CN111610235A - Clinical blood on-line analysis and detection device and method - Google Patents
Clinical blood on-line analysis and detection device and method Download PDFInfo
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- CN111610235A CN111610235A CN202010497188.0A CN202010497188A CN111610235A CN 111610235 A CN111610235 A CN 111610235A CN 202010497188 A CN202010497188 A CN 202010497188A CN 111610235 A CN111610235 A CN 111610235A
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- 238000003860 storage Methods 0.000 claims abstract description 42
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Abstract
The invention relates to a clinical blood on-line analysis and detection device and a method, which are characterized by consisting of a blood storage shell (1), a blood inlet catheter (4), a separation sensing membrane (6), a blood emptying pipe (5) and a signal acquisition and analysis module (10); the separation sensing membrane is connected with the blood collection tube, when blood flows into the device, the separation sensing membrane can separate the blood into serum and respond and identify specific components in the serum at the same time, the serum is converted into an electric signal to enter the signal acquisition and analysis module to output a component concentration value, and the measured blood is discharged in time to allow fresh blood to continuously flow into the device for continuous analysis. Can be used for on-line dynamic monitoring of important physiological index parameters in blood in the clinical blood drawing process, such as blood sugar, blood lactic acid, transaminase, virus, cancer markers, and the like. The detection method is simple, the device is portable, the device can be coupled with a blood drawing process, and important method support is provided for rapid and dynamic monitoring of specific important physiological indexes in different medical occasions.
Description
Technical Field
The invention relates to a clinical blood on-line analysis and detection device and a clinical blood on-line analysis and detection method, which can continuously carry out on-line detection on the concentration of important components such as blood sugar, blood lactate, transaminase, virus, cancer markers and the like in blood in the blood drawing process and is beneficial to providing important diagnosis and treatment basis in medical occasions such as operations, first aid and the like.
Background
In clinical medicine, the detection of blood has become the most routine and major basis for disease diagnosis. The dynamic change of physiological indexes in blood is closely related to human vital signs, however, the existing blood detection technology is usually an off-line analysis means and cannot continuously monitor the concentration of important physiological components in situ and on line. The main reason is that the conventional blood detection method at present needs to extract serum from collected whole blood by a centrifugation technology, and then quantitatively detect the component concentration by a biochemical analyzer, and the ex-situ and segmentation two-step operation cannot realize long-time dynamic detection of blood and cannot be used for the treatment work requiring long-time operation such as surgery, first aid and the like.
The separation and detection techniques adopted by the existing blood analysis method are all ex-situ techniques, and are long in time, for example, the centrifugal separation process needs at least 20 minutes to complete the extraction of serum. The key to realize on-line blood detection is how to adopt in-situ and instant separation and biochemical analysis technology and combine the two into one. The membrane separation and biosensing technology can well meet the requirements, and the working principles of the membrane separation and biosensing technology have the characteristics of in-situ performance, rapidness, no damage and the like, so that the fusion of the membrane separation and biosensing technology provides a new method and thought for the online detection of blood.
Disclosure of Invention
The invention aims to provide a device and a method for on-line analysis and detection of clinical blood, which can be used together with a blood drawing process to realize the method and a matching device for on-line analysis of the clinical blood, provide important component concentration detection data for medical occasions such as operations, first aid and the like, and reduce process risks. The method is based on the blood separation sensing membrane device, has simple structure and lower cost, is suitable for the dynamic detection of the concentration of important blood components for a long time, can be expanded to the simultaneous detection of various biological components, such as important components of blood sugar, blood lactic acid, transaminase, viruses, cancer markers and the like, and has good medical prospect.
The technical scheme of the invention is as follows: a clinical blood on-line analysis detection device, characterized by: the device consists of a blood storage shell 1, a blood inlet conduit 4, a separation sensing membrane 6, a blood emptying pipe 5 and a signal acquisition and analysis module 10; wherein, the front end of the blood storage shell 1 is provided with an inlet sealing plug 2, the rear end is provided with a tail end sealing plug 3, one end of the blood inlet conduit 4 is inserted into the upper part of the blood storage shell 1 through the inlet sealing plug 2, and the other end of the blood inlet conduit 4 is connected with a blood collection tube; one end of the blood emptying tube 5 is inserted into the lower part of the blood storage shell 1 through the tail end sealing plug 3; the rear end of the separation sensing membrane 6 is inserted into the blood storage housing 1 through the inlet seal plug center 2; one ends of a reference electrode 8 and a counter electrode 9 are respectively inserted into the blood storage shell 1 through the lower part of the inlet sealing plug 2, and a membrane signal lead 7 is inserted into the inner cavity of the separation sensing membrane 6 from the front end hole thereof to the rear end of the blood storage shell 1; the other ends of the membrane signal lead 7, the reference electrode 8 and the counter electrode 9 are connected with a signal acquisition and analysis module 10.
