CN100435719C - 专用于非介入检查内科健康状况的局部施压器械 - Google Patents

专用于非介入检查内科健康状况的局部施压器械 Download PDF

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CN100435719C
CN100435719C CNB2005101318915A CN200510131891A CN100435719C CN 100435719 C CN100435719 C CN 100435719C CN B2005101318915 A CNB2005101318915 A CN B2005101318915A CN 200510131891 A CN200510131891 A CN 200510131891A CN 100435719 C CN100435719 C CN 100435719C
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finger
pressure
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patient
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CN1820700A (zh
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R·P·施纳尔
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Itamar Medical Ltd
Itamar Medical CM 1997 Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6825Hand
    • A61B5/6826Finger
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/02007Evaluating blood vessel condition, e.g. elasticity, compliance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1073Measuring volume, e.g. of limbs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683Means for maintaining contact with the body
    • A61B5/6838Clamps or clips

Abstract

一种应用于病人身体部位,特别是手指上的探测器,可检测出病人身体状况的变化。这种探测器包括外壳(2),其内室(3)的一端封闭,另一端敞开,可放进病人手指的末端;内有探测器自含的介质,可向病人手指末端四周相当均匀地作用静压场,其强度是以防止静脉脉管系统的扩张,失控的静脉回流,冲击波反向传播到手指末端,并在病人心脏犯病或未犯病时局部缓解,而不堵塞,手指末端中动脉管壁的张力。传感器(6a)可感测到病人手指末端中动脉血液量改变相关的变化。

Description

专用于非介入检查内科健康状况的局部施压器械
本申请为分案申请,原申请的申请号是99806966.3(PCT/IL99/00292),申请日是1999年6月2日,发明名称为“专用于非介入检查内科健康状况的局部施压器械”。本发明要求1998年6月7日在以色列申请的以色列申请号为124787的专利申请的外国优先权,该申请在此引证作为参考。
发明领域及背景
本发明涉及施加预定值的静压到病人身体部位的施压器械。本发明专门用作套到病人的指趾(即手指或足趾)的探测器,按照我们PCT申请PCT/IL97/00249中描述的方法对一定的身体状况作非介入检查;因此本发明在下面专对该申请作描述。
