A blood perfusion purifier system and control method for measuring coagulation status

Abstract

The present invention relates to a blood perfusion purifying system and a control method for determining a blood coagulation state. The blood perfusion purifying system includes: a blood purification circuit including an arterial-side blood circuit and a venous-side blood circuit; a blood perfusion device connected between the arterial-side blood circuit and the venous-side blood circuit, wherein the blood perfusion device includes an adsorption column, and the adsorption column is configured with at least two adsorption regions that are oppositely arranged and allow the blood to be purified to remain in contact with the adsorbent, and an observation region formed between the at least two adsorption regions and allowing the blood to be purified to flow independently; a blood state monitor for acquiring blood flow information of the blood to be purified in the observation region; and a controller configured to determine the current coagulation state of the blood perfusion device based on the blood flow information of the blood to be purified in the observation region, and selectively adjust the working states of a blood pumping device, an anticoagulant pumping device, and / or a heating device in the blood circuit based on the current coagulation state.

Description

Technical Field

[0001] The present invention relates to the technical field of blood purification equipment, and in particular to a blood perfusion purifier system and a control method for measuring the coagulation state. Background Art

[0002] Blood purification is commonly used for patients who cannot effectively remove substances from their blood. For example, when a patient has temporary or permanent renal failure, these patients and other patients may undergo extracorporeal blood treatment, such as to increase or remove substances in the blood, maintain acid / base balance, or remove excess body fluid.

[0003] Currently, the basic treatment methods of blood purification include hemodialysis (HD), hemoperfusion (HP), hemofiltration (HF), plasma exchange (PE), etc., as well as the combined application of the above multiple techniques. Hemodialysis (HD) uses the principles of diffusion, ultrafiltration, and convection to remove harmful substances and excess water in the blood, and it is one of the most commonly used renal replacement therapies. However, hemodialysis (HD) mainly removes small molecule toxins such as creatinine, urea nitrogen, uric acid, and phosphate, and has very weak or almost no ability to remove medium and large molecule toxins. Alternatively, hemoperfusion (HP) can remove medium and large molecule toxins in the blood. Therefore, hemoperfusion (HP) is often intervened during or after hemodialysis (HD) to be combined with hemodialysis (HD) for blood purification.

[0004] A blood perfusion device is a device used in the blood purification treatment method and is often used in combination with a hemodialyzer. Its working principle is: drawing the patient's blood to the outside of the body and making this part of the blood contact with the adsorbent in the blood perfusion device to remove certain exogenous or endogenous toxins by adsorption, and then returning the purified blood to the patient's body, so as to achieve the treatment purpose of purifying the blood.

[0005] When the blood circulates and flows outside the body, it is easy to generate prothrombin and deposit fibrin, causing blood coagulation. Therefore, anticoagulants need to be pre-flushed before blood purification or heparin needs to be added during blood purification to weaken the blood coagulation situation of blood purification devices (such as perfusion devices and dialyzers).

[0006] During the clinical treatment of patients undergoing blood purification, blood coagulation often occurs, which may even lead to the blockage of blood purifiers. The existing methods for evaluating blood coagulation in blood purifiers usually rely on doctors' personal experience through clinical experiments. There are strong subjective and uncertain factors, and the reference value in different coagulation scenarios is not strong, making it impossible to accurately analyze and predict the internal coagulation state of blood purifiers to provide reliable guidance for blood purification treatment.

[0007] CN113499495A discloses a coagulation status monitoring system applied to a dialyzer connected to a dialysate circuit and a blood circuit. The dialysate circuit is provided with a dialysate inlet pressure sensor for detecting the pressure at the dialysate inlet and a dialysate outlet pressure sensor for detecting the pressure at the dialysate outlet. The blood circuit is provided with a blood chamber inlet pressure sensor for detecting the pressure at the blood chamber inlet and a blood chamber outlet pressure sensor for detecting the pressure at the blood chamber outlet. The control system is used to calculate the transmembrane pressure based on the pressure at the dialysate inlet, the pressure at the dialysate outlet, the pressure at the blood chamber inlet, and the pressure at the blood chamber outlet, and calculate the flux at different times based on the transmembrane pressure. Since the transmembrane pressure increases sharply and the flux decays significantly when the coagulation of the dialyzer worsens and blocks, this solution determines the coagulation state of the dialyzer during the treatment process by monitoring the decay of the dialyzer flux. However, due to the time lag of the coagulation process, when the pressure change in the blood circuit reaches the warning value to determine the coagulation state, the coagulation process is already relatively advanced. Therefore, the method based on pressure change for monitoring has low sensitivity.

[0008] CN113962946A discloses a blood dialysis venous chamber coagulation monitoring system, including a near-infrared CMOS camera and two near-infrared LED light sources symmetrically arranged on the upper and lower sides of the near-infrared CMOS camera. A filter for eliminating the interference of ambient light is placed in front of the lens of the near-infrared CMOS camera; a polarizer for weakening the reflected light of the glass wall of the venous chamber is placed in front of the filter; the image of the venous chamber captured by the near-infrared CMOS camera is sent to the embedded system, and the setting information input by the touch screen is sent to the embedded system. The embedded system outputs a control signal to the buzzer and the near-infrared LED light source; the entire system is fixed on the mechanical sliding structure, and the mechanical sliding structure drives it to slide up and down. This solution determines the coagulation state of the venous chamber by image recognition of the blood image in the venous chamber. However, the venous chamber is usually the last execution object on the extracorporeal circulation loop of blood purification. Usually, when blood coagulation is observed in the venous chamber, the coagulation is already obvious, and it is necessary to stop the extracorporeal blood circulation treatment process. However, suddenly interrupting the blood circulation may make the patient feel uncomfortable or even cause life-threatening risks.

