Heating needle and method of heating thereof

Abstract

The present application relates to a heating needle and a heating method thereof, wherein the heating needle is applied to an in-vitro diagnostic device and comprises: a tube shell having an accommodation space inside, one end of the tube shell having an interface for connecting an external liquid path system, the other end of the tube shell being provided with a needle tip; a heating tube assembly arranged in the accommodation space, one end of the heating tube assembly being in communication with the interface, the other end of the heating tube assembly being in communication with the needle tip; and a temperature sensor arranged at a position of the heating tube assembly close to the needle tip; wherein the heating tube assembly and the temperature sensor are respectively electrically connected to a temperature control system, and the temperature control system is configured to regulate the heating power of the heating tube assembly based on a temperature sensing signal sensed by the temperature sensor. The heating needle of the present application can heat the reagent to a target temperature during the process of the reagent being sucked and moved to a target position and then being discharged, which is conducive to ensuring the stability of the reagent and improving the detection efficiency of the device.

Description

Technical Field

[0001] This invention relates to the field of in vitro diagnostic equipment, and more specifically, to a heating needle that can be applied to in vitro diagnostic equipment such as fully automated coagulation analyzers, chemiluminescence immunoassay analyzers, and biochemical analyzers. Background Technology

[0002] In in vitro diagnostics (e.g., coagulation tests, biochemical reactions, and immunological reactions), the reaction between reagents and samples is extremely sensitive to temperature and usually needs to be carried out at a constant temperature of 37°C to ensure the stability of reaction kinetics and the accuracy and repeatability of test results.

[0003] Currently, existing in vitro diagnostic equipment typically uses the following two methods to maintain the temperature of reagents before mixing with samples: 1. Reagent compartment / tray preheating involves preheating the entire reagent compartment / tray to 37°C and maintaining a constant temperature before the test. This method exposes reagents (such as clotting factors, enzymes, and antibodies) to a high-temperature environment for an extended period, leading to decreased reagent stability and accelerated activity decay. This significantly shortens the "onboard time" (the duration the reagents can be stably stored on the instrument), increasing the risk and cost of reagent waste, requiring frequent reagent replacements by laboratory personnel, reducing equipment operating efficiency, and potentially impacting clinical diagnosis due to abnormal test results. Furthermore, maintaining a constant temperature in the reagent compartment / tray requires a continuous large amount of energy, increasing testing costs, and the transition from a cooled state (the state of reagents in standby storage) to a heated state (the state of reagents during testing) is slow, making it difficult to quickly enter the testing state.

[0004] 2. Precise energy input involves real-time monitoring of reagent temperature, ambient temperature, and tubing system liquid temperature. A fuzzy algorithm and PID algorithm are used, combined with the sample volume, to calculate the required heating energy for the reagent and compensate for heat loss due to reagent heating. In this approach, if a "heating wait" mode is used, the reagent needs to be heated to above 37°C to store more heat energy; however, excessively high reagent temperatures may lead to reagent inactivation, affecting test results. If a "preheating-heating wait" mode is used, it requires waiting for the reagent in the needle to rise to the target temperature after each aspiration, significantly extending the sample dispensing time and affecting equipment detection efficiency. Furthermore, equipment using this method has a complex mechanical structure, high manufacturing costs, and cumbersome production processes. Precise energy input also relies on multi-parameter temperature calibration, resulting in high algorithm complexity and difficulty in guaranteeing reliability.

[0005] In summary, existing in vitro diagnostic equipment cannot achieve a good balance between ensuring reagent stability, maintaining high detection efficiency, and controlling system complexity and cost in the process of ensuring the temperature before reagents and samples are mixed. Therefore, improvements are necessary.

[0006] The information included in the background section of this invention is intended only to enhance the understanding of the overall background of the invention and should not be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art. Summary of the Invention

[0007] The purpose of this invention is to provide a heating needle that can be used in in vitro diagnostic equipment and can heat the reagent to the target temperature during the process of the reagent being drawn up, moved to the target position and then ejected. This helps to ensure the stability of the reagent and improve the detection efficiency of the equipment. In addition, it has a simple structure, low cost and high reliability.

