Peritoneal dialysis fluid regeneration system and peritoneal dialysis apparatus

Abstract

The application discloses a peritoneal dialysis solution regeneration system and a peritoneal dialysis device, wherein a treatment module is arranged in the peritoneal dialysis solution regeneration system, so that the treatment of toxins in dialysis waste liquid is realized; a liquid supplementing unit connected with a regeneration liquid pipeline is arranged, so that the supplement of components in the regeneration liquid pipeline is realized, and the regeneration liquid which can be exchanged with peritoneal fluid again is obtained; the liquid supplementing unit is configured to include at least two liquid supplementing branches, and each liquid supplementing branch is configured to supplement target liquid based on active control, so that different components can be physically separated and independently transported, thereby breaking the fixed proportion of components in the traditional liquid supplementing mode, and the individualization and fine supplement of the components are realized.

Description

Technical Field

[0001] This application relates to the field of medical device technology, specifically to a peritoneal dialysis fluid regeneration system and peritoneal dialysis equipment used in the field of peritoneal dialysis. Background Technology

[0002] Peritoneal dialysis (PD) is a renal replacement therapy that uses the patient's own peritoneum as a semipermeable membrane to purify the blood. The core process involves infusing peritoneal dialysate into the peritoneal cavity through a catheter placed in the peritoneum. The dialysate remains in the peritoneal cavity for a period of time (this process is called "retention"). During this time, metabolic waste products (such as urea, creatinine, electrolytes, etc.) and excess water in the blood pass through the peritoneal capillaries and interstitium due to the concentration gradient and osmotic pressure difference and enter the dialysate. After the predetermined retention time is reached, the "dialysis waste fluid" containing waste products is drained from the body, and fresh dialysate is infused again, thus repeating the cycle. Compared to hemodialysis, peritoneal dialysis patients can receive treatment at home in relative comfort, with more flexible treatment scheduling, and without significantly altering the patient's hemodynamics. During treatment, patients undergo continuous and gentle removal of toxins and water, without the significant blood pressure changes that can occur during hemodialysis, and it also helps maintain residual renal function.

[0003] To create an osmotic pressure gradient to remove excess water from the body, a substance called an osmotic agent is added to the dialysate to generate osmotic pressure, driving water from the blood into the dialysate (ultrafiltration). Glucose is currently the most commonly used osmotic agent. The glucose concentration in the dialysate (usually 1.5%, 2.5%, or 4.25% by mass) determines the osmotic pressure. During treatment, as toxins and water enter the dialysate from the body, glucose also enters the body in the reverse direction. The glucose concentration in the peritoneal dialysis fluid gradually decreases, reducing its ultrafiltration capacity. When this concentration drops to a certain level, fresh peritoneal dialysis fluid needs to be replaced to maintain the concentration and osmotic pressure gradient at an effective level; otherwise, the overall ultrafiltration effect will be affected.

[0004] In related technologies, dialysis waste fluid can be transformed into a standard regenerated fluid through dialysate regeneration technology and supplementation with the components of the replenishing fluid. This regenerated fluid is then injected into the peritoneal cavity for dialysis. However, when replenishing the components, glucose and electrolytes are usually mixed into a concentrated solution and replenished through the same pump. Therefore, it is difficult to personalize the glucose and electrolyte ratios, making it unsuitable for the different prescription management needs of different patients, different peritoneal conditions, and different treatment modes in next-generation peritoneal dialysis technologies. Therefore, how to provide a peritoneal dialysis fluid regeneration system that can personalize and precisely replenish the components of the replenishing fluid is a technical problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0005] In view of the shortcomings of the above-mentioned related technologies, the purpose of this application is to provide a peritoneal dialysis fluid regeneration system and peritoneal dialysis equipment to overcome the technical problem of difficulty in personalized adjustment and fine control when replenishing the components of dialysis waste fluid in the above-mentioned related technologies.

[0006] To achieve the above and other related objectives, a first aspect of this application provides a peritoneal dialysis fluid regeneration system, comprising: a waste fluid pipeline with its input end receiving dialysis waste fluid; a processing module with its inlet connected to the waste fluid passage for treating toxins in the dialysis waste fluid before outputting it; a regeneration fluid pipeline connected to the outlet of the reactor for receiving the reaction liquid treated by the processing module; and a replenishment unit comprising at least two replenishment branches respectively connected to the regeneration fluid pipeline, each of the replenishment branches replenishing at least one target fluid to the regeneration fluid pipeline based on active control to obtain a regeneration fluid that can be exchanged with peritoneal fluid again; the regeneration fluid is a dialysis waste fluid regeneration fluid formed after some or most of the toxins or toxic molecules have been removed from the dialysis waste fluid after the exchange of dialysis fluid and peritoneal fluid.

[0007] A second aspect of this application provides a peritoneal dialysis device, comprising: a peritoneal dialysis fluid regeneration system as described in any embodiment of the first aspect of this application; a peritoneal dialysis tubing, one end of which is connected to the peritoneal cavity of a human body, and the other end of which is connected to the dialysis fluid regeneration system for peritoneal dialysis; a driving device disposed on the peritoneal dialysis tubing for driving fluid to flow periodically or continuously in the peritoneal dialysis tubing; and a control device for executing a treatment mode to periodically or continuously exchange fluid within the peritoneum of a human body.

[0008] In summary, the peritoneal dialysis fluid regeneration system and peritoneal dialysis device disclosed in this application achieve toxin treatment of dialysis waste fluid by setting a processing module in the peritoneal dialysis fluid regeneration system, and achieve replenishment of components in the regeneration fluid pipeline by setting a replenishment unit connected to the regeneration fluid pipeline, thus obtaining regeneration fluid that can be exchanged with peritoneal fluid again. By configuring the replenishment unit to include at least two replenishment branches, and configuring each replenishment branch to replenish the target fluid separately based on active control, different components can be physically separated and independently transported, thereby breaking the fixed mixing ratio of components in the traditional replenishment method, realizing personalized replenishment and fine control of relevant components of the regeneration fluid, so as to meet the needs of different prescriptions, different dialysis scenarios, and different individuals. Attached Figure Description

[0009] The specific features involved in this application are shown in the appended claims. The features and advantages of the invention can be better understood by referring to the exemplary embodiments and accompanying drawings described in detail below. A brief description of the drawings is as follows:

[0010] Figure 1a The diagram shown is a schematic representation of the peritoneal dialysis fluid regeneration system in one embodiment of this application.

[0011] Figure 1b The diagram shown is a schematic representation of the peritoneal dialysis fluid regeneration system in another embodiment of this application.

[0012] Figure 2 The diagram shown is a schematic representation of the structure of the first fluid replenishment branch in one embodiment of this application.

[0013] Figure 3 The diagram shown is a schematic diagram of N replenishment branches in one embodiment of this application.

[0014] Figure 4 The diagram shown is a schematic of two replenishment branches connected by a binary pump in one embodiment of this application.

[0015] Figure 5 The diagram shown is a schematic diagram of N replenishment branches connected by an N-element pump in one embodiment of this application.

[0016] Figure 6 and Figure 7 The images shown are schematic diagrams illustrating the principles of the peritoneal dialysis fluid regeneration system in different embodiments of this application.

[0017] Figure 8 The diagram shown is a schematic representation of a peritoneal dialysis fluid regeneration system in another embodiment of this application.

[0018] Figure 9 The diagram shown is a schematic representation of the peritoneal dialysis fluid regeneration system in another embodiment of this application.

[0019] Figure 10 The diagram shown is a schematic representation of a peritoneal dialysis device in one embodiment of this application.

[0020] Figures 11 to 13 The following are schematic diagrams of dual-channel peritoneal dialysis catheters in different embodiments of this application. Detailed Implementation

[0021] The following specific embodiments illustrate the implementation of this application. Those skilled in the art can easily understand the advantages and technical effects of this application from the content disclosed in this specification. In the following description, some embodiments may be referenced to the accompanying drawings. It should be understood that other embodiments not shown in the drawings may also be used, and changes in specific structures, parts or mechanisms, components, and operations may be made without departing from the spirit and scope of this application. The following detailed description should not be considered limiting, and the scope of the embodiments of this application is limited only by the claims published in this application. The terminology used herein is for describing particular embodiments only and is not intended to limit this application.

[0022] It should be understood that although the terms first, second, or third, etc., may be used herein to describe various elements or parameters in some embodiments, these elements or parameters should not be limited by these terms. These terms are used only to distinguish one element or parameter from another, and not to define the order, priority, or importance of multiple elements. For example, a first replenishment branch may be referred to as a second replenishment branch, and similarly, a second replenishment branch may be referred to as a first replenishment branch, without departing from the scope of the various described embodiments.

[0023] Furthermore, as used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context indicates otherwise. It should be further understood that the terms “comprising,” “including,” and “including” indicate the presence of the stated features, steps, operations, elements, components, items, kinds, and / or groups, but do not exclude the presence, occurrence, or addition of one or more other features, steps, operations, elements, components, items, kinds, and / or groups. For example, a process, method, system, product, or device that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to these processes, methods, products, or devices. Additionally, the term “and / or,” which may be used hereinafter, describes the relationship between related objects, indicating that three relationships may exist; for example, A and / or B can represent: A alone, A and B simultaneously, and B alone. Furthermore, the character “ / ”, unless otherwise specified, generally indicates that the preceding and following related objects have an “and / or” relationship. Additionally, in the description of embodiments of this application, “multiple” refers to two or more. Furthermore, the terms “or” and “and / or” as used herein are interpreted as inclusive, or mean either one or any combination thereof. Exceptions to this definition only arise when a combination of elements, functions, steps, or operations is inherently mutually exclusive in some way.

[0024] Unless otherwise specified, all terms used herein (including technical and scientific terms) shall have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. It will also be understood that terms used herein shall be interpreted as having the meaning consistent with their meaning in the context of this specification and the relevant field, and shall not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0025] Relative terms such as “below,” “above,” “upper,” “lower,” “horizontal,” or “vertical” may be used herein to describe the relationship between one element, layer, or region and another element, layer, or region illustrated in the figures. It will be understood that these terms are intended to cover different device orientations other than those depicted in the figures. In this application, “vertical,” “horizontal,” and “parallel” are defined as including cases within ±10% of the standard definition. For example, vertical typically refers to an angle of 90° relative to a reference line, but in this application, vertical refers to cases including those within 80° to 100°. Unless otherwise expressly stated, comparative quantitative terms (such as “above” and “below”) are intended to cover the concept of equality. As an example, “above” can mean not only “greater than” in a mathematical sense but also “equal to.”

[0026] Furthermore, the use of endpoints to define numerical ranges herein includes all values ​​contained within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc.). Unless otherwise indicated, all numerical values ​​used in the specification and claims to indicate the number of components, molecular weight, etc., should be understood to be modified by the term "approximately" in all cases. Accordingly, unless otherwise indicated, the numerical parameters listed in this specification and claims are approximate values, which may vary according to the desired characteristics sought to be obtained according to the invention. Each numerical parameter should be constructed at least according to the declared number of significant digits and by applying general rounding techniques, but this does not limit the basic principle of equivalence with the scope of the claims.

[0027] While the numerical ranges and parameters used to illustrate the overall scope of the invention are approximate, the values ​​given in specific examples are provided with the greatest possible accuracy. However, all values ​​necessarily include a range resulting from the standard deviation of the individual experimental measurements.

[0028] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the application. When used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will also be understood that, when used herein, the terms “comprising,” “including,” “containing,” and / or “comprising” designate the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or combinations thereof.