[0009] In addition, on the one hand, there are differences in the understanding of those skilled in the art; on the other hand, when the applicant made this invention, a large number of documents and patents were studied, but due to space limitations, all details and content were not listed in detail. However, this by no means means that this invention does not possess the features of these prior arts. On the contrary, this invention already possesses all the features of the prior arts, and the applicant reserves the right to add relevant prior arts in the background art. Summary of the Invention

[0010] With the increase in the number of patients in need of blood purification, the demand for hemodialysis devices will increase significantly, and at the same time, there are higher requirements for the effect of blood purification. The prior art attempts to monitor different coagulation states through image detection of hemodialyzers to accurately issue a coagulation warning during hemodialysis. For example, the patent document with the publication number CN106770282A discloses a blood dialysis extracorporeal circulation coagulation classifier, which includes a detection box for enclosing a dropper or a dialyzer of an extracorporeal circulation pipeline therein, and a detection unit including an infrared emission structure and an external red line receiving structure. Both the infrared emission structure and the external red line receiving structure are arranged on the inner side wall of the detection box, and the infrared emission structure and the external red line receiving structure are arranged opposite to each other. The area corresponding to each point is calculated through the resolution of the infrared image, and the actual coagulation area is obtained by multiplying the total number of coagulation points by the area corresponding to each point, thereby realizing blood classification and coagulation judgment. This technical solution can automatically classify the coagulation of blood in the dialyzer and the extracorporeal circulation pipeline through infrared image detection, providing an accurate alarm basis for the occurrence of coagulation. However, this technical solution is only used for the detection of the current blood state and cannot take immediate blood purification parameter regulation measures according to the change of the blood state. If the medical staff is still notified in the form of an alarm and then corresponding emergency treatment is carried out, the coagulation state information at this time has also lagged behind the actual coagulation state, and the coagulation process of the patient has also been relatively advanced, and the timely response degree for preventing the occurrence of coagulation state according to this technical solution is also relatively low. In view of the deficiencies of the prior art, the present invention provides a hemoperfusion purifying system and a control method for measuring the coagulation state, aiming to solve at least one or more technical problems existing in the prior art.

[0011] To achieve the above object, the present invention provides a hemoperfusion purifying system for measuring the coagulation state, including:

[0012] A blood purification circuit, including an arterial side blood circuit connected to the patient's artery and a venous side blood circuit connected to the patient's vein;

[0013] A hemoperfusion device is connected between an arterial-side blood circuit and a venous-side blood circuit. The hemoperfusion device includes an adsorption column, and the adsorption column is configured with at least two adsorption regions that are oppositely arranged and allow the blood to be purified to remain in contact with the adsorbent, and an observation region formed between the at least two adsorption regions that allows the blood to be purified to flow independently;

[0014] A blood state monitor for obtaining blood flow information of the blood to be purified in the observation region;

[0015] A controller configured to determine the current coagulation state of the hemoperfusion device based on the blood flow information of the blood to be purified in the observation region, and selectively adjust the operating states of a blood pumping device, an anticoagulant pumping device, and / or a heating device in the blood circuit based on the current coagulation state.

[0016] Compared with the prior art, the present invention can determine the progress degree of the current coagulation state of the hemoperfusion device according to the blood flow information of the blood to be purified in the observation region, and can selectively adjust the operating states of a blood pumping device, an anticoagulant pumping device, and / or a heating device in the blood circuit according to the current coagulation state. Based on the above distinguishing technical features, the technical problem to be solved by the present invention is how to provide control parameters for adjusting the purified blood to prevent the occurrence of a coagulation state. The coagulation process does not occur instantaneously and usually has a time lag. Even if parameters such as flow rate and pressure threshold are set and the machine is used to supervise and alarm instead of manual operation, coagulation cannot be detected in time, resulting in improper alarm timing or treatment measures for the coagulation result. The venous chamber is the last execution object for returning the purified blood to the patient's body through extracorporeal circulation. Usually, when blood coagulation is observed in the venous chamber, the coagulation is already relatively obvious. Compared with monitoring blood coagulation in the venous chamber, the present invention monitors the blood flow state at the blood purification region, that is, at the hemoperfusion device, to judge the blood coagulation state, greatly alleviating the lag in the judgment and treatment of the coagulation process caused by coagulation monitoring downstream of the hemoperfusion device (such as in the venous chamber), and determining the coagulation process as early as possible, and correspondingly adjusting the operating parameters of the relevant devices affecting the blood flow process in the blood purification circuit to promote the smooth extracorporeal circulation of blood, ensure the continuity of the blood purification process, and avoid sudden changes in the blood pressure difference between inside and outside the patient's body causing physiological discomfort.

[0017] On the other hand, when the present invention monitors the blood flow state of the blood to be purified at the hemoperfusion device, it does not directly monitor the blood flow state in the entire hemoperfusion device. Instead, an observation area is separately set up to monitor the blood flow state in this observation area. This is because different types of adsorption columns (such as activated carbon, resin, or cytokines) result in diverse blood flow states when the blood contacts the adsorption column, which increases the difficulty of image analysis and recognition by the processor. In particular, the color performance of the adsorption column itself may increase the duration and error of blood feature extraction and analysis, thereby affecting the accuracy of the judgment of the coagulation state and the response rate. Therefore, setting up an independent observation area is beneficial for the controller to obtain accurate coagulation information, especially clear blood flow images. By setting up a separate observation area for the blood flow state, the present invention can more clearly and accurately detect the image information of different types of coagulation states. For example, the image information representing different coagulation states includes: the blood color significantly deepens; dark shadows or stripes appear in the hemoperfusion device; and blood clots or foams can be seen in the hemoperfusion device, etc. Different coagulation states require adjustment of different blood purification control parameters to reduce the possibility of the patient developing a coagulation state. That is to say, the present invention can accurately analyze the image information of the coagulation state through the observation area that allows the blood to be purified to flow independently, thereby being able to provide a more accurate reference for the adjustment parameters of the working states of the blood pumping device, anticoagulant pumping device, and / or heating device in the blood circuit, and thus being able to timely and accurately delay the risk of coagulation in the patient. Further, in the prior art, there already exists a hemoperfusion device structure with inlets and outlets provided at both ends. For example, the patent document with the publication number CN204618991U discloses a hemoperfusion device, which includes an inlet end for allowing blood to flow into the hemoperfusion device, an outlet end for allowing blood to flow out of the hemoperfusion device, the inlet end is provided below the outlet end, and an adsorption module that is detachably connected between the inlet end and the outlet end in sequence. However, there is no observation area in this technical solution of the present invention that allows the blood to be purified to flow independently. Therefore, even if the above prior art is combined, it cannot obtain the technical solution of the present invention that can achieve more accurate detection of coagulation state information.