[0008] To achieve the above objectives, the present invention provides a heated needle, which is applied to an in vitro diagnostic device and may include: a tube shell having an internal receiving space, one end of the tube shell having an interface for connecting to an external fluid system, and the other end of the tube shell having a needle tip; a heated tube assembly disposed in the receiving space, one end of the heated tube assembly communicating with the interface, and the other end of the heated tube assembly communicating with the needle tip; and a temperature sensor disposed on the heated tube assembly near the needle tip; wherein the heated tube assembly and the temperature sensor are electrically connected to a temperature control system, and the temperature control system is configured to adjust the heating power of the heated tube assembly based on the temperature sensing signal sensed by the temperature sensor.

[0009] According to an exemplary embodiment of the present invention, the heating tube assembly includes a tube body and a heating element, the heating element being disposed on the outer wall of the tube body and electrically connected to a temperature control system; the temperature sensor sending the sensed temperature sensing signal to the temperature control system; the temperature control system, based on the received temperature sensing signal, adjusting the duty cycle of the heating element through pulse width modulation technology, or continuously adjusting the current and / or voltage of the heating element through a PID algorithm, thereby adjusting the heating power of the heating element.

[0010] According to an exemplary embodiment of the present invention, the heating tube assembly further includes a copper foil covering the outer wall of the tube body.

[0011] According to an exemplary embodiment of the present invention, the heating element is configured as a heating wire, which is wound around the surface of the copper foil; the temperature control system regulates the heating power of the heating wire by adjusting the duty cycle of the heating wire through pulse width modulation technology, or by continuously adjusting the current and / or voltage of the heating wire through a PID algorithm.

[0012] According to an exemplary embodiment of the present invention, the outer casing includes an upper casing and a lower casing, the outer diameter of the upper casing is larger than the outer diameter of the lower casing, the upper casing defines a first receiving space, and the lower casing defines a second receiving space, the first receiving space and the second receiving space together constitute the receiving space.

[0013] According to an exemplary embodiment of the present invention, the tube body includes a first tube body and a second tube body that are interconnected, the first tube body being located in the first accommodating space and communicating with the interface, the second tube body being located in the second accommodating space and communicating with the needle tip, and the diameter of the first tube body being larger than the diameter of the second tube body to accommodate more liquid.

[0014] According to an exemplary embodiment of the present invention, a tapered transition zone is provided at the connection between the first tube and the second tube, wherein the inner diameter of the tapered transition zone gradually decreases from the first tube to the second tube to form a smooth tapered transition.

[0015] According to an exemplary embodiment of the present invention, the copper foil is wrapped around the outer wall of the first tube.

[0016] According to an exemplary embodiment of the present invention, the tube body is made of a material with a thermal conductivity higher than 15 W / (m·K) and biological inertness.

[0017] This invention also provides a heating method for a heating needle, comprising: a tube preheating step: setting a target temperature in advance, and controlling the heating element of the heating tube assembly to heat it with a predetermined heating power by a temperature control system; a liquid aspiration and first heating step: allowing liquid to flow through the needle tip through the second tube of the heating tube assembly and into the first tube by an external liquid circuit system, and the liquid being first heated by the second tube during its flow through the second tube; a liquid second heating step: allowing the liquid flowing into the first tube to remain in the first tube for a predetermined time, and being second heated by the first tube; and a liquid third heating and dispensing step: allowing the liquid that has remained in the first tube for the predetermined time to be dispensing from the first tube by an external liquid circuit system. The liquid flows through a second tube and exits through a needle tip, and is heated a third time by the second tube during its flow. Temperature sensing step: A temperature sensor senses the temperature of the liquid after the third heating in the second tube and sends the sensed temperature signal to a temperature control system. Temperature regulation step: Based on the received temperature signal, the temperature control system regulates the duty cycle of the heating element using pulse width modulation technology, or continuously regulates the current and / or voltage of the heating element using a PID algorithm, to regulate the heating power of the heating tube assembly. The heating tube assembly is located within the housing space inside the tube shell, and the temperature sensor is positioned near the needle tip in the second tube.

