Peritoneal dialysis system

Abstract

The invention discloses a peritoneal dialysis system which comprises an abdominal cavity pipeline with the first end communicated with the abdominal cavity of a human body; the semi-permeable membrane assembly comprises a membrane, a first side and a second side, the first side and the second side are separated by the membrane, and the first side is communicated with the second end of the abdominal cavity pipeline so as to receive the abdominal cavity dialysate from the abdominal cavity pipeline and inject the abdominal cavity dialysate into the abdominal cavity of the human body; the external liquid path system comprises an external liquid pipeline communicated with the second side, and the external liquid pipeline comprises a waste liquid outlet for outputting dialysis waste liquid led out from the peritoneal dialysis liquid through the membrane; when the peritoneal dialysis solution is led out, the membrane allows moisture and small molecular solutes in the peritoneal dialysis solution to permeate into the second side and entraps a macromolecular penetrant on the first side so as to maintain the osmotic pressure of the peritoneal dialysis solution.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a peritoneal dialysis system. Background Technology

[0002] Peritoneal dialysis (PD) is a method of blood purification that uses the peritoneum as a semipermeable membrane. Its core process involves infusing prepared dialysate into the patient's peritoneal cavity through a catheter and leaving it there for a period of time. During this period, metabolic waste products in the blood of the connective tissue layer, such as urea, creatinine, and electrolytes, will enter the dialysate along the concentration gradient of solutes on both sides of the peritoneum (diffusion), while water will enter the hypertonic dialysate from the hypotonic blood side due to the osmotic pressure difference (osmosis).

[0003] In related technologies, glucose is usually added to the dialysate as an osmotic agent to drive water from the blood into the dialysate. However, during the treatment process, as metabolic waste and water continuously enter the dialysate, and glucose also enters the body in reverse, the concentration of glucose in the dialysate will continuously decrease, affecting the treatment effect.

[0004] Therefore, in clinical practice, macromolecular osmotic agents such as icodextrin are used to provide better osmotic pressure. Icodextrin is a high molecular weight glucose polymer that generates continuous ultrafiltration through colloidal osmotic pressure. It can maintain positive ultrafiltration for up to 16 hours. Furthermore, icodextrin does not easily cross the membrane and a small amount is slowly absorbed through the lymphatic system. Its main metabolite is maltose, which is eventually 80% hydrolyzed into glucose. A small amount can be removed through urine or dialysis.

[0005] However, macromolecular osmotic agents are expensive. For patients who need daily treatment, replacing the entire daily dose of glucose dialysis solution with icodextrin dialysis solution (approximately 8 to 12 liters) would be a significant financial burden. How to continuously remove metabolic waste and water while using a small amount of macromolecular osmotic agent is a technical problem that this application urgently needs to solve. Summary of the Invention

[0006] In view of the shortcomings of the above-mentioned related technologies, the purpose of this application is to provide a peritoneal dialysis system to overcome the problem of high cost of peritoneal dialysis in the prior art.

[0007] To achieve the above and other related objectives, a first aspect of this application provides a peritoneal dialysis system, comprising: a peritoneal tubing with a first end connected to a human peritoneal cavity; a semipermeable membrane assembly including a membrane and a first side and a second side separated by the membrane, the first side being connected to the second end of the peritoneal tubing to receive and inject peritoneal dialysis fluid into the human peritoneal cavity from the peritoneal tubing; and an external fluid system including an external fluid line connected to the second side, the external fluid line including a waste fluid outlet to output dialysis waste fluid drawn from the peritoneal dialysis fluid via the membrane; wherein, when the peritoneal dialysis fluid is drawn out, the membrane allows water and small molecule solutes in the peritoneal dialysis fluid to permeate into the second side while retaining large molecule permeabilizers on the first side to maintain the osmotic pressure of the peritoneal dialysis fluid.

[0008] In some examples of the first aspect, the external fluid line further includes an inlet for receiving replenishment fluid, and the flow direction and flow rate of the peritoneal line and / or the external fluid line are controlled by a flow control device so that the external fluid line cooperates with the membrane to periodically draw out dialysis waste fluid and add the replenishment fluid to the peritoneal dialysis fluid.

[0009] In some examples of the first aspect, the dialysis efficiency can also be adjusted by changing the volume of output dialysis waste and added replenishment fluid within a cycle using a flow control device. The change in volume can be controlled by changing the time and / or rate of output dialysis waste and added replenishment fluid.

[0010] In some examples of the first aspect, the peritoneal tubing includes a single-lumen peritoneal catheter, and the external fluid tubing includes a single-lumen external fluid catheter communicating with the second side and the waste fluid outlet and the fluid inlet, wherein, under the control of the flow control device, the single-lumen external fluid catheter alternately outputs the dialysis waste fluid and adds the replenishing fluid to the peritoneal dialysis fluid during a cycle.

[0011] In some examples of the first aspect, the abdominal conduit includes a single-lumen peritoneal catheter, and the external fluid conduit includes a first external fluid passage communicating with the second side and the waste fluid outlet, and a second external fluid passage communicating with the second side and the inlet.

[0012] In some examples of the first aspect, the flow control device is used to control the flow direction and flow rate on the first external liquid passage and the second external liquid passage respectively to form an external circulating liquid flow from the inlet through the second side to the waste liquid outlet and through the flow rate difference formed between the first external liquid passage and the second external liquid passage so that the external circulating liquid flow can output the dialysis waste liquid and add the replenishment liquid during the cycle.

[0013] In some examples of the first aspect, the external fluid conduit includes a single-lumen external fluid conduit connecting the second side and the waste fluid outlet and the inlet, and the abdominal conduit includes a first internal fluid passage and a second internal fluid passage connecting the human abdominal cavity and the first side.

[0014] In some examples of the first aspect, the flow control device is used to control the flow direction and flow rate of the first internal fluid passage and / or the second internal fluid passage to form an internal circulating fluid flow from the human peritoneum through a first side back to the human peritoneum, and to control the flow direction and flow rate in the single-lumen external fluid catheter by forming a flow difference in the first internal fluid passage and the second internal fluid passage, or by cooperating to control the flow direction and flow rate in the single-lumen external fluid catheter, so that the single-lumen external fluid catheter alternately outputs the dialysis waste fluid and adds the replenishing fluid to the peritoneal dialysis fluid during the cycle.

[0015] In some examples of the first aspect, the abdominal conduit includes a first internal fluid passage and a second internal fluid passage connecting the human abdominal cavity and the first side, and the external fluid conduit includes a first external fluid passage connecting the second side and the waste fluid outlet and a second external fluid passage connecting the second side and the inlet.

[0016] In some examples of the first aspect, the flow control device is used to control the peritoneal tubing to form an internal circulating fluid flow from the human peritoneum through the first side back to the human peritoneum and to control the external fluid tubing to form an external circulating fluid flow from the inlet through the second side to the waste fluid outlet, and to form a flow difference in the internal circulating fluid flow and / or the external circulating fluid flow so that the external circulating fluid flow can output the dialysis waste fluid and add the replenishment fluid during the cycle.

[0017] In some examples of the first aspect, a buffer container is also included that connects the abdominal cavity tubing to the first side and / or connects the second side to the external fluid tubing.

[0018] In some examples of the first aspect, the external fluid system further includes a waste liquid container connected to the waste liquid outlet to receive discharged dialysis waste liquid.

[0019] In some examples of the first aspect, the external fluid system further includes a dispensing device connected to the inlet to generate the replenishment fluid.

[0020] In some examples of the first aspect, the external fluid system further includes a replenishment bag containing the replenishment fluid connected to the inlet.

[0021] In some examples of the first aspect, the external fluid system further includes a regeneration device connected between the waste outlet and the inlet for treating the dialysis waste output from the waste outlet to form the replenishment fluid, which is then delivered to the inlet.

[0022] In some examples of the first aspect, the regeneration device includes an adsorption device for toxin treatment of the dialysis waste liquid.

[0023] In some examples of the first aspect, the adsorption device is configured as a single mixed column containing a variety of adsorbent materials, or as comprising a plurality of columns connected in series, wherein each column contains one or more adsorbent materials.

[0024] In some examples of the first aspect, the adsorption device comprises a single column of any one of activated carbon, anion exchanger, cation exchanger, and urease; or a mixed column formed by any combination of activated carbon, anion exchanger, cation exchanger, and urease.

[0025] In some examples of the first aspect, the regeneration device includes a reactor for breaking down toxins in the dialysis wastewater.

[0026] In some examples of the first aspect, the regeneration device includes a replenishment branch connected to the inlet for supplying replenishment fluid to the inlet.

[0027] In some examples of the first aspect, the replenishment branch is provided with a container for storing replenishment fluid and a replenishment fluid pump for conveying the replenishment fluid in the container to the replenishment fluid branch.

[0028] In some examples of the first aspect, the membrane is also used to retain macromolecular substances that are beneficial to the human body when dialysis waste is drawn out.

[0029] In some examples of the first aspect, the macromolecular penetrant is configured as icodextrin.

[0030] In some examples of the first aspect, the membrane is configured as a tubular membrane, a hollow fiber membrane, a flat sheet membrane, or a spiral wound membrane.

[0031] In summary, the peritoneal dialysis system provided in this application retains macromolecular permeate by introducing a semipermeable membrane component between the peritoneal cavity and the waste fluid outlet. Only a certain amount of macromolecular permeate is needed to continuously maintain the osmotic pressure of the dialysate in the peritoneum, ensuring the continuous ultrafiltration of excess water and removal of metabolic waste, and reducing the amount of high-cost dialysate used. Attached Figure Description

[0032] The specific features involved in this application are shown in the appended claims. A better understanding of the features and advantages of the invention can be achieved by referring to the exemplary embodiments and accompanying drawings described in detail below. A brief description of the drawings is as follows:

[0033] Figure 1The diagram shown is a schematic representation of the peritoneal dialysis system in one embodiment of this application.