我们的专利申请PCT/IL97/00249(WO98/04182,发表于1998年2月5日,在此引证作为参考)公开的方法和设备是通过监测病人身体部位,最好是指趾(手指或足趾)末端中动脉血液量的变化所显示的外周动脉紧张性变化,来非介入检查病人生理状况的改变。在该项申请中所描述的方法和设备专供探测心脏缺血和睡眠呼吸暂停,也可对血压进行连续监测。所述的设备包括一台套在病人身体部位(为手指)的探测器,该探测器有一包住病人身体部位末端的外壳和增压装置,当病人身体部位末端,包括其手指最端部套在内腔室中时,其四周相当均匀地加上静压场。静压场的强度是预先决定的,足以基本防止静脉脉管系统的扩张、失控的静脉回流和冲击波反向传播到身体部位末端,并且局部缓解心脏犯病或未犯病时身体部位末端中动脉尚未堵塞管壁张力。探测器还包括传感器,该传感器在外壳内,可感测与动脉紧张性相关的瞬时血液量变化所引起的病人身体部位末端中血量改变。
该申请描述了许多探测器结构,远处的压力源通过软管连接到探测器内该体腔来产生静压场。但是应用这种远处的压力源使设备结构复杂化,也限制病人的移动性。
发明目的和发明概述
本发明的目的是提供一种专门用作上面提到的PCT申请中的探测器的仪器,但与其中所述仪器相比结构更简单并有改进。另一目的是所提供的探测器不影响病人走动。
按照本发明的主要图形,所提供的仪器用于贴合病人的指趾来探测他身体状况的变化;该仪器的探测器包括:外壳,增压装置和传感器,外表所形成的内室,其一端封闭;另一端敞开,可插入病人身体部位的末端;增压装置在病人身体部位末端插入内室时可在其四周,包括身体部位最顶端的四周作用相当均匀的静压场,静压场强度的预定值足以基本防止静脉脉管系统的扩张,失控的静脉回流和冲击波反向传播到末端,并足以在心脏犯病或未犯病时局部缓解,但不堵塞末端中动脉的管壁张力;传感器可感测与动脉血液量有关的瞬时血容量变化引起的病人身体部位末端血容量变化;其特征在于:增压装置在病人身体部位末端,包括其最远端周围基本均匀地施加静压场,且内含探测器自备的介质。
下面说明的许多实施例是为了举例。
根据下述有一类实施例的特点,其增压装置包括一层弹性内膜,内膜在外壳中并与外壳形成一内腔,内腔中充满流体,通过内膜可在病人身体部位末端,包括其最远端的四周作用静压力。
根据后面叙述的实施例的特点,增压装置还包括弹性外膜,外膜附着在外壳的外部并与外壳形成一外腔,外腔通过外壳上的孔与内腔连通以扩大内腔的有效容积,以致不管病人身体部位末端体积如何改变,内腔作用的静压力基本相同。
下面叙述另一实施例是为了举例,其中加压装置包括一块有凹槽的海绵体,它就是病人身体部位插入时内腔的边界。
下面叙述外壳中的传感器是为了举例,例如可以是用光学方法检测的光学传感器,也可以是用磁力检测的霍尔效应传感器,探测到伴随与脉搏相关的血流量变化和相应手指长变化的人的手指的体积变化。
正如下面要作更具体说明的,本发明使探测器包括静压增压装置,该装置完全位于探测器外壳内,因而简化了探测器结构并减少对使用此探测器的病人的活动限制。但本发明还提出一种两段的探测器,其中一段包括第一外壳,第一外壳套在身体部位上并形成静压增压装置的一部分;第二段落包括一第二外壳,是静压增压装置的另一部分,并与第一部分流体连通,传感器位于第二段内。
虽然本发明特别适用于上面提到的PCT申请中的方法和设备,但本发明,或其各种部件也能用于其他用途,将在下面作说明。
本发明的其他结构和优点从下面说明中变得明显起来。
附图简述
本发明在此所述仅仅为了举例,请参照附图,其中:
图1是纵剖面图,图1a是图1旋转90°时的视图,示出一种根据本发明做成的手指探测器;
图2是压力一体积图,而图3是压力一时间图,这两图对于说明图1中的手指探测器的有效范围有帮助;
图4和图1类似,但未示传感器,并在所述手指探测器的结构上作了修改;
图5和图1类似,但示出根据本发明构成的另一种手指探测器;
图6a-6c示出将图5中的探测器套到病人手指上的另一方法;
图7a-7c所示探测器对图5的结构作了修改,其套到病人手指上的方法也有改变;
图8a-8c示出根据本发明构成的另一探测器;
图9是一侧视图,其所示探测器与图8a-8c中的类似,但有另一种连接方案来将二个半段接合在一起;
图10a-10c与图8a-8c相当,但所示的是根据本发明构成的另一探测器;
图11a-11c示出与图10a-10c类似的另一结构的探测器;
图12示出将图11a-11c中的探测器套到病人手上的一种方式和电路的数示显示装置;