[0018] Preferably, the controller performs the adjustment of the working states of the blood pumping device, anticoagulant pumping device, and / or heating device in the blood circuit in an interrelated manner.

[0019] Preferably, the controller can determine the adjustment priority of any one of the blood pumping device, anticoagulant pumping device, and heating device in the blood circuit based on the patient type.

[0020] Preferably, the controller determines the adjustment of the working states of the blood pumping device, anticoagulant pumping device, and / or heating device in the blood circuit in association with the patient's coagulation type.

[0021] Preferably, the adjustment of the operating states of the blood pumping device, anticoagulant pumping device, and / or heating device in the blood circuit by the controller is determined in association with the coagulation type of the patient, including:

[0022] If the target patient is of the coagulable type, the controller stops the operation of the blood pumping device, anticoagulant pumping device, and / or heating device, and generates a warning reminder signal to at least one processing terminal in a manner that associates the coagulation status information with a time stamp and the patient number with each other;

[0023] If the target patient is of the non - coagulable type, the controller dynamically adjusts the output power and / or output time of the blood pumping device, anticoagulant pumping device, and / or heating device based on the coagulation status information.

[0024] Based on the embodiments that are different from the prior art, the technical problem to be solved by the present invention is how to accurately control the parameters related to blood purification according to the coagulation type of the target patient. In the above prior art, the coagulation grade and coagulation judgment are obtained by analyzing the infrared image information. When coagulation is judged, an alarm signal is sent out. At this time, the medical staff takes emergency treatment measures to relieve the coagulation phenomenon according to the alarm signal. Before specifically taking the emergency treatment measures, the medical staff still need to determine the corresponding coagulation type by manual judgment. On the contrary, when the patient has an unexpected coagulation phenomenon, the present invention fully considers the coagulation characteristics of the patient, and achieves the following: for patients with easy coagulation, to ensure their life safety by stopping the continuation of the blood purification cycle; for patients with difficult coagulation, according to their possible coagulation states (such as the coagulation ratio), to intervene in the blood purification treatment process, and timely adjust the blood pump flow rate, anticoagulant pump flow rate and / or heating power to ensure the continuity of the extracorporeal circulation treatment of blood purification. Specifically, the present invention can adopt different blood purification treatment process control parameters according to the different coagulation abilities (easy coagulation type and difficult coagulation type) of the patient. Based on the different coagulation abilities of different patients, the present invention can characterize different coagulation types through different determination methods. For example, patients with the easy coagulation type can be represented as having a coagulation duration or coagulation area / ratio greater than the set value in a certain or certain treatment cycles; the difficult coagulation type can be represented as having a coagulation duration or coagulation area / ratio less than the set value in a certain or certain treatment cycles. Since blood purification is usually a medical task that needs to be maintained irregularly and for a long time, the coagulation type of the patient can be determined by the medical staff according to the patient's historical blood purification data. The present invention can import the physiological indexes and their coagulation state indexes of various patients as input set data into the corresponding machine learning model, and use some of the data as the test set, so as to train the corresponding coagulation state evaluation model for determining the coagulation performance of the patient, so as to quickly know the possible coagulation performance of the newly admitted patient in the later stage, and thus carry out coagulation intervention in the blood purification process in advance.

[0025] Preferably, the blood state monitor is configured to acquire a blood flow image of the observation area, so that the controller can determine the coagulation grade of the hemoperfusion device based on the blood flow image. Based on an embodiment that is different from the above-mentioned prior art, the technical problem to be solved by the present invention is how to determine the corresponding coagulation grade through the acquired blood flow image. As mentioned above, different blood flow images in the observation area can reflect different blood flow states. The controller in the present invention can determine the coagulation ratio in the hemoperfusion device based on the ratio of the second coagulation value to the cross-sectional area of the hemoperfusion device, that is, the ratio of blood aggregates such as blood clots, blood coagulation flocs or blood coagulation groups in the entire blood-containing cavity of the hemoperfusion device. The meaning of the above-mentioned second coagulation value is significantly different from the coagulation grade judgment method in the above-mentioned prior art and the meaning of the first coagulation value in this application. The first coagulation value in this application has the same meaning as the coagulation ratio in the above-mentioned prior art, that is, the controller determines the first coagulation value based on the ratio of the total number of points (that is, the sum of the number of pixel points with a gray value greater than the set value) to the resolution of the observation area image, and this first coagulation value represents the actual coagulation area in the observation area. Different from the above technical solution, the second coagulation value of the present invention is determined by the ratio of the resolution of the observation area image to the resolution of the hemoperfusion device image, and this second coagulation value represents the total coagulation area in the hemoperfusion device. That is to say, the second coagulation value in this application can be more accurately matched with the real coagulation grade image information, so as to achieve more accurate coagulation state recognition and judgment.

[0026] Preferably, the hemoperfusion device purification system provided by the present invention further includes a clamping module for clamping the hemoperfusion device, and the hemoperfusion device is rotatably installed in the clamping module to allow the blood state monitor to acquire blood flow images of the hemoperfusion device at multiple rotational positions.

[0027] Preferably, the present invention also relates to a control method based on the coagulation state of a hemoperfusion device, including the following steps:

[0028] Provide an arterial-side blood circuit connected to the patient's artery and a venous-side blood circuit connected to the patient's vein;

[0029] Provide a hemoperfusion device connected between the arterial-side blood circuit and the venous-side blood circuit, wherein the hemoperfusion device includes an adsorption column, and the adsorption column is configured with at least two adsorption regions that are oppositely arranged and allow the blood to be purified to remain in contact with the adsorbent, and an observation region formed between the at least two adsorption regions that allows the blood to be purified to flow independently;

[0030] Acquire the blood flow information of the blood to be purified in the observation region;

[0031] Determine the current coagulation state of the hemoperfusion cartridge based on the blood flow information of the blood to be purified in the observation area, and optionally adjust the blood pumping state, anticoagulant pumping state, and / or heating state in the blood circuit based on the current coagulation state.

