Flow channel box of dialysis equipment and portable dialysis equipment

Abstract

According to the flow channel box (13) of the dialysis equipment and the portable dialysis equipment, a plurality of fluid channels (1313) for controlling fluid to flow forwards or backwards through air pressure are arranged in a box body of the flow channel box (13); a plurality of independent first pneumatic interfaces (1322) which are respectively butted with a plurality of second pneumatic interfaces (103) of the dialysis equipment are arranged on a box body of the flow channel box (13), so that a pneumatic system in the dialysis equipment can control fluid in a fluid channel (1313) to flow forwards or backwards by utilizing air pressure after the flow channel box (13) is butted with the second pneumatic interfaces (103) by a user; the operation complexity and the operation threshold are greatly reduced, the integration level of dialysis equipment is higher, the size is smaller, and dialysis treatment in the scenes such as first aid, travel, rescue and relief work and home is particularly facilitated.

Description

Flow channel box of dialysis equipment and portable dialysis equipment Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a flow channel box of a dialysis device and a portable dialysis device. Background Art

[0002] Dialysis includes hemodialysis and peritoneal dialysis. Hemodialysis involves removing blood from the body, removing toxins through various physical and chemical methods, and then returning it to the body. Hemodialysis involves drawing blood from the body, passing it through the permeable membranes and hollow fiber membranes of a hemodialysis machine, removing metabolic waste products, impurities, and excess water, and then returning the purified blood to the body. Currently, over 3.6 million patients with end-stage renal disease (ESRD) worldwide are receiving hemodialysis treatment, and the number is increasing annually. Peritoneal dialysis involves injecting dialysate into the peritoneal cavity, using the body's peritoneal membrane to filter out metabolic waste products and excess water. It is an alternative treatment for kidney failure, in addition to hemodialysis. For example, the vast majority of hemodialysis patients worldwide require three weekly visits to a dialysis center, each lasting approximately four hours. The travel and treatment often leave patients exhausted, and this daily routine contributes to unemployment rates exceeding 80%.

[0003] Home hemodialysis (HHD), a treatment method that has gained popularity in recent years, is performed in the patient's home. HHD is not restricted by time or location, allowing patients to schedule treatment based on their needs and schedule in a more comfortable and relaxed environment, providing greater flexibility and convenience. At the same time, HHD requires patients or their families to learn how to operate the equipment and handle related matters, thus increasing patient autonomy.

[0004] However, for the current dialysis equipment for home hemodialysis, such as Nxstage Medical Inc. Outset Medical Inc. and Quanta Dialysis Technologies, LTD of the UK SC+ brand dialysis equipment consumes a large amount of water during treatment and requires additional water treatment equipment. As a result, the overall size and weight of the equipment are still large, and the operational convenience and cost control are still unsatisfactory.

[0005] Therefore, how to make the dialysis equipment for home dialysis smaller and more portable, more integrated, and more convenient to operate is a technical problem that needs to be solved urgently.

[0006] Summary of the Invention

[0007] In view of the shortcomings of the above-mentioned related technologies, the purpose of this application is to provide a flow channel box for a dialysis device and a portable dialysis device to solve the technical problems of the existing dialysis device in the art, such as cumbersome and complicated operation and large size.

[0008] To achieve the above-mentioned objectives and other related objectives, the present application provides, in a first aspect, a flow channel box for a dialysis device, comprising a box body detachably mounted on the body of the dialysis device, wherein the interior of the box body is provided with a plurality of fluid channels for controlling the forward or reverse flow of the fluid by air pressure, and the corresponding combination of the box body is provided with at least one first pneumatic interface on one side of the body of the dialysis device, wherein the first pneumatic interface is used to connect to the second pneumatic interface of the dialysis device to connect to the pneumatic system of the dialysis device; the box body is also provided with a plurality of fluid interfaces for connecting to liquid pipelines outside the box.

