CN101039618A - Dvt检测 - Google Patents
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Abstract
本发明涉及一种包含光传输及检测系统的装置，所述光传输及检测系统具有传感器(1，2，7，8)、控制构件(5)及输出构件(7)。传感器安置于患者身体上的多个部位且测量这些部位所吸收及/或反射的光且收集与血管舒缩活动相关的信号。输出可采取详细展示从传感器(1，2，7，8)所收集的血管舒缩信号直至简单指示病状存在或不存在的形式。例如，可通过测量来自患者脚底的两个传感器信号之间的差异来检测单侧DVT的存在。本发明也可用来提供例如DVT及糖尿病周围神经病变存在与否的指示。
Description
技术领域
本发明是关于通过评估身体上个别部位处微循环中血管舒缩活性来检测包括深静脉血栓形成(DVT)及糖尿病周围神经病变、严重肢体局部缺血、自主神经功能及动脉及静脉疾病的一系列临床病状，且尤其检测深静脉血栓形成(DVT)及糖尿病周围神经病变。
背景技术
腿部深静脉血栓形成(DVT)为静脉中形成血栓，导致血管部分或完全阻塞的病状。栓塞起因可归因于由手术程序或外伤，或长期不活动(例如远程飞行、残疾)所引起的止血期而导致的血管损伤。DVT的明显后果可自轻微疼痛及肿胀至致命肺栓塞而有所不同。
临床实践中用于检测DVT的已知测试包括诸如静脉造影术及双功能超声波扫描术的成像测试。静脉造影术需要注射不透放射线的成像介质且X-射线需要专业诠释且对患者有害并使其不适、耗费时间、昂贵且不适于最初保健护理或全科医师(GP)。同样，双功能超声波扫描术为不适于最初保健护理或不适于全科医师的耗费时间及昂贵的方法，其需要高度熟练医师。
体积描记术为低成本、相对快速且用于受训最初保健护理或由受训GP使用的已知测试。然而体积描记术需要患者在测试期间锻炼(其不适合于所有患者)且测试需要专业操作者且不总是可靠。还有D-二聚体分析测试，其测量血液中的栓塞作用物且经推荐与其他测试结合使用。体积描记术及D-二聚体测试用作第一线筛选方法以排除尽可能多的不具有DVT的患者以免其进行至较麻烦的双功能超声波扫描术或静脉造影术成像测试。本发明试图作出改良。因此，本发明提供包含光传输及检测系统的装置以评估身体上个别部位处微循环中血管舒缩活性来监控及评估包括疑似DVT及糖尿病周围神经病变、严重肢体局部缺血、自主神经功能及动脉及静脉疾病的一系列临床病状。
微循环中血管舒缩活性为微血管收缩与舒张的连续过程且满足包括血压调节、温度调节、组织充氧及滋养的若干重要功能。此过程的控制具有局部性及全身性。局部控制由自相邻组织传输的化学信号来启动而全身控制源自自主交感神经系统，主要用于调节核心温度及全身血压。所导致的局部血容量变化提供了关于许多局部及全身生物过程的信息。
发明内容
在较佳实施例中，本发明包含光传输及检测系统，其包括波传感器(波传感器安置于身体上一个或一个以上部位)、测量此或多个部位吸收及/或反射的光且提供与此或多个部位处绝对值及/或部位之间的差值相关的信号的控制构件。较佳传感器为红外波传感器。
本发明使用传感器以连续监控传感器下方的微循环血容量变化。光吸收与血容量成正比或，相反，光反射与血容量成反比。对于处于端坐或仰卧的稳定环境中的休止患者，血容量的重大变化指示全身控制。此外，全身血管舒缩控制在肢体中为对称的。因此，通过安置传感器于健康受检者的各脚底上，来自各传感器的信号即使不同也是相似的。单侧DVT的存在可通过测量两个传感器信号之间的差异来检测，因为患病腿的远端容量归因于外流阻力增加而增加。此情形造成在患病腿的血管舒缩变化中频率及相位特性改变且因此影响双侧对称。
在本发明的另一方面，从传感器接收的信号用于评估自主全身及周围神经病变。惯常全身性自主功能测试通常分析从ECG波形中获得的心率变化。然而，可在身体周围皮肤上多点处通过使用传感器收集的信号中发现心脏脉动。因此，可从此信号中获得心率变化。可接着将心率分量变化分析与来自传感器的信号的低频变化进行比较，从而允许直接比较周围及全身自主功能。在健康受检者中，两种变化源应相似，而在仅罹患周围神经病变的患者中，将有差异。
使用脚部血管舒缩活动来评估DVT、血管疾病及神经功能的优点包含能够使用不需要患者一方运动的被动测试。优选的，通过例如瓦耳萨耳瓦氏法(valsalva manoeuvre)的应激测试或呼气阻抗的适度分级来扩充神经功能测试。患者身体上待使用的部位可易于接近，从而需要低成本仪器、比现有测试低的技能水平且提供可靠的结果。
迄今为止，由于对于血管舒缩活性及相关生物过程了解甚少，所以关于使用血管舒缩活性来评估临床症状(诸如本发明的那些临床症状)的公开著作极少。我们已发现血管舒缩信号提供关于许多在健康及非健康身体内同时发生的生物过程的有价值信息。
附图说明
本发明现将参考下图仅举例说明，其中：
图1显示本发明的光传输及检测系统；
图2显示图1中传感器的结构图；
图3a、3b、3c示意图示图1中本发明之较佳实施例施用于患者身上不同部位；
图4为自如图3a中所施用之实施例输出的信号；
图5显示本发明的另一较佳实施例；
图6显示如图5中所示实施例中来自患者腿部不同部位的输出；及
图7显示对于呼吸阻抗增加及握紧拳头的信号响应。
图8显示血管舒缩信号及心率变化的提取。
具体实施方式
参看图1及2，本发明包含光传输及检测系统，其包括具有如图2中所示的合适放大器3、4的包含一LED及光电检测器的传感器1、2。一旦传感器1、2附接于皮肤，则中央控制单元5通过用检测来自光电检测器2的中级电压的合适电压来驱动LED 1以校准传感器。光电检测器2信号由A/D1及A/D2数字化。自D/A1及D/A2的输出产生用于LED的驱动电压。一旦标准过程完成，则中央控制单元5以适合于此应用的取样率自光电检测器4(图2)收集数据。对于DVT检测，使用6Hz的抽样率。使用诸如小键盘的使用者输入装置6及用于输出的显示器，例如LCD屏或LED指示器或类似物。也提供用于PC连接、打印机或其他形式的数据登记装置的输入/输出埠。