[0029] The present application will be further described in detail below with reference to the accompanying drawings and specific embodiments. The technical solutions in the embodiments of the present application are clearly and completely described. Obviously, the described embodiments are only a part of the embodiments of the present application, not all of them. Based on the embodiments in the present application, all other embodiments and technical effects obtained by those skilled in the art without creative effort should fall within the scope of protection of the present application. The terms "an embodiment," "implementation," or similar wording used throughout this specification mean that a specific feature, structure, or characteristic described together with an embodiment is included in at least one embodiment of the present application. Therefore, the appearance of the phrases "in an embodiment," "in an embodiment," and similar wording throughout this specification may (but does not necessarily) refer to the same embodiment.

[0030] As described in patent applications WO2024120144A1 and CN119215253A, the dialysis fluid regeneration technology transforms dialysis waste fluid into a standard-compliant "new" dialysis fluid after passing through a specially designed regeneration system and being replenished with supplemental fluid components, allowing for renewed treatment. The working principle of this regeneration system primarily involves the selective capture and removal of specific toxins (such as urea, creatinine, phosphorus, and medium-molecular-weight substances) and some water from the waste fluid through physical adsorption or chemical reactions using various specific substances (including but not limited to activated carbon, resin, zirconium hydroxide, zirconium phosphate, alumina, and urease).

[0031] As mentioned above, the loss rate of glucose in the original dialysate is relatively low, with most glucose passing through the adsorption bed and remaining in the regenerated dialysate. However, since glucose consumption primarily occurs within the body, the glucose concentration needs to be replenished to an appropriate level before the regenerated peritoneal dialysis fluid is reintroduced. Because the regenerated peritoneal dialysis fluid also requires the replenishment of electrolytes such as calcium and magnesium ions, the specific implementation of related technologies often involves preparing a concentrated mixture (or replenishment solution) of glucose and electrolytes, which is then replenished using the same pump. Therefore, it is difficult to personalize the glucose and electrolyte levels, as the technology does not address the need for personalized precision. However, next-generation peritoneal dialysis technologies require different prescription management functions for different patients, different peritoneal conditions, and different treatment modalities.

[0032] As described in patent applications WO2024120144A1 and CN119215253A, the dialysate regeneration system's flow path design involves the dialysis waste liquid passing through decomposition and adsorption materials such as activated carbon, a urease layer, cation exchangers, and anion exchangers to remove small organic molecules like creatinine, urea, potassium, calcium, magnesium ions, and ammonium ions from the waste liquid. The liquid exiting the adsorption column has essentially zero calcium and magnesium ion content, and the glucose concentration is basically the same as that in the waste liquid. However, clinical peritoneal dialysis fluid has specific requirements for calcium, magnesium, and glucose concentrations. Therefore, a replenishing solution needs to be introduced after the adsorption column to replenish these components via pumping. Since glucose, calcium, and magnesium are mixed in the same solution, the proportions of each component added during the replenishment process remain unchanged and consistent with the pre-mixed ratio. Generally, there are bagged peritoneal dialysis fluids on the market with different glucose concentrations, but their calcium, magnesium, and sodium ion concentrations are basically the same (unless it is a low-calcium type). Furthermore, according to the principles of the regeneration system, calcium and magnesium are replenished only after the system has been completely emptied, so their concentrations are generally relatively fixed. However, the glucose concentration in the waste liquid can vary greatly depending on factors such as the patient and the prescription.

[0033] For example, the clinically required peritoneal dialysis fluid should have a glucose concentration of 83.3 mmol / L (1.5%), a calcium ion concentration of 1.77 mmol / L, and a magnesium ion concentration of 0.25 mmol / L. Suppose that in the waste fluid leaving patient A's peritoneum, due to peritoneal absorption and ultrafiltration, the glucose concentration is 40 mmol / L, while the calcium and magnesium ions are reduced to 0 mmol / L after passing through the regeneration system's adsorption column, leaving the glucose concentration unchanged at 40 mmol / L. If the concentrate is then replenished to the main dialysis line at a 50-fold dilution, the replenishment fluid should contain 88.5 mmol / L calcium, 12.5 mmol / L magnesium, and 2165 mmol / L glucose. If patient A's in-abdomen retention time changes for the next treatment, or if the same system is used for other patients such as patient B, the concentrations in the waste fluid will change, and this replenishment fluid will no longer be effectively adapted to the new situation. For example, if a patient needs to increase their glucose concentration from 83.3 mmol / L to 138.89 mmol / L (2.5%) during a certain treatment as prescribed by their doctor, the aforementioned peritoneal dialysis solution formula cannot supplement sufficient glucose while maintaining adequate calcium and magnesium ion levels.

[0034] In view of this, this application provides a peritoneal dialysis fluid regeneration system and a peritoneal dialysis device. By setting a processing module in the peritoneal dialysis fluid regeneration system, the toxins in the dialysis waste fluid are treated. By setting a replenishment unit connected to the regeneration fluid pipeline, the components in the regeneration fluid pipeline are replenished, resulting in a regeneration fluid that can be exchanged with peritoneal fluid again. By configuring the replenishment unit to include at least two replenishment branches, and configuring each replenishment branch to replenish the target fluid separately based on active control, different components can be physically separated and independently transported. This breaks the fixed mixing ratio of components in traditional replenishment methods, and realizes personalized replenishment and fine control of relevant components of the regeneration fluid to meet the needs of different prescriptions, different dialysis scenarios, and different individuals.

[0035] In the embodiments of this application, the "dialysis waste fluid" refers to the liquid discharged after the exchange of substances between the dialysate and peritoneal fluid, containing glucose, toxins or toxic molecules such as urea, creatinine, and uric acid, as well as excess electrolytes such as potassium, calcium, and magnesium ions. The "regenerated fluid" refers to the dialysis waste fluid regenerated after some or most of the toxins or toxic molecules have been removed from the dialysis waste fluid; simply referred to as regenerated fluid. Further, the "regenerated fluid" can also be the dialysis waste fluid regenerated after some or most of the toxins or toxic molecules have been removed from the dialysis waste fluid and then supplemented with glucose and beneficial or essential molecules such as potassium, calcium, and magnesium; also simply referred to as regenerated fluid. The regenerated fluid can be considered as fresh dialysate, and the peritoneal fluid is exchanged again. This cycle is repeated to continuously remove toxins from the peritoneal fluid, achieving the therapeutic purpose. Dialysis equipment that uses this dialysate regeneration mode is called a dialysate regeneration dialysis machine. It includes dialysate regeneration hemodialysis machines and dialysate regeneration peritoneal dialysis machines. The biggest advantage of this type of dialysis machine is that it does not require a continuous water source and water treatment system, so it is very small and portable, making it suitable for home hemodialysis and wearable dialysis devices.

[0036] In the embodiments of this application, the "prescription" refers to a dialysis treatment plan formulated by a doctor based on the individual conditions of a uremia patient, such as weight, residual renal function, electrolyte level, and fluid retention. Its contents usually include the target concentration of electrolytes and glucose in the dialysate, the fluid replacement volume, dialysis time and frequency, etc., and are used to guide the peritoneal dialysis fluid regeneration system described in this application to configure and output regenerated dialysate that meets the patient's needs.

[0037] In the embodiments of this application, the users of the peritoneal dialysis fluid regeneration system include uremia patients and medical staff who need to use the peritoneal dialysis fluid regeneration system.

[0038] The peritoneal dialysis fluid regeneration system provided in some embodiments of this application can be configured in a peritoneal dialysis (PD) device. Please refer to... Figure 1a The image shows a schematic diagram of the peritoneal dialysis fluid regeneration system in one embodiment of this application. Figure 1a As shown, the dialysate regeneration system includes a waste liquid passage L2-1, a regeneration liquid pipeline L2-2, and a processing module 1. The input terminal a1 of the waste liquid passage L2-1 receives dialysis waste liquid; the inlet of the processing module 1 is connected to the waste liquid passage L2-1 and is used to treat the toxins in the dialysis waste liquid before outputting it; the regeneration liquid pipeline L2-2 is connected to the outlet of the processing module 1 to receive the treated reaction liquid.

[0039] Please see Figure 1b The diagram shows a schematic representation of the peritoneal dialysis fluid regeneration system in another embodiment of this application. Figure 1bAs shown, the processing module 1 may include a reactor 11 and an adsorption unit 12. The reactor 11 and the adsorption unit 12 can be used to decompose and treat toxins in the dialysis waste liquid, respectively. Of course, in some other embodiments, the processing module 1 may be configured as either the reactor 11 or the adsorption unit 12, or it may not be limited to the above two methods of treating dialysis waste liquid. Any device, mechanism, structure or component capable of removing some or most of the toxins in the dialysis waste liquid may be used as the processing module described in this application.

[0040] exist Figure 1b In the illustrated embodiment, the dialysate regeneration system, in addition to the waste liquid passage L2-1 and the regeneration liquid pipeline L2-2, also includes a reactor 11 and an adsorption unit 12. Specifically, the input end a1 of the waste liquid passage L2-1 receives dialysis waste liquid; the inlet of the reactor 11 is connected to the waste liquid passage L2-1 for decomposing toxins in the dialysis waste liquid; the regeneration liquid pipeline L2-2 is connected to the outlet of the reactor 11 for receiving the reaction liquid treated by the reactor 11. The adsorption unit 12 is connected to the reactor 11 through the regeneration liquid pipeline L2-2 for further toxin treatment of the reaction liquid after toxin decomposition by the reactor 11.

[0041] It should be noted that the following configuration is based on a dialysate regeneration system. Figure 1b The form shown (i.e., the processing module is configured to include reactor 11 and adsorption unit) is used to describe subsequent embodiments and should not be construed as limiting this application.

[0042] The decomposition refers to the reaction process of converting toxins or toxic molecules in dialysis waste into harmless or easily removable small molecules through chemical reactions or biocatalysis. This includes the catalytic synthesis of toxins into harmless products and the catalytic decomposition into easily removable small molecules. As long as the toxicity of the dialysis waste is reduced to a certain extent, it is within the scope of the decomposition defined in this application.

[0043] The inlet of reactor 11 refers to the location where dialysis waste liquid is input into reactor 11 through waste liquid passage L2-1, and the outlet of reactor 11 refers to the location where the dialysis waste liquid is output from reactor 11 after being treated by reactor 11. Figure 1b The following description uses an example where the upper side of reactor 11 is configured as the inlet and the lower side of reactor 11 is configured as the outlet. Figure 1b In the example shown, dialysis waste flows from input a1 to waste flow path L2-1, and then along... Figure 1bThe arrow in the diagram indicates that the regenerated liquid flows towards the inlet of reactor 11, where it is decomposed into toxins to form the regenerated liquid. The regenerated liquid flows from the outlet of reactor 11 to the regenerated liquid pipeline L2-2 and is output from the output end a2 of the regenerated liquid pipeline L2-2.

[0044] Specifically, the input end a1 of the waste fluid passage L2-1 can be directly connected to a waste fluid container for storing dialysis waste fluid, or it can be connected to the outlet of the dialysis waste fluid in a peritoneal dialysis (PD) device. It should be noted that this application does not limit the specific connection location and form of the input end of the waste fluid passage, as long as the input end of the waste fluid passage can receive dialysis waste fluid. In the example where the peritoneal dialysis fluid regeneration system is applied to a peritoneal dialysis device, the input end a1 of the waste fluid passage L2-1 is connected to the channel in the peritoneal dialysis tubing of the peritoneal dialysis device used for outputting dialysis fluid, so as to receive the dialysis waste fluid output from the peritoneal dialysis tubing.

