,以防止当盖体260被抵靠皮肤放置时盖体260对浅脉管的压迫。注意的是,如果期望的话,超声凝胶也可以被放置在膜268和患者的皮肤之间来改善信号传递。
图29A-图29D描绘根据另一实施方案的探测器盖体组件310的细节,如前述的,其中组件包括盖体本体,该盖体本体限定用于将超声探测器12的头32接纳在其中的腔312。同样如前述的,接合构件314被包括来将盖体本体固定到探测器12。
盖体本体在支架340的两个平行轨350之间是可移动的。每个轨350包括多个槽352,该多个槽352与相对的轨350上的相应槽对齐。如在图29A-图29D中所示的,被包括在盖体本体的两纵向端上的舌319被配置来选择性地接纳到轨350的相应的相对槽352中。在图示说明的实施方案中,盖体本体通过这样的手动移动沿支架轨350是选择性地可重新定位的(repositionable):抬起盖体本体从而将舌319从相应的槽352移除,根据期望相对于支架轨槽改变盖体本体的位置,然后将舌插入选定的槽。在其他实施方案中,要理解的是,用于相对于支架移动盖体本体的其他方式是可能的,包括滑动运动、齿轮驱动运动等。
如在图29B-图29D中最佳可见的,针导引件342被包括在支架中,来在探测器盖体组件310被放置在患者的皮肤上时导引针进入患者的身体。观察孔346也被包括在支架340上,从而使插入针的临床医生能够在针进入皮下脉管时观察血液回溅(flashback)。
注意的是,本实施方案中的针导引件342相对于支架340以固定角度被设置并且盖体本体相对于针导引件沿支架是可移动的。该布置由此使皮下组织能够通过设置在盖体本体中的超声探测器在距针导引件342不同的离散距离处被成像。此外,该布置使通过针导引件342插入的针能够进入在皮肤下方多个深度中的任一个处的被超声成像的脉管或其他目标,而无需调节针的攻角。
更具体地,探测器12在被设置在探测器盖体组件310的盖体本体中的同时可以对患者体内的皮下脉管进行超声成像并且确定脉管在皮肤表面下方所处的深度。一个或更多个槽352被标记有编号,指示在皮肤下方将会发生通过针导引件342插入患者体内的针交会皮下脉管的深度。因此,支架340可以被调节直到其舌319被设置在两轨350上对应于被成像的脉管的深度的槽352中。当针通过针导引件342被插入患者的皮肤时,如所期望的,其可以被推进直到其在确定的深度交会并且进入被成像的脉管。这样,可以理解的是,无论脉管的深度如何,通过固定角度的针导引件,探测器盖体组件310可以辅助超声成像的脉管的针进入,由此在本实施方案中消除对可调节角度的针导引件的需求。注意的是,支架的深度测值可以不同于所示出的内容,但是在一个实施方案中,经由探测器盖体组件310可进入的深度从约0.3cm变化到约1.5cm。
图30A和图30B描绘根据另一实施方案的探测器盖体360,其中盖体本体限定腔362和接合构件364,该腔362用来将超声探测器12的头32接纳于其中,该接合构件364用于将盖体本体固定到探测器12。稳定臂365从盖体本体延伸,从而使盖体360(以及接纳于其中的探测器12)能够通过例如围绕稳定臂和患者的手臂缠绕的带被固定到患者。
如所示的,探测器盖体360进一步包括偏转部分(deflector portion)390,该偏转部分390既用于使从超声探测器12的换能器发出的超声信号偏转,又用于使行进到超声探测器12的换能器的超声信号偏转。偏转部分390被形成为探测器盖体360的一部分并且限定通道392和孔径396,超声信号可以通过通道392和孔径396。偏转部分390进一步包括设置在通道392中的偏转表面394。在本实施方案中,偏转表面394以相对于探测器头32的换能器表面成约45度角被设置,从而使从中发出的超声信号偏转通过约90度的角,然而在其他实施方案中,偏转表面可以以其他角度被安置,从而相对于探测器换能器产生不同的最终信号偏转角。
