Method and device for monitoring process operation of medical consumables using TOF sensor

Abstract

The present invention discloses a method and device for monitoring the process operation of medical consumables using a TOF sensor, comprising at least one TOF sensor detection unit, which can correspond to at least one medical consumable unit and continuously obtain the distance information from at least one medical consumable unit to at least one TOF sensor detection unit within the time period when at least one acquisition sub-unit is connected to at least one medical consumable unit, and / or within the time period when at least one medical consumable unit moves to a sample processing module, and / or within the time period when at least one medical consumable unit is transferred to a consumable recovery module. The processing module determines whether the process operation is correctly performed in different time periods based on the distance information. This solution overcomes the error risks that may be introduced by manual sluggish operation and fatigue status, and at the same time, compared with other designs, has process characteristics and characteristics that are closer to manual visual operation.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a method and device for monitoring the process operation of medical consumables using a TOF sensor. Background Art

[0002] With the improvement of living standards and the increasing health concerns of most people in contemporary life, a large number of samples need to be examined in medical, chemical, analytical or pharmaceutical laboratories. The operation and transfer of these samples cannot be separated from pipettes. In the case of manual transfer, the operator usually aligns the pipette with the pipette tip by visual means, and then reliably connects the pipette tip to the pipette by applying downward pressure. The operator completes the operation manually and can rely on his own experience and visual coordination to confirm the reliability of the pipetting process throughout the process.

[0003] In fact, manual pipetting will cause the following problems when a large number of samples need to be processed: 1) Visual alignment is very cumbersome because reliable reference points must usually be determined and frequently relied upon for positioning and alignment; 2) Due to the subjectivity of the visual alignment process, it is impossible to quantify and determine the error in the reference point position in the analyzer system coordinates; 3) Manual operations are at high risk of dull operation in a large amount of repetitive work, which may lead to some pipetting errors, and human fatigue may further increase the risk of operational errors.

[0004] Automated laboratory systems or equipment are commonly used today to quickly and reliably process individual samples. These systems are typically designed to handle specific fluid volumes within liquid handling systems. These systems can include, among other things, the injection of pharmaceuticals into animals and humans, the aspiration and dispensing of liquids into specific containers, or simply the transfer of liquids using a pipette. Most laboratory or automated system applications require extremely precise pipetting to achieve satisfactory accuracy. Therefore, the ability of a pipette to transfer accurate volumes of liquid is crucial. In automated processes, due to the risk of contamination, each new sample must be processed using a different pipette tip (also known as a pipette tip). Therefore, these tips are typically designed for single use. Depending on the application, different pipette tips may be used during pipetting. These tips may vary in volume, color, or conductivity of the internal material. However, the actual volume of liquid transferred is influenced by numerous factors, such as the consistency of tip dimensions, the consistency of the pipette's actuation force, and the precise fit of the tip with the pipette's mounting head. The most basic requirement is that in an automatic pipetting device, it can detect whether the tip is connected to the pipette mounting head. Only when the tip is correctly connected can the entire liquid transfer process be accurately executed. In automated equipment systems, since no one has the subjective initiative to accurately identify whether the tip is correctly installed, it may often be impossible to make timely and accurate adjustments. Of course, some companies have made some improvements, such as using visual cameras for real-time acquisition. However, since the entire transfer process is constantly changing, the background changes are complex and special processing of the background is required to determine whether the tip is correctly installed and whether there is a risk of it falling off during the process, etc., making the entire system design and data processing extremely complex. In addition, this requires special requirements for ambient light intensity and brightness.

[0005] Therefore, in order to achieve a small amount of data processing and to quickly and in real time obtain whether the pipette and the Tip head are correctly connected during different operations, it is a technical problem that needs to be solved. At the same time, similar operations, such as using a stirring sleeve for nucleic acid extraction, also need to determine whether the stirring sleeve is connected during at least part of the time period, so as to obtain whether different operations are performed correctly. Summary of the Invention

[0006] The purpose of the present invention is to: In response to the above-mentioned problems, the present invention provides a method and device for monitoring the process operation of medical consumables using a TOF sensor.

[0007] The present invention is achieved through the following solutions:

[0008] A device using a TOF sensor to monitor the process operation of medical consumables:

[0009] It includes an intake module, which includes at least one intake sub-unit for direct or indirect one-to-one connection with at least one medical consumable unit; the intake module connected to the at least one medical consumable unit moves to the sample processing module, and relies on the at least one medical consumable unit to process the sample liquid in the sample processing module; after completing the sample liquid processing, the intake module can transfer the at least one connected medical consumable unit to the consumable recovery module for recycling; the monitoring module includes at least one TOF sensor detection unit, which can correspond to the at least one medical consumable unit and continuously obtain the distance information from the at least one medical consumable unit to the at least one TOF sensor detection unit within the time period when the at least one intake sub-unit is connected to the at least one medical consumable unit, and / or within the time period when the at least one medical consumable unit moves to the sample processing module, and / or within the time period when the at least one medical consumable unit is transferred to the consumable recovery module, and the processing module determines whether the process operations in the different time periods are correctly executed based on the distance information.

[0010] Furthermore, the acquisition module includes no less than two sub-acquisition modules, the first sub-acquisition module includes at least one first acquisition sub-unit for direct or indirect one-to-one connection with at least one first medical consumables unit; the second sub-acquisition module includes at least one second acquisition sub-unit for direct or indirect one-to-one connection with at least one second medical consumables unit.

[0011] Furthermore, the first sub-acquisition module is a pipette sub-module, which includes at least one pipette head sub-unit for direct or indirect one-to-one connection with at least one pipette Tip head; the second sub-acquisition module is a magnetic bead extraction sub-module, which includes at least one magnetic stirring sub-unit for direct or indirect one-to-one connection with at least one stirring sleeve.

[0012] Furthermore, at least one pipetting head subunit included in the pipette submodule is connected to at least one first pipetting Tip head with a first capacity in a first time period, and is connected to at least one second pipetting Tip head with a second capacity in a second time period.

