Blood coagulation detection device, blood coagulation analyzer and blood coagulation analysis method

Abstract

The invention discloses a blood coagulation detection device, a blood coagulation analyzer and an analysis method, and particularly relates to the technical field of medical analysis. An optical detection mechanism performs optical detection on a first area of a to-be-detected sample in a test tube, and a magnetic particle detection mechanism performs magnetic particle detection on a second area of the to-be-detected sample in the test tube; therefore, optical detection and magnetic particle detection of the to-be-detected sample are completed, the contrast of the detection result is improved, and the detection efficiency is improved. Meanwhile, the to-be-detected sample does not need to be replaced in the process of detecting the to-be-detected sample, so that waste of the to-be-detected sample is avoided.

Description

Technical Field

[0001] The present invention relates to the field of medical analysis technology, and in particular to a blood coagulation detection device, a blood coagulation analyzer and an analysis method. Background Art

[0002] In traditional technologies, the methodologies used by coagulation analyzers include "magnetic bead method" and "optical method", and the detection principles of different methodologies are different. In the past one or two years, the applicant has introduced a new detection theory, "magnetic particle method", based on a large number of basic research results.

[0003] However, whether it is the traditional magnetic bead method, optical method, or the newly proposed magnetic microparticle method, there are still temporary unavoidable defects or shortcomings when used alone. For example, the magnetic bead method has a large inertia when it moves under the action of the magnetic field due to its own large mass, and has a large force on the protein fiber network, which may even cause the fibrin network to rupture; the optical method is greatly affected by the quality of the sample, for example, the presence of substances such as lipemia and hemolysis has a more obvious impact on the test results.

[0004] Based on this, it has become a practical need in this field to integrate different methodologies in a weighted manner, or to compare the test results of each methodology with each other.

[0005] At the same time, if each methodology independently supplies corresponding samples and reagents during testing, it will inevitably lead to a significant increase in sample volume and actual volume. The increased testing costs will also lead to waste of samples / reagents. Therefore, maintaining a lower sample volume and reagent volume based on the above requirements has also become a realistic need in this field. Summary of the invention

[0006] The main purpose of the present invention is to propose a coagulation detection device, a coagulation analyzer and an analysis method, aiming to solve the technical problem in the prior art that when optical or magnetic particle methods are used to detect the samples to be tested, a large number of samples need to be used separately, resulting in waste of samples to be tested and affecting the detection efficiency.

[0007] To achieve the above object, the present invention provides a blood coagulation detection device, comprising:

[0008] A base, provided with a placement hole whose axis extends along a first direction, for placing a test tube containing a sample to be tested;

[0009] An optical detection mechanism, used for optically detecting the first area of ​​the sample to be detected;

[0010] A magnetic particle detection mechanism, used for performing magnetic particle detection on the second area of ​​the sample to be tested;

[0011] The first area and the second area are arranged at least partially in different regions on the test tube.

[0012] In one embodiment, the optical detection mechanism comprises:

[0013] A first light source assembly is controlled to form an output light of a specified condition;

[0014] An optical signal receiving component, which is controlled to receive the optical signal that has completed the detection and carries the information;

[0015] A first detection channel terminates at a first position of the placement hole in a through manner, the first position being arranged corresponding to the first area;

[0016] The first light source assembly and the optical signal receiving assembly are disposed at different sides of the first position.

[0017] In one embodiment, the first detection channel includes a first portion extending along a second direction and / or a second portion extending along a third direction; the first direction is different from the second direction or the third direction.

[0018] In one embodiment, the first light source assembly is installed in the second direction or the third direction; and / or the optical signal receiving assembly is correspondingly installed in the third direction or the second direction.

[0019] In one embodiment, the magnetic particle detection mechanism comprises:

[0020] A magnetic field manufacturing component, used for applying a changing magnetic field to the second area;

[0021] a magnetic particle detection component, used for collecting movement characteristics of magnetic particles in the second region; and

[0022] A second detection channel, at least partially terminated in a through-going manner at a second position of the placement hole;

[0023] The second position corresponds to the second regional setting.

[0024] In one embodiment, the second detection channel includes: a third portion terminating at the second position in a through manner along the fourth direction, and / or a fourth portion terminating at the second position of the placement hole in a through or non-through manner along the fifth direction; the first direction, the fourth direction and the fifth direction are all different.

[0025] In one embodiment, the magnetic field manufacturing assembly is arranged in the fifth direction, including:

[0026] magnet;

[0027] The magnetic field changing component is used to make the magnet form a changing magnetic field in the second area.

[0028] In one embodiment, the magnet comprises a permanent magnet;

[0029] The magnetic field changing component includes a magnet moving component, and the magnet moving component drives at least part of the magnet to move to form a changing magnetic field in the second area.

[0030] In one embodiment, the magnet comprises an electromagnet;

[0031] The magnetic field varying component includes a circuit control component, and the circuit control component controls at least part of the electrical characteristics of the electromagnet to form a varying magnetic field in the second area.