[0045] The output end a2 of the regenerated fluid pipeline L2-2 can be directly connected to a regenerated fluid container for storing regenerated fluid, or it can be connected to the regenerated fluid inlet of a peritoneal dialysis (PD) device. It should be noted that this application does not limit the specific connection location or form of the output end a2 of the regenerated fluid pipeline L2-2, as long as the output end a2 of the regenerated fluid pipeline L2-2 has an inlet or device capable of receiving regenerated fluid. In the example where the peritoneal dialysis fluid regeneration system is applied to a peritoneal dialysis device, the output end a2 of the regenerated fluid pipeline L2-2 is connected to the peritoneal dialysis tubing in the peritoneal dialysis device to input the regenerated fluid into the channel for inputting the regenerated fluid within the peritoneal dialysis tubing.

[0046] In one embodiment, such as Figure 1b As shown, a dialysate pump 20 is provided on the waste liquid passage L2-1, the dialysate pump 20 being used to drive the fluid in the waste liquid passage L2-1 along... Figure 1b The arrow in the diagram indicates the flow direction. Specifically, the dialysate pump 20 is used to power the dialysis waste liquid in the waste liquid passage L2-1, causing the dialysis waste liquid to flow in the direction of the arrow. Examples of the dialysate pump 20 include peristaltic pumps, pneumatic diaphragm pumps, or pressure pumps. In some other examples, the dialysate pump 20 is used to drive the dialysis waste liquid along the direction of the arrow. Figure 1b The flow is in the opposite direction to the middle arrow.

[0047] In another embodiment, a dialysate pump can be installed on the regeneration fluid line L2-2. The peritoneal dialysis fluid regeneration system changes the total amount of liquid in the peritoneal dialysis fluid regeneration system by the differential speed between the dialysate pump 20 on the waste fluid passage L2-1 and the dialysate pump on the regeneration fluid line L2-2.

[0048] In one embodiment, a pre-prepared liquid bypass (not shown) is provided on the waste liquid passage L2-1. The pre-prepared liquid bypass is used for pre-filling, emptying, or flushing the passage of the peritoneal dialysis fluid regeneration system. Specifically, pre-filling and emptying operations can be achieved by connecting a storage container (e.g., a liquid bag made of medical plastic) to the peritoneal dialysis fluid regeneration system, coordinating the operating mode of the dialysis fluid pump 20, and adjusting the upright or inverted position of the storage container. In pre-filling mode, the liquid outlet of the storage container is at a low position; while in emptying mode, the gas outlet of the storage container is at a high position. In some embodiments, the pre-prepared liquid bypass is, for example, the pre-filling and emptying purification circuit system described in patent document CN2022108507945; the entire text of patent document CN2022108507945 is incorporated herein by reference.

[0049] In one embodiment, reactor 11 may be configured to include a cavity, a membrane having a first side and a second side, and an enzyme disposed on the first or second side of the membrane. The enzyme is used to decompose toxins in dialysis wastewater, the cavity provides a site for the enzyme to react with the toxins, and the membrane is used to retain the enzyme on the first or second side while allowing the reaction solution to decompose the toxins to pass through. The membrane has an inlet for the dialysis wastewater to flow in and an outlet for the reaction solution to flow out.

[0050] For example, in Figure 1b In the example shown, the cavity is a hollow portion inside the reactor 11 that provides space for decomposing toxins. Its upper side is configured as the inlet, and its lower side as the outlet. A membrane is inclinedly arranged inside the cavity, and an enzyme is disposed on the upper side of the membrane. The dialysis waste liquid enters the cavity through the upper inlet, and after sufficient contact with the enzyme on the upper side of the membrane, the resulting reaction solution can flow across the membrane to the lower side and exit the reactor 11 through the outlet. During this process, the enzyme is always retained on the upper side of the membrane.

[0051] In one embodiment, the membrane can be a membrane of different geometries. In one example, the membrane includes one or more of tubular membranes, spiral wound membranes, flat sheet membranes, and hollow fiber membranes. The membrane pore size needs to allow the enzyme to be retained on one side of the membrane while the liquid can be filtered to the other side; for example, the membrane pore size is smaller than the size of the enzyme-carrying microspheres, enzyme-carrying microparticles, or enzyme-carrying microcapsules described later. It should be noted that, in embodiments where the membrane is a planar membrane, the first side and the second side are opposite sides of the planar structure of the flat sheet membrane; similarly, in embodiments where the membrane is a hollow fiber membrane, the first side is the outer side of the wall of each hollow fiber membrane tube, and the second side is the inner side of the wall of each hollow fiber membrane tube.

[0052] In one embodiment, the enzyme is used to decompose toxins in the dialysis waste liquid. The decomposition described in this embodiment refers to the catalytic decomposition or synthesis of toxins to remove them from the dialysis waste liquid, and should not be simply understood as catalytic decomposition. The type of enzyme varies depending on the toxins to be decomposed by the reactor. Any enzyme with corresponding catalytic decomposition or synthesis functions can alter the concentration of any toxin in the dialysis waste liquid to achieve the purpose of removing toxins. For example, if the reactor is used to decompose urea in the dialysis waste liquid, the corresponding enzyme is urease. Similarly, if the reactor is used to decompose ethanol in the dialysis waste liquid, the corresponding enzyme is ethanol oxidase, which can oxidize ethanol. Furthermore, if the reactor is used to decompose uric acid in the dialysis waste liquid, the corresponding enzyme is urate oxidase, which can oxidize uric acid. And if the reactor is used to decompose phenylalanine in the dialysis waste liquid, the corresponding enzyme is phenylalanine ammonia-lyase, which can decompose phenylalanine. It should be noted that the enzyme disposed on the first or second side of the membrane can be one enzyme or multiple enzymes.

[0053] In one embodiment, the enzyme is formulated in a free state. Compared to enzymes in a fixed state, enzymes in a free state can ensure that the concentration of toxins in the dialysis waste fluid that the enzyme comes into contact with is similar, further solving the problem of severe activity loss caused by enzymes in different locations not coming into contact with sufficient concentrations of dialysis waste fluid.

[0054] In one embodiment, the enzyme may be carried in the form of an enzyme preparation or enzyme-loaded microspheres. The enzyme-loaded microspheres are microspheres immobilized with an enzyme; for example, urease microspheres are microspheres immobilized with urease. The enzyme preparation refers to a preparation containing an enzyme. In another embodiment, the enzyme may also be carried in the form of enzyme-loaded microparticles or enzyme-loaded microcapsules. For example, urease microparticles are microparticles immobilized with urease, and urease microcapsules are microcapsules immobilized with urease. An enzyme carried in the form of enzyme-loaded microspheres, enzyme-loaded microparticles, enzyme-loaded microcapsules, or enzyme preparations is considered to be in a free state when its carrier is in a free state. Of course, in other embodiments, the enzyme may also exist in a free state independently without being attached to a carrier. This application does not limit whether the enzyme needs to be carried by a carrier, as long as it is ensured that it is free on its side.

[0055] In the embodiments of this application, the inlet of the dialysis waste liquid is connected to the side of the membrane where the enzyme is located, while the outlet of the reaction solution is connected to the other side of the membrane (the side without the enzyme). With this structure, the dialysis waste liquid, after flowing in from the inlet and reacting with the enzyme, needs to be forced by pressure to cross the membrane before it can flow out through the outlet on the other side. This further allows the dialysis waste liquid to directly contact the enzyme after entering the enzyme-containing side of the reactor in this application, rather than only partially contacting the enzyme through diffusion. Thus, before crossing the membrane, the dialysis waste liquid directly impacts the enzyme, ensuring continuous and prolonged contact with it. This avoids the incomplete removal / decomposition of toxins due to insufficient or short-duration contact with the enzyme. The reaction solution of this application is discharged directly from the outlet on the other side after crossing the membrane, without having to go through the reciprocating process of crossing the membrane to discharge from the outlet located on the same side as the inlet, and without having to contact the enzyme through circulating flow, thereby improving the efficiency of toxin removal / decomposition; furthermore, the enzyme in the reactor is prepared in a free state, which can make the concentration of toxins in the dialysis waste liquid that the enzyme contacts similar, solving the problem of severe activity loss due to the enzyme not contacting the dialysis waste liquid of sufficient concentration at different locations; the membrane of this application is retained on the side where the enzyme is located, which can make the enzyme continuously and efficiently decompose toxins on the first side, so as to avoid the problem of low toxin decomposition efficiency caused by the reduction of enzyme quantity.

[0056] In one embodiment, such as Figure 1b As shown, the adsorption unit 12 is located downstream of the reactor 11 and is used to further treat the reaction liquid after the toxins have been decomposed by the reactor 11. For example, the adsorption unit 12 is mainly used to adsorb toxins such as creatinine, phosphate, and ammonium ions formed after the decomposition of urea, and also adsorbs ions such as potassium, calcium, and magnesium.

[0057] The adsorption unit 12 may also include one or more adsorption materials. The adsorption materials include activated carbon, cation exchangers, or anion exchangers. The cation exchangers include zirconium phosphate or cation exchange resins, and the anion exchangers include hydrated zirconium oxide, zirconium hydroxide, sodium zirconium carbonate, or anion exchange resins. In an example where the adsorption unit 12 is configured with one adsorption material, for example, the adsorption unit 12 may contain only one activated carbon column. In an example where the adsorption unit 12 is configured with multiple adsorption materials, for example, the adsorption unit 12 may be configured as a mixed column of activated carbon and anion exchangers. Another example is that the adsorption unit 12 is a mixed column of activated carbon and cation exchangers. Yet another example is that the adsorption unit 12 is a mixed column of anion exchangers and cation exchangers. Still another example is that the adsorption unit 12 is a mixed column of activated carbon, anion exchangers, and cation exchangers. In this configuration, the activated carbon material is used to adsorb organic matter, the cation exchanger is used to adsorb various cations, including potassium, calcium, and magnesium, and the anion exchanger is used to adsorb various anions, such as phosphate and acetate. Figure 1bIn the illustrated embodiment, the adsorption unit 12 is configured with a variety of adsorption materials.

[0058] In another embodiment, the adsorption unit can be configured on the waste liquid passage L2-1, that is, upstream of reactor 11. In this embodiment, the output end of the adsorption unit is connected to the inlet of reactor 11 to perform preliminary toxin treatment on the dialysis waste liquid, so that the dialysis waste liquid that has undergone preliminary toxin treatment by the adsorption unit enters reactor 11 from the inlet for further toxin treatment. In one example, the adsorption unit is mainly used to adsorb potassium, calcium, magnesium and other ions in the dialysis waste liquid.

[0059] In another embodiment, the adsorption unit is disposed on both the waste liquid passage L2-1 and the regenerated liquid line L2-2 to enhance the toxin removal effect of the peritoneal dialysis fluid regeneration system. In some examples, the size of the column, the filling ratio of the adsorption material, and the filling amount of the adsorption material of the adsorption unit on the waste liquid passage L2-1 and the adsorption unit on the regenerated liquid line L2-2 may be the same or different. For example, the column of the adsorption unit on the regenerated liquid line L2-2 may be larger than the column of the adsorption unit on the waste liquid passage L2-1.

[0060] In another embodiment, the adsorption unit 12 includes multiple columns connected in series, such as columns containing zirconium phosphate, hydrated zirconium oxide, and activated carbon materials, respectively, arranged in series. It should be noted that this application does not limit the number of columns connected in series in the adsorption unit 12; it can include two or more adsorption columns, and each adsorption column can also include one or more adsorption materials. In this embodiment, a pressure sensor, a degassing device, and a pH sensor, or one or more of these, can be provided between the multiple columns connected in series.

