CN104288854A - Method and device for high-precision closed-loop blood constituent real-time separation blood sampling - Google Patents

Method and device for high-precision closed-loop blood constituent real-time separation blood sampling Download PDF

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CN104288854A
CN104288854A CN201410583668.3A CN201410583668A CN104288854A CN 104288854 A CN104288854 A CN 104288854A CN 201410583668 A CN201410583668 A CN 201410583668A CN 104288854 A CN104288854 A CN 104288854A
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blood
real
separation
time
component
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CN104288854B (en
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刘忠英
刘�文
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北京麦邦光电仪器有限公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02Blood transfusion apparatus
    • A61M1/0281Apparatus for treatment of blood or blood constituents prior to transfusion, e.g. washing, filtering or thawing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/38Removing constituents from donor blood and storing or returning remainder to body, e.g. for transfusion
    • A61M1/382Optimization of blood component yield
    • A61M1/385Optimization of blood component yield taking into account of the patient characteristics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/04Liquids
    • A61M2202/0413Blood
    • A61M2202/0415Plasma
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/04Liquids
    • A61M2202/0413Blood
    • A61M2202/0427Platelets; Thrombocytes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/04Liquids
    • A61M2202/0413Blood
    • A61M2202/0429Red blood cells; Erythrocytes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/005Anatomical parts of the body used as an access side to the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00Measuring parameters of the user
    • A61M2230/20Blood composition characteristics

Abstract

The invention relates to a method and device for high-precision closed-loop blood constituent real-time separation blood sampling. The method includes the steps that the blood drawn from the body of a blood donor is separated in real time, blood constituents which should be infused back are infused back to the body of the blood donor in a field, the required blood constituents are stored in a corresponding required blood constituent container, indexes of the blood constituents in the body of the blood donor are detected in real time in a non-invasive mode in the blood drawing process, blood sampling is stopped when the indexes of the blood constituents in the body of the blood donor are reduced below safety threshold values, the separated blood constituents are detected in real time so that the operation speed of a blood centrifugal machine can be controlled according to a detection result, and the optimal separation effect is achieved. The device for high-precision closed-loop blood constituent real-time separation blood sampling comprises a blood drawing unit, a blood separation unit, a storage unit, a back infusion unit, a constituent quality detection unit, a fluid infusion unit, a real-time physiological monitoring unit and a central processing unit. According to the method and device, on the premise that safety is guaranteed, the maximum blood donation volume can be accurately determined according to physical indexes of the blood donor, and the blood separation quality can be improved and guaranteed.

Description

高精度闭环血液成分实时分离采血方法及采血装置 Precision real-time closed loop blood component separation apparatus lancing and blood collection

技术领域 FIELD

[0001] 本发明涉及一种高精度闭环血液成分实时分离采血方法及采血装置。 [0001] The present invention relates to a high-precision real-time closed-loop blood component separation method of blood collection and blood collection devices.

背景技术 Background technique

[0002] 现有采血装置通常为抽血血泵以及相应的储血袋,抽血血泵通过抽血管以及抽血针头将血液从人体内抽出,送入储血袋存储,由于这种方式采集的是全血,而实际需要的则可能是血液中的部分有用成分,由此发展起了一种新型的分离采血方式,通过血液分离技术进行采血的设备主要是血液分离机,将采用的全血分离后,不需要的成分(例如血浆)回输到献血者体内,由此减少献血对献血者的不利影响,并提高血液的利用功效,现有这种技术存在如下缺陷:一是无法准确地确定献血者的最大献血量,一次最大采血量往往控制在一个相对保守的水平,不利于在保证安全的情况下最大限度地利用献血资源,特别是对于一些特殊血液,由于献血来源非常少,易于出现血源不足的现象,而对于自体回输,则更是难以从病人身上获得足够的回输血量,二是血液 [0002] Existing lancing devices generally corresponding blood and blood pump blood storage bags, blood vessels and pumping blood through the blood pump draws blood from the needle body, to storage in the storage bags, because in this way gathering of whole blood, it actually needs may be partially useful component in blood, which developed from a novel manner of separating blood, blood is collected through the blood separation device is a blood separator primarily, the use of whole blood separation, unnecessary components (e.g., plasma) reinfusion to the donor body, thereby reducing the adverse effects on blood donors, and increase the effectiveness of using blood, such prior art has the following defects: First, can not be accurately determine the maximum amount of blood donors, a maximum amount of blood is often controlled in a relatively conservative level, is not conducive to maximize the use of resources in ensuring safe blood donation cases, especially for some special blood, because the blood source is very small, prone to the phenomenon of insufficient blood and for autotransfusion, is even more difficult to obtain a sufficient amount of blood back from the patient, the second is the blood 分离机只有开环、定量型的,分离过程中没有对分离成分进行实时检测,分离质量难以控制。 Only open loop separator, quantitative type, the separation process is not real-time detection of the separated components, is difficult to control the quality of separation.

发明内容 SUMMARY

[0003] 为本发明的目的克服现有技术的上述缺陷,提供了一种高精度闭环血液成分实时分离采血方法及采血装置,以便在保证安全的前提下,根据献血者的生理指标,准确地确定最大献血量。 Objective [0003] The present invention overcomes the aforementioned drawbacks of the prior art, there is provided a high-precision real-time closed-loop blood component separation method of blood collection and blood collection apparatus, in order to ensure the safety of the premise, according to the physiological index donors accurately determine the maximum amount of blood.

[0004] 本发明进一步的目的是对分离的血液成分进行实时检测,通过反馈控制,提高和保证分离质量。 A further object of the [0004] present invention is the separation of blood components for real-time detection, by the feedback control, and to ensure improved quality of the separation.

