A, b concentrate monitoring control system for hemodialysis
Patent Information
- Application Number
- CN202610891156.6
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-06-18
- Publication Date
- 2026-08-21
AI Technical Summary
[0005]因此,本发明提供了用于血液透析的A、B浓缩液监测控制系统解决A、B浓缩液钠负荷和碳酸氢盐负荷难以同循环联动控制的问题
[0016]本发明有益效果为:通过旁路恒温恒压微流控校验腔完成受控中和校验,并进行气液双相耦合换算,获得当前控制循环下的碳酸氢盐有效负荷,使碳酸氢盐负荷状态可与总钠负荷一致性状态同步归并为A、B浓缩液联动许可状态,进一步驱动A浓缩液、B浓缩液和透析用水的流量修正、供液路径约束写入以及阀位切换顺序更新,提高透析液供给控制连续性、配液响应协调性和负荷状态闭环性。
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Figure CN122605029A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of dialysis solution preparation technology, and in particular to a monitoring and control system for A and B concentrates used in hemodialysis. Background Technology
[0002] Hemodialysis solution preparation is usually completed by proportional pumping of concentrate A, concentrate B, and dialysis water. Related monitoring mainly focuses on parameters such as conductivity, temperature, pH, flow rate, and pressure. Through sampling channels, online sensors, and solution preparation control relationships, the sodium concentration and bicarbonate buffer components in the dialysate are confirmed in the process, so that the electrolyte targets in the dialysis prescription can be converted into actionable solution preparation adjustment criteria under continuous solution supply conditions.
[0003] In actual solution preparation, the bicarbonate component in concentrate B contributes to the sodium load and is also affected by changes in temperature, flow rate pulses, channel hysteresis, and dilution ratio. Current methods typically perform sodium concentration monitoring and bicarbonate load verification separately. In scenarios where the acid contribution from solution A, the bicarbonate contribution from solution B, and the dilution relationship with dialysis water all change simultaneously, it's easy to encounter situations where the total sodium load is within acceptable limits, but the acid-base buffer load has not yet been confirmed within the same cycle. This is because the two load conditions lack synchronous calibration, bypass reaction verification, and supply path linkage constraints under the same control cycle. Summary of the Invention
[0004] In view of the aforementioned existing problems, the present invention is proposed.
[0005] Therefore, the present invention provides a monitoring and control system for A and B concentrates for hemodialysis to solve the problem that the sodium load and bicarbonate load of A and B concentrates are difficult to control in conjunction with the circulation.
[0006] To solve the above-mentioned technical problems, the present invention provides the following technical solution: This invention provides a monitoring and control system for A and B concentrates in hemodialysis, comprising: a synchronous calibration module, which receives solution preparation reference information and performs synchronous calibration on the A and B solution sampling channels to establish a synchronous calibration state; a hidden sodium correction module, which, based on the synchronous calibration state, applies stepped micro-flow pulse control to the B solution sampling channel and uses time-domain differential filtering to extract the steady-state plateau value and transient jump component of the B solution sampling channel, maps the steady-state plateau value to the baseline sodium contribution, maps the transient jump component after synchronous calibration state compensation to the hidden sodium contribution, and performs a dynamic reference three-level correction operation to generate the hidden sodium correction amount for the B solution; and a sodium load verification module, which converts the sodium response of the A solution in the A solution sampling channel and the hidden sodium correction amount of the B solution into a total sodium load, and... The system combines the target sodium value and allowable deviation range for deviation verification to generate a total sodium load consistency status. The bicarbonate load verification module, based on the total sodium load consistency status, connects the acid contribution sampling response of solution A in the solution A sampling channel to the bicarbonate load verification link. A controlled neutralization reaction is triggered within the bypass isothermal and isobaric microfluidic verification chamber, and gas-liquid two-phase coupling conversion is performed to generate the bicarbonate load status. The supply control module performs control loop alignment of the total sodium load consistency status and the bicarbonate load status, and performs permissible merging processing based on the solution preparation reference information to generate an A / B concentrate linkage permissible status. Based on the A / B concentrate linkage permissible status, the flow rates of A / B concentrates and dialysis water are adjusted, and the dialysis fluid supply path is switched to form a dialysis fluid supply control status.
[0007] As a preferred embodiment of the A and B concentrate monitoring and control system for hemodialysis described in this invention, the specific steps for establishing the synchronous calibration state are as follows: Write the sampling calibration requirements in the solution preparation reference information into the sampling control record for this time, and open the sampling channels for solution A and solution B to perform residual liquid discharge, low flow stabilization and sampling pressure stabilization to form a stable sampling state for both channels. Based on the stable state of the two sampling channels, the sampling calibration elements of the A liquid sampling channel and the B liquid sampling channel are subjected to benchmark normalization processing, correction and control cycle binding to establish a synchronous calibration state.
[0008] As a preferred embodiment of the A and B concentrate monitoring and control system for hemodialysis described in this invention, the specific steps for extracting the steady-state plateau value and transient jump component of the B concentrate sampling channel using time-domain differential filtering are as follows: Based on the synchronous calibration status, a stepped micro-flow pulse sampling command is sent to the sampling channel of liquid B to control the sampling channel of liquid B to generate a continuous pulse response curve according to the stepped flow rate change; Baseline subtraction is performed on the continuous pulse response curve according to the sampling time scale, and the response difference between adjacent sampling points is calculated to form a time-domain difference sequence. According to the hold phase and switching phase in the step-type micro-flow pulse sampling command, the time-domain difference sequence is divided into a stable response segment and a rapid change segment. The response hold value corresponding to the stable response segment is taken as the steady-state plateau value, and the response mutation value corresponding to the rapid change segment is taken as the transient jump component.
[0009] As a preferred embodiment of the A and B concentrate monitoring and control system for hemodialysis described in this invention, the specific steps for generating the implicit sodium correction amount in concentrate B are as follows: Based on the component registration relationship in the solution preparation reference information, the steady-state plateau value of each step in the step-by-step micro-flow pulse sampling command is matched with the main response of sodium bicarbonate in solution B. The response baseline in the synchronous calibration state is subtracted from the steady-state plateau value, and the subtracted steady-state plateau value is converted according to the sampling flow rate and holding time corresponding to each step to obtain the basic sodium contribution. The basic sodium contribution under each step is collected according to the control cycle number to establish the basic sodium contribution baseline of solution B. The transient jump component is compensated according to the synchronous calibration status. The transient offset caused by the change in sampling flow rate, channel response hysteresis and temperature drift during the step switching stage is deducted from the transient jump component to obtain the compensated transient jump component. The difference between the compensated transient jump component and the baseline sodium contribution of liquid B is separated. The response part explained by the sodium contribution of sodium bicarbonate is deducted, and the sodium response difference exceeding the baseline sodium contribution of liquid B is retained to form the implicit sodium contribution. The contribution of implied sodium is corrected sequentially according to the sampling channel benchmark, temperature compensation benchmark, and current solution conversion benchmark to eliminate the influence of sampling condition fluctuations, ion response drift, and solution ratio conversion deviation on the contribution of implied sodium. The corrected contribution of implied sodium is converted into sodium load increment according to the solution ratio of solution B in the current control cycle and the dilution relationship of dialysis water, thus generating the implied sodium correction amount of solution B.
[0010] As a preferred embodiment of the A and B concentrate monitoring and control system for hemodialysis described in this invention, the specific steps for converting the sodium response of solution A in the A solution sampling channel and the implicit sodium correction amount of solution B into the total sodium load are as follows: Based on the synchronous calibration status, the sodium response of liquid A in the sampling channel of liquid A is time-aligned with the implicit sodium correction amount of liquid B under the current control cycle, and the response baseline corresponding to the synchronous calibration status is subtracted from the sodium response of liquid A. The sodium response of liquid A after subtraction is converted into the sodium contribution amount of liquid A according to the liquid preparation reference information. The sodium contribution of solution A and the implicit sodium correction of solution B are unified to the same sodium load measurement standard, and the total sodium load under the current control cycle is obtained by combining and converting the solutions A, B concentrates and dialysis water according to the solution mixing relationship.