[0032] In one embodiment, the electrical characteristics include at least one of circuit on and off, current size, voltage level, resistance size, and capacitance size; the circuit control component includes at least one of a switch, a converter, a transformer, a resistor, a diode, and a capacitor.

[0033] In one embodiment, a moving path is formed in the second detection channel, and the magnet moving assembly includes a power source, and the power source drives at least a portion of the magnet to move along the moving path.

[0034] In one embodiment, the magnetic particle detection component is arranged in the fourth direction, including:

[0035] A second light source assembly is controlled to form an output light of a specified condition;

[0036] The information collection component is used to control the collection of the movement characteristics of the magnetic particles in the second area.

[0037] In one embodiment, the specified condition includes at least one of a specified type, a specified light intensity, a specified wavelength, a specified brightness, and a specified light spot area;

[0038] and / or,

[0039] The motion characteristics include at least one of a motion trajectory, a motion range, a start and stop time, and a duration.

[0040] In one embodiment, the information collection component includes one or a combination of a built-in camera of a mobile terminal, a common digital camera, a CCD camera, an ultra-high-speed camera, a video recorder, an infrared imager, and a laser scanner.

[0041] In one embodiment, the base is a columnar structure, and the optical detection mechanism and the magnetic particle detection mechanism are arranged at intervals on the side of the columnar structure;

[0042] and / or,

[0043] The base is made of non-magnetic material.

[0044] In one embodiment, the base is a cylindrical structure or an octagonal prism structure;

[0045] and / or,

[0046] The non-magnetic material is aluminum or a material containing aluminum.

[0047] Based on the same technical concept, in a second aspect, the present invention also proposes a coagulation analyzer, comprising:

[0048] Controller;

[0049] The blood coagulation detection device described in the first aspect is controlled by the controller to perform optical detection and / or magnetic particle detection in an alternative or combined manner.

[0050] In one embodiment, a HIL identification device is further included.

[0051] In one embodiment, the HIL recognition device is independent of the coagulation detection device.

[0052] In one embodiment, the HIL identification device and the magnetic particle detection mechanism share a second light source component and / or an information acquisition component.

[0053] Based on the same technical concept, in a third aspect, the present invention further proposes a coagulation analysis method, using the coagulation analysis device described in the first aspect or the coagulation analyzer described in the second aspect, comprising the following steps:

[0054] Generate control instructions for testing samples to be tested;

[0055] The control instruction is transmitted to the coagulation analysis device to execute the detection operation; wherein the detection operation is to perform optical detection operation and / or magnetic particle detection operation in a selective or combined manner.

[0056] In one embodiment, before generating a control instruction for performing a detection operation on the sample to be detected, the method further includes:

[0057] Perform information identification operations on the samples to be tested.

[0058] In one embodiment, it also includes:

[0059] Generate test results based on the test job and send them to the display device.

[0060] In one embodiment, the display device includes a display screen of the coagulation analyzer, or a display screen independent of the analyzer, or a display screen of an authorized mobile device.

[0061] In one embodiment, the display screen of the authorized mobile device is at least one of a mobile phone, a tablet, a projector, and a car display.

[0062] The technical solution of the present invention integrates an optical detection mechanism and a magnetic particle detection mechanism. The optical detection mechanism performs optical detection on a first area of ​​the sample to be tested in a test tube, and the magnetic particle detection mechanism performs magnetic particle detection on a second area of ​​the sample to be tested in the test tube. Therefore, the present invention can perform optical detection and magnetic particle detection on samples to be tested in different areas in the same test tube when in use. It has the function of performing optical detection and magnetic particle detection using one test tube to hold the sample to be tested, thereby improving the comparability of the detection results. In addition, since the sample to be tested in the same test tube can be used for optical detection and magnetic particle detection, there is no need to use more samples to be tested, thereby avoiding the waste of samples to be tested. Therefore, the present invention does not need to replace the sample to be tested during the detection operation of the sample to be tested, thereby avoiding the waste of samples to be tested and improving the detection efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0063] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the structures shown in these drawings without paying creative work.

[0064] Figure 1 A schematic structural diagram of an embodiment of a blood coagulation detection device provided by the present invention;

[0065] Figure 2 A schematic diagram of the planar structure of the blood coagulation detection device provided by the present invention;

[0066] Figure 3 A schematic diagram of the side structure of the blood coagulation detection device provided by the present invention;

[0067] Figure 4 for Figure 3 A schematic diagram of the structure of the AA section of the example;

[0068] Figure 5 for Figure 4 The magnetic field manufacturing component in the example is a schematic diagram of the structure of an electromagnet;

[0069] Figure 6 for Figure 3 A schematic diagram of the structure of the BB section of the example;

[0070] Figure 7 for Figure 6The magnetic field manufacturing component in the example is a schematic diagram of the structure of an electromagnet;

[0071] Figure 8 A schematic diagram of the partition structure of the test tube provided by the present invention;

[0072] Fig. 9 The present invention provides a flow chart of the coagulation analysis method.

