A miniaturized multi-station thromboelastography instrument

Abstract

This invention relates to the field of coagulation testing technology, and more specifically, to a miniaturized multi-station thromboelastography (TEG) instrument. The invention discloses a miniaturized multi-station thromboelastography (TEG) instrument, comprising: a base plate, N blood storage devices, N pressure rods, a lifting device, and a measuring device. The invention uses the lifting device to reciprocately compress the blood samples to be tested via the pressure rods. The blood samples act on a magnetic sensor, generating an induced current in the coil and reflecting the magnitude of the thromboelastic force in real time, thus reflecting the entire process of blood coagulation and fibrinolysis. The invention has a simple structure and is easy to manufacture; moreover, some components can be reused, avoiding unnecessary waste. The multi-station design of this invention allows for multiple tests with a single instrument, while each blood sample does not interfere with others, thereby achieving miniaturization of the thromboelastography instrument. This invention solves the problem that existing thromboelastography instruments have complex structures and cannot simultaneously test multiple blood samples.

Description

Technical Field

[0001] This invention relates to the field of coagulation detection technology, and more specifically, to a miniaturized multi-station thromboelastography instrument. Background Technology

[0002] Thromboelastography is an effective measurement instrument for assessing coagulation mechanisms in clinical patients.

[0003] Traditional thromboelastography (TEG) systems are generally based on capacitive sensors, optical sensors, and magnetic bead sensors. However, TEG systems based on these principles are complex in construction, expensive, and not easily adopted by small and medium-sized hospitals. Furthermore, current TEG systems are designed for one-time testing, and cannot simultaneously test multiple blood samples. Summary of the Invention

[0004] Therefore, it is necessary to provide a miniaturized, multi-station thromboelastography instrument to address the problems of existing thromboelastography instruments having complex structures and being unable to detect multiple blood samples simultaneously.

[0005] This invention is achieved using the following technical solution:

[0006] This invention discloses a miniaturized multi-station thromboelastography instrument, comprising: a base plate, N blood storage devices, N pressure rods, a lifting device, and a measuring device.

[0007] N blood storage devices are distributed on a base plate, where N ≥ 2. Each blood storage device includes a base, a shell, and a connecting assembly. The base is connected to the base plate; a permanent magnet containing a coil is disposed inside the base; the connecting assembly is used to detachably connect the shell to the base; the shell includes a cup and a magnetic sensor; one end of the cup has an opening for adding blood to be tested; the other end of the cup has a magnetic sensor for sensing the pressure from the blood and, in conjunction with the permanent magnet, causing the coil to generate an induced current. N pressure rods are arranged one-to-one with the N blood storage devices. The pressure rods extend into the cup from the opening. A lifting device is connected to the N pressure rods to simultaneously reciprocate and compress the blood to be tested, which then acts on the N magnetic sensors. A measuring device is connected to the N coils to acquire the generated N induced currents and process them into N thromboelastography maps.

[0008] As a further embodiment of the present invention, the base includes: a base and a positioning plate. A first groove is provided on the side of the base facing the housing. The positioning plate is provided on the side of the base facing the housing. A second groove is provided on the side of the positioning plate facing the base. The base and the positioning plate are integrated, so that the first groove and the second groove form a cavity for accommodating the permanent magnet.

[0009] As a further embodiment of the present invention, the positioning plate and the base are provided with corresponding positioning holes and are connected as one unit by locking screws.

[0010] As a further embodiment of the present invention, the connecting assembly includes a male buckle and a female buckle. The male buckle is located at the other end of the cup body and supports the magnetic sensor from its outer edge. The female buckle is located on the side of the positioning piece facing the housing. The female buckle has a connecting hole, into which the male buckle snaps and is detachably connected to the female buckle.

[0011] As a further aspect of the present invention, the male buckle is provided with a slot on its side, and the connecting hole is provided with a retractable locking block. The female buckle is provided with a spring switch to control the extension and retraction of the locking block, and thus cooperate with the slot to realize the detachable connection between the male and female buckles.

