Dialysis concentrated solution preparation system and dynamic solution preparation control method

Abstract

A dialysis concentrated solution preparation system comprises a main machine, a dialysis powder bag body and accessories, the main machine is an all-in-one machine and comprises a plurality of independently controlled dissolution stations, each station is provided with a multi-mode dissolution device, and the multi-mode dissolution device integrates three working modes of a mechanical shaking mechanism, an ultrasonic generator and a magnetic stirrer. The hemodialysis powder bag body comprises a flexible bag body, the flexible bag body is designed to be foldable, and hemodialysis dry powder is contained in the flexible bag body. The dialysate can be prepared and used on site, and the efficient and flexible liquid preparation effect is achieved through the liquid preparation system. The invention further provides a dialysis dry powder dynamic liquid preparation control method.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular, to a dialysis concentrate preparation system and a dynamic preparation control method. Background Art

[0002] The composition of dialysis fluid directly affects the clinical condition and prognosis of hemodialysis patients. Moreover, there are individual differences among hemodialysis patients. Especially for special patients, it is necessary to continuously improve and update the prescription content of dialysis fluid as the disease progresses, so as to achieve a physiological balance of the patient's electrolyte acid-base. Using personalized prescription dialysis fluid can reduce the occurrence of dialysis complications. Providing dialysis fluid with different ion concentrations can reflect the dialysis quality of a hospital and is an important part of realizing clinical individualized treatment; and it also solves the liquid supply mode for home hemodialysis. The company has carried out research and development on hemodialysis concentrates with personalized dialysis formulas.

[0003] At the same time, the transportation, storage, and packaging costs of concentrates in the existing mode are high, and the physical and chemical properties of electrolytes will change during storage and transportation, resulting in a decline in dialysis quality (such as the precipitation of sodium bicarbonate crystals); there is a risk of concentrate contamination during centralized liquid supply transportation. All existing hemodialysis products on the market are filled in plastic barrels and require the use of special hemodialysis machines to complete the configuration process. Moreover, the containers used are all hard plastic barrels, which are prone to breakage during transportation. And due to the heavy barrel body, it has a certain impact on the mobility of patients. When using dialysis powder or dialysis concentrate, it is still necessary to transfer the dialysis powder or concentrate to a new container and add water for dilution, resulting in problems such as easy contamination and inconvenient use, and the new container will also increase costs. Summary of the Invention

[0004] The present invention aims to solve at least one of the technical problems existing in the prior art. For this purpose, the present invention provides a dialysis concentrate preparation system and a dynamic preparation control method, and the specific technical solutions are as follows:

[0005] The present invention provides a dialysis concentrate preparation system, comprising a host, a dialysis powder bag body and matching parts, wherein the host is an integrated machine, comprising: a plurality of independently controlled dissolution stations, each station is equipped with a multi-modal dissolution device, and the multi-modal dissolution device integrates three working modes of a mechanical shaking mechanism, an ultrasonic generator and a magnetic stirrer; the dissolution station is also provided with a transmittance sensor, which is located on the side of the dialysis powder bag body; a temperature control circulation pipeline, with a built-in RO water heating module and a temperature sensor; a distributed control unit, which adopts a PLC and an HMI human-machine interface to work in coordination, and the PLC is equipped with a dissolution mode decision algorithm, which automatically selects the best dissolution mode combination according to the powder type; a robot hand The robot arm is used to connect the temperature-controlled circulation pipeline and the dialysis powder bag body, so as to add liquid to the dialysis powder bag body; the dialysis powder bag body includes: a flexible bag body, the flexible bag body adopts a foldable design, and the flexible bag body contains hemodialysis dry powder; a cover is used to seal the bag opening of the flexible bag body, and the cover is provided with a connector, and the connector is used to install the dialysis powder bag body on the dissolution station; the cover is provided with a liquid addition port and a pipette port for directly adding water to dissolve the dialysis dry powder, and an airtight connection is formed with the docking port of the dissolution station through a self-locking quick connector; the matching parts include: a dialysis machine pipette filter element and a dialysis powder bag placement bucket.

[0006] Furthermore, the dissolution mode decision algorithm performs the following steps: reading the powder type code through the powder bag RFID tag, controlling the RO pure water to be heated to the corresponding temperature and then entering the dialysis powder bag body; calling the pre-stored database to match the corresponding dissolution parameter combination, including: ultrasonic power, shaking frequency, stirring speed, and finally preparing a standard concentrated solution through quantitative automatic control of the water volume; dynamically adjusting parameters according to real-time solubility detection data, and the solubility is measured by a transmittance sensor.

[0007] Furthermore, the cover is also provided with a drug adding port, and the distributed control unit controls the robot arm to perform drug adding operations.