[0011] As a preferred embodiment of the A and B concentrate monitoring and control system for hemodialysis described in this invention, the specific steps for generating a consistent total sodium load are as follows: Using the sodium target value and allowable deviation range in the solution preparation reference information as the verification reference, the total sodium load under the current control cycle and the sodium target value are placed under the same sodium load measurement reference, and the load deviation between the total sodium load and the sodium target value is calculated. The load deviation is checked against the allowable deviation range. When the load deviation falls within the allowable deviation range, the current control cycle is marked as sodium load consistent. When the load deviation exceeds the allowable deviation range, the current control cycle is marked as sodium load deviation. The deviation direction and deviation magnitude are recorded to generate the total sodium load consistent state.
[0012] As a preferred embodiment of the A and B concentrate monitoring and control system for hemodialysis described in this invention, the specific steps for triggering the controlled neutralization reaction within the bypass isothermal and isobaric microfluidic calibration chamber are as follows: Based on the sodium load consistency status and control cycle number in the total sodium load consistency status, the corresponding control cycle is used as the bicarbonate load verification trigger cycle, and the A solution acid contribution sampling response, synchronous calibration status and solution preparation reference information in the A solution sampling channel are bound to form the A solution acid contribution verification input. According to the acid contribution verification input of liquid A, the trace acid contribution sample in the sampling channel of liquid A is introduced into the bypass constant temperature and pressure microfluidic verification chamber, and according to the verification ratio corresponding to the liquid preparation reference information, the bicarbonate verification sample is introduced from the sampling channel of liquid B to form the bypass controlled reaction sample. Within the bypass isothermal and isobaric microfluidic calibration chamber, temperature locking, pressure constraint, and laminar flow disturbance mixing are performed on the bypass controlled reaction sample through a temperature control channel, a pressure limiting microvalve, and a micro-mixing channel. This controls the bypass controlled reaction sample to undergo a controlled neutralization reaction under bypass calibration conditions, forming a neutralization calibration response.
[0013] As a preferred embodiment of the A and B concentrate monitoring and control system for hemodialysis described in this invention, the specific steps for generating bicarbonate load are as follows: Based on the neutralization verification response, the bypass controlled reaction sample is introduced into the liquid phase detection path and the gas phase detection path through the gas-liquid separation section in the bypass isothermal and isobaric microfluidic verification chamber. In the liquid phase detection path, the residual bicarbonate response, pH response and conductivity response of the liquid after the reaction are collected to form the liquid phase residual response. In the gas phase detection path, the amount of gas emitted from the reaction, pressure change and carbon dioxide response are collected to form the gas phase emission response. Based on the dynamic dissociation equilibrium of bicarbonate, the residual response in the liquid phase is converted into the contribution of unreacted bicarbonate, and the gas phase escape response is converted into the contribution of converted bicarbonate. The contributions of unreacted bicarbonate and converted bicarbonate are coupled and calculated to obtain the effective load of bicarbonate. According to the verification ratio corresponding to the solution preparation reference information, the effective load of bicarbonate is back-calculated to the solution preparation load range under the current control cycle. Based on the correspondence between the effective load of bicarbonate and the bicarbonate load requirements in the solution preparation reference information, the effective load of bicarbonate is classified into intervals and marked with status to generate the bicarbonate load status.
[0014] As a preferred embodiment of the A and B concentrate monitoring and control system for hemodialysis described in this invention, the specific steps for generating the A and B concentrate linkage permission state are as follows: Based on the current control cycle number and sampling time scale, the total sodium load consistency status and bicarbonate load status are linked to the same control cycle, and status items with inconsistent cycle numbers and time scales exceeding the effective sampling window are screened out to form a load status group in the same cycle. Based on the solution preparation reference information, the correspondence between the total sodium load consistency status and bicarbonate load status in the same cycle load status group is converted into supply permit requirements, solution preparation correction requirements and path constraint requirements, and written into the same linkage permit record to generate the linkage permit status of concentrates A and B.
[0015] As a preferred embodiment of the A and B concentrate monitoring and control system for hemodialysis described in this invention, the specific steps for establishing the dialysate supply control state are as follows: Based on the status correspondence in the linkage permit status of concentrates A and B and the liquid preparation relationship in the liquid preparation reference information, the flow correction direction of concentrate A, concentrate B and dialysis water is determined, and the corresponding liquid preparation flow correction amount is generated according to the difference between the current actual liquid preparation flow and the target liquid preparation flow. The entry ratio of concentrate A, concentrate B and dialysis water is adjusted according to the liquid preparation flow correction amount to form the liquid preparation flow adjustment status. Based on the supply permit requirements and path constraints, and combined with the flow adjustment completion status in the solution preparation flow adjustment status, the supply path control relationship in the solution preparation reference information is compared and assigned. The supply permit requirements are written into the corresponding supply path, and the flow adjustment completion status is written into the valve position switching sequence and pumping maintenance conditions of the corresponding path, thus forming the dialysate supply control status.
[0016] The beneficial effects of this invention are as follows: controlled neutralization verification is completed through a bypass constant temperature and pressure microfluidic verification chamber, and gas-liquid two-phase coupling conversion is performed to obtain the effective load of bicarbonate under the current control cycle. This allows the bicarbonate load state to be synchronized with the total sodium load state and merged into the A and B concentrate linkage permission state. This further drives the flow correction of A concentrate, B concentrate and dialysis water, the writing of supply path constraints and the updating of valve position switching sequence, thereby improving the continuity of dialysis fluid supply control, the coordination of solution preparation response and the closed-loop nature of load state. Attached Figure Description
[0017] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the following description of the embodiments will be briefly introduced. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0018] Figure 1 This is a schematic diagram of the A and B concentrate monitoring and control system used in hemodialysis.
[0019] Figure 2 The flowchart for correcting the implicit sodium content in solution B.
[0020] Figure 3 This is a flowchart for dual-load status verification.
[0021] Figure 4 This is a flowchart for the liquid supply linkage control. Detailed Implementation
[0022] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.
[0023] Many specific details are set forth in the following description in order to provide a full understanding of the invention. However, the invention may also be practiced in other ways different from those described herein, and those skilled in the art can make similar extensions without departing from the spirit of the invention. Therefore, the invention is not limited to the specific embodiments disclosed below.
[0024] Secondly, the term "one embodiment" or "embodiment" as used herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the present invention. The phrase "in one embodiment" appearing in different places in this specification does not necessarily refer to the same embodiment, nor is it a single or selective embodiment that is mutually exclusive with other embodiments.
[0025] Reference Figures 1-4This is one embodiment of the present invention, which provides a monitoring and control system for A and B concentrates in hemodialysis, comprising the following steps: The synchronous calibration module receives the solution preparation reference information and performs synchronous calibration on the sampling channels of solution A and solution B, establishing a synchronous calibration status.
[0026] Write the sampling calibration requirements from the solution preparation reference information into the current sampling control record, and open the sampling channels for solution A and solution B. Perform residual liquid discharge, low flow stabilization and sampling pressure stabilization to form a stable sampling state for both channels.
[0027] It should be noted that the solution preparation reference information includes: sampling and calibration requirements, component registration relationship, solution preparation relationship, sodium target value and allowable deviation range, bicarbonate load requirements, calibration ratio, target solution preparation flow rate, solution supply path control relationship and control cycle number; among which, the component registration relationship includes at least the component identifier, response acceptance range, response conversion relationship, unit of measurement and applicable control cycle; Furthermore, the channel opening and closing sequence, sampling start time, sampling flow target and control cycle number related to this sampling are written into the sampling control record from the liquid preparation reference information, and the A liquid sampling channel and the B liquid sampling channel are opened according to the channel opening and closing sequence. After the two sampling channels are opened, the residual liquid in the front section of the channel is introduced into the waste liquid branch, and the initial response changes in the channel are continuously collected until the response corresponding to the residual liquid of the previous control cycle gradually decays, and the sampling response corresponding to the current liquid A and liquid B begins to stabilize. After the current sampling response is established, the two sampling channels are controlled to enter the micro-sampling state according to the sampling flow target. Based on the flow fluctuation, channel pressure difference change and sensor response drift under the continuous sampling time scale, the opening of the sampling valve, the micro-pump drive and the back pressure of the detection section are adjusted in linkage until the flow change, pressure difference change and response drift of the two sampling channels converge to the stable range corresponding to the sampling calibration requirements, forming a stable state of two-channel sampling.
[0028] Based on the stable state of the two sampling channels, the sampling calibration elements of the A liquid sampling channel and the B liquid sampling channel are subjected to benchmark normalization processing, correction and control cycle binding to establish a synchronous calibration state.