[0012] As a further aspect of the invention, a mounting groove is provided on the side of the buckle facing the housing for placing the magnetic sensor. The other end of the cup body presses the magnetic sensor into the mounting groove via a washer; a through hole is provided in the center of the mounting groove to provide space for the deformation of the magnetic sensor.

[0013] As a further embodiment of the present invention, a second through hole is provided on the side of the positioning piece facing the housing, and the second through hole communicates with the second groove.

[0014] As a further embodiment of the present invention, the end of the pressure rod that extends into the cup body is convex spherical, and the gap between its maximum diameter and the inner wall of the cup body is 1 to 1.5 mm.

[0015] As a further embodiment of the present invention, the lifting device includes: a connecting frame and a controllable telescopic component. The connecting frame is connected to the ends of the N pressure rods furthest from the cup body. One end of the controllable telescopic component is fixed to the base plate, and the other end is connected to the connecting frame, for driving the N pressure rods to move synchronously via the connecting frame.

[0016] As a further embodiment of the present invention, the miniaturized multi-station thromboelastography instrument also includes an outer cover, which is detachably fastened to the base plate and covers N blood storage devices, N pressure rods, and lifting devices.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] 1. This invention is based on the cooperation of a magnetic sensor and a permanent magnet containing a coil. The lifting device carries the pressure rod to reciprocate to squeeze the blood to be tested. The blood to be tested acts on the magnetic sensor, generating an induced current in the coil and reflecting the magnitude of the thrombus elasticity in real time, thereby reflecting the entire process of blood coagulation and fibrinolysis.

[0019] 2. The present invention has a simple structure and is easy to process. By cooperating with a magnetic sensor and a permanent magnet containing a coil, the magnitude of thromboelastography is converted into the magnitude of induced current amplitude in real time, thereby simplifying circuit processing and reducing the manufacturing cost of the entire thromboelastography instrument. Furthermore, some components of the present invention can be reused, avoiding unnecessary waste.

[0020] 3. The multi-station design of this invention can perform multiple tests on one machine, while each blood sample does not interfere with each other, thereby realizing the miniaturization of the thromboelastography instrument, which can improve the efficiency of thrombosis detection and its popularity in small and medium-sized hospitals. Attached Figure Description

[0021] Figure 1 This is a structural diagram of a miniaturized multi-station thromboelastography instrument according to the present invention;

[0022] Figure 2 for Figure 1 Partial exploded view;

[0023] Figure 3 for Figure 2 A fully exploded view of the blood storage device in China;

[0024] Figure 4 for Figure 1 The process of coagulation testing using a thromboelastography instrument.

[0025] The attached diagram lists the components represented by each number as follows:

[0026] 10. Outer cover; 20. Pressure rod; 30. Blood storage device; 31. Cup body; 32. Washer; 33. Magnetic sensor; 34. Female buckle; 35. Female buckle; 351. Spring switch; 36. Positioning piece; 37. Permanent magnet; 38. Base; 40. Base plate. Detailed Implementation

[0027] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0028] It should be noted that when a component is said to be "installed on" another component, it can be directly on the other component or it may be in a component that is centered on it. When a component is said to be "set on" another component, it can be directly set on the other component or it may also be in a component that is centered on it. When a component is said to be "fixed to" another component, it can be directly fixed to the other component or it may also be in a component that is centered on it.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the specification of this invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "or / and" as used herein includes any and all combinations of one or more of the associated listed items.

[0030] Example 1

[0031] Please see Figure 1 , Figure 1 This is a structural diagram of a miniaturized, multi-station thromboelastography instrument. See also... Figure 2 ,for Figure 1 Partial exploded view. The miniaturized multi-station thromboelastography instrument includes: a base plate 40, N blood storage devices 30, N pressure rods 20, a lifting device, and a measuring device (not shown). N ≥ 2 to ensure multi-station coagulation testing.