[0073] Description of Figure Numbers:

[0074] 100, base; 110, mounting hole; 400, test tube; 120, first chamber; 130, second chamber; 140, first detection channel; 150, second detection channel; 131, first cavity; 132, second cavity;

[0075] 200, optical detection mechanism; 210, first area; 220, second light source emitting element; 230, optical signal receiving component;

[0076] 300, magnetic particle detection mechanism; 310, second area; 320, magnetic particle detection component; 330, magnetic field manufacturing component; 321, first light source emitting element; 322, image collector; 323, homogenizing plate; 324, focusing lens; 10, coagulation detection device; 30, HIL information recognition module.

[0077] The realization of the purpose, functional features and advantages of the present invention will be further explained in conjunction with embodiments and with reference to the accompanying drawings. DETAILED DESCRIPTION

[0078] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0079] It should be noted that if the embodiments of the present invention involve directional indications (such as up, down, left, right, front, back, etc.), the directional indications are only used to explain the relative position relationship, movement status, etc. between the components in a certain specific posture. If the specific posture changes, the directional indication will also change accordingly.

[0080] In addition, if there are descriptions involving "first", "second", etc. in the embodiments of the present invention, the descriptions of "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of technical features indicated. Therefore, the features limited to "first" and "second" may explicitly or implicitly include at least one of the features. In addition, if "and / or" or "and / or" appears in the full text, its meaning includes three parallel solutions. Taking "A and / or B" as an example, it includes solution A, solution B, or solutions that satisfy both A and B. In addition, the technical solutions between the various embodiments can be combined with each other, but it must be based on the ability of ordinary technicians in this field to implement. When the combination of technical solutions is contradictory or cannot be implemented, it should be deemed that such combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0081] In this field, coagulation detection is an important detection item. It is well known that newly collected blood samples will form a mesh structure due to the growth of fibrin in cells. Therefore, the traditional magnetic bead method uses the mesh structure to hinder the movement of magnetic beads, and detects the position of magnetic beads during the process from movement to gradual slowing down until the final stop to obtain the coagulation detection result. However, the magnetic beads used in the traditional magnetic bead method are relatively large, all of which are millimeter-level, so the force exerted on the fibrin network during its movement is relatively large, which will affect the detection accuracy to a certain extent. Based on this, the applicant has proposed a new magnetic particle method, which uses micron-level and / or nano-level magnetic particles to move in the sample to be tested under the action of a changing magnetic field, and collects parameters such as movement trajectory, coverage area, and vibration time, so that coagulation information can be obtained more accurately and comprehensively. This application is a coagulation detection device further proposed on the basis of this research result.

[0082] See also Figures 1 to 9 In one embodiment of the present invention, the blood coagulation detection device 10 comprises:

[0083] A base, provided with a placement hole whose axis extends along a first direction, for placing a test tube containing a sample to be tested;

[0084] An optical detection mechanism, used for optically detecting a first area of ​​the sample to be detected;

[0085] A magnetic particle detection mechanism, used for performing magnetic particle detection on a second area of ​​the sample to be tested;

[0086] The first area and the second area are arranged at least partially in different regions on the test tube, and the first area and the second area respectively correspond to at least a portion of the sample to be tested contained in the test tube.

[0087] In this embodiment, the optical detection mechanism 200 or / and the magnetic particle detection mechanism 300 can be used to select optical detection or magnetic particle detection for the sample to be detected according to actual detection requirements, or optical detection and magnetic particle detection can be performed in a balanced manner. It can be understood that selecting one means only performing one of the optical detection or magnetic particle detection; while taking both into account means performing both optical detection and magnetic particle detection for the same sample to be detected, for example, the optical detection and magnetic particle detection can be performed simultaneously, or they can be performed asynchronously before the sample to be detected fails and after the magnetic particles are added, such as the two are performed separately at a certain interval, or they are performed continuously without an interval, or there is a certain overlap in the time of the two. This is because, on the one hand, the detection methods based on different principles are not completely consistent in the acquisition, interpretation and expression of coagulation information, and even the detection accuracy for different types of samples is not exactly the same. Therefore, simultaneous implementation can achieve the comparison and reference of two different schemes; but on the other hand, different methodologies have different abilities to obtain information, capture and fix details at each stage of the coagulation process. Therefore, this application allows different detection methods to intervene at different stages of coagulation, so that the advantages of the two methodologies can be integrated and complementary to obtain accurate detection conclusions. Through this setting method, the present invention can be made more flexible in use, better meet the customized needs of samples to be tested, customers or professionals, and improve detection efficiency and pertinence.

[0088] In this embodiment, the optical detection mechanism, the magnetic particle detection mechanism and the placement hole are correspondingly arranged, and the three form an organic whole. Therefore, the coagulation detection device can perform optical detection and magnetic particle detection on the same sample to be tested to obtain detection results based on different methodologies, which greatly improves the detection efficiency, enriches the dimensions of the detection results, and improves the referenceability of the detection results; in addition, the present invention uses the same tube of sample to be tested for the optical method and the magnetic particle method, so there is a highly reliable mutual reference between different detection conclusions, which helps to improve the technical personnel in this field to understand different methodologies, as well as the understanding and judgment of the detection results; in addition, the corresponding detection mechanisms are arranged and set in a targeted manner, therefore, compared with the traditional optical method or magnetic bead method, the coagulation detection device 10 described in the present application will not significantly increase the amount of samples to be tested.

