Blood coagulation detection device and blood coagulation analyzer

Abstract

The utility model discloses a blood coagulation detection device and a blood coagulation analyzer, 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 utility model relates to the technical field of medical analysis, in particular to a blood coagulation detection device and a blood coagulation analyzer. Background Art

[0002] Traditionally, coagulation analyzers utilize methodologies such as the magnetic bead method and the optical method, each based on different detection principles. In the past year or two, based on extensive basic research, the applicant has introduced a new detection theory, the magnetic microparticle method.

[0003] However, whether it's the traditional magnetic bead method, the optical method, or the newly proposed magnetic microparticle method, all have unavoidable flaws or shortcomings when used alone. For example, due to their large mass, the magnetic bead method experiences greater inertia when subjected to a magnetic field, exerting a greater force on the protein fiber network, potentially even causing it to rupture. Optical methods are also significantly affected by sample quality. For example, the presence of substances like lipemia and hemolysis can significantly impact test results.

[0004] Based on this, how to integrate different methods in a weighted manner, or to compare the test results of each method, has become a real need in this field.

[0005] At the same time, if each methodology is independently supplied with 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. Utility Model Content

[0006] The main purpose of the utility model is to provide a coagulation detection device and a coagulation analyzer, which aims to solve the technical problem in the prior art that when performing optical or magnetic particle detection on the samples to be tested, a large number of samples need to be used separately, resulting in waste of the samples to be tested and affecting the detection efficiency.

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

[0008] The base is provided with a placement hole with an axis extending along a first direction, for placing a test tube containing a sample to be tested;

[0009] an optical detection mechanism, configured to perform optical detection on the first area of ​​the sample to be tested;

[0010] a magnetic particle detection mechanism, configured to perform magnetic particle detection on the second region of the sample to be tested;

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

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

[0013] A first light source assembly is controlled to form output light under specified conditions;

[0014] An optical signal receiving component is controlled to receive the optical signal that has been detected and carries information;

[0015] a first detection channel, terminating 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 respectively arranged on 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 generating component, configured to apply a changing magnetic field to the second region;

[0021] a magnetic particle detection component, configured to collect movement characteristics of magnetic particles in the second region; and

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

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

[0024] In one embodiment, the second detection channel comprises:

[0025] The third portion terminates at the second position in a through manner along the fourth direction, and / or the fourth portion terminates 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.

[0026] In one embodiment, the magnetic field generating assembly is arranged in the fifth direction, comprising:

[0027] magnet;

[0028] The magnetic field changing component is used to enable the magnet to form a changing magnetic field in the second area.

[0029] In one embodiment, the magnet comprises a permanent magnet;

[0030] The magnetic field changing component includes a magnet moving component, and the magnet moving component drives at least part of the magnet to move, so as to form a changing magnetic field in the second area.

[0031] In one embodiment, the magnet comprises an electromagnet;

[0032] The magnetic field varying component includes a circuit control component, which controls at least part of the electrical characteristics of the electromagnet to form a varying magnetic field in the second area.

[0033] In one embodiment, the electrical characteristics include at least one of circuit on / off, current, voltage, resistance, and capacitance; the circuit control component includes at least one of a switch, a converter, a transformer, a resistor, a diode, and a capacitor.

[0034] 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.

[0035] In one embodiment, the magnetic particle detection component is arranged in the fourth direction and includes:

[0036] A second light source assembly is controlled to form output light under specified conditions;

[0037] The information collection component is configured to controllably collect the motion characteristics of the magnetic particles in the second area.

[0038] 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;

[0039] and / or,

[0040] The motion characteristics include at least one of a motion trajectory, a motion range, a start / stop time, and a duration.

[0041] In one embodiment, the information collection component includes any 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.

[0042] In one embodiment, the base is a columnar structure, and the optical detection mechanism and the magnetic particle detection mechanism are spaced apart and arranged on the side of the columnar structure;

[0043] and / or,

[0044] The base is made of non-magnetic material.