[0032] like Figure 1 As shown, an outer cover 10 can be added to the base plate 40. The outer cover 10 can be arched or cylindrical. The outer cover 10 is detachably fastened to the base plate 40, thereby covering the N blood storage devices 30, N pressure rods 20, and lifting device, isolating the internal blood from the external environment during coagulation testing to avoid interference. Of course, an insulation layer can also be applied to the interlayer or outer wall of the outer shell to improve the insulation effect and make the internal temperature more stable.

[0033] Regarding the blood storage device 30: The blood storage device 30 is the core of this invention. N blood storage devices 30 are distributed on the base plate 40. Naturally, the more N there are, the larger the space occupied, and the larger the overall size of the thromboelastography instrument. For the sake of miniaturization, the number of N is preferably no more than 10. See [reference needed] Figure 2 In this embodiment 1, N is 6, and it is evenly distributed circumferentially on the base plate 40.

[0034] See Figure 3 The blood storage device 30 includes a base, a housing, and connecting components.

[0035] First, let's look at the base. The base is connected to the base plate 40. A permanent magnet 37 containing a coil is installed inside the base. Generally, the base is designed as a hollow structure with an internal cavity for storing the permanent magnet 37. In this embodiment 1, for ease of assembly, the base is processed into two parts: a base 38 and a positioning plate 36. The side of the base 38 facing the housing has a groove 1. The positioning plate 36 is located on the side of the base 38 facing the housing. The side of the positioning plate 36 facing the base 38 has a groove 2. The positioning plate 36 and the base 38 have corresponding positioning holes and are connected as one unit by locking screws. Thus, the base 38 and the positioning plate 36 fit together as one unit, with groove 1 and groove 2 forming a cavity for accommodating the permanent magnet 37. The permanent magnet 37 can be made of AlNiCo, permanent magnet ferrite, SmCo 1:5 type (SmCo5), or SmCo 2:17 type (Sm2Co). 17 ), sintered Nd2Fe 14 B) Bonded NdFeB (Nd2Fe) 14 B) One of the following: rubber magnets. The thickness of the permanent magnet 37 is 3-5 mm, or may be appropriately increased or decreased depending on the actual situation. Several coils (not shown) are provided on one side or inside the permanent magnet 37 to generate induced current. See also Figure 3 The coil can be installed in the groove and held in place by the permanent magnet 37. The coil can be configured using a winding method similar to that of a magnetic levitation coil.

[0036] Next, let's look at the housing. The housing includes a cup body 31 and a magnetic sensor 33. One end of the cup body 31 has an opening for adding the blood to be tested. The other end of the cup body 31 has a magnetic sensor 33, which is used to sense the pressure from the blood and cooperate with the permanent magnet 37 to generate an induced current in the coil.

[0037] The cup body 31 is recommended to be made of a rigid material that is blood-reactive—it will neither promote nor hinder blood clotting.

[0038] The other end of the cup body 31 also has an opening, but it is sealed by the magnetic sensor 33. The magnetic sensor 33 is a flexible magnetic thin-film sensor, made of a blood-reactive material, with a thickness of 100-300 μm. Specifically, the magnetic sensor 33 is made of a flexible and magnetic thin-film material, obtained by adding magnetic materials to the thin-film sensor material. The thin-film sensor material can be one of silicone, polydimethylsiloxane, or thermoplastic polyurethane elastomer. The magnetic material can be an alloy permanent magnet material, such as rare earth permanent magnet material (neodymium iron boron Nd2Fe). 14 B) Samarium cobalt (SmCo, SmCo5 and Sm2Co) 17It can be one of the following: AlNiCo powder, or one of silicon steel, permalloy, iron-based, iron-nickel-based, cobalt-based amorphous alloys, and iron-based nanocrystalline alloys.

[0039] Let's continue with the connecting components. These components allow for a detachable connection between the housing and the base. This allows the base to serve as a long-term, secure fixture. The housing is designed for single-use only, depending on the intended use: if single-use, simply remove the used housing and replace it with a new one after each use; if you wish to reuse the housing, remove the used housing, clean it using ultrasonic or rapid rinsing, allow it to dry, and then reinstall it.