[0029] It should be noted that the sampling calibration element refers to the channel calibration object used to characterize the sampling consistency of liquid A and liquid B sampling channels under this control cycle; Furthermore, based on the stable state of the two sampling channels, the sampling calibration elements of the A liquid sampling channel and the B liquid sampling channel are written into the same sampling control record. In accordance with the sampling calibration requirements in the liquid preparation reference information, the sampling time scale of the two sampling channels is adjusted to the same time reference, the response start point of the two channels is adjusted to the same response reference, and the compensation parameters of the two channels are adjusted to the same compensation reference. The response offset, channel hysteresis, and compensation offset generated during the adjustment process are written into the correction queue under the current control cycle, and the sampling status of the two sampling channels is updated item by item according to the correction order corresponding to the sampling control record. The updated sampling status of the two channels is associated with the current control cycle number, sampling time scale, and liquid preparation reference information to establish a synchronous calibration status.
[0030] The hidden sodium correction module applies stepped micro-flow pulse control to the sampling channel of liquid B according to the synchronous calibration status, and uses time-domain differential filtering to extract the steady-state plateau value and transient jump component of the sampling channel of liquid B. The steady-state plateau value is mapped to the basic sodium contribution, and the transient jump component after synchronous calibration compensation is mapped to the hidden sodium contribution. Then, the dynamic reference three-level correction operation is performed to generate the hidden sodium correction amount of liquid B.
[0031] Based on the synchronous calibration status, a stepped micro-flow pulse sampling command is issued to the sampling channel of liquid B, controlling the sampling channel of liquid B to generate a continuous pulse response curve according to the stepped flow rate change.
[0032] Furthermore, the sampling control record is retrieved based on the control cycle number in the synchronous calibration state. The start time, holding time and switching interval are assigned to each step pulse according to the sampling time scale. The micro-pump drive quantity, sampling valve opening and flow rate of liquid B sampling channel are corrected according to the sampling calibration elements associated in the synchronous calibration state. The modified start time, hold time, switching interval, micro-pump drive quantity, sampling valve opening degree and flow rate change are arranged into a continuous step control sequence according to the control cycle number to form a step-type micro-flow pulse sampling command. A stepped micro-flow pulse sampling command is written into the micro-pump drive queue and sampling valve opening control queue of the B liquid sampling channel. After the command is issued, the B liquid sampling channel is controlled to perform micro-sampling according to the stepped flow rate that alternates between low to high and high to low. During each step holding period, the sensor response change of the B liquid sampling channel is collected. During the step flow rate switching period, the flow rate switching time stamp, the response start time stamp, and the response fall time stamp are recorded. The stable response during each step holding period and the changing response during each step switching period are continuously spliced according to the sampling time stamp to generate a continuous pulse response curve.
[0033] It should be noted that the start time, hold duration, and switching interval in the stepped micro-flow pulse sampling command are jointly limited by the sampling timestamp in the synchronous calibration state, the sensor response stabilization time, the micro-pump response delay, the sampling valve switching hysteresis, and the current sampling cycle; among them, the hold duration is determined according to the time required for the sensor response to enter the stable response section under the same step flow, and the switching interval is determined according to the time required for the micro-pump drive and sampling valve opening to complete the stepped switching and form an identifiable transient jump component; Micro-flow rate refers to a sampling flow rate lower than the normal mixing flow rate of concentrate B, used for bypass sampling and detection, and not entering the main supply path of dialysate. It is limited by the sampling calibration requirements in the mixing reference information and determined by the detection section volume of the B solution sampling channel, the sensor response stabilization time, and the sampling flow rate reference in the synchronous calibration state. Stepped micro-flow pulse control refers to controlling the micro-pump drive and sampling valve opening of the B solution sampling channel in the synchronous calibration state to change the B solution sampling flow rate in multiple small steps, and maintaining short-term sampling at each step flow rate, forming a flow rate switch between adjacent steps, so that the B solution sampling channel generates a continuous pulse response curve with a stable holding section and a rapid change section.
[0034] Baseline subtraction is performed on the continuous pulse response curve according to the sampling time scale, and the response difference between adjacent sampling points is calculated to form a time-domain difference sequence. According to the hold phase and switching phase in the step-type micro-flow pulse sampling command, the time-domain difference sequence is divided into a stable response segment and a rapid change segment. The response hold value corresponding to the stable response segment is taken as the steady-state plateau value, and the response mutation value corresponding to the rapid change segment is taken as the transient jump component.
[0035] Furthermore, based on the continuous impulse response curve, using the response baseline in the synchronous calibration state as the subtraction reference, the sampling points are arranged in the order of sampling time scale. The original response of each sampling point is subtracted from the baseline response under the corresponding time scale to obtain the response sequence after baseline subtraction. The response difference between adjacent sampling points is calculated along the sampling time scale direction, and the response difference is associated with the corresponding sampling interval to form a time-domain difference sequence with time scale. Based on the start and end times of the step hold and the start and end times of the step switch recorded in the step-type micro-flow pulse sampling command, segments with continuous low fluctuations and a gradual response in the differential sequence are classified into the stable response segment, and segments with concentrated response differences and an upward or downward trend are classified into the rapid change segment. The sampling points in the stable response segment are sorted according to the sampling time scale, and the transition response points in the initial and final stages of the step hold are removed. After filtering out discrete jump points, the remaining response values are collected according to the hold duration to obtain the response hold amount corresponding to the stable response segment, and the response hold amount is used as the steady-state plateau value. The response differences between adjacent sampling points in the rapidly changing section are collected according to the step switching direction. Continuous response differences consistent with the step switching direction are retained, and the amplitude of the continuous response differences is accumulated to obtain the response mutation amount corresponding to the rapidly changing section. The response mutation amount is used as the transient jump component.
[0036] It should be noted that time-domain differential filtering is a signal processing method that compares the response changes of adjacent sampling points in time sequence, using the response difference to highlight the rapidly changing parts and weaken the slowly drifting parts.
[0037] Based on the component registration relationship in the solution preparation reference information, the steady-state plateau value of each step in the step-by-step micro-flow pulse sampling command is correlated with the main response of sodium bicarbonate in solution B. The response baseline in the synchronous calibration state is subtracted from the steady-state plateau value, and the subtracted steady-state plateau value is converted according to the sampling flow rate and holding time corresponding to each step to obtain the basic sodium contribution. The basic sodium contribution under each step is collected according to the control cycle number to establish the basic sodium contribution baseline of solution B.
[0038] Furthermore, based on the component registration relationship in the solution preparation reference information, the response acceptance interval and response conversion relationship corresponding to the sodium bicarbonate main component in solution B are retrieved, and the steady-state plateau values of each step holding stage in the step-type micro-flow pulse sampling command are written into the same sampling record according to the step sequence number, holding time and control cycle number. During each step holding phase, the response range into which the steady-state plateau value falls is associated with the main response of sodium bicarbonate in solution B and the response baseline in the synchronous calibration state is used as the basis for zero-point correction. The channel background response, temperature baseline drift and the residual response of the previous step are subtracted from the steady-state plateau value to obtain the baseline-removed plateau response. Based on the sampling flow rate and holding time corresponding to each step, the baseline platform response is converted into the sodium response capacity per unit sampling amount, and then converted into the basic sodium contribution formed by the sodium bicarbonate main component of solution B according to the response conversion relationship in the component registration relationship. The basic sodium contribution obtained in each step holding stage is collected according to the control cycle number, step sequence number and sampling time scale. After removing the influence of the transition response in the initial and final stages of step holding, the baseline of basic sodium contribution of solution B is formed.
[0039] The transient jump component is compensated based on the synchronous calibration status. The transient offset caused by the change in sampling flow rate, channel response hysteresis and temperature drift during the step switching stage is deducted from the transient jump component to obtain the compensated transient jump component. The difference between the compensated transient jump component and the baseline sodium contribution of liquid B is separated. The response part explained by the sodium contribution of sodium bicarbonate is deducted, and the sodium response difference exceeding the baseline sodium contribution of liquid B is retained to form the implicit sodium contribution.