[0005] 本发明所采用的技术方案为: [0005] The technical proposal of the present invention are:

[0006] 一种高精度闭环血液成分实时分离采血方法,其对从献血者体内抽取的血液进行实时分离,分离为不同的血液成分,所述不同的血液成分包括应回输血液成分和一种或多种所需血液成分,将应回输血液成分(不需要采集的且应回输到献血者体内的血液成分)现场回输到献血者体内,将所需血液成分存储于相应的所需血液成分容器,在从献血者体内抽取血液的过程中,实时无创检测献血者体内的血液成分指标,以献血者体内的血液成分指标(例如,一种或多种血液成分的浓度指标)作为限定最大采血量的独立指标,当献血者体内的血液成分指标降到安全门值(下限阈值)时,停止采血。 [0006] a high-precision real-time closed-loop blood component blood separation method for real-time separation of the blood drawn from a donor, separated into different blood component, the blood component comprises a different blood component to be recirculated, and one or more desired blood component, blood component transfusion to be (and need not be collected blood component to donor reinfusion in vivo) reinfusion to the donor site in vivo, the desired blood component is stored in the corresponding desired blood components container, during the withdrawal of blood from a donor in vivo, real-time non-invasive blood component in vivo index detection donors, blood components to the donor body indicators (e.g., one or more indicators of the blood component concentration) is defined as the largest independent indicator of the volume of blood, blood component in vivo when donors index down security gate value (lower threshold), the blood stops. 另外,除本发明依据献血者生理信息特别是体内血液成分检测信息确定的最大采血量外,在采血中还应当同时依据现有其他标准和规范(如果有的话)对应停止采血的情形进行相应的检测和判断,在出现任意一种应停止采血的情形时,均应依据相应的标准和规范停止采血。 Further, in addition to the present invention is based on the maximum amount of blood outside the particular blood component in vivo detection information to determine physiological information donors, while in the blood also be based on other existing standards and specifications (if any) corresponding to the case of the corresponding stop blood detection and determination, in the case when any of the blood appears to be stopped, stop the blood should be according to appropriate standards and specifications.

[0007] 优选的,对分离中和/或分离后的血液成分进行实时检测,依据检测信息对血液分离装置进行在线实时反馈控制,调节用于血液分离的血液离心分离机的运行速度,以达到最佳分离效果。 [0007] Preferably, the separation of blood components and / or after separation detected in real time, on-line real-time feedback control of the blood separation means according to the detection information, for adjusting the speed of a blood separation centrifuge of the blood, in order to achieve optimum separation.

[0008] 优选的,当所述所需血液成分包括血小板时,所述分离中和/或分离后的血液成分的实时检测至少包括对分离中和/或分离后的血小板的纯度检测。 [0008] Preferably, when the desired blood component comprises platelets, blood components and detected in real time or in post / separating comprise at least platelets, and detection of the purity or the separation / isolation of the separation.

[0009] 优选的,所述实时无创检测献血者体内的血液成分指标的算法采用动态光谱积分自归一化解多元方程法,在全光谱分析范围内设有m个谱频率f 1、f2...fm,相应谱功率为ρΐ、ρ2...pm,对第i 个功率谱pi 分别在0-fdc (如0.5Hz)和facl (如0.5Hz) -fac2 (如25Hz)积分,分别为pidc和piac, [0009] Preferably, the real-time non-invasive blood component in vivo the donor index detection algorithm from the dynamic spectrum integral equation method polyhydric normalized to resolve, in the full range of spectral features of m spectral frequency f 1, f2 .. .fm, the corresponding spectral power of ρΐ, ρ2 ... pm, the power spectrum of the i-th pi in 0-fdc (eg 0.5Hz), respectively, and facl (e.g., 0.5Hz) -fac2 (eg 25Hz) integral, respectively pidc and piac,

[0010] pidc = / pidf fe (0-fdc) [0010] pidc = / pidf fe (0-fdc)

[0011] piac = / pidf fe (facl-fac2) [0011] piac = / pidf fe (facl-fac2)

[0012] 对于有干扰的动态谱积分,则piac积分限选择脉搏谱分布的半功率区域: [0012] For dynamic interference spectral integration, the integration limits piac selection pulse half power spectral distribution regions:

[0013] piac = / pidf fe (f0.51-f0.5h),式中f0.51、f0.5h 分别为上下半功率点, [0013] piac = / pidf fe (f0.51-f0.5h), wherein f0.51, f0.5h respectively upper and lower half-power point,

[0014] 取两者对数比值In (piac)/In (pidc) =ri,列矩阵方程: [0014] whichever is the log ratio In (piac) / In (pidc) = ri, column matrix equation:

[0015]第 i 种成分Ci = al*rl+a2*r2+...+an*rn [0015] i th component Ci = al * rl + a2 * r2 + ... + an * rn

[0016] 解η个方程得成分ci。 [0016] Solutions of equations obtained η component ci.

[0017] 优选的,所述对分离中和/或分离后的血液成分进行实时检测的算法采用光谱积分比例系数法,自动控制血液离心分离机系统的运行速度,达到控制精度的目的,具体为: [0017] Preferably, the algorithm for real-time detection of blood component separation and / or after separation method using proportional coefficient spectrum integral, automatic speed control system blood centrifuges, accuracy control purposes, specifically for the :

[0018] 设血液中有η种成分,xl、x2......χη为各种成分的光谱密度函数,当系统运转时,光谱密度与运转速度V有关,设第i种有用成分(如血红蛋白)的光谱密度函数为xi,该有用成分的谱能量与总谱能量之比为: [0018] provided in the blood η ingredients, xl, x2 ...... χη spectral density function of the various components, when the system is running, the spectral density and the running speed V related to the i-th set of useful components ( such as hemoglobin) is the spectral density function of xi, the spectral energy ratio of the energy of useful components of the score is:

[0019] y = / xidf/{ / xldf+ / x2df+.../ xndf},f 为光谱频率 [0019] y = / xidf / {/ xldf + / x2df + ... / xndf}, f is the frequency spectrum

[0020]对 y 求导数,dy/dv= { / xidf/[ f xldf+ f x2df+...f xndf]} /dv[0021 ] 令dy/dv = 0,得出最佳运行速度, [0020] the derivative of y, dy / dv = {/ xidf / [f xldf + f x2df + ... f xndf]} / dv [0021] Order dy / dv = 0, optimum speed,

[0022] 在不同成分影响不同需要权重考虑的情况下,该有用成分的谱能量与总谱能量之比则为: [0022] In the case where the influence of different components of different weights need to be considered, and the spectral energy ratio of the energy of the useful component score is compared:

[0023] y = / xidf/{kl* f xldf+k2* f x2df+...kn* f xndf},其中kl、k2...kn 为权重系数,其他公式不变。 [0023] y = / xidf / {kl * f xldf + k2 * f x2df + ... kn * f xndf}, where kl, k2 ... kn is a weighting factor, other formulas unchanged.