[0045] In one embodiment, the base is a cylindrical structure or an octagonal prism structure;

[0046] and / or,

[0047] The non-magnetic material is aluminum or a material containing aluminum.

[0048] Based on the same technical concept, in a second aspect, the present invention further proposes a coagulation analyzer, comprising:

[0049] Controller;

[0050] 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.

[0051] In one embodiment, a HIL identification device is further included.

[0052] In one embodiment, the HIL identification device is independent of the coagulation detection device.

[0053] 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.

[0054] 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 the first area of ​​the sample to be tested in the test tube, and the magnetic particle detection mechanism performs magnetic particle detection on the 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 the 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 contain the sample to be tested, thereby improving the comparability of the detection results. Moreover, 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 waste of the sample 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 waste of the sample to be tested and improving the detection efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. 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 any creative work.

[0056] Figure 1 This is a structural diagram of an embodiment of a blood coagulation detection device provided by the present invention;

[0057] Figure 2 This is a schematic diagram of the planar structure of the blood coagulation detection device provided by the utility model;

[0058] Figure 3 This is a side structural diagram of the blood coagulation detection device provided by the utility model;

[0059] Figure 4 for Figure 3 Schematic diagram of the structure of the AA section of the example;

[0060] Figure 5 for Figure 4 The magnetic field generating component in the example is a schematic structural diagram of an electromagnet;

[0061] Figure 6 for Figure 3 Schematic diagram of the structure of the BB section of the example;

[0062] Figure 7 for Figure 6 The magnetic field generating component in the example is a schematic structural diagram of an electromagnet;

[0063] Figure 8 This is a schematic diagram of the partition structure of the test tube provided by the utility model.

[0064] Description of Figure Numbers:

[0065] 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;

[0066] 200, optical detection mechanism; 210, first area; 220, second light source emitting element; 230, optical signal receiving component;

[0067] 300, magnetic particle detection mechanism; 310, second area; 320, magnetic particle detection component; 330, magnetic field generation component; 321, first light source emitter; 322, image collector; 323, light homogenizer; 324, focusing lens; 10, coagulation detection device; 30, HIL information recognition module.

[0068] 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

[0069] 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 embodiments described 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 making creative efforts shall fall within the scope of protection of the present invention.

[0070] 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 indications will also change accordingly.

[0071] 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 for descriptive purposes and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features limited to "first" and "second" may explicitly or implicitly include at least one of such features. In addition, if "and / or" or "and / or" appears in the full text, its meaning includes three parallel schemes. Taking "A and / or B" as an example, it includes scheme A, or scheme B, or a scheme in which A and B are satisfied at the same time. 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 mutually contradictory or cannot be implemented, it should be deemed that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0072] 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 the cells. Therefore, the traditional magnetic bead method uses the mesh structure to hinder the movement of magnetic beads, and detects the position of the magnetic beads during the process from movement to gradual slowing down until the final stop, to obtain the coagulation detection results. However, the magnetic beads used in the traditional magnetic bead method are relatively large, all on the millimeter level, so the force exerted on the fibrin network during the 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, vibration time, etc., which can obtain coagulation information more accurately and comprehensively. The present application is a coagulation detection device further proposed on the basis of the research results.

[0073] See also Figures 1 to 8 In one embodiment of the present invention, the blood coagulation detection device 10 includes:

[0074] The base is provided with a placement hole with an axis extending along a first direction, for placing a test tube containing a sample to be tested;

[0075] An optical detection mechanism, configured to perform optical detection on a first area of ​​the sample to be detected;

[0076] a magnetic particle detection mechanism, configured to perform magnetic particle detection on a second region of the sample to be tested;

[0077] 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 part of the sample to be tested contained in the test tube.