Preferably, the blood storage housing 1, the inlet sealing plug 2 and the end sealing plug 3 are all cylinders in shape; wherein the blood storage shell 1 is made of glass, stainless steel, resin or plastic, the circular diameter of the bottom of the cylinder is preferably 1-10cm, and the height is preferably 5-15 cm; the inlet sealing plug 2 and the end sealing plug 3 are made of resin, rubber or plastic, and the circular diameter of the cylindrical bottom of the inlet sealing plug and the circular diameter of the cylindrical bottom of the end sealing plug are preferably 2-12cm, and the height of the cylindrical bottom of the end sealing plug is preferably 0.5-2 cm.
The blood inlet catheter 4 and the blood emptying tube 5 are preferably medical catheters; the reference electrode 8 and the counter electrode 9 are both made of conductive materials and are L-shaped, and the materials are preferably gold, silver, platinum, silver chloride, graphite or graphene; the membrane signal lead 7 is made of conductive material, preferably gold, silver, platinum or copper, and extends into the inner cavity of the blood separation sensing membrane 6.
Preferably, the separation sensing membrane 6 is made of ceramic, stainless steel, polysulfone, polyethersulfone or acetate fiber, has an outer diameter of 0.5-5mm, and preferably has a length of 6-20cm, and preferably has a length of 2-12cm when it extends into the blood storage case 1.
The invention also provides a method for carrying out clinical blood on-line analysis and detection by using the device, which is characterized by comprising the following specific steps:
the blood inlet catheter 4 is connected with a blood collection tube containing a blood sample, then the exposed end of the separation sensing membrane 6 is subjected to vacuum filtration, negative pressure is generated in the blood storage shell 1 to enable the blood to fill the shell, when the blood contacts the separation sensing membrane 6, the separation layer on the surface of the membrane is screened to enable the blood to flow into a pore channel, meanwhile, sensing materials in the membrane respond to specific physiological components in the blood, concentration signals are converted into electric signals, the component concentration values are output by a signal acquisition and analysis module through a membrane signal lead 7, a reference electrode 8 and a counter electrode 9, the detected blood is emptied through the blood emptying tube 5, and then, fresh blood can flow in to achieve continuous detection.
The pressure for vacuum filtration of the exposed end of the separation sensing membrane 6 is preferably controlled within the range of 0-0.01 MPa.
The clinical blood on-line analysis and detection method needs to be used in a blood sampling process, the method depends on a designed separation sensing membrane detection device to be connected with a blood sampling tube, blood which is freshly collected in the blood sampling tube is injected into a device cavity through vacuum force, serum is separated from the blood by using the separation sensing membrane in the device, meanwhile, a sensing material in the membrane responds to specific physiological components in the serum, a concentration signal is converted into an electric signal, a component concentration value is output by a signal collection and analysis module, the detected blood is emptied, and the subsequent fresh blood can flow in to realize continuous detection.
Has the advantages that:
the invention aims to provide a brand-new method and a brand-new device for online analysis and detection of blood, which are used for providing the concentration of important lethal physiological components in clinical treatment occasions (such as operations, first aid and the like) to realize online real-time data, are beneficial to reducing treatment risks and maintaining physiological signs of patients. The method integrates the principles of membrane separation and electrochemical biosensing, quickly separates serum from whole blood in situ and quantitatively detects target physiological substances by simply coupling with a blood sampling process, is practical and feasible, is simple to operate, has a simple structure, low cost and simple and convenient operation, can be used for batch large-scale production, and has important medical application prospect and great economic value.
Drawings
Fig. 1 is a schematic view of a clinical blood on-line analysis and detection device, wherein: 1-a blood storage housing; 2-inlet sealing plug; 3-end sealing plug; 4-blood inlet catheter; 5-blood evacuation tube; 6-separating the sensing membrane; 7-membrane signal conductors; 8-a reference electrode; 9-a counter electrode; 10-a signal acquisition and analysis module.