[0040] Furthermore, under the sampling reference, temperature compensation reference, and channel response reference provided by the synchronous calibration state, the step switching time scale, response jump amplitude, and response fall amplitude corresponding to the transient jump component are collected and processed. The flow disturbance caused by the step flow switching, the hysteresis offset caused by the response lag of the B liquid sampling channel, and the response drift caused by the detection temperature change are deducted from the transient jump component to obtain the compensated transient jump component. The compensated transient jump components are linked to the baseline sodium contribution of liquid B according to the control cycle number and step sequence number. The converted value of the baseline sodium contribution response in the same step holding stage is used as the central bearing quantity. The calibration error band is formed by the channel residual, temperature compensation residual and step holding fluctuation in the synchronous calibration state. The interpretable response range is defined by the central bearing quantity and the calibration error band. The response portion of the compensated transient jump components that falls within the interpretable response range is classified as the sodium bicarbonate baseline sodium contribution. The continuous sodium response difference that exceeds the interpretable response range and is consistent with the step switching direction is classified as the implicit sodium candidate response. Isolated jump points and opposite-direction differences in the implicit sodium candidate responses are eliminated. The retained continuous sodium response differences are collected according to the sampling time scale continuity and the step switching direction to form the implicit sodium contribution.
[0041] The contribution of implied sodium is corrected sequentially according to the sampling channel benchmark, temperature compensation benchmark, and current solution conversion benchmark to eliminate the influence of sampling condition fluctuations, ion response drift, and solution ratio conversion deviation on the contribution of implied sodium. The corrected contribution of implied sodium is converted into sodium load increment according to the solution ratio of solution B in the current control cycle and the dilution relationship of dialysis water, thus generating the implied sodium correction amount of solution B.
[0042] Furthermore, retrieve the sampling channel reference, temperature compensation reference, and current solution conversion reference corresponding to the current control cycle in the synchronous calibration state, and first include the implicit sodium contribution in the channel offset processing under the sampling channel reference, and deduct the sampling offset caused by small fluctuations in sampling flow rate, channel residue, and detection segment lag. After completing the channel offset processing, the implicit sodium contribution is incorporated into the response drift processing under the temperature compensation benchmark. The ion response change is corrected according to the offset relationship between the current sampling temperature and the temperature compensation benchmark to obtain the temperature-corrected implicit sodium contribution. Before the temperature-corrected implicit sodium contribution is included in the solution preparation calculation, a proportional conversion is performed according to the current solution preparation conversion benchmark. The entry ratio of solution B in the current control cycle, the conversion relationship between the sample volume of solution B and the actual solution preparation volume, and the dilution relationship of dialysis water are all included in the conversion link to obtain the corrected implicit sodium contribution. The corrected implicit sodium contribution is converted into the sodium load increment entering the final dialysate, and the sodium load increment is registered as the implicit sodium correction amount of solution B.
[0043] The sodium load verification module converts the sodium response of liquid A in the sampling channel of liquid A and the implicit sodium correction amount of liquid B into the total sodium load, and performs deviation verification in combination with the sodium target value and allowable deviation range to generate the consistency status of the total sodium load.
[0044] Based on the synchronous calibration status, the sodium response of liquid A in the sampling channel of liquid A is time-scaled with the implicit sodium correction amount of liquid B under the current control cycle, and the response baseline corresponding to the synchronous calibration status is subtracted from the sodium response of liquid A. The sodium response of liquid A after subtraction is converted into the sodium contribution of liquid A according to the liquid preparation reference information.
[0045] Furthermore, the sodium response of liquid A in the same control loop in the sampling channel of liquid A is written into the total sodium load calculation link. When there is a deviation between the sampling time scale of the sodium response of liquid A and the implicit sodium correction of liquid B, the time window of the sodium response of liquid A is truncated and the response points are merged according to the sampling time scale order in the synchronous calibration state, so that the sodium response of liquid A and the implicit sodium correction of liquid B fall into the same effective sampling window. When there is no offset between the sampling timescale of the sodium response of solution A and the implicit sodium correction of solution B, the sodium response of solution A is directly marked as the same window response. After completing the timescale merging or same window marking, the channel background response, residual response and zero drift response corresponding to the synchronous calibration state are subtracted from the sodium response of solution A to obtain the net sodium response of solution A. According to the solution preparation relationship of solution A in the solution preparation reference information, the net sodium response of solution A is combined with the solution preparation ratio of solution A entering the solution preparation path, the conversion relationship between the sampling amount and the actual solution preparation amount, and the dilution relationship of dialysis water to calculate the contribution of sodium in solution A under the current control cycle.
[0046] The sodium contribution of solution A and the implicit sodium correction of solution B are unified to the same sodium load measurement standard, and the total sodium load under the current control cycle is obtained by combining and converting the solutions A, B concentrates and dialysis water according to the solution mixing relationship.
[0047] Furthermore, under the current control cycle, the sodium load measurement unit, A concentrate ratio, B concentrate ratio, dialysis water dilution ratio, and final solution volume reference in the solution preparation reference information are used as a unified conversion basis to measure and normalize the sodium contribution of solution A and the implicit sodium correction of solution B. When the sodium contribution of solution A and the implicit sodium correction of solution B are already at the same sodium load measurement reference, the sodium contribution of solution A and the implicit sodium correction of solution B are directly written into the same total sodium load calculation link. When the sodium contribution of liquid A and the implicit sodium correction of liquid B are not at the same sodium load measurement benchmark, the equivalent amount of sampling corresponding to the sodium contribution of liquid A is used as the benchmark. Combined with the actual amount of liquid A entering the current control cycle and the ratio of liquid A, the sodium contribution of liquid A is converted into the sodium load carried by liquid A after it actually enters the mixing path, forming the sodium load contribution of liquid A after it enters the mixing path. Based on the equivalent sampling amount corresponding to the implicit sodium correction of solution B, and combined with the actual amount of solution B entering the current control cycle and the ratio of solution B, the implicit sodium correction of solution B is converted into the additional sodium load carried by solution B after it actually enters the mixing path, forming the implicit sodium load contribution of solution B after entering the mixing path. The sodium load contribution of solution A after entering the mixing path and the implicit sodium load contribution of solution B after entering the mixing path are combined, and diluted according to the dialysis water intake and the final solution volume, the combined sodium load is calculated and distributed to the unit dialysate volume to obtain the total sodium load under the current control cycle.
[0048] Using the sodium target value and allowable deviation range in the solution preparation reference information as the verification benchmark, the total sodium load under the current control cycle and the sodium target value are placed under the same sodium load measurement benchmark, and the load deviation between the total sodium load and the sodium target value is calculated.
[0049] Furthermore, the total sodium load is written into the sodium load deviation processing link, and the sodium target value, allowable deviation range, and sodium load measurement unit in the solution preparation reference information are used as the deviation processing reference; when the total sodium load is consistent with the sodium target value in terms of measurement unit, dilution volume reference, and control cycle number, the total sodium load and sodium target value are directly included in the same deviation calculation record. When the total sodium load and the sodium target value have inconsistent units of measurement or dilution volume references, the total sodium load is normalized and converted to volume according to the sodium load unit of measurement and the final liquid preparation volume reference in the liquid preparation reference information. The normalized and converted total sodium load and the sodium target value are written into the deviation calculation record corresponding to the same control cycle. In the deviation calculation record, the difference between the normalized and converted total sodium load and the sodium target value is calculated, and the positive and negative directions and numerical values of the difference are retained to form the load deviation under the current control cycle.
[0050] The load deviation is checked against the allowable deviation range. When the load deviation falls within the allowable deviation range, the current control cycle is marked as sodium load consistent. When the load deviation exceeds the allowable deviation range, the current control cycle is marked as sodium load deviation. The deviation direction and deviation magnitude are recorded to generate the total sodium load consistent state.
[0051] Furthermore, the load deviation is written into the sodium load status processing record corresponding to the current control cycle, and the allowable deviation range in the solution preparation reference information is used as the basis for interval assignment; when the load deviation is within the allowable deviation range, the sodium load status of the current control cycle is marked as sodium load consistent status, and the sodium load consistent status is associated with the total sodium load, sodium target value and control cycle number. When the load deviation is outside the allowable deviation range, the sodium load status of the current control cycle is marked as a sodium load deviation state. When the load deviation is higher than the upper limit of the allowable deviation range, the direction of deviation is recorded, and the difference between the load deviation and the upper limit of the allowable deviation range is used as the deviation magnitude. When the load deviation is lower than the lower limit of the allowable deviation range, the direction of deviation is recorded, and the difference between the lower limit of the allowable deviation range and the load deviation is used as the deviation magnitude. The sodium load consistency state or sodium load deviation state, deviation direction, deviation magnitude and control cycle number are merged and registered to generate the total sodium load consistency state.
