REGIONAL CITRATE ANTICOAGULATION INFUSION SYSTEM, CONTROL METHOD AND SYSTEM, AND MEDIUM
20240115788 ยท 2024-04-11
Assignee
Inventors
Cpc classification
A61M2205/3379
HUMAN NECESSITIES
International classification
A61M1/36
HUMAN NECESSITIES
Abstract
A method for controlling an infusion rotation speed of a citrate pump comprises: collecting parameters of the regional citrate anticoagulation infusion system (S101), the parameters include blood flow velocity and red blood cell hematocrit; determining a citrate infusion volume per unit time based on the parameters (S102); and controlling the infusion rotation speed of the citrate pump based on the citrate infusion volume per unit time (S103). A method for controlling an infusion rotation speed of a calcium pump includes: determining an amount of calcium supplementation required for the regional citrate anticoagulation infusion system (S201); and controlling the infusion rotation speed of the calcium pump according to the amount of calcium supplementation (S202). The citrate infusion volume per unit time and the amount of calcium supplementation required by the regional citrate anticoagulation infusion system is determined through specific formulas.
Claims
1. A method for controlling an infusion rotation speed of a citrate pump, comprising: collecting a plurality of parameters of a regional citrate anticoagulation infusion system, wherein the plurality of parameters comprises blood flow velocity and red blood cell hematocrit; determining a citrate infusion volume per unit time based on the plurality of parameters; and controlling the infusion rotation speed of the citrate pump based on the citrate infusion volume per unit time; wherein the citrate infusion volume per unit time is obtained through the following equation:
Qcit (mmol/h)=4-5 (mmol/L)?Qb (ml/min)?(1?Hct%) wherein Qcit is the citrate infusion volume per unit time, Qb is the blood flow velocity, and Hct is the red blood cell hematocrit.
2. A method for controlling an infusion rotation speed of a calcium pump, comprising: determining an amount of calcium supplementation required for a regional citrate anticoagulation infusion system; and controlling the infusion rotation speed of the calcium pump according to the amount of calcium supplementation; wherein the determining of the amount of calcium supplementation required for the regional citrate anticoagulation infusion system comprises: for a post-dilution continuous venovenous hemodiafiltration (CVVHDF) mode, calculating an amount of calcium supplementation required in each stage of a two-stage calcium supplement model; wherein an amount of calcium supplementation required in a first stage is obtained through the following equation:
Eca (mmol/L)=fa?Cca_T?Cln-ca?60/1000 wherein Qb is a blood flow velocity; Quf is an ultrafiltration rate; and Eca (mmol/L) is the amount of calcium cleared in extracorporeal circulation per hour.
3. A module for controlling an infusion rotation speed of a citrate pump, comprising: a parameter acquisition module, for collecting a plurality of parameters of a regional citrate anticoagulation infusion system, wherein the plurality of parameters comprises blood flow velocity and red blood cell hematocrit; an infusion volume determination module, for determining a citrate infusion volume per unit time based on the plurality of parameters; and a citrate pump speed control module, for controlling the infusion rotation speed of the citrate pump based on the citrate infusion volume per unit time; wherein the infusion volume determination module obtains the citrate infusion volume per unit time based on the following equation:
Qcit (mmol/h)=4-5 (mmol/L)?Qb (ml/min)?(1?Hct%) wherein Qcit is the citrate infusion volume per unit time, Qb is the blood flow velocity, and Hct is the red blood cell hematocrit.
4. A module for controlling an infusion rotation speed of a calcium pump, comprising: a calcium supplementation determination module, for determining an amount of calcium supplementation required for a regional citrate anticoagulation infusion system; and a calcium pump speed control module, for controlling the infusion rotation speed of the calcium pump according to the amount of calcium supplementation; wherein the calcium supplementation determination module determines the amount of calcium supplementation required for the regional citrate anticoagulation infusion system according to the following; for a post-dilution CVVHD model, an amount of calcium supplementation required in each stage of a two-stage calcium supplement model is calculated; an amount of calcium supplementation required in a first stage is obtained through the following equation:
Eca (mmol/L)=fa?Cca_T?Cln-ca?60/1000 wherein Qb is a blood flow velocity; Quf is an ultrafiltration rate; and Eca (mmol/L) is the amount of calcium cleared in extracorporeal circulation per hour.