Detailed Description
Example 1
As shown in FIG. 1, the on-line detection device of the present invention comprises a blood storage casing 1, a blood inlet conduit 4, a separation sensing membrane 6, a blood evacuation tube 5 and a signal collection and analysis module 10. Wherein the blood inlet conduit 4 is inserted into the blood storage case 1 through the upper end of the inlet seal stopper 2, and introduces blood from the blood collection tube into the case; the blood emptying pipe 5 is inserted into the blood storage shell 1 through a tail end sealing plug, and the waste blood after detection is emptied; the separation sensing membrane 6 is inserted into the blood storage shell 1 through the center of the inlet sealing plug 2 to separate and detect the blood in the shell; a reference electrode 8 and a counter electrode 9 are inserted into the blood storage shell 1 through the lower end of the inlet sealing plug 2, and a membrane signal lead 7 is inserted into the inner cavity of the separation sensing membrane; the membrane signal lead 7, the reference electrode 8 and the counter electrode 9 are connected into the signal acquisition and analysis module 10 to construct a complete electrochemical detection loop for acquiring detection signals output by the separation sensing membrane 6 in real time.
The specific online analysis and detection method comprises the following steps: utilize the vacuum test tube to collect the blood sample freshly, go into the blood pipe 4 and insert and communicate in the vacuum test tube rubber buffer, when the separation sensing membrane exposes the end evacuation, blood gets into blood storage casing 1 through going into the blood pipe by the heparin tube, separation sensing membrane 6 carries out the analysis to specific physiological component in the blood, the signal is by membrane signal wire 7, reference electrode 8, common input signal acquisition analysis module 10 of counter electrode 9, show on the display screen through data fitting calibration, stop to separate sensing membrane evacuation and communicate atmosphere this moment, the blood of storage is evacuated by blood evacuation pipe 5, again carry out the continuous detection of fresh blood to separating sensing membrane evacuation as required after the evacuation.
Example 2
Referring to fig. 1, the blood storage case 1 is made of glass, and has a cylindrical bottom with a circular diameter of 1cm and a height of 5 cm; the inlet sealing plug 2 and the tail sealing plug 3 are made of rubber, the circular diameter of the cylindrical bottom of the inlet sealing plug is 2cm, and the height of the cylindrical bottom of the inlet sealing plug is 0.5 cm.
The blood inlet catheter 4 and the blood emptying tube 5 are medical catheters; the reference electrode 8 and the counter electrode 9 are made of silver, and the membrane signal lead 7 is made of copper.
The separation sensing membrane (6) is made of ceramic, the outer diameter size is 0.5mm, the length is 6cm, and the length of the separation sensing membrane extending into the blood storage shell body 1 is 2 cm.
When the vacuum pump works, the vacuum pressure is controlled to be 0 MPa.
Under these conditions, the preliminary test tests the blood components before and after separation as follows:
the detection sensitivity to blood sugar and blood lactic acid is
| Blood sugar | Blood lactic acid | |
| Sensitivity of the probe | 12.1μA·mM | 20.7μA·mM |
| Detecting errors | 5.2％ | 3.1％ |
Example 3
Referring to fig. 1, the blood storage case 1 is made of plastic, and has a cylindrical bottom with a circular diameter of 10cm and a height of 15 cm; the inlet sealing plug 2 and the end sealing plug 3 are made of plastic, and the circular diameter of the cylindrical bottom of the inlet sealing plug and the circular diameter of the end sealing plug are 12cm, and the height of the cylindrical bottom of the inlet sealing plug and the end sealing plug is 2 cm.
The blood inlet catheter 4 and the blood emptying tube 5 are medical catheters; the reference electrode 8 and the counter electrode 9 are made of platinum, and the membrane signal lead 7 is made of silver.
The separation sensing membrane 6 is made of stainless steel, the outer diameter is 5mm, the length is 20cm, and the length of the separation sensing membrane extending into the blood storage shell 1 is 12 cm.
When the vacuum pump works, the vacuum pressure is controlled to be 0.01 MPa.
