Immunoabsorption system and method for controlling the same

Abstract

The application provides an immunoadsorption system and a control method thereof. The immunoadsorption system in the embodiment can automatically switch between a treatment state and a regeneration state under the control of a controller. In particular, in the regeneration state, a first pH sensor and a second pH sensor are additionally arranged, and the controller monitors the first pH value and the second pH value to determine whether the pipeline is filled with a single liquid corresponding to the current stage according to whether the pH values of the liquids at the two ends of the adsorption column match, so as to determine whether the current stage is ended, realize automatic switching of each stage of the regeneration process, get rid of the error influence caused by human factors, and improve the safety and efficiency of the system.

Description

Technical Field

[0001] This application relates to the field of blood purification technology, and in particular to an immune adsorption system and its control method. Background Technology

[0002] Immunoadsorption is a relatively new technology developed in recent years for treating diseases that are difficult to treat with traditional methods. It utilizes the specific adsorption properties of ligands to selectively or specifically remove pathogenic factors from the patient's blood. During treatment, once the adsorbent in the column becomes saturated, it can be washed and regenerated using a specific eluent. After regeneration and restoration of adsorption activity, the treatment is repeated, achieving the therapeutic goal. However, the use of acid or alkali solutions for washing during regeneration can cause harm if residual acid or alkali solutions remain in the column and enter the body. To prevent this, traditional techniques use pH test strips to manually test the waste liquid from the regeneration process. This method relies on colorimetric analysis based on the pH range specified in the regeneration solution's label to determine if any regeneration solution remains in the column. This method requires multiple manual checks, has low system state switching efficiency, and is highly susceptible to human error, easily leading to the presence of harmful regeneration liquid in the system. Summary of the Invention

[0003] The purpose of this application is to at least solve one of the aforementioned technical defects, particularly the problem that existing immunoadsorption systems are unable to efficiently and accurately switch states, thus compromising the safety of system use.

[0004] In a first aspect, this application provides an immunoadsorption system, including a plasma circuit and a controller. The plasma circuit includes a first pre-column branch, a second pre-column branch, an adsorption column branch, a first post-column branch, and a second post-column branch. The first pre-column branch is used to introduce plasma to be adsorbed. The second pre-column branch includes a regeneration fluid module and a first pH sensor. The regeneration fluid module includes an elution fluid unit, a balancing fluid unit, and a rinsing fluid unit connected in parallel. The first pH sensor is located at the output end of the regeneration fluid module and is used to output a first pH value. An adsorption column is provided on the adsorption column branch. The first post-column branch is used to output the adsorbed plasma. The second post-column branch includes a waste liquid tank and a second pH sensor. The second pH sensor is located at the input end of the waste liquid tank and is used to output a second pH value.

[0005] The controller is used to connect the second pre-column branch and the second post-column branch to the adsorption column branch when the immunoadsorption system enters the regeneration state, and to control the eluent unit to output eluent until the first pH value matches the second pH value and both are less than the first preset value. Then, the controller stops the output of eluent and controls the equilibration unit to output equilibration solution until the first pH value matches the second pH value. Then, the controller stops the output of equilibration solution and controls the rinsing solution unit to output rinsing solution until the first pH value matches the second pH value, so as to complete the regeneration of the adsorption column. The controller also controls the first pre-column branch and the first post-column branch to connect to the adsorption column branch so that the immunoadsorption system enters the treatment state.

[0006] In one embodiment, the immunoadsorption system further includes an arterial blood circuit, a venous blood circuit, and a plasma separator; the arterial blood circuit is connected to the input end of the plasma separator, the first output end of the plasma separator is connected to the first pre-column branch, and the venous blood circuit is connected to the first post-column branch and the second output end of the plasma separator, respectively.

[0007] The arterial blood circuit includes a first pressure sensor for detecting the pressure in the arterial blood circuit and outputting a first pressure value;

[0008] The venous blood circuit includes a second pressure sensor for detecting the pressure in the venous blood circuit and outputting a second pressure value;

[0009] The controller is used to issue a first alarm when the immune adsorption system is in a treatment state and the first pressure value and the second pressure value meet the first alarm condition.

[0010] In one embodiment, the controller is configured to determine that the first pressure value and the second pressure value satisfy a first alarm condition when any of the following conditions are met:

[0011] The first pressure value is less than or equal to the second pressure value;

[0012] The first pressure value exceeds the first preset range;

[0013] The second pressure value exceeds the second preset range.