[0018] According to an exemplary embodiment of the present invention, in a heating method, in a second heating step of the liquid, the predetermined time for the liquid to remain in the first tube is the time for the pipetting device to move the heating needle to the target position.

[0019] The heating needle of this invention heats the reagent to the target temperature during the process of the reagent being drawn up, moved to the target location, and then ejected. This avoids the need for heating and waiting before the reagent is mixed with the sample, or for preheating the entire reagent chamber / tray, which helps ensure the stability of the reagent and improves the detection efficiency of the equipment. In addition, the heating needle of this invention has a simple structure, low cost, and high reliability.

[0020] The methods and apparatus of the present invention have other features and advantages that will be apparent from or will be set forth in detail in the accompanying drawings and subsequent embodiments incorporated herein, which together serve to explain the particular principles of the invention. Attached Figure Description

[0021] The above and other aspects, features, and advantages of the invention will become clearer from the detailed description presented thereafter in conjunction with the accompanying drawings, wherein: Figure 1 This is a three-dimensional schematic diagram of a heating needle according to an exemplary embodiment of the present invention.

[0022] Figure 2 This is a cross-sectional view of a heating needle according to an exemplary embodiment of the present invention.

[0023] Figure 3 This is a partial cross-sectional view of a heating needle according to an exemplary embodiment of the present invention.

[0024] Figure 4 This is another partial cross-sectional view of a heating needle according to an exemplary embodiment of the present invention.

[0025] Figure 5 A block diagram illustrating the configuration of a heating needle according to an exemplary embodiment of the present invention.

[0026] Figure 6 A flowchart illustrating a heating method for a heating needle according to an exemplary embodiment of the present invention is provided.

[0027] Explanation of reference numerals in the attached figures: 100: Tube outer casing 110: Interface; 120: Pin tip 130: Upper shell 140: Lower shell 150: First containment space; 160: Second containment space 200: Heating tube assembly 210: Pipe body 211: First pipe body 212: Second tube body; 220: Heating element 230: Copper foil 240: Conical transition zone 300: Temperature sensor 400: Temperature control system.

[0028] It should be understood that the accompanying drawings are not necessarily drawn to scale, but rather present simplified representations of various features to illustrate the basic principles of the invention. Specific design features disclosed in this invention (including, for example, specific dimensions, orientations, positions, and shapes) will be determined in part by the specific environment in which they are intended for application and use.

[0029] Throughout these figures, the same reference numerals denote the same or equivalent parts of the invention. Detailed Implementation

[0030] Reference will now be made in detail to various embodiments of the invention, examples of which are shown in the accompanying drawings and described below. Although the invention will be described in conjunction with exemplary embodiments thereof, it will be understood that this specification is not intended to limit the invention to those exemplary embodiments. On the contrary, the invention is intended to cover not only the exemplary embodiments thereof, but also various alternatives, modifications, equivalents, and other embodiments included within the spirit and scope of the invention as defined in the appended claims.

[0031] The specific structural and functional descriptions of the embodiments of the present invention disclosed herein are for illustrative purposes only. The present invention can be implemented in many different forms without departing from its spirit and essential features. Therefore, the embodiments of the present invention are disclosed for illustrative purposes only and should not be construed as limiting the invention.

[0032] Although the terms "first," "second," etc., may be used herein to describe various elements, these elements should not be limited by these terms. These terms are used only to distinguish one element from another. For example, without departing from the teachings of the invention, the first element discussed below may be referred to as the second element. Similarly, the second element may also be referred to as the first element.

[0033] Certain terms are used throughout the application documents of this invention to refer to specific system components. As those skilled in the art will recognize, the same components can often be referred to by different names, and therefore the application documents of this invention are not intended to distinguish those components that differ only in name and not in function. In the document documents of this invention, the terms “comprising,” “including,” and “having” are used in an open form and should therefore be interpreted as meaning “including but not limited to…”.

