Full-automatic thrombus detector

Abstract

The utility model provides a full-automatic thrombus detector. The full-automatic thrombus detector comprises a box body, a detection unit, a temperature control unit and a driving unit, the full-automatic thrombus detector provided by the utility model can simulate the blood circulation environment of a human body, especially the temperature of the human body and the blood circulation speed of the human body, and performs a thrombus formation test of medical equipment / materials in vitro under the condition of simulating the blood flow of the human body.

Description

Technical Field

[0001] The utility model relates to the technical field of detection equipment, in particular to a full-automatic thrombus detector. Background Art

[0002] At present, with the continuous progress of medical science, medical devices or materials have been widely used in the treatment of human diseases. These medical devices or materials have benefited mankind, but also brought some risks to human health. If the quality of such medical devices or materials is unqualified or improperly operated, it is very easy to cause medical accidents and endanger human health. Human blood is composed of blood cells and plasma. Blood cells include red blood cells, white blood cells and platelets, and plasma contains a large amount of protein. The treatment of many diseases requires the use of implanted or interventional devices, among which the devices used in blood vessels (such as artificial blood vessels, vascular stents, interventional valves, etc.) will come into contact with blood. When the device comes into contact with blood, the proteins in the blood (such as albumin, fibrinogen, etc.) will be quickly adsorbed on the surface of the device material, and platelets and white blood cells will then adhere to the surface. The adsorbed proteins will also lead to the activation of coagulation factors, especially the production of thrombin, which will affect the activation of platelets and other coagulation factors. Thrombin will convert fibrinogen into insoluble fibrin, and fibrin will cross-link with each other to form a fibrin clot. Fibrin clots will wrap platelets and other blood cells, eventually forming a thrombus. A thrombus is like a "time bomb" placed in the body. After the thrombus breaks off, it will flow with the blood and cause blood vessels to become blocked again. If it blocks the coronary artery, myocardial infarction will occur; if it blocks the cerebral artery, cerebral infarction will occur; if it blocks the pulmonary artery, pulmonary embolism will occur. These are all serious diseases that can even be life-threatening.

[0003] In this regard, it is necessary to construct an anticoagulant coating on the surface of medical devices to avoid the formation of thrombus. At present, commercial anticoagulant coatings are usually based on two anticoagulant principles, one is the inert anticoagulant principle, and the other is the active anticoagulant principle. Representatives of inert anticoagulant coatings include phosphorylcholine coatings, such as constructing phosphorylcholine coatings on the surface of metal dense mesh stents (CN116370723A), and representatives of active anticoagulant coatings include heparin coatings, such as fixing heparin on the surface of metal stents for anticoagulant modification (Journal of Biomedical Materials Research 2008, 86A, 648-661).

[0004] However, the research and development of medical devices with anticoagulant coatings in China has just started, and there is a lack of research on the functionality and safety evaluation of anticoagulant coatings. However, the evaluation of the anticoagulant performance of implantable interventional devices is crucial. According to data from the Medical Device Technology Review Center of the National Medical Products Administration, cardiovascular interventional medical devices are currently the "main battlefield" for medical device innovation in China. In 2022, more than 50% of the products entering the special approval channel for innovative medical devices are cardiovascular interventional medical devices. If the performance of anticoagulant coatings cannot be accurately and effectively evaluated, it will be impossible to screen out truly safe and effective products, which will not only be detrimental to the formulation of relevant industry standards, but may also pose risks to human health.

[0005] At present, in vitro thrombosis tests are commonly used to evaluate thrombosis. Fully automatic thrombosis detectors are widely used in thrombosis tests due to their unique advantages. The fully automatic thrombosis detector uses the Chandler ring experiment to perfectly combine the rotation and temperature control functions to simulate human body temperature and the flow rate of blood in human blood vessels. It can simulate the process of thrombosis in human blood vessels in vitro. Its working principle is to use the centrifugal technology of the thrombometer to aggregate the thrombotic factors carried in the blood and compare the length, dry weight and wet weight of the formed thrombus. Although thrombus detectors have been widely used, there are still some disadvantages in the thrombus detectors currently on the market: (1) The temperature control of traditional thrombus detectors is uneven, which often leads to abnormal changes in blood components in the tube, aggregation and reduction of blood cells or platelets, and it is impossible to verify the authenticity of the anticoagulant effect of coated samples. Although there are products with more accurate temperature control than traditional thrombus detectors, the temperature control method is too cumbersome, the manufacturing cost is high, and it is more complicated to use; (2) The object of traditional thrombus detectors is blood, and there is no need to consider whether the inside contains device samples. Ordinary plastic rings can meet the detection requirements. However, when the object of detection is a device, there are more requirements for the shape of the detection ring; (3) Most traditional thrombus detectors have non-adjustable speeds or a small adjustable speed range. However, in fact, there are large differences in blood flow velocities among people of different genders and ages and in different parts of the same human body (the blood flow velocity of the aorta can be more than twice that of the vena cava). It is necessary to set up a thrombus detector with a larger adjustable speed range and more precise speed control.