[0014] In one embodiment, the first pillar front branch includes a third pressure sensor for detecting the pressure in the first pillar front branch to output a third pressure value;

[0015] The controller is used to issue a second alarm when the immune adsorption system is in a treatment state and the first pressure value, the second pressure value, and the third pressure value meet the second alarm conditions.

[0016] In one embodiment, the second alarm condition includes the difference between the third pressure value and the first average pressure value exceeding a third preset range; the first average pressure value is the average of the first pressure value and the second pressure value.

[0017] In one embodiment, the first pre-column branch includes a color sensor for detecting the color of the liquid in the first pre-column branch to output a first color detection value;

[0018] The controller is used to issue a third alarm when the immune adsorption system is in treatment mode and the first color detection value does not match the preset color value.

[0019] In one embodiment, the immunoadsorption system further includes a first three-way valve and a second three-way valve;

[0020] The first end of the first three-way valve is connected to the first column front branch, the second end of the first three-way valve is connected to the second column front branch, the third end of the first three-way valve is connected to the adsorption column branch, the first end of the second three-way valve is connected to the first column rear branch, the second end of the second three-way valve is connected to the second column rear branch, and the third end of the second three-way valve is connected to the adsorption column branch.

[0021] The controller is used to connect the second column front branch and the second column rear branch with the adsorption column branch by controlling the connection between the second and third ends of the first three-way valve and the second three-way valve. It is also used to connect the first column front branch and the first column rear branch with the adsorption column branch by controlling the connection between the first and third ends of the first three-way valve and the first and third ends of the second three-way valve.

[0022] In one embodiment, the adsorption column branch also includes a first pump body;

[0023] The controller is used to control the first pump to operate in the regeneration state, so as to transport the liquid in the pre-second column branch to the post-second column branch through the adsorption column branch, and to control the first pump to operate in the treatment state, so as to transport the liquid in the pre-second column branch to the post-second column branch through the adsorption column branch.

[0024] In one embodiment, the arterial blood circuit further includes a second pump body;

[0025] The controller is used to control the operation of the second pump in the treatment state to pump fluid from the arterial blood circuit to the plasma separator.

[0026] Secondly, this application provides a control method for an immunoadsorption system. The immunoadsorption system includes a plasma circuit, which comprises a first pre-column branch, a second pre-column branch, an adsorption column branch, a first post-column branch, and a second post-column branch. The first pre-column branch is used to introduce plasma to be adsorbed. The second pre-column branch includes a regeneration fluid module and a first pH sensor. The regeneration fluid module includes an elution fluid unit, a balancing fluid unit, and a rinsing fluid unit connected in parallel. The first pH sensor is located at the output end of the regeneration fluid module and is used to output a first pH value. An adsorption column is provided on the adsorption column branch. The first post-column branch is used to output the adsorbed plasma. The second post-column branch includes a waste liquid tank and a second pH sensor. The second pH sensor is located at the input end of the waste liquid tank and is used to output a second pH value. The control method includes:

[0027] When the immunoadsorption system enters the regeneration state, the second column front branch and the second column rear branch are connected to the adsorption column branch.

[0028] Control the output of eluent from the eluent unit until the first pH value matches the second pH value and both are less than the first preset value, then stop the output of eluent;

[0029] The balance solution unit outputs balance solution until the first pH value matches the second pH value, at which point the output of balance solution stops.

[0030] The flushing solution unit outputs flushing solution until the first pH value matches the second pH value, thereby completing the regeneration of the adsorption column;

[0031] The first pre-column branch and the first post-column branch are connected to the adsorption column branch to enable the immunoadsorption system to enter the treatment state.

[0032] As can be seen from the above technical solutions, the embodiments of this application have the following advantages:

[0033] The immunoadsorption system in this embodiment can automatically switch between treatment and regeneration states under the control of a controller. Particularly in the regeneration state, due to the addition of a first and second pH sensor, the controller monitors the first and second pH values ​​to determine whether the pipeline is filled with the single liquid corresponding to the current stage based on whether the pH values ​​of the liquids before and after the adsorption column match. This determines whether the current stage has ended, achieving automatic switching between each stage of the regeneration process, eliminating the influence of human error, and improving the safety and efficiency of the system. Furthermore, traditional single-point measurement methods require high accuracy in pH testing when switching between these two stages because the pH values ​​of the equilibration solution and the rinsing solution are relatively close. This embodiment, however, uses a two-end comparison method. By selecting sensors of the same precision or even the same model, even if the detection results are inaccurate, the system will output matching results for the same liquid and mismatched results for different liquids. This eliminates dependence on detection accuracy and provides a strong guarantee against the impact of harmful regeneration solution residues. Attached Figure Description