[0024] 一种高精度闭环血液成分实时分离采血装置,其采用上述任意一种方法,包括: [0024] a high-precision real-time closed-loop blood component separation lancing device, which uses any of the above method, comprising:

[0025] 抽血单元,设有抽血血泵,所述抽血血泵设有抽血管; [0025] blood cells, blood with the blood pump, the blood pump has pumped blood vessel;

[0026] 血液分离单元,设有用于分离血液成分的分离机,所述分离机优选血液离心分离机,所述分离机的进口连接所述抽血血泵的输出,对来自所述抽血血泵的血液进行成分分离,设有多个用于输出不同血液成分的输出管道,例如包括一个用于输出应回输血液成分的输出管道和一个或多个用于输出所需血液成分的输出管道,当所需血液成分为多种时,不同的血液成分分别通过不同的血液成分输出管道输出; [0026] The blood separation means is provided for separating blood component separator, the separator is preferably a centrifugal blood separator, the separator unit is connected to the output of blood inlet pump blood, blood from said blood component separation blood pump is provided with a plurality of different blood components for outputting an output conduit, for example conduit includes an output for outputting a desired blood component transfusion to be output duct or blood components and a plurality of outputs for when the desired blood component is a variety of different blood component output through the output pipe are of different blood components;

[0027] 存储单元,设有一个或多个存储血泵及与所述一个或多个存储血泵配套的一种或多种所需血液成分的存储容器,例如储血袋,所述存储血泵的进口连接所述分离机相应血液成分的输出管道,所述存储血泵的出口连接相应的所需血液成分的存储容器; [0027] storage unit, provided with one or more of the stored blood pump and a blood pump stops or more memory one or more of the desired blood component storage container, such as blood storage bags, the blood storage a pump connected to a respective inlet of the blood component separator of the output pipe, an outlet connected to the blood pump storage corresponding desired blood component storage container;

[0028] 实时生理监护单元,用于实时采集献血者生理信息,至少包括体内血液成分实时无创检测装置,所述体内血液成分实时无创检测装置设有信号传输线缆和/或无线通信模块,用于与中央控制单元通信连接; [0028] Real-time monitoring of physiological means for real-time acquisition donor physiological information, including at least real-time noninvasive in vivo blood component detecting means, said real-time noninvasive in vivo blood component detecting means is provided with a signal transmission cable and / or wireless communication module, with in a communication connection with the central control unit;

[0029] 中央控制单元,主要由中控计算机或者中控数据处理器构成,用于控制抽血血泵工作,以便从献血者体内抽取血液,接收来自所述生理监护单元的献血者生理信息并进行分析比对,当献血者生理指标降到抽血安全门值(下限阈值)时或者采集的血液成分达到设定的量时,控制抽血血泵停止工作,所述献血者信息至少包括所述体内血液成分实时无创检测装置所获得的献血者的体内血液成分指标信息。 [0029] The central control unit, the main central control computer or data processor in the control configuration, the blood pump for controlling the blood, blood was drawn from a donor to the body, to receive information from the donors physiological and physiological monitoring unit when analysis and comparison, when donor blood physiological indexes down security door value (lower threshold) or the collected blood component reaches a set amount, the control blood blood pump stops working, the information comprising at least the donor real-time noninvasive in vivo blood component obtained by the detection means donors of the blood component index information.

[0030] 优选的,这种装置还包括成分质量检测单元,所述成分质量检测单元设有血液分离成分实时检测装置,用于对所述分离机新分离出来(包括分离过程中和/或分离完成后的)的血液成分进行实时检测,所述血液分离成分实时检测装置将相应的检测信息通过有线和/或无线方式传至所述中央处理单元,所述中央处理单元对所述血液分离成分实时检测装置的检测信息进行分析,依据分析结果控制所述分离机的工作参数(例如,当所述分离机采用血液分离机时,调整分离转速,以获得所需的分离成分纯度)。 [0030] Preferably, such apparatus further comprises a component quality detection means, said detection unit is provided with a blood component quality real-time detection component separation means for separating the new separator (including separation and / or isolation after completion of the blood component) is detected in real time, real-time detection of the blood component separation device for detecting information transmitted to the corresponding central processing unit via wired and / or wireless manner, the central processing unit of the blood component separation detecting means detecting information in real time is analyzed based on the analysis result of said separator machine operating parameters (e.g., when using the blood separator separator, to adjust the speed of separation to obtain the desired purity of the separated components).

[0031] 优选的,这种装置还包括回输单元,所述回输单元设有回输血泵,所述回输血泵的进口连接所述分离机的应回输血液成分的输出管道,所述回输血泵的出口连接有回输管,在采血过程中和/或者抽血完毕后,所述中央控制单元控制所述抽血血泵停止工作,然后控制所述回输血泵工作,以便将所述分离机分离出来的应回输血液成分回输到献血者体内。 [0031] Preferably, such apparatus further comprising a recirculation unit, said recirculation unit provided with an output pipe back to pump blood, the blood back to the pump inlet connected to the separator should reinfusion of blood components, the blood return pump outlet is connected to return line, in the course of blood collection and / or after completion of blood, the blood central control unit controls the blood pump stops working, the control of the pump and then back to the blood, so the said separator separated blood component transfusion to be exported back to the donor body.