[0013] Furthermore, during different time periods of the processed operation of the medical consumables, the relative distance between the at least one TOF sensor detection unit and the at least one medical consumables unit is a basically fixed value.

[0014] Furthermore, during different time periods of the processed operation of medical consumables, the processing module can determine whether the at least one medical consumable unit is connected to the at least one acquisition sub-unit without tilt based on the distance information from the at least one medical consumable unit to the at least one TOF sensor detection unit.

[0015] Furthermore, when the distance information from the at least one medical consumables unit to the at least one TOF sensor detection unit is abnormal, the processing module generates an error signal and provides a corresponding error handling mechanism.

[0016] Furthermore, it also includes a calibration module, the distance between the calibration module and the at least one TOF sensor detection unit is a standard value, and the processing module can adaptively calibrate the accuracy of the at least one TOF sensor detection unit according to the standard distance.

[0017] The present invention also discloses a method for monitoring the process operation of medical consumables using a TOF sensor, wherein at least one TOF sensor detection unit can correspond to at least one medical consumable unit, and continuously obtain the distance information from at least one medical consumable unit to at least one TOF sensor detection unit within the time period when at least one acquisition sub-unit is connected to at least one medical consumable unit, and / or within the time period when at least one medical consumable unit is moved to a sample processing module, and / or within the time period when at least one medical consumable unit is transferred to a consumable recovery module. The processing module determines whether the process operation is performed correctly in different time periods based on the distance information.

[0018] Furthermore, the present method includes no less than two sub-acquisition modules, the first sub-acquisition module includes at least one first acquisition sub-unit for direct or indirect one-to-one connection with at least one first medical consumables unit; the second sub-acquisition module includes at least one second acquisition sub-unit for direct or indirect one-to-one connection with at least one second medical consumables unit.

[0019] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0020] 1. The present invention adopts a TOF near-infrared type sensor, and achieves a real-time detection scheme that adapts to the ambient light intensity through an adaptive background light elimination correction scheme. The design itself can directly perform background light elimination operations at the computing circuit or pixel circuit level, and no longer uses a data processing stage to process the acquired image, so that the entire system design will not be too complicated. At the same time, it can be monitored by multiple acquisition sub-units corresponding to multiple automatic operating systems, and a multi-object parallel processing scheme can be implemented to achieve efficient processing requirements. At the same time, the TOF sensor and the acquisition module that needs to move can be configured on the same motion drive mechanism, which can achieve the time period when at least one acquisition sub-unit is connected to the at least one medical consumables unit, and / or the at least one medical consumables unit. The distance information from the at least one medical consumables unit to the at least one TOF sensor detection unit is continuously obtained within the time period when the medical consumables unit moves to the sample processing module, and / or the at least one medical consumables unit is transferred to the consumables recovery module. The final processing module determines whether the procedural operation in the different time periods is correctly performed based on the distance information, thereby realizing the process-based and continuous detection of the connection status between the acquisition sub-unit and the consumables, thereby simulating the continuous visual operation effect in the manual operation process. At the same time, the partial reference is integrated to ensure that the entire dynamic operation can achieve results similar to those of manual visual reference operations, and overcome the error risks that may be introduced by manual sluggish operation and fatigue status. At the same time, compared with other designs, it has process characteristics and characteristics that are closer to manual visual operations.

[0021] 2. The present invention adopts two sub-acquisition modules to complete different functions. For example, one sub-acquisition module can be a pipette sub-module and the other sub-acquisition module can be a magnetic bead extraction sub-module. In this way, in an automated system with a magnetic bead nucleic acid extraction module and a pipette multifunction, it is possible to detect whether the two types of consumables, the pipette tip head and the stirring sleeve, are correctly installed, and whether the pipetting process and / or the nucleic acid extraction process are correctly executed, etc., thereby achieving the effect that different functions in a complex multifunctional system can be monitored in a process-based manner.

[0022] 3. The pipette submodule used in the present invention can match at least two pipette tip consumables of different capacities, achieving the compatibility of a pipette for different pipetting scenarios and ensuring the simple design of the entire system.

[0023] 4. The TOF sensor used in the present invention can obtain a distance signal, and different sub-capture modules are set to move relative to the sensor at the same time, so that the sub-units connected with different consumables and the corresponding TOF sensors can remain relatively still in one dimension. For example, the distance between them in the dimension of relative movement of the driving sub-capture module is a relatively fixed value. At this time, it can be determined by setting a predetermined value whether the distance meets the requirements. In conjunction with the up and down movement and / or rotational movement, it can further determine whether the consumables are installed on the capture sub-unit without tilt, and in conjunction with the processing module, it can quickly give a corresponding error processing solution, further ensuring the intelligence of the entire system. In addition, in conjunction with some reference base units designed as an integral part of the module, the accuracy of the TOF sensor can be adaptively corrected, and it is also ensured that the entire system can always accurately and efficiently complete different operation processes. Of course, in the above process, the TOF sensor can also cooperate with the control sensor that drives the capture module to move, and can cooperate with the characteristic position points in the system to locate and correct the accuracy of the corresponding positions of different operations. In more special scenarios, in conjunction with the characteristic of the constant predetermined distance within a fixed time, it can also identify whether the tightness of the consumable connection is consistent, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 This is a schematic diagram of the connection process between the pipetting head subunit and the Tip head using TOF detection provided by the present invention;

[0025] Figure 2 This is a schematic diagram of the principle of obtaining Tip head distance information using TOF provided by the present invention;

[0026] Figure 3 This is a schematic diagram of the connection between a multi-tip head and a multi-pipetting head subunit provided by the present invention;

[0027] Figure 4 This is a schematic diagram of a multi-Tip head provided by the present invention connected and coordinated with multiple TOF detection units to perform different state detection;

[0028] Figure 5 This is a schematic diagram of the connection process between multiple stirring sleeve mounting parts and stirring sleeves of an extraction submodule provided by the present invention;