[0034] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0035] Figure 1 This is a schematic diagram of the structure of an immunoadsorption system provided in one embodiment of this application;

[0036] Figure 2 A schematic flowchart of a control method for an immunoadsorption system provided in one embodiment of this application;

[0037] Figure reference numerals: 1. Plasma circuit; 110. First pre-column branch; 111. Third pressure sensor; 112. Fourth flow-blocking clamp; 113. Color sensor; 120. Second pre-column branch; 121. First pH sensor; 122. Elution buffer unit; 123. Equilibration buffer unit; 124. Washing buffer unit; 125. First flow-blocking clamp; 126. Second flow-blocking clamp; 127. Third flow-blocking clamp; 130. Adsorption column branch; 1 31. Adsorption column; 132. First pump body; 140. First post-column branch; 150. Second post-column branch; 151. Waste liquid tank; 152. Second pH sensor; 160. First three-way valve; 170. Second three-way valve; 2. Plasma separator; 3. Arterial blood circuit; 310. Anticoagulant pump; 320. Second pump body; 330. First pressure sensor; 4. Venous blood circuit; 410. Venous reservoir; 420. Second pressure sensor. Detailed Implementation

[0038] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0039] This application provides an immunoadsorption system; please refer to [link / reference]. Figure 1 The system includes a plasma circuit 100 and a controller. The plasma circuit includes a first pre-column branch 110, a second pre-column branch 120, an adsorption column branch 130, a first post-column branch 140, and a second post-column branch 150. Both the first pre-column branch 110 and the second pre-column branch 120 are connected to the adsorption column branch, but only one of these branches can be connected to the adsorption column branch 130. Figure 1 A first three-way valve 160 is used to connect the first pre-column branch 110, the second pre-column branch 120, and the adsorption column branch 130. The controller controls the state of the first three-way valve 160 to allow the adsorption column branch 130 to be connected between the first pre-column branch 110 and the second pre-column branch 120. Similarly, the first post-column branch 140 and the second post-column branch 150 are both connected to the adsorption column branch 130, but only one of these branches can be connected to the adsorption column branch 130. Figure 1 The second three-way valve 170 is used to connect the first post-column branch 140, the second post-column branch 150 and the adsorption column branch 130. The controller controls the state of the second three-way valve 170 so that the adsorption column branch 130 can be selected between the first post-column branch 140 and the second post-column branch 150.

[0040] The first pre-column branch 110 is used to introduce the plasma to be adsorbed, and the first post-column branch 140 is used to output the adsorbed plasma. When the immunoadsorption system is in treatment mode, the controller will control the conduction of the first pre-column branch 110, the adsorption column branch 130, and the first post-column branch 140. Blood requiring purification will be separated into plasma and other components by the plasma separator 2. The separated plasma will become the plasma to be adsorbed and will be input into the first pre-column branch 110. The plasma to be adsorbed flows into the adsorption column branch 130 under the power provided by the power source in the plasma circuit 100. After specific adsorption by the adsorption column 131, pathogenic factors in the plasma to be adsorbed are removed, becoming adsorbed plasma. The adsorbed plasma flows into the first post-column branch 140 under the drive of the power source. The adsorbed plasma output from the first post-column branch 140 will be mixed with other components again at the venous reservoir 410 to become complete blood.