[0032] 优选的,这种装置还包括补液单元,所述补液单元设有补液血泵,所述补液血泵设有进液管和补液管,当需要对献血者补液时,所述中央控制单元控制所述抽血血泵停止工作,然后控制补液血泵工作,以便将补液液体送入献血者体内,可以通过所述进液管连接装有补液用液的袋(或瓶等)进行补液,还可以通过在瓶内配制所需的药物通过补液血泵进行药物注射。 [0032] Preferably, such apparatus further comprising a fluid means, fluid unit is provided with a fluid pump blood, the blood pump is provided with fluid inlet tube and fluid tube when fluid need of blood donors, the central control the blood unit controls the blood pump stops working, the control fluid and the blood pump, so that the donor fluid into the body of liquid, through said inlet pipe is connected with fluid replacement fluid bag (or bottle) solution , you may also be required by formulating a pharmaceutical vial injection by drug infusion pump blood.

[0033] 优选的,所述补液管和回输管连接于同一个输入管,所述输入管配有用于检测管中气泡信息和压力信息的超声气泡/压力检测装置,所述超声气泡/压力检测装置将相应的检测信息通过有线和/或无线方式传至所述中央处理单元,所述中央处理单元对来自所述输入管超声气泡/压力检测装置的检测信息进行分析,当所述输入管内存在气泡时,所述中央处理单元控制所述补液血泵或回输血泵停止工作。 [0033] Preferably, the tube and the fluid return line connected to the same inlet pipe, pipe with a bubble tube for detecting the information and the pressure information of the ultrasonic air bubble / input said pressure detecting means, the ultrasonic bubble / pressure detecting means for detecting the information transmitted to the corresponding central processing unit via wired and / or wireless manner, the central processing unit detects input information from the ultrasonic bubble tube / pressure detection device for analysis, when the input inner tube presence of gas bubbles, said central processing unit controls the blood pump or infusion pump stops blood return.

[0034] 优选的,所述存储单元设有用于检测所述所需血液成分的存储容器内液位信息的存储液位超声检测装置,所述存储液位超声检测装置将相应的检测信息通过有线和/或无线方式传至所述中央处理单元,所述中央处理单元对来自所述存储液位超声检测装置的检测信息进行分析,当所述所需血液成分的存储容器内液位达到设定高度时,所述中央处理单元控制所述抽血血泵停止工作。 [0034] Preferably, the memory storage unit is provided with the ultrasonic liquid level detecting means of the blood component storage container for detecting the level of information required, the stored ultrasonic liquid level detecting means for detecting information corresponding cable and / or wirelessly transmitted to the central processing unit, the central processing unit of the ultrasonic liquid level detecting device detects information from the storage for analysis, when the storage container of the desired blood component reaches a set level when the height of the central processing unit controls the blood pump stops blood.

[0035] 优选的,所述体内血液成分实时无创检测装置为至少能够检测体内血液中红细胞、血浆和血小板浓度之一(细胞、血浆和血小板浓度中任意一项指标)的体内血液成分实时无创检测装置,可以采用各种适宜的无创检测技术,例如,通过选用适宜频率/频率范围的红外线照射献血者的手指或身体其他适宜部位,检测透射光谱,利用不同成分对不同频率的红外线的吸收状况不同,通过分析对特定频率/频率范围的红外线吸收情况,分析出血液中相应成分的浓度。 [0035] Preferably, the real-time noninvasive in vivo blood component detecting device capable of detecting at least the red blood cells in the blood, one of plasma and platelet concentration (cells, platelets, and plasma concentrations of any one indicator) in real time in vivo noninvasive measurement of blood components means may employ various suitable noninvasive detection techniques, e.g., by selecting a suitable frequency / frequency range infrared irradiation donor's finger or other suitable body parts of the transmission spectrum is detected, different components with different infrared absorption conditions at different frequencies by analyzing the infrared absorption specific frequency / frequency range, the analysis of the respective concentration in the blood component.

[0036] 优选的,所述血液分离成分实时检测装置为至少能够检测血小板纯度的实时检测装置,可以采用各种适宜的检测技术,例如适于血小板的光谱物质检测技术和光谱检测装置,用于血小板纯度在线实时反馈控制,从而提升血小板纯度与质量。 [0036] Preferably, the blood component separation device is a real time detection means detecting at least capable of detecting platelet purity, may employ various suitable detection techniques, such as spectroscopy and spectroscopic techniques substance detection means adapted to detect platelets, for platelet purity online real-time feedback control, thereby improving the quality and purity of platelets.

[0037] 本发明的有益效果:由于实时无创检测献血者体内的血液成分指标,并在当献血者体内的血液成分指标降到安全门值停止抽血,为确定最大采血量提供了科学的依据,由此实现了对最大采血量的准确控制,特别是在血源紧张及其他特殊情况下,有利于充分利用献血资源;由于对血液分离的实时检测,通过反馈控制的方式对分离装置进行控制,有利于提高分离质量;由于提供了涉及对献血者体内血液成分指标和分离质量控制的适宜算法,有利于实现相应的检测和控制目的,保证检测和控制质量。 [0037] The invention has the advantages: Due to the real-time noninvasive blood components donors index detection in vivo, and in vivo when donor blood component index value dropped to secure the door to stop the blood, provide a scientific basis for determining the maximum amount of blood, thereby achieving accurate control of the maximum volume of blood, especially in the blood tension and other special circumstances, blood help make full use of resources; as real-time detection of blood separation, separation means controlled by means of feedback control, help improve the quality of the separation; relates to the provision of the appropriate algorithm for the blood component separation quality indicators and control donor body, it is conducive to the corresponding detection and control purposes, quality control and assurance testing.