[0061] In one embodiment, such as Figure 1a and 1b As shown, the peritoneal dialysis fluid regeneration system may further include a replenishment unit 4, which is used to replenish the components of the reaction fluid output from the outlet of reactor 11 or the processed fluid output from the adsorption unit 12 on the regeneration fluid pipeline L2-2 to form the regeneration fluid. The components may include, for example, solutes such as permeabilizers or electrolytes. The permeabilizers may include, for example, one or more of glucose, icodextrin, mannitol, and sorbitol, and the electrolytes may include, for example, one or more of calcium ions, magnesium ions, and sodium ions. These solutes are typically dissolved in a specific solvent and added to the reaction fluid in the form of a concentrated solution.

[0062] In this application, the concentrated solution added to the reaction solution is referred to as the target solution. Specifically, the target solution includes a penetrant concentrate and an electrolyte concentrate. The penetrant concentrate includes one or more of the following: a concentrated solution, an icodextrin concentrate, a mannitol concentrate, and a sorbitol concentrate. The electrolyte concentrate includes one or a mixture of two or more of the following: a calcium ion concentrate, a magnesium ion concentrate, and a sodium ion concentrate. In some embodiments, the target solution may also include a buffer solution for adjusting the pH of the regenerated solution, such as a sodium bicarbonate solution, a sodium carbonate solution, or a sodium citrate solution. Further details regarding the target solution will not be elaborated upon thereafter.

[0063] For example, in one specific example, the osmotic concentrate is a substance that provides osmotic pressure, represented by glucose. Taking glucose as an example, the osmotic concentrate mainly contains 5-68% glucose (g glucose mass / total solution volume mL), that is, 5-68g of glucose per 100mL of concentrate, preferably 50%. The packaging volume of the osmotic concentrate is between 50mL and 2L. In addition, the osmotic concentrate may also contain small amounts of stabilizers, acid-base adjusters, etc. The electrolyte concentrate mainly contains calcium chloride and magnesium chloride, as well as other possible stabilizers, acid-base adjusters, etc., wherein the concentration of calcium chloride is between 0-4.5mol / L, preferably 0.1-1mol / L, and the concentration of magnesium chloride is between 0-4mol / L, preferably 0.1-1mol / L. The packaging volume of the electrolyte concentrate is between 10mL and 1L.

[0064] As mentioned above, in related technologies, when supplementing the above-mentioned reaction solution to form the regenerated solution, all the osmotic concentrate and electrolyte concentrate in the target solution are usually mixed and supplemented through the same pump. Therefore, it is difficult to make personalized adjustments to the osmotic concentrate (e.g., glucose) and electrolyte, making it difficult to adapt to the different prescription management needs of different patients, different peritoneal conditions, and different treatment modes in the new generation of peritoneal dialysis technology. In view of this, the fluid replenishment unit 4 described in this application includes at least two fluid replenishment branches respectively connected to the regenerated solution pipeline L2-2. Each of the fluid replenishment branches replenishes at least one target solution to the regenerated solution pipeline L2-2 based on active control to obtain a regenerated solution that can be exchanged with peritoneal fluid again.

[0065] The active control refers to the replenishment unit 4 selectively opening or closing at least one of the replenishment branches based on detected liquid parameters. This controls the type, flow rate, and replenishment ratio of different types of liquids, thereby precisely replenishing the target liquid into the regenerated liquid pipeline L2-2 to achieve personalized replenishment of components such as permeabilizers and electrolytes in the regenerated liquid. The liquid parameters may include, for example, the concentration, pH value, and osmotic pressure of permeabilizers and / or electrolytes in the dialysis waste liquid, but are not limited to these. The data used for replenishing the target liquid in subsequent embodiments all fall under the liquid parameters described in this application.

[0066] It should be noted here that, Figure 1b The example shown is only illustrative, illustrating the concept of replenishment unit 4 having two replenishment branches, and should not be construed as a limitation of this application. In some other examples, replenishment unit 4 may also be configured to include more than two replenishment branches, such as three, four, five, six, etc., depending on the actual needs of replenishing the target liquid, and this application does not impose any limitations in this regard. In subsequent embodiments, for ease of distinction and explanation, [the following will also be used]. Figure 1b The two replenishment branches are referred to as the first replenishment branch 41 and the second replenishment branch 42, respectively.

[0067] In one embodiment, at least two replenishment branches connected to the regenerated liquid pipeline L2-2 in the replenishment unit 4 are configured in parallel. In other words, each replenishment branch can form a complete, functionally independent fluid delivery module, and the operating state (e.g., on, off, speed) of one branch does not affect the fluid delivery in the other branch. For example, in... Figure 1b In the example shown, the first replenishment branch 41 and the second replenishment branch 42 are arranged in parallel and can be controlled independently, so as to selectively replenish the target liquid in the first replenishment branch 41 and / or the target liquid in the second replenishment branch 42 to the regeneration liquid pipeline L2-2 according to the concentration of components such as permeate and electrolyte in the reaction liquid output from the reactor 11 or the treatment liquid output from the adsorption unit 12.

[0068] In one embodiment, the at least two fluid resuscitation lines include an electrolyte line and a glucose line. The electrolyte line is used to replenish the regenerated fluid line L2-2 with electrolyte components such as sodium, potassium, calcium, and magnesium ions to ensure that the electrolyte concentration in the regenerated fluid is maintained within the physiological range required by the peritoneal dialysis fluid formulation. The glucose line is used to replenish the regenerated fluid line L2-2 with the osmotic agent glucose to ensure that the osmotic pressure of the regenerated fluid meets the requirements of the peritoneal dialysis fluid. In this embodiment, the electrolyte line and the glucose line can be actively controlled to replenish the required electrolyte solution and glucose solution to the regenerated fluid line L2-2, respectively, so that the final regenerated fluid has a composition and physicochemical properties comparable to fresh peritoneal dialysis fluid, thereby enabling effective material exchange with the patient's peritoneal fluid again.

[0069] In one example, the electrolyte branch is connected upstream of the regenerated liquid line L2-2, and the glucose branch is connected downstream of the regenerated liquid line L2-2. For example, in Figure 1b In the example shown, the first replenishment branch 41 is configured as an electrolyte branch, and the second replenishment branch 42 is configured as a glucose branch. This allows the treated liquid output from the adsorption unit 12 to be replenished with electrolyte solution first via the first replenishment branch 41, and then with glucose via the second replenishment branch 42, along its flow direction. It should be understood that in this example, placing the glucose branch downstream helps avoid interference between electrolyte concentration and glucose osmotic pressure regulation, while also allowing for precise control of the final osmotic concentration of the regenerated liquid near the output end a2. Of course, in other examples, the glucose branch can be placed upstream of the regenerated liquid pipeline, and the electrolyte branch downstream, depending on the specific application requirements and the mixing order of the target liquids.

[0070] In embodiments with more than two replenishment branches, in one example, the first replenishment branch can be configured as a glucose branch, the second branch as a branch solely for replenishing a specific electrolyte A (e.g., sodium ions), the third branch as a branch solely for replenishing a specific electrolyte B (e.g., potassium ions), the fourth branch as a branch solely for replenishing a specific electrolyte C (e.g., calcium ions), the fifth branch as a branch solely for replenishing a specific electrolyte D (e.g., magnesium ions), and so on. Each replenishment branch replenishes a concentrated solution of only one component. Furthermore, the relative order of replenishment by the first, second, third, fourth, and fifth replenishment branches can be determined based on actual replenishment needs. This example is only used to illustrate replenishment unit 4 with five replenishment branches and should not be construed as limiting this application.

[0071] In another example, the first rehydration branch can be configured to replenish glucose and electrolyte A, the second branch to replenish electrolyte B and electrolyte C, and the third branch to replenish electrolyte D. Alternatively, the first rehydration branch can be configured to replenish glucose, the second branch to replenish electrolyte A and electrolyte B, and the third branch to replenish electrolyte C and electrolyte D. Or, the first rehydration branch can be configured to replenish glucose, the second branch to replenish electrolytes A, B, and C, and the third branch to replenish electrolyte D. And so on, wherein at least one rehydration branch replenishes a mixed concentrate containing glucose and electrolytes, or a mixed concentrate containing multiple electrolytes. Further, the relative order of rehydration by the first, second, and third rehydration branches can be determined according to actual rehydration needs. This example is only used to illustrate the case of the replenishment unit 4 having three replenishment branches, and should not be construed as limiting this application.

[0072] It should be understood that various components such as osmotic agents and electrolytes can be separated or combined in various ways according to actual application needs and then replenished separately using a certain replenishment branch, thereby achieving personalized and precise replenishment of osmotic agents such as glucose and electrolytes of various components.

[0073] In one embodiment, each replenishment branch in the replenishment unit 4 includes a branch pipeline connected to the regenerated liquid pipeline, a container for holding the target liquid connected to the branch pipeline, and a replenishment pump for conveying the target liquid in the container to the regenerated liquid pipeline. In some examples, each replenishment branch may be configured with the same structure. The structure of the replenishment branch will be described in detail below using the first replenishment branch as an example.

[0074] Please see Figure 2 The diagram shows a schematic representation of the structure of the first fluid replenishment branch in one embodiment of this application. Figure 2 As shown, the first replenishment branch 41 includes a first branch pipe 411, a first container 412, and a first replenishment pump 413. The first branch pipe 411 is connected to the regenerated liquid pipeline L2-2. The first container 412 is connected to the first branch pipe 411 and is used to hold the target liquid. The first replenishment pump 413 is used to transport the target liquid in the first container 412 to the regenerated liquid pipeline L2-2. It should be noted that, in subsequent embodiments, for ease of distinction, the branch pipe, container, and replenishment pump included in the first replenishment branch 42 will also be referred to as the second branch pipe, the second container, and the second replenishment pump, respectively. The second branch pipe, the second container, and the second replenishment pump will not be described again in subsequent embodiments.

[0075] In one embodiment, one end of the first branch pipe 411 is connected to the regenerated liquid pipe L2-2, and the other end is connected to the first container 412, to provide a flow path from the target liquid to the regenerated liquid pipe L2-2. In some examples, an anti-backflow structure may be configured on the first branch pipe 411 to prevent the regenerated liquid in the regenerated liquid pipe L2-2 from flowing back into the first container 412. The anti-backflow structure may be configured as a one-way valve or a check valve, allowing only the target liquid to flow along... Figure 2 The flow direction is indicated by the arrow shown. Alternatively, the first replenishment branch 41 can be positioned at a higher level to utilize the height difference and the gravity of the liquid column to reduce the risk of regenerated liquid backflow. In some examples, the first branch line 411 may be configured to be made of materials such as medical-grade silicone, polyurethane, or polypropylene for use in manufacturing disposable sterile products or to support reusable sterilization protocols.

[0076] In one embodiment, the containers in at least two replenishment branches are in the form of disposable bottles or bags. In an example where the containers are configured as disposable bags, the containers may be made of a multi-layered composite co-extruded film, for example, it may include an inner layer made of medical-grade polyethylene or polypropylene to ensure compatibility with the target liquid, a middle layer for isolating oxygen to prevent oxidative deterioration of the target liquid, and an outer layer with high mechanical strength to provide protection. In this example, the target liquid may be pre-filled into the inner layer.

[0077] In the example where the container is configured as a disposable bottle, it can be made of medical-grade polyethylene terephthalate or polypropylene to ensure good biocompatibility with the target liquid, while having high mechanical strength and preventing oxygen from penetrating and causing oxidation and deterioration of the target liquid.