[0052] The bicarbonate load verification module, based on the total sodium load consistency status, connects the A liquid acid contribution sampling response in the A liquid sampling channel to the bicarbonate load verification link, triggers a controlled neutralization reaction in the bypass isothermal and isobaric microfluidic verification chamber, and performs gas-liquid two-phase coupling conversion to generate the bicarbonate load status.
[0053] Based on the sodium load consistency status and control cycle number in the total sodium load consistency status, the corresponding control cycle is used as the bicarbonate load verification trigger cycle, and the A solution acid contribution sampling response, synchronous calibration status and solution preparation reference information in the A solution sampling channel are bound to form the A solution acid contribution verification input.
[0054] It should be noted that control cycle numbers with consistent sodium load status are selected and written into the trigger queue of the bicarbonate load verification link as bicarbonate load verification trigger cycles. When the overall sodium load consistency status carries a sodium load deviation status, the corresponding control cycle is marked as a sodium load correction cycle, and the deviation direction, deviation magnitude, and control cycle number are written into the verification queue of the bicarbonate load verification link. Within the sodium load correction cycle, the bypass isothermal and isobaric microfluidic verification chamber does not enter normal neutralization verification. The bicarbonate load status of the corresponding control cycle is registered as a verification status, and the verification status is associated with the sodium load deviation status, deviation direction, deviation magnitude, and control cycle number as input for linkage permission processing. Furthermore, within the bicarbonate load verification trigger loop, the A solution acid contribution sampling response at the corresponding sampling time point in the A solution sampling channel is associated and registered with the sampling reference, response reference, and control loop number in the synchronous calibration state. In accordance with the verification ratio, bicarbonate load requirements, and bypass verification requirements in the solution preparation reference information, the A solution acid contribution sampling response is written with the verification time point, verification ratio, and bypass verification identifier to form the A solution acid contribution verification input.
[0055] According to the acid contribution verification input of solution A, the trace acid contribution sample in the sampling channel of solution A is introduced into the bypass constant temperature and pressure microfluidic verification chamber, and according to the verification ratio corresponding to the solution preparation reference information, the bicarbonate verification sample is introduced from the sampling channel of solution B to form the bypass controlled reaction sample.
[0056] Furthermore, the calibration time stamp, calibration ratio, and bypass calibration identifier in the A-liquid acid contribution calibration input are written into the injection control record of the bypass isothermal and isobaric microfluidic calibration chamber, and the micro-injection branch between the A-liquid sampling channel and the bypass calibration chamber is opened according to the calibration time stamp; the A-liquid acid contribution sampling liquid corresponding to the current control cycle is extracted from the A-liquid sampling channel and distributed according to the micro-injection volume in the A-liquid acid contribution calibration input to form a micro-acid contribution sample; A trace acid contribution sample is introduced into the bypass isothermal and isobaric microfluidic calibration chamber. According to the calibration ratio corresponding to the solution preparation reference information, the micro-injection branch between the B solution sampling channel and the bypass calibration chamber is opened, and the bicarbonate sample solution corresponding to the same control cycle of the B solution is extracted from the B solution sampling channel to form a bicarbonate calibration sample. The bicarbonate calibration sample is introduced into the bypass isothermal and isobaric microfluidic calibration chamber in proportion, and the trace acid contribution sample and the bicarbonate calibration sample are registered according to the injection time scale, injection volume and position in the chamber to form the bypass controlled reaction sample.
[0057] It should be noted that the bypass constant temperature and pressure microfluidic calibration chamber refers to a micro-sampling calibration chamber isolated from the dialysate supply path. It is connected to the A liquid sampling channel and the B liquid sampling channel respectively, and is equipped with a temperature control channel, a pressure limiting micro-valve, a micro-mixing channel, a gas-liquid separation section, a liquid phase detection path, and a gas phase detection path. The trace acid contribution sample refers to the acid contribution sample intercepted from the sampling channel of liquid A and introduced into the bypass isothermal and isobaric microfluidic calibration chamber. Its injection volume is limited by the trace injection volume in the liquid A acid contribution calibration input. The trace injection volume is determined based on the effective reaction volume of the bypass isothermal and isobaric microfluidic calibration chamber, the separation requirements of the gas-liquid separation section, and the sensor response stability requirements of the liquid phase detection path and the gas phase detection path. The calibration ratio refers to the correspondence between the injection volume of the trace acid contribution sample and the bicarbonate calibration sample when entering the bypass isothermal and isobaric microfluidic calibration chamber. It is jointly limited by the A and B concentrate ratio, acid-base neutralization equivalent relationship, effective reaction volume of the bypass isothermal and isobaric microfluidic calibration chamber, and sensor response linear interval in the liquid preparation reference information, and is written into the liquid A acid contribution calibration input to constrain the introduction volume of the trace acid contribution sample and the bicarbonate calibration sample under the same control cycle.
[0058] Within the bypass isothermal and isobaric microfluidic calibration chamber, temperature locking, pressure constraint, and laminar flow disturbance mixing are performed on the bypass controlled reaction sample through a temperature control channel, a pressure limiting microvalve, and a micro-mixing channel. This controls the bypass controlled reaction sample to undergo a controlled neutralization reaction under bypass calibration conditions, forming a neutralization calibration response.
[0059] It should be noted that the bypass verification conditions refer to the reaction control constraints used when carrying out controlled neutralization reactions on trace acid contribution samples and bicarbonate verification samples in a bypass isothermal and isobaric microfluidic verification chamber. Furthermore, after the bypass controlled reaction sample enters the bypass isothermal and isobaric microfluidic calibration chamber, the temperature control channel adjusts the heat of the sample residence area according to the target temperature curve corresponding to the bypass calibration conditions, and the temperature fluctuation in the chamber converges to the corresponding temperature range. The pressure-limiting microvalve adjusts its opening according to the injection pressure and the back pressure inside the cavity, constraining the flow rate, pressure, and residence time of the sample in the reaction section within the range corresponding to the bypass verification conditions; the micro-mixing channel continuously updates the contact interface between the trace acid contribution sample and the bicarbonate verification sample through the bend channel, the diversion and merging section, and the micro-perturbation structure, controlling the acid component in the trace acid contribution sample and the bicarbonate component in the bicarbonate verification sample to complete the controlled neutralization reaction in laminar flow. During the reaction, the changes in liquid phase pH, liquid phase conductivity, residual bicarbonate response, intracavitary pressure, and gas escape response are recorded simultaneously and registered according to the reaction time scale to form a neutralization verification response.
[0060] Based on the neutralization verification response, the bypass controlled reaction sample is introduced into the liquid phase detection path and the gas phase detection path through the gas-liquid separation section in the bypass isothermal and isobaric microfluidic verification chamber. In the liquid phase detection path, the residual bicarbonate response, pH response and conductivity response of the liquid after the reaction are collected to form the liquid phase residual response. In the gas phase detection path, the amount of gas emitted from the reaction, pressure change and carbon dioxide response are collected to form the gas phase emission response.
[0061] Furthermore, based on the neutralization verification response, the bypass isothermal and isobaric microfluidic verification chamber opens the gas-liquid separation section according to the reaction timescale, and the bypass controlled reaction sample after the controlled neutralization reaction is introduced into the separation inlet; the gas-liquid separation section diverts the reaction sample through the liquid phase guiding microchannel and the gas phase escaping microchannel, wherein the liquid phase part enters the liquid phase detection path along the liquid phase guiding microchannel, and completes flow stabilization, defoaming and detection positioning within the liquid phase detection path, continuously collecting the residual bicarbonate response, liquid phase pH response and liquid phase conductivity response in the liquid after the reaction, and associating and registering them according to the reaction timescale, liquid phase residence position and detection sequence to form the liquid phase residual response; The gas phase enters the gas phase detection path along the gas phase escape microchannel, and passes through gas collection, pressure buffering and carbon dioxide detection and positioning within the gas phase detection path. The amount of gas escaped, pressure changes and carbon dioxide response generated by the reaction are continuously collected and recorded in sequence according to the escape time scale, gas collection location and pressure change, forming a gas phase escape response.
[0062] It should be noted that the liquid-phase residual response is used to characterize the retention of bicarbonate that did not participate in the conversion after the reaction, while the gas-phase escape response is used to characterize the gas-phase release of bicarbonate after the neutralization reaction.
[0063] Based on the dynamic dissociation equilibrium of bicarbonate, the residual response in the liquid phase is converted into the contribution of unreacted bicarbonate, and the gas phase escape response is converted into the contribution of converted bicarbonate. The contributions of unreacted bicarbonate and converted bicarbonate are coupled and calculated to obtain the effective load of bicarbonate.