5. A method for controlling a regional citrate anticoagulation infusion, comprising: controlling an infusion rotation speed of a citrate pump; and controlling an infusion rotation speed of a calcium pump; wherein the controlling of the infusion rotation speed of the citrate pump is realized by the method for controlling the infusion rotation speed of the citrate pump according to claim 1, and the controlling of the infusion rotation speed of the calcium pump is realized by the method for controlling the infusion rotation speed of the calcium pump according to claim 2.
6. A control system for a regional citrate anticoagulation infusion, comprising: a control module for an infusion rotation speed of a citrate pump, and a control module for an infusion rotation speed of a calcium pump, wherein the control module for the infusion rotation speed of the citrate pump is the module for controlling the infusion rotation speed of the citrate pump according to claim 3, and the control module for the infusion rotation speed of the calcium pump is the module for controlling the infusion rotation speed of the calcium pump according to claim 4.
7. A regional citrate anticoagulation infusion system, comprising: a citrate pump, for infusing a sodium citrate anticoagulant; a calcium pump, for infusing a calcium chloride solution; and a controller, for controlling infusion speeds of the citrate pump and the calcium pump. wherein the controller comprises the module for controlling the infusion rotation speed of the citrate pump according to claim 3 and the module for controlling the infusion rotation speed of the calcium pump according to claim 4.
8. The regional citrate anticoagulation infusion system according to claim 7, wherein the controller further comprises: a sampling and executing module, for collecting external signals and executing controller commands, which collects a plurality of parameters from an infusion tube, receives commands from the controller regarding the infusion speeds of the citrate pump and the calcium pump, and controls a drive motor to make the citrate pump and calcium pump work at a specified speed, respectively; and a therapeutic analysis module, for regularly measuring flow volumes of the citrate pump and the calcium pump and feeding each flow volume back to the modules for controlling the infusion rotation speeds of the citrate pump and the calcium pump, wherein the modules control rotation speeds of the citrate pump and the calcium pump according to the flow volumes and predetermined parameters.
9. The regional citrate anticoagulation infusion system according to claim 8, wherein the controller further comprises a safety module, wherein the safety module analyzes a running condition of a real-time monitoring device through sampling data and prompts alarm and operation according to an accident that occurred in a treatment process proposed by an accident occurrence-treatment module.
10. The regional citrate anticoagulation infusion system according to claim 9, wherein the sampling and executing module, the therapeutic analysis module, and the safety module run in parallel and independently exchange data with a database.
11. The regional citrate anticoagulation infusion system according to claim 8, wherein the therapeutic analysis module is further configured to: receive and analyze in real-time data signals transmitted from the sampling and executing module; record data to a database or share data for recording and reading treatment records and treatment incidents by external devices; analyze patient information and therapeutic information according to a predetermined procedure, calculate in real time desired citrate and calcium chloride infusion speeds according to a two-stage theoretical model, and transmit signals of calculated infusion speeds to the sampling and executing module; exchange sampling data in real-time with the safety module, analyze whether a device is in normal operation according to an accident treatment opinion and prompt protective actions and audible and visual alarms in response to an operation status of the device.
12. The regional citrate anticoagulation infusion system according to claim 8, wherein a fuzzy adaptive tuning PID control is used for a single citrate pump and a single calcium pump, respectively; and according to a response of the system, a fuzzy inference is applied with reference to fuzzy control rules stored in advance in computer to automatically achieve an optimal adjustment of PID parameters of the single citrate pump and the single calcium pump, respectively.
13. An electronic device, comprising a memory, a processor, and a computer program stored in the memory and executed on the processor, wherein one of the following methods is performed when the processor executes the computer program: the method for controlling the infusion rotation speed of the citrate pump according to claim 1; the method for controlling the infusion rotation speed of the calcium pump according to claim 2; and the method for controlling the regional citrate anticoagulation infusion according to claim 5.
14. A computer-readable storage medium, having a computer program stored thereon, wherein one of the following methods is performed when the computer program is executed by a processor: the method for controlling the infusion rotation speed of the citrate pump according to claim 1; the method for controlling the infusion rotation speed of the calcium pump according to claim 2; and the method for controlling the regional citrate anticoagulation infusion according to claim 5.