[0029] Figure 6 This is a schematic diagram of a different method for identifying an inclined installation state provided by the present invention;

[0030] Figure 7 This is a schematic diagram of the principle of a partial nucleic acid extraction operation performed in an integrated consumable provided by the present invention;

[0031] Figure 8This is a schematic diagram of the principle of another part of the nucleic acid extraction operation performed in the integrated consumables provided by the present invention;

[0032] Figure 9 This is a schematic diagram of an integrated consumable provided by the present invention;

[0033] Figure 10 This is a schematic diagram of a combined nucleic acid extraction submodule and a pipetting submodule provided by the present invention;

[0034] Figure 11 This is a partial structural diagram of a multifunctional device provided by the present invention that can simultaneously perform extraction and pipetting;

[0035] Figure 12 This is a schematic diagram of an extraction and pipetting method for process detection based on a collection of consumables provided by the present invention;

[0036] Figure 13 The present invention provides a schematic diagram of a method for realizing pipetting or cupping under detection using a pipetting head subunit and a tip head. DETAILED DESCRIPTION

[0037] To make the objectives, technical solutions, and advantages of the embodiments of the present application more clear, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Generally, the components of the embodiments of the present application described and shown in the drawings herein can be arranged and designed in various different configurations.

[0038] Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the present application for protection, but merely represents selected embodiments of the present application. All other embodiments obtained by persons of ordinary skill in the art based on the embodiments in the present application without creative work are within the scope of protection of the present application.

[0039] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, it does not need to be further defined or explained in subsequent drawings.

[0040] Among many medical devices, more functions are used to process sample liquids using disposable consumables, such as using a pipette with a tip head to transfer sample liquids, using a stirring sleeve to extract nucleic acids, etc. The premise for accurate pipetting by the pipette and efficient extraction of nucleic acid fragments by the stirring sleeve in these operations is to ensure the correct connection between the mounting part and the consumables in the automated equipment. Therefore, it is necessary to set up sensors to monitor different operating processes in a process-based manner, so as to achieve accurate execution of different operating steps similar to the human eye vision mode. This design has also become the optimal solution for fast and continuous process monitoring with low data volume. The principle of the present invention will be explained below with reference to specific drawings.

[0041] Example 1

[0042] This embodiment provides a device for monitoring the process operation of medical consumables using a TOF sensor, which includes at least one acquisition sub-unit for directly connecting one-to-one with at least one medical consumable unit; the acquisition module connected to the medical consumable unit moves to the sample processing module, and relies on the connected medical consumable unit to process the sample liquid in the sample processing module; after completing the sample liquid processing, the acquisition module can transfer the connected medical consumable unit to the consumable recovery module for recycling; the monitoring module includes at least one TOF sensor detection unit, which can correspond to at least one medical consumable unit, and continuously obtain the distance information from the medical consumable unit to the TOF sensor detection unit during the time period when the acquisition sub-unit is connected to the medical consumable unit, and / or the time period when the medical consumable unit moves to the sample processing module, and / or the time period when the medical consumable unit is transferred to the consumable recovery module, and the processing module determines whether the process operation is correctly executed in different time periods based on the distance information.

[0043] That is, the TOF sensor detection unit monitors the distance information from the medical consumables unit to the TOF sensor detection unit within at least one of the time periods when the acquisition sub-unit is connected to the medical consumables unit, the time period when the medical consumables unit moves to the sample processing module, and the time period when the medical consumables unit is transferred to the consumables recovery module.

[0044] The acquisition module includes at least one sub-acquisition module, which in this embodiment may include a first sub-acquisition module and a second acquisition sub-unit. The first sub-acquisition module includes at least one first acquisition sub-unit for one-to-one connection with at least one first medical consumables unit; the second sub-acquisition module includes at least one second acquisition sub-unit for one-to-one connection with at least one second medical consumables unit.

[0045] That is, in this embodiment, the acquisition module can process different types of medical consumables units, and the TOF sensor detection unit can monitor their different processing processes at the same time.

[0046] As an example, the first sub-acquisition module can be a pipette sub-module, which includes at least one pipette head sub-unit for one-to-one connection with at least one pipette Tip head; the second sub-acquisition module can be a magnetic bead extraction sub-module, which includes at least one magnetic stirring sub-unit for one-to-one connection with at least one stirring sleeve.

[0047] As an example, at least one pipette head subunit included in the pipette submodule is connected to at least one first pipette Tip head with a first capacity in a first time period, and can be connected to at least one second pipette Tip head with a second capacity in a second time period.

[0048] As an example, during different time periods of the medical consumables processing operation, the relative distance between at least one TOF sensor detection unit and at least one medical consumables unit is a substantially fixed value.

[0049] As an example, during different time periods of the medical consumables processing operation, the processing module can determine whether at least one medical consumables unit is connected to at least one acquisition sub-unit without tilt based on the distance information from at least one medical consumables unit to at least one TOF sensor detection unit.

[0050] As an example, when the distance information from at least one medical consumables unit to at least one TOF sensor detection unit is abnormal, the processing module generates an error signal and provides a corresponding error handling mechanism.

[0051] As an example, a calibration module is further included, the distance between the calibration module and at least one TOF sensor detection unit is a standard value, and the processing module can adaptively calibrate the accuracy of at least one TOF sensor detection unit according to the standard distance.

[0052] Example 2

[0053] This embodiment describes in detail how the pipette head subunit included in the pipette submodule in Example 1 is connected to at least one first pipette tip with a first capacity within a first time period, and / or how the pipette head subunit included in the pipette submodule is connected to at least one second pipette tip with a second capacity within a second time period. Figure 1 Schematic diagram of the connection between the pipetting head subunit provided in an embodiment of the present invention and the Tip head consumables under TOF detection.