[0034] Figure 2 The diagram shown is a schematic representation of the peritoneal dialysis system in one embodiment of this application.

[0035] Figure 3A The diagram shown is a structural schematic of a peritoneal dialysis system configured in a single-channel-single-channel mode in one embodiment of this application.

[0036] Figure 3B and Figure 3C These are shown as in this application. Figure 3A The diagram shown illustrates the flow direction of the peritoneal dialysis system during the cycle of outputting dialysis waste fluid and adding replenishing fluid in one embodiment.

[0037] Figure 4A The diagram shown is a structural schematic of a peritoneal dialysis system configured in a single-channel-dual-channel mode in one embodiment of this application.

[0038] Figure 4B This application is displayed. Figure 4A The diagram shown illustrates the flow direction of the peritoneal dialysis system during a cycle for discharging dialysis waste fluid and adding replenishing fluid in one embodiment.

[0039] Figure 4C and Figure 4D These are shown as in this application. Figure 4A The diagram shown illustrates the flow direction of the peritoneal dialysis system during the cycle of outputting dialysis waste fluid and adding replenishing fluid in one embodiment.

[0040] Figure 5A The diagram shown is a structural schematic of a peritoneal dialysis system configured in a dual-channel-single-channel mode in one embodiment of this application.

[0041] Figure 5B and Figure 5C These are shown as in this application. Figure 5A The diagram shown illustrates the flow direction of the peritoneal dialysis system during the cycle of outputting dialysis waste fluid and adding replenishing fluid in one embodiment.

[0042] Figure 6A The diagram shown is a structural schematic of a peritoneal dialysis system configured in a dual-channel-dual-channel mode in one embodiment of this application.

[0043] Figure 6B and Figure 6C These are shown as in this application. Figure 6A The diagram shown illustrates the flow direction of the peritoneal dialysis system during the cycle of outputting dialysis waste fluid and adding replenishing fluid in one embodiment.

[0044] Figure 7The diagram shown is a schematic representation of the peritoneal dialysis system in one embodiment of this application.

[0045] Figure 8 The diagram shown is a connection diagram of the buffer container in one embodiment of this application.

[0046] Figure 9 The diagram shown is a schematic representation of the peritoneal dialysis system in one embodiment of this application. Detailed Implementation

[0047] 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.

[0048] 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 connection portion may be referred to as a second connection portion, and similarly, a second connection portion may be referred to as a first connection portion, without departing from the scope of the various described embodiments.

[0049] 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.

[0050] 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.

[0051] The terms “treatment” and “management” and their variations in this text refer to any reduction in the degree, frequency or severity of one or more symptoms or signs related to the condition.

[0052] The term "duration" and its variations refer to the period of time from the start to the end of a prescribed treatment, regardless of whether the treatment ends due to the cure of the condition or is discontinued for any reason. During the duration of treatment, multiple treatment sessions may be prescribed, in which one or more prescribed stimuli are applied to the subject.

[0053] The term "dialysis" refers to a type of filtration, or selective diffusion through a membrane. Dialysis removes solutes of a specific molecular weight range from a fluid to be dialyzed into dialysate via diffusion through a membrane. During dialysis, the fluid to be dialyzed passes through a filter membrane, while the dialysate passes through the other side of the membrane. The dissolved solute is transported through the filter membrane by diffusion between the fluids. The dialysate is used to remove solutes from the fluid to be dialyzed. The dialysate can also enrich other fluids.

[0054] 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.”

[0055] 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.

[0056] 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.

[0057] 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 phrases "in an embodiment," "in an embodiment," and similar wording throughout this specification may (but do not necessarily) refer to the same embodiment.

[0058] In view of the technical problems described in the background art, this application discloses a peritoneal dialysis system that uses a semi-permeable membrane component to retain macromolecular permeate by introducing a semi-permeable membrane component between the human peritoneal cavity and the waste fluid outlet. Only a certain amount of macromolecular permeate is needed to continuously maintain the osmotic pressure of the peritoneal dialysis fluid, ensuring the continuous ultrafiltration of excess water and removal of metabolic waste, and reducing the amount of high-cost dialysis fluid used.

[0059] Please see Figure 1 The figure shows a schematic diagram of the peritoneal dialysis system according to one embodiment of this application. As shown, the peritoneal dialysis system 1 includes a peritoneal tubing 10, a semipermeable membrane assembly 11, and an external fluid system 12. The first end of the peritoneal tubing 10 is connected to the human peritoneal cavity, and the second end is connected to the semipermeable membrane assembly 11. The semipermeable membrane assembly 11 includes a membrane 110 and a first side 111 and a second side 112 separated by the membrane 110. The first side 111 is connected to the second end of the peritoneal tubing 10 to receive peritoneal dialysis fluid from the peritoneal tubing 10 or to inject peritoneal dialysis fluid into the human peritoneal cavity. The external fluid line system 12 includes an external fluid line 120 connected to the second side 112 of the semipermeable membrane assembly 11. The external fluid line 120 includes a waste fluid outlet O1 to output dialysis waste fluid drawn from the peritoneal dialysis fluid via the membrane 110. When the dialysis waste fluid is drawn out, the membrane 110 allows water and small molecule solutes 21 in the peritoneal dialysis fluid to permeate into the second side 112 and retains large molecule permeabilizers 20 on the first side 111 to maintain the osmotic pressure of the peritoneal dialysis fluid formed on the first side.

[0060] The peritoneal dialysis fluid refers to the fluid bounded by membrane 110, including the used dialysis fluid located on the first side and within the peritoneal cavity of the human body, which has undergone solute exchange and ultrafiltration with the patient, and the regenerated dialysis fluid after some or all metabolic waste and excess water have been removed. The regenerated dialysis fluid becomes used dialysis fluid after being retained in the peritoneum and can enter the first side. After being processed by the semipermeable membrane assembly and the external fluid circuit system on the first side, it becomes regenerated dialysis fluid and returns to the peritoneal cavity of the human body. In peritoneal dialysis, after solute exchange and ultrafiltration with the patient's blood within the peritoneal cavity, the fluid contains a high concentration of metabolic waste and excess water. As the excess water increases, the osmotic pressure of the peritoneal dialysis fluid continuously decreases (i.e., the concentration of large molecular weight osmotic agents decreases). Upon entering the first side, the semipermeable membrane assembly and external fluid system remove some or all of the metabolic waste and excess water, while the large molecular weight osmotic agents are retained. This causes the osmotic pressure of the peritoneal dialysis fluid to rise again, allowing for further solute exchange and ultrafiltration with the blood entering the peritoneal cavity. The removed metabolic waste and excess water then cross the membrane as dialysis waste and are output from the second side. For example, the small molecular weight solutes that can permeate the dialysis waste can be considered metabolic waste, which may include small molecular weight toxins and excess electrolytes. Small molecular weight toxins include urea, creatinine, and uric acid, while the retained large molecular weight osmotic agents include, for example, icodextrin.

[0061] Maintaining the osmotic pressure of peritoneal dialysis fluid refers to keeping the concentration of the macromolecular osmotic agent in the peritoneal dialysis fluid within a desired range. This desired range ensures that the osmotic pressure on the side of the peritoneum containing the dialysis fluid is higher than that on the other side, thus maintaining the osmotic pressure difference and generating osmosis. In one example, the desired range may be no lower than a fixed concentration, or a fluctuation range above or below a fixed concentration. In another example, the desired range may be no lower than the concentration of the macromolecular osmotic agent in the initial dialysis fluid, or only allowed to be lower than the concentration of the macromolecular osmotic agent in the dialysis fluid within a certain range. The initial dialysis fluid refers to the dialysis fluid initially infused into the peritoneal cavity before solute exchange and ultrafiltration have occurred.

[0062] For example, a predetermined amount of initial dialysate containing a predetermined concentration of macromolecular osmotic agent can be pre-infused into the peritoneal cavity. This initial dialysate can remain in the peritoneal cavity and flow between the peritoneal cavity and the first side; this is peritoneal dialysis fluid. In some examples, it can be used as... Figure 1The peritoneal dialysis system 1 shown includes a reservoir (e.g., a medical plastic bag) containing initial dialysate that can be connected to the peritoneal tubing 10, allowing the initial dialysate to be infused into the peritoneal cavity through the tubing 10. In other examples, an additional infusion device can be used to infuse the initial dialysate into the peritoneal cavity; this application does not limit this. The preset volume of the initial dialysate can be, for example, 1000 mL, 1500 mL, 2000 mL, or 2500 mL, or other prescribed volumes or standardized single-bag volumes, and the preset concentration can be set to 7.5% or other prescribed or standard concentrations.

[0063] The above are as follows Figure 1 In the embodiment of the peritoneal dialysis system shown, a semipermeable membrane assembly 11 is introduced between the peritoneal tubing 10 and the external fluid system 12 to allow water and small-molecule solutes to pass through while retaining large-molecule osmotic agents during the dialysis waste removal process, thereby achieving reprocessing of the peritoneal dialysis fluid. During this process, metabolic waste and excess water in the peritoneal dialysis fluid on the first side 111 are introduced to the second side so that the peritoneal dialysis fluid can be reused. As excess water leaves the first side 111 and large-molecule osmotic agents remain on the first side 111, the concentration of large-molecule osmotic agents in the peritoneal dialysis fluid gradually increases, thus maintaining the osmotic pressure of the peritoneal dialysis fluid for continued dialysis without consuming large-molecule osmotic agents.