[0008] Furthermore, the average pore size of the filter element of the dialysis machine pipette is 20 μm, which can filter particles and undissolved powder.

[0009] Furthermore, the host is also provided with an automatic alarm, which automatically monitors abnormal leakage and the like and gives an alarm in real time.

[0010] Furthermore, the host is also provided with a timed cleaning device, which can pre-adjust the timed cleaning time and program, and perform cleaning when the system is not in use.

[0011] Furthermore, the host is also provided with a timed disinfection device, and the disinfection time and program are preset according to the use of the equipment.

[0012] The present invention also provides a dynamic liquid preparation control method for dialysis dry powder, which is applied to the above-mentioned dialysis concentrate liquid preparation system, and includes the following steps: establishing a powder dissolution characteristic library to record the solubility time curves of different powders; when a new powder is used for the first time, starting the learning mode: successively testing the dissolution efficiencies of three basic modes and two combined modes, generating an optimal parameter combination and storing it in the database; during continuous production, automatically optimizing the dissolution order according to the current station load, and preferentially processing the powder bags with a high prescription urgency level.

[0013] The technical solution of the present invention has the following advantages:

[0014] The present invention uses a flexible bag filled with hemodialysis dry powder, directly completes the water addition and liquid preparation in the bag, and the dialysis powder dissolution and configuration are completed in the original bag, avoiding infections during the transfer of concentrates, solving the problems of the large amount of medical plastic particles required for making barrels for barreled dialysis fluid and the post-use barrel waste treatment, and realizing the application of three major scenarios: on-site preparation and use in hospitals, home dialysis, and personalized treatment; the volume of the concentrate is reduced by 20%, reducing the transportation breakage rate and storage space. Further, the dialysis concentrate liquid preparation system adopts a multi-modal collaborative dissolution technology: through the sequential cooperation of mechanical shaking (amplitude 3mm / frequency 3Hz), ultrasonic cavitation (28kHz / 200W), and magnetic stirring (300rpm), the dissolution time is shortened to 58 minutes; the dynamic liquid preparation logic: automatically retrieves historical data based on the powder characteristic code to optimize parameters, improving the dissolution efficiency compared to the traditional fixed parameter mode; the distributed liquid supply architecture: multiple independent stations can either process different prescriptions in parallel or cooperate to supply high-demand scenarios, greatly improving the system throughput; using an intelligent robotic arm to achieve the flexibility and safety of automatic liquid addition and medicine addition, and improving production efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The accompanying drawings here are incorporated into the specification and form a part of this specification, showing embodiments consistent with the present invention and used together with the specification to explain the principles of the present invention.

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the accompanying drawings required for use in the description of the embodiments or the prior art. Obviously, for those of ordinary skill in the art, other drawings can also be obtained based on these drawings without creative efforts.

[0017] Figure 1 It is a schematic structural diagram of the dialysis concentrate liquid preparation system provided by the embodiment of the present invention;

[0018] Figure 2 It is a schematic structural diagram of the multi-modal dissolution device at the dissolution station provided by the embodiment of the present invention;

[0019] Figure 3Schematic diagram of the temperature control circulation pipeline structure provided by the embodiment of the present invention;

[0020] Figure 4 Schematic diagram of the lid interface structure provided by the embodiment of the present invention;

[0021] Figure 5 Schematic diagram of the accessory structure provided by the embodiment of the present invention.

[0022] Reference numerals:

[0023] 100, mainframe; 110, dissolution station; 111, multi-modal dissolution device; 111a, mechanical shaking mechanism; 111b, ultrasonic generator; 111c, magnetic stirrer; 120, temperature control circulation pipeline; 121, RO water heating module; 122, temperature sensor; 130, distributed control unit; 131, PLC; 132, HMI human-machine interface; 140, robotic arm; 200, dialysis powder bag body; 210, flexible bag body; 220, lid; 221, connecting piece; 222, liquid adding port; 223, straw port; 225, medicine adding port; 240, powder bag RFID tag; 300, accessory; 310, dialysis machine liquid suction pipe filter element; 320, dialysis powder bag body placement barrel; 113, light transmittance sensor. Detailed implementation manners

[0024] To make the objectives, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Apparently, the described embodiments are some, but not all, of the embodiments of the present application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present application without creative efforts shall fall within the scope of protection of the present application.

[0025] The present invention relates to a dialysis concentrate preparation system and its control method, aiming to achieve efficient dissolution and precise preparation of dialysis dry powder through automated and intelligent equipment design. The technical solutions of the present invention will be described in detail below in conjunction with specific implementation manners.

[0026] I. System structure and functional modules

[0027] 1. Structure and function of the mainframe 100

[0028] Dissolution station 110: The mainframe is equipped with multiple independently controlled dissolution stations, and each station is configured with a multi-modal dissolution device 111. The multi-modal dissolution device integrates three working modes: mechanical shaking mechanism 111a, ultrasonic generator 111b, and magnetic stirrer 111c. These three modes can be used alone or in combination to meet the dissolution requirements of different powder types.