Under these conditions, the preliminary test tests the blood components before and after separation as follows:
| blood (before separation) | Blood (after separation) | |
| Red blood cell | 4.2×1012/L | 0 |
| White blood cell | 7.3×1012/L | 0 |
| Blood platelet | 1.8×1011/L | 0 |
| Fibrinogen | 2.6g/L | 0 |
The detection sensitivity to blood sugar and blood lactic acid is
| Blood sugar | Blood lactic acid | |
| Sensitivity of the probe | 43.5μA·mM | 82.1μA·mM |
| Detecting errors | 1.8％ | 1.2％ |
Example 4
Referring to fig. 1, the blood storage case 1 is made of resin, and has a cylindrical bottom with a circular diameter of 3cm and a height of 8 cm; the inlet sealing plug 2 and the end sealing plug 3 are made of resin, and the circular diameter of the cylindrical bottom of the inlet sealing plug and the circular diameter of the end sealing plug are 4cm, and the height of the cylindrical bottom of the inlet sealing plug and the end sealing plug is 1 cm.
The blood inlet catheter 4 and the blood emptying tube 5 are medical catheters; the reference electrode 8 and the counter electrode 9 are made of graphene, and the membrane signal lead 7 is made of gold.
The separation sensing membrane 6 is made of polyether sulfone, the outer diameter size is 2mm, the length is 10cm, and the length of the separation sensing membrane extending into the blood storage shell 1 is 5 cm.
When the vacuum pump works, the vacuum pressure is controlled to be 0.005 MPa.
Under these conditions, the preliminary test tests the blood components before and after separation as follows:
| blood (before separation) | Blood (after separation) | |
| Red blood cell | 3.8×1012/L | 0 |
| |
9×1012/L | 0 |
| Blood platelet | 2.8×1011/L | 0 |
| Fibrinogen | 4g/L | 0 |
The detection sensitivity to blood sugar and blood lactic acid is
| Blood sugar | Blood lactic acid | |
| Sensitivity of the probe | 24.5μA·mM | 44.1μA·mM |
| Detecting errors | 2.8％ | 3.2％ |
Example 5
Referring to fig. 1, the blood storage case 1 is made of stainless steel, and has a cylindrical bottom with a circular diameter of 6cm and a height of 6 cm; the inlet sealing plug 2 and the end sealing plug 3 are made of rubber, the circular diameter of the cylindrical bottom of the inlet sealing plug is 7cm, and the height of the cylindrical bottom of the inlet sealing plug is 1.5 cm.
The blood inlet catheter 4 and the blood emptying tube 5 are medical catheters; the reference electrode 8 and the counter electrode 9 are made of silver chloride, and the membrane signal lead 7 is made of platinum.
The separation sensing membrane 6 is made of cellulose acetate, the outer diameter of the separation sensing membrane is 3mm, the length of the separation sensing membrane is 8cm, and the length of the separation sensing membrane extending into the blood storage shell 1 is 4.5 cm.
When the vacuum pump works, the vacuum pressure is controlled to be 0.001 MPa.
Under these conditions, the preliminary test tests the blood components before and after separation as follows:
| blood (before separation) | Blood (after separation) | |
| Red blood cell | 4.8×1012/L | 0 |
| White blood cell | 7.6×1012/L | 0 |
| Blood platelet | 1.8×1011/L | 0 |
| Fibrinogen | 2.8g/L | 0 |
The detection sensitivity to blood sugar and blood lactic acid is
| Blood sugar | Blood lactic acid | |
| Sensitivity of the probe | 17.5μA·mM | 34.1μA·mM |
| Detecting errors | 2.2％ | 1.8％ |
The working principle of the blood on-line analysis and detection method of the invention is described.
The method combines the membrane separation and the biosensing mechanism, and can realize the rapid and dynamic determination of the concentration of the key physiological index from the freshly collected serum. When the device works, the separation sensing membrane detection device is connected with a blood collection tube by using a blood inlet catheter, vacuum drawing force is applied to the outer end of the separation sensing membrane, negative pressure is formed inside a blood storage shell, blood in the blood collection tube is driven to flow into the shell, when the shell is filled with blood, the separation sensing membrane separates serum in the blood by using aperture screening effect and flows into an inner pore channel, a biological sensing material in the inner pore can perform catalytic reaction with a specific physiological component, under the assistance of a reference electrode and a counter electrode, a concentration signal is converted into an electric signal to form a loop, the signal is transmitted into a signal acquisition and analysis module to output a component concentration value, the detected blood is emptied by a blood emptying tube, and subsequent fresh blood can flow in to realize continuous detection.
The four embodiments described above are only preferred embodiments of the present invention, and corresponding modifications and substitutions should be considered as the protection scope of the present invention without departing from the technical principles of the present invention.