[0064] When dialysis waste is drawn from peritoneal dialysis fluid through a semipermeable membrane assembly, some components and volume loss is inevitable, which is detrimental to the stability of long-term dialysis treatment. Therefore, in one embodiment, please refer to... Figure 2 The figure shows a schematic diagram of the principle architecture of a peritoneal dialysis system in one embodiment of this application. Figure 1 Based on the embodiment shown, the external fluid line 120 may further include an inlet I1 for receiving replenishment fluid. The flow direction and flow rate of the peritoneal line 10 and / or the external fluid line 120 are controlled by a flow control device (not shown) so that the external fluid line 120 cooperates with the membrane 110 to periodically draw out dialysis waste fluid (as indicated by the arrow marked Out in Figure 2) and add replenishment fluid to the peritoneal dialysis fluid (as indicated by the arrow marked In in Figure 2).

[0065] It should be understood that the periodic removal of dialysis waste fluid and the addition of replenishing fluid refer to a cycle that includes both the removal of dialysis waste fluid and the addition of replenishing fluid. This does not preclude the possibility of other phases within the cycle, nor does it limit the duration or sequence of each phase. For example, in some embodiments, a phase of peritoneal dialysis fluid retention in the peritoneal cavity may also be included. Specifically, within a cycle, the cycle first includes the retention phase of peritoneal dialysis fluid in the peritoneal cavity, followed by the removal of dialysis waste fluid, and then the addition of replenishing fluid, and so on, until the entire treatment is completed.

[0066] It should be noted that the dialysis waste liquid discharged from the waste liquid outlet in the embodiments of this application refers to the dialysis waste liquid discharged from the waste liquid outlet that includes the dialysis waste liquid discharged from the first side across the membrane. In some embodiments, the liquid discharged from the waste liquid outlet may also include the portion input from the external fluid line. The net discharge from the external fluid line can be regarded as the amount of dialysis waste liquid. Similarly, the supplemental fluid entering from the inlet in the external fluid line is not necessarily all added to the peritoneal dialysis fluid across the membrane. The net input from the external fluid line can be regarded as the amount added to the peritoneal dialysis fluid across the membrane.

[0067] Specifically, the above embodiments continuously concentrate the peritoneal dialysis fluid to remove excess water and metabolic waste during waste dialysis, without losing the macromolecular osmotic agent. After concentrating to a certain volume, a certain amount of replenishing fluid can be added to the peritoneal dialysis fluid through the membrane 110. The replenished peritoneal dialysis fluid, carrying the macromolecular osmotic agent, re-enters the peritoneal cavity for dialysis. By periodically keeping the membrane 110 in a mode of waste dialysis fluid extraction and replenishing fluid addition, the osmotic pressure of the peritoneal dialysis fluid in the peritoneal cavity can be maintained at low cost, ensuring the performance of the peritoneal dialysis fluid. In addition, the membrane 110 can separate the fluids on both sides, reducing the risk of bacterial infection. It should be understood that the added replenishing fluid will mix with the peritoneal dialysis fluid, and although it will dilute the concentration of the macromolecular osmotic agent to some extent, the concentration effect during waste dialysis fluid extraction and the control of the amount of replenishing fluid added can still maintain the osmotic pressure of the peritoneal dialysis fluid within the desired range.

[0068] Since the macromolecular permeabilizer is largely retained without loss, the replenishment solution is prepared as a solution free of macromolecular permeabilizer. In some examples, the replenishment solution may be, for example, the portion of the initial dialysate from which the macromolecular permeabilizer has been removed, or for example, the regenerated solution after metabolic waste removal from the dialysis waste liquid in this application. In some examples, the replenishment solution includes an electrolyte, which includes one or more of a sodium ion source, a calcium ion source, and a magnesium ion source. The sodium ion source may be selected from one or more of sodium chloride, sodium bicarbonate, and sodium acetate; the calcium ion source may be selected from one or more of calcium chloride and calcium gluconate; and the magnesium ion source may be selected from one or more of magnesium chloride and magnesium sulfate. The replenishment solution may further include a pH buffer, such as a bicarbonate buffer or an acetate buffer. A certain amount of glucose may also be added to the replenishment solution. In other examples, the replenishment solution may be a pre-prepared physiological saline, lactated Ringer's solution, dialysis replacement fluid, glucose injection, amino acid injection, acetate Ringer's solution, etc.

[0069] In one embodiment, the supplemental fluid may be a bagged supplemental fluid or an online-generated supplemental fluid. Taking a bagged supplemental fluid as an example, the external fluid system may further include a supplemental fluid bag (e.g., a medical plastic bag) connected to the inlet for delivering the supplemental fluid toward the inlet; one or more supplemental fluid bags may be configured. Taking an online-generated supplemental fluid as an example, the external fluid system may further include a dispensing device connected to the inlet, which generates the supplemental fluid. For example, the dispensing device may generate the supplemental fluid using acidic calcium magnesium A solution, alkaline B solution / powder (e.g., sodium bicarbonate), and dialysis water; it may also generate the supplemental fluid using electrolyte concentrate and dialysis water; or it may use physiological saline, electrolyte concentrate, and dialysis water.

[0070] In one embodiment, such as Figure 1 or Figure 2 In the peritoneal dialysis system shown, the waste outlet O1 can also be connected to a waste container to hold the dialysis waste fluid. The waste fluid solution can also be configured as an empty medical fluid bag or box container, etc. Multiple waste containers can be configured to sequentially receive the dialysis waste fluid, thus allowing the dialysis waste fluid to be temporarily stored for subsequent processing.

[0071] Furthermore, in peritoneal dialysis, although the primary purpose of using the peritoneum is to remove metabolic waste and excess water while retaining beneficial macromolecules as much as possible, some macromolecules are inevitably lost into the peritoneal dialysis fluid. This can negatively impact the patient's nutritional status and immunity in the long run. Therefore, in situations such as... Figure 1 or Figure 2In the illustrated embodiment, when dialysis waste is drained, the membrane 110 is used to retain beneficial macromolecules on the first side to reduce the loss of beneficial substances. Beneficial macromolecules may include human proteins (such as albumin, immunoglobulins, transferrin, etc.), amino acids, peptide hormones, and regulatory factors.

[0072] In one embodiment, the membrane can be a membrane with different geometries. In one example, the membrane can be configured as a tubular membrane, a spiral wound membrane, a flat sheet membrane, or a hollow fiber membrane. The membrane pore size needs to allow large molecular permeaters to be retained on a first side of the membrane while water and small molecular solutes can permeate to a second side; for example, the membrane pore size is smaller than that of icodextrin. It should be noted that in embodiments where the membrane is a planar membrane, the first and second sides are opposite sides of a planar membrane barrier; similarly, in embodiments where the membrane is a hollow fiber membrane, the first and second sides are the outer and inner sides of the tube wall of each hollow fiber membrane, respectively. The membrane can be selected from materials such as polysulfone, polyethersulfone, poly(methyl methacrylate), modified cellulose, or other materials known to those skilled in the art.

[0073] In such Figure 1 Or such as Figure 2 In the illustrated embodiment, a flow control device (not shown) may be provided on the peritoneal tubing 10 and / or the external fluid tubing 120. This flow control device can control the flow direction and flow rate within the tubing, allowing the external fluid tubing 120 to cooperate with the membrane 110 for draining dialysis waste fluid or adding replenishing fluid to the peritoneal dialysis fluid towards the first side 111. In some examples, the flow control device includes a pump, valve, sensor, etc. Examples of pumps include peristaltic pumps, pneumatic diaphragm pumps, or pressure pumps, and sensors include flow sensors, weighing sensors, etc. In some examples, the flow control device can also be used to change the volume of dialysis waste fluid output and replenishing fluid added within a cycle to adjust dialysis efficiency. This volume change can be controlled by altering the time and / or speed of dialysis waste fluid output and replenishing fluid addition.

[0074] In such Figure 1 Or such as Figure 2 In the illustrated embodiment, the peritoneal tubing is used to deliver peritoneal dialysis fluid from the peritoneal cavity to a first side and to inject peritoneal dialysis fluid into the peritoneal cavity. The external fluid tubing can be used to output transmembrane dialysis waste fluid from a second side to a waste fluid outlet, and can also be further used to input replenishment fluid to the second side and then across the membrane to the first side. In other words, the tubing structure of the peritoneal tubing allows fluid flow in two directions, and the tubing structure of the external fluid tubing allows fluid flow in at least one direction, and in, for example... Figure 2In the illustrated embodiments, it is necessary to allow fluid flow in at least two directions. Therefore, in some embodiments provided in this application, the peritoneal tubing can be configured with a single-channel or dual-channel tubing structure, and the external fluid tubing can also be configured with a single-channel or dual-channel tubing structure. The single-channel tubing structure can alternately deliver two fluid flows, while the dual-channel tubing structure can deliver two fluid flows separately or in combination. Subsequent embodiments will use a peritoneal dialysis system configured as follows... Figure 2 The architecture shown is used as an example to illustrate the abdominal tubing, external fluid tubing, working mode, and principle. It should not be construed as a limitation of this application. In subsequent embodiments, for ease of explanation and representation, the direction of fluid flow from the human body side to the system side is referred to as forward, the flow control component driving the fluid flow in the forward direction is referred to as forward power or forward rotation, the direction of fluid flow from the system side to the human body side is referred to as reverse, and the flow control component driving the fluid flow in the reverse direction is referred to as reverse power or reverse rotation.

[0075] Please see Figure 3A The figure shows a schematic diagram of the peritoneal dialysis system configured in a single-channel-single-channel mode in one embodiment of this application. As shown, the peritoneal tubing 10 and the external fluid tubing 120 are each configured with a single-channel tubing structure, and the corresponding working mode is also referred to as the single-channel-single-channel mode. Specifically, the peritoneal tubing 10 includes a single-lumen peritoneal catheter 100 connecting the first side 111 of the semipermeable membrane assembly 11 to the human peritoneal cavity, and the external fluid tubing 120 includes a single-lumen external fluid tubing 1200 connecting the second side 112 and the waste fluid outlet O1 and the fluid inlet I1. A flow control device (not shown) is provided on the peritoneal tubing 10 and / or the external fluid tubing 120. Under the control of the flow control device, the single-lumen external fluid tubing 120 is used alternately to output the dialysis waste fluid and add the replenishing fluid to the peritoneal dialysis fluid during the cycle.