[0054] Figure 1(a) in the figure shows that the pipette head subunit 101 is driven to move to the position directly above the Tip head consumable 301. In order to achieve the purpose of process detection, the corresponding TOF detection unit 201 is installed on the mounting portion 21 that moves relative to the pipette head subunit 101 at the same time as the pipette head subunit 101 is driven. This ensures that the relative distance between the TOF detection unit 201 and the pipette head subunit 101 remains basically unchanged in terms of the direction and dimension of movement under the driving action. At this time, the TOF detection unit can perform a detection and determine whether the pipette head subunit 101 carries an undisassembled Tip head consumable according to the detection result. If no Tip head consumable is detected, the status is correct and the pipette head subunit 101 can be driven to move downward. Go to Figure 1 As shown in (b), the pipette head subunit 101 contacts the Tip head consumable 301 under the action of the downward driving force, and is reliably connected to the Tip head consumable 301 under the action of an appropriate driving force. After the connection between the two is completed, the upward driving force can enable the pipette head subunit 101 to drive the connected Tip head consumable 301 to move upward. Since the TOF detection unit 201 can be used for detection in at least part of the time period during the upward return movement, it is possible to timely detect whether the Tip head is connected to the pipette head subunit 101. If it is detected that the two are not connected, the control module can drive the pipette head subunit 101 to move downward again to reconnect the two. When it is detected that the two are already connected, it can continue to drive upward as shown in FIG. Figure 1 As shown in (c), the TOF detection unit 201 can obtain the length of the entire Tip head consumable 301, thereby realizing the effect of using the TOF detection unit 201 to identify the consumable type and whether the application is accurate. Similarly, this information can also be used to accurately determine whether the Tip head consumable 301 is correctly connected to the pipetting head subunit 101 (because when the connection is loose, the length obtained will be longer than the actual length of the Tip head consumable, and when the connection is too tight or deformed, the length obtained will be shorter than the actual length of the Tip head consumable). Figure 1 (d) in the figure indicates that after the connection judgment is completed, the pipetting head subunit 101 needs to move the connected Tip head consumable 301 to a predetermined position for subsequent operations, such as sample liquid transfer, or extract liquid transfer and distribution. During this movement time period, the TOF detection unit can continuously obtain the relative distance between the Tip head consumable 301 and it (the preset position of the Tip head consumable 301 can be set to be aligned with the TOF detection unit 101). Through the recognition and conversion of the distance information, it is possible to detect whether the Tip head is reliably connected to the pipetting head subunit 101 during the time period of transfer to the predetermined position, thereby dynamically obtaining the detection effect of the entire movement process.

[0055] Figure 2The figure illustrates the basic principle of how the TOF detection unit 201 obtains the distance to the Tip head consumable 301. TOF stands for time-of-flight detection method. The detection unit used in the present invention is an infrared sensor, especially a time-of-flight sensor within the near-infrared band. It adopts a direct time-of-flight solution, in which a pulsed light wave is emitted by a laser source. After encountering the Tip head and other consumables, at least part of the light wave is reflected back and becomes return light to be received by the sensor's receiving probe. Here, the edge trigger design such as leading edge triggering and trailing edge triggering can be used to sense the returned photons. As shown in the figure, the time difference between the triggering edge of the emitted light and the return light is used to obtain the flight time tF, so that the distance between the TOF detection unit and the Tip head consumable and the like can be obtained. Of course, the above-mentioned selection of near-infrared type of emission light mainly considers human eye safety and other interference. In addition, due to the longer wavelength, the deeper absorption depth of the infrared sensor at the receiving end can also enhance the reliability of the detection unit results. The wavelength of the near-infrared emission light source can be selected within the wavelength range of 700-1000nm. Of course, in order to further reduce the interference of ambient light, the sensor can also be equipped with an ambient light correction module to perform background light elimination operations directly inside the sensor, thereby reducing the amount of data transmitted from the entire sensor to the system processor, thereby greatly enhancing the dynamic and high-speed performance of the entire system.

[0056] Figure 3 and Figure 4 The diagram shows the connection between multiple pipetting head sub-units and multiple Tip head consumables included in the pipetting sub-module, as shown in the figure. Figure 3 The pipetting submodule 10 in (a) comprises N parallel pipetting head subunits, each pipetting head subunit is marked as 101, 102, . . . , 10N, where N is an integer not less than 2. Figure 3 (b) in the figure shows 8 parallel pipetting head subunits, which can achieve the effect of simultaneous transfer of N groups of samples, ensuring the efficiency of the entire automated system. At the same time, the mounting part 21 is provided with corresponding N TOF detection units 201, 202,..., 20N. The mounting part 21 and the pipetting submodule share the same drive, thereby achieving the characteristic that the relative distance between the N TOF detection units and their corresponding pipetting head subunits in one dimension remains basically unchanged. Similar to the previous embodiment, the pipetting submodule 10 is driven to the top of the Tip head consumable. Here, the number of Tip head consumables and pipetting head subunits is also the same, N (that is, each Tip head consumable unit is marked as 301, 302,..., 30N). Before the pipetting head subunit is connected to the Tip head, each corresponding TOF detection unit can first check whether there is a Tip head consumable connected to the pipetting head subunit. On the premise of confirming that there is no Tip head consumable, the pipetting submodule 10 can be driven downward to achieve the connection of N pipetting head subunits with the corresponding Tip head consumable unit. Figure 3As shown in (b), after the connection is completed, the pipetting submodule 10 is driven to move upward. Figure 4 As shown in (a), during at least part of the rising time period, each corresponding TOF detection unit can confirm whether each pipetting head subunit is connected to the corresponding Tip head consumable unit through corresponding detection. When there is at least partial connection failure, the pipetting submodule 10 can control the corresponding pipetting head subunit to move downward again in whole or in part to achieve the purpose of reconnection and re-detection. In this way, dynamic process detection can be achieved during the connection process of the Tip head consumable unit. Of course, in order to ensure the model and connection status of each Tip head, the pipetting submodule 10 can also be driven to continue to move upward, and each TOF detection unit can be detected in real time during the process, such as Figure 4 (b) and Figure 4 As shown in (c), when the entire Tip head consumable unit is completely pulled upward and finally out of the detection range of the TOF detection unit, the model and size of the Tip head consumable can be finally determined. Of course, by comparing different Tip head consumables, the consistency of the installation of different consumables can be finally confirmed. In one case, the pipetting head subunit is connected to the first volume of sample liquid transfer Tip head. After the connection is confirmed, the pipetting submodule is driven to maintain the following Figure 4In state (a), the sample liquid is transferred to a predetermined position. During the process of reaching the predetermined position, the corresponding TOF detection unit can dynamically and in real time determine whether the sample liquid transfer Tip is normal. After reaching the predetermined position, the pipetting submodule 10 is driven to absorb the sample liquid in the sample tube. After completion, it returns upward and transfers to the predetermined position, and then descends to transfer the sample liquid to the processing container hole, for example, the lysis hole of the extraction consumable. During the entire sample transfer time period, the TOF detection unit can detect whether the sample liquid transfer Tip is normal during at least part of the time period to ensure the normal reliability of the pipetting operation process. After completing the sample liquid transfer, the pipetting submodule 10 is driven to move to the recovery part of the Tip consumable. Of course, in some design scenarios, the Tip consumable recovery part is the storage part of the Tip consumable. After that, the pipetting head subunit 101 and the corresponding Tip consumable 301 are also separated, and at this time, the corresponding TOF detection unit can also detect whether the process is accurately executed. In another case, the pipetting head subunit 10 is connected to the second capacity extraction liquid transfer Tip head to perform the extraction liquid transfer or cupping operation. The transfer process and the corresponding detection are similar to the sample liquid transfer process and will not be repeated here. The cupping process is to continue to be driven to the next position after completing a transfer and continue to discharge a quantitative liquid. Of course, the TOF detection unit can realize the detection results of each cupping process. Each cupping can, for example, quantitatively spit out 20, 30, 40, 50 μL and other volumes of liquid in each cup hole to achieve equal cupping. In this way, more target gene detection can be achieved for the same sample, ensuring the efficiency of the entire system.