[0032] Preferably, optionally adjusting the blood pumping state, anticoagulant pumping state, and / or heating state in the blood circuit based on the current coagulation state includes:

[0033] Adjust the adjustment priority for any one of the blood pumping state, anticoagulant pumping state, and heating state in the blood circuit in a manner associated with the patient type based on the patient's current coagulation state;

[0034] And / or optionally perform any one of the actions of stopping blood pumping, anticoagulant pumping, and heating in the blood circuit, or dynamically adjust the power and / or time of blood pumping, anticoagulant pumping, and / or heating in the blood circuit in a manner associated with the patient's coagulation type based on the patient's current coagulation state.

[0035] Preferably, determining the current coagulation state of the hemoperfusion cartridge based on the blood flow information of the blood to be purified in the observation area includes:

[0036] Traverse the gray values of each pixel point in the blood flow image of the observation area of the hemoperfusion cartridge;

[0037] Record the total number of pixel points in the blood flow image whose gray values are greater than the set value;

[0038] Determine a first coagulation value representing the current coagulation state of the hemoperfusion cartridge based on the ratio of the total number of pixel points to the resolution of the blood flow image of the observation area. Brief Description of the Drawings

[0039] Figure 1 It is a schematic diagram of pipeline connection in the clinical application of a hemoperfusion cartridge under a preferred embodiment;

[0040] Figure 2 It is a schematic cross-sectional view of a hemoperfusion cartridge according to a preferred embodiment provided by the present invention.

[0041] List of Reference Numerals

[0042] 10: Adsorption area; 20: Observation area. Detailed Description of the Embodiment

[0043] The preferred embodiments of the present invention are described in detail below in conjunction with the accompanying drawings, so that the advantages and features of the present invention can be more easily understood by those skilled in the art, thereby making a clearer and more explicit definition of the protection scope of the present invention. Although the exemplary embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments described herein.

[0044] The blood perfusion device includes an adsorption column. An inlet end and an outlet end are respectively provided at both ends of the adsorption column, wherein the inlet end is used to connect to the arterial blood circuit, and the outlet end is used to connect to the venous blood circuit. Further, the adsorption column has a hollow filter chamber. The filter chamber is filled with an adsorbent. Optionally, the adsorbent can be any one or more of a resin adsorbent and a cytokine adsorption column.

[0045] like Figure 1 As shown in the figure, the process and principle of blood purification by the hemoperfusion device are as follows: the arterial blood circuit, driven by the blood pump, introduces the human blood into the inlet end of the hemoperfusion device, and the blood contacts the solid adsorbent in the adsorption column, and the adsorbent adsorbs the medium and large molecular toxins in the blood to filter them out. Then the purified blood flows out from the outlet end of the hemoperfusion device to the venous blood circuit and reaches the venous pot, where the gas in the purified blood is removed and then the blood is returned to the human vein.

[0046] Before the patient is given blood perfusion treatment, it is necessary to pre-flushing the blood purification line to completely remove the gas and impurities in the blood perfusion device and the extracorporeal circulation line to avoid air embolism. At the same time, exhausting the air in the blood purification line as much as possible can also reduce the probability of coagulation inside the perfusion device in the later treatment. Specifically, the process of removing the gas and impurities in the blood perfusion device and the extracorporeal circulation line is: the liquid storage bag encapsulated with the priming liquid is connected to the inlet end of the adsorption column of the blood perfusion device through the arterial side line, and the waste liquid bag for storing the discharged waste is connected to the outlet end of the adsorption column of the blood perfusion device through the venous side line. When the arterial side line is connected, the priming liquid is introduced through the arterial side line through the inlet end of the adsorption column; and when the venous side line is connected, the priming waste liquid and bubbles in the adsorption column are discharged through the outlet end of the adsorption column.

[0047] According to a preferred embodiment, the exhaust process before performing hemoperfusion treatment on a patient may generally include a dynamic exhaust phase and a static exhaust phase. In particular, when exhausting the gas and impurities in the hemoperfusion device and the extracorporeal circulation circuit, the dynamic exhaust phase and the static exhaust phase may be performed in sequence, or only one of the exhaust phases may be performed.

[0048] Specifically, the dynamic exhaust stage can represent the process in which the pre-flush liquid from the liquid storage bag is introduced into the adsorption column through the arterial side pipeline, the adsorption column is flushed with the pre-flush liquid, and the pre-flush liquid after flushing, together with bubbles and impurities, is discharged from the adsorption column through the venous side pipeline. Further, the dynamic exhaust stage can include a first exhaust stage in which, with the arterial side pipeline in the conducting state, the pre-flush liquid circulates through the adsorption column and is continuously discharged outward through the venous side pipeline, and a second exhaust stage in which, with the arterial side pipeline in the closed state, the pre-flush liquid remaining inside the adsorption column is continuously discharged outward through the venous side pipeline. During the first exhaust stage or the second exhaust stage, one or more of knocking, tilting, and rotating can be applied to the adsorption column to assist the bubbles inside the adsorption column to be discharged through the venous side pipeline. On the other hand, the static exhaust stage can represent the process of leaving the adsorption column stationary to enable the bubbles inside the adsorption column to be discharged from the outlet end of the adsorption column.

[0049] As an illustration of a non-limiting example, the exhaust system of the hemoperfusion device can include a pre-flush module, a first detection module, a second detection module, and a processing module. The processing module is electrically connected to the pre-flush module, the first detection module, and the second detection module. Specifically, the pre-flush module can be disposed on the arterial side pipeline to introduce the pre-flush liquid of the liquid storage bag into the adsorption column through the arterial side pipeline when the arterial side pipeline is conducting. Further, the pre-flush module can include a liquid storage unit and a pumping unit (such as a peristaltic pump). The pumping unit is used to provide power to the arterial side pipeline to introduce the pre-flush liquid in the liquid storage unit (such as a liquid storage bag) into the adsorption column through the arterial side pipeline, and then discharge the pre-flush liquid inside the adsorption column to the waste liquid bag through the venous side pipeline, and discharge the bubbles and impurities inside the adsorption column through this flow cycle.