[0076] Please see Figure 3B and Figure 3C The following are respectively displayed as in this application. Figure 3A The diagram shown illustrates the flow direction of the peritoneal dialysis system during a cycle, specifically when waste dialysis fluid is discharged and replenishment fluid is added. Figure 3B and Figure 3C The flow control device includes, for example, a liquid pump P11 mounted on a single-lumen external liquid conduit 120. Figure 3B As shown, when discharging dialysis waste fluid, the liquid pump P11 can provide positive power at a preset speed to control the single-lumen extracorporeal fluid catheter 1200 to generate a positive fluid flow at a preset flow rate. At this time, the fluid flow in the peritoneal dialysis system is as follows: Figure 3BAs indicated by the dashed arrow. Specifically, under the action of the pump P11, the peritoneal dialysis fluid enters the first side 111 through the single-lumen peritoneal catheter 100 and flows across the membrane 110 towards the second side 112 and the single-lumen extracorporeal fluid catheter 1200. During the transmembrane 110 process, the large molecule permeabilizer 20 in the peritoneal dialysis fluid is retained on the first side 111, while water and small molecule solutes 21 permeate into the second side 112 and flow through the single-lumen extracorporeal fluid catheter 1200 to the waste outlet O1. After a preset time is reached, the pump P11 provides a reverse force at a preset speed to control the single-lumen extracorporeal fluid catheter 1200 to change to generate a reverse flow at a preset flow rate. At this time, the fluid flow in the peritoneal dialysis system is as follows: Figure 3C As indicated by the dashed arrow. Specifically, under the action of the liquid pump P11, the supplemental fluid enters the second side transmembrane 110 through the single-lumen external fluid catheter 1200 and then enters the first side 111. The supplemental fluid is added to the peritoneal dialysis fluid on the first side and carries the retained macromolecular permeabilizing agent 20 through the single-lumen peritoneal catheter 100 for re-infusion into the human peritoneal cavity.

[0077] It should be noted that, Figure 3B and Figure 3C The flow control device, including liquid pump P11, is only one example. In another example, the flow control device may also be configured to include two liquid pumps respectively connected to waste liquid outlet O1 and inlet I1. When dialysis waste is drawn out, the liquid pump connected to waste liquid outlet O1 provides power to generate... Figure 3B The positive liquid flow shown is powered by a liquid pump connected to inlet I1 when replenishment liquid is added, to generate the flow as described above. Figure 3C The reverse fluid flow is shown in the example. In yet another example, the flow control device... Figure 3B and Figure 3C Based on the liquid pump P11 shown, the device may further include valves connected to the waste liquid outlet O1 and the inlet I1, respectively, which can close the other port when one port is in operation. In yet another example, the flow control device may also be configured to include a liquid pump connected to the single-lumen peritoneal catheter 100, through which power is provided to generate, as shown in the example. Figure 3B and Figure 3C The flow control device can also be configured to include two pumps connected to a single-lumen peritoneal catheter 100 and a single-lumen extracorporeal fluid catheter 1200, respectively. The differential speed of the two pumps creates a flow rate difference in the two lines, thereby generating power to provide, for example, the forward and reverse fluid flow. Figure 3B and Figure 3C The fluid flow shown is illustrated above. It should be understood that the examples above are merely illustrative, and those skilled in the art can reasonably configure the components included in the flow control device within the inventive concept of this application, as long as the flow rate and direction of the abdominal cavity conduit 10, external fluid conduit 120, or simultaneously control of both the abdominal cavity conduit 10 and external fluid conduit 120 can be controlled to produce the fluid flow shown above. Figure 3B and Figure 3CThe two liquid flows in the middle are sufficient.

[0078] by Figures 3A to 3C The following describes a dialysis procedure using a human peritoneal cavity filled with 2000 mL of peritoneal dialysis fluid as an example. In one example, the inactivity time of the pump P11 is controlled to allow the peritoneal dialysis fluid to remain in the peritoneal cavity for 200 mL of ultrafiltration, resulting in a total volume of 2200 mL of peritoneal dialysis fluid. Then, the pump P11 is controlled to rotate forward at a first preset speed for a first preset time to output, for example, 700 mL of dialysis waste fluid from the waste fluid outlet O1. The remaining volume of peritoneal dialysis fluid can be considered as 1500 mL. The dialysis waste fluid includes excess water and small molecule substances 21, while the large molecule permeabilizer 20 is retained on the first side, and the total amount of large molecule permeabilizer 20 remains unchanged. Then, the pump P11 is controlled to rotate backward at a second preset speed for a second preset time to add 500 mL of peritoneal dialysis fluid. At this point, the peritoneal cavity can be considered to maintain a volume of 2000 mL of peritoneal dialysis fluid. This cycle can continuously remove metabolic waste while maintaining a stable concentration of large molecule permeabilizer 20.

[0079] In another example, the inactivity time of the pump P11 can be controlled to allow for an ultrafiltration volume of 200 mL, resulting in a total peritoneal dialysis fluid volume of 2200 mL. Then, the pump P11 is controlled to rotate forward at a first preset speed for a first preset time to output, for example, 700 mL of dialysis waste fluid from the waste fluid outlet O1, leaving a residual volume of 1500 mL of peritoneal dialysis fluid. Next, the pump P11 is controlled to rotate backward at a second preset speed for a second preset time to replenish the peritoneal dialysis fluid with 600 mL, at which point the peritoneal cavity can be considered to contain 2100 mL of peritoneal dialysis fluid. In the second cycle, the inactivity time of the pump P11 can be controlled to ensure that the indwelling time generates 100% ultrafiltration volume. Combined with the 2100 mL from the first cycle, the total peritoneal dialysis fluid volume is 2200 mL. At this point, the pump P11 can be controlled to continue the pattern from the previous cycle, removing 700 mL of dialysis waste fluid and adding 600 mL of replenishing fluid. At this point, there is 2100 mL of peritoneal dialysis fluid in the peritoneal cavity. The cycle is repeated for the second cycle until treatment is completed. Compared to the previous example, this example increases the total indwelling volume in the peritoneal cavity within the cycle, effectively increasing the exchange volume, thus enabling the removal of more metabolic waste with the same net ultrafiltration volume.

[0080] In another example, the inactivity time of pump P11 can be controlled to generate an ultrafiltration volume of 10 mL during the indwelling time, resulting in a total peritoneal dialysis fluid volume of 2010 mL. Then, pump P11 is controlled to rotate forward at a first preset speed for a first preset time to draw out, for example, 210 mL of dialysis waste fluid from the waste fluid outlet O1, leaving a residual volume of 1800 mL of peritoneal dialysis fluid. Next, pump P11 is controlled to rotate backward at a second preset speed for a second preset time to add 200 mL of peritoneal dialysis fluid, resulting in a total peritoneal dialysis fluid volume of 2000 mL. This cycle is repeated until the treatment is completed. Compared to the previous two examples, this example significantly reduces the volume generated during each indwelling, the volume of dialysis waste fluid drawn out, and the volume of replenished fluid, as well as the time required per cycle, thereby accelerating the exchange frequency and improving the efficiency of removing metabolic waste.

[0081] Please see Figure 4A The figure shows a schematic diagram of the peritoneal dialysis system configured in a single-channel-dual-channel mode in one embodiment of this application. As shown, the peritoneal tubing 10 is configured with a single-channel tubing structure, and the external fluid tubing 120 is configured with a dual-channel tubing structure. This working mode corresponding to this structure is also referred to as the single-channel-dual-channel mode. Specifically, the peritoneal tubing 10 includes a single-lumen peritoneal catheter 100 connecting the first side 111 of the semipermeable membrane assembly 11 to the human peritoneal cavity. The external fluid tubing 120 includes a first external fluid passage 1201 connecting the second side 112 to the waste fluid outlet O1, and a second external fluid passage 1202 connecting the second side 112 to the inlet I1.

[0082] For example, in some examples, the external liquid conduit 120 may be configured to include two single-lumen external liquid conduits, each having an inner lumen. The inner lumen of one single-lumen external liquid conduit corresponds to the first external liquid passage 1201, and the inner lumen of the other single-lumen external liquid conduit corresponds to the second external liquid passage 1202. Furthermore, the two single-lumen external liquid conduits are independently separable. Their first ends can be connected to either one or two interfaces on the second side, and their second ends can be connected to the waste liquid outlet and the liquid inlet, respectively, as long as communication between the second side and the waste liquid outlet, and between the second side and the liquid inlet, is ensured. In other examples, the external liquid line 120 may be configured as a dual-lumen external liquid conduit, which is a conduit comprising two lumens (a first lumen and a second lumen). The first external liquid passage 1201 corresponds to the first lumen of the dual-lumen conduit, and the second external liquid passage 1202 corresponds to the second lumen of the dual-lumen conduit. One end of the first lumen and the second lumen are connected to a second side, and the other end of the first lumen and the second lumen are connected to a waste liquid outlet and a liquid inlet, respectively.