[0057] Example 3

[0058] Figure 5 This is a schematic diagram of the extraction consumables installation part of the extraction submodule and the connection and detection of the extraction consumables. In many scenarios, especially in in vitro diagnostic technologies involving nucleic acid detection, the extraction process is necessary. In this scenario, designing a TOF detection unit similar to the aforementioned pipetting process can also achieve the effect of process detection, thereby ensuring that the nucleic acid extraction process can be executed accurately and efficiently. Figure 5 (a) and Figure 3Similar to (a) in FIG. 1 , the extraction submodule 40 includes N extraction consumable stirring sleeve mounting parts 401, 402, ···, 40N, each mounting part can be driven up and down individually or as a whole, and the extraction submodule 40 is driven to move to the top of the stirring sleeve (each stirring sleeve unit is marked as 501, 502, ···, 50N), and cooperates with the corresponding N TOF detection units 221, 222, ···, 22N. First, it is detected whether there is a stirring sleeve on each stirring sleeve mounting part. When it is confirmed that there is no stirring sleeve, the extraction submodule is driven downward until the stirring sleeve mounting part 401 is connected to the corresponding stirring sleeve as shown in FIG. Figure 5 As shown in (b), after the connection is completed, the extraction submodule is driven to move upward. During the upward return movement time period, the detection results of the corresponding N TOF detection units can be quickly determined regardless of the time period to determine whether the connection process is correctly executed. Under the premise that at least part of the stirring sleeve is not correctly installed, the extraction submodule is driven to move downward again to re-connect the operation. When the connection is correct, the extraction submodule and the installation part 21 of the N TOF detection units are jointly driven to the predetermined position to perform the nucleic acid extraction operation. During the driven movement process, the TOF detection unit can dynamically obtain the state of the stirring sleeve to prevent the risk of falling off during the movement, and also achieve the effect of process detection.

[0059] Example 4

[0060] This embodiment describes in detail how, in Example 1, the processing module can determine whether at least one medical consumable unit is connected to at least one acquisition sub-unit without tilt based on the distance information from at least one medical consumable unit to at least one TOF sensor detection unit during different time periods of the medical consumables processing operation.

[0061] Figure 6 A schematic diagram illustrating the use of the TOF detection unit to identify abnormal installation status of the stirring sleeve. Figure 6 (a) in the figure shows a schematic diagram of detecting the distance d1 between the stirring sleeve and the TOF detection unit at a certain vertical position in an inclined installation state. One solution uses the difference in different detection positions during the rising process of the stirring sleeve to identify this state, such as Figure 6As shown in (b), the distance d2 between the stirring sleeve and the TOF detection unit detected at another position near the end of the stirring sleeve during the rising process can be used to determine whether the stirring sleeve is installed at an angle. Of course, the rising process can also be used to detect the length and dimensional characteristics of the stirring sleeve to determine its model and installation status, etc., which is not limited here. Of course, another solution is to set the stirring sleeve mounting portion to rotate about the axis to cooperate with the detection solution. During the rotation process, the distance d1 from the stirring sleeve to the TOF detection unit can be obtained at one position, and the distance d3 from the stirring sleeve to the TOF detection unit at another position. This can also determine whether the stirring sleeve is installed at an angle. Of course, this method can also be applied to the detection of pipette tip consumables and will not be repeated here. Of course, at least one of the above two detection methods is provided with a reference module. Using the reference within the device or system, the TOF detection unit can be calibrated in a timed, non-timed, or adaptively scheduled manner to ensure that the TOF detection unit is always in an efficient state. In addition, some references can be set as markers for different steps of the pipetting or extraction operation to ensure that each step is executed with high precision.

[0062] Example 5

[0063] In order to clearly explain the entire processing flow in this embodiment, each process of nucleic acid extraction is described in detail below.