[0041] As adsorption proceeds, the adsorption capacity of adsorption column 131 gradually weakens, requiring regeneration. The controller can determine whether regeneration is needed based on switching conditions, automatically switching the immunoadsorption system from treatment mode to regeneration mode. After regeneration of adsorption column 131 is complete, the system can automatically switch back to treatment mode, achieving fully automatic state switching. Switching conditions can include the immunoadsorption system being in treatment mode for a preset duration, or the adsorption amount of adsorption column 131 reaching a preset amount. When the immunoadsorption system is in regeneration mode, the controller will control the second column pre-branch 120, adsorption column branch 130, and second column post-branch 150 to be connected. The second column pre-branch 120 includes a regeneration fluid module. The regeneration fluid module includes an elution fluid unit 122, a equilibration fluid unit 123, and a rinsing fluid unit 124 connected in parallel. The regeneration of adsorption column 131 requires three stages in sequence: elution, equilibration, and pre-rinsing. The elution fluid unit 122, equilibration fluid unit 123, and rinsing fluid unit 124 store the liquids required for each stage, respectively. Specifically, the eluent unit 122 stores the eluent. During regeneration, the controller first controls the eluent unit 122 to output the eluent. Driven by the power source of the plasma circuit 100, it can be used to remove pathogenic factors adsorbed on the adsorption column 131, restoring the adsorption capacity of the adsorption column 131. The eluent is generally an acidic liquid with a pH range of 2.2 to 2.8. After elution is complete, the controller stops the output of the eluent unit 122 and starts the output of the equilibration solution unit 123. Driven by the power source of the plasma circuit 100, it is used to neutralize the eluent and help to drain the eluent from the plasma circuit 100. The equilibration solution is generally a slightly neutral liquid with a pH range of 6.8 to 7.6. After balancing is complete, the controller will stop the output of the balancing fluid unit 123 and start the flushing fluid unit 124 to output flushing fluid. The flushing fluid is a harmless liquid to the human body. Driven by the power source of the plasma circuit 100, it fills the plasma circuit 100 with a liquid that can be transported into the human body. The flushing fluid is generally physiological saline, with a pH of around 7, but it is different from the balancing fluid.

[0042] After flowing through the adsorption column 131, the liquids from each of the above stages will flow into the waste liquid tank 151 via the second post-column branch 150. Since the liquids used in each stage have a specific pH value, conventional technology relies on manual detection of the pH value of the liquid flowing out of the waste liquid tank 151 to determine whether each regeneration stage has ended. In this embodiment, the second pre-column branch 120 also includes a first pH sensor 121, which is located at the output end of the regeneration liquid module to detect the pH value of the liquid output by the regeneration liquid module, i.e., the first pH value. The second post-column branch 150 also includes a second pH sensor 152, which is located at the input end of the waste liquid tank 151 to detect the pH value of the liquid flowing into the waste liquid tank 151, i.e., the second pH value. During regeneration, the controller will first control the eluent unit 122 to output eluent and continuously acquire the first and second pH values. While elution is incomplete, the substances to be eluted on the adsorption column 131 will continue to react chemically with the eluent, causing changes in the pH value of the eluent flowing through the adsorption column 131. Specifically, the first pH value and the second pH value will not be equal until elution is complete, at which point the eluent will no longer react, making the first and second pH values ​​equal. Therefore, considering sensor detection errors, when the error between the first and second pH values ​​is within a preset range, the first and second pH values ​​can be considered matched. Based on the pH range of the eluent, a first preset value slightly higher than its range can also be set, such as 3.0. When both the first and second pH values ​​are less than this first preset value, it indicates that the liquid in the pipeline is the eluent. When the first and second pH values ​​match and are less than the first preset value, it means that the same liquid has completely filled the second pre-column branch 120, the adsorption column branch 130, and the second post-column branch 150, and this liquid is the eluent. At this point, the controller can determine that the elution stage has ended and the balancing stage should begin.

[0043] During the equilibration phase, the controller stops the output of the eluent and controls the equilibration liquid unit 123 to output the equilibration liquid. Because the equilibration liquid has a different pH value than the eluent, it neutralizes the liquid in the pipeline, causing a mismatch between the first and second pH values ​​if the pipeline is not completely filled with equilibration liquid. Therefore, the controller will continuously acquire the first and second pH values ​​until the first pH value matches the second pH value, at which point the equilibration phase is considered complete, and the rinsing phase should begin.

[0044] During the rinsing phase, the controller stops the output of the equilibration solution and controls the rinsing solution unit 124 to output the rinsing solution. Similarly, since the pH values ​​of the equilibration solution and the rinsing solution are different, the first pH value and the second pH value will not match when the pipeline is not completely filled with rinsing solution. Therefore, the controller will continuously acquire the first pH value and the second pH value until the first pH value matches the second pH value, at which point the rinsing phase is considered complete and the regeneration of the adsorption column 131 is finished. The controller can connect the first pre-column branch 110 and the first post-column branch 140 to the adsorption column branch 130 to put the immunoadsorption system into the treatment state.