[0064] Furthermore, based on the liquid-phase residual response and the gas-phase escape response, the reaction temperature, cavity pressure, sample volume and reaction time scale in the bypass verification conditions are used as conversion benchmarks, and the dynamic dissociation equilibrium relationship of bicarbonate is established according to the dynamic transition relationship of bicarbonate from liquid-phase retention state to gas-phase escape state under the action of acid. Under dynamic dissociation equilibrium, the residual bicarbonate response, pH response and conductivity response in the liquid phase residual response are associated with the same liquid phase reaction timescale. After deducting the liquid phase background response and temperature drift response corresponding to the synchronous calibration state, the contribution of unreacted bicarbonate that remains in the liquid phase after the reaction is calculated. The gas escape amount, pressure change and carbon dioxide response in the gas phase escape response are associated with the same gas phase escape time scale. After deducting the background escape response of the gas phase detection path, the contribution of the converted bicarbonate formed by the contribution of bicarbonate after the contribution of liquid A acid is obtained according to the conversion relationship of gas phase volume, pressure constraint and carbon dioxide response of the bypass isothermal microfluidic calibration chamber. The effective load of bicarbonate is calculated by incorporating the contributions of unreacted bicarbonate and converted bicarbonate into the gas-liquid two-phase transition link under the same reaction time scale, and deducting the conversion offset caused by the residue in the gas-liquid separation section, liquid phase gas carrying, and gas phase retention.
[0065] Before converting the residual response in the liquid phase, the liquid phase reference load corresponding to the bicarbonate calibration sample is determined based on the calibration ratio, bicarbonate load requirement, and injection volume of the bypass controlled reaction sample in the liquid preparation reference information. The liquid phase reference load is then correlated with the liquid phase reference response, liquid phase background response, temperature drift response, and liquid phase reference volume collected under the same bypass calibration conditions to calculate the calibration coefficient of the liquid phase response to the bicarbonate load.
[0066] The effective load of bicarbonate is calculated using the following formula: ; In the formula, Indicates the current control loop The effective load of bicarbonate under the following conditions Indicates the current control loop Calibration factor for the lower liquid phase response to bicarbonate loading. Indicates the current control loop The remaining bicarbonate response, Indicates liquid phase, Indicates the current control loop The background response of the liquid phase in the lower synchronous calibration state. Indicates the current control loop Temperature drift response corresponding to the next synchronous calibration state Indicates the current control loop Sample volume in the lower liquid phase detection path Indicates the current control loop pH response in the lower liquid phase detection path Indicates the current control loop Conductivity response in the lower liquid phase detection path Indicates the current control loop The gas phase escape response below, Indicates the current control loop Background evaporation response of the lower gas phase detection path Indicates the gas phase; Indicates the current control loop Pressure changes in the lower gas phase detection path Indicates the current control loop Gas volume of the lower bypass isothermal and isobaric microfluidic calibration chamber Indicates the current control loop The conversion relationship between the lower gas phase escape response and the carbon dioxide response. Indicates the current control loop The conversion offset is caused by residues in the gas-liquid separation section, gas carried by the liquid phase, and gas retention. This indicates the gas-liquid separation and two-phase transfer process.
[0067] in, and All are dimensionless responses after normalization of the liquid phase response conversion relationship; during the factory calibration or pre-use calibration stage of the calibration chamber, a calibration sample with known carbon dioxide release or known bicarbonate conversion is passed into the gas phase detection path, and the corresponding gas emission, pressure change and carbon dioxide detection response are recorded to establish the conversion relationship between the gas phase response and carbon dioxide release. The residual liquid response in the gas-liquid separation section, the gas-carrying response in the liquid phase detection path, and the stagnant gas response in the gas phase detection path are collected. According to the sample volume, reaction time scale, and intracavity pressure constraints in the bypass verification conditions, the residual liquid response is converted into the residual offset of the gas-liquid separation section, the gas-carrying response is converted into the liquid phase gas-carrying offset, and the stagnant gas response is converted into the gas phase stagnant offset. The residual offset of the gas-liquid separation section, the liquid phase gas-carrying offset, and the gas phase stagnant offset are combined to obtain the conversion offset.
[0068] According to the verification ratio corresponding to the solution preparation reference information, the effective load of bicarbonate is back-calculated to the solution preparation load range under the current control cycle. Based on the correspondence between the effective load of bicarbonate and the bicarbonate load requirements in the solution preparation reference information, the effective load of bicarbonate is classified into intervals and marked with status to generate the bicarbonate load status.
[0069] Furthermore, based on the calibration ratio in the solution preparation baseline information, the effective load of bicarbonate is converted to the actual solution preparation volume, the proportion of B concentrate entering, and the dilution relationship of dialysis water corresponding to the current control cycle, so as to obtain the back-calculated bicarbonate solution preparation load. Write the calculated bicarbonate solution load into the bicarbonate load processing record corresponding to the current control cycle, and use the bicarbonate load requirement in the solution preparation reference information as the basis for interval classification; when the calculated bicarbonate solution load falls within the allowable load range corresponding to the bicarbonate load requirement, mark the current control cycle as a consistent bicarbonate load state; when the calculated bicarbonate solution load is lower than the lower limit of the allowable load range, mark the current control cycle as an insufficient bicarbonate load state, and record the insufficient range. When the calculated bicarbonate solution load exceeds the upper limit of the allowable load range, the current control cycle is marked as an excessive bicarbonate load state, and the excess magnitude is recorded. The corresponding states in the bicarbonate load consistency state, insufficient bicarbonate load state, and excessive bicarbonate load state are associated and registered with the current control cycle number, the calculated bicarbonate solution load, and the corresponding magnitude to generate the bicarbonate load state.
[0070] The liquid supply control module controls and aligns the total sodium load consistency status and bicarbonate load status, performs permission merging processing based on the liquid preparation reference information, generates A and B concentrate linkage permission status, adjusts the liquid preparation flow rate of A and B concentrates and dialysis water based on the A and B concentrate linkage permission status, and switches the dialysate supply path to form dialysate supply control status.
[0071] Based on the current control cycle number and sampling time scale, the total sodium load consistency status and bicarbonate load status are linked to the same control cycle, and status items with inconsistent cycle numbers and time scales exceeding the effective sampling window are screened out to form a load status group in the same cycle.
[0072] It should be noted that the effective sampling window refers to the time range jointly defined by the control cycle period, sampling start time, sampling hold duration, and channel response stability period in the solution preparation reference information, which is used to constrain the total sodium load consistency state and bicarbonate load state to participate in the linkage permission processing under the same control cycle. Furthermore, the total sodium load consistency status is written into the sodium load field of the current load linkage processing record, and the bicarbonate load status is written into the bicarbonate load field of the current load linkage processing record; using the current control cycle number as the main index and the sampling time stamp as the validity index, the source cycle and sampling time of the total sodium load consistency status and the source cycle and sampling time of the bicarbonate load status are merged respectively. When the control cycle number corresponding to the total sodium load consistency state is consistent with the current control cycle number, and the sampling time stamp corresponding to the total sodium load consistency state falls into the sampling effective window, and at the same time, the control cycle number corresponding to the bicarbonate load state is consistent with the current control cycle number, and the sampling time stamp corresponding to the bicarbonate load state falls into the sampling effective window, the total sodium load consistency state and the bicarbonate load state are retained in the same load linkage processing record. When the bicarbonate load status is pending verification, and the associated control cycle number is consistent with the control cycle number of the sodium load deviation status in the total sodium load consistency status, the pending verification status is retained as an effective linkage status in the same load linkage processing record, and the pending verification status is prohibited from participating in the normal liquid supply release judgment as a bicarbonate load consistency status; when the control cycle number of either the total sodium load consistency status or the bicarbonate load status is inconsistent with the current control cycle number, or when the sampling timescale of either status exceeds the sampling effective window, the corresponding status is written into the failure status record, and the corresponding status is prohibited from participating in this linkage permission processing; after completing the cycle number merging and timescale screening, the retained total sodium load consistency status, bicarbonate load status, corresponding sampling timescale, and current control cycle number are associated and registered to form a load status group in the same cycle.
[0073] Based on the solution preparation reference information, the correspondence between the total sodium load consistency status and bicarbonate load status in the same cycle load status group is converted into supply permit requirements, solution preparation correction requirements and path constraint requirements, and written into the same linkage permit record to generate the linkage permit status of concentrates A and B.