[0078] In the above example, the container may be equipped with a sterile interface, such as a Luer connector, to achieve both sterile connection between the container and the branch tubing and rapid container replacement. When the target solution in the container is used up or after each treatment, the user can discard the disposable container as medical waste and replace it with a new disposable container before the next use. This embodiment achieves one-person-one-use and one-disposal of the container, avoiding the risk of contamination and cross-infection caused by reuse.

[0079] Of course, in some other embodiments, the container may also be configured as a reusable bottle to control costs or reduce environmental pollution. In some examples, the container may be configured as a medical-grade glass, stainless steel, or heat-resistant plastic such as polycarbonate to allow for multiple cleaning and high-temperature sterilization operations. In some examples, the container is transparent and has precise graduations to allow the user to observe the liquid level. In other examples, the container may be equipped with a liquid level sensor to monitor the remaining liquid level in real time, indicating to the user to add liquid or replace the container.

[0080] In one embodiment, the container has a barcode identification label. Users can read the information in the barcode identification label using a corresponding barcode recognition device. This information may include, for example, the concentrations of glucose and electrolytes in the regenerated fluid required for peritoneal dialysis by a patient using the peritoneal dialysis regeneration system, or the concentrations of glucose and electrolytes in the target fluid to be replenished. This ensures that the target fluid selected in the peritoneal dialysis regeneration system is consistent with the patient's dialysis prescription, guaranteeing that the target fluid in a container of a particular peritoneal dialysis regeneration system is exclusively for a specific patient. In some examples, the barcode identification label may be made of waterproof, alcohol-resistant medical-grade material to ensure stable reading even in a clinical environment. In some examples, the barcode identification label may be configured as a barcode, QR code, or other machine-readable information code, with each barcode corresponding one-to-one with a prescription or patient information.

[0081] In one embodiment, each of the containers in the at least two replenishment branches contains a concentrated mixture of target liquid permeabilizer and electrolyte, and the mixing ratio or type of the concentrated mixture in the different containers is different.

[0082] When the replenishment branch is configured as two, in examples where the types of concentrate in different containers are different, such as... Figure 1b As shown, the first container 411 of the first replenishment branch 41 contains an electrolyte concentrate, and the second container of the second replenishment branch 42 contains a glucose concentrate. Alternatively, the first container 411 of the first replenishment branch 41 contains a mixed concentrate of glucose and electrolyte A, and the second container of the second replenishment branch 42 contains a mixed concentrate of electrolyte B and electrolyte C. Or, the first container 411 contains a mixed concentrate of glucose and electrolyte A, and the second container contains a mixed concentrate of glucose and electrolyte B. Or, the first container 411 contains a mixed concentrate of glucose and electrolyte A, and the second container contains a mixed concentrate of electrolyte A and electrolyte B. In the above examples, the mixing ratio of each component in the mixed concentrate in each container can be the same or different. It should be noted that the above examples are not exhaustive; any difference in one or more components in the concentrates contained in the two containers is within the scope of this example.

[0083] When the replenishment branch is configured with two containers, in examples where the mixing ratio of the concentrate in different containers differs, for instance, both the first container 411 of the first replenishment branch 41 and the second container of the second replenishment branch 42 contain a mixed concentrate of glucose and electrolyte A, but the mixed concentrate in the first container 411 has a first mixing ratio, and the mixed concentrate in the second container has a second mixing ratio. Alternatively, both the first container 411 and the second container of the second replenishment branch 42 contain a mixed concentrate of glucose, electrolyte A, and electrolyte B, but the mixed concentrate in the first container 411 has a first mixing ratio, and the mixed concentrate in the second container has a second mixing ratio. The above examples are not exhaustive; any situation where the components of the concentrate in the two containers are the same, but the mixing ratios of the components differ, is acceptable.

[0084] When multiple replenishment branches are configured, for example, the container of the first replenishment branch contains a glucose concentrate, the container of the second replenishment branch contains a concentrate of electrolyte A, the container of the third replenishment branch contains a concentrate of electrolyte B, and the container of the fourth replenishment branch contains a concentrate of electrolyte C. Alternatively, the container of the first replenishment branch may contain a mixed concentrate of glucose and electrolyte A, the container of the second replenishment branch may contain a mixed concentrate of electrolyte B and electrolyte C, and so on. Or, the container of the first replenishment branch may contain a mixed concentrate of glucose and electrolyte A, the container of the second replenishment branch may contain a mixed concentrate of glucose and electrolyte B, and the container of the third replenishment branch may contain a mixed concentrate of glucose and electrolyte C. Alternatively, the container in the first replenishment branch may contain a glucose concentrate, the container in the second replenishment branch may contain a mixed concentrate of glucose and electrolyte A, and the container in the third replenishment branch may contain a mixed concentrate of electrolyte B and electrolyte C. Or, the container in the first replenishment branch may contain a glucose concentrate, the container in the second replenishment branch may contain a mixed concentrate of electrolytes A, B, and C, and the container in the third replenishment branch may contain a mixed concentrate of electrolyte D. In the above examples, the mixing ratio of each component in the mixed concentrate in each container may be the same or different. It should be noted that the above examples are not exhaustive; any difference in one or more components in the concentrate contained in each container is within the scope of this application.

[0085] In one embodiment, the replenishment pump is located on a branch pipeline and is used to actively control the delivery of the target liquid in the container to the regenerated liquid pipeline. For example, in... Figure 2 In the example shown, the first replenishment pump 413 of the first replenishment branch 41 is disposed in the first branch pipeline 411 to deliver the target liquid in the first container 412 to the regenerated liquid pipeline L2-2. In some examples, the replenishment pump is configured as a peristaltic pump, gear pump, syringe pump, or diaphragm pump. For example, in the example where the replenishment pump is configured as a peristaltic pump, it can achieve high-precision quantitative delivery of the target liquid by squeezing the branch pipeline; in the example where the replenishment pump is configured as a syringe pump, it can achieve high-precision quantitative delivery of the target liquid by pushing the piston of the syringe with a stepper motor to accurately push the liquid in the syringe; in the example where the replenishment pump is configured as a diaphragm pump, it can drive the diaphragm to reciprocate through electromagnetic or motor drive, and form a pumping effect in conjunction with inlet and outlet check valves.

[0086] In this embodiment, the rehydration pump can be electrically connected to the first control device 5 described in subsequent embodiments, so as to precisely control the amount of target fluid delivered by the rehydration pump through the first control device 5. Specifically, monitoring devices such as liquid level sensors, flow sensors, or target fluid concentration sensors can be installed in the branch pipeline or the container. The first control device 5 automatically adjusts the start / stop and flow rate of the rehydration pump by receiving feedback signals from the monitoring devices, thereby ensuring that the target fluid injected into the regenerated fluid pipeline meets the patient's treatment needs.

[0087] In some examples, the replenishment pump may also be equipped with an anti-dry running detection and alarm device to issue an alarm when the target liquid in the container is insufficient or when the branch pipeline is abnormal, thereby preventing air from entering the regenerated liquid pipeline and affecting dialysis safety.

[0088] In one embodiment, each of the at least two replenishment branches is equipped with a replenishment pump for driving the target liquid. In other words, each replenishment branch is equipped with a replenishment pump to drive the target liquid in its respective container to be transported into the regenerated liquid pipeline, thus forming a dedicated pump-based operating mode. For example, in... Figure 1b In the example shown, the replenishment unit 4 is configured to include two replenishment branches. The first replenishment branch 41 has a first replenishment pump 413, which is used only to drive the target liquid in the first container 411 to be transported to the regenerated liquid pipeline L2-2. The second replenishment branch 42 has a second replenishment pump, which is used only to drive the target liquid in the second container to be transported to the regenerated liquid pipeline L2-2.

[0089] Please see Figure 3 The diagram shows a configuration of N fluid replenishment branches in one embodiment of this application. Wherein, N is greater than 2. Figure 3 In the example shown, the replenishment unit 4 is configured to include N replenishment branches. Specifically, the first replenishment branch, the second replenishment branch, the third replenishment branch, ..., the Nth replenishment branch each have their own replenishment pump to drive the target liquid in their respective containers to be delivered to the regenerated liquid pipeline L2-2 in the direction of the arrow in the figure.

[0090] In the above embodiments, since each replenishment pump is arranged independently, its flow rate, start / stop time, and injection volume can be set separately according to the prescription requirements, without interference, ensuring precise and controllable composition of the final regenerated solution. Furthermore, this dedicated pump working mode ensures that each replenishment pump is only responsible for delivering a specific target solution from one container, physically preventing the possibility of mixing of target solutions from different containers within the pump.

[0091] In another embodiment, the at least two replenishment branches are connected to the regenerated liquid pipeline via a binary or multi-element pump. The binary or multi-element pump is used to mix the target liquids on each of the replenishment branches and then deliver them to the regenerated liquid pipeline. In other words, each replenishment branch extracts the target liquid from its respective container through its branch pipeline, mixes these target liquids using the binary or multi-element pump, and then delivers them to the regenerated liquid pipeline.

[0092] In an embodiment where the replenishment unit 4 is configured to include two replenishment branches, the two branches are connected via the binary pump. The binary pump refers to a pump system with two independent pump channels whose target liquid flow rates can be controlled separately, allowing the target liquids in each container to ultimately converge at a common outlet. Please refer to [link to relevant documentation]. Figure 4 The diagram shows a schematic of two replenishment branches connected by a binary pump in one embodiment of this application. For example, in... Figure 4 In the example shown, the target liquid contained in the container of the first replenishment branch is glucose concentrate, and the target liquid contained in the second replenishment branch is electrolyte concentrate. Specifically, under the control of the first control device 5, the binary pump can extract a specific flow rate of glucose concentrate from one pump channel and a specific flow rate of electrolyte concentrate from the other pump channel according to the concentration ratio of glucose and electrolyte in the prescription. The glucose concentrate and electrolyte concentrate are then mixed according to the concentration ratio in the prescription and transported to the regenerated liquid pipeline L2-2 from the common outlet.

[0093] In an embodiment where the replenishment unit 4 is configured to include more than two replenishment branches, these branches are connected via the multi-element pump. The multi-element pump refers to a pump system with more than two independent pump channels, each capable of controlling the flow rate of the target liquid, so that the target liquid in each container can ultimately converge at a common outlet. For example, in an example where the replenishment unit 4 is configured to include N replenishment branches (N>2), the multi-element pump is configured as an N-element pump, containing N independent pump channels. Please refer to [link / reference]. Figure 5 The diagram shows N replenishment branches connected by an N-element pump in one embodiment of this application. For example, in... Figure 5In the example shown, the target solution in the container of the first replenishment branch is glucose concentrate, the target solution in the second replenishment branch is electrolyte A concentrate, the target solution in the third replenishment branch is electrolyte B concentrate, ..., the target solution in the Nth replenishment branch is a concentrate of different types of specific electrolytes. Specifically, under the control of the first control device 5, the N-element pump can, according to the concentration ratio of glucose and various electrolytes in the prescription, draw a specific flow rate of glucose concentrate from the container of the first replenishment branch to the first pump channel, a specific flow rate of electrolyte A concentrate from the container of the second replenishment branch to the second pump channel, a specific flow rate of electrolyte B concentrate from the container of the third replenishment branch to the third pump channel, ..., and a specific flow rate of another electrolyte concentrate from the container of the Nth replenishment branch to the Nth pump channel. The glucose concentrate, electrolyte A concentrate, electrolyte B concentrate, ..., and the other electrolyte concentrate are mixed according to the concentration ratio in the prescription and then transported from the common outlet to the regenerated liquid pipeline L2-2.