图31示出抵靠患者的皮肤356安置以致从探测器头32的换能器发出的信号行进通过通道392的探测器盖体360,所述信号被偏转表面394偏转并且被向下导引进入患者的身体。由身体内的成像目标反射以及被接收到通道392中的超声信号也类似地被偏转表面394朝向探测器头32偏转来被换能器接收。偏转表面394可以包括具有适合的密度的任何适合的材料,从而反射行进通过通道392的超声信号。在一个实施方案中,偏转表面包括塑料材料。同样,在一个实施方案中,通道392至少部分地以超声透射介质填充,例如超声凝胶。在另一实施方案中,如在前面的实施方案中一样的,基于水凝胶的隔离体组件可以被设置在通道392中。在又另一实施方案中,偏转部分可以被整合到探测器头自身中,而无需存在探测器盖体。偏转探测器盖体360的使用使探测器12能够平行于患者的皮肤36被安置,由此消除对临床医生在使用期间直立握持探测器的需要。
与图29A-图29D中所示的内容类似的,图32示出偏转探测器盖体360在一个实施方案中可以被包括作为组件的一部分,其中盖体本体在支架400的两个轨410之间是选择性地可移动的。轨410的每个包括相应的槽412,用于接收被包括在盖体本体上的舌369,从而将探测器盖体安置在距被包括在支架400上的针导引件402的多个可能距离中的一个处。如前述的,邻近针导引件402包括观察孔406。如上面结合图29A-图29D进一步描述的,通过相对于探测器盖体360移动支架400,图32中所示的组件使各种各样皮下深度处的脉管能够被超声成像并且由设置在固定角度针导引件402中的针进入,以致针在所预期的深度交会被成像的脉管。
图33A和图33B描绘根据一个实施方案的偏转探测器盖体360,其中偏转部分390通过铰接部件420(例如包括机械或活动铰链)被以铰接方式连接到盖体本体的剩余部分。这样配置的,偏转部件可以被选择性地安置,从而使超声信号沿偏转信号路径424A偏转(图33A),或者旋转离开(rotate out)超声信号路径(图33B),从而使超声信号能够沿非偏转信号路径424B行进。闩锁426或其他适合的方式可以被包括来选择性地将偏转部分390固定在适当位置。注意的是,在一个实施方案中,偏转探测器盖体可以是可调节的,以致可以实现超声信号通过各种各样的角度的偏转。
图34示出根据一个实施方案的针导引件450,该针导引件450可以与本文所描述的一个或更多个探测器盖体(例如,图35B中所示的探测器盖体460)一起采用,或者可以被直接附接到超声探测器。如所示的,针导引件450包括弯曲的V形敞开通道454,该弯曲的V形敞开通道454使针在该通道内位于中心,如图35A所示的,该通道还使临床医生能够在针插入期间于插入部位连续调节针的攻角θ。注意的是,通道的形状可以不同于所示出和描述的内容。
本发明的实施方案可以以其他具体的形式实施,而不偏离本发明的精神。所述已描述的实施方案应被认为是在各方面都仅是作为图示说明性的而非限制性的。因而,本发明实施方案的范围由所附的权利要求书而非前述说明书所示出。在权利要求书的含义和等同范围内的所有变化都应被包含在本发明的范围内。
Claims (23)
1.一种用于与超声探测器一起使用的盖体,所述盖体包括:
本体,所述本体限定腔,所述探测器的头部分被可移除地接纳到所述腔中;
从所述盖体本体延伸的稳定臂,所述稳定臂用于使所述盖体抵靠患者的皮肤表面被稳定;以及
与所述盖体一起被包括的针导引件。
2.如权利要求1所限定的盖体,其中所述稳定臂还限定孔,以使临床医生能够接触邻近针插入区域的患者皮肤,邻近所述孔的周边区域是轮廓化的。
3.如权利要求1所限定的盖体,还包括用于将所述盖体固定到所述超声探测器的接合构件,其中相应的接合构件与所述超声探测器头的头部分一起被包括。
4.如权利要求1所限定的盖体,其中所述针导引件可移除地可附接到被包括在所述盖体本体上的固定装置。
5.如权利要求1所限定的盖体,其中所述针导引件包括通道,针的一部分可以被可移动地接纳在所述通道中,所述通道包括端接表面,基于所述端接表面所述针可以在所述通道中枢转,从而选择性地调整所述针相对于患者皮肤的攻角。
6.如权利要求1所限定的盖体,其中环或带被用来将所述稳定臂固定到所述患者,从而抵靠所述患者皮肤支撑所述超声探测器。
7.一种用于与超声探测器一起使用的盖体,所述盖体包括:
本体,所述本体限定腔,所述探测器的头部分被可移除地接纳到所述腔中;
限定在所述盖体本体的远侧端的孔径,孔径的周边的一部分凹入成形,从而限定第一和第二间隔体部件;以及
被成形来覆盖所述孔径的膜,所述膜是顺从的,从而当所述膜被抵靠患者皮肤放置时使所述膜能够与凹入成形的孔径周边一致。
8.如权利要求7所限定的盖体,其中所述间隔体部件辅助防止当所述盖体的所述远侧端被抵靠所述患者皮肤放置时皮肤被所述孔径周边的凹入成形的部分压迫。