[0078] In this embodiment, the optical detection mechanism 200 and / or the magnetic particle detection mechanism 300 can be used to selectively perform optical detection or magnetic particle detection on the sample to be tested, or to perform both optical detection and magnetic particle detection in a balanced manner, based on actual detection requirements. It is understood that selectively performing either optical detection or magnetic particle detection refers to performing only one of the detection operations, while performing both optical detection and magnetic particle detection on the same sample to be tested refers to performing both optical detection and magnetic particle detection on the same sample to be tested. For example, the optical detection and magnetic particle detection can be performed simultaneously, or they can be performed asynchronously before the sample to be tested expires and after the magnetic particles are added, such as performing them separately with a certain time interval, or performing them continuously without a time interval, or with a certain overlap in the time of the two detections. 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 the same. Therefore, simultaneous detection can achieve the comparison and reference of two different schemes; but on the other hand, the ability of different methodologies to obtain information at each stage of the coagulation process, and the ability to capture and fix details are all different. Therefore, this application allows different detection methods to intervene at different stages of coagulation, so that the respective advantages of the two methodologies can be integrated and complementary to obtain accurate detection conclusions. Through this setting method, the utility model can be made more flexible in use, better able to meet the customized needs of the samples to be tested, customers or professionals, and improve the detection efficiency and pertinence.

[0079] 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 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 does not significantly increase the amount of samples to be tested.

[0080] It should be noted that, in this embodiment, the first area 210 and the second area 310 are merely area divisions made within the sample to be tested corresponding to different methodologies (optical method and magnetic particle method), and do not limit the independence between the first area 210 and the second area 310. 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 are necessarily two different areas. In fact, the first area 210 and the second area 310 can be two independent and 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 manifested in the height direction of the test tube 400, or in the circumferential or horizontal direction. Preferably, the first area 210 and the second area 310 are two independent and different areas in the height direction of the test tube (i.e., staggered or spaced apart).

[0081] The first area 210 and the second area 310 can also be two non-independent areas. The non-independence here means that the boundaries of the first area 210 and the second area 310 are close to, intersecting, or contained. 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 partially overlap, 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 testing two non-independent areas, equally accurate data can be obtained through data processing. This part of the content is not the focus of this application and will not be elaborated here.

[0082] It should also be noted that the first area 210 and the second area 310 are area divisions made based on the sample to be tested, but in fact, since the sample to be tested is placed in a test tube in this application, the first area 210 and the second area 310 can also be area divisions made based on the sample to be tested and the test tube surrounding it. In this application, unless otherwise specified, the area divisions in these two situations can be considered to be equivalent.

[0083] 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, the mounting hole 110 being 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.

[0084] 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, 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 interior 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.

[0085] Furthermore, the base 100 is made of non-magnetic 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 polyhedron, 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 toward the mounting hole 110, terminating at the 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 toward the mounting hole 110, and at least part of the second detection channel 150 terminates at the 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.

[0086] 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.

[0087] 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 larger than the radius r of the first detection channel 140. In a specific embodiment, 0.5 mm <r<1.0mm,3mm<R<3.5mm。

[0088] 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. The first light source component provides emission light for detection, and at the same time, the light source component can complete the formation of specified conditions for the emission light, such as 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 the emission light, and / or homogenization of the emission light, and / or collimation of the emission light, etc. The optical signal receiving component 230 can receive the 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 the first light source emitting element 220, such as a halogen lamp, LED, monochromatic light, laser, etc.; the optical signal receiving component can be the light source receiving component 230, such as a photodiode, PD sensor, etc.

[0089] Based on the structure of the optical detection mechanism 200, refer to Figure 4-Figure 7 The first chamber 120 includes third cavities 121 and 121' for mounting a first light source assembly and an optical signal receiving assembly 230, respectively. More specifically, the first light source assembly is mounted in the third cavity 121 and establishes an optical connection with the first region 210 of the test tube 400 along the second direction through at least a portion of the first detection channel 140, such as providing emitted light. The optical signal receiving assembly 230 is mounted in the third cavity 121' and establishes an optical connection with the first region 210 of the test tube 400 along the third direction through at least a portion of the first detection channel 140, 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 can be a straight line, a broken line, or the like. 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 assembly, the test tube 400 (first area 210) and the optical signal receiving assembly 230 are distributed in a straight line along the first detection channel 140.