[0094] It should be understood that in the binary pump or the multi-element pump, the flow rate of the target liquid in each pump channel can be the same or different, and is independently controlled according to the component ratio in the formulation. In this embodiment, the ratio of each concentrate in the mixture can be changed by changing the flow rate of the target liquid in each pump channel to adapt to different formulation requirements.

[0095] In one embodiment, such as Figure 1b As shown, the peritoneal dialysis fluid regeneration system also includes a control device 5, which is used to control each of the replenishment branches to replenish at least one target fluid to the regeneration fluid pipeline L2-2. It should be noted that, to distinguish it from the control device included in the peritoneal dialysis equipment in subsequent embodiments, the control device 5 is referred to as the first control device 5, and the control device included in the peritoneal dialysis equipment is referred to as the second control device. Further details regarding the first control device 5 and the second control device will not be repeated hereafter.

[0096] also, Figure 1b The placement of the first control device 5 in the fluid replenishment unit 4 is merely illustrative. In specific application scenarios, the first control device 5 may be placed, for example, in the peritoneal dialysis fluid regeneration system, or in a computer device connected to the peritoneal dialysis fluid regeneration system.

[0097] exist Figure 1b or Figure 3 In the illustrated embodiment, each replenishment branch is equipped with a replenishment pump that drives the target liquid. In this case, the first control device 5 can control the type and quantity of the target liquid entering the regenerated liquid pipeline L2-2 by controlling the start and stop of each replenishment pump. For example, in... Figure 1b In the example shown, the first control device 5 can control the first replenishment pump 413 to turn on while simultaneously controlling the second replenishment pump to turn off, or control the first replenishment pump 413 to turn off while simultaneously controlling the second replenishment pump to turn on, so as to selectively deliver the target liquid from a certain container into the regenerated liquid pipeline L2-2. Alternatively, the first control device 5 can control the flow rate of the target liquid in the first branch pipeline 411 and the second branch pipeline respectively while controlling the first replenishment pump 413 and the second replenishment pump to turn on, thereby controlling the proportion of each target liquid delivered from each container to the regenerated liquid pipeline.

[0098] exist Figure 4 or Figure 5 In the illustrated embodiment, each replenishment branch is connected to the regenerated liquid pipeline via a binary or multi-element pump. The first control device 5 can control the type and quantity of the target liquid entering the regenerated liquid pipeline L2-2 by controlling the opening, closing, or flow rate of each pump channel in the binary or multi-element pump. For example, in Figure 1b In the example shown, the first control device 5 can control one pump channel to open and the other pump channel to close, so as to selectively deliver the target liquid from a container into the regenerated liquid pipeline L2-2. Alternatively, the first control device 5 can control the flow rate of the target liquid in the two pump channels while controlling the opening of the two pump channels, thereby controlling the proportion of each target liquid delivered from each container to the regenerated liquid pipeline.

[0099] In one embodiment, the first control device 5 controls each fluid replenishment branch to replenish the target fluid into the regenerated fluid line L2-2 according to a preset retention time. The retention time refers to the time the dialysate remains in the patient's peritoneal cavity. It should be understood that different retention times result in different degrees of substance exchange between the dialysate and peritoneal fluid, leading to different concentrations of glucose and electrolytes in the resulting dialysis waste fluid. This necessitates differentiated glucose and electrolyte replenishment in each fluid replenishment branch. For example, regarding glucose, a longer retention time results in lower glucose content in the dialysis waste fluid, requiring more glucose to be subsequently added to the regenerated fluid line.

[0100] In one embodiment, the first control device 5 includes a storage module, a processing module, and an execution module. In one example, the storage module can pre-store parameters or curves such as glucose consumption and electrolyte change trends corresponding to different retention times. The processing module can receive a preset retention time input by the user at the start of dialysis and retrieve the corresponding glucose consumption, electrolyte change, and other parameters from the storage module based on the retention time. The execution module generates a control command based on the retrieved parameters to adjust the start / stop timing, flow rate, and duration of each infusion pump, binary pump, or multi-pump in each infusion branch, thereby generating regenerated fluid that meets the prescription requirements.

[0101] In one embodiment, the first control device 5 controls each of the fluid replenishment branches to replenish the target fluid into the regenerated fluid pipeline based on the read clinical prescription data. The clinical prescription data refers to parameters such as the required glucose concentration, electrolyte concentration, single dialysate volume, and retention time of the dialysate in the individualized treatment plan customized by the physician for the patient. In the foregoing and subsequent embodiments, this is also referred to as prescription information. It should be understood that the parameters in the clinical prescription data will differ for different patients due to variations in their physiological and pathological states, such as weight, residual renal function, electrolyte levels, and fluid retention. For the same patient, if the condition is stable, the patient can consistently use the same clinical prescription data for a certain period.

[0102] In one embodiment, the first control device 5 includes a storage module, a processing module, and an execution module. In one example, the storage module may pre-store specific clinical prescription data of patients using the peritoneal dialysis fluid regeneration system or peritoneal dialysis equipment, and / or historical clinical prescription data used by the patient. The processing module may parse the clinical prescription data to obtain the type, concentration, and volume of target fluid required for each infusion branch. Specifically, the processing module may prioritize parsing the most recent clinical prescription data. For example, if the storage module stores the doctor's latest clinical prescription data, the processing module will prioritize calling and parsing that data; if the clinical prescription data in the storage module has not been updated, the processing module may prioritize calling and parsing the previously used clinical prescription data. The execution module may generate a control command based on the parsing result of the processing module. The control command may send start / stop signals and / or flow regulation signals to the infusion pump, binary pump, or multi-stage pump, thereby enabling at least one infusion branch to quantitatively replenish the target fluid into the regeneration fluid pipeline.

[0103] In one embodiment, the first control device 5 controls each of the fluid replenishment branches to replenish the target fluid into the regenerated fluid pipeline according to a preset time period. It should be understood that during the dialysis cycle, in which dialysis waste is continuously aspirated from the patient's peritoneum and regenerated fluid is continuously infused into the patient's peritoneum to achieve dialysis, the amount of glucose and electrolytes required needs to be adjusted in real time. Taking glucose as an example, in the early stages of dialysis, a larger amount of glucose solution needs to be replenished into the regenerated fluid pipeline, while in the middle and later stages of dialysis, the amount of glucose required gradually decreases. Furthermore, throughout the entire treatment cycle, for example, if a patient needs to undergo dialysis three times a day (morning, noon, and evening) according to a doctor's prescription, the amount of glucose and electrolytes required during dialysis will vary due to differences in the patient's diet, activity level, and metabolic state at different times.

[0104] In one embodiment, the first control device 5 includes a storage module, a processing module, and an execution module. In one example, the storage module can pre-store parameters or curves such as glucose consumption and electrolyte change trends at different stages of the entire dialysis cycle, as well as parameters such as the concentrations of glucose and electrolytes required in the patient's dialysate at different times throughout the treatment cycle. The processing module can retrieve and analyze the required component parameters of the dialysate for a specific time period based on the actual dialysis time, and call up corresponding parameters such as glucose consumption and electrolyte changes according to a specific period, while simultaneously calculating the target fluid parameters that the patient needs to replenish at any given time. The execution module generates a control command based on the target fluid parameters calculated by the processing module. This control command is used to send start / stop signals and / or flow adjustment signals to the replenishment pump, binary pump, or multi-stage pump in real time, thereby replenishing the target fluid according to the real-time dialysis status.

[0105] In one embodiment, the first control device 5 controls each of the replenishment branches to replenish the target liquid into the regenerated liquid pipeline in real time based on the detected content of the target liquid to be replenished in the waste liquid pipeline. In some examples, the first control device 5 may first obtain the content of the target liquid to be replenished based on the content of components such as glucose and electrolytes in the dialysis waste liquid in the waste liquid pipeline. Specifically, the content of the target liquid to be replenished may be the content of components such as glucose and electrolytes required for dialysis by the patient in the prescription information minus the content of the corresponding components in the dialysis waste liquid, or it may be the content of components such as glucose and electrolytes required for dialysis by the patient in the prescription information minus the content of the corresponding components in the dialysis waste liquid plus the content of the corresponding components adsorbed in the adsorption unit 12.

[0106] In one embodiment, the first control device 5 includes a storage module, a processing module, and an execution module. In one example, the storage module can pre-store concentration parameters of components such as glucose and electrolytes in the dialysis waste liquid in the waste liquid pipeline. The processing module can calculate the content of the target liquid to be replenished based on the concentration parameters stored in the storage module. The execution module can generate a control command based on the concentration parameters calculated by the processing module. The control command is used to send start / stop signals and / or flow regulation signals to the replenishment pump, binary pump, or multi-element pump in real time to control at least one of the replenishment branches to replenish the target liquid into the regenerated liquid pipeline.

[0107] In one embodiment, the first control device 5 controls each of the replenishment branches to replenish the target fluid into the regenerated fluid pipeline in real time based on the detected content of the target fluid to be replenished in the regenerated fluid pipeline. In some examples, the first control device 5 may first obtain the content of the target fluid to be replenished based on the content of components such as glucose and electrolytes in the regenerated fluid pipeline after treatment by reactor 11, or after treatment by reactor 11 and adsorption unit 12. Specifically, the content of the target fluid to be replenished can be the content of components such as glucose and electrolytes required for dialysis by the patient in the prescription information minus the content of the corresponding components in the treatment fluid.

[0108] In one embodiment, the first control device 5 includes a storage module, a processing module, and an execution module. In one example, the storage module can pre-store concentration parameters of components such as glucose and electrolytes in the processed liquid within the regenerated liquid pipeline. The processing module can calculate the content of the target liquid to be replenished based on the concentration parameters stored in the storage module. The execution module can generate a control command based on the concentration parameters calculated by the processing module. The control command is used to send start / stop signals and / or flow regulation signals to the replenishment pump, binary pump, or multi-element pump in real time to control at least one of the replenishment branches to replenish the target liquid into the regenerated liquid pipeline.

[0109] In one embodiment, the first control device 5 controls one replenishment branch to replenish a target fluid into the regenerated fluid pipeline in a narrow-window fluctuation mode according to a preset active mode, and controls another replenishment branch to replenish another target fluid into the regenerated fluid pipeline in a time-series curve dynamic mode. The preset active mode refers to the control method by which the first control device 5 replenishes the target fluid based on information pre-stored in its storage module. This mode can be set to any one or more of the aforementioned control methods, such as the retention time, clinical prescription data, a certain period in the treatment cycle, the content of the target fluid to be replenished in the waste fluid pipeline, and the content of the target fluid to be replenished in the regenerated fluid pipeline.

[0110] The narrow-window fluctuation mode refers to the first control device 5 using a preset content of one or more components as the target value, allowing the target liquid in the corresponding replenishment branch to fluctuate within a very small concentration or flow range, thereby maintaining the dynamic stability of the component content in the regenerated liquid. For example, such as Figure 1b As shown, in the example where the first rehydration branch 41 is used to replenish electrolyte solutions and the second rehydration branch 42 is used to replenish glucose solutions, the patient uses... Figure 1bThroughout the peritoneal dialysis process, the first control device 5 controls the first replenishment branch 41 to quantitatively replenish electrolytes such as potassium, calcium, and magnesium ions, ensuring that the electrolyte content in the regenerated solution remains essentially constant. Specifically, a concentration sensor for detecting electrolyte content can be installed on the regenerated solution pipeline downstream of the replenishment unit 4. This sensor monitors the electrolyte content in the regenerated solution in real time. When the electrolyte content exceeds or falls below a preset target value, the first control device 5 will correspondingly reduce or increase the electrolyte replenishment amount in the first replenishment branch 41 until the electrolyte content in the regenerated solution is equal to the target value again.