图3a至3c显示使用一使用两个传感器1、2用于差异信号分析的两通道系统的本发明较佳实施例。为检测DVT，传感器1、2定位于患者脚底上，此如图3a所示。3b的配置可给出DVT大概位置的指示。若血管舒缩信号相似，则DVT位于大腿，而若血管舒缩信号不同，则DVT位于小腿。图3c中的布置指示上肢与下肢之间的脉冲传输时间且因此指示动脉僵硬。图4显示使用两通道系统时源自健康受检者的脚底的信号。各传感器的信号即使不同也相似。单侧DVT的存在由测量两个信号之间的任何差异来检测。
呈递给使用者的输出可采取如图4中所示详细显示自传感器1、2所收集的血管舒缩信号至简单指示病状存在或不存在的形式。可按照应用来配置显示。
若心率在所执行的评估中受关注(例如在自主功能测试中)，则传感器1、2信号的取样率使得心率分量可拆分至+/-1ms内或更优。否则满足Nyquist要求的取样频率合适。
获自各传感器1、2的信号经受适当分析算法。信号尤其经受复解调，用于研究以具有根据此应用(例如DVT检测)所选带宽的特定频率为中心的血管舒缩活性的算术技术。复解调算法的输出由具有有限带宽，皆以解调频率为中心的振幅信号及相位信号组成，其在组合时，产生由振幅及相位两者调变的时变信号。
如同图3a至3c中所示的配置，另一优选的实施例具有应用于膝下的用于如图5中所示的四通道系统的另外两个传感器7、8。信号经过包括过滤及DC移除继而在一组所选频率(例如第分钟8至30循环)下复解调的信号预处理阶段。对于每一频率，计算来自右脚(RF)及左脚(LF)的平均绝对相差(MAPD)以产生谱RFLF(MAPD)且接着由例如预训人工神经网络的模式分类器使用RFLF(MAPD)以在屏幕上提供“DVT存在(DVT PRESENT)”或“DVT不存在(DVT NOT PRESENT)”的输出。
对于如图5中所示的四通道系统，将存在如图6中所示的六个MAPD：
右脚左脚：RFLF＝平均值(abs(RF(Φ)-LF(Φ)))，
右膝左膝：RKLK＝平均值(abs(RK(Φ)-LK(Φ)))，
右脚右膝：RFRK＝平均值(abs(RF(Φ)-RK(Φ)))，
左脚左膝：LFLK＝平均值(abs(LF(Φ)-LK(Φ)))，
右脚左膝：RFLK＝平均值(abs(RF(Φ)-LK(Φ)))，
右膝左脚：RKLF＝平均值(abs(RK(Φ)-LF(Φ)))，
此给出六倍的上述两通道系统的诊断信息。
除检测DVT以外，本发明还可监控且评估包括糖尿病周围神经病变、严重肢体局部缺血、自主神经功能及动脉及静脉疾病的一系列临床病状。
在这些病状的每一者中，微循环的血管舒缩活动具有使用适当信号处理算法提取且评估的唯一特征。这些算法被调整到由所关注的临床病状所确定的合适频带。算法利用左脚及右脚之间的血管舒缩对称性质且也使用血管舒缩活动的低频率分量与心率变化的低频率分量之间的相似性。如图8中所示，本发明装置从血管舒缩信号提取心率变化且同时低频率心率变化与低频率血管舒缩变化的直接比较提供关于糖尿病交感神经病变的信息，两分量之间的任何差异指示糖尿病交感神经病变。
图7显示与健康人的呼吸阻抗增加及握紧拳头测试相关的血管舒缩活性变化。这些测试影响全身血压及心脏输出，其转而导致如由脚底上的传感器所观察到的心率及血管舒缩活性的神经介导响应。图7中休止阶段与呼吸阻抗增加及握紧拳头测试之间的任何信号变化指示糖尿病交感神经病变，此归因于更新脚部微血管的交感神经纤维的病变导致血管舒缩行为的显著变化。
Claims (7)
1.一种包含一光传输及检测系统的装置，其用以评估身体上个别部位处血管舒缩活动以便监控及评估包括疑似DVT及糖尿病周围神经病变在内的一系列临床病状。
2.根据权利要求1所述的装置，其中所述装置包含一多通道光传输及检测系统，所述多通道光传输及检测系统包括一个或一个以上波传感器、控制构件，所述波传感器安置于身体上一个或一个以上部位处，所述控制构件用以连续测量所述或多个部位处所吸收的光且提供与所述或多个部位处绝对值相关的信号。
3.根据权利要求1所述的装置，其中所述装置包含一多通道光传输及检测系统，所述多通道光传输及检测系统包括一个或一个以上波传感器、控制构件，所述波传感器安置于身体上一个或一个以上部位处，所述控制构件用以连续测量所述或多个部位处所反射的光且提供与所述或多个部位处绝对值相关的信号。
4.根据权利要求2所述的装置，其中所述控制构件测量所述或多个部位处所吸收的光且提供与所述部位之间的差分值相关的信号。
5.根据权利要求3所述的装置，其中所述控制构件测量所述或多个部位处所反射的光且提供与所述部位之间的差分值相关的信号。
6.根据权利要求1、2或3所述的装置，其中提取且比较与同时发生的低频率心率变化及低频率血管舒缩变化相关的信号。
7.根据前述权利要求中任一权利要求所述的装置，其中所述传感器为红外波传感器。
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| GBGB0423289.8A GB0423289D0 (en) | 2004-10-20 | 2004-10-20 | DVT detection |
| GB0423289.8 | 2004-10-20 |
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| CN101039618A true CN101039618A (zh) | 2007-09-19 |
| CN100574699C CN100574699C (zh) | 2009-12-30 |
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| GB (2) | GB0423289D0 (zh) |
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| US20090099465A1 (en) * | 2007-10-15 | 2009-04-16 | Summit Doppler Systems, Inc. | System and method for a non-supine extremity blood pressure ratio examination |