[0083] In one embodiment, such as Figure 4AThe peritoneal dialysis system shown also includes a flow control device. This device controls the flow direction and flow rate of the single-lumen peritoneal catheter 100 and / or the external fluid passage 120, allowing dialysis waste fluid to be alternately discharged through the first external fluid passage 1201 towards the waste fluid outlet O1 and replenishment fluid to be added through the inlet I1 and the second external fluid passage 1202 during the cycle. Please refer to [link / reference]. Figure 4B This application is displayed as such. Figure 4A The diagram shown illustrates the flow direction of the peritoneal dialysis system during a cycle for discharging dialysis waste fluid and adding replenishing fluid in one embodiment. Figure 4B The flow control device includes, for example, a first liquid pump P21 installed on the first external liquid passage 1201 and a second liquid pump P22 installed on the second external liquid passage 1202. The flow direction of the output dialysis waste liquid is as follows: Figure 4B The solid line arrow indicates that the first pump P21 provides forward power at a preset speed to generate a forward flow at a preset flow rate in the first external fluid passage 1201. At this time, the peritoneal dialysis fluid enters the first side 111 through the single-lumen peritoneal catheter 100 and flows across the membrane 110 towards the second side 112 and the first external fluid passage 1201. During the transmembrane 110 process, the large molecule permeabilizer 20 in the peritoneal dialysis fluid is retained in the first side 111, while water and small molecule solutes permeate into the second side 112 and flow through the first external fluid passage 1201 to the waste outlet O1. After a preset time, the first pump P21 stops working, and the second pump P22 provides reverse power at a preset speed to generate a reverse flow at a preset flow rate in the second external fluid passage 1202. At this time, the fluid flow in the peritoneal dialysis system is as follows: Figure 4B As indicated by the dashed arrow, the supplemental fluid enters the second side transmembrane 110 through the second external fluid passage 1202 and then enters the first side 111. The supplemental fluid is added to the peritoneal dialysis fluid on the first side and carries the retained macromolecular permeabilizing agent 20 through the single-lumen peritoneal catheter 100 for re-infusion into the human peritoneal cavity.

[0084] In one embodiment, such as Figure 4A The flow control device in the peritoneal dialysis system shown is used to control the flow direction and flow rate on the first external fluid passage 1201 and the second external fluid passage 1202 respectively to form an external circulating fluid flow from the inlet I1 through the second side 112 to the waste fluid outlet O1. The flow rate difference between the first and second external fluid passages 1201 and 1202 ensures that the external circulating fluid flow can output the dialysis waste fluid and add the replenishing fluid during a cycle. In one example, when the flow rate on the first external fluid passage 1201 is greater than the flow rate on the second external fluid passage 1202, the external circulating fluid flow is used to extract the dialysis waste fluid; when the flow rate on the first external fluid passage 1201 is less than the flow rate on the second external fluid passage 1202, the external circulating fluid flow is used to add the replenishing fluid.

[0085] Please see Figure 4C and Figure 4D The following are respectively displayed as in this application. Figure 4A The diagram shown illustrates the flow direction of the peritoneal dialysis system during a cycle, specifically when waste dialysis fluid is discharged and replenishment fluid is added. Figure 4C and Figure 4D The flow control device includes a first pump P21 installed on the first external liquid passage 1201 and a second pump P22 installed on the second external liquid passage 1202, as illustrated below. During one cycle, at the end of the retention phase, the first pump P21 provides forward power, and the second pump P22 provides reverse power to form an external circulation flow C1 from the inlet I1 through the second side 112 to the waste liquid outlet O1. Furthermore, the rotational speed of the first pump P21 is greater than that of the second pump P22, so that the flow rate of the first external liquid passage 1201 is greater than that of the second external liquid passage 1202. This further enables the external circulation flow C1 to introduce dialysis waste liquid from the first side 111 across the membrane 110 into the second side 112, as shown in the diagram. Figure 4C As shown, the macromolecular permeabilizer 20 in the peritoneal dialysis fluid is retained on the first side 111, while water and small molecule solutes permeate into the second side 112 and flow to the waste outlet O1 via the external circulation fluid flow C1. When the dialysis waste fluid is drained, the rotation speeds of the first pump P21 and the second pump P22 are adjusted so that the rotation speed of the first pump P21 is less than that of the second pump P22. This ensures that the flow rate of the first external fluid passage 1201 is less than the flow rate of the second external fluid passage 1202, further enabling the external circulation fluid flow C1 to introduce the replenishing fluid from the second side 112 across the membrane 110 into the first side 111, as shown in the diagram. Figure 4D As shown, the supplemental fluid added to the peritoneal dialysis fluid on the first side can carry the retained macromolecular permeabilizing agent 20 and be re-infused into the human peritoneal cavity through the single-lumen peritoneal catheter 100.

[0086] It should be noted that, Figure 4B , Figure 4C and Figure 4D The configuration of the flow control device, including a first liquid pump P21 and a second liquid pump P22, is only one example; other examples include... Figure 4B The flow control device may further include a fluid pump disposed on the single-lumen peritoneal catheter 100, thereby controlling the operation of the first fluid pump P21 and the fluid pump on the single-lumen peritoneal catheter 100 to generate, for example Figure 4B The flow of output dialysis waste fluid shown is generated by controlling the operation of the second pump P22 and the pump on the single-lumen peritoneal catheter 100 to produce the following: Figure 4B The image shows the flow of replenishing fluid. Similarly, Figure 4C and Figure 4DThe flow control device may further include a pump mounted on the single-lumen peritoneal catheter 100, controlling the pump to work in conjunction with the external circulation fluid flow C1 therein. It should be understood that the above examples are merely illustrative, and those skilled in the art can reasonably configure the components of the flow control device within the inventive concept of this application, as long as the flow rate and direction of the peritoneal tubing 10, the external fluid tubing 120, or both the peritoneal tubing 10 and the external fluid tubing 120 can be controlled to produce the desired effect. Figure 4B or Figure 4C and Figure 4D The external circulation fluid flow is sufficient.

[0087] by Figure 4C and Figure 4D The following is an explanation of dialysis work using a human peritoneal cavity perfused with 2000 mL of peritoneal dialysis fluid as an example. In one example, the inactivity time of the first pump P21 and the second pump P22 can be controlled so that the retention time of the peritoneal dialysis fluid in the human peritoneal cavity can generate an ultrafiltration volume of 100 mL, for a total peritoneal dialysis fluid volume of 2100 mL. Then, the forward rotation speed of the first pump P21 is controlled so that the flow rate of the waste fluid outlet O1 is 60 mL / min, and the reverse rotation speed of the second pump P22 is controlled so that the inlet flow rate of the inlet I1 is 50 mL / min. This stage lasts for 20 minutes, and the external fluid circulation flow C1 can output a net 200 mL of dialysis waste fluid, leaving 1900 mL in the peritoneal cavity. Then, the forward rotation speed of the first liquid pump P21 is controlled to achieve a flow rate of 50 mL / min at the waste liquid outlet O1, and the reverse rotation speed of the second liquid pump P22 is controlled to achieve a flow rate of 55 mL / min at the inlet I1. This stage lasts for 20 minutes. During this stage, the external fluid circulation flow C1 can add 100 mL of replenishing fluid to the first side, and simultaneously, an additional 100 mL of ultrafiltration volume is added to the peritoneal cavity, for a total of 2100 mL. It should be noted that in actual applications, ultrafiltration is continuous when peritoneal dialysis fluid is present in the human peritoneal cavity. That is, in this example, during the net output of dialysis waste fluid and the net addition of replenishing fluid by the external fluid circulation flow C1, ultrafiltration in the peritoneal cavity will continue to operate. The addition of 100 mL in this stage is an illustrative example. The additional ultrafiltration volume in the peritoneal cavity during the output of dialysis fluid and the addition of replenishing fluid mentioned in the foregoing or subsequent embodiments should also be understood in this way, and will not be elaborated further.

[0088] Please see Figure 5AThe figure shows a schematic diagram of the peritoneal dialysis system configured in a dual-channel-single-channel mode in one embodiment of this application. As shown, the peritoneal tubing 10 is configured with a dual-channel structure, and the external fluid tubing 120 is configured with a single-channel structure. This working mode corresponding to this structure is also referred to as the dual-channel-single-channel mode. Specifically, the peritoneal tubing 10 includes a first internal fluid passage 101 and a second internal fluid passage 102 connecting the human peritoneal cavity and the first side 111. The external fluid tubing 120 includes a single-lumen external fluid conduit 1203 connecting the second side 112, the waste fluid outlet O1, and the fluid inlet I1.

[0089] For example, in some examples, the abdominal cavity conduit 10 may be configured to include two single-lumen peritoneal catheters, each having an inner lumen. The inner lumen of one single-lumen peritoneal catheter corresponds to the first internal fluid passage 101, and the inner lumen of the other single-lumen peritoneal catheter corresponds to the second internal fluid passage 102. Furthermore, the two single-lumen peritoneal catheters are independently separable. Their first ends can be connected to the same or both interfaces in the human abdominal cavity, and their second ends can be connected to either of the two interfaces or one interface on the first side, as long as communication between the first side and the human abdominal cavity is ensured. In other examples, the abdominal conduit 10 may be configured to include a double-lumen peritoneal catheter, which is a catheter that includes two lumens (a first lumen and a second lumen) in a single catheter. The first internal fluid passage 101 corresponds to the first lumen of the double-lumen peritoneal catheter, and the second internal fluid passage 102 corresponds to the second lumen of the double-lumen peritoneal catheter. One end of the first lumen and the second lumen are connected to the human peritoneum, and the other end of the first lumen and the second lumen are respectively connected to a first side.

[0090] In one embodiment, such as Figure 5A The peritoneal dialysis system shown also includes a flow control device. This device controls the flow direction and flow rate of any one or more of the single-lumen external fluid catheter 1203, the first internal fluid passage 101, and the second internal fluid passage 102, so that the single-lumen external fluid catheter 1203 alternately outputs dialysis waste fluid and adds replenishing fluid through the waste fluid outlet O1 and the fluid inlet I1. The alternating flow of dialysis waste fluid and replenishing fluid can be seen in the following example... Figure 4B As shown, adjustments can be made simply according to the different channels. Of course, flow control devices can also be used to control the flow. Figure 5A The peritoneal dialysis system shown is equivalent to, for example: Figures 3A to 3C It operates in a single-channel-single-channel mode as shown, which will not be elaborated upon here.