[0045] The immunoadsorption system in this embodiment can automatically switch between treatment and regeneration states under the control of the controller. Especially in the regeneration state, due to the addition of a first and second pH sensor, the controller monitors the first and second pH values ​​to determine whether the pipeline is filled with the single liquid corresponding to the current stage based on whether the pH values ​​of the liquids before and after the adsorption column 131 match, thus determining whether the current stage has ended. This achieves automatic switching between each stage of the regeneration process, eliminating the influence of human error and improving the safety and efficiency of the system. Furthermore, traditional single-point measurement methods require high accuracy in pH testing when switching between these two stages because the pH values ​​of the equilibration solution and the rinsing solution are relatively close. This embodiment, however, uses a two-end comparison method. By selecting sensors of the same precision or even the same model, even if the detection results are inaccurate, the system will output matching results for the same liquid and mismatched results for different liquids, eliminating reliance on detection accuracy and providing a strong guarantee against the impact of harmful regeneration solution residues.

[0046] In some embodiments, to facilitate controller control of the output of each unit in the regeneration fluid module, a first flow-blocking clamp 125 is provided at the output end of the eluent unit 122, a second flow-blocking clamp 126 is provided at the output end of the equilibration fluid unit 123, and a third flow-blocking clamp 127 is provided at the output end of the rinsing fluid unit 124. The controller can control the corresponding flow-blocking clamp switches to control the output of the liquid required for a specific stage of the regeneration process by each unit of the regeneration fluid module. Since the adsorption column branch 130 is a common branch in both states, to facilitate the power supply to the liquid in the plasma circuit 100, a first pump body 132 can be selected to be provided on the adsorption column branch 130.

[0047] In one embodiment, please refer to Figure 1The immunoadsorption system also includes a plasma separator 2, an arterial blood circuit 3, and a venous blood circuit 4. The arterial blood circuit 3 connects to the input of the plasma separator 2, and the first output of the plasma separator 2 connects to the first pre-column branch 110. When the immunoadsorption system is in treatment mode, the arterial blood circuit 3 is used to draw blood from the patient and deliver it to the plasma separator 2 for separation. To prevent blood clotting, the blood needs to be mixed with an anticoagulant before entering the plasma separator 2. Therefore, an anticoagulant pump 310 is also provided on the arterial circuit for injecting anticoagulant into the arterial circuit. To facilitate the flow of liquid between the arterial circuit, the plasma separator 2, and the venous reservoir 410 circuit, Figure 1 The immunoadsorption system in this embodiment has a second pump 320 installed in the arterial circuit. The venous blood circuit 4 is connected to the first post-column branch 140 and the second output end of the plasma separator 2. That is, the adsorbed plasma and other components separated in the plasma separator 2 are remixed in the venous reservoir 410 and then returned to the patient via the venous blood circuit 4. In this embodiment, the plasma separator 2 adopts membrane separation technology. Under the separation of this plasma separator 2, the plasma will be located outside the membrane and flow into the first pre-column branch 110 from the first output end, while other components in the blood will be retained inside the membrane and flow into the venous blood circuit 4 from the second output end.

[0048] To detect the condition of the intramembrane pathway of the plasma separator 2 and prevent blockage, the arterial blood circuit 3 also includes a first pressure sensor 330 for detecting the pressure of the arterial blood circuit 3 and outputting a first pressure value. The first pressure sensor 330 can be located before the input end of the plasma separator 2. The venous blood circuit 4 includes a second pressure sensor 420 for detecting the pressure of the venous blood circuit 4 and outputting a second pressure value. The second pressure sensor 420 can be located at the venous reservoir 410. When an abnormality occurs in the intramembrane pathway, it will be reflected in the first and second pressure values. Therefore, the controller can continuously monitor the first and second pressure values ​​when the immune adsorption system is in treatment mode, and issue a first alarm prompt when the first and second pressure values ​​meet the first alarm condition to remind medical staff to perform appropriate safety operations. At this time, the controller can also control the corresponding pump to stop working to protect patient safety. In a specific embodiment, the controller is used to determine that the first and second pressure values ​​meet the first alarm condition when any of the following conditions are met:

[0049] (1) The first pressure value is less than or equal to the second pressure value.

[0050] (2) The first pressure value exceeds the first preset range.

[0051] (3) The second pressure value exceeds the second preset range.

[0052] That is, the pressure in either the arterial or venous circuit should be within their corresponding numerical range, and the pressure in arterial blood circuit 3 should be greater than the pressure in venous blood circuit 4 for the intramembrane passage of plasma separator 2 to be in normal condition and able to maintain its working state. Otherwise, the controller should issue an alarm.