[0034] In the following, exemplary embodiments of the invention will be described in more detail with reference to the accompanying drawings.

[0035] Figure 1 This is a three-dimensional schematic diagram of a heating needle according to an exemplary embodiment of the present invention. Figure 2 This is a cross-sectional view of a heating needle according to an exemplary embodiment of the present invention. Figure 3 This is a partial cross-sectional view of a heating needle according to an exemplary embodiment of the present invention. Figure 4 This is another partial cross-sectional view of a heating needle according to an exemplary embodiment of the present invention. Figure 5 A block diagram illustrating the configuration of a heating needle according to an exemplary embodiment of the present invention.

[0036] This invention relates to a heated needle that can be applied to in vitro diagnostic devices such as fully automated coagulation analyzers, chemiluminescence immunoassay analyzers, and biochemical analyzers. These in vitro diagnostic devices include temperature control systems, external fluid systems, and other auxiliary equipment (e.g., pipetting devices). [Reference] Figure 1 , Figure 2 and Figure 5 As shown, the heating needle of the present invention may include: a tube shell 100, a heating tube assembly 200, and a temperature sensor 300. The tube shell 100 has an internal accommodating space, one end of the tube shell 100 has an interface 110 for connecting to an external liquid circuit system, and the other end of the tube shell 100 is provided with a needle tip 120. The heating tube assembly 200 is disposed in the accommodating space inside the tube shell 100. The heating tube assembly 200 has an internal accommodating cavity. One end of the heating tube assembly 200 is connected to the interface 110, and the other end of the heating tube assembly 200 is connected to the needle tip 120. The temperature sensor 300 is disposed on the heating tube assembly 200 near the needle tip 120. The heating tube assembly 200 and the temperature sensor 300 are electrically connected to a temperature control system 400, which is configured to regulate the heating power of the heating tube assembly 200 based on the temperature sensing signal sensed by the temperature sensor 300.

[0037] In applying the heating needle of this invention to an in vitro diagnostic device, the heating needle needs to be moved to the position corresponding to the reagent compartment / tray where the liquid to be tested is stored using a pipetting device (not shown). An external fluid system is used to create a negative pressure state in the internal cavity of the heating tube assembly 200. Under this negative pressure, the liquid is drawn into the internal cavity of the heating tube assembly 200 through the needle tip 120 and heated by the heating tube assembly 200. Subsequently, the heating needle is moved to the position corresponding to the sample to be tested using a pipetting device. During this process, the liquid remains in the internal cavity of the heating tube assembly 200 for a predetermined time and is heated by the heating tube assembly 200. Finally, the heating needle of this invention creates a positive pressure state in the internal cavity of the heating tube assembly 200 through the external fluid system. Under this positive pressure, the liquid is expelled through the needle tip 120 and mixed with the sample for reaction. In the above process, since the temperature sensor 300 is located near the needle tip 120 of the heating tube assembly 200, the temperature sensed by the temperature sensor 300 when the liquid is expelled is the temperature at which the liquid mixes with the sample.

[0038] Further, refer to Figure 2 and Figure 5 As shown, the heating tube assembly 200 may include a tube body 210 and a heating element 220. The tube body 210 has the aforementioned internal receiving cavity, and the heating element 220 is disposed on the outer wall of the tube body and electrically connected to the temperature control system 400. The temperature sensor 300 can sense the temperature of the tube body 210 in real time and send the sensed temperature sensing signal to the temperature control system 400. Based on the received temperature sensing signal, the temperature control system 400 regulates the heating power of the heating element 220 by adjusting the duty cycle of the heating time of the heating element 220 through pulse width modulation (PWM) technology, or by continuously adjusting the current and / or voltage of the heating element 220 through a PID algorithm. Here, pulse width modulation (PWM) technology and PID algorithm are existing technologies commonly used in related fields for regulating the heating power of heating elements, and will not be described in detail here.