Description
BRIEF DESCRIPTION OF DRAWINGS
[0078] A detailed description of non-limiting embodiments is provided with reference to the following drawings. For those skilled in the art, other features, objects, and advantages may be obtained without effort.
[0079]
[0080]
[0081]
[0082]
[0083]
[0084]
[0085]
[0086]
[0087]
[0088]
[0089]
DETAILED DESCRIPTION OF THE INVENTION
[0090] The present disclosure will be described in detail by using the embodiments below. The following embodiments are intended to assist those skilled in the art to further understand the present disclosure, and not to limit the present disclosure. It should be noted that to a person of ordinary skill in the art, a number of variations and changes can be made without departing from the conception of the present disclosure, which still falls within the protection scope of the present disclosure.
[0091] In regional citrate anticoagulation, the amount of citrate and calcium supplementation under various modes and dosages of RCA is precisely and quantitatively controlled based on the two-stage calcium supplement model of regional citrate anticoagulation combined with the citrate pharmacokinetics theory and the blood purification clearance kinetics theory, and the main principles are as follows: [0092] 1. The infusion speed of citrate during RCA is correlated with the flow rate of plasma in extracorporeal circulation. [0093] 2. The rate of calcium supplementation during blood purification technique (e.g., continuous renal replacement therapy (CRRT)) RCA with low solute clearance has two stages, which is characterized by the heterogeneity of calcium requirements, i.e., more calcium is required in the first stage and less calcium in the second stage. The reason for this is that the citrate clearance during inefficient blood purification is low, which leads to the accumulation of citrate in the patient's body, citrate is mostly in the form of calcium citrate in the body, and the steady state of citrate and blood calcium is reached after 3 to 5 half-lives of citrate metabolism in the body. Therefore, during the first stage of RCA-CRRT, calcium supplementation includes cleared calcium in extracorporeal circulation and accumulated calcium, whereas during the subsequent second stage, only cleared calcium in extracorporeal circulation is included. [0094] 3. The concentration of the effluent liquid calcium does not equilibrate with that of the blood calcium during CRRT, i.e., the calcium clearance in extracorporeal circulation is correlated with the dose and mode of CRRT. [0095] 4. The amount of calcium supplementation of high-efficiency blood purification techniques (e.g., IHD) is mainly correlated with the clearance in extracorporeal circulation, and there is a correlation between the calcium clearance, and the creatinine clearance and phosphate clearance of the dialyzer.
[0096]
[0097]
[0098] Based on the above principles, embodiments of the present disclosure provide a regional citrate anticoagulation infusion system, a control method and system, and a medium, for realizing automatic control of the infusion rotation speed of the citrate anticoagulant in the treatment tubes in regional citrate anticoagulation, and further for realizing automatic control of the infusion rotation speed of the calcium pump in the treatment tubes to prevent the loss of ionized calcium in the patient's body. Infusion of citrate anticoagulant and calcium supplementation at a desired rate to the patient is achieved, thereby avoiding prolonged exposure of the patient to heparin and reducing the risk of bleeding.
[0099]
[0103] In S102, the citrate infusion volume per unit time is obtained through the following equation:
Qcit (mmol/h)=4-5 (mmol/L)?Qb (ml/min)?(1?Hct%)(1)
[0104] In the above equation, Qcit is the citrate infusion volume per unit time, Qb is the blood flow velocity, and Hct is the red blood cell hematocrit.
[0105] In S103, the amount of infused citrate per unit time is determined, and the infusion rotation speed of the citrate pump can be determined according to the model of the citrate pump, so that the infusion of citrate anticoagulant in the treatment tubes can be controlled automatically.
[0106]
[0107] S201, determining an amount of calcium supplementation required for a regional citrate anticoagulation infusion system;
[0108] S202, controlling an infusion rotation speed of the calcium pump according to the amount of calcium supplementation.