[0053] In one embodiment, since the plasma separator 2 is based on a separation membrane for plasma separation, the separation membrane is susceptible to damage. For membrane rupture detection, please refer to [link to relevant documentation]. Figure 1 The first pre-column branch 110 includes a third pressure sensor 111 for detecting the pressure in the first pre-column branch 110 and outputting a third pressure value. When the plasma separator 2 experiences membrane rupture, this will be directly reflected in the first, second, and third pressure values. When the immunoadsorption system is in treatment mode, the controller will continuously monitor the first, second, and third pressure values, and if the first, second, and third pressure values ​​meet the second alarm conditions, it will issue a second alarm prompt to alert medical personnel to perform appropriate safety procedures. At this time, the controller can also control the corresponding pump to stop working to protect patient safety. A fourth flow-blocking clamp 112 can also be installed at the very beginning of the first pre-column branch 110. When membrane rupture is detected, the controller can simultaneously control the fourth flow-blocking clamp 112 to close. In one specific embodiment, the second alarm condition includes the difference between the third pressure value and the first average pressure value exceeding a third preset range; the first average pressure value is the average of the first and second pressure values. The first average pressure value reflects the intra-membrane pressure of the plasma separator 2, while the third pressure value reflects the extra-membrane pressure of the plasma separator 2. When the difference between the intra-membrane pressure and the extra-membrane pressure exceeds the third preset range, it indicates that the membrane has ruptured.

[0054] In one embodiment, to further ensure the accuracy of membrane rupture detection, please refer to [link to relevant documentation]. Figure 1 The first pre-column branch 110 includes a color sensor 113 for detecting the color of the liquid within the first pre-column branch 110 and outputting a first color detection value. It can be understood that when the membrane is intact, the liquid flowing in the first pre-column branch 110 is plasma; after membrane rupture, the liquid flowing in the first pre-column branch 110 will be blood, which is pale yellow and red respectively. Therefore, the controller can store a preset color value, which is the result of color detection of plasma. When the controller detects a mismatch between the first color detection value and the preset color value, it determines that the liquid flowing through the first pre-column branch 110 is not plasma, but rather blood flowing in after the plasma separator membrane ruptures, and the controller should issue a third alarm. The controller can also control the corresponding pump to stop working and control the fourth flow-blocking clamp 112 to close, etc., to protect patient safety.

[0055] This application provides a control method for an immunoadsorption system, applied to the immunoadsorption system described in the above embodiments. Please refer to... Figure 2 The control method includes steps S202 to S210.

[0056] S202, when the immunoadsorption system enters the regeneration state, controls the connection between the pre-column branch and the post-column branch and the adsorption column branch.

[0057] S204, control the output of eluent from the eluent unit until the first pH value matches the second pH value and both are less than the first preset value, then stop the output of eluent.

[0058] S206 controls the output of the equilibrium liquid unit until the first pH value matches the second pH value, then stops the output of the equilibrium liquid.

[0059] S208 controls the output of the rinsing solution unit until the first pH value matches the second pH value, thereby completing the regeneration of the adsorption column.

[0060] S210 controls the connection between the first column pre-branch and the first column post-branch and the adsorption column branch, so that the immunoadsorption system enters the treatment state.

[0061] The explanation of steps S202 to S210 can be found above.

[0062] In one embodiment, the immunoadsorption system further includes an arterial blood circuit, a venous blood circuit, and a plasma separator; the arterial blood circuit is connected to the input end of the plasma separator, the first output end of the plasma separator is connected to a first pre-column branch, and the venous blood circuit is connected to a second pre-column branch and a second output end of the plasma separator, respectively; the arterial blood circuit includes a first pressure sensor for detecting the pressure of the arterial blood circuit to output a first pressure value; the venous blood circuit includes a second pressure sensor for detecting the pressure of the venous blood circuit to output a second pressure value. The control method further includes: when the immunoadsorption system is in a treatment state and it is determined that the first pressure value and the second pressure value meet a first alarm condition, issuing a first alarm prompt. Wherein, the first pressure value and the second pressure value are determined to meet the first alarm condition when any of the following conditions are met:

[0063] (1) The first pressure value is less than or equal to the second pressure value.

[0064] (2) The first pressure value exceeds the first preset range.

[0065] (3) The second pressure value exceeds the second preset range.

[0066] In one embodiment, the first pre-column branch includes a third pressure sensor for detecting the pressure in the first pre-column branch to output a third pressure value. The control method includes issuing a second alarm when the immunoadsorption system is in treatment mode and the first, second, and third pressure values ​​meet a second alarm condition. The second alarm condition includes the difference between the third pressure value and the first average pressure value exceeding a third preset range; the first average pressure value is the average of the first and second pressure values.