图13a-13c示出根据本发明构成的另一探测器,具体显示传感器的组件和其与电路连接的方法;
图14示出的探测器和图1或4类似,但有一与探测器里端(贴近端)相接触的压力封套,用于扩大传感元件的压力场;
图15示出根据本发明另一图形的又一结构的探测器;
图15a示出包括图15的探测器在内的整套设备;
图16及16a示出按照本发明的另一探测器结构;
图17示出描述过的任一探测器的全套设备;
及图18a-18d示出按照本发明的又一种探测器结构。
优选实施例的描述
图1及1a示出根据本发明构成的一种形式的探测器,特别适合应用在上面提及的PCT申请中的方法和设备中,可监测病人身体部位(为指趾)的外周的脉紧张度,以便以非介入方法显示病人的生理状态或健康状况。如上简述并在上面提到的PCT申请中较详细说明的,这样的探测器有一增压装置,可在病人的指趾,包括其最末端的周围基本均匀地作用静压场;还有一传感器,可感测与动脉血流量相关的瞬时血容量的变化引起的病人指趾末端体积的变化。但是图1所示探测器比上面提到的PCT申请中说明的探测器结构简单,因为图1的探测器中的静压装置中的介质完全装在探测器中。
图1及1a所示的探测器包括一硬塑料的外壳2,其一端封闭而另一端敞开,且形成的内室可插入病人的手指3。外壳2中的内膜4与外壳构成一内腔5,可装入诸为空气那样的流体,它能在手指3的末端,包括其最末端的周围相当均匀地施加静压场。图1及1a所示的探测器还包括一传感器,它的一部分6a位于手指一侧,而另一部分6b位于手指相对侧,可测量由于动脉血流量引起的病人手指体积的变化。所示的探测器还包括一由环形圈8固定在外壳中的U形保险杆7,使内膜4可以比较稳定地贴住伸进的病人手指3。
上面提到的PCT申请特此插入供参考,以便对监测病人生理状态和健康状况的探测器结构及其使用方法作进一步的说明。
但图1及1a所示的探测器与上面提到的PCT专利申请中所述的不同,在于它能在病人手指末端周围提供施加相当均匀的静压的方式。虽然上面提到的PCT申请中所示实例中,这样的静压是用位于远处的压力源通过软管通到探测器来提供的,但在图1及1a所示的探测器包括一静压增压装置,它是完全装在探测器外壳中的。
为此,图1及1a所示探测器包括一弹性外膜10,附着在其外部并与外壳2形成一外腔11。外膜10是圆环形结构,且贴到外壳环状部分周围并与其端部隔开一定距离,因此外腔11是环形结构,环形的外腔11通过许多穿过外壳2的孔12与内腔5与连通。
外膜10扩大了内腔5的有效容积,以致按照拉普拉斯定律使内膜4在病人手指3的末端周围作用基本一致的静压,不管腔5中的容积是否改变。因此,拉普拉斯(Laplace)定律主要说明,可膨胀的中空物体内的膨胀压力(P)在平衡状态下等于壁的张力(T)除以物体的二个主轴曲率半径(R1,R2);即P=T(1/R1+1/R2)。球体的R1=R2,所以P=2T/R。当壁的传力与半径成正比(即T/R=常数)时,就像橡皮气球在其最小和最大膨胀之间的情况一样,气球膨胀压力基本保持不变,不管容积是否变化。
图2示出压力与容积的关系,详细说明随着体积变化压力基本保持不变的工作区很大。实际压力是弹性材料厚度和机械性能的函数。
图1及1a所示的探测器有效地扩大了内腔5的容积,增加了外腔11的体积,内腔与外腔通过外壳2上的孔12连通,因此,腔5中的流体所施加的静压基本保持不变,不管插入探测器内病人手指3中的动脉血流量变化所引起的腔5的容积如何变化。如果手指在探测器中退出一部分,则由于拉普拉斯效应余下部分仍受到同样的外压。
在手指末端指骨整个表面上施加近似的舒张反压(40-70mmHg),没有发现对组织灌注有不利影响,尽管知道组织上施加局部压力会造成微循环的衰竭。这是由于虽然动脉压大于允许动脉血液渗透的反压,但对通过静脉返回的血液而言静脉压必须克服外部施加的压力。静脉压的外部力量引起的上升会使上游微循环增压到离开的静脉血和进来的动脉的中间压力,因此外加的压力场内微循环的透壁压力大于零而防止了微循环的衰竭。
指尖表面温度保持在36℃左右很狭的范围内以及在70mmHg压力作用2小时后表面温度没有下降趋势,这二点支持上述维持微循环开放和因此产生的组织灌注的模型,因为夜间将增压探测器作用到60个人的120个手指上都能很好地忍受而无有害影响这一事实也支持这一模型。