[0029] The dissolution station 110 is also provided with a light transmittance sensor 113, which is located on the side of the dialysis powder bag body 200.

[0030] Thermostatic circulation pipeline 120: It is internally equipped with an RO water heating module 121 and a temperature sensor 122, which are used to accurately control the liquid addition temperature to ensure that the powder is dissolved at the optimal temperature.

[0031] Distributed control unit 130: The PLC 131 and the HMI human-machine interface 132 work together. The PLC is configured with a dissolution mode decision algorithm, which can automatically select the best dissolution mode combination according to the powder type. The PLC module 131 is internally equipped with a memory 133, and different dissolution parameter combinations corresponding to different dialysis powder types are pre-stored in the memory 133.

[0032] Robot arm 140: It is used to connect the thermostatic circulation pipeline 120 and the dialysis powder bag body 200 to realize the liquid addition operation of the dialysis powder bag body. An air-operated gripper 141 is provided at the end, and the air-operated gripper 141 is adapted to the connecting piece 221 of the dialysis powder bag body 200, and is used to connect the water outlet of the thermostatic circulation pipeline 120 to the liquid addition port 222 of the dialysis powder bag body 200.

[0033] 2. Structure and functions of the dialysis powder bag body 200

[0034] Flexible bag body 210: It adopts a foldable design and contains hemodialysis dry powder inside.

[0035] Cover 220: It is used to seal the bag mouth of the flexible bag body. A connecting piece 221 is provided on the cover, which is used to install the dialysis powder bag body on the dissolution station. A liquid addition port 222 and a straw port 223 are also provided on the cover, and a gas-tight connection is formed with the docking port of the dissolution station through a self-locking quick connector. In addition, a medicine addition port 225 is provided on the cover, and the distributed control unit controls the robot arm to perform the medicine addition operation.

[0036] 3. Accessories 300

[0037] Dialysis machine liquid suction pipe filter element 310: The average pore diameter is 20μm, which is used to filter particles and undissolved powder.

[0038] Dialysis powder bag body placement bucket 320: It is used to store the dialysis powder bag body.

[0039] II. Implementation of the dissolution mode decision algorithm

[0040] The specific implementation steps of the dissolution mode decision algorithm are as follows:

[0041] 1. Powder type identification: Read the powder type code through the RFID tag 240 on the powder bag, and control the RO pure water to be heated to the corresponding temperature and then enter the dialysis powder bag body 200.

[0042] 2. Parameter matching: Call the pre-stored database to match the corresponding dissolution parameter combinations, including ultrasonic power, shaking frequency, stirring speed, etc., and finally prepare a standard concentrated solution through quantitative automatic control of the water volume.

[0043] 3. Dynamic adjustment: Measure the solubility in real time through the light transmittance sensor 113, and dynamically adjust the dissolution parameters according to the real-time data to ensure the efficiency and stability of the dissolution process.

[0044] The memory 133 of the PLC module 131 pre-stores the dissolution parameter combinations corresponding to different powder types, including ultrasonic power, shaking frequency, and stirring speed; the light transmittance sensor 113 is connected to the PLC module 131 through a signal line to feedback the light transmittance data to the HMI human-machine interface 132 in real time.

[0045] III. Implementation of the drug addition operation

[0046] The drug addition port 225 on the lid 220 is controlled by the distributed control unit 130. When drug addition is required, the robotic arm 140 injects the drug into the dialysis powder bag body through the drug addition port according to the control instruction to complete the drug addition operation.

[0047] IV. Implementation of the automatic alarm and cleaning and disinfection functions

[0048] 1. Automatic alarm: The main unit is equipped with an automatic alarm to monitor abnormal situations such as liquid leakage in real time and give an alarm in time when an abnormality occurs.

[0049] 2. Timed cleaning: The main unit is provided with a timed cleaning device, which can perform cleaning when the system is not in use according to the preset timed cleaning time and program.

[0050] 3. Timed disinfection: The main unit is provided with a timed disinfection device, which presets the disinfection time and program according to the usage situation of the equipment to ensure the cleanliness and hygiene of the equipment.

[0051] V. Implementation of the dialysis dry powder dynamic liquid preparation control method

[0052] The present invention also provides a dialysis dry powder dynamic liquid preparation control method, and the specific implementation steps are as follows:

[0053] 1. Establishment of the powder dissolution feature library: Record the solubility time curves of different powders to establish a powder dissolution feature library.