附图说明 BRIEF DESCRIPTION

[0038] 图1是本发明的系统结构框图。 [0038] FIG. 1 is a block diagram of the system of the present invention.

具体实施方式 Detailed ways

[0039] 参见图1,这种装置的执行部分主要包括:抽血单元、血液分离单元、存储单元、回输单元和补液单元,这些执行部分(单元)在中央处理单元的控制下进行抽血(采集全血)、血液分离、所需血液成分的存储、应回输血液成分的回输以及必要时的补液(例如营养液和药液,根据实际需要确定),中央控制单元对来自实时生理监护单元中的体内血液成分实时无创检测装置和成分质量检测单元中的血液分离成分实时检测装置所获得的信息进行分析,并依据相应的操作规范等,控制抽血单元的抽血血泵、血液分离单元的分离机、存储单元的存储血泵、回输单元的回输血泵以及补液单元的补液血泵工作,实现抽血、分离、存储、回输和补液等功能。 [0039] Referring to Figure 1, the operative part of this device include: blood cells, blood separation unit, a storage unit, and fluid reinfusion unit cell, the operative part (means) for blood under the control of the central processing unit (collection of whole blood), blood separation, the desired blood component storage, transfusion of blood components should transfusion and infusion, if necessary (e.g. nutrient solution, and the solution, according to the actual needs), the central control unit in real time from a physiological vivo blood component monitoring unit in real time non-invasive detection means and the component information detection unit mass separation of blood components obtained by real-time detection device for analysis, and the like according to the corresponding operating specifications, the control unit of blood blood blood pump, blood separator separating unit, the storage unit stores the blood pump, blood reinfusion back to the pump unit and a fluid infusion pump blood cells to achieve blood separation, storage, and transfusion rehydration functions. 其中, among them,

[0040] 抽血单元,用于采集全血。 [0040] blood cells, is used to collect blood.

[0041] 血液分离单元,用于实现将全血中血液成分的分离,主要是对血液中的血浆、血红细胞和血小板进行相互分离。 [0041] The blood separation means for effecting the separation of whole blood in a blood component, mainly in the blood plasma, red blood cells and platelets are separated from each other.

[0042] 实时生理监护单元,用于对献血者在献血过程中生理信息的监测并向中央处理单元反馈,主要是用于对体内血液成分的无创检测,也可以根据实际需要包括对献血者其他生理信息的采集,例如在采血中,动态无创检测体内血红细胞数量,建立专家系统运算模型,在保障机体组织的供氧能力下,尽量减少采血时间和次数。 [0042] Real-time physiology monitoring means for monitoring of blood donors and in the process of blood physiological feedback information in a central processing unit, is mainly used for noninvasive measurement of blood components in the body, you may actually need to include other donors collecting physiological information, for example, in blood, the dynamic non-invasive in vivo detection of the number of red blood cells, expert system operation model, the ability to protect the oxygen in the body tissue, and to minimize the number of blood collection time.

[0043] 回输单元和补液单元:中央处理单元根据体内动态血液成分无创检测信息,动态计算补液成分及用量,通过回输单兀和补液单兀分别将应回输血液成分和补液用液输入人体,达到安全采血的目标。 [0043] The recirculation unit and a fluid unit: a central processing unit according to the dynamic blood component in vivo noninvasive detection information dynamically calculates rehydration composition and amount by reinfusion single Wu and rehydration single Wu respectively should reinfusion of blood components and fluids by liquid input the human body, to achieve the goal of safe blood.

[0044] 这种装置的工作过程为: [0044] The working process of such a device is:

[0045] 首先由中央处理单元的中控数据处理器(计算机)指令体内血液成分实时无创检测装置对献血者的体内血液成分进行检测,确定体内血液成分指标是否处于安全范围内,如果安全,则指令打开抽血泵开始抽血,可以每抽1ml血,无创检测一次献血者的血液成分检测。 [0045] First, a central processing unit in the control of the data processor (computer) instructions in real time the blood component in vivo non-invasive blood component detecting means for detecting blood donors, the blood component is determined whether the index is within a safe range, if the security, the open blood pump start instruction blood, can be pumped per 1ml of blood, noninvasive measurement of a blood component detection donors. 血液自抽血针头经抽血血泵进入血液分离单元,血液分离单元通过离心机将血液分离,所述成分质量检测单元的血液分离成分实时检测装置(检测电路)对分离出的血液成分进行实时检测,优选对刚刚分离出的(新分离出的)血液成分进行检测,以便进行及时的反馈,在可能的情况下,优选对对位于所述分离机内部的分离出的血液成分进行检测,也可以对所述分离机相应血液成分的输出管道内的血液成分进行检测,检测点宜为近远离分离机的位置,依据分离机的设置,经中央处理单元分析处理后将结果输入离心机的自动控制单元或者由血液分离成分实时检测装置和/或离心机的自动控制单元直接对相应的检测信息进行分析,通过离心机的自动控制单元调整离心机的运行速度,达到最佳分离精度,分离后各种所需血液成分通过不同的输出管道在存储血泵的作 Of blood from the blood through the needle into the blood blood blood pump separation unit, the separation unit of blood through a centrifuge separating blood, the blood component separation quality detection unit real component detecting means (detection circuit) of the separated blood components in real time detection, and preferably for (newly isolated) just separated blood component is detected, for timely feedback, where possible, it is preferable to separate the blood components separator is located inside the machine is detected, but also automatic blood component can be detected in the respective output conduit of the blood component separator, away from the detection points should be as near disengaged position machine according separator is provided, the results of analysis by the central processing unit after the input of the centrifuge or after the control unit and / or centrifuge unit for automatic control of the respective detection information by the blood component separation device is directly detected in real time analysis, the centrifuge unit adjustment by automatically controlling the speed of the centrifuge, to achieve optimum separation accuracy, isolated various blood components required by the different output duct for storing the blood pump 下储存于不同储血袋中,分离后不需要的成分(应回输血液成分)接入回输血泵,计算机指令抽血泵停止,启动回输血泵并同时开启输出管超声气泡检测装置(检测电路)进行气泡,将应回输血液成分回输献血者体内。 Stored under different storage bags, no separation of the components (blood component transfusion to be) pump blood back to the access computer instructions blood pump is stopped, and simultaneously start the pump blood back to open outlet tube ultrasonic bubble detection means (detection circuit) bubbles will be reinfusion in vivo blood component transfusion donors.