在图1及1a所示的探测器中,内腔5通过孔13注满了流体,孔13中有单向阀14允许流体(如空气)流入腔内但不能流出。图3示出压力是如何随时间而改变的,并表明当加入一定量空气后,仪器内的压力在24小时内保持不变。
图4示出和上述图1及1a有同样结构的探测器,但为了简单起见传感器元件已省略,同理也省略了孔13和单向阀14,代之以完量的流体永久封入由内膜4和外膜10所限定的空间内。
图5示出和图4结构相似的探测器,但外膜20是管状结构,并与外壳2的前端形成外腔21。外腔21通过外壳端部的孔22与内腔5连通,从而有效地扩大内腔5的容积,为上所述不管其体积如何变化,人的手指3上都会作用相对稳定的静压。虽然图5没有包括和图1及1a上元件13和14相应的补充孔和单向阀,但这些元件可装在外壳3上未被外膜21罩住的部分。
图6a-6c所示的方法使如图5中构造的探测器可熟练地将病人的手指3插入探测器中。为此,探测器的外壳2在其与外膜20向里隔开距离的刚性段上装一环形圈23。包括缸体24和柱塞25的灌注器用于将流体从内腔5推移到外腔21,以便让病人将手指插入探测器。图6a示出缸体24的开口端接到环23上;图6b示出柱塞25缩进缸体24,从而将内腔5中的流体吸入外腔21,让人将手指插入探测器中,随后柱塞25可回复到它在缸体24中的正常位置;而图6c示出灌注器被移开的情况。
图7a-7c示出使用图5中的探测器让人的手指插入的另一办法。这可在外膜20上装一指状物,指状物包括一球形捏手26,是从外膜向外凸出并固定到与外膜内表面连接的背衬构件28上。于是,使用者可抓住球形捏手26并向外拉(图7b)使外腔21扩大,因而从内腔吸入流体并让病人将手指3插入探测器中。病人的手指插入后,松开球形捏手26,随后探测器便采取图7c所示的工作位置。
图7a-7c结构的外膜20的功能是促成上述结构中发生拉普拉斯效应。
图8a-8c示出由互相铰接在一起的二段组成的探测器,这样,探测器能环绕病人的手指打开和合上(图8c)。因此,如图8a所示,外壳,通常标以32,也是管状结构,其一端封闭,另一端敞开,可插进手指33。但这种情况下,外壳32被劈成二半32a,32b,它们沿其长度方向用一整条连接带32c粘连在一起。每一段外壳32a,32b包括一条内膜片34a,34b,它们与各自的管状段的侧面和端壁接合,从而形成二个内腔35a,35b。探测器的每一外壳段32a,32b还有一外膜36a,36b,它们与各自的外壳段的外表面附着,从而形成二个外腔37a,37b,它们通过外壳段上的孔38与二个内腔35a,35b连通。二个外壳段的非铰接侧携带维可牢(velcro商标)尼龙扣紧搭链39a,39b,可使这二段绕病人的手指33扎紧,以施加要求的压力。
图9示出类似于图8a-8c的两段结构,但不用维可牢尼龙扣紧搭链39a,39b将二段扣紧在一起,而用图9所示结构中的接合件,它包括在两外壳段32a,32b的接角边缘中成一体的槽40b和插入其中的雄榫40a。
图10a-10c示出另一种两段结构的探测器,但在此实例中两个半段42a,42b在各自端壁43a,43b的相邻边缘处铰接在一起。此外,不用整条铰接带而用易弯的不可拉伸的条带44粘合到两个端壁43a,43b上。两个半段用二条维可牢条(velcro商标)带45a,45b关紧闭合,条带45a,45b在外壳开口端固定到一个半段42a上同时与固定在另一外壳半段42b上的条带46啮合。无论从哪方面看,图10a-10c所示的探测器结构基本上与上述的结构相同且包括外膜,外膜形成的外腔与内腔连通从而提供上述的拉普拉斯效应。
图11a-11c及图12示出戴在一只手51的手指上的探测器50(图12)。探测器50和图10a-10c中一样是二段结构,详细示于图11a-11c。该图上还示出二段的内膜53a和二段的外膜53b,它们分别形成二段的内腔54a,54b和二段的外腔56a,56b,内腔与外腔通过孔57连通。
图11a还示出在两内膜53a,53b上安装二个传感元件58a,58b,当如图11b所示将手指插在探测器形成的内室中时,它们位于手指相对二侧。这两传感元件58a,58b通过电线59直接或经手套连接到固定在松紧带61上的电路60(图12)中。例如,电路60可包括电源及驱动传感元件58a,58b的其他电路元件,用以接受并储存这些元件的输出信号,例如可储存在存储器中,因而使用时不需要外部的电气接线。
