CN101212927A - 能够进行nibp计算的耳内多测量传感器的尺寸测量和定位技术 - Google Patents
能够进行nibp计算的耳内多测量传感器的尺寸测量和定位技术 Download PDFInfo
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Abstract
一种耳内(ITE)生理测量设备(2)包括形成为易于***多种形状和尺寸的耳道内的结构(4)。可充气气囊(6)包围待放置到耳内的结构(4)端部。视需要,蘑菇形尖部(22)与结构(4)的端部相连并携带有多个传感器(8)。气囊的(6)充气使尖部(22)径向膨胀以将传感器(8)放置到耳道内脉管组织附近。一旦放置在合适的位置,一个或多个传感器(8)就从脉管组织和骨结构感测生理信号。
Description
技术领域
以下涉及监测生理学。其尤其可应用于一种***耳道内以使一个或多个生理传感器在内耳内合适定位,从而获取表示生理现象的信息的耳内结构,该生理现象包括例如血压、呼吸、灌注指数、血氧、脉搏率和身体温度。
背景技术
生理信号已可从耳内测量。然而,还没有从耳内无创测量血压的多参数生理测量设备。阻挠这种研制的障碍的实例包括人与人之间人类耳道的不同尺寸和形状,不能将传感器有策略地放入耳道内以最佳化地接收生理信号,以及不能保护感测设备在测量生理信号时不受由于与内耳接触而产生的污染。
发明内容
在一方面,一种内耳生理测量设备包括一形成为用于***耳道内的结构。一个或多个传感器可操作地耦接到该结构放置在耳内的一部分。可充气气囊可操作地耦接到该结构放置在耳内的一部分并且充气以将该一个或多个传感器放置到耳道内组织附近。一旦放置到合适位置,该一个或多个传感器就从周围组织和骨结构感测生理信号。
一个优点包括从耳内测量生理信号。
另一个优点在于从耳内无创测量血压。
另一个优点是从耳内连续无创地测量血压。
另一个优点在于一种耳内设备,其针对不同形状和尺寸的耳道而形成。
另一个优点是将传感器放置到耳道内以从耳道内最佳化地接收生理信号。
另一个优点是将传感器以理想的力量和压力放置在耳道内,从而确保传感器与组织紧密耦接,而不会导致组织变苍白(blanching)。
另一个优点是即使身体正经受由于震动(shock)或其它状况而导致的***停滞(peripheral shutdown)时也能将传感器放置到良好灌注的生理位置处。
另一个优点是防止过度***耳内。
另一个优点是通过减轻生理传感器污染的护套来测量生理信号。
另一个优点在于一种耳内生理信号测量设备,其使耳压与环境气压相平衡,特别是在气囊充气和放气期间。
附图说明
在阅读和理解优选实施例的详细描述后,更进一步的优点对本领域普通技术人员将会变得更明显。
图1示出用于从耳内测量生理信号的耳内生理测量装置。
图2示出具有单通道的耳内生理测量装置,该单通道用于容纳传感器走线并为可充气气囊充气/放气以将传感器放置到内耳组织附近。
图3示出具有分立通道的耳内生理测量装置,所述分立通道用于容纳传感器走线和为可充气气囊充气/放气。
图4示出具有气道通道的耳内生理测量装置,该气道通道用于当气囊充气和放气时平衡耳和环境之间的气压。
图5示出放置在耳内的耳内生理测量装置。
图6示出耳内生理测量装置、耳后支承设备和减轻生理传感器污染的保护套之间的连接点。
图7示出连接至耳后支承设备的耳内生理测量装置。
图8-12示出用于保持传感器与在耳内生理测量装置相连的适当尖部的各视图。
图13是示出用于***耳道内的未充气气囊部分截面的透视图。
图14是示出充气气囊的部分截面的透视图。
具体实施方式
图1示出用于从耳道内测量一个或多个生理信号(例如,血压、脉搏、血氧、灌注、体温、呼吸…)的耳内(ITE)生理测量装置2(此后称为“ITE装置2”)。ITE装置包括***耳道内的结构4。结构4的尺寸适于以合适的深度进入耳道并适合于各种形状的耳道(例如,不同弯曲度)。也就是说,结构4的直径比耳道直径小。在优选实施例中,结构4伸入耳道内,从而端部放置到耳的有骨区域或其它耳道较安静的地带附近。