[0046] 当获得的所需血液成分满足设置的采集量或检查到献血者的生理指标降到安全门限时停止抽血。 [0046] When the desired blood component collection available to meet the set amount of physiological parameters or to check the donor's safety threshold down to stop the blood.

[0047] 当献血者需要补充药物时,计算机指令抽血血泵I和回输血泵停,开启补液血泵输注药物。 [0047] When donor drugs need to be supplemented, the computer instructions blood transfusion blood pump I and the return pump stops, the blood pump is turned on rehydration drug infusion.

[0048] 所述各种血泵均采用精密输血泵。 [0048] The various types of blood transfusion pump using precision pump.

[0049] 本发明所述的各种单元,除明确记载的具有主要和/或基本功能的件/装置之外,还可以包括各种相应的配套和/或附属的件/装置,例如所述具有主要或基本功能的装置的安装组件、所述具有主要和/或基本功能的装置的配套控制电路、用于实现液体传输的连接管或其他形式的连接管道等等,这些配套和/或附属的件/装置可以依据现有技术实现。 [0049] The various elements of the present invention, in addition to the member / device having a primary and / or basic functions explicitly recited, but also may include various appropriate supporting and / or members / devices attached, for example, the mounting assembly having a primary or basic functions of the apparatus, said control circuit means having a supporting primary and / or basic functionality for implementing the fluid transfer tube connected to the pipe or other form of connection, etc., these supporting and / or affiliates the element / means may be implemented according to the prior art.

[0050] 本发明涉及用于传输血液或血液成分的连接可以采用各种适宜的管道连接,所述用于连接的管道可以为橡胶管、塑料管和金属管等,并可以设有各种所需的管道连接件,所述用于连接的管道上可以设有或者不设有液体的暂存空间/暂存容器。 [0050] The present invention relates to a connector for transmission of blood or blood components may employ various suitable pipe connection, duct means for connecting may be a rubber tube, plastic pipes and metal pipes, etc., and may be provided with the various pipe connection required, means for connecting the pipe may be provided or not provided with temporary liquid space / temporary container.

[0051] 本发明各单元的机械组装或集成可以依据现有技术。 [0051] or an integrated mechanical assembly of each unit of the invention can be based on the prior art.

[0052] 所述中央控制单元用于控制各血泵及分离机的硬件架构和/或通信方式可以依据现有技术,可以为通过控制线缆分别连接各血泵及分离器的控制接口。 [0052] The central control unit for controlling the blood pump and the respective interface control separator hardware architecture and / or communications mode can be based on the prior art, and can be connected to each of the blood pump to the separator through the control cable separately.

[0053] 本发明所称与中央控制单元通信连接或涉及与中央控制单元之间的信息/数据传送,为直接或间接方式与所述中央控制单元的中控计算机或者中控数据处理器通信连接或与所述中央控制单元的中控计算机或者中控数据处理器之间的信息/数据传送,所述中控计算机或者中控数据处理器可以设有相应的接口电路或数据转换电路等,实现所述的通信连接或信息/数据传送,所述通信方式和信息/数据传送方式及相应的硬件架构可以依据现有技术。 [0053] The present invention is referred to a central control unit in communication with the information related to or connected between the central control unit and / data transfer, or direct control of the central control computer or data processor in communication with indirectly connected to said central control unit information / data transfer between the central computer or in the control of the data processor or the central control unit, the central control computer or processor may be provided in the control data corresponding interface circuit or a data converting circuit, to achieve or communication connection of the information / data transmission, the communication and information / data transmission mode and the corresponding hardware architecture according to the prior art.

[0054] 本发明可以依据现有技术,设置各种显示、报警和输出/输入装置。 [0054] The present invention according to the prior art, various types of display set, and the alarm output / input means.

[0055] 本发明公开的各优选技术手段,除特别说明外及一个优选技术手段为另一技术手段的进一步限定外,均可以任意组合,形成若干不同的技术方案。 [0055] Preferably each of technical means disclosed in the present invention, and unless otherwise stated a preferred techniques to further define an outer another technical means, can be arbitrarily combined to form several different technical solutions.

Claims (10)