图11a还示出在内膜53b上装一压敏开关P或其他压敏部件,如应变计,确保不发生漏气并且探测器套到人的手指上时有合适的压强。压敏部件可与光学传感器串联,也可与控制器并联。
虽然在许多图上,如图4,7a-7c,8a-8c,9及图10a-10c上,并没有与图1及1a中的传感元件6a,6b及图11a-11c中的58a,58b相当的传感元件,显然加以省略仅仅为了简化对这些探测器的图示和说明,这样的探测器在上述具体应用中还是要包括这些传感器的。如前指示,所有实例中的传感元件可以是光学传感器,如光源(发光二极管)及光学方法感测套在探测器中手指变化的光线接收器;磁性传感器,如永久磁铁及感测因霍尔效应引起手指围长度化的磁场检测器;或其他型或式的传感器,如在上面引用的PCT专利申请中所述的那种传感器。
图13a-13c示出传感元件58a,58b固定到手指探测器上和将外部电气接线与传感元件连接的一种方法。这样,每个传感元件58a,58b接电线59a,59b的一端,电线另一端穿过橡皮塞62a,62b,提供气密性密封件以便维持上述的拉普拉斯效应。塞子62a,62b插入二个外壳段52a,52b的壁孔63a,63b内,这二个外壳段用了弯曲不能拉伸材料制成的条带44铰接在一起。二个传感元件58a,58b安装到由二外壳段52a,52b形成的内室中的二个膜53a,53b上,这样,当装配传感元件且二个外壳段处于图13c所示的闭合状态时,这二个传感元件贴到套在外壳内室中手指的相对二侧上。传感元件通过电线59a,59b输出信号,电线穿过外壳壁接到电气处理系统及/或贮存系统,如在病人松紧带61上的电路60(图12)。
塞子之一,如62a,可装有压敏部件P,以确保不发生漏气且在应用探测器时压力已达适当值,正如对图11a所作的说明。
图14示出有封底管段72和环状压套74的手指探测器,封底管段72可容纳病人手指73的端部而环状压套74与封底管段72的敞开端接近且在探测器套到病人手指上时更靠近病人的心脏。这样的压套使静压场扩大,经传感元件58a,58b向病人的心脏侧延伸,正如上面提到的PCT申请中所述。在此实例中,内膜75沿其周边附着到封底管封72的内表面,并与之形成内腔76;同样,另一内膜77沿其周边附着到环状套管段74的内表面,与之形成环形内腔78。此外,外膜79沿其周边的一侧附着到封底管段72的外表面,周边的另一侧附着到环形段74的外表面,与两段形成一公共的外腔80。外腔80通过封底管段72中的孔89与内腔76连通,又通过环状套管段74中的孔82与内腔78连通。
传感元件58a,58b位于封底管段72内,该段向人的手指73的末端周围施加前述的基本均匀的静压场。如上面提到的PCT中所述,由环状套管段74与膜77形成的内腔78将此静压场通过传感元件向病人的心脏侧延伸。但这时由外膜79形成的公共外腔80保持封底管段72和环形段74中的静压场根据上述的拉普拉斯定律是基本相同,不管其中容积是否改变。
在上述探测器中传感元件(如图1a,1b中的6a,6b)包含在手指探测器中,因而病人手指插入探测器时传感元件位于手指相对两侧,在这样的结构中,传感元件产生电信号经电线输出到处理及/或储存电路元件,如图12中的电线59及储存电路元件60。
图15及16示出二种结构,其中传感元件不在手指探测器的外壳中而在手指探测器分开并用流体导管连接的另一外壳中。
图15所示探测器是图14所示那种,包括封底管段72和环状套管段74。封底管段72的内腔76用流体软管90连接到置于刚性的第二外壳93内的容器92,该外壳最好安放在靠近手指探测器处,例如固定到人的肘节处,容器92的筒身94底部是端壁95,顶部是膜96。
套管段74的环形腔78通过另一软管97连接到第二外壳93内的另一容器98。容器98的筒身99的底部100封闭,另一端是另外的膜101。
可以看出,第二外壳93内的二个容器92和98分别与探测器的封底管段72中的内腔76和套管段74中的内腔78有相同的压力。这二个压力与第二外壳93中的压力平衡。外壳93中的压力可用灌注器102预先调节,灌注器包括缸体103和柱塞104,前者与外壳93内部相连,而后者可以移动来改变外壳93的体积,因而改变压力。