位于耳道内的结构4端部包括环形可充气气囊6。可充气气囊6包围结构4的端部(如图所示)或者其合适的部分。可充气气囊6理想地支承一个或多个传感器8,传感器8可操作地耦接至气囊6的表面并测量生理信号。合适的传感器包括例如发光二极管(LED),红外线(IR)源、光探测器、压力换能器、麦克风和热敏电阻。传感器8策略地放置在气囊6上。例如,光探测器典型地放置成使不指示被测量生理过程的光吸收最小化或阻止该光吸收(例如,来自耳外的光,从位于气囊6上的另一传感器发出的光)。虽然在图1表示为圆形,一个或多个传感器8可以是任何形状。根据需要,传感器可以安装在结构4的端部内并且一旦***耳内就可移动至与组织相接触。
可充气气囊6充气以用理想的力量和压力将一个或多个传感器8放置到耳道内适当的组织附近,从而在不会引起灌注减少或组织变苍白的情况下确保传感器与组织的紧密耦接。对于成人,这包括对气囊6充气以符合从约6mm到约1 3mm宽范围变化的耳道直径。对于婴儿和小孩,其耳道直径从直径约4mm到直径约7mm变化,可采用较小且较短的ITE设备。典型地,测量血氧的传感器放置在由外颈动脉支和内颈动脉支供应的动脉血灌注的耳道组织附近,从而即使当身体在震动或其它状况期间正经受***停滞时也可用作良好的灌注生理部位。这类传感器包括能量发射装置(例如,LED,IR源…)和检测穿过脉管组织的能量传输的能量检测装置。在另一实例中,温度传感器(例如,热敏电阻)也放置在脉管组织附近。在又一实例中,用于感测指示脉搏压声音和/或呼吸的音频信号的传感器(例如,麦克风)适当地放置在耳道相对较安静的区域内以减轻感测的外来音频信号(噪声)。
可充气气囊6还用于有利于无创测量血压。对于无创血压测量,对可充气气囊6充气直到其阻塞靠近血压传感器(例如,压力换能器)的耳部内的血流,所述传感器可操作地连接至可充气气囊6。然后,适当释放可充气气囊6内的压力以使可充气气囊6放气。在充气和/或放气期间,采用听诊法(例如,通过可操作地连接到气囊6的麦克风)和/或示波法(例如,通过附着于气囊的光学感测部件)获得收缩压和舒张压。
通过如上所述获得初始血压,然后使气囊再充气至平均压力,从而无创地连续测量出血压。伺服机构定期性地调整气囊压力以确定指示平均血压的最大脉冲波形幅度的位置。只要所得出的平均压力相对接近于初始压力和/或脉搏波形幅度相对接近,就能以高精度计算出所得出的连续收缩压、舒张压和平均压。
结构4包括一个或多个延伸穿过结构4的通路(如在下面图2-4中所示出的)。这些通路容纳传感器数据线、电源线和控制线,为气囊6的充气/放气提供密封通道,和/或在气囊充气/放气期间允许耳内压力与周围环境相平衡。图2示出一个方面,其中结构4包括用于容纳传感器走线和使气囊6充气/放气的分立通道10。通道10使导线与内耳环境隔离开,减轻了耳部和传感器走线的污染,并且为气囊6提供加压气道。图3示出一个方面,其中结构4包括用于传感器走线和使气囊6充气/放气的分立通道;一个或多个第一通道12容纳传感器走线,且第二通道14为气囊6的充气/放气提供增压气道。图4示出一个方面,其中选择性通道16提供耳部压力稳定机构,其在气囊充气和/或放气期间允许耳压与周围环境相平衡。通道16减轻气囊充气和/或放气期间耳内建立起来的压力以及由其引起的潜在疼痛。图2-4中的实例示出了具有圆形横截面的结构4和通路10-16。这些特定形状不是限制性的,而是提供解释说明的目的。应当理解,结构4和/或通路10-16可以基本上为有益于耳道的任何形状(例如,椭圆形,矩形,不规则形…)。
图5示出***耳道内的ITE装置2。***结构4,从而使位于耳道内带有气囊6的端部处于耳部有骨区域。使气囊6充气成将传感器8放置到内耳组织附近以感测指示生理状态的信号,所述生理状态包括例如血压、温度、脉搏、呼吸和血氧。