[0090] 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 generation component 330. The magnetic field generation component 330 is configured to generate 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 tested to move, such as reciprocating motion. The magnetic field generation component 330 can be any component or combination of components capable of generating a variable magnetic field, such as an electromagnet, a permanent magnet, or a combination thereof. As the coagulation phenomenon of the sample to be tested occurs and progresses, the movement of the magnetic particles will gradually be hindered and eventually stop. By detecting relevant parameters of the movement (such as the start time, duration, movement distance, coverage area, etc.), the coagulation information of the sample to be tested can be obtained. This part 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 magnetic particle movement and transmit them to a data processing device. The magnetic particle detection component 320 can be any component or combination of components capable of collecting the movement of the magnetic particles.

[0091] 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 is 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', and 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 in 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 obtaining video files, and the data files can reflect the relevant parameters of the movement of magnetic particles, such as start time, duration, movement trajectory, movement stroke, 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 placed on both sides of the test tube 400 .

[0092] Further, continue to refer to Figure 4 or Figure 6In this embodiment, the magnetic field generating assembly 330 of the present invention is configured to include at least magnetic components respectively installed in the first cavities 131 and 131'. In the first case, the magnetic components in the first cavities 131 and 131' are all permanent magnets, and the magnetic field generating assembly 330 is configured to further include a moving assembly for achieving a variable magnetic field (such as changes in magnetic field intensity, magnetic field line distribution density, magnetic field direction, etc.) loaded on the second region 310 through the displacement of the permanent magnet, thereby driving the magnetic particles placed in the second region 310 to move, preferably in a regular motion, such as a reciprocating motion. In this case, the moving component includes at least a power source and a path for the movement of the permanent magnet, 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 generating component 330 is configured to also include a circuit control component for controlling the circuit characteristics to realize changes in the magnetic field characteristics loaded on the second area 310 to form a changing magnetic field, wherein the circuit characteristics at least include the on-off state of the circuit, the current magnitude, the voltage level, the capacitance magnitude, 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 generating component 330 is configured to also include one or a combination of a circuit control component and / or a moving component.

[0093] Furthermore, in this embodiment, the magnetic member and the mounting hole are arranged along at least a portion of the second detection channel 150. The at least portion of the second detection channel can establish a connection between the first cavity 131, 131' and the mounting hole in a through-going manner, or can establish a connection between the first cavity 131, 131' and the mounting hole in a non-through-going manner. That is, the portion of the second detection channel has an opening provided in the first cavity 131, 131' and an end that terminates in the interior 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 arranged in a straight line in the fifth direction.

[0094] 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 surface, preferably perpendicular.

[0095] It should be noted that, in this embodiment, the fourth direction is the extension direction of the second cavity, and the fifth direction is the extension direction of the first cavity.

[0096] For further information, see Figure 8 In one embodiment, taking the example of 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), 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, and the liquid level of the sample to be tested in the test tube 400 is controlled within 6mm. The height occupied by the first area 210 is 2mm, and the axis range of the movement of the magnetic particles can be specifically set to be 3.5-5.5mm in height; the height occupied by the second area 310 is 2mm, and 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, thereby realizing the selection or consideration of the two methodologies. According to actual calculations, when the 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 120 uL, which is substantially the same as the volume used in conventional single optical method or magnetic particle method.

[0097] Based on the same technical concept, in a second aspect, the present invention provides a coagulation analyzer, comprising:

[0098] Controller;

[0099] 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.

[0100] In this embodiment, the coagulation detection device 10 illustrated in the above embodiments is set on the base 20, and optical detection and / or magnetic particle detection are performed in a selective or combined manner for the sample to be detected that has completed the preliminary work. The above-mentioned preliminary work includes but is not limited to scanning, sample distribution, test tube transfer, reagent distribution, incubation, mixing, etc. Accordingly, 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 all basic preparatory work and / or common structures for optical detection or magnetic particle detection, which are either common knowledge in this field or have been described in other related patents of the applicant and will not be repeated here.