[0067] In one embodiment, the first pre-column branch includes a color sensor for detecting the color of the liquid within the first pre-column branch to output a first color detection value. The control method includes issuing a third alarm when the immunoadsorption system is in a treatment state and it is determined that the first color detection value does not match a preset color value.

[0068] This application provides a control device for an immunoadsorption system, applied to the immunoadsorption system described in the above embodiments. The control device includes a first control module, a second control module, a third control module, a fourth control module, and a fifth control module.

[0069] The first control module is used to control the connection between the second pre-column branch and the second post-column branch and the adsorption column branch when the immunoadsorption system enters the regeneration state.

[0070] The second control module is used to control the output of eluent from the eluent unit until the first pH value matches the second pH value and both are less than the first preset value, at which point the output of eluent is stopped.

[0071] The third control module is used to control the output of the equilibrium liquid unit until the first pH value matches the second pH value, at which point the output of the equilibrium liquid stops.

[0072] The fourth control module is used to control the output of the rinsing solution unit until the first pH value matches the second pH value, so as to complete the regeneration of the adsorption column.

[0073] The fifth control module is used to control the connection between the first column pre-branch and the first column post-branch and the adsorption column branch, so that the immunoadsorption system enters the treatment state.

[0074] In one embodiment, the immunoadsorption system further includes an arterial blood circuit, a venous blood circuit, and a plasma separator; the arterial blood circuit is connected to the input end of the plasma separator, the first output end of the plasma separator is connected to a first pre-column branch, and the venous blood circuit is connected to a second pre-column branch and a second output end of the plasma separator; the arterial blood circuit includes a first pressure sensor for detecting the pressure in the arterial blood circuit to output a first pressure value; the venous blood circuit includes a second pressure sensor for detecting the pressure in the venous blood circuit to output a second pressure value. The control device further includes a first alarm module. The first alarm module is used to issue a first alarm prompt when the immunoadsorption system is in a treatment state and the first and second pressure values ​​meet a first alarm condition.

[0075] In one embodiment, the first pre-column branch includes a third pressure sensor for detecting the pressure in the first pre-column branch and outputting a third pressure value. The control device also includes a second alarm module. The second alarm module is used to issue a second alarm prompt when the immunoadsorption system is in treatment mode and the first, second, and third pressure values ​​meet the second alarm conditions.

[0076] In one embodiment, the first pre-column branch includes a color sensor for detecting the color of the liquid within the first pre-column branch to output a first color detection value. The control device also includes a third alarm module. The third alarm module is used to issue a third alarm prompt when the immunoadsorption system is in treatment mode and it is determined that the first color detection value does not match a preset color value.

[0077] The various embodiments in this specification are described in a progressive manner. Each embodiment focuses on the differences from other embodiments. The various embodiments can be combined as needed, and the same or similar parts can be referred to each other.

[0078] The above description of the disclosed embodiments enables those skilled in the art to make or use this application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of this application. Therefore, this application is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. An immunoadsorption system, characterized in that, The system includes a plasma circuit and a controller. The plasma circuit includes a first pre-column branch, a second pre-column branch, an adsorption column branch, a first post-column branch, and a second post-column branch. The first pre-column branch is used to introduce plasma to be adsorbed. The second pre-column branch includes a regeneration fluid module and a first pH sensor. The regeneration fluid module includes an elution fluid unit, a balancing fluid unit, and a rinsing fluid unit connected in parallel. The first pH sensor is located at the output end of the regeneration fluid module and is used to output a first pH value. An adsorption column is provided on the adsorption column branch. The first post-column branch is used to output the adsorbed plasma. The second post-column branch includes a waste liquid tank and a second pH sensor. The second pH sensor is located at the input end of the waste liquid tank and is used to output a second pH value. The controller is used to, when the immunoadsorption system enters the regeneration state, control the second pre-column branch and the second post-column branch to connect with the adsorption column branch, and control the elution unit to output elution solution until the first pH value matches the second pH value and both are less than the first preset value, then stop the output of the elution solution and control the equilibration solution unit to output equilibration solution until the first pH value matches the second pH value, then stop the output of the equilibration solution and control the flushing solution unit to output flushing solution until the first pH value matches the second pH value, thereby completing the regeneration of the adsorption column, and controlling the first pre-column branch and the first post-column branch to connect with the adsorption column branch, so that the immunoadsorption system enters the treatment state.