| GB2465230B (en) | 2008-11-17 | 2013-08-21 | Dialog Devices Ltd | Assessing a subject's circulatory system |
| US20120078126A1 (en) | 2010-09-23 | 2012-03-29 | Summit Doppler Systems, Inc. | Validation of an oscillometric signal for use in a peripheral arterial disease evaluation |
| GB201107046D0 (en) | 2011-04-26 | 2011-06-08 | Univ Brighton | Neuropathy test device |
| US8793522B2 (en) * | 2011-06-11 | 2014-07-29 | Aliphcom | Power management in a data-capable strapband |
| RU2501517C2 (ru) * | 2011-06-30 | 2013-12-20 | Закрытое акционерное общество "Медицинский центр "Философия красоты и здоровья" | Способ диагностики стадии нейропатии у больных с сахарным диабетом 2 типа |
| US9375150B2 (en) | 2012-04-25 | 2016-06-28 | Summit Doppler Systems, Inc. | Identification of pressure cuff conditions using frequency content of an oscillometric pressure signal |
| US20150018631A1 (en) * | 2013-07-14 | 2015-01-15 | Avita Corporation | Apparatus and Method for Measuring Physiological Signals |
| GB201409599D0 (en) | 2014-05-30 | 2014-07-16 | Huntleigh Technology Ltd | Tissue variability compensation apparatus and method |
| GB201703575D0 (en) * | 2017-03-06 | 2017-04-19 | Thinksono Ltd | Blood vessel obstruction diagnosis method, apparatus & system |
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| DE3100610C2 (de) * | 1981-01-12 | 1983-07-07 | Vladimir Dr.-Ing. Blazek | Meßeinrichtung zur nichtinvasiven Feststellung venöser bzw. arterieller Abfluß- und Durchflußstörungen |
| DE3609075A1 (de) * | 1986-03-18 | 1987-09-24 | Hans J Prof Dr Rer Nat Schmitt | Mikroprozessorgesteuerte einrichtung zur nichtinvasiven feststellung peripherer abfluss- und durchflussstoerungen |
| US5090417A (en) * | 1987-10-22 | 1992-02-25 | Mollan Raymond A B | Medical diagnostic apparatus |
| US5365924A (en) * | 1992-07-31 | 1994-11-22 | Frederick Erdman Association | Method and apparatus for non-invasive cardiovascular diagnosis |
| US5542421A (en) * | 1992-07-31 | 1996-08-06 | Frederick Erdman Association | Method and apparatus for cardiovascular diagnosis |
| US5282467A (en) | 1992-08-13 | 1994-02-01 | Duke University | Non-invasive method for detecting deep venous thrombosis in the human body |
| DE4226972A1 (de) * | 1992-08-14 | 1994-02-17 | Vladimir Dr Blazek | Verfahren und Meßvorrichtung zur nichtinvasiven Bestimmung der venösen und arteriellen Blutdruckwerte |
| EP0771546B1 (de) * | 1995-11-03 | 2002-09-11 | Lutz Ott | Auswerteverfahren zur Detektion des Blutflusses und/oder intra- und/oder extrakorporal fliessender Flüssigkeiten in biologischem Gewebe |