[0050] Optionally, the first detection module can be disposed on the venous side blood return line to obtain bubble information of the liquid on the venous side pipeline. As an illustration of a non-limiting example, the first detection module can be a detection circuit based on the optical principle, and specifically can include an infrared light emitter, an infrared light receiver, a signal amplifier, etc. Particularly, when there are bubbles in the liquid in the venous side pipeline, the amount of infrared light transmitted received by the infrared light receiver is different from the amount of infrared light transmitted generated only by irradiating on the liquid, causing a change in the resistance value generated by the infrared light receiver, and further causing a change in the output voltage of the infrared light receiver. Moreover, the output voltage value of the infrared light receiver is usually positively correlated with the amount of bubbles in the liquid on the venous side pipeline. Therefore, when exhausting the adsorption column, the bubble information (such as the amount of bubbles) of the liquid on the venous side pipeline can be obtained based on the output voltage value of the first detection module.

[0051] Optionally, the second detection module can be used to monitor the cumulative conduction time of the arterial-side pipeline. As an illustration of a non-limiting example, the second detection module can be an RC circuit, and its principle is as follows: the switch control circuit outputs a high level to charge the capacitor in response to the access of the conduction signal, and the cumulative charging time of the capacitor corresponds to the cumulative conduction time of the arterial-side pipeline. The longer the charging time of the capacitor, the greater the output voltage of the capacitor. Therefore, the output voltage value of the capacitor can be used to characterize the cumulative conduction time of the arterial-side pipeline. In other words, according to the output voltage value of the capacitor, the time for the pre-flush liquid to cumulatively flush the adsorption column can be determined.

[0052] Optionally, the processing module can include a control unit and a calculation unit. The control unit can include a switch control circuit and pipeline clamps. Specifically, the pipeline clamps include an arterial clamp disposed on the arterial-side pipeline and a venous clamp disposed on the venous-side pipeline. The switch control circuit can be used to separately control the arterial clamp and the venous clamp to switch the on-off states of the arterial-side pipeline and the venous-side pipeline. When the switch control circuit opens the arterial clamp and / or the venous clamp in response to the conduction signal generated by the calculation unit, the arterial-side pipeline and / or the venous-side pipeline is / are conducted, and the pre-flush liquid is introduced into the arterial-side pipeline and / or the venous-side pipeline. In particular, the venous clamp and its corresponding venous-side pipeline are usually kept connected throughout the air exhaust stage, so that the air bubbles in the adsorption column can be discharged to the waste liquid bag through the venous pipeline.

[0053] Optionally, the calculation unit is used to compare and calculate the first voltage value generated by the first detection module and / or compare the second voltage value generated by the second detection module. Specifically, when the first voltage value generated by the first detection module is greater than the first preset voltage value (i.e., the amount of air bubbles in the liquid on the venous-side pipeline is greater than the set value), and / or the second voltage value generated by the second detection module is less than the second preset voltage value (i.e., the cumulative conduction time of the arterial-side pipeline is less than the set value), it indicates that the adsorption column has not been sufficiently flushed and exhausted by the pre-flush liquid, and thus the pre-flush liquid needs to be continuously used to exhaust the adsorption column. On the contrary, if the first voltage value generated by the first detection module is less than the first preset voltage value (i.e., the amount of air bubbles in the liquid on the venous-side pipeline is less than the set value), and the second voltage value generated by the second detection module is greater than the second preset voltage value (i.e., the cumulative conduction time of the arterial-side pipeline is greater than the set value), it indicates that the air exhaust stage of the adsorption column can end, and then the calculation unit can generate a shutdown signal and shut off the arterial-side pipeline through the control unit.

[0054] After the pre-flush and air exhaust stage ends, the arterial-side pipeline is connected to the patient's artery and the venous-side pipeline is connected to the patient's vein to prepare for hemoperfusion treatment.

[0055] Example 1

[0056] The present invention provides a blood perfusion purifying system for determining the coagulation state, which may include a blood purification circuit, a blood perfusion device, a blood state monitor, a controller, and devices such as a blood pumping device (e.g., a blood pump), an anticoagulant pumping device (e.g., a heparin pump), and a heating device (e.g., a heater) arranged on the blood purification circuit.

[0057] Specifically, the blood purification circuit may include an arterial-side blood circuit and a venous-side blood circuit connected to a blood perfusion device having an adsorption column and / or a dialyzer having a hollow fiber membrane. An arterial-side puncture needle and a venous-side puncture needle are installed at the respective front ends of the arterial-side blood circuit and the venous-side blood circuit, and the arterial-side puncture needle and the venous-side puncture needle are respectively punctured into the patient's artery and vein for extracorporeal circulation treatment of blood purification.

[0058] According to a preferred embodiment, the blood perfusion device may include an adsorption column having an inlet end connected to the arterial-side blood circuit and an outlet end connected to the venous-side blood circuit, and an adsorbent is filled therein. Figure 2 The cross-sectional structural schematic diagram of a blood perfusion device according to a preferred embodiment provided by the present invention is shown. Specifically, the blood perfusion device of the present invention has discontinuously or spaced adsorption columns, that is, the adsorption column has at least two adsorption regions 10 arranged oppositely and an observation region 20 formed between at least two adsorption regions 10. Specifically, at least two adsorption regions 10 are respectively and independently filled with adsorbent particles, so that when the blood to be purified flows through the adsorption regions 10, it can keep in contact with the adsorbent particles filled in the adsorption regions 10 to allow the adsorbent particles to filter blood impurities. And an independent observation region 20 allowing the blood state monitor to obtain blood flow information is constructed between at least two adsorption regions 10 arranged oppositely, so that the system controller can determine the coagulation process on the blood purification circuit according to the blood flow information. Preferably, the observation region 20 of the blood perfusion device is not filled with adsorbent, so that the blood to be purified can flow in the observation region 20 in a manner not in contact with the adsorbent. Optionally, at least two adsorption regions 10 can be spaced by a fiber membrane or a baffle structure with filter holes, so as to form an observation region 20 not filled or incompletely filled with adsorbent particles therebetween.