容器92通过软管90连接到探测器的封底管段72并包括传感器,可感测封底管段72内腔76的体积变化,从而感测在套上封底管段的病人的身体状况。这样,传感元件105a和105b可被用于与膜96固定,因而随此膜而发生位移,而另一传感元件105b固定到容器92的底壁95上,因此传感元件105a可测出筒身94内的体积变化。
虽然图15的结构没有前述结构因具有增压装置所带来的优点,可以在病人指末端周围基本均匀地施加静压力,该装置中的介质完全装在手指探测器中,但它确实有许多其他优点:例如,图15中探测器的封底管段72不需要比如在图1及1a所述那样的外腔,因为第二外壳93内的容器94如果与周围气体相通就会起外腔作用,给探测器提供上述拉普拉斯P/V特性曲线。同样,如果外壳不通用这周围气体,则这种结构能方便地设定探测器的封底管段72和环状套管段74中的压力。
此结构还使套到病人手指上的探测器结构简化。因为它将传感元件置于单独外壳93中而不在探测器本身上。因此,探测器的封底管段可包括二根柔软的塑料管件,每根管件一端封闭,另一端敞开并位于封底管段内,当病人的手指插入其中时贴合在手指相对两侧,结果每一管件构成一半增压室。此外,套管段74也可省略。
图15结构的另一可能优点是它可避免对较细的表面血管产生偏压。而且内含传感元件105a,105b的壳体93可以放置在非常靠近套在手指上的探测器,如放在肘节松紧带上(图12),从而减少对病人行走的限制,也缩短流体软管90,97的长度。
图15a示出对图15中的装置结构上的改动,其单独的壳体93有一压力传感器150,感测壳体内的压力并将信号送给CPU106,CPU106还接收从压力源107(如图15中的灌注器102)传来的数据,压力源预先规定壳体93中的压力,从壳体93中的传感元件105a,105b输出的信号经放大,滤波或在电路108中处理后由CPU106接收。CPU106按上面提及的PCT申请中所述将上述输入信号作处理并产生输出信号显示在显示器109上。
从所有其他方面来看,图15a所示装置与图15中的在构造和操作上是相似的,因此相同部件标以相同标号。
图16及16a示出的手指探测器与上述的有相同结构,特别与图15及15a中的所示相似,但包括与套在手指探测器上的病人手指相接角的粘连层。此粘连层是一双面胶粘条107,有内层107a和外层107b。内胶粘层107a贴上保护层108,在手指插入探测器时予以撕掉,使内胶粘层107a与人的手指接角并粘牢。
从其他方面看,图16和16a所示的探测器和上述的,特别是图15,15a中的结构相似。
图17示出的装置采用新颖的手指探测器,类似于上面提到的PCT申请中的图23,可用于连续的非介入血压测量。为了举例说明起见,图17所示手指探测器的结构和上述图11a-11c中的相似,虽然显而易见它也可以是任何一种其他的结构。
至此,图17所示手指探测器包括一电加热线圈110,装在探测器外壳52a,52b的外表面,对插入探测器内腔54a,54b中的病人手指加热到任何预定的温度最好是35-40℃。热敏电阻111或其他元件控制电加热器,以便维持此温度扩张手指血管。
图17所示探测器还包括一垂直位置传感器112,用于感测手指探测器相对于某一参考点垂直位置。传感器112可以是上述PCT申请中所示相同的结构,包括一充满液体(最好是水)的外壳,其一端用易弯膜片112a封闭,另一端通过注水软管113连接到压力传感器114。传感器114发出与传感器112的垂直位置相应的输出电信号。因而也是与人的心脏状态相对应的手指探测器的输出电信号。
前述的手指探测器的传感元件58a,58b通过电线115接到电路115a,对输出信号放大并处理,再经模拟/数字变换器送到CPU117。电加热线圈110经电线118接到电源的119,电源119还向CPU117供电。热敏电阻117经导线120接到控制电路121,再经模拟/数字变换器116产生通到CPU117的输出信号。CPU117产生的输出信号送到显示器122。
上面提到的PCT申请中说明了图17所示装置校正并作连续的非介入血压测量的方法。
图18a-18d示出另一种手指探测器,它包括一装在内部的压力供应源,因而不需要从探测器到外部的增压流体供应源的流体连接件。但在图18a-18d所示的探测器中,向病人手指施加静压的压力供应源并不像前述实施例中那样由手指探测器中的流体内腔提供,而由手指探测器中的弹性海绵材料块提供。