| US5991654A (en) * | 1997-06-06 | 1999-11-23 | Kci New Technologies, Inc. | Apparatus and method for detecting deep vein thrombosis |
| US6280390B1 (en) * | 1999-12-29 | 2001-08-28 | Ramot University Authority For Applied Research And Industrial Development Ltd. | System and method for non-invasively monitoring hemodynamic parameters |
| JP3643565B2 (ja) * | 2002-02-21 | 2005-04-27 | コーリンメディカルテクノロジー株式会社 | 動脈波形検査装置 |
| WO2003071938A1 (en) * | 2002-02-22 | 2003-09-04 | Datex-Ohmeda, Inc. | Monitoring physiological parameters based on variations in a photoplethysmographic signal |
| US7376457B2 (en) * | 2002-03-01 | 2008-05-20 | Christine Ross | Utilization of heart rate variability in animals |
| GB0205653D0 (en) * | 2002-03-11 | 2002-04-24 | Micro Medical Ltd | A method of measuring endothelial function in a person |
| GB0303797D0 (en) | 2003-02-19 | 2003-03-26 | Huntleigh Technology Plc | Blood assessment |
| US8007436B2 (en) * | 2003-04-10 | 2011-08-30 | Intellectual Property Bank Corp. | Biological information monitoring system |
| US8611977B2 (en) * | 2004-03-08 | 2013-12-17 | Covidien Lp | Method and apparatus for optical detection of mixed venous and arterial blood pulsation in tissue |
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2004
- 2004-10-20 GB GBGB0423289.8A patent/GB0423289D0/en not_active Ceased
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2005
- 2005-10-19 JP JP2007537375A patent/JP2008516719A/ja active Pending
- 2005-10-19 US US11/577,654 patent/US20080076984A1/en not_active Abandoned
- 2005-10-19 CA CA2583095A patent/CA2583095C/en not_active Expired - Fee Related
- 2005-10-19 WO PCT/GB2005/004022 patent/WO2006043052A1/en active Application Filing
- 2005-10-19 EP EP05801375A patent/EP1824382B1/en not_active Not-in-force
- 2005-10-19 CN CN200580035023A patent/CN100574699C/zh not_active Expired - Fee Related
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Also Published As
| Publication number | Publication date |
|---|---|
| GB0423289D0 (en) | 2004-11-24 |
| AU2005297051A1 (en) | 2006-04-27 |
| US20080076984A1 (en) | 2008-03-27 |
| EP1824382A1 (en) | 2007-08-29 |
| WO2006043052A1 (en) | 2006-04-27 |
| JP2008516719A (ja) | 2008-05-22 |
| GB2419403A (en) | 2006-04-26 |
| CA2583095C (en) | 2015-04-07 |
| EP1824382B1 (en) | 2012-08-29 |
| CA2583095A1 (en) | 2006-04-27 |
| AU2005297051B2 (en) | 2011-05-19 |
| DK1824382T3 (da) | 2013-01-07 |
| US20120065523A1 (en) | 2012-03-15 |
| GB0521249D0 (en) | 2005-11-30 |
| ZA200703510B (en) | 2008-07-30 |
| CN100574699C (zh) | 2009-12-30 |
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