[0111] The dynamic time-series curve mode refers to the first control device 5 dynamically adjusting the content of a target fluid added to the regenerated fluid pipeline according to a preset time-series curve, so that the corresponding components can show regular changes with the duration of dialysis, treatment cycle, or different times of the day. For example, in the initial stage of the dialysis cycle, a higher concentration of glucose solution is needed to enhance the ultrafiltration effect. In the middle stage, the amount of glucose added is gradually reduced to maintain a stable osmotic pressure environment. In the later stage of dialysis, the addition is further reduced or stopped to avoid excessive absorption. This process of glucose content changing over time is the time-series curve, and the adjustment method of the first control device 5 adjusting the amount of glucose added to the regenerated fluid pipeline according to the time-series curve is the dynamic time-series curve mode. This method can realize the dynamic adjustment of glucose concentration throughout the dialysis cycle, improving the physiological matching and treatment safety of the regenerated dialysate.

[0112] For example, such as Figure 1b As shown, in the example where the first replenishment branch 41 is used to replenish electrolyte solution and the second replenishment branch 42 is used to replenish glucose solution, the first control device 5 can control the second replenishment branch 42 to adjust the amount of glucose concentrate replenished into the regenerated solution pipeline according to the time series curve. Specifically, a concentration sensor for detecting glucose content can be installed on the regenerated solution pipeline located downstream of the replenishment unit 4. This concentration sensor can monitor the glucose content in the regenerated solution in real time. The first control device 5 will determine whether the glucose content matches the current dialysis stage and adjust the flow rate of the replenishment pump in the second replenishment branch 42 in real time so that the glucose content in the regenerated solution always matches the time series curve.

[0113] In one embodiment, the first control device 5 is used to dynamically adjust the delivery rate of the penetrant concentrate while maintaining a constant replenishment rate of the electrolyte concentrate. In this embodiment, the first control device 5 can control at least one replenishment branch for replenishing the electrolyte concentrate to replenish the regenerated liquid pipeline in the narrow-window fluctuation mode, and simultaneously control at least one replenishment branch for replenishing the penetrant concentrate to replenish the regenerated liquid pipeline in the time-series curve dynamic mode.

[0114] In some embodiments, each of the fluid replenishment branches, based on an active control mechanism, replenishes at least one target fluid to the regenerated fluid pipeline. Real-time information or feedback can also be provided by corresponding detection modules, and the equipment comprehensively processes and calculates this information in real time to provide refined adjustments. Therefore, in subsequent embodiments, a detection module is set in the peritoneal dialysis fluid regeneration system to provide real-time information or feedback. This detection module can be various detectors, sensors, electrodes, or combinations thereof, targeting glucose, conductivity, electrolytes, etc. The detection modules used according to the embodiments of this application can be configured upstream, downstream, or both upstream and downstream of the fluid replenishment unit. For example, the detection module can be installed only on the dialysis fluid regeneration device, only on the peritoneal dialysis machine connected to the dialysis fluid regeneration device, or both.

[0115] Please see Figure 6 and Figure 7 The figures below show schematic diagrams of the peritoneal dialysis fluid regeneration system in different embodiments of this application. A detection module 6 for detecting the concentration of the target fluid is installed on the regeneration fluid pipeline L2-2. Specifically, the detection module 6 can monitor the concentration parameter of the target fluid in the regeneration fluid pipeline L2-2 in real time and feed the concentration parameter back to the first control device 5. The storage module of the first control device 5 stores the parameter, which is then retrieved by the processing module. The processing module compares the concentration parameter with a preset target concentration value added to the regeneration fluid pipeline and generates a control command based on the comparison result. The execution module can dynamically adjust the replenishment of the target fluid in each replenishment branch in real time according to the control command.

[0116] In one embodiment, the detection module 6 includes a conductivity detection electrode, an ion-selective electrode, and / or an optical electrode. Specifically, the conductivity detection electrode can detect the total amount of dissolved ions in the regenerated liquid by applying an alternating electric field in the regenerated liquid pipeline and measuring the conductivity of the liquid, thereby reflecting changes in electrolyte concentration. The ion-selective electrode selectively detects the concentration of one or more specific ions in the liquid by covering the electrode surface with a specific ion-selective film and measuring the potential difference across the film. The optical electrode uses a built-in light source and a photosensitive detection element to reflect the glucose concentration in the liquid by utilizing the characteristic absorption peak of glucose in the near-infrared band.

[0117] It should be noted that the detection module 6 can be configured with a single electrode or a combination of multiple electrodes. For example, in an example where the detection module 6 is configured with multiple electrodes, it can be a combination of a conductivity detection electrode and an ion-selective electrode. When the conductivity detection electrode detects a decrease in the overall conductivity of the liquid, it indicates that the total electrolyte content is insufficient. At this time, the first control device 5 can further read the detection structure of the ion-selective electrode to determine which specific electrolytes are deficient, thereby avoiding excessive replenishment of certain electrolyte components during replenishment. In some examples, the detection module 6 can be configured as a combination of an optical electrode and a conductivity detection electrode to simultaneously detect the glucose and electrolyte content of the liquid in the regenerated liquid pipeline. In some examples, the detection module 6 can be configured as a combination of a conductivity detection electrode, an ion-selective electrode, and an optical electrode, so that the first control device 5 can accurately control the replenishment of electrolytes and glucose in each replenishment branch.

[0118] In one embodiment, such as Figure 6 As shown, the detection module 6 is positioned upstream of the replenishment unit 4. Figure 6 In the example shown, the detection module 6 is used to detect the concentration of glucose and / or electrolytes in the treated solution after treatment by the adsorption unit 12. That is, the detection module 6 completes the detection of the treated solution before the replenishment unit 4 replenishes the solution, thereby providing accurate data on the compositional state before replenishment. In this way, the first control device 5 can calculate the required type and dosage of replenishment solution in advance based on the detection results, realize feedforward control, avoid insufficient or excessive replenishment, and improve the accuracy and efficiency of replenishment operation.

[0119] In another embodiment, such as Figure 7 As shown, the detection module 6 is positioned downstream of the replenishment unit 4. Figure 7 In the example shown, the detection module 6 is used to detect the concentration of glucose and / or electrolytes in the regenerated fluid formed after replenishment by the fluid replenishment unit 4. That is, the detection module 6 completes the detection of the regenerated fluid after the fluid replenishment unit 4 has performed the replenishment, which can directly reflect whether the final regenerated fluid meets the clinical prescription requirements. In this way, the fluid replenishment effect can be verified, and if deviations occur, they can be corrected by replenishing fluid again, thereby ensuring that the dialysate entering the patient's peritoneal cavity is safe and reliable.

[0120] In some other embodiments, the detection module 6 can be simultaneously configured upstream and downstream of the fluid replenishment unit 4, so that the first control device 5 can simultaneously perform feedforward control and feedback control of the fluid replenishment. Specifically, the upstream detection module 6 is used to detect the fluid replenishment requirement in advance, and the downstream detection module 6 is used to verify and correct the fluid replenishment effect. This dual detection mode can reduce fluid replenishment errors and ensure that the final dialysate composition is highly consistent with the prescription.

[0121] Please see Figure 8 This is a schematic diagram illustrating the principle of a peritoneal dialysis fluid regeneration system in another embodiment of this application. Figure 8 As shown, the output end a2 of the regenerated fluid pipeline L2-2 is connected to a peritoneal dialysis module 7 for connecting to the patient's peritoneal cavity. In this embodiment, the peritoneal dialysis module 7 is used to introduce the regenerated fluid, after regeneration and fluid replenishment, into the patient's peritoneal cavity, and to achieve material exchange between the peritoneal fluid and the dialysis fluid during the retention of the peritoneum. In other words, the peritoneal dialysis module 7 can serve as an interface unit connecting the peritoneal dialysis fluid regeneration system and the patient's peritoneal cavity, allowing the regenerated fluid to be safely and quantitatively delivered to the peritoneal cavity. In some other embodiments, the peritoneal dialysis module 7 can also be connected to the input end a1 of the waste fluid passage L2-1 to drain the dialysis waste fluid formed after the regenerated fluid has performed its dialysis function from the peritoneal cavity. In some examples, the peritoneal dialysis module 7 can be configured to include a peritoneal dialysis catheter; the specific structure of the peritoneal dialysis catheter can be referred to the description in the subsequent embodiments, and will not be repeated here.

[0122] Please see Figure 9 This is a schematic diagram illustrating the principle of the peritoneal dialysis fluid regeneration system in another embodiment of this application. Figure 9 As shown, the peritoneal dialysis module 7 is equipped with a detection module 6 for detecting the concentration of the target fluid. In some examples, the detection module 6 is located downstream of the output end a2 of the regenerated fluid line L2-2, and is used to detect the concentration parameters of the target fluid in real time before the regenerated fluid is injected into the patient's peritoneal cavity to ensure that the infused regenerated fluid meets the clinical prescription requirements. If the concentration is found to deviate from the set value, the first control device 5 can adjust the fluid replenishment branch or suspend the infusion, thereby preventing unqualified dialysate from entering the patient's peritoneal cavity and improving treatment safety. In some examples, the detection module 6 is located upstream of the input end a1 of the waste fluid passage L2-1, and is used to detect the content of components such as glucose and electrolytes in the dialysis waste fluid discharged from the patient's peritoneal cavity in real time. This allows the first control device 5 to assess dialysis efficiency and the transport of substances in the body, and adjust subsequent fluid replenishment strategies or treatment parameters based on the detection results, thereby facilitating the optimization of the treatment plan.

[0123] This application also provides a peritoneal dialysis device for dialysis treatment; please refer to [link to relevant documentation]. Figure 10 The figure shows a schematic diagram of a peritoneal dialysis device in one embodiment of this application. As shown, the peritoneal dialysis device includes a peritoneal dialysis fluid regeneration system, a peritoneal dialysis tubing L1, a drive device 8, and a second control device 9. One end of the peritoneal dialysis tubing L1 is connected to the peritoneal cavity 10 of the human body, and the other end is connected to the peritoneal dialysis fluid regeneration system. The drive device 8 is disposed on the peritoneal dialysis tubing L1 and is used to drive the fluid to flow periodically or continuously in the peritoneal dialysis tubing L1. The second control device 9 is used to execute the treatment mode to periodically or continuously exchange the fluid in the peritoneum of the human body.

[0124] The connection method and working principle of the peritoneal dialysis fluid regeneration system are as described above. Figures 1b to 9 The methods described in the various embodiments and their related descriptions will not be repeated here. However, it should be noted that in this embodiment, please refer to... Figure 1b and Figure 10 The dialysate pump 20 in the peritoneal dialysis fluid regeneration system can be replaced by the drive device 8, and the first control device 5 can be replaced by the second control device 9. The drive device 8 drives the circulation of the dialysis waste fluid and the regenerated fluid, and the second control device 9 controls the replenishment unit 4.