[0040] In this embodiment 1, the connecting assembly adopts a snap-fit ​​design, including a male snap-fit ​​34 and a female snap-fit ​​35. The male snap-fit ​​34 is fixed to the other end of the cup body 31 and supports the magnetic sensor 33 from its outer edge. The side of the male snap-fit ​​34 facing the housing has a mounting groove for placing the magnetic sensor 33. The other end of the cup body 31 is pressed into the mounting groove by a washer 32. (See reference...) Figure 2 A clip is machined at the other end of the cup body 31. The clip engages with the mounting groove and presses down on the magnetic sensor 33 via a washer 32. This achieves both the fixation of the magnetic sensor 33 and the sealing of the other end of the cup body 31. Furthermore, a through hole is machined in the center of the mounting groove to provide space for the magnetic sensor 33 to deform; that is, the magnetic sensor 33 can deform through the through hole under the pressure of incoming blood. A female buckle 35 is fixed to the side of the positioning piece 36 facing the housing. The female buckle 35 has a connecting hole, into which a male buckle 34 engages and is detachably connected to the female buckle 35.

[0041] In addition, the side of the positioning piece 36 facing the housing has a through hole 2, which is connected to the groove 2, thus providing more space for the magnetic sensor 33 to deform.

[0042] In general, there is a certain gap between the magnetic sensor 33 and the base, with the distance controlled at 5-8mm, to ensure that the deformation of the magnetic sensor 33 is not hindered.

[0043] To improve the reliability of the connection between the male and female buckles 35, a slot can be machined on the side of the female buckle 34, and a retractable locking block is provided on the inner ring of the connection hole. A spring-loaded switch 351 is provided on the female buckle 35 to control the extension and retraction of the locking block, which then engages with the slot to achieve a detachable connection between the female buckle 34 and the female buckle 35. Specifically, pressing the spring-loaded switch 351 retracts the locking block into the inner ring of the connection hole, allowing the female buckle 34 and the female buckle 35 to disengage; releasing the spring-loaded switch 351 causes the locking block to automatically pop out, engaging with the slot and locking the female buckle 34 within the connection hole.

[0044] For the lever 20: N levers 20 are set up one-to-one with N blood storage devices 30. The lever 20 extends into the cup body 31 from the opening of the cup body 31.

[0045] For the lifting device: the lifting device is connected to N pressure rods 20, which are used to drive the N pressure rods 20 to reciprocate and squeeze the blood to be tested simultaneously, and the blood to be tested acts on N magnetic sensors 33. Of course, the material of the pressure rods 20 is also blood-inert – it will not promote blood coagulation, nor will it hinder blood coagulation.

[0046] The lifting device includes a connecting frame and a controllable telescopic component. The connecting frame is connected to the ends of the N pressure rods 20 furthest from the cup body 31. One end of the controllable telescopic component is fixed to the base plate 40, and the other end is connected to the connecting frame, used to drive the N pressure rods 20 to move synchronously through the connecting frame. The controllable telescopic component can be an electric push rod, an electric telescopic rod, etc. In this embodiment 1, the controllable telescopic component is located at the center of the base plate 40, between the six blood storage devices 30. The connecting frame is in the shape of an inverted "*", with its six ends connected to the six pressure rods 20 respectively. The controllable telescopic component can be set to a constant pressure and a constant squeezing distance, and moves up and down reciprocally, thereby driving the pressure rods 20 to squeeze the blood in the cup. It should be noted that the squeezing depth of the controllable telescopic component cannot exceed the threshold to avoid excessive squeezing causing damage to the magnetic sensor 33 and blood overflowing from the cup body 31. Of course, see Figure 2 Alternatively, a limiting plate can be set at the end of the pressure rod 20 away from the cup body 31. When the pressure rod 20 extends downward into the cup body 31, the limiting plate can lock the opening of the cup body 31 to restrict it and prevent the pressure rod 20 from moving down excessively.