[0039] This invention will be illustrated by taking the example of a temperature control system 400 continuously adjusting the current of the heating element 220 using a PID algorithm to regulate the heating power of the heating element 220. First, the temperature control system 400 can preset a target temperature and an initial current for the heating element 220 to raise the temperature of the heating tube assembly 200 and maintain it at the target temperature. Here, the target temperature is the appropriate temperature required for the liquid to react with the sample, for example, 37 ± 0.2 °C. The temperature control system 400 can also convert the real-time temperature sensing signal received from the temperature sensor 300 into a corresponding sensed temperature and compare the sensed temperature with the target temperature. The PID algorithm can continuously output a control signal based on the deviation between the sensed temperature and the target temperature to ensure that the sensed temperature eventually stabilizes near the target temperature value.

[0040] Here, the initial current of the heating element 220 corresponds to the initial temperature, and the initial current of the heating element 220 can be set empirically. For example, in an exemplary embodiment of the present invention, when the target temperature is 37±0.2℃, the initial current of the heating element 220 can be set to 0.05 to 0.3A (24V driving voltage).

[0041] Through the above implementation scheme, the heating needle of the present invention can heat the reagent to the target temperature during the process of the reagent being drawn into the internal cavity of the heating tube assembly and ejected from the internal cavity. The reliability of the heating process is ensured by the real-time sensing of the temperature sensor and the real-time control of the temperature control system. This avoids the heating wait before the reagent is mixed with the sample or the overall preheating of the reagent chamber / tray, which helps to ensure the stability of the reagent and improve the detection efficiency of the equipment.

[0042] Furthermore, during the repeated operation of the above process, that is, during the repeated absorption and dispensing of reagents using the heating needle, the heating needle of the present invention can temporarily increase the heating power of the heating element through the temperature control system as needed, in order to quickly compensate for the heat loss of the tube body caused by heat exchange during the process of the liquid being drawn into the internal cavity of the tube body and dispensing it, so as to ensure that the heating needle of the present invention can always heat the liquid to the target temperature during the repeated absorption and dispensing of liquid, thereby further ensuring the reliability of the heating process.

[0043] According to an exemplary embodiment of the present invention, reference Figure 3 and Figure 4As shown, the outer casing 100 may include an upper casing 130 and a lower casing 140. The outer diameter of the upper casing 130 is larger than the outer diameter of the lower casing 140, and the casing thickness of the upper casing 130 is larger than the casing thickness of the lower casing 140, in order to ensure the overall structural strength of the heating needle. The upper casing 130 defines a first receiving space 150, and the lower casing 140 defines a second receiving space 160. The first receiving space 150 and the second receiving space 160 together constitute the receiving space of the outer casing 100.

[0044] The tube body 210 may include a first tube body 211 and a second tube body 212 that are connected to each other. The first tube body 211 is located in the first receiving space 150 and is connected to the interface 110, and the second tube body 212 is located in the second receiving space 160 and is connected to the needle tip 120.

[0045] Through the above technical solution, during the process of the heating needle drawing liquid, the liquid flows through the needle tip 120 through the second tube 212 of the heating tube assembly 200 and then into the first tube 211, where it is first heated. During the flow of the liquid through the second tube 212, the liquid is heated for the first time. During the process of the heating needle moving to the position corresponding to the sample to be tested using a pipetting device, the liquid flowing into the first tube 211 remains in the first tube 211 for a predetermined time and is heated a second time. During the process of the heating needle discharging liquid, the liquid flows from the first tube 211 through the second tube 212 and is discharged through the needle tip 120, where it is heated a third time.

[0046] Furthermore, as a preferred implementation scheme, refer to Figure 3 As shown, a tapered transition zone 240 is provided at the connection between the first tube 211 and the second tube 212. The inner diameter of the tapered transition zone 240 gradually decreases from the first tube 211 to the second tube 212 to form a smooth tapered transition. Furthermore, the inner wall of the tapered transition zone 240 is polished, with a roughness Ra of less than 0.4 μm. This design eliminates eddies that may be generated at the point of abrupt change in diameter, effectively preventing physical residues of reagents or bubbles adhering to the walls, thereby improving cleaning efficiency and reducing the risk of cross-contamination.