图6示出带有选择性护套9的ITE装置2,选择性护套9放在结构4和气囊6上以保护耳部和结构/气囊/传感器组件不受污染。在一方面,护套可以是半渗透性的以允许气体流过,但阻止液体从护套的一边流到另一边。在另一方面,护套基本上阻止所有的物质从护套的一边移动到另一边。结构/气囊/传感器组件可以一次性的、可洗涤的、和/或可消毒的。
结构4示出为由(BTE)耳部件18支承在耳内。结构4可以操作性地附着到耳部件18上。这种附着可以通过固定装置实现,固定装置包括螺纹连接器、按扣、固定螺丝、粘附剂、铆钉等。图6示出结构4和选择性耳部件18之间的示范性连接区域20。保护性护套9在需要的情况下可用于减轻生理传感器的污染。在另一方面,结构4和耳部件18可以形成为一个单个单元。
图7示出连接至ITE设备2的BTE设备18。IET设备2包括为这两个设备供电的电池21。在该实施例中,ITE设备2和电池21为低成本的和一次性的。
上面的图5-7将选择性耳部件18示出为耳后支承设备。在优选实施例中,ITE装置通过半刚性连接器管连接至耳后(BTE)设备(18),该半刚性连接器管形成为可装配到耳部上和/或周围以防止***并且使ITE设备保持最佳取向和定位的位置上。应当理解,也可考虑其它类型的支承设备。例如,结构4可安装到附着于头部、颈部、肩部等区域的支承设备上。
BTE设备18可以容纳从传感器8接收生理信号(例如,通过延伸穿过如上面简要描述的通路10和12的传感器导线)的各种电子器件,并向主体佩带的另一收发器(未示出)(例如,带在颈部和腕部的收发器)或者向监视设备、数据库、计算机和图形显示器这样的远程设备(未示出)发送该生理信号。BTE设备18可视需要包括处理器(未示出),存储器(未示出)和电池(未示出)。处理器用于控制传感器和电子器件,处理原始数据,以及从传感器读取数据;存储器用于存储数据和/或配置;以及电池为处理器、有源传感器和收发器供电。
在图8-11的实施例中,一个或多个传感器8位于柔软、挠性的尖部22(而不是直接位于可充气气囊6上或者位于在可充气气囊6相对侧的ITE设备尖部上),尖部22可操作地连接至***耳内的结构4的端部。气囊6在图8中示出,但为显示清楚起见,已从图9-11中去除。当将结构4***耳内时,传感器8仍由可充气气囊6进行放置;然而对气囊6充气会使携带尖部22叶片24的传感器膨胀,其将传感器8放置到内耳组织附近。
图12-14示出尖部22为可膨胀蘑菇状元件。在该实施例中,气囊6从图13的***水平充气会膨胀柔软、挠性的尖部22,其将传感器8定位在内耳组织附近(见图14)。尖部22和/或气囊6还用作光学反射器,帮助来自光发射器的反射光透过组织,从骨返回,透过组织,反射性地和透射性地射向反射器,再从反射器返回透过组织,如此下去,直到其最终到达光探测器。尖部22的背面是不透明的,其阻挡不需要的环境光线进入耳道内。尖部(22)和/或气囊(6)还用作外部环境气流和测量芯体温度替代物的热敏电阻(8)之间的缓冲器。挠曲电路连接器26分别穿过结构4延伸,绕气囊6弯曲,并且与相关传感器8相互柔性连接。
已参照优选实施例对本发明进行了描述。在阅读和理解前述详细描述的基础上,各种变型和更改对其他人而言是易于想到的。本发明应当解释为包括全部这些变型和更改,只要它们落入附加权利要求书或其等同表述的范围内。
Claims (27)
1.一种耳内(ITE)生理测量设备(2),包括:
形成为易于***耳道内的结构(4);
一个或多个传感器(8),其可操作地耦接到该结构***耳内的一部分;和
可充气气囊(6),其可操作地耦接至该结构***耳内的部分,对可充气气囊(6)进行充气以将一个或多个传感器(8)放置到耳道内组织附近,从而一个或多个传感器(8)可从周围组织和骨结构感测生理信号。
2.根据权利要求1所述的ITE生理测量设备(2),其中一个或多个传感器(8)无创感测指示血压、连续血压、脉搏、血氧水平、灌注、体温和呼吸的信号。