[0047] The end of the pressure rod 20 that extends into the cup body 31 is convex spherical, and the gap between its maximum diameter and the inner wall of the cup body 31 is 1 to 1.5 mm. When the convex spherical end squeezes the blood, if the blood is liquid, it can easily rise through this gap, but if the blood is solid, it becomes more difficult to rise through this gap.

[0048] Therefore, by applying pressure to the blood using the pressure rod 20, the process of the blood changing from a liquid state to a solid state and then back to a liquid state will, in turn, affect the change in distance between the magnetic sensor 33 and the permanent magnet 37. The magnetic sensor 33 itself also has a magnetic field; the deformation of the magnetic sensor 33 will affect the magnetic field of the permanent magnet 37, causing a change in the magnetic field of the permanent magnet 37, which in turn induces a current in the coil. Based on this characteristic, the state of the blood can be reflected.

[0049] With N blood storage devices (30 units) and N pressure levers (20 units) operating simultaneously, synchronous coagulation testing can be achieved at N workstations. For details, please refer to... Figure 4 This shows the four status states of a coagulation test at one of the workstations as time progresses:

[0050] After the blood to be tested is added to the cup 31, the lever 20 is still in the high position and the blood has not been squeezed. Set this as the initial state, that is, the position shown in (i).

[0051] The lifting device, according to the set parameters, uses the pressure rod 20 to reciprocate and squeeze the blood, capturing one state point, as shown in position (ii). The convex spherical end contacts the blood, and the blood is squeezed; however, since the blood is still in a liquid state at this time, it can rise through the gap between the convex spherical end and the inner wall of the cup 31. Therefore, although the bottom magnetic sensor 33 has deformation, the deformation is not large, that is, the distance between the magnetic sensor 33 and the permanent magnet 37 is small, and the induced current generated is also small.

[0052] As time progresses, the blood gradually coagulates from a liquid state to a solid state. The lifting device, still using the same set parameters, repeatedly compresses the blood with the pressure rod 20, capturing one state point, as shown in position (iii). Similar to (ii), the convex spherical end contacts the blood, and the blood is compressed. Unlike (ii), because the blood is solid, it can no longer rise through the gap; although the pressure on the magnetic sensor 33 remains unchanged, the inability of the blood to rise causes the deformation of the magnetic sensor 33 to increase, and the distance between the magnetic sensor 33 and the permanent magnet 37 gradually decreases. Thus, as the degree of blood solidification reaches its maximum, the distance between the magnetic sensor 33 and the permanent magnet 37 reaches its minimum, causing the induced current to reach its peak.

[0053] As time progresses, the blood begins to fibrinoly dissolve and changes from a solid to a liquid state. The lifting device, still using the same set parameters, repeatedly squeezes the blood with the pressure rod 20, capturing one state point, as shown in position (vi). Similar to (ii), the blood can rise through the gap between the convex spherical end and the inner wall of the cup 31; therefore, compared to (iii), the magnetic sensor 33 retracts, its deformation decreases, the distance between the magnetic sensor 33 and the permanent magnet 37 increases, and the induced current decreases.

[0054] Then, return lever 20 to its high position, that is, back to its initial state.

[0055] Thus, the blood undergoes the entire process of changing from a liquid state to a solid state and then fibrinoly back to a liquid state. The induced current generated corresponds to this process, and the magnitude of the induced current reflects the magnitude of the thrombus elasticity in real time, which can be used to diagnose the patient's blood condition.

[0056] For the measuring device: The measuring device is connected to N coils to acquire the N induced currents generated and process them into N thromboelastography maps. The measuring device includes a data acquisition module and a processing module. The data acquisition module is used to acquire the induced currents generated by the N coils and transmit the N induced currents to the processing module. The processing module can be a host computer such as an industrial control computer, which processes the N induced currents into N thromboelastography maps.

[0057] In addition, the blood needs to be kept at a constant temperature during coagulation testing: for example, by placing the thromboelastography instrument in a constant temperature environment; or by adding a heat preservation device to the outside of the blood storage device 30; or by applying a heat preservation coating to the outer wall of the cup 31, so as to ensure that the temperature is kept at 37°C during the thromboelastography test.