Claims (6)
1. A clinical blood on-line analysis detection device, characterized by:
the clinical blood on-line detection device consists of a blood storage shell (1), a blood inlet catheter (4), a separation sensing membrane (6), a blood emptying pipe (5) and a signal acquisition and analysis module (10); the blood collection device comprises a blood storage shell (1), an inlet sealing plug (2) and a tail end sealing plug (3), wherein the front end of the blood storage shell (1) is provided with the inlet sealing plug (2), the rear end of the blood storage shell is provided with the tail end sealing plug (3), one end of a blood inlet guide pipe (4) is inserted into the upper part of the blood storage shell (1) through the inlet sealing plug (2), and the other end of the blood inlet guide pipe; one end of the blood emptying pipe (5) is inserted into the lower part of the blood storage shell (1) through the tail end sealing plug (3); the rear end of the separation sensing membrane (6) is inserted into the blood storage shell (1) through the inlet sealing plug center (2); one ends of a reference electrode (8) and a counter electrode (9) are respectively inserted into the blood storage shell (1) through the lower part of the inlet sealing plug (2), and a membrane signal lead (7) is inserted into the inner cavity of the separation sensing membrane (6) from the front end hole of the separation sensing membrane to the rear end of the blood storage shell (1); the other ends of the membrane signal lead (7), the reference electrode (8) and the counter electrode (9) are connected with a signal acquisition and analysis module (10).
2. The clinical blood on-line analysis and detection device according to claim 1, wherein: the blood storage shell (1), the inlet sealing plug (2) and the tail end sealing plug (3) are all cylinders in shape; wherein the blood storage shell (1) is made of glass, stainless steel, resin or plastic, the circular diameter of the bottom of the cylinder is preferably 1-10cm, and the height is preferably 5-15 cm; the inlet sealing plug (2) and the tail sealing plug (3) are made of resin, rubber or plastic, the circular diameter of the cylindrical bottom of the inlet sealing plug and the circular diameter of the cylindrical bottom of the tail sealing plug are preferably 2-12cm, and the height of the cylindrical bottom of the inlet sealing plug and the tail sealing plug is preferably 0.5-2 cm.
3. The clinical blood on-line analysis and detection device according to claim 1, wherein: the blood inlet catheter (4) and the blood emptying tube (5) are medical catheters; the reference electrode (8) and the counter electrode (9) are both made of conductive materials and are L-shaped, and the materials are preferably gold, silver, platinum, silver chloride, graphite or graphene; the membrane signal lead (7) is made of conductive materials, preferably gold, silver, platinum and copper, and extends into the inner cavity of the blood separation sensing membrane (6).
4. The clinical blood on-line analysis and detection device according to claim 1, wherein: the separation sensing membrane (6) is made of ceramic, stainless steel, polysulfone, polyethersulfone or acetate fiber, has the outer diameter of 0.5-5mm, and preferably has the length of 6-20cm, and the length of the separation sensing membrane extending into the blood storage shell (1) is preferably 2-12 cm.
5. A method for on-line clinical blood analysis and testing using the device of claim, wherein:
the blood inlet catheter (4) is connected with a blood collection tube containing a blood sample, then the exposed end of the separation sensing membrane (6) is subjected to vacuum filtration, negative pressure is generated in the blood storage shell (1) to enable the blood to fill the shell, when the blood contacts the separation sensing membrane (6), the separation layer on the surface of the membrane is screened to enable the blood to flow into a pore channel, meanwhile, sensing materials in the membrane are used for responding specific physiological components in the blood, concentration signals are converted into electric signals, the component concentration values are output in a signal acquisition and analysis module through a membrane signal lead (7), a reference electrode (8) and a counter electrode (9), the detected blood is emptied through the blood emptying tube (5), and subsequent fresh blood can flow in to realize continuous detection.
6. The clinical blood on-line analysis and detection method as claimed in claim 5, wherein: the pressure for vacuum filtration of the exposed end of the separation sensing membrane (6) is controlled within the range of 0-0.01 MPa.
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| CN202010497188.0A CN111610235A (en) | 2020-06-03 | 2020-06-03 | Clinical blood on-line analysis and detection device and method |
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| CN114778639B (en) * | 2022-05-13 | 2024-04-16 | 南京工业大学 | Physiological index on-line monitoring instrument based on separation sensing film |
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