[0064] Figure 7 and Figure 8The figure shows a detailed schematic diagram of each possible process of nucleic acid extraction with the cooperation of the stirring sleeve. The pipette transfers at least part of the sample to be tested to the lysis well for lysis operation. In order to ensure the adequacy of the lysis, the stirring sleeve can be immersed in the lysis solution of the lysis well. At this time, the magnetic rod can hardly extend out of the mounting head. The stirring sleeve is not magnetic at this time. The rotation and / or up and down oscillation of the stirring sleeve can achieve full stirring of the solution in the lysis well at this time, so that the sample liquid is lysed more thoroughly. Of course, there are no magnetic beads in the sample liquid at this time, and the magnetic rod can also be partially or completely exposed from the mounting head for stirring. The stirring operation required in other subsequent steps is explained by the up and down oscillation stirring as an example. In fact, any stirring can be achieved by up and down oscillation and / or rotation stirring to ensure the mixing effect. The number of holes of the integrated consumables in the figure is not the actual number of holes of the integrated consumables actually used, and the attached figure is only a schematic illustration of various operations that may occur in the integrated consumables. When the lysis process is completed, it can be considered that the sample liquid has been fully lysed. At this time, the magnetic rod with the stirring sleeve is extended into the magnetic bead storage well. In order to ensure the activity of the magnetic beads and more convenient transfer, the magnetic beads are placed in the magnetic bead storage solution. Before transfer, they can be fully stirred and mixed. Then, during the transfer operation, the magnetic rod fully and maximally extends beyond the mounting head, so that the magnetic force of the magnetic rod maximizes the impact of the environment outside the stirring sleeve. The generated magnetic force can more reliably adsorb the magnetic beads on the outer side wall of the stirring sleeve. Then, the stirring sleeve drives the magnetic beads to be transferred to the lysis well, and then the magnetic rod retracts back to the mounting head so that the magnetic influence of the magnetic rod disappears. At this time, the magnetic beads will be released into the lysis solution. After stirring and mixing by the stirring sleeve, the lysis solution and the magnetic beads are fully mixed, so that the magnetic beads can adsorb the nucleic acid fragments to complete the combination of the magnetic beads and the nucleic acid fragments. Then, the magnetic beads are collected, and the operation of collecting magnetic beads also requires The magnetic rod extends out of the mounting head to the maximum extent. Under the action of the magnetic rod, the magnetic beads bound to the nucleic acid fragments are adsorbed on the outer wall of the stirring sleeve and transferred to the salt washing well. The impurities such as proteins can be removed by salt washing to ensure that the purity of the nucleic acid extracted subsequently is higher. Of course, during the salt washing process, the demagnetized stirring sleeve can also be used for stirring and mixing to quickly complete the salt washing process. After the salt washing operation is completed, the magnetic beads with nucleic acid fragments are transferred to the washing well in a similar way. Here, the more commonly used three washes are used as an example. First, the magnetic beads with nucleic acid fragments transferred to the washing well 1 are stirred and mixed to complete the first wash. Then, the magnetic beads with nucleic acid fragments are transferred to the washing well 2 and stirred and mixed to complete the second wash. Finally, the magnetic beads with nucleic acid fragments are transferred to the washing well 3 and stirred and mixed to complete the third wash. After three washes, there are basically no other impurities that may affect the results.The magnetic beads with nucleic acid fragments are slightly dried by the magnetic force of the magnetic rod, and then they can be transferred to the elution well for elution operation. Under the action of the eluent, the separation of the nucleic acid fragments and the magnetic beads is completed by stirring and mixing. Then, the magnetic rod is inserted to apply magnetic force so that the magnetic beads separated from the nucleic acid fragments are re-adsorbed on the wall of the stirring sleeve. The transferred magnetic beads are transferred into the previous magnetic bead storage wells, and the stirring sleeve is also placed back to the stirring sleeve placement well corresponding to the integrated extraction consumables to complete the entire extraction process. After that, another Tip head in the integrated extraction consumables absorbs at least part of the eluate from the elution well and transfers it to the PCR amplification consumables. Of course, in actual applications, some operations can also be reduced, omitted or merged. For example, there may be no salt wash operation or only two washes are required, etc. It is not limited here to all the functions of all the wells in the figure. Of course, in the above-mentioned different processes, the TOF detection unit moving together can realize dynamic detection of the operation process of different steps, ensuring real-time and efficient acquisition of whether multiple steps are accurately executed.

[0065] Example 6

[0066] like Figure 9 As shown, this embodiment is an integrated consumable design provided by the present invention. In an automated system using such consumables, a complete PCR extraction function can be performed. At the same time, when combined with PCR amplification consumables, a multifunctional system integrating extraction and amplification can be realized. The integrated consumables include a first-capacity sample pipetting Tip consumable, different well positions and supporting reagents required for extraction, a stirring sleeve, and a second-capacity extraction liquid transfer Tip consumable.

[0067] Example 7

[0068] like Figure 10 As shown, this embodiment is a combined structure provided by the present invention including a pipetting submodule and an extraction submodule. The pipetting head subunit 101 can be connected to the Tip head consumable 301, and can cooperate with the TOF detection unit 201 to perform process detection for the connection process and subsequent liquid transfer or cup separation detection. At the same time, its mounting portion 21 is shared with the TOF detection unit 221 used in conjunction with the extraction module, ensuring the compactness of the entire system design. At the same time, the mounting portion can also be provided with other driving circuits and related components to complete the driving of the detection units 201 and 221. The stirring sleeve mounting portion 401 of the extraction submodule can be installed with the stirring sleeve 501 with the assistance of the detection unit 221, or the process detection results in different steps can be extracted.

[0069] Example 8

[0070] like Figure 11As shown, this embodiment is a partial structure of a pipetting detection system and an extraction detection system provided by the present invention, which includes a pipetting submodule 10 and an extraction submodule 40, and a TOF detection unit mounting portion 21 is included between the two. At the same time, in order to achieve high efficiency of the system, the pipetting submodule 10 includes N pipetting head subunits, and correspondingly, the extraction submodule 40 includes N stirring sleeve mounting portions. The three are installed on a module base connected to a drive motor 60, so as to ensure that when the drive motor drives the entire module base to move relative to one dimension, the three remain stationary in the dimension of the driven movement, and the distance between the three remains constant, thus constructing the basis for real-time process detection of the TOF detection unit.