[0125] In some embodiments, the peritoneal dialysis tubing includes two single-channel peritoneal dialysis catheters or one dual-channel peritoneal dialysis catheter. In one example, the peritoneal dialysis catheter is configured as a single-channel catheter, and the peritoneal dialysis tubing includes two single-channel peritoneal dialysis catheters, one for discharging dialysis waste fluid and the other for receiving regenerated fluid. In other words, the channel of one peritoneal dialysis catheter is connected to the input end of the waste fluid line, and the channel of the other peritoneal dialysis catheter is connected to the output end of the regenerated fluid line. In another example, the peritoneal dialysis catheter is configured as a dual-channel catheter, specifically, one peritoneal dialysis catheter includes two channels. One channel is used for discharging dialysis waste fluid, and the other channel is used for receiving regenerated fluid; in other words, one channel is connected to the input end of the waste fluid line, and the other channel is connected to the output end of the regenerated fluid line. For ease of explanation, the channel for discharging dialysis waste fluid is referred to as the first channel, and the channel for receiving regenerated fluid is referred to as the second channel. In the following embodiments, the peritoneal dialysis catheter is configured as a dual-channel catheter as an example.

[0126] Please see Figures 11 to 13 The figures shown are schematic diagrams of dual-channel peritoneal dialysis catheters in different embodiments of this application, as follows: Figures 11 to 13 As shown, the first channel L1-1 and the second channel L1-2 of the peritoneal dialysis catheter can be configured as follows: Figure 11 As shown, the peritoneal dialysis catheters are configured in a parallel manner, with one end connected to the peritoneal dialysis fluid regeneration system as follows: Figure 12 The acute-angle configuration shown can also be as follows: Figure 13 The configuration shown is 180 degrees.

[0127] In one embodiment, after a dual-channel peritoneal dialysis catheter is inserted into the peritoneal cavity, the regeneration fluid can enter from the second channel and the dialysis waste fluid can flow out from the first channel. In this way, the flow rate of fluid flowing into the peritoneal cavity and the flow rate of fluid flowing out of the peritoneal cavity can be kept the same, thereby enabling the peritoneal dialysis device to achieve CFPD (continuous flow peritoneal dialysis) mode.

[0128] After the regenerated fluid is introduced into the peritoneal cavity 10 of the patient, the drive device 8, located on the peritoneal dialysis tubing L1, can drive the fluid to flow periodically or continuously within the peritoneal dialysis tubing L1. In one example, the drive device 8 continuously drives the dialysis waste fluid from the outlet of the peritoneal dialysis tubing L1 into the waste fluid passage L2-1 of the peritoneal dialysis fluid regeneration system. After treatment and replenishment by the peritoneal dialysis fluid regeneration system, the dialysis waste fluid forms regenerated fluid, which flows from the regenerated fluid line L2-2 of the peritoneal dialysis fluid regeneration system into the inlet of the peritoneal dialysis tubing L1. Thus, the fluid flows continuously within the peritoneal dialysis tubing L1. In another example, the drive device 8 periodically drives the dialysis waste fluid from the outlet of the peritoneal dialysis tubing L1 into the waste fluid passage L2-1 of the peritoneal dialysis fluid regeneration system to achieve periodic fluid flow within the peritoneal dialysis tubing L1.

[0129] The driving device 8 includes one or more pumps mounted on the peritoneal dialysis tubing L1. The pumps provide power to the fluid in the tubing, causing the fluid to circulate in a predetermined flow direction. In embodiments, the pump can be a peristaltic pump, a pneumatic diaphragm pump, or a pressure pump. In medical applications, the driving device 8 should not directly contact the fluid, but only apply pressure to the tubing and drive the fluid flow. A preferred embodiment of the driving device 8 is a non-contact pump such as a peristaltic pump or a pneumatic diaphragm pump. The forward and reverse rotation (reverse rotation) of the peristaltic pump will cause the fluid in the peritoneal diaphragm tubing L1 to flow in different directions.

[0130] The second control device 9 is used to execute the treatment mode to periodically or continuously exchange the fluid within the peritoneum of the human body. In an embodiment, the second control device 9 is, for example, a controller or system processor of the peritoneal dialysis device, which outputs corresponding control commands by writing a program into the system processor; or it accepts trigger commands input by the operator through an input device such as a touch screen to execute related control commands. In the treatment mode, the peritoneal dialysis device can achieve periodic or continuous exchange of the fluid within the human peritoneum. Specifically, the peritoneal dialysis device controls the periodic or continuous flow of fluid to continuously draw dialysis waste fluid from the peritoneal cavity and continuously introduce regenerated fluid into the peritoneal cavity to achieve dialysis.

[0131] In some embodiments, the peritoneal dialysis device is configured as a combination of one or more treatment modes selected from CAPD, APD, TPD, and CFPD. In one example, the peritoneal dialysis device may be configured as only CAPD, APD, TPD, or CFPD. In another example, the peritoneal dialysis device is configured as a combination of multiple treatment modes selected from CAPD, APD, TPD, and CFPD. For example, the peritoneal dialysis device includes a mode selection device for receiving an input mode selection signal and sending determined operating mode information to a second control device to execute operations corresponding to the operating mode, thereby enabling the peritoneal dialysis device to achieve combinations of multiple treatment modes.

[0132] In one specific embodiment, the peritoneal dialysis device is configured in CFPD mode, and the peritoneal dialysis catheter is configured as a dual-channel device. When the amount of dialysis fluid in the peritoneal cavity reaches the required amount, one channel of the peritoneal dialysis catheter continuously outputs dialysis waste fluid, and the other channel continuously inputs regenerated fluid. This can maintain the same flow rate of fluid flowing into and out of the peritoneal cavity, thereby enabling the peritoneal dialysis device to achieve CFPD (continuous flow peritoneal dialysis) mode.

[0133] It should be noted that although the CAPD treatment mode, APD treatment mode, TPD treatment mode and CFPD treatment mode are used as examples in the embodiments of this application, they are not limited thereto. In other embodiments, the peritoneal dialysis device can also be configured as other periodic or continuous treatment modes.

[0134] In summary, the peritoneal dialysis fluid regeneration system and peritoneal dialysis device disclosed in this application achieve toxin treatment of dialysis waste fluid by incorporating a processing module within the peritoneal dialysis fluid regeneration system. By setting up a replenishment unit connected to the regeneration fluid pipeline, components are replenished to the regeneration fluid pipeline, resulting in a regeneration fluid that can be exchanged with peritoneal fluid again. By configuring the replenishment unit to include at least two replenishment branches, and configuring each replenishment branch to replenish the target fluid independently based on active control, different components can be physically separated and independently transported. This breaks the fixed mixing ratio of components in traditional replenishment methods, enabling personalized replenishment and refined control of relevant components in the regeneration fluid to meet the needs of different prescriptions, different dialysis scenarios, and different individuals.

[0135] The above embodiments are merely illustrative of the inventive essence and beneficial effects of this application, and are not intended to limit this application. Any person skilled in the art can modify or alter the above embodiments without departing from the principles and scope of this application. Therefore, all equivalent modifications or alterations achieved by those skilled in the art without departing from the spirit and technical concept disclosed in this application should still be covered by the claims of this application.

Claims

1. A peritoneal dialysis fluid regeneration system, characterized in that, include: The waste liquid passage receives dialysis waste liquid at its input end; The processing module, whose inlet is connected to the waste liquid passage, is used to process the toxins in the dialysis waste liquid and then output it. A regenerated liquid pipeline is connected to the outlet of the processing module to receive the processed reaction liquid; The fluid replenishment unit includes at least two fluid replenishment branches respectively connected to the regenerated fluid pipeline. Each fluid replenishment branch replenishes at least one target fluid to the regenerated fluid pipeline based on active control to obtain a regenerated fluid that can be exchanged with peritoneal fluid again. The regenerated fluid is a dialysis waste fluid regenerated fluid formed after some or most of the toxins or toxic molecules have been removed from the dialysis waste fluid after the exchange of dialysis fluid and peritoneal fluid.

2. The peritoneal dialysis fluid regeneration system according to claim 1, characterized in that, It also includes a control device for controlling each of the replenishment branches to replenish at least one target liquid into the regenerated liquid pipeline.

3. The peritoneal dialysis fluid regeneration system according to claim 1, characterized in that, Each of the replenishment branches in the replenishment unit includes a branch pipeline connected to the regenerated liquid pipeline, a container connected to the branch pipeline for holding the target liquid, and a replenishment pump for transporting the target liquid in the container to the regenerated liquid pipeline.

4. The peritoneal dialysis fluid regeneration system according to claim 1, characterized in that, In the replenishment unit, at least two replenishment branches connected to the regenerated liquid pipeline are configured in parallel.

5. The peritoneal dialysis fluid regeneration system according to claim 3, characterized in that, Each of the containers in the at least two fluid replenishment branches is in the form of a disposable bottle or bag.

6. The peritoneal dialysis fluid regeneration system according to claim 5, characterized in that, The container has a barcode identification label.

7. The peritoneal dialysis fluid regeneration system according to claim 4, characterized in that, Each of the at least two replenishment branches is equipped with a replenishment pump that drives the target liquid.

8. The peritoneal dialysis fluid regeneration system according to claim 7, characterized in that, The replenishment pump is configured as a peristaltic pump, gear pump, syringe pump, or diaphragm pump.

9. The peritoneal dialysis fluid regeneration system according to claim 4, characterized in that, The at least two replenishment branches are connected to the regenerated liquid pipeline via a binary pump or a multi-element pump. The binary pump or multi-element pump is used to mix the target liquids on each replenishment branch and then deliver them to the regenerated liquid pipeline.

10. The peritoneal dialysis fluid regeneration system according to claim 4, characterized in that, The at least two fluid resuscitation branches include an electrolyte branch and a glucose branch.

11. The peritoneal dialysis fluid regeneration system according to claim 10, characterized in that, The electrolyte branch is connected upstream of the regenerated liquid pipeline, and the glucose branch is connected downstream of the regenerated liquid pipeline.

12. The peritoneal dialysis fluid regeneration system according to claim 1, characterized in that, The regenerated liquid pipeline is equipped with a detection module for detecting the concentration of the target liquid.

13. The peritoneal dialysis fluid regeneration system according to claim 12, characterized in that, The detection module is configured upstream or downstream of the replenishment unit.

14. The peritoneal dialysis fluid regeneration system according to claim 12, characterized in that, The detection module includes a conductivity detection electrode, an ion-selective electrode, and / or an optical electrode.

15. The peritoneal dialysis fluid regeneration system according to claim 1, characterized in that, The output end of the regenerated fluid pipeline is connected to a peritoneal dialysis module for connecting to the human abdominal cavity.

16. The peritoneal dialysis fluid regeneration system according to claim 15, characterized in that, The peritoneal dialysis module is equipped with a detection module for detecting the concentration of the target solution.

17. The peritoneal dialysis fluid regeneration system according to claim 1, characterized in that, The processing module includes: The reactor, whose inlet is connected to the waste liquid passage, is used to decompose toxins in the dialysis waste liquid to output the reaction liquid; The adsorption unit, connected to the reactor via the regeneration liquid pipeline, is used to further treat the reaction liquid after the toxins have been decomposed by the reactor.

18. A peritoneal dialysis device, characterized in that, include: The peritoneal dialysis fluid regeneration system as described in any one of claims 1 to 17; The peritoneal dialysis tubing has one end connected to the human peritoneal cavity and the other end connected to the peritoneal dialysis fluid regeneration system. A driving device, disposed on the peritoneal dialysis tubing, is used to drive the fluid to flow periodically or continuously in the peritoneal dialysis tubing; A control device used to execute treatment modes to periodically or continuously exchange fluid within the human peritoneum.

19. The peritoneal dialysis device according to claim 18, characterized in that, The peritoneal dialysis tubing includes two single-channel peritoneal dialysis catheters or one dual-channel peritoneal dialysis catheter.

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