[0054] 2. Learning mode: When a new powder is used for the first time, start the learning mode. Sequentially test the dissolution efficiencies of the three basic modes of mechanical shaking, ultrasonic, and magnetic stirring and the two combined modes, and generate the optimal parameter combination and store it in the database.

[0055] 3. Dynamic Optimization: During continuous production, automatically optimize the dissolution sequence according to the current station load, prioritize the powder bags with high prescription urgency, and improve the overall production efficiency.

[0056] Through technical means such as a multi-modal dissolution device, intelligent control algorithm, and robotic arm, the present invention realizes the efficient dissolution and precise liquid preparation of dialysis dry powder. The system features automation and intelligence, can significantly improve the preparation efficiency and quality of dialysis concentrate, and at the same time reduce the errors and risks of manual operation.

[0057] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, they specify the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0058] Of course, the above are the preferred embodiments of the present invention. It should be pointed out that for those of ordinary skill in the art in this technical field, without departing from the basic principle of the present invention, several improvements and refinements can be made, and these improvements and refinements are also regarded as the protection scope of the present invention.

Claims

1. A dialysis concentrate preparation system, comprising a main unit (100), a dialysis powder bag body (200) and a supporting component (300), characterized in that, The host computer (100) is an all-in-one machine, including: Multiple independently controlled dissolution stations (110), each station is configured with a multimodal dissolution device (111), and the multimodal dissolution device integrates three working modes: a mechanical shaking mechanism (111a), an ultrasonic generator (111b), and a magnetic stirrer (111c); a light transmittance sensor (113) is further provided at the dissolution station (110), located on the side of the dialysis powder bag body (200); A temperature-controlled circulation pipeline (120), with an RO water heating module (121) and a temperature sensor (122) built therein; A distributed control unit (130), which uses a PLC (131) and an HMI human-machine interface (132) to work together. The PLC is configured with a dissolution mode decision algorithm to automatically select the best dissolution mode combination according to the powder type; A robotic arm (140), which is used to connect the temperature-controlled circulation pipeline (120) and the dialysis powder bag body (200) to add liquid to the dialysis powder bag body (200); The dialysis powder bag body (200) includes: A flexible bag body (210), which adopts a foldable design and contains dry hemodialysis powder inside; A lid (220), used to seal the bag mouth of the flexible bag body. A connecting piece (221) is provided on the lid, and the connecting piece is used to install the dialysis powder bag body on the dissolution station; a liquid addition port (222) and a straw port (223) for directly adding water to dissolve the dry dialysis powder are provided on the lid, and form an airtight connection with the docking port of the dissolution station (110) through a self-locking quick connector; The accessory (300) includes: A dialysis machine liquid suction pipe filter element (310) and a dialysis powder bag body placement bucket (320).

2. The dialysis concentrate preparation system according to claim 1, wherein The dissolution mode decision algorithm performs the following steps: (i) Read the powder type code through the powder bag RFID tag (240), control the RO pure water to be heated to the corresponding temperature and then enter the dialysis powder bag body |(200); (ii) Call the pre-stored database to match the corresponding dissolution parameter combination, including: ultrasonic power, shaking frequency, stirring speed, and finally prepare a standard concentrated solution through quantitative automatic control of the water volume; (iii) Dynamically adjust the parameters according to the real-time solubility detection data, and the solubility is measured by the light transmittance sensor (113).

3. The dialysis concentrate preparation system according to claim 1, wherein A medicine addition port (225) is further provided on the lid (220), and the distributed control unit (130) controls the robotic arm (140) to perform the medicine addition operation.

4. The dialysis concentrate preparation system according to claim 1, wherein The average pore diameter of the dialysis machine liquid suction pipe filter element is 20μm, which can filter out particles and undissolved powder.

5. The dialysis concentrate preparation system according to claim 1, characterized in that, The host computer is also provided with an automatic alarm, which automatically monitors liquid leakage abnormalities, etc. and gives a real-time alarm.

6. The dialysis concentrate preparation system according to claim 1, characterized in that, The host computer is also provided with a timed cleaning device, which can preset the timed cleaning time and program, and perform cleaning during the time when the system is not in use.

7. The dialysis concentrate preparation system according to claim 1, wherein, The host computer is also provided with a timed disinfection device, which presets the disinfection time and program according to the equipment usage situation.

8. A dynamic liquid preparation control method for dialysis dry powder, which is applied to the dialysis concentrate liquid preparation system according to any one of claims 1-7, is characterized in that, Including the following steps: (a) Establish a powder dissolution characteristic library and record the solubility time curves of different powders; (b) When using the new powder for the first time, start the learning mode: test the dissolution efficiency of the three basic modes and the two combined modes in sequence, and generate the optimal parameter combination and store it in the database; (c) During continuous production, automatically optimize the dissolution sequence according to the current station load, and give priority to processing the powder bags with a high prescription urgency.

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