[0009] According to a second aspect of the present application, a portable dialysis device is disclosed, comprising: a portable housing, comprising a lower housing and an upper housing that can be opened and closed relative to the lower housing, the upper housing and the lower housing defining an internal space; in a transport or non-operating state, the upper housing and the lower housing are closed; in an operating state, the upper housing is opened upward relative to the lower housing; a first mounting surface is located in the upper housing and is in an upright position with an angle of 70°-110° to a horizontal plane when the portable housing is opened, a plurality of fluid containers are mounted on the first mounting surface, the plurality of fluid containers can be in an upright position when the portable housing is opened; a pipeline is arranged in the internal space defined by the portable housing, comprising a blood circuit for connecting to a human body and a dialysate circuit for connecting to the blood circuit, a portion of the pipeline being connected to the plurality of fluid containers; a second mounting surface is located in the lower housing and is in a horizontal position when the portable housing is opened, a plurality of drive devices for driving fluid to circulate in the pipeline are fixed to the second mounting surface.

[0010] In summary, the dialysis device provided by the present application is provided with a plurality of fluid channels that control the forward or reverse flow of the fluid by air pressure inside the box body of the flow channel box, and at least one first pneumatic interface that is docked with the second pneumatic interface of the dialysis device is provided on the box body of the flow channel box, so that after the user docks the flow channel box with the second pneumatic interface, the pneumatic system in the dialysis device can use air pressure to control the forward or reverse flow of the fluid in the fluid channel. In other words, the flow channel box body is integrated with a plurality of pumps and valves, and the pneumatic system can control the forward or reverse flow of the fluid in the fluid channel by using air pressure to control the pumps and valves through the second pneumatic interface. Therefore, the present application greatly reduces the complexity and operational threshold of the operation, and the dialysis device has a higher degree of integration and a smaller device size, which is particularly beneficial for dialysis treatment in scenarios such as first aid, travel, disaster relief, and home.

[0011] In addition, the portable dialysis equipment provided in the present application arranges the core components of the dialysis operation, such as the dialyzer, pump device, pipeline, sensor, etc., in a portable box through a rational layout, and through the design of the blood circuit and the dialysate circuit, the dialysis operation can be completed based on the various modular functions provided by a portable box. The portable dialysis equipment is unfolded when in use and closed when transported or not in use, which greatly reduces the operating threshold and the size of the equipment. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The specific features of the present application are set forth in the appended claims. The features and advantages of the present invention can be better understood by referring to the exemplary embodiments described in detail below and the accompanying drawings. A brief description of the drawings is as follows:

[0013] FIG1 is a schematic diagram showing the structure of a portable dialysis device according to an embodiment of the present application.

[0014] FIG2 is a schematic diagram showing the circuit and principle of the portable dialysis device of the present application in one embodiment.

[0015] FIG3 is a schematic diagram showing a venous pot and a gas collecting chamber in a blood circuit of the present application in one embodiment.

[0016] FIG4 is a schematic diagram showing a blood circuit of the present application in another embodiment adopting a gas collecting chamber with another structure.

[0017] FIG5 is a schematic structural diagram of an adsorption device according to an embodiment of the present application.

[0018] FIG6 is a schematic diagram showing the principle of the portable dialysis device of the present application in another embodiment.

[0019] FIG7 is a schematic structural diagram of another embodiment of the adsorption device of the present application.

[0020] FIG8 is a schematic diagram showing the portable dialysis device of the present application in an open state in one embodiment.

[0021] FIG9 is a schematic diagram showing an application of a portable dialysis device in one embodiment of the present application.

[0022] FIG10 is a schematic structural diagram of a portable dialysis device without a flow channel box in one embodiment of the present application.

[0023] FIG. 11 is a schematic diagram showing the structure of the flow channel box from a front perspective in one embodiment of the present application.

[0024] FIG. 12 is a schematic structural diagram showing a back view of a flow channel box in one embodiment of the present application.

[0025] FIG13 a is a schematic diagram showing a partial structure of a box body in one embodiment of the present application.

[0026] FIG13 b shows a cross-sectional view taken along line AA in FIG13 a.

[0027] FIG14 is a schematic structural diagram of the gas collecting chamber of the present application in one embodiment.

[0028] FIG15 is a schematic structural diagram of the gas collecting chamber of the present application in another embodiment.

[0029] FIG16 is a schematic structural diagram of the gas collecting chamber of the present application in yet another embodiment.

[0030] FIG17 is a schematic structural diagram of the gas collecting chamber of the present application in another embodiment.

[0031] FIG18 is a schematic diagram showing an application of a reaction pot of a metabolic circulation device in one embodiment of the present application.