[0089] It should be noted that, in this embodiment, the first area 210 and the second area 310 are only area divisions made in the sample to be detected corresponding to different methodologies (optical method and magnetic particle method), and the independence between the first area 210 and the second area 310 is not limited. For example, the first area 210 and the second area 310 are preferably areas corresponding to the sample to be tested and the relevant methodology, and the first area 210 and the second area 310 in the above example do not mean that the first area 210 and the second area 310 must be two different areas. In fact, the first area 210 and the second area 310 can be two independent different areas. Independence here means that the adjacent boundaries of the first area 210 and the second area 310 are separated from each other, and the first area 210 and the second area 310 are staggered or spaced apart from each other. This staggering or spacing can be expressed in the height direction of the test tube 400, or in the circumference or horizontal direction. Preferably, the first area 210 and the second area 310 are two independent different areas (that is, staggered or spaced) in the height direction of the test tube.

[0090] The first area 210 and the second area 310 may also be two non-independent areas. The non-independence here means that the first area 210 and the second area 310 have a relationship of being close, intersecting or being contained at the adjacent boundaries. More specifically, one situation is that the first area 210 and the second area 310 are set closely, another situation is that the first area 210 and the second area 310 are partially overlapped, and the third situation is that the first area 210 or the second area 310 is entirely contained in the second area 310 or the first area 210. When the two non-independent areas are tested, the same accurate data can be obtained by data processing. This part of the content is not the focus of this application and will not be repeated here.

[0091] It should also be noted that the first area 210 and the second area 310 are area divisions made based on the samples to be tested, but in fact, since the samples to be tested are placed in test tubes in the present application, the first area 210 and the second area 310 can also be area divisions made based on the samples to be tested and the test tubes surrounding them as a whole. In the present application, unless otherwise specified, the area divisions in these two situations can be considered to be equivalent.

[0092] Please refer to Figure 1-5 In another specific embodiment, the coagulation detection device 10 further includes a base 100 having a mounting hole 110 formed thereon, and the mounting hole 110 is used to place a test tube 400 containing a sample to be tested; the optical detection mechanism 200 and the magnetic particle detection mechanism 300 are installed at intervals on the base 100.

[0093] In this embodiment, the mounting hole 110 can be set at any position on the upper surface of the base 100, preferably at the center position, so as to facilitate the arrangement of the optical detection mechanism 200 and the magnetic particle detection mechanism 300; the mounting hole 110 extends from the surface of the base 100 to the inside in a first direction, and a preferred solution is that under normal working conditions, the first direction is a vertical direction; the mounting hole 110 includes an opening formed on the surface of the base 100 for inserting the test tube 400, and a bottom interrupted inside the base 100 for supporting the test tube 400; the overall shape of the mounting hole 110 matches the shape of the test tube 400, and the inner surface of its bottom is preferably an arc surface.

[0094] Furthermore, the base 100 is made of non-magnetized material, that is, it is not magnetized by a magnetic field under natural conditions, or is not magnetized by a magnetic field under specified conditions, and is preferably made of aluminum material or aluminum-containing material; the base 100 is generally cylindrical or polyhedral, preferably a polygonal prism, and more preferably an octagonal prism; a first chamber 120 and a second chamber 130 are formed in the base 100, which are spaced apart. Among them, the first chamber 120 is used to install the optical detection mechanism 200, and the first chamber 120 is provided with a first detection channel 140 towards the mounting hole 110, and terminates at a first position of the mounting hole 110 in a through manner, and the first position corresponds to the first area 210 of the test tube 400, thereby establishing an optical connection between the optical detection mechanism 200 and the test tube 400; the second chamber 130 is used to install the magnetic particle detection mechanism 300, and the second chamber 130 is provided with a second detection channel 150 towards the mounting hole 110, and at least part of the second detection channel 150 terminates at a second position of the mounting hole 110 in a through manner, and the second position corresponds to the second area 310 of the test tube 400, thereby establishing a detection connection between the magnetic particle detection mechanism 300 and the test tube 400. Based on the structure of this embodiment, the optical detection mechanism 200 installed in the first chamber 120 of the present invention can perform optical detection on the first area 210, or / and use the magnetic particle detection mechanism 300 installed in the second chamber 130 to perform magnetic particle detection on the second area 310.

[0095] Preferably, the first chamber 120 and the second chamber 130 are disposed on a side surface of the base 100 , such as a circumferential surface of a cylinder or a side surface of a polygonal column.