[0091] In one embodiment, such as Figure 5AIn the peritoneal dialysis system shown, the flow control device is used to control the flow direction and flow rate of the peritoneal tubing 10 to form an internal circulating fluid flow from the human peritoneum through the first side back to the human peritoneum. It also controls the flow direction and flow rate in the single-lumen external fluid catheter 1203 by forming a flow difference in the first internal fluid passage 101 and the second internal fluid passage 102, so that the single-lumen external fluid catheter 1203 alternately outputs the dialysis waste fluid and adds the replenishing fluid to the peritoneal dialysis fluid during the cycle.

[0092] Please see Figure 5B and Figure 5C The following are respectively displayed as in this application. Figure 5A The diagram shown illustrates the flow direction of the peritoneal dialysis system during a cycle, specifically when waste dialysis fluid is discharged and replenishment fluid is added. Figure 5B and Figure 5C The flow control device includes a third pump P31 installed on the first internal fluid passage 101 and a fourth pump P32 installed on the single-lumen external fluid conduit 1203, as an example. Specifically, in one cycle, the third pump P31 provides positive power to form an internal circulating fluid flow C2 from the human abdominal cavity through the first side 111 to the waste fluid outlet O1. During the concentration, the fourth pump P32 is controlled to provide positive power at a preset speed to control the single-lumen external fluid conduit 1200 to generate a positive fluid flow at a preset flow rate. At this time, in conjunction with the action of the fourth pump P32, a transmembrane 110 fluid flow is generated in the internal circulating fluid flow C2 towards the second side 112 and the single-lumen external fluid conduit 1203. Among them, the macromolecular permeate 20 is retained on the first side 111, and water and small molecule solute 21 enter the second side 112 and flow to the waste fluid outlet O1 through the single-lumen external fluid conduit 1203, presenting a state as follows. Figure 5B The dotted arrow in the diagram indicates the process. After the preset time is reached, the fourth liquid pump P32 provides reverse force at a preset speed to control the single-lumen external liquid conduit 1203 to change to generate a reverse liquid flow at a preset flow rate. At this time, in conjunction with the action of the fourth liquid pump 32, the supplemental fluid enters the second side transmembrane 110 through the single-lumen external liquid conduit 1203 and then enters the first side 111 to be added to the internal circulation fluid flow C2 and infused into the human abdominal cavity, as shown in the diagram. Figure 5C The dashed line in the middle indicates the meaning of the arrow.

[0093] It should be noted that, Figure 5B and Figure 5C The flow control device described herein is merely one example; in other examples, the flow control device may further include a liquid pump disposed in the second internal liquid passage 102 (wherein, for example...). Figure 5B and Figure 5CThe fourth liquid pump P32 can be omitted. This allows for further control of the pump speeds in the two internal liquid pathways, creating a flow difference between the first and second internal liquid pathways 101 and 102. This enables the single-lumen external liquid conduit to periodically draw out dialysis waste and add replenishing fluid. When the flow rate in the first internal liquid pathway 101 is greater than that in the second internal liquid pathway 102, dialysis waste is drawn out; when the flow rate in the first internal liquid pathway 101 is less than that in the second internal liquid pathway 102, replenishing fluid is added. The specific principle is similar to... Figure 4C and Figure 4D Similarly, details will not be repeated here. It should be understood that the above examples are merely illustrative, and those skilled in the art can reasonably configure the components included in the flow control device within the inventive concept of this application.

[0094] by Figure 5B and Figure 5C The following is an explanation of dialysis work using the example of 2000 mL of peritoneal dialysis fluid instilled into the human peritoneum. In one example, the third pump P31 is first controlled to generate an internal circulation fluid flow C2 in the human peritoneum and the first side at a flow rate of 50 mL / min, and the duration is such that 200 mL of ultrafiltration volume can be generated in the human peritoneum. During this period, the fourth pump P32 is controlled to rotate forward until 700 mL of dialysis waste fluid is drawn out to the waste fluid outlet O1. Then, the fourth pump P32 is controlled to rotate in reverse to add 500 mL of replenishment fluid to the internal circulation fluid flow C2. In one cycle, 2000 mL of fluid is maintained in the peritoneum for dialysis.

[0095] Please see Figure 6A The figure shows a schematic diagram of a peritoneal dialysis system configured in a dual-channel-dual-channel mode in one embodiment of this application. As shown, the peritoneal tubing 10 is configured with a dual-channel structure, and the external fluid tubing 120 is also configured with a dual-channel structure. This working mode corresponding to this structure is also referred to as the dual-channel-dual-channel mode. Specifically, the peritoneal tubing 10 includes a first internal fluid passage 101 and a second internal fluid passage 102 connecting the human peritoneal cavity and the first side 111. The external fluid tubing 120 includes a first external fluid passage 1201 connecting the second side 112 and the waste fluid outlet O1, and a second external fluid passage 1202 connecting the second side 112 and the inlet I1. The flow direction and flow rate of any one or any of the four passages are controlled by a flow control device (not shown) so that the external fluid tubing cooperates with the membrane to periodically draw out dialysis waste fluid and add the replenishing fluid to the peritoneal dialysis fluid.

[0096] For example, such as Figure 6A The abdominal conduit 10 can be configured to include two single-lumen peritoneal catheters or a double-lumen peritoneal catheter, thereby forming a first internal fluid passage 101 and a second internal fluid passage 102, as detailed in the following document. Figure 5AExamples of intra-abdominal tubing are provided below and will not be repeated here. Figure 6A The external fluid conduit 120 can also be configured to include two single-lumen external fluid conduits or a double-lumen external fluid conduit, thereby forming a first external fluid passage 1201 and a second external fluid passage 1202. For details, please refer to... Figure 4A Examples of domestic and foreign fluid pipelines will not be repeated here.

[0097] In one embodiment, such as Figure 6A In the peritoneal dialysis system shown, the flow control device controls the flow direction and flow rate of any one or any one of the four pathways to ensure that the external fluid tubing flows in an equivalent manner to... Figures 3A to 5C The fluid flow method described in any embodiment of the invention is used to draw out dialysis waste fluid and add replenishing fluid. For example, the fluid flow to draw out dialysis waste fluid can pass through membrane 110 from either the first internal fluid passage 101 or the second internal fluid passage 102 towards the first external fluid passage 1201 to the waste fluid outlet O1. The fluid flow to add replenishing fluid can pass through membrane 110 from inlet I1 via the second external fluid passage 1202 and then be injected into the human abdominal cavity from either the first internal fluid passage 101 or the second internal fluid passage 102. Those skilled in the art can reasonably set the components and positions included in the flow control device under the concept of the present invention, which will not be elaborated in this application.

[0098] In one embodiment, such as Figure 6A In the peritoneal dialysis system shown, the flow control device forms an internal circulating fluid flow from the peritoneal cavity back to the peritoneal cavity via a first side by controlling the flow direction and flow rate in the first internal fluid passage 101 and / or the second internal fluid passage 102. It also forms an external circulating fluid flow from the inlet I1 via the second side 112 to the waste fluid outlet O1 by controlling the flow direction and flow rate in the first external fluid passage 1201 and / or the second external fluid passage 1202. A flow difference is created between the internal and / or external circulating fluid flows to ensure that the external circulating fluid can output the dialysis waste fluid and add the replenishing fluid during the cycle. In this mode, a continuous fluid flow is formed on both sides of the membrane throughout the cycle, thereby carrying out more metabolic waste fluid and improving efficiency.

[0099] Please see Figure 6B and Figure 6C The following are respectively displayed as in this application. Figure 6A The diagram shown illustrates the flow direction of the peritoneal dialysis system during a cycle, specifically when waste dialysis fluid is discharged and replenishment fluid is added. Figure 6B and Figure 6CThe flow control device includes a fifth pump P41 installed on the first internal fluid passage 101, a sixth pump P42 installed on the first external fluid passage 1201, and a seventh pump P43 installed on the second external fluid passage 1202. Specifically, in one cycle, the fifth pump P41 provides forward power to form an internal circulating fluid flow C2 from the abdominal cavity through the first side 111 to the waste fluid outlet O1. The sixth pump P42 provides forward power, and the seventh pump P43 provides reverse power to form an external circulating fluid flow C1 from the inlet I1 through the second side 112 to the waste fluid outlet O1. Furthermore, the rotational speed of the sixth pump P42 is greater than that of the seventh pump P43, so that the flow rate of the first external fluid passage 1201 is greater than that of the second external fluid passage 1202. That is, a flow difference is formed in the external circulating fluid flow C1, further enabling the external circulating fluid flow C1 to introduce dialysis waste fluid from the first side 111 across the membrane 110 into the second side 112, as shown in the diagram. Figure 6B As shown, the macromolecular permeabilizer 20 in the peritoneal dialysis fluid is retained on the first side 111, while water and small molecule solutes permeate into the second side 112 and flow to the waste outlet O1 via the external circulation fluid flow C1. When the dialysis waste fluid is drained, the speeds of the sixth pump P42 and the seventh pump P43 are adjusted so that the speed of the sixth pump P42 is less than that of the seventh pump P43. This ensures that the flow rate of the first external fluid passage 1201 is less than the flow rate of the second external fluid passage 1202, further enabling the external circulation fluid flow C1 to introduce the replenishing fluid from the second side 112 across the membrane 110 into the first side 111, as shown in the diagram. Figure 6C As shown, the supplemental fluid added to the peritoneal dialysis fluid on the first side can carry the retained macromolecular permeabilizer 20 and be re-infused into the human peritoneal cavity along with the internal circulation fluid flow C2.