1.一种高精度闭环血液成分实时分离采血方法,其对从献血者体内抽取的血液进行实时分离,分离为不同的血液成分,所述不同的血液成分包括应回输血液成分和一种或多种所需血液成分,将应回输血液成分现场回输到献血者体内,将所需血液成分存储于相应的所需血液成分容器,在从献血者体内抽取血液的过程中,实时无创检测献血者体内的血液成分指标,以献血者体内的血液成分指标作为限定最大采血量的独立指标,当献血者体内的血液成分指标降到安全门值时,停止采血。 A closed blood component in real time with high precision blood separation method for real-time separation of the blood drawn from a donor, separated into various blood components, including the different blood components of blood to be recirculated ingredient and one or more desired blood component, blood component transfusion to be exported back to the donor site in vivo, the desired blood component is stored in the corresponding desired blood component container, during the withdrawal of blood from a donor in vivo, non-invasive detection in real time donor blood components in vivo indicators to the body indicator donor blood components as separate indicators define the maximum amount of blood, when the blood component in vivo donor index value drops to a safe door, stops blood.
2.如权利要求1所述的采血方法,其特征在于对分离中和/或分离后的血液成分进行实时检测,依据检测信息对血液分离装置进行在线实时反馈控制,调节用于血液分离的血液离心分离机的运行速度,以达到最佳分离效果。 2. The blood collection method according to claim 1, characterized in that the separation of blood components and / or after separation detected in real time, on-line real-time feedback control of the blood separation means according to the detection information, for regulating blood separating blood speed centrifugal separator, in order to achieve optimum separation. 例如:当所述所需血液成分包括血小板时,所述分离中和/或分离后的血液成分的实时检测至少包括对分离中和/或分离后的血小板的纯度检测。 For example: when the desired blood component comprises platelets, the separation of blood components and the real-time detection of the rear or / separating comprise at least a purity of separation and detection of platelets / or after separation.
3.如权利要求2所述的采血方法,其特征在于: 所述实时无创检测献血者体内的血液成分指标的算法采用动态光谱积分自归一化解多元方程法,在全光谱分析范围内设有m个谱频率fl、f2...fm,相应谱功率为pl、p2...pm,对第i个功率谱pi分别在O-fdc (如0.5Hz)和facl (如0.5Hz) -fac2 (如25Hz)积分,分别为pi dc和pi ac, pidc = f pidf fe (0-fdc) piac = f pidf fe (facl-fac2) 对于有干扰的动态谱积分,则Piac积分限选择脉搏谱分布的半功率区域: piac = / pi df fe (f0.51_f0.5h),式中f0.51、f0.5h 分别为上下半功率点, 取两者对数比值In (piac)/In (pidc) = ri,列矩阵方程: 第i 种成分Ci = al*rl+a2*r2+...+an*rn 解n个方程得成分ci, 所述对分离中和/或分离后的血液成分进行实时检测的算法采用光谱积分比例系数法,自动控制血液离心分离机系统的运行速度,达到控制精度的目的,具体为: 设血液中有η种成分,xl、x2 3. The blood collection method according to claim 2, wherein: the real-time non-invasive blood component in vivo donors index detection algorithm using dynamic spectrum integral equation from multivariate method to resolve a normalized, equipped with the whole spectral range the m spectral frequency fl, f2 ... fm, the corresponding spectral power of pl, p2 ... pm, the power spectrum of the i-th pi respectively O-fdc (eg 0.5Hz) and facl (eg 0.5Hz) -fac2 (e.g., 25Hz) integral, respectively pi dc and pi ac, pidc = f pidf fe (0-fdc) piac = f pidf fe (facl-fac2) for dynamic spectrum integral interference, the Piac integration limits selection pulse spectral distribution half power region: piac = / pi df fe (f0.51_f0.5h), wherein f0.51, f0.5h respectively upper and lower half-power point, whichever is the log ratio of in (piac) / in (pidc) = ri, column matrix equation: i th component Ci = al * rl + a2 * r2 + ... + an * rn solution of n equations to obtain components ci, the real-time separation of blood components and / or after separation the detection algorithm uses the spectrum integral proportional coefficient, the automatic control system of the blood centrifuge speed, precision control purposes, specifically: in the blood provided η ingredients, xl, x2 ......χη为各种成分的光谱密度函数,当系统运转时,光谱密度与运转速度ν有关,设第i种有用成分(如血红蛋白)的光谱密度函数为xi,该有用成分的谱能量与总谱能量之比为: y = / xidf/{ f xldf+ f x2df+...f xndf},f 为光谱频率对y 求导数,dy/dv= { f xidf/[ f xldf+ f x2df+...f xndf]} /dv 令dy/dv = 0,得出最佳运行速度, 在不同成分影响不同需要权重考虑的情况下,该有用成分的谱能量与总谱能量之比则为: y = / xidf/{kl* f xldf+k2* f x2df+...kn* f xndf},其中kl、k2...kn 为权重系数,其他公式不变。 ...... χη spectral density function of the various components, when the system is running, the spectral density and the operation speed ν related to the i-th set of useful components (such as hemoglobin) is the spectral density function of xi, the useful components ratio of spectral energy to score energies as: y = / xidf / {f xldf + f x2df + ... f xndf}, f spectral frequency y the derivative, dy / dv = {f xidf / [f xldf + f x2df +. ..f xndf]} / dv order dy / dv = 0, optimum speed, affecting the different weights need to be considered, and the spectral energy ratio of the energy of the useful component score is compared in different components: y = / xidf / {kl * f xldf + k2 * f x2df + ... kn * f xndf}, where kl, k2 ... kn is a weighting factor, other formulas unchanged.
4.一种采用权利要求1-3中任意一项权利要求所述方法的高精度闭环血液成分实时分离采血装置,其特征在于包括: 抽血单元,设有抽血血泵,所述抽血血泵设有抽血管; 血液分尚单兀,设有用于分尚血液成分的分尚机,所述分尚机优选血液尚心分尚机,对来自所述抽血血泵的血液进行成分分离,设有多个用于输出不同血液成分的输出管道; 存储单元,设有一个或多个存储血泵及与所述一个或多个存储血泵配套的一种或多种所需血液成分的存储容器,所述存储血泵的进口连接所述分离机相应血液成分的输出管道,所述存储血泵的出口连接相应的所需血液成分的存储容器; 实时生理监护单元,用于实时采集献血者生理信息,至少包括体内血液成分实时无创检测装置,所述体内血液成分实时无创检测装置设有信号传输线缆和/或无线通信模块,用于与所述 Precision closed loop blood component to any one of claims 1-3 in claim 4. A use of the method claimed in claim real blood separating apparatus, characterized by comprising: a blood cell, the blood pump with blood, the blood the blood pump with pumping vessel; Wu single blood fraction is still provided for dividing machine yet still sub blood component, preferably blood of the sub-machine is still yet still sub-machine heart, blood from said blood pump is a blood component separation, for outputting a plurality of output pipes of different blood components; a storage unit, provided with one or more of the stored blood pump and a blood pump stops or more memory one or more desired blood component storage container, the inlet of the blood pump is connected to the output of storage pipes corresponding to the blood component separation machine, the outlet of the blood pump is connected to a respective memory storage containers required for the blood component; real-time physiology monitoring unit, for real-time acquisition donor physiological information, comprising at least a real-time noninvasive in vivo blood component detecting means, said real-time noninvasive in vivo blood component detecting means is provided with a signal transmission cable and / or wireless communication module for communicating with the 央控制单元通信连接; 中央控制单元,主要由中控计算机或者中控数据处理器构成,用于控制抽血血泵工作,接收来自所述生理监护单元的献血者生理信息并进行分析比对,当献血者生理指标降到抽血安全门值(下限阈值)时或者采集的血液成分达到设定的量时,控制抽血血泵停止工作,所述献血者信息至少包括所述体内血液成分实时无创检测装置所获得的献血者的体内血液成分指标信息。 