[0071] Example 9

[0072] like Figure 12 As shown, this embodiment is a detailed explanation of the steps of the method for performing process operation detection using the device of the present invention. After the process operation is started with the cooperation of the TOF detection unit, the visual camera unit such as the camera equipped with the device can be used to detect and confirm whether the consumables and different consumable units are placed correctly, for example, Figure 9Integrated consumables can be used with a visual camera to detect the consumable barcode to determine the type of experiment to be performed, the type of sample solution in the consumable, and so on. After opening the lid of the integrated consumable, the consumables and sample reagents in different well positions can be inspected to ensure that tips and stirring sleeves of different capacities are in their corresponding positions. Of course, in non-integrated consumables, a visual camera can also be used to obtain the placement status of the consumable units at each consumable location. When the acquired consumable position corresponds to the correct information, subsequent connection steps can be performed. If the correct consumable is not detected, the integrated consumable is judged as unqualified and this information is transmitted to the control module. The control module can then issue a control instruction to stop the experiment and allow the operator to replace the integrated consumable, or mark the consumable so that the sample solution corresponding to the integrated consumable is not processed in subsequent operations, while the sample solution corresponding to other normal integrated consumables can be processed normally in subsequent experiments. For non-integrated consumables, incorrect consumable placement or consumable marking as unqualified transmits this information to the control module, which can control the subsequent operation to skip the marked unqualified portion. The pipetting head subunit can first be connected to the sample transfer Tip head of the first capacity, and rely on the corresponding TOF sensor (that is, the TOF detection unit) to dynamically obtain whether the pipetting process is executed correctly. Of course, the sample transfer process includes the sample transfer Tip head and the pipetting head subunit connection step, the step of moving to the predetermined position after the connection, the step of absorbing the sample liquid, the step of transferring the sample liquid to the processing site such as the lysis well position step and the step of separating and recovering the sample transfer Tip head and the pipetting head subunit after the transfer is finally completed, etc. The TOF detection unit can rely on the relatively constant distance in one dimension with the pipetting head subunit, so that at least one of the above steps can be processed to realize process detection and dynamically obtain whether the step is executed correctly. In this system, the tip head that has completed sample liquid transfer is placed back into the consumables recovery well. The magnetic stirring subunit is connected to the stirring sleeve, and the corresponding TOF sensor is used to determine whether the extraction process has been correctly executed. Of course, the nucleic acid extraction process also includes a series of sub-steps, such as the stirring sleeve connection step, the stirring sleeve transfer step, the lysis step, the washing step, the elution step, etc. Similarly, the corresponding TOF sensor can detect the process results of at least one step to promptly determine whether the extraction step has been correctly executed. The stirring sleeve is placed back into the consumables recovery well. The pipette head subunit is connected to the tip head of the second volume of nucleic acid extraction liquid. The corresponding TOF sensor is used to dynamically determine whether the extraction liquid transfer and subsequent cupping process have been correctly executed. The extraction liquid transfer step in this process is similar to the previous sample liquid transfer step and method, and will not be repeated here. The cupping process is actually multiple mixed liquid transfer steps, and the amount of liquid transferred each time can be the same quantitative value.The used nucleic acid extraction liquid Tip head is similarly placed back into the consumables recovery hole to complete the pipetting and extraction operations under the monitoring of the TOF sensor, realizing the rapid and accurate acquisition of different operation results of the system in a procedural manner.

[0073] Example 10

[0074] like Figure 13As shown, this embodiment provides a method for pipetting process implemented under the monitoring of a TOF sensor. First, when starting to use, a TOF monitoring is performed on whether a Tip head already exists in the pipetting head subunit. When a connected Tip head already exists, an error signal is generated and the signal is transmitted to the control module. At this time, the control module can drive the visual camera unit to visually identify the integrated consumables according to the error signal. If the corresponding consumable position is vacant, it may be a problem caused by a power outage or other factors that cause the interruption of the experiment. At this time, further instructions can be given in combination with historical memory information. For example, a short power outage can be restored to continue execution, and a long power outage requires the termination of the experiment and a warning message is given to remind the operator to replace the sample. A waste consumables collection unit can be set for non-integrated consumables. When it is detected that a Tip head already exists in the pipetting head subunit, it can be directly transferred to the waste consumables collection unit according to the control module instruction and a removal and separation operation is performed. The TOF sensor is then used to confirm that it has been removed. When there is no Tip head connected to the pipette head subunit, the driving motor can drive the pipette head subunit to lower its height and connect with the Tip head. During at least part of the time period of completing the connection rising time, it is detected whether the pipette head subunit is connected to the Tip head. When the connection between the two is not detected, it means that the connection is not successful at this time. The connection between the pipette head subunit and the Tip head is repeatedly driven. Similarly, whether the two are correctly connected during the rising process is detected. Of course, at this time, multiple connection attempts can be made by setting a threshold number of connection attempts, for example, setting it to 2 times, 3 times, 4 times, etc. When the correct connection between the two is still not detected after the number of connection attempts exceeds the threshold, an error signal is generated and the error signal is transmitted to the control module. At this time, there may be a problem with the consumables and the inspection personnel need to replace the consumables. When the TOF sensor detects a correctly connected Tip head, it drives the pipetting submodule and the TOF installation module to move to the specified position at the same time. Of course, during the movement, the TOF sensor can detect whether the Tip head is connected normally. When it reaches the specified position, the sample liquid transfer operation can be performed, which includes multiple sub-steps, or the extraction liquid can be transferred using the Tip head of the second capacity. Similarly, it includes multiple sub-steps. Therefore, in at least part of the time period, the TOF sensor and the Tip head maintain a constant distance in one dimension. The relatively constant distance characteristic is used to dynamically obtain whether the transfer operation is performed correctly. The specific steps and solutions have been explained before and will not be repeated here.After completing the transfer of the sample liquid or extract, the pipetting submodule and the TOF mounting module are driven to the consumables recovery section. At this time, the pipetting head subunit and the Tip head are separated, and the separation operation is detected to see if it is performed correctly, similar to the connection. When it is performed correctly, the entire transfer operation is completed, and the system can perform other operations. When it is detected that the pipetting head subunit is not correctly separated from the Tip head, the separation of the pipetting head subunit and the Tip head is repeated, and similarly, it is detected whether the two are correctly separated. The threshold separation times are set to 2 times, 3 times, 4 times, etc. When the threshold times are reached and the two are not correctly separated, an error signal is generated and transmitted to the control module, thereby generating a warning message to guide the operator to check the root cause of the problem. Of course, the detection process of the stirring sleeve mounting part and the stirring sleeve of the extraction submodule is also similar to the above-mentioned pipetting process, thereby completing the detection of different sub-steps of the entire extraction process, which will not be repeated here.