[0059] According to a preferred embodiment, in the present invention, the blood state monitor is configured to obtain blood flow information of the blood to be purified in the observation region 20. Optionally, the blood state monitor of the present invention may be an acquisition module based on image detection. Specifically, the blood state monitor may include an image acquisition module, and the image acquisition module may be a digital camera with a built-in flash or a combination of a digital camera and a light source, and can be used to acquire an image formed by transmitted or reflected light generated by the blood perfusion device.

[0060] By way of illustration of a non-limiting example, the image acquisition module may include a near-infrared light source, a near-infrared camera, and a motion adjustment module. The near-infrared light source may be arranged on both sides of the near-infrared camera. The near-infrared light source and the near-infrared camera may be mounted on the motion adjustment module. Optionally, the motion adjustment module is a mechanical sliding structure, which may include a motor, a connecting rod, and a fixing clip. The near-infrared camera is fixed by the fixing clip, and the motor drive can be used to control the near-infrared camera to obtain blood flow images at different interval positions in the observation area 20 of the hemoperfusion device.

[0061] According to a preferred embodiment, the blood coagulation state of the hemoperfusion device at the observation area 20 obtained by using the image acquisition module can be determined, for example, by the following method:

[0062] In response to the received observation area image containing blood flow information acquired by the image acquisition module in the blood state monitor, the controller traverses the gray values of each pixel point in the hemoperfusion device observation area image.

[0063] The controller records each pixel point in the hemoperfusion device observation area image with a gray value greater than the set value and obtains the total number of points. That is, the light transmittance of normal blood is better, and the light transmittance of coagulated blood is poor. Therefore, the gray value at the coagulated part is larger, and the gray value at the normal blood part is smaller. By judging the gray value, it can be determined whether the pixel point belongs to coagulated blood or normal blood.

[0064] The controller can determine a first coagulation value based on the ratio of the total number of points (i.e., the sum of the number of pixel points with a gray value greater than the set value) to the resolution of the observation area image. This first coagulation value can represent the actual coagulation area in the observation area 20.

[0065] Further, the controller can determine a second coagulation value based on the ratio of the resolution of the observation area image to the resolution of the hemoperfusion device image. This second coagulation value can represent the total coagulation area in the hemoperfusion device. Specifically, the second coagulation value can be determined by the product of the first coagulation value and the ratio of the volume (or cross-sectional area) of the hemoperfusion device to the volume (or cross-sectional area) of the observation area 20.

[0066] According to a preferred embodiment, the controller can determine the coagulation ratio in the hemoperfusion device based on the ratio of the second coagulation value to the cross-sectional area of the hemoperfusion device, that is, the ratio of blood aggregates such as blood clots, blood flocs, or blood clumps in the entire blood-containing cavity of the hemoperfusion device. Further, the coagulation ratio in the hemoperfusion device can characterize the coagulation grade (or coagulation degree) of the hemoperfusion device, thereby allowing the controller to adjust the working state of related devices affecting the coagulation progress in the blood circuit based on the coagulation ratio (or coagulation degree) of the hemoperfusion device.

[0067] According to a preferred embodiment, before determining the coagulation state of the hemoperfusion cartridge using the blood flow image obtained by the blood state monitor, it is usually necessary to preprocess the obtained blood flow image. Specifically, the preprocessing of the blood flow image may include image skew correction, grayscale processing, and generating an image matrix. The skew image can be corrected using the Hough method. The grayscale processing may be to convert the color image into a grayscale image according to the grayscale processing formula. The image matrix is to process each pixel point in the image into a numerical value within a certain range according to a set algorithm, so as to convert the pixels of the image into a two-dimensional matrix form.

[0068] Alternatively, in addition to using image recognition to analyze the blood flow image to determine the coagulation state of the hemoperfusion cartridge, it can also be completed by monitoring the blood flow pressure change of the hemoperfusion cartridge. That is, the blood state monitor described in the present invention may also include pressure sensors arranged at the inlet and outlet of the hemoperfusion cartridge. Specifically, by recording the blood pressure change information at the inlet and outlet of the hemoperfusion cartridge, and calculating through the corresponding difference, the change in the blood flow rate in the hemoperfusion cartridge can be determined, so as to determine the coagulation state of the hemoperfusion cartridge. It can be understood that many related solutions for monitoring the coagulation state change of the pipeline using pressure change have been disclosed in the prior art. To avoid being verbose, they will not be elaborated here.

[0069] According to a preferred embodiment, the hemoperfusion cartridge purification system may further include a clamping module for clamping the hemoperfusion cartridge, so that the hemoperfusion cartridge can be rotatably installed in the clamping portion of the clamping module. Optionally, the clamping portion of the clamping module may be a robotic arm in the prior art, which can be realized through a motor drive circuit. In particular, the rotatable installation of the hemoperfusion cartridge in the clamping module enables the hemoperfusion cartridge to have multiple rotation positions, thereby allowing the blood state monitor to obtain multiple blood flow images of the hemoperfusion cartridge at multiple different rotation positions.

[0070] According to a preferred embodiment, the controller is communicatively coupled to the blood state monitor and is configured to determine the current coagulation state of the hemoperfusion cartridge based on the blood flow information (such as blood flow image) of the blood to be purified in the observation area 20, and selectively adjust the working states of the blood pumping device, anticoagulant pumping device, and / or heating device in the blood circuit based on the current coagulation state.

[0071] According to a preferred embodiment, in response to the first coagulation value and / or the second coagulation value of the hemoperfusion device or the observation area 20 of the hemoperfusion device obtained in the above manner, the controller dynamically adjusts the operating states of devices affecting the blood coagulation state in the blood circuit, such as the blood pumping device, the anticoagulant pumping device, and / or the heating device, etc., to slow down the blood coagulation progress in the blood circuit and promote the smooth flow of extracorporeal blood circulation. Specifically, the adjustment of the operating state of the blood pumping device by the controller can be to adjust the blood pumping flow rate, the blood pumping time, or a combination thereof. The adjustment of the operating state of the anticoagulant pumping device by the controller can be to adjust the anticoagulant pumping flow rate, the anticoagulant pumping time, or a combination thereof. The adjustment of the operating state of the heating device by the controller can be to adjust the heating temperature, the heating time, or a combination thereof.

[0072] As an example, when the first coagulation value and / or the second coagulation value is greater than the coagulation set value, the controller can perform one or more actions of increasing the power of the blood pumping device, increasing the output of the anticoagulant pumping device, or increasing the heating temperature of the heating device.