[0096] Preferably, the longitudinal sections of the first detection channel 140 and the second detection channel 150 are circular, and the radius R of the second detection channel 150 is greater than the radius r of the first detection channel 140. In a specific embodiment, 0.5 mm <r<1.0mm,3mm<R<3.5mm。

[0097] Further, refer to Figure 4 or Figure 6In one embodiment, the optical detection mechanism 200 includes a first light source component for providing light for analysis, and an optical signal receiving component 230 for receiving light that has completed detection and carries detection information; wherein the first light source component provides emission light for detection, and at the same time, the first light source component can complete the formation of specified conditions for emission light, and the specified conditions include, for example, wavelength selection (such as light of a certain wavelength, or light of a certain wavelength range, or a series of lights of a certain wavelength), and / or shaping of emission light, and / or homogenization of emission light, and / or collimation of emission light, etc.; the optical signal receiving component 230 can receive emission light that has completed detection and carries detection information, and the emission light can be transmitted light, and / or scattered light, and / or refracted light, etc. Specifically, in one embodiment, the light source component is a first light source emitting element 220, such as a halogen lamp, LED, monochromatic light, laser, etc.; the optical signal receiving component can be a light source receiving component 230, such as a photodiode, PD sensor, etc.

[0098] Based on the structure of the optical detection mechanism 200, refer to Figure 4-Figure 7 , the first chamber 120 includes third cavities 121, 121' for installing the first light source emitting element 220 and the optical signal receiving component 230 respectively. More specifically, the first light source emitting element 220 is installed in the third cavity 121, and establishes an optical connection with the first area 210 of the test tube 400 through at least part of the first detection channel 140 along the second direction, such as providing emitted light; the optical signal receiving component 230 is installed in the third cavity 121', and establishes an optical connection with the first area 210 of the test tube 400 through at least part of the first detection channel 140 along the third direction, such as receiving emitted light. The emitted light can be one or a combination of transmitted light, scattered light or refracted light; the angle α between the second direction and the third direction is within the range of 0-180°, preferably 90°<α<180°; the first detection channel 140 is a straight line, a broken line, etc. Preferably, the emitted light is transmitted light, and the angle between the second direction and the third direction is 0°, that is, the first detection channel 140 is linear, and the first light source emitting element 220, the test tube 400 (first area 210) and the optical signal receiving component 230 are distributed in a straight line along the first detection channel 140.

[0099] Further, refer to Figure 4-7In one embodiment, the magnetic particle detection mechanism 300 includes a magnetic particle detection component 320 and a magnetic field manufacturing component 330. The magnetic field manufacturing component 330 is configured to form a variable magnetic field and apply the variable magnetic field to the second region 310 to drive the magnetic particles placed in the sample to be detected to move, such as reciprocating motion. The magnetic field manufacturing component 330 can be any component or component combination that can form a variable magnetic field, such as an electromagnet, a permanent magnet or a combination thereof. As the coagulation phenomenon of the sample to be detected occurs and develops, the movement of the magnetic particles will gradually be blocked and eventually stop. The coagulation information of the sample to be detected can be obtained by detecting the relevant parameters of the movement (such as start time, duration, movement stroke, coverage area, etc.). This part of the content has been described in other related patent applications of the applicant and will not be repeated here; the magnetic particle detection component 320 is configured to collect the characteristics of the movement of the magnetic particles and send them to the data processing device. The magnetic particle detection component 320 can be any component or component combination that can collect the movement of the magnetic particles.

[0100] Further, refer to Figure 4 or Figure 6 In one embodiment, based on the structure of the magnetic particle detection mechanism 300, the second chamber 130 of the present invention includes a group of first cavities 131, 131' and a group of second cavities 132, 132' distributed along the circumferential interval of the base 100, wherein the first cavities 131, 131' are used to install the magnetic field manufacturing component 330, and the second cavities 132, 132' are used to install the magnetic particle detection component 320. Specifically, the magnetic particle detection component 320 includes a second light source component installed in the second cavity 132, and the second light source component includes, for example, a second light source emitter 321 and a light homogenizer 323, which are used to form output light of specified conditions, such as a specified wavelength, and / or a specified light intensity, and / or a specified brightness, and / or a specified spot area, and guide it to the second area 310 of the test tube 400 through at least part of the second detection channel 150; the magnetic particle detection component 320 also includes an information acquisition component installed in the second cavity 132', for example, the information acquisition component may include a focusing lens 324 and an image collector 322, wherein the image collector 322 includes but is not limited to a built-in camera of a mobile terminal, an ordinary digital camera, a CCD camera, an ultra-high-speed camera, a video recorder, etc., to obtain data files in the form of photos, videos, etc., preferably video files, and the data files can reflect the relevant parameters of the movement of magnetic particles, such as start time, duration, movement trajectory, stroke size, coverage area, etc. The second cavities 132 , 132 ′ and the test tube 400 (the second area 310 ) are distributed in a straight line along the fourth direction, and the second cavities 132 , 132 ′ are respectively disposed on both sides of the test tube 400 .