[0100] It should be noted that, Figure 6B and Figure 6C The flow control device and its control method described are merely one example; for instance, other methods could also be used... Figure 6B and Figure 6C The seventh liquid pump P43 is omitted, and a liquid pump is added to the second internal liquid passage 102. This allows for the simultaneous formation of internal circulating liquid flow C2 and external circulating liquid flow C1 within one cycle. Simultaneously, by coordinating the flow rate difference in the internal circulating liquid flow—where the inflow to the first side is greater than the outflow from the first side—the external circulating liquid flow C1 is used to remove dialysis waste liquid. Conversely, by forming a flow rate difference in the internal circulating liquid flow—where the inflow to the first side is less than the outflow from the first side—the external circulating liquid flow C2 is used to add makeup liquid towards the first side. Furthermore, it is also possible to… Figure 6B and Figure 6CBased on this, a pump is added to the second internal liquid passage 102. This allows the external circulating liquid flow C1 to be used to draw out dialysis waste liquid and add replenishment liquid towards the first side, in conjunction with the flow difference formed in the internal and external circulating liquid flows. Specifically, the flow difference between the internal circulating liquid flow C2 entering the first side and exiting the first side can be controlled to be equal to the flow difference between the external circulating liquid flow C1 leaving the second side and entering the second side, so that the external circulating liquid flow C1 is used to draw out dialysis waste liquid. Then, the flow difference between the internal circulating liquid flow C2 entering the first side and exiting the first side can be controlled to be equal to the flow difference between the external circulating liquid flow C1 leaving the second side and entering the second side, so that the external circulating liquid flow C1 is used to add replenishment liquid towards the first side. It should be understood that the above examples are merely illustrative. Those skilled in the art can reasonably set the components and positions of the flow control device under the inventive concept of this application, as long as it can be achieved in such a way. Figure 6B and Figure 6C The dialysis waste solution can be drawn out and replenished as shown in the diagram.

[0101] by Figure 6B and Figure 6C The following describes a dialysis procedure using a human peritoneal cavity infused with 2000 mL of peritoneal dialysis fluid as an example. In one example, the fifth pump P41 is controlled to generate an internal circulating fluid flow C2 at a flow rate of 50 mL / min between the human peritoneal cavity and the first side, and this flow is sustained for a duration that allows 100 mL of ultrafiltration to be produced within the human peritoneal cavity. During this period, the sixth pump P42 is controlled to generate a flow rate of 60 mL / min towards the waste fluid outlet through the first external fluid passage 1201, and the seventh pump P43 is controlled to input supplemental fluid to the second side through the inlet I1 at a flow rate of 50 mL / min via the second external fluid passage 1201. After 20 minutes, 200 mL of fluid can be drawn out from the waste fluid outlet O1, leaving 1900 mL of fluid in the human peritoneal cavity. At this time, the flow rate of the waste liquid outlet is controlled at 50 mL / min, and the flow rate of the liquid inlet is 55 mL / min. Then, after 20 minutes, 100 mL of liquid is added to the first side, and at the same time, 100 mL of new ultrafiltration is carried out through the peritoneum in the human abdominal cavity. At this time, a total of 2100 mL of dialysis is carried out in the human abdominal cavity.

[0102] Please see Figure 7The figure shows a schematic diagram of the peritoneal dialysis system in one embodiment of this application. As shown, the peritoneal dialysis system 1 also includes a buffer container 13 connecting the peritoneal tubing 10 and the first side 111. The buffer container 13 can maintain a certain liquid volume between the semipermeable membrane and the human body, and the liquid in the buffer container 13 interacts with the first side. In other embodiments, a buffer container connecting the second side 112 and the external fluid tubing 12 can also be provided, or buffer containers can be provided simultaneously between the peritoneal tubing 10 and the first side 111 and between the second side 112 and the external fluid tubing 12, so as to use the buffer container as a buffer to facilitate liquid interaction with the corresponding side. For example,... Figure 1 The architecture shown includes a buffer container, but this application does not impose any restrictions on it.

[0103] Please see Figure 8 The diagram shows a connection schematic of the buffer container in one embodiment of this application. In this embodiment, the peritoneal tubing 10 and the external fluid tubing 12 in a peritoneal dialysis system are configured as follows: Figure 4A The single-channel-dual-channel mode shown is used as an example for explanation. Figure 8 As shown, the buffer container 13 is connected between the single-lumen peritoneal catheter 100 and the first side 111 of the semipermeable membrane assembly 11. Specifically, the buffer container 13 can be connected to the first side 111 of the semipermeable membrane assembly 11 via a buffer line 14, which includes a first buffer passage 141 and a second buffer passage 142 connected to the first side 111.

[0104] In one embodiment, the flow control device can form a buffer circulating liquid flow C3 from the buffer container 13 back to the buffer container via the first side by controlling the flow direction and flow rate in the first buffer passage 141 and the second buffer passage 142, and form an external circulating liquid flow C1 from the inlet I1 via the second side 112 to the waste liquid outlet O1 by controlling the flow direction and flow rate in the first external liquid passage 1201 and / or the second external liquid passage 1202. A flow difference is created between the buffer circulating liquid flow C3 and / or the external circulating liquid flow C1 to allow the external liquid pipeline to periodically draw out dialysis waste liquid and add replenishing liquid. It should be noted that the formation method and working principle of the buffer circulating liquid flow C3 and the external circulating liquid flow C1 in this embodiment are different from those of the other embodiments. Figure 6B and Figure 6C The embodiments shown are similar, representing an equivalent dual-loop mode. For details, please refer to the documentation for... Figure 6B and Figure 6C The embodiments described herein will not be elaborated upon here.

[0105] by Figure 8The following is an explanation of dialysis work using a human peritoneal cavity filled with 2000mL of peritoneal dialysis fluid and a buffer container containing 500mL of peritoneal dialysis fluid as an example. The flow control device can be used to control the flow of the buffer circulating fluid C3 at a flow rate of 100mL / min. Within 30 minutes, the flow control device can control the injection of 600mL of liquid from the human peritoneal cavity into the buffer container 13 and then the return of 500mL from the buffer container 13 into the human peritoneal cavity (i.e., a net injection of 100mL of liquid into the buffer container 13). During this period, the flow control device also controls the flow rate of the external circulating fluid C1 toward the waste liquid outlet O1 to be 103.33mL / min and the inlet flow rate of the inlet I1 to be 100mL / min, so that the external circulating fluid C1 continuously carries out the metabolic waste liquid and excess water in the buffer circulating fluid C3.

[0106] In one implementation, the flow control device can control the flow direction and flow rate in the first buffer passage 141 and the second buffer passage 142 to form a buffer circulating fluid flow C3 that returns from the buffer container 13 to the buffer container via the first side, and coordinate with controlling the flow direction and flow rate of the first external fluid passage 1201 or the second external fluid passage 1202 so that the first external fluid passage 1201 and the second external fluid passage 1202 are used alternately for outputting the drawn dialysis waste fluid and adding replenishing fluid. In other words, compared to Figure 8 Instead of forming an external circulation flow C1, the flow direction and flow rate of the first external fluid passage 1201 and the second external fluid passage 1202 are controlled separately to achieve the purpose of drawing out dialysis waste fluid and adding replenishing fluid. Taking the example of a human peritoneal cavity infused with 2000mL of peritoneal dialysis fluid and a buffer container containing 500mL of peritoneal dialysis fluid, the flow control device can control the buffer circulation flow C3 to flow at a flow rate of 100mL / min. Within 30 minutes, the flow control device can control the injection of 600mL of liquid from the human peritoneal cavity into the buffer container 13 and then the return of 500mL from the buffer container 13 into the human peritoneal cavity (i.e., a net injection of 100mL of liquid into the buffer container 13). During this period, in the first 15 minutes, the flow control device can control the inlet I1 to inject 500mL of liquid across the membrane into the buffer container, and in the last 15 minutes, the flow control device can control the waste fluid outlet to draw 600mL of liquid out of the buffer container across the membrane. In other examples, the frequency can be further increased. For instance, in the first 5 minutes, 100 mL is injected into the buffer container through the inlet membrane, and in the next 5 minutes, 133.3 mL is withdrawn from the buffer container through the outlet membrane, and so on. Alternatively, in the first 1 minute, 100 mL is injected into the buffer container through the inlet membrane, and in the next 1 minute, 106.7 mL is withdrawn from the buffer container through the outlet membrane, and so on.

[0107] Please see Figure 9The figure shows a schematic diagram of the peritoneal dialysis system in one embodiment of the present application. As shown in the figure, the external fluid pipeline system 12 also includes a regeneration device 121 connected between the waste fluid outlet O1 and the fluid inlet I1. The regeneration device 121 is used to process the dialysis waste fluid discharged from the waste fluid outlet O1 to form a replenishing fluid which is then input into the fluid inlet I1.

[0108] In one embodiment, the regeneration apparatus includes a toxin treatment device for treating the dialysis waste liquid with toxins. It can be connected between the waste liquid outlet and the inlet to treat toxins in the dialysis waste liquid by decomposition and / or adsorption. In one example, the toxin treatment device can be configured as an adsorption device, the output of which is connected to the inlet, so that the liquid treated by the adsorption device is added to the inlet.

[0109] In some embodiments, the adsorption device may include one or more adsorption materials. The adsorption materials include activated carbon, cation exchangers, anion exchangers, urease, etc. The cation exchangers include zirconium phosphate or cation exchange resins, etc., and the anion exchangers include hydrated zirconium oxide, zirconium hydroxide, sodium zirconium carbonate, or anion exchange resins, etc. In one example, the adsorption device includes one adsorption material. For example, the adsorption device may contain only one activated carbon column. In another example, the adsorption device includes multiple adsorption materials. For example, the adsorption device is a mixed column of activated carbon and anion exchangers. Another example is a mixed column of activated carbon and cation exchangers. Yet another example is a mixed column of anion exchangers and cation exchangers. Still another example is a mixed column of activated carbon, anion exchangers, and cation exchangers. Yet another example is a mixed column of activated carbon, cation exchangers, anion exchangers, and urease. Activated carbon is used to adsorb organic matter, cation exchangers are used to adsorb various cationic substances, including potassium, calcium, and magnesium, and anion exchangers are used to adsorb various anionic substances, such as phosphate and acetate. The following examples illustrate this using an adsorption device containing multiple materials.