[0058] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0059] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A miniaturized multi-station thromboelastography instrument, characterized in that, include: Base plate; N A blood storage device is disposed separately on the base plate; N ≥2; The blood storage device includes a base, a shell, and a connecting assembly; the base is connected to a bottom plate; a permanent magnet containing a coil is disposed inside the base; the connecting assembly is used to detachably connect the shell and the base; the shell includes a cup and a magnetic sensor; one end of the cup is provided with an opening for adding blood to be tested into the cup; the other end of the cup is provided with a magnetic sensor for sensing the pressure from the blood to be tested, generating deformation, and cooperating with the permanent magnet to induce a current in the coil; N root compression bar, and its relationship with N Each blood storage device is provided in a corresponding manner; the pressure rod extends into the cup body from the opening of the cup body; there is a gap between the end of the pressure rod extending into the cup body and the inner wall of the cup body; Lifting device, and its relationship with N Root pressure rod connection, used to drive N The pressure bar simultaneously applies reciprocating pressure to the blood being tested, and through the blood being tested, it acts on... N One magnetic sensor; as well as Measuring device, which is related to N A coil is connected to obtain the generated... N An induced current is processed accordingly. N Zhang's thromboelastography.

2. The miniaturized multi-station thromboelastography instrument according to claim 1, characterized in that, The base includes: The base has a groove on the side facing the shell. as well as A positioning piece is provided on the side of the base facing the housing; the side of the positioning piece facing the base is provided with a groove. The base and the positioning plate are integrated into one piece, so that groove one and groove two form a storage cavity to accommodate the permanent magnet.

3. The miniaturized multi-station thromboelastography instrument according to claim 2, characterized in that, The positioning plate and the base are provided with corresponding positioning holes and are connected as one unit by locking screws.

4. The miniaturized multi-station thromboelastography instrument according to claim 1, characterized in that, The connection component includes: The buckle is located at the other end of the cup body and supports the magnetic sensor from the outer edge; as well as The female buckle is located on the side of the positioning piece facing the housing; the female buckle is provided with a connecting hole, and the male buckle is inserted into the connecting hole and detachably connected to the female buckle.

5. The miniaturized multi-station thromboelastography instrument according to claim 4, characterized in that, The male buckle has a slot on its side, and a retractable locking block is provided on the inner ring of the connecting hole; the female buckle has a spring switch to control the extension and retraction of the locking block, and thus cooperate with the slot to realize the detachable connection between the male buckle and the female buckle.

6. The miniaturized multi-station thromboelastography instrument according to claim 4 or 5, characterized in that, The side of the buckle facing the housing has a mounting groove for placing the magnetic sensor; the other end of the cup body presses the magnetic sensor into the mounting groove through a gasket; the center of the mounting groove has a through hole to provide space for the deformation of the magnetic sensor.

7. The miniaturized multi-station thromboelastography instrument according to claim 2, characterized in that, The side of the positioning piece facing the housing has a second through hole, which communicates with the second groove.

8. The miniaturized multi-station thromboelastography instrument according to claim 1, characterized in that, The end of the pressure rod that extends into the cup body is convex spherical, and the gap between its maximum diameter and the inner wall of the cup body is 1~1.5mm.

9. The miniaturized multi-station thromboelastography instrument according to claim 1, characterized in that, The lifting device includes: Connecting bracket, which is with N The end of the pressure bar furthest from the cup body is connected; as well as The controllable telescopic component has one end fixed to the base plate and the other end connected to the connecting frame, and is used to drive the telescopic component through the connecting frame. N The root pressure bar moves synchronously.

10. The miniaturized multi-station thromboelastography instrument according to claim 1, characterized in that, The miniaturized multi-station thromboelastography instrument also includes an outer cover, which is detachably fastened to the base plate, and... N A blood storage device, N The pressure bar and lifting device are covered.

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