9.如权利要求7所限定的盖体,其中所述膜包括围绕所述孔径的周边适配的缘,其中所述盖体包括固定装置,针导引件可以被可移除地附接到所述固定装置,并且其中所述膜包括硅有机树脂。
10.一种用于与超声探测器一起使用的盖体组件,所述盖体组件包括:
盖体本体,所述盖体本体限定腔,所述超声探测器的头部分被可移除地接纳到所述腔中;以及
可移动地支撑所述盖体本体的支架,所述支架包括针导引件,所述盖体本体相对于所述支架是可移动的,从而使所述针导引件和所述盖体本体之间的距离能够被选择性地改变。
11.如权利要求10所限定的盖体组件,其中所述针导引件为设置于其中的针限定固定攻角,并且其中所述针导引件和所述盖体本体之间的距离的选择性的改变使所述针的皮下路径与被所述超声探测器成像的期望皮下目标的交会得以进行。
12.如权利要求11所限定的盖体组件,其中所述支架包括指示所述针与所述被成像的皮下目标的交会深度的分界线。
13.如权利要求10所限定的盖体组件,其中所述支架包括第一和第二轨,所述盖体本体被可移动地设置在所述第一和第二轨之间,所述第一和第二轨包括多个对齐的槽,设置在所述盖体本体上的舌可以被可移除地接纳到所述多个对齐的槽中,以将所述盖体本体安置在距所述针导引件一预先确定的距离处。
14.如权利要求10所限定的盖体组件,其中所述盖体组件抵靠使用者的皮肤被放置,以致超声探测器产生的超声信号被定向到所述患者体内。
15.如权利要求10所限定的盖体组件,其中所述支架还包括邻近所述针导引件的观察孔,用于观察来自所述针的血液回溅。
16.一种用于与超声探测器一起使用的盖体,所述盖体包括:
本体,所述本体限定腔,所述探测器的头部分被可移除地接纳到所述腔中;以及
偏转部分,所述偏转部分通过从第一方向到第二方向的偏转角重定向从所述探测器发射的超声信号,以便离开所述探测器盖体的孔径。
17.如权利要求16所限定的盖体,其中所述孔径抵靠患者皮肤被放置,以致所述超声探测器基本上平行于皮肤表面并且其中所述盖体还包括设置在所述偏转部分上的针导引件以及从所述盖体本体延伸的稳定臂。
18.如权利要求16所限定的盖体,其中所述盖体被可移动地附接到包括第一和第二轨的支架,所述支架包括针导引件。
19.如权利要求16所限定的盖体,其中所述偏转部分包括偏转表面,以致所述偏转角基本上为约90度。
20.如权利要求16所限定的盖体,其中所述偏转部分被以铰接方式附接到盖体本体,从而被选择性地从所述超声信号路径移除。
21.如权利要求16所限定的盖体,其中所述偏转部分是从所述盖体本体可移除的。
22.一种针导引件,所述针导引件包括:
弯曲的敞开通道,所述弯曲的敞开通道使设置在所述通道中的针的攻角能够相对于患者的皮肤表面被连续调节。
23.如权利要求22所限定的针导引件,其中所述通道是V形的,从而在所述通道内使所述针位于中心。
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Also Published As
Publication number | Publication date |
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EP2603145A2 (en) | 2013-06-19 |
CA2806353A1 (en) | 2012-02-16 |
AU2011289513A1 (en) | 2013-02-07 |
WO2012021542A3 (en) | 2013-05-23 |
WO2012021542A2 (en) | 2012-02-16 |
US20200245971A1 (en) | 2020-08-06 |
US10639008B2 (en) | 2020-05-05 |
AU2011289513B2 (en) | 2014-05-29 |
CN103228219B (zh) | 2016-04-27 |
US20110313293A1 (en) | 2011-12-22 |
JP2013535301A (ja) | 2013-09-12 |
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