[0006] Therefore, in view of the above-mentioned existing technical problems, it is necessary to propose a new technical solution. Utility Model Content

[0007] The purpose of the utility model is to provide a fully automatic thrombus detector for thrombus testing of medical devices or materials. Through structural design, it can simulate human body temperature and human blood circulation speed, conduct thrombus formation tests on medical devices or materials in vitro, and is conducive to evaluating the actual safety of the devices.

[0008] To achieve the purpose of the utility model, the utility model provides a fully automatic thrombus detector for thrombus testing of medical devices or materials, characterized in that it includes: a housing; a detection unit, including a rotating device, a fixing device and a detection ring; the detection ring is used to accommodate blood and samples to be tested, the fixing device is used to fix the detection ring, and the fixing device is installed on the rotating device; a temperature control unit, including a water bath and a heating device, the heating device is used to heat the liquid in the water bath; a driving unit, connected to the rotating device through a driving shaft, and used to drive the rotating device to rotate.

[0009] Optionally, the temperature control unit may be provided with a heating device to enable the liquid in the water bath to reach or maintain a specific temperature.

[0010] Optionally, the specific temperature is human body temperature.

[0011] Optionally, one of the rotating devices is connected to one, two or more fixing devices.

[0012] Optionally, the fixing device includes at least one fixing position for fixing the detection ring.

[0013] Optionally, the fixing position has one or more sizes and is adapted to one or more sizes of detection rings.

[0014] Optionally, the detection ring is made of chemically inert materials, including any one of fluoroplastics, quartz glass, borosilicate glass, polytetrafluoroethylene, polyethylene, polyvinyl chloride, polypropylene, and polyether polyurethane.

[0015] Optionally, it also includes a lifting unit, which is connected to the rotating device through a driving shaft to adjust the lifting of the rotating device.

[0016] Optionally, the up and down movement of the lifting unit is achieved by a driving unit driving a hydraulic or mechanical device.

[0017] Optionally, the driving unit is a motor.

[0018] Optionally, a digital display device is also included, which can display the rotation speed of the rotating device and the temperature in the water bath, so as to facilitate real-time monitoring of the rotation speed and temperature.

[0019] Optionally, a control unit is further included, and the control unit is used to control the detection time, the operation of the driving unit and the temperature control unit.

[0020] The implementation of the utility model has the following effects: 1. A temperature control unit is provided to simulate the temperature of human blood in vitro; 2. In the temperature control unit, the heating device adopts a water bath heating method, the blood is heated evenly, the temperature control accuracy is high, the performance is more reliable, and the anti-interference ability is strong; 3. The rotation speed of the rotating device is adjustable, and the blood flow rate of different people and different parts of the human body can be simulated in vitro; 4. The detection unit can hold multiple detection rings at the same time, and multiple samples can be detected at the same time. In actual detection, multiple detection rings rotate coaxially, which is more convenient for comparative analysis, and has higher efficiency and accuracy; 5. A lifting unit is provided. When the temperature of the liquid in the water bath is stabilized at the set temperature, the lifting unit drives the rotating device to descend until the detection ring is immersed in the liquid in the water bath, so that the detection result is more accurate and more suitable for control experiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a schematic diagram of the overall structure of the fully automatic thrombus detector provided by the embodiment of the utility model;

[0022] Figure 2 This is a top view of the overall structure of the fully automatic thrombus detector provided by the embodiment of the utility model;

[0023] Figure 3 It is a schematic diagram of a detection system provided by an embodiment of the utility model;

[0024] Figure 4 It is a schematic diagram of the structure of the driving unit and the lifting unit provided in the embodiment of the utility model;

[0025] Figure 5 This is a flow chart of the testing method of the fully automatic thrombus detector provided by an embodiment of the utility model; the figure numerals in the figure: 1- box; 2- detection unit; 3- temperature control unit; 4- main switch; 5- water bath; 6- heating device; 7- handle; 8- digital display device; 9- drain outlet; 10- driving unit; 11- rotating device; 12- fixing device; 13- fixing position; 14- detection ring; 15- driving shaft; 16- lifting unit; 17- control unit. DETAILED DESCRIPTION

[0026] In order to further make the above-mentioned objects, features and advantages of the present invention more obvious and understandable, the specific implementation methods of the present invention are described below in conjunction with the accompanying drawings.