[0047] Considering factors such as the precision required for the heating needle to draw liquid, the second tube 212 of the heating needle needs to be formed into a slender tube, which is common knowledge known to those skilled in the art. Furthermore, since the overall height of the heating needle is limited by the operating environment and other devices, in this embodiment of the invention, the diameter of the first tube 211 is larger than the diameter of the second tube 212 to accommodate more liquid. Simultaneously, to ensure that the heating needle of the present invention can adequately guarantee that the liquid reaches the target temperature after the first, second, and third heating cycles, the first tube 211 and / or the second tube 212 can be made of a material with a thermal conductivity higher than 15 W / (m·K) and bio-inertness. For example, the first tube 211 and / or the second tube 212 can be made of 316L stainless steel, titanium alloy, or a thermally conductive metal material with a Teflon coating on the inner wall.

[0048] Based on the data from the experiment, taking 50 μL of prothrombin time (PT) test reagent (hereinafter referred to as PT reagent) at 10℃ drawn from the refrigerated chamber by the heating needle as an example, the heating needle is first heated to about 35.5℃ by the second tube 212 during the process of drawing the PT reagent (about 800 ms); during the process of the heating needle moving to the position corresponding to the sample to be tested by the pipette, the PT reagent stays in the first tube 211 for a predetermined time (about 500 ms) and is then heated to 36.5℃ by the first tube 211; during the process of the heating needle discharging the PT reagent (about 400 ms), the PT reagent sweeps across the inner wall of the second tube 212 at a high flow rate, and completes the third temperature rise compensation through instantaneous heat exchange to ensure that the temperature of the finally discharged reagent is accurately constant at 37±0.2℃ (target temperature). This demonstrates that the heating needle of the present invention can heat the reagent to the target temperature during the process of the reagent being drawn into and ejected from the internal cavity of the heating tube assembly, ensuring the reliability of the heating process, avoiding the need for heating waiting before the reagent is mixed with the sample or the overall preheating of the reagent chamber / tray, which helps to ensure the stability of the reagent and improve the detection efficiency of the equipment.

[0049] According to an exemplary embodiment of the present invention, reference Figure 3As shown, the heating tube assembly 200 further includes a copper foil 230, which covers the outer wall of the tube body 210. Preferably, in an exemplary embodiment of the present invention, the copper foil 230 covers the outer wall of the first tube body 211. However, it should be understood that the copper foil 230 can also cover the outer wall of the second tube body 212, and the present invention is not limited thereto. The heating element 220 is configured as a heating wire, which can be wound around the surface of the copper foil 230. If the outer wall of the second tube body 212 is not covered with copper foil, the heating wire can be directly wound around the outer wall of the second tube body 212. The temperature control system 400 regulates the duty cycle of the heating wire through pulse width modulation technology, or continuously regulates the current and / or voltage of the heating wire through a PID algorithm to regulate the heating power of the heating wire, thereby regulating the heating temperature of the heating element 220 and thus regulating the temperature of the heating tube assembly 200. The copper foil 230 can make the heat of the heating element 220 more evenly transferred to the tube body 210, thereby ensuring the uniformity of heating of the liquid by the tube body 210.

[0050] Alternatively, the heating element 220 can also be a heating film or other heating elements existing in the prior art, as long as they can meet the heating requirements, and the present invention is not limited thereto.

[0051] Furthermore, the gap between the second tube 212 and the heating wire and the lower housing 140 is small, and the gap can be filled with insulating colloid to ensure the stability of the tube 210 within the outer housing 100. Additionally, the gap between the first tube 211 and the heating wire and the upper housing 130 can also be filled with insulating colloid; the invention is not limited thereto.

[0052] Figure 6 A flowchart illustrating a heating method for a heating needle according to an exemplary embodiment of the present invention is provided.