[0074] Furthermore, based on the same cycle load state group, and according to the permissible merging rules in the liquid preparation reference information, the total sodium load consistency state is written into the sodium load permissible field, the bicarbonate load state is written into the bicarbonate permissible field, and the load deviation amount, deviation direction and deviation magnitude corresponding to the total sodium load consistency state, as well as the load classification result, load insufficiency magnitude and load excess magnitude corresponding to the bicarbonate load state, are associated with the same control cycle. It should be noted that, for example, when the sodium load permit field carries a sodium load consistency status and the bicarbonate permit field carries a bicarbonate load consistency status, the sodium load permit field and the bicarbonate permit field are jointly classified into the liquid supply permit requirement. The deviation direction, deviation magnitude, insufficient magnitude and excessive magnitude in the liquid preparation correction requirement are registered as null values, and the corresponding liquid preparation flow correction amount is registered as zero. The path constraint requirement is registered as the path status field of dialysate supply path release, bypass discharge path closure and verification sampling path closure.
[0075] During the permit merging process, the sodium load permit field and the bicarbonate permit field are jointly included in the liquid supply permit requirements. The deviation direction and deviation magnitude in the total sodium load consistency status, as well as the insufficient and excessive magnitude in the bicarbonate load status, are jointly included in the liquid preparation correction requirements. The liquid supply path restrictions corresponding to the liquid supply permit requirements and liquid preparation correction requirements are included in the path constraint requirements. The liquid supply permit requirements, liquid preparation correction requirements, path constraint requirements, current control cycle number, and sampling time stamp are written into the same linkage permit record to generate the linkage permit status of concentrates A and B.
[0076] It should be noted that the liquid supply permit requirements include release markings, verification markings, and liquid supply prohibition markings; the liquid preparation correction requirements include the correction object, correction direction, and correction range source; the path constraint requirements include the supply path status, bypass discharge path status, verification sampling path status, and valve position switching sequence index.
[0077] Based on the status correspondence in the linkage permit status of concentrates A and B and the liquid preparation relationship in the liquid preparation reference information, the flow correction direction of concentrate A, concentrate B and dialysis water is determined, and the corresponding liquid preparation flow correction amount is generated according to the difference between the current actual liquid preparation flow rate and the target liquid preparation flow rate. The entry ratio of concentrate A, concentrate B and dialysis water is adjusted according to the liquid preparation flow correction amount to form the liquid preparation flow rate adjustment status.
[0078] Furthermore, the supply permission requirements, dispensing correction requirements, and path constraint requirements in the linkage permission status of concentrates A and B are written into the dispensing adjustment record of the current control cycle. According to the dispensing relationship in the dispensing reference information, the deviation sources corresponding to the total sodium load consistency status and bicarbonate load status are respectively assigned to the flow adjustment objects of concentrate A, concentrate B, and dialysis water. Among them, the amount of concentrate entering the system corresponding to higher load is classified as the downward adjustment direction, the amount of concentrate entering the system corresponding to lower load is classified as the upward adjustment direction, and the amount of dialysis water entering the system is classified as the compensation direction according to the dilution and connection relationship corresponding to the change of concentrate load, thus forming the flow correction direction. Based on the flow correction direction, the current actual solution flow rate and the target solution flow rate in the solution preparation reference information are written into the same flow correction record. The flow difference between the current actual solution flow rate and the solution preparation reference information is used as the source of the correction range to form the solution flow correction amount for concentrate A, concentrate B and dialysis water respectively. The entry ratio of concentrate A, concentrate B and dialysis water is adjusted according to the solution flow correction amount, and the adjusted entry ratio, flow correction direction, solution flow correction amount and current control cycle number are associated and registered to form the solution flow adjustment status.
[0079] Based on the supply permit requirements and path constraints, and combined with the flow adjustment completion status in the solution preparation flow adjustment status, the supply path control relationship in the solution preparation reference information is compared and assigned. The supply permit requirements are written into the corresponding supply path, and the flow adjustment completion status is written into the valve position switching sequence and pumping maintenance conditions of the corresponding path, thus forming the dialysate supply control status.
[0080] It should be noted that the release path in the liquid supply permit requirement is taken as the target path, and the restricted path in the path constraint requirement is taken as the prohibited path. According to the valve position acceptance sequence in the liquid supply path control relationship, the closing action of the valve corresponding to the prohibited path is arranged first, the closing action of the valve in the non-target path is arranged, and the opening action of the upstream and downstream valves of the target path is arranged to form the valve position switching sequence. The flow rate adjustment completion status in the solution preparation flow rate adjustment state is compared with the solution preparation flow rate correction amount. When the flow rate adjustment completion status reaches the solution preparation flow rate correction amount, the adjusted entry ratio of A concentrate, B concentrate and dialysis water is used as the pumping maintenance ratio. When the flow rate adjustment completion status does not reach the solution preparation flow rate correction amount, the corresponding flow path is written with pause entry condition or low flow rate maintenance condition to form pumping maintenance condition.
[0081] Furthermore, the supply permit requirements and path constraints in the A and B concentrate linkage permit status are written into the current supply path control record, and the flow rate adjustment completion status in the liquid preparation flow rate adjustment status is simultaneously written into the control record; according to the supply path control relationship in the liquid preparation reference information, the supply permit requirements are written into the release field of the dialysate supply path, and the path constraints are written into the path status fields of the dialysate supply path, bypass discharge path, and verification sampling path, and the flow rate adjustment completion status is written into the valve position switching sequence and pumping maintenance conditions of the corresponding path; under the same control cycle, the release field, path status field, valve position switching sequence, and pumping maintenance conditions are associated and registered to form a dialysate supply control status that constrains the current dialysate flow direction, liquid preparation maintenance status, and supply release status.
[0082] In summary, this invention achieves controlled neutralization verification through a bypass constant-temperature and constant-pressure microfluidic verification chamber, and performs gas-liquid two-phase coupling conversion to obtain the effective load of bicarbonate under the current control cycle. This allows the bicarbonate load state to be synchronized with the total sodium load state and merged into the A and B concentrate linkage permission state. This further drives the flow correction of A concentrate, B concentrate and dialysis water, the writing of supply path constraints and the updating of valve position switching sequence, thereby improving the continuity of dialysis fluid supply control, the coordination of solution preparation response and the closed-loop nature of load state.
[0083] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.
Claims
1. A monitoring and control system for A and B concentrates used in hemodialysis, characterized in that, include: The synchronous calibration module receives the solution preparation reference information and performs synchronous calibration on the sampling channels of solution A and solution B, establishing a synchronous calibration status. The hidden sodium correction module applies stepped micro-flow pulse control to the sampling channel of liquid B according to the synchronous calibration state, and uses time-domain differential filtering to extract the steady-state plateau value and transient jump component of the sampling channel of liquid B. The steady-state plateau value is mapped to the basic sodium contribution, and the transient jump component after synchronous calibration state compensation is mapped to the hidden sodium contribution. The module also performs dynamic reference three-level correction calculation to generate the hidden sodium correction amount of liquid B. The sodium load verification module converts the sodium response of liquid A in the sampling channel of liquid A and the implicit sodium correction amount of liquid B into the total sodium load, and performs deviation verification in combination with the sodium target value and allowable deviation range to generate the consistency status of the total sodium load. The carbon salt verification module, based on the total sodium load consistency status, connects the A liquid acid contribution sampling response in the A liquid sampling channel to the bicarbonate load verification link, triggers a controlled neutralization reaction in the bypass constant temperature and pressure microfluidic verification chamber, and performs gas-liquid two-phase coupling conversion to generate the bicarbonate load status. The liquid supply control module controls and aligns the total sodium load consistency status and bicarbonate load status, performs permission merging processing based on the liquid preparation reference information, generates A and B concentrate linkage permission status, adjusts the liquid preparation flow rate of A and B concentrates and dialysis water based on the A and B concentrate linkage permission status, and switches the dialysate supply path to form dialysate supply control status.
2. The A and B concentrate monitoring and control system for hemodialysis as described in claim 1, characterized in that, The specific steps for establishing a synchronous calibration state are as follows: Write the sampling calibration requirements in the solution preparation reference information into the sampling control record for this time, and open the sampling channels for solution A and solution B to perform residual liquid discharge, low flow stabilization and sampling pressure stabilization to form a stable sampling state for both channels. Based on the stable state of the two sampling channels, the sampling calibration elements of the A liquid sampling channel and the B liquid sampling channel are subjected to benchmark normalization processing, correction and control cycle binding to establish a synchronous calibration state.