[0073] According to a preferred embodiment, the adjustment of any one of the blood pumping device, the anticoagulant pumping device, and the heating device by the controller is performed in an associated manner. For example, when the coagulation grade (or degree of coagulation) of the hemoperfusion device or the observation area 20 of the hemoperfusion device increases from the first coagulation grade (i.e., greater than the first coagulation set value and less than the second coagulation set value) to the second coagulation grade (i.e., greater than the second coagulation set value), compared with the first coagulation grade, when increasing the content of anticoagulant (such as heparin, heparin analogs, or citric acid, etc.) output by the anticoagulant pumping device, the blood pumping rate / flow rate of the blood pumping device can be appropriately reduced instead of continuously increasing the blood pumping speed. This is because although increasing the blood pumping speed (or blood flow rate) can slow down the blood coagulation progress to a certain extent, it should not be too high, otherwise it will cause physiological discomfort to the patient. At the same time, too high a blood pumping speed is likely to cause incomplete contact between the anticoagulant and thrombin or coagulation factors in the blood, reducing the anticoagulant effect; in addition, the blood pumping speed is also restricted by multiple factors such as the patient's age, weight, and disease.

[0074] In particular, the control and adjustment of the operating states of devices affecting the blood coagulation state, such as the blood pumping device, the anticoagulant pumping device, and / or the heating device, by the controller based on the coagulation state (i.e., the first coagulation value and / or the second coagulation value) of the hemoperfusion device or the observation area 20 of the hemoperfusion device can come from the self-setting of medical staff, or preferably from the results of custom threshold programming and machine learning.

[0075] According to a preferred embodiment, in the present invention, the adjustment of the operating states of the blood pumping device, anticoagulant pumping device, and / or heating device in the blood circuit by the controller is determined in association with the coagulation type of the patient. Specifically, based on the patient's coagulation ability, the coagulation type of the patient can be roughly divided into the easy-to-coagulate type and the not-easy-to-coagulate type. These two types of patients usually show relatively obvious or stable coagulation signs during multiple blood purification treatments. For example, patients of the easy-to-coagulate type can indicate that during a certain or certain treatment cycles, the duration of coagulation or the coagulation area / ratio is greater than the set value. Conversely, the not-easy-to-coagulate type can indicate that during a certain or certain treatment cycles, the duration of coagulation or the coagulation area / ratio is less than the set value.

[0076] In particular, since blood purification is usually a medical task that needs to be maintained irregularly and for a long time, the coagulation type of the patient can be determined by medical staff based on the patient's historical blood purification data. Further, whether a patient is easy to coagulate is usually closely related to various indicators of the patient, such as age, gender, height, weight, blood sugar, blood lipid, and past medical history (such as hypertension, tumors, etc.). Therefore, the physiological indicators and coagulation state indicators of various patients can be used as input set data and imported into the corresponding machine learning model, and part of the data can be used as the test set. Thus, a corresponding coagulation state assessment model for determining the coagulation performance of the patient can be trained, so as to quickly know the possible coagulation performance of newly admitted patients in the later stage, and thus carry out coagulation intervention during blood purification in advance.

[0077] As an illustration of a non-limiting example, when the target patient is of the easy-to-coagulate type, the controller selects to stop the operation of the blood pumping device, anticoagulant pumping device, and / or heating device, and generates a corresponding warning reminder signal to at least one processing terminal that can be carried by medical staff in a manner that associates the coagulation state information with a time stamp and the patient number (such as the bed number). The coagulation function of patients with easy coagulation is poor. Continuing with blood purification treatment is likely to further exacerbate the degree of coagulation in the blood circuit. Especially when the pump blood flow is high, due to more blood coagulating outside the body, the difference between the amount of blood flowing back into the patient's body and the amount of blood drawn out of the body is greater, which is likely to pose a threat to the safety of the patient. When the target patient is of the not-easy-to-coagulate type, the controller dynamically adjusts the operating state of at least one of the blood pumping device, anticoagulant pumping device, and heating device based on the change in the patient's coagulation state, such as adjusting the blood pumping flow of the blood pumping device or the pumping time at different blood flows.

[0078] According to a preferred embodiment, in the present invention, the adjustment priority of the controller for any one of the blood pumping device, anticoagulant pumping device, and / or heating device in the blood circuit is executed based on the patient type. Specifically, for different types of blood purification patients, the best means for adjusting the coagulation state should be determined based on the blood purification purpose of the target patient or the type of the blood purification patient. For example, if the patient is an arteriovenous fistula patient, during blood purification, if the coagulation grade represented by the hemoperfusion cartridge increases, what the controller preferentially executes can be to increase the output of the anticoagulant pumping device rather than increasing the blood flow output of the blood pumping device. Because fistula patients are very sensitive to blood flow, and it is not easy to grasp the correlation between blood flow and the limit that fistula patients can bear. Therefore, once the blood flow suddenly increases, it may cause the blood vessel wall of the fistula to collapse and be damaged. Or, if the patient is a patient with heart failure, since high blood flow is likely to increase the burden on the heart, the range of blood flow that this type of patient can adapt to is limited compared to other patients. Then, the coagulation state in the blood circuit is preferentially improved by adjusting the anticoagulant pumping device and / or heating device. Or, if the patient is a patient with a synthetic vascular graft, because the lumen of the synthetic blood vessel is large and not easy to collapse, and has strong tolerance, it can adapt to a higher blood flow compared to ordinary patients. Therefore, not only can the way of increasing the output of the blood pumping device be preferentially executed, but also the range of blood flow set by the controller for the blood pumping device can be larger compared to other types of patients.

[0079] The hemoperfusion cartridge is usually used in combination with a hemodialyzer. Therefore, in Figure 1 In the schematic diagram of the hemoperfusion cartridge pipeline shown, a hemodialyzer (not shown in the figure) can also be connected in series upstream or downstream of the hemoperfusion cartridge. In view of this, the blood state monitor described in the present invention can also be used to obtain the blood flow information of the blood to be purified in the hemodialyzer.