[0053] refer to Figure 6 As shown, the heating method of the heating needle of the present invention includes the following steps: Tube preheating step: The target temperature is preset, and the heating element 220 of the heating tube assembly 200 is controlled by the temperature control system 400 to heat at a predetermined heating power (S110). Liquid absorption and first heating step: The liquid is drawn through the needle tip 120 and flows through the second tube 212 of the heating tube assembly 200 into the first tube 211 by the external liquid circuit system, and the liquid is first heated by the second tube 212 during the flow through the second tube 212 (S120). Secondary heating step of liquid: The liquid flowing into the first tube 211 is kept in the first tube 211 for a predetermined time and is heated a second time by the first tube 211 (S130). The third heating and discharge step of the liquid: The liquid, which has stayed in the first tube 211 for a predetermined time, is discharged from the first tube 211 through the second tube 212 by the external liquid circuit system and discharged through the needle tip 120. During the process of the liquid flowing through the second tube 212, it is heated for the third time by the second tube 212 (S140). Temperature sensing step: Temperature sensor 300 senses the temperature of the liquid after the third heating by the second tube 212 (S150), and sends the sensed temperature sensing signal to temperature control system 400; Temperature control steps: The temperature control system 400 adjusts the heating power of the heating tube assembly 200 based on the received temperature sensing signal (S160). The heating tube assembly 200 is located in the housing space inside the tube shell 100, and the temperature sensor 300 is located on the second tube body 212 near the needle tip 120.

[0054] Furthermore, in an embodiment of the present invention, the temperature control system 400 is configured to preset a target temperature and an initial heating power of the heating element 220 (S111) to raise the temperature of the heating tube assembly 200 and maintain it at the target temperature.

[0055] Furthermore, in an embodiment of the present invention, the temperature control system 400 is configured to convert the received temperature sensing signal into a corresponding sensing temperature and compare the sensing temperature with a target temperature, so as to regulate the duty cycle of the heating element 220 by pulse width modulation technology or to continuously regulate the current and / or voltage of the heating element 220 by PID algorithm, thereby regulating the heating power of the heating element 220.

[0056] Furthermore, in the second liquid heating step S130, the predetermined time for the liquid to remain in the first tube 211 is the time it takes for the pipette to move the heating needle to the target position. This time is determined by the distance between the reagent and the sample to be tested and is usually only a few hundred milliseconds to 2 seconds. This ensures that the liquid is fully heated in the first tube 211 while effectively ensuring the detection efficiency of the device.

[0057] The heating needle of this invention can heat the reagent to the target temperature during the process of the reagent being drawn up, moved to the target position and then ejected. This avoids the need for heating and waiting before the reagent is mixed with the sample or for overall preheating of the reagent chamber / tray, which helps to ensure the stability of the reagent and improve the detection efficiency of the equipment.

[0058] Furthermore, the heating needle of the present invention has a compact structure, and its temperature control system has simple control logic and high accuracy, which can effectively reduce the processing, manufacturing and use costs of the heating needle of the present invention, and ensure high reliability.

[0059] The foregoing description of specific exemplary embodiments of the invention is for illustrative and descriptive purposes. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed, and it will be apparent that many modifications and variations can be made in light of the foregoing teachings. The exemplary embodiments were chosen and described to explain certain principles of the invention and its practical application, thereby enabling those skilled in the art to make and utilize various exemplary embodiments of the invention and their different alternatives and modifications. The scope of the invention is intended to be defined by the appended claims and their equivalents.

[0060] Unless otherwise specifically stated or otherwise understood in the context in which they are used, conditional languages ​​such as “can,” “may,” “may,” or “can” are generally intended to convey that certain embodiments may include, but are not required to include, certain features and / or elements. Therefore, such conditional languages ​​are not generally intended to imply in any way that one or more embodiments must include said features and / or elements.