[0032] FIG. 19 a and FIG. 19 b are schematic structural diagrams showing a metabolic circulation device according to an embodiment of the present application.

[0033] FIG. 20 is a schematic diagram showing the fluid flow direction of the blood circuit of the present application in a flushing embodiment.

[0034] FIG. 21 is a schematic diagram showing the principle of a pneumatic system in one embodiment of the present application.

[0035] FIG22 is a schematic diagram showing the principle of a pneumatic system in another embodiment of the present application.

[0036] FIG23 is a schematic diagram showing the structure of a portable dialysis device according to another embodiment of the present application.

[0037] FIG. 24 is a schematic diagram showing the component layout on the first and second mounting surfaces of the portable dialysis device shown in FIG. 23 .

[0038] FIG. 25 is a schematic diagram showing the back side of the first mounting surface of the portable dialysis device shown in FIG. 23 .

[0039] FIG26 is a schematic diagram showing the back side of the second mounting surface of the portable dialysis device shown in FIG23 . DETAILED DESCRIPTION

[0040] The following describes the implementation of the present application through specific embodiments. People familiar with this technology can easily understand other advantages and effects of the present application from the contents disclosed in this specification.

[0041] As described in the background art, although home hemodialysis has advantages over traditional hemodialysis such as flexibility and convenience, dialysis equipment for home hemodialysis is often larger in size, less integrated, and less convenient to operate.

[0042] In the related art, in order to reduce the number of pipes that the user needs to connect before dialysis, the integration and convenience of operation of the dialysis equipment are improved. The pump in the dialysate circuit of the dialysis equipment is set as a membrane pump, and the liquid cavity (also referred to as the fluid cavity) in the membrane pump and the membrane that seals the fluid cavity are integrated on a pressure plate consisting of a fluid cavity and a membrane. Correspondingly, the drive cavity (also referred to as the gas cavity) of the membrane pump is arranged on the dialysis equipment in an irremovable manner. Before dialysis, the user fixes the pressure plate as a disposable consumable on the dialysis equipment. During this process, the membrane of the pressure plate needs to be covered on the gas cavity in a strictly airtight manner to form the drive cavity of the membrane pump. Subsequently, when the dialysis equipment is performing dialysis, the pneumatic system in the dialysis equipment controls the downward deformation or upward deformation of the membrane by introducing positive pressure airflow or negative pressure airflow into the gas cavity, thereby controlling the fluid cavity to push or pump fluid (such as dialysate, etc.).

[0043] In this way, although the integration and convenience of the dialysis equipment can be improved to a certain extent, the pressure plate is fixed to the dialysis equipment by the user before operation. Due to the uncertainty of human operation, it is difficult to ensure the sealing between the membrane of the pressure plate and the gas cavity on the dialysis equipment. For example, due to careless operation, the membrane does not tightly cover the driver and indicates pressure leakage, which will affect the normal operation of the dialysis equipment. What's more, in the case of improper human operation, aging and deformation of the sealing ring on the dialysis equipment after long-term use, or accidental damage to the membrane in the pressure plate, the membrane and the gas cavity cannot maintain good sealing, which will cause the actual amount of liquid sucked or pushed to be inconsistent with the theoretical value or the expected treatment control.

[0044] In view of this, the present application proposes a flow channel box for a dialysis device and a portable dialysis device, wherein a plurality of fluid channels for controlling the forward or reverse flow of the fluid by air pressure are provided inside the box body of the flow channel box, and a plurality of independent first pneumatic interfaces respectively connected to the plurality of second pneumatic interfaces of the dialysis device are provided on the box body of the flow channel box, so that after the user connects the flow channel box with the second pneumatic interfaces, the pneumatic system in the dialysis device can use air pressure to control the forward or reverse flow of the fluid in the fluid channel, thereby greatly reducing the complexity and threshold of operation, and the dialysis device has a higher degree of integration and a smaller device size, which is particularly beneficial for dialysis treatment in scenarios such as first aid, travel, disaster relief, and home.

[0045] In the present application, the portable dialysis equipment includes, but is not limited to, blood purification equipment, extracorporeal circulation clearance system, extracorporeal enrichment and clearance equipment, hemodialysis equipment, plasma exchange equipment, extracorporeal peritoneal dialysis equipment, or extracorporeal membrane oxygenation equipment. Among them, the blood purification equipment includes, but is not limited to, hemodialysis (HD), hemofiltration (HF), hemodiafiltration (HDF), hemoperfusion (HP), blood exchange (PE), immunoadsorption (IA) and continuous blood purification (CRRT), peritoneal dialysis (PD) and other equipment.