[0109] In S201, for the post-dilution CVVHDF mode, a two-stage calcium supplementation equation can be simplified and quantified based on a two-stage calcium supplementation model combined with in vivo calcium accumulation, where calcium clearance in extracorporeal circulation per hour is obtained by using diffusible calcium clearance and the proportion of diffusible calcium to total calcium at the upstream of the dialyzer after citrate infusion at the arterial end. Specifically, in order to determine the amount of the calcium supplementation required for the regional citrate anticoagulation infusion system, the amount of calcium supplementation required in each stage of a two-stage calcium supplement model is calculated as follows:
[0110] An amount of calcium supplementation required in the first stage is obtained through the following equation:
[0111] An amount of calcium supplementation required in the second stage is obtained through the following equation:
[0112] In the above equations, Qca1 is the amount of calcium supplementation required in the first stage, Qca2 is the amount of calcium supplementation required in the second stage, fa is a proportion of diffusible calcium at the upstream of the dialyzer after citrate infusion at the arterial end, Cca_T is a total calcium concentration at the upstream of the dialyzer after citrate infusion, Cln-ca is a diffusible calcium clearance, fb is a correlation coefficient between the accumulated calcium concentration and the citrate concentration, Csys(t) is a concentration of citrate at different time, and BW is a weight of a patient.
[0113] In an embodiment of the present disclosure, for the intermittent hemodialysis (iHD) mode, the amount of calcium supplementation is an amount of calcium cleared in extracorporeal circulation, therefore, the amount of calcium supplementation in regional citrate anticoagulation infusion system can be determined according to the following: [0114] S2011, calculating the diffusible calcium clearance Cln-ca after selecting the membrane area for the dialyzer; [0115] S2012, calculating the amount of calcium cleared in extracorporeal circulation per hour through the above diffusible calcium clearance Cln-ca.
[0116] Due to that there are a variety of dialyzers with an effective membrane area of 1.0-2.0 m.sup.2 in IHD mode and different models of dialyzers have differences in solute clearance, the following equations are obtained by analyzing the types of dialyzers, the linear relationship between the actual diffusible calcium clearance and the clearance of creatinine and phosphate for each dialyzer:
Cln-Ca=0.79?(1?Hct)?(CliCr+CliP)/2+2.24(R2=0.31,p=0.0165)(6)
[0117] where Cln-Ca is actual diffusible calcium clearance, CliCr is creatinine clearance, CliP is phosphate clearance, and Hct is red blood cell hematocrit.
[0118] Equation (6) works when the ultrafiltration rate is 0. In clinical treatment, the ultrafiltration rate is usually not 0, so the clearance corresponding to the ultrafiltration rate needs to be taken into consideration. According to previous studies, when the ultrafiltration rate is less than 70 ml/min, the clearance and ultrafiltration rate satisfy the following equation:
CIB=CIB0+0.46?Quf(7)
[0119] In the above equation, CIB is a clearance corresponding to the actual ultrafiltration rate; CIB0 is a clearance when the ultrafiltration rate is 0, Quf is the ultrafiltration rate.
[0120] The actual ultrafiltration rate is incorporated into the above equation to yield the following:
Cln-Ca=0.79?(1?Hct)?(CliCr+CliP)/2+2.24+0.46?Quf(8)
[0121] When the blood flow velocity of the dialyzer is 150-300 m l/m in, the solute clearance is approximately linear with the blood flow velocity, therefore, the relationship between the solute clearance and blood flow velocity can be calculated according to the dialyzer manual, and the formula for estimating the actual diffusible calcium clearance and blood flow velocity can be obtained by incorporating the clearance formula. The effective membrane area of the dialyzers can be classified into three categories:
[0122] When the membrane area is less than 1.2 m.sup.2,
Cln-Ca=0.7944?(Qb?0.43+80.5)?(1?Hct)+2.2421+0.46?Quf.(9)
[0123] When the membrane area ranges from 1.2 to 1.8 m.sup.2,
Cln-Ca=0.7944?(Qb?0.29+95)?(1?Hct)+2.2421+0.46?Quf.(10)
[0124] And when the membrane area is greater than 1.8 m.sup.2,
Cln-Ca=0.7944?(Qb?0.53+75.5)?(1?Hct)+2.2421+0.46?Quf.(11)
[0125] More than 80% of calcium citrate is removed by the dialyzer and little citrate accumulates because of the fast flow rate of dialysate in IHD model. Therefore, the amount of calcium supplementation in IHD is mainly the calcium removed in extracorporeal circulation. As described above, the equation for calcium clearance in extracorporeal circulation can be expressed as follows:
Eca (mmol/L)=fa?Cca_T?Cln-Ca?60/1000(12)
[0126] In the above equation, Qb is the blood flow velocity, Quf is the ultrafiltration rate, and Eca (mmol/L) is the amount of calcium cleared in extracorporeal circulation per hour.