2. The immunoadsorption system according to claim 1, characterized in that, It also includes an arterial blood circuit, a venous blood circuit, and a plasma separator; the arterial blood circuit is connected to the input end of the plasma separator, the first output end of the plasma separator is connected to the first pre-column branch, and the venous blood circuit is connected to the first post-column branch and the second output end of the plasma separator, respectively. The arterial blood circuit includes a first pressure sensor for detecting the pressure in the arterial blood circuit and outputting a first pressure value; The venous blood circuit includes a second pressure sensor for detecting the pressure in the venous blood circuit and outputting a second pressure value; The controller is used to issue a first alarm prompt when the immune adsorption system is in the treatment state and the first pressure value and the second pressure value meet the first alarm condition.

3. The immunoadsorption system according to claim 2, characterized in that, The controller is configured to determine that the first pressure value and the second pressure value meet the first alarm condition when any of the following conditions are met: The first pressure value is less than or equal to the second pressure value; The first pressure value exceeds the first preset range; The second pressure value exceeds the second preset range.

4. The immunoadsorption system according to claim 2, characterized in that, The first pillar front branch includes a third pressure sensor for detecting the pressure in the first pillar front branch and outputting a third pressure value; The controller is used to issue a second alarm when the immune adsorption system is in the treatment state and the first pressure value, the second pressure value, and the third pressure value meet the second alarm conditions.

5. The immunoadsorption system according to claim 4, characterized in that, The second alarm condition includes the difference between the third pressure value and the first average pressure value exceeding a third preset range; the first average pressure value is the average of the first pressure value and the second pressure value.

6. The immunoadsorption system according to claim 2, characterized in that, The first pre-column branch includes a color sensor for detecting the color of the liquid in the first pre-column branch, so as to output a first color detection value; The controller is used to issue a third alarm when the immune adsorption system is in the treatment state and the first color detection value does not match the preset color value.

7. The immunoadsorption system according to claim 1, characterized in that, It also includes a first three-way valve and a second three-way valve; The first end of the first three-way valve is connected to the first pre-column branch, the second end of the first three-way valve is connected to the second pre-column branch, the third end of the first three-way valve is connected to the adsorption column branch, the first end of the second three-way valve is connected to the first post-column branch, the second end of the second three-way valve is connected to the second post-column branch, and the third end of the second three-way valve is connected to the adsorption column branch. The controller is used to connect the second pre-column branch and the second post-column branch to the adsorption column branch by controlling the connection between the second and third ends of the first three-way valve and the second three-way valve. It is also used to connect the first pre-column branch and the first post-column branch to the adsorption column branch by controlling the connection between the first and third ends of the first three-way valve and the second three-way valve.

8. The immunoadsorption system according to claim 1, characterized in that, The adsorption column branch also includes a first pump body; The controller is used to control the first pump to operate in the regeneration state to transport the liquid in the pre-column branch to the post-column branch through the adsorption column branch, and to control the first pump to operate in the treatment state to transport the liquid in the pre-column branch to the post-column branch through the adsorption column branch.

9. The immunoadsorption system according to claim 2, characterized in that, The arterial blood circuit also includes a second pump body; The controller is used to control the second pump to operate in the treatment state to pump the fluid in the arterial blood circuit to the plasma separator.

10. A method for controlling an immunoadsorption system, characterized in that, The immunoadsorption system includes a plasma circuit, comprising a first pre-column branch, a second pre-column branch, an adsorption column branch, a first post-column branch, and a second post-column branch. The first pre-column branch is used to introduce the plasma to be adsorbed. The second pre-column branch includes a regeneration fluid module and a first pH sensor. The regeneration fluid module includes an elution fluid unit, a balancing fluid unit, and a rinsing fluid unit connected in parallel. The first pH sensor is located at the output end of the regeneration fluid module and is used to output a first pH value. An adsorption column is provided on the adsorption column branch. The first post-column branch is used to output the adsorbed plasma. The second post-column branch includes a waste liquid tank and a second pH sensor. The second pH sensor is located at the input end of the waste liquid tank and is used to output a second pH value. The control method includes: When the immunoadsorption system enters the regeneration state, the second pre-column branch and the second post-column branch are connected to the adsorption column branch. The output of the eluent unit is controlled until the first pH value matches the second pH value and both are less than the first preset value, at which point the output of the eluent is stopped. The balance solution unit is controlled to output balance solution until the first pH value matches the second pH value, at which point the output of the balance solution is stopped. The flushing solution unit is controlled to output flushing solution until the first pH value matches the second pH value, so as to complete the regeneration of the adsorption column; The first pre-column branch and the first post-column branch are connected to the adsorption column branch to enable the immunoadsorption system to enter the treatment state.

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