[0101] Further, continue to refer to Figure 4 or Figure 6In this embodiment, the magnetic field manufacturing assembly 330 of the present invention is configured to include at least magnetic parts respectively installed in the first cavity 131, 131'. In the first case, the magnetic parts in the first cavity 131, 131' are all permanent magnets, and the magnetic field manufacturing assembly 330 is configured to also include a moving assembly, which is used to realize the magnetic field loaded on the second area 310 as a variable magnetic field (such as changes in magnetic field intensity, magnetic field line distribution density, magnetic field direction, etc.) through the displacement of the permanent magnet, thereby driving the magnetic particles placed in the second area 310 to move, preferably regular motion, such as reciprocating motion. In this case, the moving component at least includes a power source and a path for the permanent magnet to move, so as to form independent movement control or unified movement control for different permanent magnets; in the second case, the magnetic parts in the first cavity 131, 131' are all electromagnets, then the magnetic field manufacturing component 330 is configured to also include a circuit control component for controlling the circuit characteristics to achieve changes in the magnetic field characteristics loaded on the second area 310 to form a changing magnetic field, the circuit characteristics at least include the on and off of the circuit, the current, the voltage, the capacitance, etc., and the circuit control component is implemented in a manner including but not limited to a switch component, a converter, a transformer, a rheostat, a capacitor, a diode, etc.; it should be noted that in this case, the moving component in the first case can also be combined to obtain a changing magnetic field in the second area 310 in a composite manner of displacement and circuit control; in the third case, the magnetic parts in the first cavity 131, 131' are permanent magnets and / or electromagnets, respectively, then the magnetic field manufacturing component 330 is configured to also include one or a combination of a circuit control component and / or a moving component.

[0102] Further, in this embodiment, the magnetic member and the mounting hole are arranged along at least part of the second detection channel 150, and the at least part of the second detection channel can establish a connection between the first cavity 131, 131' and the mounting hole in a through form, or can establish a connection between the first cavity 131, 131' and the mounting hole in a non-through form, that is, the part of the second detection channel has an opening set in the first cavity 131, 131' and an end that stops at the inside of the base, that is, the end is not connected to the mounting hole. Preferably, the first cavity 131, 131' and the mounting hole are distributed in a straight line in the fifth direction.

[0103] In the aforementioned embodiment, the angle between the fourth direction and the fifth direction is β, 30°≤β≤150°, preferably 60°≤β≤120°, and more preferably β=90°; in the aforementioned embodiment, the second direction, the third direction, the fourth direction and the fifth direction are preferably coplanar, and the first direction intersects with the plane, preferably perpendicularly.

[0104] It should be noted that, in this embodiment, the fourth direction of the example is the extension direction of the second cavity, and the fifth direction of the example is the extension direction of the first cavity.

[0105] For further information, see Figure 8 In one embodiment, taking the first area 210 and the second area 310 being independently set at the height of the test tube 400 (that is, the two areas are isolated and staggered from each other) as an example, the first area corresponds to a height position A of the test tube, and the second area corresponds to a height position B of the test tube, wherein 3.5mm≤A≤5.5mm, 1mm≤B≤3mm, the liquid level of the sample to be detected in the test tube 400 is controlled within 6mm, the height occupied by the first area 210 is 2mm, and the specific range of the axis of movement of the magnetic particles can be set to 3.5-5.5mm in height; the height occupied by the second area 310 is 2mm, which can be specifically set within a height range of 1-3mm; accordingly, there is a height difference between the optical detection mechanism 200 and the magnetic particle detection mechanism 300 in the first direction, so as to cooperate with the first area 210 and the second area 310 to perform corresponding detection operations respectively, thereby realizing the selection or consideration of the two methodologies. According to actual calculations, when the blood coagulation detection device 10 illustrated in this embodiment is used for optical detection and magnetic particle detection, the required volume of the sample to be detected is 120uL, which is substantially the same as the volume used in conventional single optical method or magnetic particle method.

[0106] Based on the same technical concept, in a second aspect, the present invention provides a coagulation analyzer, comprising:

[0107] Controller;

[0108] The blood coagulation detection device 10 of the first aspect is controlled by the controller to perform optical detection and / or magnetic particle detection in an alternative or combined manner.

[0109] In this embodiment, the coagulation detection device 10 illustrated in the above embodiment is arranged on the base 20, and optical detection and / or magnetic particle detection are performed in a selective or balanced manner for the sample to be detected that has completed the preliminary work. The above preliminary work includes but is not limited to scanning, sample distribution, test tube transmission, reagent distribution, incubation, mixing, etc. Correspondingly, the coagulation analyzer is provided with a sample supply module, a sample transport module, a sample suction module, a reaction cup supply module, a reagent distribution module, an incubation module, a mixing module, etc. These work contents and corresponding functional modules are the basic preparations and / or common structures for optical detection or magnetic particle detection, which are either common knowledge in the art or have been described in other related patents of the applicant, and will not be repeated here.

[0110] Further, in one embodiment, the coagulation analyzer further includes a HIL information recognition module 30, which is in communication connection with the controller to control the output of the detection mode of the sample to be tested based on the information recognized by it, and the detection mode includes optical detection and / or magnetic particle detection in a selective or balanced manner. Wherein, the HIL information recognition module 30 is used to identify the information carried by the sample to be tested, and the information includes but is not limited to the sample type (such as whole blood, serum, plasma), sample state (such as normal, hemolysis, lipemia, jaundice, clot), state index (such as hemolysis index, lipemia index, jaundice index), centrifugation state (such as centrifugation, non-centrifugation), sample volume, etc. The above-mentioned recognized information will be transmitted to the processor, and the corresponding instructions will be generated after internal calculation as one of the parameters for controlling the coagulation detection device 10.