[0127] In IHD mode, the mean value of fa is 0.85, the steady-state calcium concentration (Cca_T) in the body is close to the total calcium concentration in the body at the start of treatment, and the equations for clearance (CI) are equations (9)-(11). After selecting the membrane areas of different dialyzers, the clearance (CI) is calculated, afterwards, the calcium clearance in extracorporeal circulation per hour can be calculated after incorporating into equation (12), and then the infusion rotation speed of the corresponding calcium pump can be determined.
[0128] Based on the method for controlling the infusion rotation speed of the citrate pump in the above embodiment, which is also shown in
[0129] Based on the method for controlling the infusion rotation speed of the calcium pump in the above embodiment, which is also shown in
[0130] Based on the methods and modules for controlling the infusion rotation speed of the calcium pump and citrate pump in the above embodiments, a method for controlling the regional citrate anticoagulation infusion is also provided in another embodiment of the present disclosure, including two parts, one of which is the method for controlling the operation of the citrate pump, and the other part is the method for controlling the operation of the calcium pump. The method for controlling the regional citrate anticoagulation infusion includes the method for controlling the infusion rotation speed of the citrate pump in the embodiment corresponding to
[0131] A control system for regional citrate anticoagulation infusion is provided in another embodiment of the present disclosure. The control system includes two main modules, one of which is a module for controlling the operation of the citrate pump and the other is a module for controlling the operation of the calcium pump, i.e., a module for controlling the infusion rotation speed of the citrate pump and a module for controlling the infusion rotation speed of the calcium pump. These two main modules include the module for controlling the infusion rotation speed of the citrate pump in the embodiment corresponding to
[0132]
[0133]
[0134] The sampling and executing module collects external signals and executes controller commands, which collects a plurality of parameters from an infusion tube, receives commands from the controller regarding the infusion speed of the citrate pump and the calcium pump, and controls a drive motor to make the citrate pump and calcium pump work at a specified speed; for example, information such as bubble, pressure, and the status of the infusion pump's protective cover in the tube is collected by the sampling portion of the circuit, and a command regarding the infusion speed of the infusion pump from the controller is transmitted to the sampling and executing module, which controls the DC brushless motor and drive module to enable the infusion pump to operate at the specified speed.
[0135] The therapeutic analysis module regularly measures flow volumes of the citrate pump and the calcium pump and feeds each flow volume back to the modules for controlling the infusion rotation speed of the citrate pump and the calcium pump, where the control modules control a rotation speed of the citrate pump and the calcium pump according to the flow volume and predetermined parameters.
[0136] In order to ensure the safety of regional citrate anticoagulation infusion, the controller further includes a safety module. The safety module analyzes the running condition of a real-time monitoring device through sampling data and prompting alarm and operation according to an accident that occurred in a treatment process proposed by an accident occurrence-treatment module.
[0137] In the above embodiment, the sampling and executing module, the therapeutic analysis module, and the safety module run in parallel and independently exchange data with the database.
[0138] For example, in one embodiment, the signal from the sampling module is sent to a calculation module of the MCU controller, and the calculation module exchanges data with the safety module to check whether the signal is reasonable. If the signal is reasonable, it means that the device is operating normally and the treatment will continue; if the signal is unreasonable, it means that the device is not operating normally and the accident will be classified into three levels according to the accident occurrence-treatment opinion, which include low priority, medium priority, and high priority, to take different protective measures and prompt the corresponding sound and light alarm.
[0139] In the above embodiment, the function of the therapeutic analysis module further includes: [0140] 1. receiving and analyzing in real-time the data signals transmitted from the sampling and executing module; [0141] 2. recording key data to a database or sharing the key data for recording and reading treatment records and treatment incidents by external devices; [0142] 3. analyzing patient information and therapeutic information according to a predetermined procedure, calculating in real time the desired citrate and calcium chloride infusion rotation speeds according to a two-stage theoretical model, and transmitting the signal to the sampling and executing module; [0143] 4. exchanging the sampling data in real-time with the safety module, analyzing whether the device is in a normal operation according to the accident treatment opinion and prompting protective actions and audible and visual alarms in response to the operation status of the device.