3.根据权利要求1所述的ITE生理测量设备(2),其中***结构(4)以将一个或多个传感器(8)放置到耳道的有骨区域和安静地带中的至少一个附近。
4.根据权利要求1所述的ITE生理测量设备(2),其中***结构(4)以将一个或多个传感器(8)放置到周围深部耳道组织附近,该组织由外颈动脉和内颈动脉中至少一个的分支供应的动脉血灌注,并且即使当身体正经受由于震动或其它状况引起的***停滞时也能用作良好的灌注生理部位。
5.根据权利要求1所述的ITE生理测量设备(2),其中充气的气囊(6)将位于其上的一个或多个传感器(8)以理想的力量和压力放置到脉管组织附近,以在不会引起灌注减少或组织变苍白的情况下确保传感器与组织的紧密耦接。
6.根据权利要求1所述的ITE生理测量设备(2),其中一个或多个传感器(8)可操作地附着于可充气气囊(6)。
7.根据权利要求1所述的ITE生理测量设备(2),还包括尖部(22),该尖部(22)可操作地连接到结构(4)***耳内的区域上,一个或多个传感器(8)可操作地连接至尖部(22)。
8.根据权利要求7所述的ITE生理测量设备(2),尖部(22)和/或气囊(6)用作反射器,以在阻挡环境光线的同时,反射性地和透射性地使源自传感器的光线透过耳组织反射和引导到光探测器内。
9.根据权利要求7所述的ITE生理测量设备,尖部(22)和/或气囊(6)用作外部环境气流和测量芯体温度替代品的热敏电阻(8)之间的缓冲器。
10.根据权利要求7所述的ITE生理测量设备(2),其中气囊(6)设置在结构(4)和尖部(22)之间以充气并使尖部(22)膨胀,以将位于其上的一个或多个传感器(8)放置到脉管组织附近。
11.根据权利要求1所述的ITE生理测量设备(2),其中一个或多个传感器(8)包括下列中的一个或多个:发光二极管,IR源,光探测器,热敏电阻,压力换能器和麦克风。
12.根据权利要求1所述的ITE生理测量设备(2),其中可充气气囊(6)膨胀以将一个或多个传感器(8)放置到从直径约为6mm至直径约为13mm的成人耳道内,以及放置到从直径约为4mm至直径约为7mm的小孩耳道内。
13.根据权利要求1所述的ITE生理测量设备(2),结构(4)包括:
延伸穿过结构(4)直到气囊(6)的通路(10,14),其用于使气囊(6)充气和放气。
14.根据权利要求1所述的ITE生理测量设备(2),结构(4)包括:
延伸穿过结构(4)直到一个或多个传感器(8)的通路(10,12),其用于容纳传感器导线(26),该导线(26)用于向传感器(8)运送电源或控制信号以及从传感器(8)运送数据。
15.根据权利要求1所述的ITE生理测量设备(2),结构(4)包括:
延伸穿过该结构(4)的通路(16),其用于使耳道内的耳压与环境气压相平衡。
16.根据权利要求1所述的ITE生理测量设备(2),还包括保护结构(4)、气囊6、一个或多个传感器(8)以及耳道不受污染的护套(9)。
17.根据权利要求1所述的ITE生理测量设备(2),还包括用于为一个或多个部件(2,18)供电的电池(21)。
18.根据权利要求1所述的生理测量设备(2),其中ITE生理测量设备(2)通过半刚性连接器管可操作地连接至BTE设备(18),该半刚性连接器管形成为装配在耳部上面和/或周围以防止过度***,并且使ITE设备(2)保持在最佳取向和定位的位置。
19.一种用于测量耳道内生理信号的方法,包括:
将耳内结构(4)***到耳道内所需深度;
对可操作连接至耳内结构(4)端部的可充气气囊(6)充气,以将一个或多个传感器(8)放置到耳道脉管组织附近;和
采用一个或多个传感器(8)从周围组织和骨结构感测生理信号。
20.根据权利要求19所述的方法,还包括通过以下测量血压:
使可充气气囊(6)充气以阻塞可充气气囊(6)附近耳组织内的血流;和
当使气囊(6)充气和/或放气时获得收缩压和舒张压。
21.根据权利要求19所述的方法,还包括通过听诊法和示波法的一种或多种来测量血压。