[0027] like Figure 1 and Figure 2As shown, the embodiment of the utility model provides a fully automatic thrombus detector, including: a box, a detection unit, a temperature control unit, and a drive unit. The fully automatic thrombus detector provided by the utility model can simulate the human blood circulation environment and human blood temperature to perform thrombus formation tests on medical devices or materials in vitro.

[0028] The specific design of each structure is as follows: Figure 4 As shown, the driving device 10 drives the lifting and rotation of the rotating device 11 through the driving shaft 15. Preferably, it also includes a lifting unit 16, which is connected to the rotating device through the driving shaft 15 and is used to adjust the lifting of the rotating device 11.

[0029] like Figure 3 As shown, the detection unit 2 includes a rotating device 11, a fixing device 12, and a detection ring 14; the rotating device 11 rotates under the drive of the driving device 10, and a rotating device includes at least one fixing device 12, and the fixing device 12 includes at least one fixing position 13. The size of the fixing position 13 has various specifications to adapt to detection rings 14 of different sizes.

[0030] like Figure 1 As shown, the control unit 16 is used to control the operation of the driving unit 10 and the temperature control unit 3, and is preferably a computer. The temperature control unit 3 includes a water bath and a heating device. The temperature control unit adopts a water bath heating method to prevent the temperature from being inaccurate and uncontrollable due to direct heating. The heating device 6 is arranged on the bottom of the water bath. The control unit can adjust the temperature of the water bath and can simulate the temperature of human blood. The water bath heating has high temperature control accuracy, more reliable performance, and strong anti-interference ability.

[0031] In such Figure 1-4 In one embodiment shown, the housing 1 includes a main switch 4 , a handle 7 , a digital display device 8 , a drain port 9 , a drive unit 10 and a lifting unit 16 .

[0032] The main switch 4 is used to control the start and stop of the fully automatic thrombus detector. The handle 7 provides convenience for moving the fully automatic thrombus detector. The digital display device 8 can display the rotation speed of the detection ring and the liquid temperature in the water bath, which is convenient for real-time monitoring of the rotation speed and temperature. The drain port 9 is convenient for draining the water in the water bath.

[0033] A rotating device 11 includes three fixing devices 12, and the fixing device 12 is a rectangular metal sheet, and the metal sheet is provided with a plurality of fixing positions 13 in the shape of grooves of different sizes and specifications. The three fixing devices are fixed on the rotating disk 11 in a triangular shape. The material of the detection ring 14 is polyethylene. In the actual test process, the main switch 4 of the device is first turned on, and clean water is injected into the water bath, and the heating temperature is set to 37°C. The stent coated with the anticoagulant coating is placed in a polyethylene detection ring 14 of appropriate size, and 1 ml of venous blood is injected into the polyethylene detection ring 14. Both ends of the polyethylene detection ring 14 are tightly plugged with organic glass sleeves. Then the polyethylene detection ring 14 is placed on the groove fixing position 13 of appropriate size to ensure that the detection ring 14 will not fall off from the fixing position 13 during the rotation process. When the temperature on the digital display device 8 stably displays 37°C, the drive unit 10 drives the rotating device 11 to move downward through the drive shaft 15 until the entire detection ring is immersed in the clean water, and the speed and duration required for the detection are set. After the test of the set duration is completed, the drain port is opened to drain the clean water in the water bath. The polyethylene detection ring 14 on the fixed position 13 is removed, the glass sleeves at both ends of the polyethylene detection ring 14 are removed, and the stent coated with the anticoagulant coating is taken out for observation and analysis, and then the performance of the anticoagulant coating is evaluated.