[0111] Furthermore, in one embodiment, the HIL information identification module 30 is independently arranged from the coagulation detection device 10; in another embodiment, the HIL information identification module 30 adopts the magnetic particle detection mechanism, that is, in this embodiment, the HIL information identification module 30 and the magnetic particle detection mechanism are the same set of mechanisms. Specifically, after the test tube 400 is placed in the mounting hole, the magnetic particle detection component 320 therein can be used to collect and identify the sample information in 400 (for example, sample type, sample status, status index, centrifugal status, sample volume, etc.). In this embodiment, the integrated design of the instrument can be further optimized, the floor space can be reduced, and the cost and initial investment of the instrument can be reduced.

[0112] Based on the same technical concept, in a third aspect, the present invention provides a coagulation analysis method, comprising the following steps:

[0113] S200, generating a control instruction for controlling the analyzer described in the above embodiment to perform a detection operation.

[0114] S300, transmitting the control instruction to the coagulation analysis device to execute the detection operation; the detection operation is to perform optical detection operation and / or magnetic particle detection operation in a selective or combined manner.

[0115] In this embodiment, after receiving the identification information of the sample to be detected, the controller needs to determine the intervention method of the optical method and / or the magnetic particle method according to its built-in algorithm, for example, it needs to determine whether to detect in a selective manner or a combined manner; if it is a combined manner, it needs to determine whether to perform the detection synchronously or asynchronously; if it is an asynchronous manner, it needs to determine the time point for the optical method and the magnetic particle method to intervene respectively. The above intervention method will also be used as one of the influencing parameters to assist in the generation of control instructions after being calculated by the processor.

[0116] In this embodiment, the corresponding control instructions include control instructions for controlling the optical detection mechanism to perform optical detection or control instructions for controlling the magnetic particle detection mechanism to perform magnetic particle detection, so as to selectively perform optical detection or magnetic particle detection; the corresponding control instructions may also be to simultaneously control the optical detection mechanism and / or the magnetic particle detection mechanism to perform a detection method that combines the magnetic particle method and the optical method.

[0117] In this embodiment, choosing one means only performing one of the detection operations, optical detection or magnetic particle detection; and taking both into account means performing both optical detection and magnetic particle detection on the same sample to be detected. For example, the optical detection and magnetic particle detection may be performed simultaneously, or they may be performed asynchronously before the sample to be detected fails. For example, the two are performed separately with a certain interval, or they are performed continuously without any interval, or there is a certain overlap in the performance time.

[0118] Before step S200, the coagulation analysis method further includes:

[0119] S100, using the coagulation analyzer described in the previous embodiment to perform information recognition on the sample to be tested.

[0120] The identification information is derived from the HIL information identification module 30, and the identification content includes but is not limited to the sample type (whole blood, serum, plasma), sample status (normal, hemolysis, lipemia, icteric), status index (hemolysis, lipemia, icteric index), centrifugation status (centrifugation, non-centrifugation), sample volume, etc. The above identification information is calculated by the processor and used as one of the influencing factors to assist in the generation of control instructions.

[0121] After step S300, the coagulation analysis method further includes:

[0122] S400: Generate a test result according to the test operation and send it to a display device.

[0123] The display device may be a display screen provided by the coagulation analyzer, a centralized display screen of a control center of a testing unit, or an authorized mobile device, such as a mobile phone, a tablet, a projector, etc.

[0124] The above description is only an exemplary embodiment of the present invention, and does not limit the patent scope of the present invention. All equivalent structural changes made by using the contents of the present invention specification and drawings under the technical concept of the present invention, or directly / indirectly applied in other related technical fields are included in the patent protection scope of the present invention.

Claims

1. A blood coagulation detection device, It is characterized in that include: A base, provided with a placement hole whose axis extends along a first direction, for placing a test tube containing a sample to be tested; An optical detection mechanism, used for optically detecting the first area of ​​the sample to be detected; A magnetic particle detection mechanism, used for performing magnetic particle detection on the second area of ​​the sample to be tested; The first area and the second area are arranged at least partially in different regions on the test tube.

2. The blood coagulation detection device according to claim 1, It is characterized in that The optical detection mechanism comprises: A first light source assembly is controlled to form an output light of a specified condition; An optical signal receiving component, which is controlled to receive the optical signal that has completed the detection and carries the information; A first detection channel terminates at a first position of the placement hole in a through manner, the first position being arranged corresponding to the first area; The first light source assembly and the optical signal receiving assembly are disposed at different sides of the first position.

3. The blood coagulation detection device according to claim 2, It is characterized in that The first detection channel includes a first portion extending along a second direction and / or a second portion extending along a third direction; the first direction is different from the second direction or the third direction.