22.根据权利要求19所述的方法,还包括通过以下步骤连续测量血压:
获得初始收缩和舒张血压测量读数的至少其中之一;
从该读数确定平均血压测量值;
使耳道内的气囊(6)充气至平均血压;
定期调整气囊压力;和
获取指示平均血压的最大脉搏波形幅度。
23.根据权利要求22所述的方法,还包括从平均血压和一个或多个脉搏波形幅度中的至少一个得出收缩和舒张血压中的至少一个。
24.一种用于从耳道内测量生理信号的生理测量设备(2),包括:
第一结构(4),其形成为易于***多种形状和尺寸的耳道内;
第二结构(18),其支承第一结构(4)以有利于保持第一结构(4)在耳道内的位置;
可充气气囊(6),其设置在第一结构放置在耳内部分的周围,该可充气气囊(6)由于充气而向径向膨胀;
径向膨胀尖部(22),其与第一结构(4)连接并且至少部分延伸于在可充气气囊(6)周围,从而气囊(6)的充气使尖部(22)径向膨胀;和
传感器(8),其由尖部(22)携带以与耳道压成感测性相互作用。
25.根据权利要求24所述的生理测量设备(2),传感器(8)感测血压、连续血压、脉搏、血氧水平、灌注、体温和呼吸中的一个或多个。
26.根据权利要求24所述的生理测量设备(2),其中一个或多个传感器(8)包括以下中的一个或多个:发光二极管,IR源,光探测器,热敏电阻,压力换能器和麦克风。
27.根据权利要求24所述的生理测量设备(2),其中生理测量设备(2)通过半刚性连接器管可操作地连接至第二设备(18),该半刚性连接器管形成为装配在耳部上面和/或周围以防止过度***,并且使生理测量设备(2)保持在最佳取向和定位的位置。
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- 2006-06-13 EP EP06765734A patent/EP1903931B1/en not_active Not-in-force
- 2006-06-13 US US11/995,006 patent/US8419637B2/en not_active Expired - Fee Related
- 2006-06-13 JP JP2008519022A patent/JP5286083B2/ja not_active Expired - Fee Related
- 2006-06-13 RU RU2008103323/14A patent/RU2424764C2/ru not_active IP Right Cessation
- 2006-06-20 CN CNA2006800320427A patent/CN101252876A/zh active Pending
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Also Published As
Publication number | Publication date |
---|---|
CN101252876A (zh) | 2008-08-27 |
EP1903931B1 (en) | 2013-03-13 |
WO2007004083A1 (en) | 2007-01-11 |
RU2008103323A (ru) | 2009-08-10 |
US20090069645A1 (en) | 2009-03-12 |
EP1903931A1 (en) | 2008-04-02 |
RU2424764C2 (ru) | 2011-07-27 |
JP2009500060A (ja) | 2009-01-08 |
JP5286083B2 (ja) | 2013-09-11 |
CN101212927B (zh) | 2011-04-06 |
US8419637B2 (en) | 2013-04-16 |
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