[0034] As mentioned above, the fixing method of the fixing device and the rotating device can be threaded connection, concave-convex matching, snap connection, welding, etc., and of course, they can also be integrally formed. The sealing method of the detection ring can be sealing using a glass sleeve as described above, or it can be sealing with a rubber ring, sealing with an adhesive tape, etc. The number of fixing devices can be one, two, or more. This application does not limit the number and shape of the fixing devices and fixing positions, as long as the detection ring can be fixed.

[0035] In the digital display device, the digital display of temperature can be realized by a temperature sensor, such as a platinum resistor, a thermocouple, a semiconductor, a thermistor, etc. The digital display of speed can be realized by a module circuit, etc., such as the digital tachometer described in CN218938297U.

[0036] The up and down movement of the lifting unit can be achieved by motor-driven hydraulic or mechanical devices.

[0037] In a possible implementation, the lifting unit may not be provided, and the detection ring is fixed to a fixed position when the liquid in the water bath is heated to human body temperature.

[0038] As shown in FIG5 , the embodiment of the utility model further provides a fully automatic thrombus detector testing method, comprising:

[0039] Step S1, placing the material to be tested in a testing ring of suitable size;

[0040] Step S2, turn on the main switch of the device and set the detection temperature through the control unit;

[0041] Step S3, inject 1 mL of venous blood into the detection ring, seal the detection ring, put it into a fixed position, set the speed and detection time through the control unit, and start the detection;

[0042] Step S4: After the test is completed, the material in the test ring is taken out and the thrombus situation is analyzed.

[0043] The above embodiment only expresses one implementation method of the utility model, and its description is relatively specific and detailed, but it cannot be understood as limiting the scope of the utility model patent. It should be pointed out that for ordinary technicians in this field, several modifications and improvements can be made without departing from the concept of the utility model, which all belong to the protection scope of the utility model. Therefore, the protection scope of the utility model patent shall be based on the attached claims.

Claims

1. A fully automatic thrombus detector, characterized in that: include: Box; The detection unit comprises a rotating device, a fixing device and a detection ring, wherein the detection ring is used to contain blood and a sample to be tested, the fixing device is used to fix the detection ring, and the fixing device is installed on the rotating device; A temperature control unit, comprising a water bath and a heating device, wherein the heating device is used to heat the liquid in the water bath; The driving unit is connected to the rotating device via a driving shaft, and is used to drive the rotating device to rotate, thereby driving the detection ring to rotate.

2. The fully automatic thrombus detector according to claim 1, characterized in that: The temperature control unit may be provided with a heating device to enable the liquid in the water bath to reach or maintain a specific temperature.

3. The fully automatic thrombus detector according to claim 2, characterized in that: The specific temperature is human body temperature.

4. The fully automatic thrombus detector according to claim 1, characterized in that: One of the rotating devices is connected to one, two or more fixing devices.

5. The fully automatic thrombus detector according to claim 1 or 4, characterized in that: The fixing device comprises at least one fixing position for fixing the detection ring.

6. The fully automatic thrombus detector according to claim 5, characterized in that: The fixing position has one or more sizes and is adapted to one or more sizes of detection rings.

7. The fully automatic thrombus detector according to claim 1, characterized in that: The detection ring is made of chemically inert materials, including any one of fluoroplastics, quartz glass, borosilicate glass, polytetrafluoroethylene, polyethylene, polyvinyl chloride, polypropylene, and polyether polyurethane.

8. The fully automatic thrombus detector according to claim 1, characterized in that: It also includes a lifting unit, which is connected to the rotating device through a driving shaft to adjust the lifting of the rotating device.

9. The fully automatic thrombus detector according to claim 8, characterized in that: The up and down movement of the lifting unit is achieved by driving a hydraulic or mechanical device through a driving unit.

10. The fully automatic thrombus detector according to claim 1 or 9, characterized in that: The driving unit is a motor.

11. The fully automatic thrombus detector according to claim 1, characterized in that: It also includes a digital display device, which can display the rotation speed of the rotating device and the temperature in the water bath, so as to facilitate real-time monitoring of the rotation speed and temperature.

12. The fully automatic thrombus detector according to claim 1, characterized in that: The digital display of the rotation speed of the rotating device is realized by a module circuit, and the digital display of the temperature in the water bath is realized by a temperature sensor.

13. The fully automatic thrombus detector according to claim 1, characterized in that: It also includes a control unit, which is used to control the detection time, control the operation of the driving unit and the temperature control unit.

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