4. The blood coagulation detection device according to claim 3, It is characterized in that The first light source assembly is installed in the second direction or the third direction; and / or the optical signal receiving assembly is correspondingly installed in the third direction or the second direction.

5. The blood coagulation detection device according to claim 1, It is characterized in that The magnetic particle detection mechanism comprises: A magnetic field manufacturing component, used for applying a changing magnetic field to the second area; a magnetic particle detection component, used for collecting movement characteristics of magnetic particles in the second region; and A second detection channel, at least partially terminated in a through-going manner at a second position of the placement hole; The second position corresponds to the second regional setting.

6. The blood coagulation detection device according to claim 5, It is characterized in that The second detection channel includes: a third part terminating at the second position in a through manner along the fourth direction, and / or a fourth part terminating at the second position of the placement hole in a through or non-through manner along the fifth direction; the first direction, the fourth direction and the fifth direction are all different.

7. The blood coagulation detection device according to claim 6, It is characterized in that The magnetic field manufacturing assembly is arranged in the fifth direction, and includes: magnet; The magnetic field changing component is used to make the magnet form a changing magnetic field in the second area.

8. The blood coagulation detection device according to claim 7, It is characterized in that The magnet comprises a permanent magnet; The magnetic field changing component includes a magnet moving component, and the magnet moving component drives at least part of the magnet to move to form a changing magnetic field in the second area.

9. The blood coagulation detection device according to claim 7 or 8, It is characterized in that The magnet comprises an electromagnet; The magnetic field varying component includes a circuit control component, and the circuit control component controls at least part of the electrical characteristics of the electromagnet to form a varying magnetic field in the second area.

10. The blood coagulation detection device according to claim 9, It is characterized in that The electrical characteristics include at least one of circuit on and off, current size, voltage level, resistance size, and capacitance size; the circuit control component includes at least one of a switch, a converter, a transformer, a resistor, a diode, and a capacitor.

11. The blood coagulation detection device according to any one of claims 8 to 10, It is characterized in that A moving path is formed in the second detection channel, and the magnet moving assembly includes a power source, and the power source drives at least a portion of the magnet to move along the moving path.

12. The blood coagulation detection device according to claim 6, It is characterized in that The magnetic particle detection component is arranged in the fourth direction and includes: A second light source assembly is controlled to form an output light of a specified condition; The information acquisition component is used to control the acquisition of the movement characteristics of the magnetic particles in the second area.

13. The blood coagulation detection device according to claim 2 or 12, It is characterized in that The specified condition includes at least one of a specified type, a specified light intensity, a specified wavelength, a specified brightness, and a specified light spot area; and / or, The motion characteristics include at least one of a motion trajectory, a motion range, a start and stop time, and a duration.

14. The blood coagulation detection device according to claim 12 or 13, It is characterized in that The information collection component includes one or a combination of a built-in camera of a mobile terminal, a common digital camera, a CCD camera, an ultra-high-speed camera, a video recorder, an infrared imager, and a laser scanner.

15. The blood coagulation detection device according to any one of claims 1 to 14, It is characterized in that The base is a columnar structure, and the optical detection mechanism and the magnetic particle detection mechanism are arranged at intervals on the side of the columnar structure; and / or, The base is made of non-magnetic material.

16. The blood coagulation detection device according to claim 15, It is characterized in that The base is a cylindrical structure or an octagonal prism structure; and / or, The non-magnetic material is aluminum or a material containing aluminum.

17. A coagulation analyzer, It is characterized in that include: Controller; The blood coagulation detection device according to any one of claims 1 to 16, is controlled by the controller to perform optical detection and / or magnetic particle detection in an alternative or combined manner.

18. The analyzer according to claim 17, It is characterized in that Also included is a HIL identification device.

19. The analyzer according to claim 18, It is characterized in that The HIL identification device is independent of the blood coagulation detection device.

20. The analyzer according to claim 18, It is characterized in that The HIL identification device and the magnetic particle detection mechanism share a second light source component and / or an information collection component.

21. A coagulation analysis method, using the coagulation analysis device according to any one of claims 1 to 16 or the coagulation analyzer according to any one of claims 17 to 20, It is characterized in that The steps include: Generate control instructions for testing samples to be tested; The control instruction is transmitted to the coagulation analysis device to execute the detection operation; wherein the detection operation is to perform optical detection operation and / or magnetic particle detection operation in a selective or combined manner.

22. The blood coagulation analysis method according to claim 21, It is characterized in that Before generating a control instruction for performing a detection operation on the sample to be detected, the method further includes: Perform information identification operations on the samples to be tested.

23. The blood coagulation analysis method according to claim 21 or 22, It is characterized in that Also includes: Generate test results based on the test job and send them to the display device.

24. The blood coagulation analysis method according to claim 23, It is characterized in that The display device includes a display screen of the coagulation analyzer, a display screen independent of the analyzer, or a display screen of an authorized mobile device.

25. The blood coagulation analysis method according to claim 24, It is characterized in that The display screen of the authorized mobile device is at least one of a mobile phone, a tablet, a projector, and a vehicle-mounted display.

Images