[0080] Example 2

[0081] On the other hand, the present invention also provides a method for intervening in the coagulation state of a hemoperfusion cartridge, or a coagulation control method based on the coagulation state of a hemoperfusion cartridge. The hemoperfusion cartridge purification system as described in Example 1 can be used. This method can include the following steps:

[0082] Use the blood state monitor to obtain the blood flow information of the blood to be purified in the observation area 20 of the blood pressure hemoperfusion cartridge;

[0083] Based on the blood flow information of the blood to be purified in the observation area 20 of the blood pressure hemoperfusion cartridge, determine the current coagulation state of the hemoperfusion cartridge, and optionally adjust the blood pumping state, anticoagulant pumping state, and / or heating state in the blood circuit based on the current coagulation state.

[0084] According to a preferred embodiment, selectively adjusting the blood pumping state, anticoagulant pumping state, and / or heating state in the blood circuit based on the current coagulation state may include:

[0085] Adjusting the adjustment priority for any one of the blood pumping state, anticoagulant pumping state, and heating state in the blood circuit in a manner associated with the patient type based on the patient's current coagulation state. For example, when the patient is a patient with heart failure, priority is given to improving the coagulation state in the blood circuit by adjusting the anticoagulant pumping device and / or heating device. When the patient is a patient with artificial blood vessel transplantation, the pump blood flow of the blood pumping device can be increased preferentially.

[0086] Furthermore, based on the patient's current coagulation state, any one of the actions of stopping blood pumping, anticoagulant pumping, and heating in the blood circuit can be selectively performed in a manner associated with the patient's coagulation type, or the power and / or time of blood pumping, anticoagulant pumping, and / or heating in the blood circuit can be dynamically adjusted. For example, when the patient is of an easily coagulable type, the operation of the blood pumping device, anticoagulant pumping device, and / or heating device is stopped, and a corresponding warning reminder signal is generated to inform relevant personnel to intervene in the blood purification process of the current patient. When the patient is of a not easily coagulable type, the output power and / or operation time of the blood pumping device, anticoagulant pumping device, and / or heating device can be dynamically adjusted based on the change of the patient's coagulation state during the blood purification process.

[0087] Those skilled in the art should understand that as long as the object of the present invention can be achieved, other steps or operations may be included before, after, or between the above steps, such as further optimizing and / or improving the method described in the present invention. In addition, although the method described in the present invention is shown and described as a series of actions performed in sequence, it should be understood that the method is not limited by the sequence. For example, some actions may occur in a different sequence from that described herein. Or, one action may occur simultaneously with another action.

[0088] It should be noted that the above specific embodiments are exemplary. Those skilled in the art can come up with various solutions inspired by the disclosure of the present invention, and these solutions also belong to the disclosure scope of the present invention and fall within the protection scope of the present invention. Those skilled in the art should understand that the description and drawings of the present invention are illustrative and do not constitute a limitation on the claims. The protection scope of the present invention is defined by the claims and their equivalents. The description of the present invention contains multiple inventive concepts. Expressions such as "preferably", "according to a preferred embodiment", or "optionally" all indicate that the corresponding paragraphs disclose an independent inventive concept. The applicant reserves the right to file divisional applications according to each inventive concept.

Claims

1. A blood perfusion purifier system for determining the coagulation state, characterized in that, Comprising: A blood purification circuit, including an arterial-side blood circuit connected to the patient's artery and a venous-side blood circuit connected to the patient's vein; A hemoperfusion cartridge, connected between the arterial-side blood circuit and the venous-side blood circuit, wherein the hemoperfusion cartridge includes an adsorption column, and the adsorption column is configured with at least two adsorption regions (10) arranged oppositely and allowing the blood to be purified to remain in contact with the adsorbent, and an observation region (20) formed between the at least two adsorption regions (10) allowing the blood to be purified to flow independently, wherein the at least two adsorption regions (10) are spaced apart by a fiber membrane or a baffle structure with pores, so as to form an observation region (20) not filled or incompletely filled with adsorbent particles therebetween; A blood state monitor, configured to acquire blood flow information of the blood to be purified in the observation region (20), wherein the blood state monitor is an acquisition module based on image detection; A controller, configured to determine the current coagulation state of the hemoperfusion cartridge based on the blood flow information of the blood to be purified in the observation region (20), and selectively adjust the working states of the blood pumping device, anticoagulant pumping device, and / or heating device in the blood circuit based on the current coagulation state.

2. The hemoperfusion purifying system according to claim 1, wherein The adjustment of the working states of the blood pumping device, anticoagulant pumping device, and / or heating device in the blood circuit by the controller is performed in an associated manner with each other.

3. The hemoperfusion purifier system according to claim 2, wherein, The controller is capable of determining the adjustment priority of any one of the blood pumping device, anticoagulant pumping device, and heating device in the blood circuit based on the patient type.

4. The hemoperfusion purifying system according to claim 3, wherein, The adjustment of the working states of the blood pumping device, anticoagulant pumping device, and / or heating device in the blood circuit by the controller is determined in association with the coagulation type of the patient.

5. The hemoperfusion purifier system according to claim 4, wherein, The adjustment of the working states of the blood pumping device, anticoagulant pumping device, and / or heating device in the blood circuit by the controller being determined in association with the coagulation type of the patient includes: If the target patient is of an easily coagulable type, the controller stops the operation of the blood pumping device, anticoagulant pumping device, and / or heating device, and generates a warning reminder signal to at least one processing terminal in a manner of associating the coagulation state information with a time stamp and the patient number with each other; If the target patient is of a not easily coagulable type, the controller dynamically adjusts the output power and / or output time of the blood pumping device, anticoagulant pumping device, and / or heating device based on the coagulation state information.

6. The hemoperfusion purifier system according to claim 5, wherein The blood state monitor is configured to acquire a blood flow image of the observation region (20), so that the controller can determine the coagulation grade of the hemoperfusion cartridge based on the blood flow image.

7. The hemoperfusion purifier system according to claim 6, wherein, It further includes a clamping module for clamping the hemoperfusion cartridge, and the hemoperfusion cartridge is rotatably mounted on the clamping module to allow the blood state monitor to acquire blood flow images of the hemoperfusion cartridge at multiple rotational positions.

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