[0075] This document uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only intended to help understand the method and its core concept. It should be noted that those skilled in the art may make various improvements and modifications to the present invention without departing from the principles of the present invention, and such improvements and modifications also fall within the scope of protection of the claims of the present invention.

[0076] It should be noted that the terms "comprises," "includes," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or apparatus that includes a series of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus. In the absence of further limitations, an element defined by the phrase "comprises a ..." does not preclude the presence of other identical elements in the process, method, article, or apparatus that includes the element.

[0077] In the description of the present invention, it should also be noted that, unless otherwise expressly specified or limited, the terms "disposed," "installed," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integral connections; they may refer to mechanical connections or electrical connections; they may refer to direct connections or indirect connections through an intermediate medium; and they may refer to internal communication between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

Claims

1. A device for monitoring the process operation of medical consumables using a TOF sensor, characterized in that: It comprises an intake module, which comprises at least one intake sub-unit for being directly or indirectly connected one-to-one with at least one medical consumable unit; the intake module connected to the at least one medical consumable unit moves to the sample processing module, and relies on the at least one medical consumable unit to process the sample liquid in the sample processing module; after completing the sample liquid processing, the intake module can transfer the at least one connected medical consumable unit to the consumable recovery module for recycling; the monitoring module comprises at least one TOF sensor detection unit, which can correspond to the at least one medical consumable unit and continuously obtain the distance information from the at least one medical consumable unit to the at least one TOF sensor detection unit within the time period when the at least one intake sub-unit is connected to the at least one medical consumable unit, and / or within the time period when the at least one medical consumable unit moves to the sample processing module, and / or within the time period when the at least one medical consumable unit is transferred to the consumable recovery module, and the processing module determines whether the process operation is correctly executed in different time periods based on the distance information; whether the process operation is correctly executed includes whether the medical consumable unit is connected to the intake sub-unit without tilt.

2. The device for monitoring the process operation of medical consumables using a TOF sensor according to claim 1, wherein: The acquisition module includes no less than two sub-acquisition modules, the first sub-acquisition module includes at least one first acquisition sub-unit for direct or indirect one-to-one connection with at least one first medical consumables unit; the second sub-acquisition module includes at least one second acquisition sub-unit for direct or indirect one-to-one connection with at least one second medical consumables unit.

3. The device for monitoring the process operation of medical consumables using a TOF sensor according to claim 2, wherein: The first sub-acquisition module is a pipette sub-module, which includes at least one pipette head sub-unit for direct or indirect one-to-one connection with at least one pipette Tip head; the second sub-acquisition module is a magnetic bead extraction sub-module, which includes at least one magnetic stirring sub-unit for direct or indirect one-to-one connection with at least one stirring sleeve.

4. The device for monitoring the process operation of medical consumables using a TOF sensor according to claim 3, wherein: At least one pipetting head subunit included in the pipette submodule is connected to at least one first pipetting Tip head with a first capacity in a first time period, and can be connected to at least one second pipetting Tip head with a second capacity in a second time period.

5. The device for monitoring the process operation of medical consumables using a TOF sensor according to claim 1, wherein: During different time periods of the medical consumables processing operation, the processing module can determine whether the at least one medical consumables unit is connected to the at least one acquisition sub-unit without tilt based on the distance information from the at least one medical consumables unit to the at least one TOF sensor detection unit.

6. The device for monitoring the process operation of medical consumables using a TOF sensor according to claim 1, wherein: When the distance information from the at least one medical consumables unit to the at least one TOF sensor detection unit is abnormal, the processing module generates an error signal and provides a corresponding error processing mechanism.

7. The device for monitoring the process operation of medical consumables using a TOF sensor according to claim 1, wherein: It also includes a calibration module, the distance between the calibration module and the at least one TOF sensor detection unit is a standard value, and the processing module can adaptively calibrate the accuracy of the at least one TOF sensor detection unit according to the standard distance.

8. A method for monitoring the process operation of medical consumables using a TOF sensor, characterized in that: At least one TOF sensor detection unit is capable of corresponding to at least one medical consumable unit, and continuously obtains distance information from at least one medical consumable unit to at least one TOF sensor detection unit within the time period when at least one acquisition sub-unit is connected to at least one medical consumable unit, and / or within the time period when at least one medical consumable unit is moved to the sample processing module, and / or within the time period when at least one medical consumable unit is transferred to the consumable recovery module. The processing module determines whether the processed operation is correctly performed in different time periods based on the distance information; whether the processed operation is correctly performed includes whether the medical consumable unit is connected to the acquisition sub-unit without tilt.

9. The method according to claim 8, wherein This method includes no less than two sub-acquisition modules, the first sub-acquisition module includes at least one first acquisition sub-unit for direct or indirect one-to-one connection with at least one first medical consumables unit; the second sub-acquisition module includes at least one second acquisition sub-unit for direct or indirect one-to-one connection with at least one second medical consumables unit.

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