3. The A and B concentrate monitoring and control system for hemodialysis as described in claim 1, characterized in that, The specific steps for extracting the steady-state plateau value and transient jump component of the sampling channel of liquid B using time-domain differential filtering are as follows: Based on the synchronous calibration status, a stepped micro-flow pulse sampling command is sent to the sampling channel of liquid B to control the sampling channel of liquid B to generate a continuous pulse response curve according to the stepped flow rate change; Baseline subtraction is performed on the continuous pulse response curve according to the sampling time scale, and the response difference between adjacent sampling points is calculated to form a time-domain difference sequence. According to the hold phase and switching phase in the step-type micro-flow pulse sampling command, the time-domain difference sequence is divided into a stable response segment and a rapid change segment. The response hold value corresponding to the stable response segment is taken as the steady-state plateau value, and the response mutation value corresponding to the rapid change segment is taken as the transient jump component.
4. The A and B concentrate monitoring and control system for hemodialysis as described in claim 3, characterized in that, The specific steps for generating the implicit sodium correction amount in solution B are as follows: Based on the component registration relationship in the solution preparation reference information, the steady-state plateau value of each step in the step-by-step micro-flow pulse sampling command is matched with the main response of sodium bicarbonate in solution B. The response baseline in the synchronous calibration state is subtracted from the steady-state plateau value, and the subtracted steady-state plateau value is converted according to the sampling flow rate and holding time corresponding to each step to obtain the basic sodium contribution. The basic sodium contribution under each step is collected according to the control cycle number to establish the basic sodium contribution baseline of solution B. The transient jump component is compensated according to the synchronous calibration status. The transient offset caused by the change in sampling flow rate, channel response hysteresis and temperature drift during the step switching stage is deducted from the transient jump component to obtain the compensated transient jump component. The difference between the compensated transient jump component and the baseline sodium contribution of liquid B is separated. The response part explained by the sodium contribution of sodium bicarbonate is deducted, and the sodium response difference exceeding the baseline sodium contribution of liquid B is retained to form the implicit sodium contribution. The contribution of implied sodium is corrected sequentially according to the sampling channel benchmark, temperature compensation benchmark, and current solution conversion benchmark to eliminate the influence of sampling condition fluctuations, ion response drift, and solution ratio conversion deviation on the contribution of implied sodium. The corrected contribution of implied sodium is converted into sodium load increment according to the solution ratio of solution B in the current control cycle and the dilution relationship of dialysis water, thus generating the implied sodium correction amount of solution B.
5. The A and B concentrate monitoring and control system for hemodialysis as described in claim 1, characterized in that, The specific steps for converting the sodium response of solution A in the sampling channel of solution A and the implicit sodium correction amount of solution B into the total sodium load are as follows: Based on the synchronous calibration status, the sodium response of liquid A in the sampling channel of liquid A is time-aligned with the implicit sodium correction amount of liquid B under the current control cycle, and the response baseline corresponding to the synchronous calibration status is subtracted from the sodium response of liquid A. The sodium response of liquid A after subtraction is converted into the sodium contribution amount of liquid A according to the liquid preparation reference information. The sodium contribution of solution A and the implicit sodium correction of solution B are unified to the same sodium load measurement standard, and the total sodium load under the current control cycle is obtained by combining and converting the solutions A, B concentrates and dialysis water according to the solution mixing relationship.
6. The A and B concentrate monitoring and control system for hemodialysis as described in claim 5, characterized in that, The specific steps for achieving a consistent total sodium load state are as follows: Using the sodium target value and allowable deviation range in the solution preparation reference information as the verification reference, the total sodium load under the current control cycle and the sodium target value are placed under the same sodium load measurement reference, and the load deviation between the total sodium load and the sodium target value is calculated. The load deviation is checked against the allowable deviation range. When the load deviation falls within the allowable deviation range, the current control cycle is marked as sodium load consistent. When the load deviation exceeds the allowable deviation range, the current control cycle is marked as sodium load deviation. The deviation direction and deviation magnitude are recorded to generate the total sodium load consistent state.
7. The A and B concentrate monitoring and control system for hemodialysis as described in claim 1, characterized in that, The specific steps for triggering the controlled neutralization reaction within the bypass isothermal and isobaric microfluidic verification chamber are as follows: Based on the sodium load consistency status and control cycle number in the total sodium load consistency status, the corresponding control cycle is used as the bicarbonate load verification trigger cycle, and the A solution acid contribution sampling response, synchronous calibration status and solution preparation reference information in the A solution sampling channel are bound to form the A solution acid contribution verification input. According to the acid contribution verification input of liquid A, the trace acid contribution sample in the sampling channel of liquid A is introduced into the bypass constant temperature and pressure microfluidic verification chamber, and according to the verification ratio corresponding to the liquid preparation reference information, the bicarbonate verification sample is introduced from the sampling channel of liquid B to form the bypass controlled reaction sample. Within the bypass isothermal and isobaric microfluidic calibration chamber, temperature locking, pressure constraint, and laminar flow disturbance mixing are performed on the bypass controlled reaction sample through a temperature control channel, a pressure limiting microvalve, and a micro-mixing channel. This controls the bypass controlled reaction sample to undergo a controlled neutralization reaction under bypass calibration conditions, forming a neutralization calibration response.
8. The A and B concentrate monitoring and control system for hemodialysis as described in claim 7, characterized in that, The specific steps for generating bicarbonate under the specified loading state are as follows: Based on the neutralization verification response, the bypass controlled reaction sample is introduced into the liquid phase detection path and the gas phase detection path through the gas-liquid separation section in the bypass isothermal and isobaric microfluidic verification chamber. In the liquid phase detection path, the residual bicarbonate response, pH response and conductivity response of the liquid after the reaction are collected to form the liquid phase residual response. In the gas phase detection path, the amount of gas emitted from the reaction, pressure change and carbon dioxide response are collected to form the gas phase emission response. Based on the dynamic dissociation equilibrium of bicarbonate, the residual response in the liquid phase is converted into the contribution of unreacted bicarbonate, and the gas phase escape response is converted into the contribution of converted bicarbonate. The contributions of unreacted bicarbonate and converted bicarbonate are coupled and calculated to obtain the effective load of bicarbonate. According to the verification ratio corresponding to the solution preparation reference information, the effective load of bicarbonate is back-calculated to the solution preparation load range under the current control cycle. Based on the correspondence between the effective load of bicarbonate and the bicarbonate load requirements in the solution preparation reference information, the effective load of bicarbonate is classified into intervals and marked with status to generate the bicarbonate load status.
9. The A and B concentrate monitoring and control system for hemodialysis as described in claim 1 or 7, characterized in that, The specific steps for generating the linkage permission status of concentrates A and B are as follows: Based on the current control cycle number and sampling time scale, the total sodium load consistency status and bicarbonate load status are linked to the same control cycle, and status items with inconsistent cycle numbers and time scales exceeding the effective sampling window are screened out to form a load status group in the same cycle. Based on the solution preparation reference information, the correspondence between the total sodium load consistency status and bicarbonate load status in the same cycle load status group is converted into supply permit requirements, solution preparation correction requirements and path constraint requirements, and written into the same linkage permit record to generate the linkage permit status of concentrates A and B.
10. The A and B concentrate monitoring and control system for hemodialysis as described in claim 9, characterized in that, The specific steps for establishing the dialysate supply control state are as follows: Based on the status correspondence in the linkage permit status of concentrates A and B and the liquid preparation relationship in the liquid preparation reference information, the flow correction direction of concentrate A, concentrate B and dialysis water is determined, and the corresponding liquid preparation flow correction amount is generated according to the difference between the current actual liquid preparation flow and the target liquid preparation flow. The entry ratio of concentrate A, concentrate B and dialysis water is adjusted according to the liquid preparation flow correction amount to form the liquid preparation flow adjustment status. Based on the supply permit requirements and path constraints, and combined with the flow adjustment completion status in the solution preparation flow adjustment status, the supply path control relationship in the solution preparation reference information is compared and assigned. The supply permit requirements are written into the corresponding supply path, and the flow adjustment completion status is written into the valve position switching sequence and pumping maintenance conditions of the corresponding path, thus forming the dialysate supply control status.