[0110] In some embodiments, the adsorption device includes a plurality of columns connected in series, each column containing one or more adsorbent materials, as described in the previous embodiments. In a specific example, columns containing zirconium phosphate, hydrated zirconium oxide, and activated carbon are arranged in series. It should be noted that this application does not limit the number of columns connected in series in the adsorption device; it may include two or more adsorption columns, and each adsorption column may include one or more adsorbent materials. In this embodiment, one or more of a pressure sensor, a degassing device, and a pH sensor may be provided between the plurality of columns connected in series.

[0111] In one embodiment, the regeneration device may further include a replenishment branch connected to the inlet for supplying replenishment fluid to the inlet. In one example, the replenishment branch may be located between the toxin treatment device and the inlet to supply replenishment fluid to the outlet and inlet of the toxin treatment device to form the replenishment fluid.

[0112] In one embodiment, the replenishing fluid branch is provided with a container for storing the replenishing fluid, and a replenishing fluid pump for conveying the replenishing fluid in the container to the replenishing branch. In one example, the substances contained in the replenishing fluid are, for example, the same substances contained in the replenishing fluid described in any of the foregoing embodiments, as can be seen in the foregoing description of the embodiments concerning the replenishing fluid. In one example, the replenishment solution may be configured as a concentrate, which, after being mixed with dialysis waste fluid treated with toxins, forms a replenishment solution that is delivered to the inlet. For example, the concentrate may be a concentrate of any or any combination of potassium, calcium, and magnesium, wherein the concentration range of the electrolyte may be configured to be from 0 to 1000 mmol / L. For example, the total concentration range of the electrolyte may be configured to be 0, 10 mmol / L, 20 mmol / L, 30 mmol / L, 40 mmol / L, 50 mmol / L, 60 mmol / L, 70 mmol / L, 80 mmol / L, 90 mmol / L, 100 mmol / L, 200 mmol / L, 300 mmol / L, 400 mmol / L, 500 mmol / L, 600 mmol / L, 700 mmol / L, 800 mmol / L, 900 mmol / L, or 1000 mmol / L.

[0113] In other embodiments, the regeneration device may be configured as a dialysate regeneration system as disclosed in patent CN119215253A, which includes a waste liquid passage, a reactor, and a regeneration liquid pipeline, with the waste liquid passage connected to a waste liquid outlet, the regeneration liquid pipeline connected to an inlet, and the reactor used to decompose toxins in the dialysate waste liquid.

[0114] In summary, this application discloses a peritoneal dialysis system that reprocesses the peritoneal dialysis fluid by introducing a semipermeable membrane component between the peritoneal tubing and the external fluid system. This allows water and small-molecule solutes to pass through while retaining large-molecule osmotic agents during the removal of dialysis waste fluid. In this process, metabolic waste and excess water from the peritoneal dialysis fluid on the first side are introduced to the second side so that the peritoneal dialysis fluid can be reused. As excess water leaves the first side and large-molecule osmotic agents are retained on the first side, the concentration of large-molecule osmotic agents in the peritoneal dialysis fluid remains stable. This maintains the osmotic pressure of the peritoneal dialysis fluid for continued dialysis without consuming large-molecule osmotic agents.

[0115] 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 system, characterized in that, include: Abdominal tubing, the first end of which connects to the human abdominal cavity; A semipermeable membrane assembly includes a membrane and a first side and a second side separated by the membrane, the first side being connected to a second end of the peritoneal tubing to receive peritoneal dialysis fluid from the peritoneal tubing and inject it into the peritoneal cavity of the human body. An external fluid system includes an external fluid line connected to the second side, the external fluid line including a waste fluid outlet for discharging dialysis waste fluid drawn from the peritoneal dialysis fluid via the membrane; wherein, when the peritoneal dialysis fluid is drawn out, the membrane allows water and small molecule solutes in the peritoneal dialysis fluid to permeate into the second side while retaining large molecule permeabilizers on the first side to maintain the osmotic pressure of the peritoneal dialysis fluid.

2. The peritoneal dialysis system according to claim 1, characterized in that, The external fluid line also includes an inlet for receiving replenishment fluid. The flow direction and flow rate of the peritoneal tubing and / or the external fluid line are controlled by a flow control device so that the external fluid line cooperates with the membrane to periodically draw out dialysis waste fluid and add replenishment fluid to the peritoneal dialysis fluid.

3. The peritoneal dialysis system according to claim 2, characterized in that, The dialysis efficiency can also be adjusted by changing the volume of output dialysis waste liquid and added replenishment liquid within the cycle through the flow control device. The change in volume can be controlled by changing the time and / or speed of output dialysis waste liquid and added replenishment liquid.

4. The peritoneal dialysis system according to claim 2, characterized in that, The peritoneal tubing includes a single-lumen peritoneal catheter, and the external fluid tubing includes a single-lumen external fluid catheter connected to the second side, the waste fluid outlet, and the fluid inlet. Under the control of the flow control device, the single-lumen external fluid catheter alternately outputs the dialysis waste fluid and adds the replenishing fluid to the peritoneal dialysis fluid during the cycle.

5. The peritoneal dialysis system according to claim 2, characterized in that, The abdominal conduit includes a single-lumen peritoneal catheter, and the external fluid conduit includes a first external fluid passage connecting the second side and the waste fluid outlet, and a second external fluid passage connecting the second side and the inlet.

6. The peritoneal dialysis system according to claim 5, characterized in that, The flow control device is used to control the flow direction and flow rate on the first external liquid passage and the second external liquid passage respectively to form an external circulating liquid flow from the inlet through the second side to the waste liquid outlet, and through the flow difference formed between the first external liquid passage and the second external liquid passage, so that the external circulating liquid flow can output the dialysis waste liquid and add the replenishing liquid within a cycle.

7. The peritoneal dialysis system according to claim 2, characterized in that, The external fluid conduit includes a single-lumen external fluid conduit connecting the second side, the waste fluid outlet, and the fluid inlet. The abdominal conduit includes a first internal fluid passage and a second internal fluid passage connecting the human abdominal cavity and the first side.

8. The peritoneal dialysis system according to claim 7, characterized in that, The flow control device is used to control the flow direction and flow rate of the first internal fluid passage and / or the second internal fluid passage to form an internal circulating fluid flow from the human peritoneum through the first side back to the human peritoneum. It also controls the flow direction and flow rate in the single-lumen external fluid catheter by forming a flow difference in the first internal fluid passage and the second internal fluid passage, so that the single-lumen external fluid catheter alternately outputs the dialysis waste fluid and adds the replenishing fluid to the peritoneal dialysis fluid during the cycle.

9. The peritoneal dialysis system according to claim 2, characterized in that, The abdominal cavity tubing includes a first internal fluid passage and a second internal fluid passage connecting the human abdominal cavity and the first side. The external fluid tubing includes a first external fluid passage connecting the second side and the waste fluid outlet, and a second external fluid passage connecting the second side and the inlet.

10. The peritoneal dialysis system according to claim 9, characterized in that, The flow control device is used to control the formation of an internal circulating fluid flow from the abdominal cavity through the first side back to the abdominal cavity and to control the formation of an external circulating fluid flow from the inlet through the second side to the waste fluid outlet. By coordinating the flow rate difference in the internal circulating fluid flow and / or the external circulating fluid flow, the external circulating fluid flow can output the dialysis waste fluid and add the replenishing fluid during the cycle.

11. The peritoneal dialysis system according to claim 1 or 2, characterized in that, It also includes a buffer container connected between the abdominal cavity tubing and the first side and / or connected between the second side and the external fluid tubing.

12. The peritoneal dialysis system according to claim 1, characterized in that, The external fluid system also includes a waste liquid container connected to the waste liquid outlet to receive the discharged dialysis waste liquid.

13. The peritoneal dialysis system according to claim 2, characterized in that, The external fluid system also includes a liquid dispensing device connected to the inlet to generate the replenishment liquid.

14. The peritoneal dialysis system according to claim 2, characterized in that, The external fluid system also includes a replenishment bag containing the replenishment fluid, which is connected to the inlet.

15. The peritoneal dialysis system according to claim 2, characterized in that, The external fluid system also includes a regeneration device connected between the waste liquid outlet and the inlet, used to process the dialysis waste liquid output from the waste liquid outlet to form the replenishment liquid, which is then delivered to the inlet.

16. The peritoneal dialysis system according to claim 15, characterized in that, The regeneration device includes an adsorption unit for treating the dialysis waste liquid for toxins.

17. The peritoneal dialysis system according to claim 16, characterized in that, The adsorption device is configured as a single mixed column containing multiple adsorbent materials, or as a plurality of columns connected in series, wherein each column contains one or more adsorbent materials.

18. The peritoneal dialysis system according to claim 16, characterized in that, The adsorption device comprises a single column of any one of activated carbon, anion exchanger, cation exchanger, and urease; or a mixed column formed by any combination of activated carbon, anion exchanger, cation exchanger, and urease.

19. The peritoneal dialysis system according to claim 15 or 16, characterized in that, The regeneration device includes a reactor for breaking down toxins in the dialysis wastewater.

20. The peritoneal dialysis system according to claim 15, characterized in that, The regeneration device includes a replenishment branch connected to the inlet for supplying replenishment fluid to the inlet.

21. The peritoneal dialysis system according to claim 20, characterized in that, The replenishment branch is equipped with a container for storing replenishment fluid and a replenishment fluid pump for conveying the replenishment fluid in the container to the replenishment fluid branch.

22. The peritoneal dialysis system according to claim 1, characterized in that, The membrane is also used to retain macromolecular substances that are beneficial to the human body when dialysis waste is drawn out.

23. The peritoneal dialysis system according to claim 1, characterized in that, The macromolecular penetrant is configured as icodextrin.

24. The peritoneal dialysis system according to claim 1, characterized in that, The membrane is configured as a tubular membrane, a hollow fiber membrane, a flat sheet membrane, or a spiral wound membrane.

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