[0101] Furthermore, in one embodiment, the coagulation analyzer further includes a HIL information recognition module 30, which is in communication with the controller and is configured to controllably output a detection mode for the sample to be tested based on the information it recognizes. The detection mode includes performing optical detection and / or magnetic particle detection in a selective or combined manner. The HIL information recognition module 30 is configured to identify information carried by the sample to be tested, including but not limited to sample type (e.g., whole blood, serum, plasma), sample status (e.g., normal, hemolysis, lipemia, icterus, clot), status index (e.g., hemolysis index, lipemia index, icterus index), centrifugation status (e.g., centrifuged, non-centrifuged), sample volume, and the like. The recognized information is transmitted to the processor, which generates corresponding instructions after internal calculations, serving as one of the parameters for controlling the coagulation detection device 10.

[0102] Furthermore, in one embodiment, the HIL information identification module 30 is independently provided 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, centrifugation 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.

[0103] The above description is merely an exemplary embodiment of the present invention and does not limit the patent scope of the present invention. All equivalent structural transformations made using the contents of the present invention specification and drawings under the technical concept of the present invention, or direct / indirect application in other related technical fields are included in the patent protection scope of the present invention.

Claims

1. A blood coagulation detection device, characterized in that: include: The base is provided with a placement hole with an axis extending along a first direction, for placing a test tube containing a sample to be tested; an optical detection mechanism, configured to perform optical detection on the first area of ​​the sample to be tested; a magnetic particle detection mechanism, configured to perform magnetic particle detection on the second region of the sample to be tested; The first area and the second area are arranged at least partially in different areas on the test tube.

2. The blood coagulation detection device according to claim 1, wherein The optical detection mechanism comprises: A first light source assembly is controlled to form output light under specified conditions; An optical signal receiving component is controlled to receive the optical signal that has been detected and carries information; a first detection channel, terminating 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 respectively arranged on different sides of the first position.

3. The blood coagulation detection device according to claim 2, wherein 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, wherein 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, wherein The magnetic particle detection mechanism comprises: a magnetic field generating component, configured to apply a changing magnetic field to the second region; a magnetic particle detection component for collecting movement characteristics of magnetic particles in the second region; and a second detection channel, at least partially terminating at a second position of the placement hole in a through manner; The second position corresponds to the second area setting.

6. The blood coagulation detection device according to claim 5, wherein: The second detection channel includes: The third portion terminates at the second position in a through manner along the fourth direction, and / or the fourth portion terminates 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, wherein: The magnetic field generating assembly is arranged in the fifth direction and includes: magnet; The magnetic field changing component is used to enable the magnet to form a changing magnetic field in the second area.

8. The blood coagulation detection device according to claim 7, wherein: The magnet includes 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, so as to form a changing magnetic field in the second area.

9. The blood coagulation detection device according to claim 8, wherein The magnet comprises an electromagnet; The magnetic field varying component includes a circuit control component, which 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, wherein: The electrical characteristics include at least one of circuit on / off, current, voltage, resistance, and capacitance; 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, characterized in that: A moving path is formed in the second detection channel, and the magnet moving assembly includes a power source, which drives at least a portion of the magnet to move along the moving path.

12. The blood coagulation detection device according to claim 6, wherein: The magnetic particle detection component is arranged in the fourth direction and includes: A second light source assembly is controlled to form output light under specified conditions; The information collection component is configured to controllably collect the motion characteristics of the magnetic particles in the second area.

13. The blood coagulation detection device according to claim 12, wherein: 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 / stop time, and a duration.

14. The blood coagulation detection device according to claim 13, wherein: The information collection component includes any 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 claim 14, wherein: 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, wherein: 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, characterized in that: include: Controller; The blood coagulation detection device according to any one of claims 1 to 16, wherein the controller is controlled to perform optical detection and / or magnetic particle detection in an alternative or combined manner.

18. The analyzer according to claim 17, wherein Also includes HIL identification device.

19. The analyzer according to claim 18, wherein The HIL identification device is independent of the blood coagulation detection device.

20. The analyzer according to claim 18, wherein The HIL identification device and the magnetic particle detection mechanism share a second light source component and / or an information acquisition component.

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