Central control unit of the communication connection; a central control unit, the main central control computer or data processor in the control configuration for controlling the blood pump the blood, the donor receives physiological information from the physiological monitoring means and analysis and comparison, when blood donor physiological indexes down security door value (lower threshold) or the collected blood component reaches a set amount, the control blood blood pump stops working, the information comprising at least the donor blood component in real-time noninvasive in vivo detecting blood component in vivo index information obtained by means of donors.
5.如权利要求4所述的采血装置,其特征在于还包括成分质量检测单元,所述成分质量检测单元设有血液分离成分实时检测装置,用于对所述分离机新分离出来的血液成分进行实时检测,所述血液分离成分实时检测装置将相应的检测信息通过有线和/或无线方式传至所述中央处理单元,所述中央处理单元对所述血液分离成分实时检测装置的检测信息进行分析,依据分析结果控制所述分离机的工作参数。 5. The lancing device according to claim 4, characterized in that the composition further comprises a quality detection unit, the detection unit is provided with a blood component mass fraction real-time detection means for the newly separated blood component separator detecting in real-time, real-time detection of the blood component separation device for detecting information transmitted to the corresponding central processing unit via wired and / or wireless manner, the central processing unit of the detection information of the blood component separation apparatus will be detected in real time analysis of the isolated machine operating parameter based on the analysis result of the control.
6.如权利要求4或5所述的采血装置,其特征在于还包括回输单元,所述回输单元设有回输血泵,所述回输血泵的进口连接所述分离机的应回输血液成分的输出管道,所述回输血泵的出口连接有回输管,在采血过程中和/或者抽血完毕后,所述中央控制单元控制所述抽血血泵停止工作,然后控制所述回输血泵工作。 6. The blood should reinfusion apparatus of claim 4 or claim 5, characterized by further comprising a recirculation unit, said recirculation unit provided with a return pump blood, the blood back to the pump inlet connected to the separator blood component outlet conduit, said outlet of the pump back to the blood return line connected to, during and after blood collection / blood or completed, the central control unit controls the blood pump stops the blood, and then controls the pump blood back to work.
7.如权利要求6所述的采血装置,其特征在于还包括补液单元,所述补液单元设有补液血泵,所述补液血泵设有进液管和补液管,当需要对献血者补液时,所述中央控制单元控制所述抽血血泵停止工作,然后控制补液血泵工作。 7. The lancing device according to claim 6, characterized by further comprising a fluid means, fluid unit is provided with a fluid pump blood, the blood pump is provided with fluid inlet tube and fluid tube when fluid need of blood donors when the central control unit controls the blood pump stops the blood, the blood pump and the control fluid.
8.如权利要求7所述的采血装置,其特征在于所述补液管和回输管连接于同一个输入管,所述输入管配有用于检测管中气泡信息和压力信息的超声气泡/压力检测装置,并将相应的检测信息通过有线和/或无线方式传至所述中央处理单元,所述中央处理单元对来自所述输入管超声气泡/压力检测装置的检测信息进行分析,当所述输入管内存在气泡时,所述中央处理单元控制所述补液血泵或回输血泵停止工作。 8. The lancing device according to claim 7, characterized in that said tube and the fluid return line connected to the same input tube, said input ultrasonic bubble vial equipped with a bubble tube for detecting information and the pressure information / pressure detection means for detecting information transmitted and the corresponding central processing unit via the wired and / or wireless manner, the central processing unit from the ultrasonic bubble detection information input pipe / pressure detecting means is analyzed, when the bubble supply line memory when the central processing unit controls the blood pump or infusion pump stops blood return.
9.如权利要求8所述的采血装置,其特征在于所述存储单元设有用于检测所述所需血液成分的存储容器内液位信息的存储液位超声检测装置,所述存储液位超声检测装置将相应的检测信息通过有线和/或无线方式传至所述中央处理单元,所述中央处理单元对来自所述存储液位超声检测装置的检测信息进行分析,当所述所需血液成分的存储容器内液位达到设定高度时,所述中央处理单元控制所述抽血血泵停止工作。 9. The lancing device according to claim 8, wherein said storage means stores provided with the ultrasonic liquid level detecting means for detecting the storage container of the desired blood component level information, the ultrasonic level storage detecting means for detecting the information transmitted to the corresponding central processing unit via wired and / or wireless manner, the central processing unit for storing the liquid level detection information from the ultrasonic testing apparatus for analysis when the desired blood component when the level reaches the set height of the storage container, said central processing unit controls the blood pump stops blood.
10.如权利要求9所述的采血装置,其特征在于所述体内血液成分实时无创检测装置为至少能够检测体内血液中红细胞、血浆和血小板浓度之一的体内血液成分实时无创检测装置,所述血液分离成分实时检测装置为至少能够检测血小板纯度的实时检测装置。 10. The lancing device according to claim 9, wherein said in vivo non-invasive blood component in real time detecting apparatus capable of detecting at least the red blood cells in the blood, the blood plasma component and a platelet concentration of one of the real-time non-invasive detection means, said blood component separation device is a real-time detection of at least the real-time detection means capable of detecting platelet purity.
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