[0144]
[0145] where (j) and (k) are sampling sequence numbers, T is a sampling time constant, k.sub.p is a proportional coefficient that is inversely related to the proportion, k.sub.i is an integral coefficient, k.sub.d is a differential coefficient, e(k) is an error between a given value and a measured value, and e(k?1) is an error within the last sampling time interval. During online operation, the control system completes the online self-correction of the PID parameters by processing the results of the fuzzy logic rules, checking tables, and performing computing.
[0146] In the above-preferred embodiment, by collecting the parameters of the citrate pump and calcium chloride pump, the speeds of the citrate pump and calcium chloride pump are kept stable and manageable through PID control. And in the event of abnormalities, an alarm can be issued in time, and emergency operations can be performed at the same time, such as stopping the pump's infusion.
[0147]
[0148] The controller collects the basic parameters of the patient and the parameters of the extracorporeal blood purification treatment, and then the therapeutic analysis module calculates the flow rates of citrate and calcium per hour according to the two-stage calcium supplement theory, citrate pharmacokinetics theory, and blood purification kinetics theory. These flow rates are automatically converted into the operating parameters of drive motors through the closed-loop control of the citrate pump and the calcium chloride pump, respectively. The drive motors of the citrate pump and the calcium chloride pump drive their respective pump heads of peristaltic pumps through deceleration mechanisms. The rotor on the pump head repeatedly squeezes the outer wall of the infusion tube to enable the continuous directional flow of the drug solution in the tube, thus achieving the purpose of precise fluid infusion.
[0149]
[0150] In another embodiment of the present disclosure, an electronic device is provided. The electronic device includes a memory, a processor, and a computer program stored in the memory and executed on the processor. When the processor executes the computer program, one of the following methods is performed: the method for controlling the infusion rotation speed of the citrate pump; the method for controlling the infusion rotation speed of the calcium pump; and the method for controlling the regional citrate anticoagulation infusion.
[0151] In another embodiment of the present disclosure, a computer-readable storage medium is provided, having a computer program stored thereon, when the processor executes the computer program, one of the following methods is performed: the method for controlling the infusion rotation speed of the citrate pump; the method for controlling the infusion rotation speed of the calcium pump; and the method for controlling the regional citrate anticoagulation infusion.
[0152] The memory described above may include volatile memory, such as random access memory (RAM), static random-access memory (SRAM), double data rate synchronous dynamic random access memory (DDR SDRAM), etc., and may also include non-volatile memory, such as flash memory. The memory is used to store computer programs (such as applications, functional modules, etc. that implement the above method), computer instructions, etc., and the above computer programs, computer instructions, and the like may be stored in one or more memories. And the above computer programs, computer instructions, data, and the like can be called by the processor.
[0153] The processor is used to execute the computer program stored in the memory to implement the various steps in the method involved in the above embodiments. The relevant descriptions of the methods can be seen in the previous embodiments.
[0154] The processor and the memory may be separate structures or integrated into a single structure. When the processor and the memory are independent structures, the memory and the processor may be in a coupling connection via a bus.
[0155] It should be noted that the steps of the method provided by the present disclosure can be implemented by using the corresponding modules, devices, units, etc. in the system, and a person skilled in the art can implement the step flow of the method with reference to the technical solution of the system, i.e., the embodiments of the system are preferred examples for implementing the method, which will not be repeated herein.
[0156] It is known to those skilled in the art that, except for an absolute computer readable program code manner, the system and its devices provided by the present disclosure may be realized in the forms of logic gates, switches, special integrated circuits, programmable logic controllers, and embedded microcontrollers, and the like by programming the steps of the method logically. Therefore, the system and its various devices provided by the present disclosure may be considered as a hardware component, and the devices included therein for implementing various functions may also be considered as structures within the hardware component. Alternatively, the devices for implementing various functions may be considered as software modules for implementing the method or structures within the hardware component.
[0157] Specific embodiments of the present disclosure have been described above. It should be understood that the above embodiments of the present disclosure are not intended to limit the implementations of the present disclosure. For those of ordinary skill in the art, changes or variations can be made within the protection scope of the present disclosure, which does not affect the substance of the present disclosure. Each of the above features may be used in combination without conflict with each other.