Claims

1. A heated needle used in an in vitro diagnostic device and comprising: The tube shell has an internal receiving space, one end of the tube shell has an interface for connecting to an external liquid circuit system, and the other end of the tube shell is provided with a needle tip; A heating tube assembly is disposed in the receiving space, one end of the heating tube assembly is connected to the interface, and the other end of the heating tube assembly is connected to the needle tip; as well as A temperature sensor is disposed near the tip of the needle in the heating tube assembly; The heating tube assembly and the temperature sensor are electrically connected to the temperature control system, which is configured to adjust the heating power of the heating tube assembly based on the temperature sensing signal detected by the temperature sensor.

2. The heating needle according to claim 1, wherein, The heating tube assembly includes a tube body and a heating element, wherein the heating element is disposed on the outer wall of the tube body and electrically connected to a temperature control system; The temperature sensor sends the sensed temperature signal to the temperature control system; The temperature control system regulates the heating power of the heating element by adjusting the duty cycle of the heating element through pulse width modulation technology or by continuously adjusting the current and / or voltage of the heating element through a PID algorithm based on the received temperature sensing signal.

3. The heating needle according to claim 2, wherein, The heating tube assembly further includes copper foil, which covers the outer wall of the tube body.

4. The heating needle according to claim 3, wherein, The heating element is configured as a heating wire, which is wound around the surface of the copper foil; The temperature control system regulates the heating power of the heating wire by adjusting the duty cycle of the heating wire through pulse width modulation technology or by continuously adjusting the current and / or voltage of the heating wire through a PID algorithm.

5. The heating needle according to claim 4, wherein, The outer casing of the tube includes an upper casing and a lower casing. The outer diameter of the upper casing is larger than the outer diameter of the lower casing. The upper casing defines a first accommodating space, and the lower casing defines a second accommodating space. The first accommodating space and the second accommodating space together constitute the accommodating space.

6. The heating needle according to claim 5, wherein, The tube body includes a first tube body and a second tube body that are interconnected. The first tube body is located in the first accommodating space and is connected to the interface. The second tube body is located in the second accommodating space and is connected to the needle tip. The diameter of the first tube body is larger than the diameter of the second tube body to accommodate more liquid.

7. The heating needle according to claim 6, wherein, A tapered transition zone is provided at the connection between the first tube and the second tube, and the inner diameter of the tapered transition zone gradually decreases from the first tube to the second tube.

8. The heating needle according to claim 6, wherein, The copper foil is wrapped around the outer wall of the first tube.

9. The heating needle according to claim 2, wherein, The tube is made of a material with a thermal conductivity higher than 15 W / (m·K) and biological inertness.

10. A method for heating a heating needle, comprising: Tube preheating step: The target temperature is set in advance, and the heating element of the heating tube assembly is controlled by the temperature control system to heat at a predetermined heating power; Liquid aspiration and first heating step: The liquid is drawn through the needle tip and flows into the first tube of the heating tube assembly by the external liquid circuit system, and the liquid is heated for the first time by the second tube as it flows through the second tube. Secondary heating step for liquid: The liquid flowing into the first tube is allowed to remain in the first tube for a predetermined time, and is then heated a second time by the first tube; The third heating and discharge step of the liquid: The liquid, which has stayed in the first tube for a predetermined time, is discharged through the needle tip after flowing through the second tube by the external liquid circuit system, and the liquid is heated for the third time in the second tube during the flow. Temperature sensing step: The temperature sensor senses the temperature of the liquid after the third heating in the second tube and sends the sensed temperature sensing signal to the temperature control system; Temperature control steps: The temperature control system adjusts the duty cycle of the heating element by pulse width modulation technology or by continuously adjusting the current and / or voltage of the heating element based on the received temperature sensing signal, thereby controlling the heating power of the heating tube assembly. The heating tube assembly is located in the housing space inside the tube shell, and the temperature sensor is located near the needle tip in the second tube body.

11. The heating method for the heating needle according to claim 10, wherein, In the second heating step of the liquid, the predetermined time for the liquid to remain in the first tube is the time it takes for the pipette to move the heating needle to the target position.

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