因此,图18a-18d所示手指探测器包括分成二个半段202a,202b的外壳202,这二个半段用一条柔性但不能拉伸的条带203在侧铰接,而另一侧有维可牢(Velcro商标)尼龙搭链204,按所施静压的要求将探测器夹紧到病人手指205上。但这时在病人手指周围施加静压的方法是用探测器二个半段中携带的弹性海绵材料块206a,206b施加。有一层胶料207a,207b涂在海绵体206a,206b的内表面,因此当病人手指插入外壳内且外壳段处于如图18c,18d所示闭合状态时胶料便直接接触手指。上述设备中任何一种传感元件208a,208b都携带在海绵体206a,206b的内表面或其各自粘连层207a,207b上。
可以看出,通过对病人手指周围二个外壳段以维可牢尼龙搭链施加适当的紧度,探测器中的病人手指可以加上要求的固定压力,粘连层207a,207b使海绵体及其传感元件较牢固地固定到手指端部且较均匀地扩散作用力。
虽然本发明已就几个优送实施例作了描述,但显然提出这几个实施例仅仅为了举例,可以有许多其他的改型。例如,可以应用不同于上面提及的光学和霍尔效应传感器,例如用在上面提到的PCT申请中描述的那些传感器。不同于维可牢或上述其他方法的连接件也可采用。此外,探测器也可合并到人所戴的手套中,比如在PCT申请中所述的那样。
再说,手指探测器可用来装一脉冲血氧计,来测量血液中的氧饱和度。在此用途中,传统的脉冲血氧计的传感器3包括在探测器外壳中,较好地测量血液中的氧饱和度(SaO2),因为静压场提供稳定的环境。
显而易见,所有图1-17所述的实施例可设计成能提供上述的拉普拉斯操作,这时膨胀压力基本保持不变,不管容积是否改变,虽然图18a-18d中的含海绵缓冲材料的探测器结构并不按拉普拉斯定律操作,但显而易见可以有混合结构,所包括的海绵缓冲垫只占据含传感器的内腔的一部分空间,因而基本保证拉普拉斯操作。
此外,本发明还可以用于非手指探测器的场合。如作为人体部位伤口包扎的附件,作为静脉穿刺准备工作的在人体部位中产生静脉扩张的手段,作为如在肘节或足踝扭伤时对软组织损伤的支撑,减压和固定的手段,作为对人体部位水肿区域加压敷抹器等。
本发明另一可能的用途是作为不可回收的传感器,它固定在有预先充气表面的膜上,通过绕在手指周围的方法可包住手指,并有粘性闭合的自由端可向包住的手指施加均匀压力。膜片可贴到可弯曲但不能拉紧的不透气材料上。如塑料薄膜,胶布套等。手指探测器和可位于肘节处的传感控制台之间用软管连通。放在远处的单向减压阀确保手指探测器开为使用时将过多的压力放掉。
本发明另一可能的用途是垂直位移传感器,它是一根充满流体的软管,一端连接以周围压力为参照的压力传感器,另一端接弹性触头。压力传感器和弹性触头分别位于心脏部位及测量点,或相反放置。
还有一个方案是在同一探测器中装上光学传感器和容积式传感器,光学传感元件不需要放在上述手指的相对两侧,可放在其它位置,有一个特别有用的结构是光学传感器和光源分别放在指趾的动脉上,彼此差140°c。
本发明显然还可许多其他的方案,修改和应用。

Claims (4)

1.一种套在病人身体部位上的仪器,包括:
外壳,由铰接在一起的二段构成,可采取打开和闭合二种状态;
分成两段的弹性海绵材料块,每段分别装在两个外壳段的一个中且在所述两个外壳段的闭合状态下形成一腔室,用于接收所述身体部位;
及至少一连接件,可将所述两个外壳段紧固成闭合状态。
2.根据权利要求1所述的仪器,其中两段弹性海绵材料块每一段包括一层外露的粘连料,当所述身体部位插入所述外壳中且所述外壳段闭合时该粘连料与所述身体部位接触。
3.根据权利要求1所述的仪器,其中所述至少一连接件是所述两个外壳段携带的维可牢钩状环形固定带。
4.根据权利要求1所述的仪器,其中所述身体部位是一手指。
CNB2005101318915A 1998-06-07 1999-06-02 专用于非介入检查内科健康状况的局部施压器械 Expired - Lifetime CN100435719C (zh)

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WO1999063884A1 (en) 1999-12-16
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