[0046] In some embodiments, the portable dialysis device can also be a component module that is integrated into other extracorporeal circulation devices, such as artificial livers, artificial kidneys, hemodialysis devices, peritoneal dialysis devices, plasma exchange devices, plasma purification devices, blood lipid purification devices, molecular adsorption recirculation systems, extracorporeal membrane oxygenation devices, leukocyte removal devices, extracorporeal circulation life support systems, etc. In other words, the portable dialysis device described in this application can be used as a medical device or therapeutic device on its own, or it can be integrated into other medical devices or devices involving the extracorporeal treatment of blood or other body fluids to form a new device.

[0047] In one embodiment, the portable dialysis device adopts a dialysis device with a dialysate circulation regeneration mode, which is called a dialysate regeneration type dialysis machine, which includes a dialysate regeneration type hemodialysis machine and a dialysate regeneration type peritoneal dialysis machine. The biggest advantage of this type of dialysis machine is that it does not require a water source and a water treatment system to obtain regeneration fluid, so it is small and portable and suitable for home dialysis treatment. The "regeneration fluid" refers to the dialysis waste liquid after the dialysate is exchanged with blood or peritoneal fluid. It is treated with adsorbent materials and enzymes (such as catalytic decomposition and adsorption treatment) to remove some or most of the toxins or toxic molecules in the dialysis waste liquid, and supplemented with beneficial or necessary molecules such as potassium, calcium, and magnesium to form a dialysis waste liquid regeneration fluid, referred to as regeneration fluid. The regeneration fluid can be regarded as fresh dialysate, which is exchanged with blood or peritoneal fluid again, and circulated repeatedly in this way to continuously remove toxins in the blood or peritoneal fluid to achieve the purpose of treatment.

[0048] In another embodiment, the portable dialysis device may also be a single-pass dialysis device. In this embodiment, the dialysate used by the dialysis device is non-regenerative.

[0049] In the following embodiments of the present application, a portable dialysis device will be described as a hemodialysis device that adopts a dialysate circulation regeneration mode.

[0050] Please refer to Figures 1 and 2. Figure 1 shows a schematic diagram of the composition structure of the portable dialysis device of the present application in one embodiment, and Figure 2 shows a schematic diagram of the circuit and principle of the portable dialysis device of the present application in one embodiment. As shown in the figure, the portable dialysis device includes: an arterial blood line L1, a dialysate regeneration flow path L2, a venous blood line L3, a dialysis device 30, and a control device 90.

[0051] The arterial blood line L1 is configured to access a first portion of the human body (e.g., a human arterial vessel) via an arterial end 20. The dialysate regeneration flow path L2 is connected to the dialysis device 30. The venous blood line L3 is configured to access a second portion of the human body (e.g., a human venous vessel). In certain embodiments, such as when a patient's blood vessels are in poor condition, such as with single-needle dialysis or a PICC central venous catheter, the first and second portions of the human body may be the same.

[0052] Please refer to Figures 3 and 4 in combination with Figure 2. Figure 3 shows a schematic diagram of the venous pot and the air collecting chamber in the blood circuit of the present application in one embodiment. Figure 4 shows a schematic diagram of the blood circuit of the present application in another embodiment using an air collecting chamber with another structure. As shown in the figure, the venous blood line L3 is provided with an air collecting chamber 80; the air collecting chamber 80 is used to enrich the gas in the blood circuit when the fluid in the blood circuit flows from the venous blood line L3 to the arterial blood line L1; in an embodiment, the blood circuit includes an arterial blood line L1 connected to the dialysis device 30, a dialysis path (dialysis fluid regeneration path in the figure) L2, and a venous blood line L3 connected to the dialysis device 30.

[0053] In the subsequent FIG. 20 , the venous end of the arterial blood line L1 and the venous end 86 of the venous blood line L3 are interconnected, forming a closed circulation loop. In the present application, this circulation loop serves as a priming loop during a priming procedure, a flushing loop during a flushing procedure, and a draining loop during a draining procedure, as described in detail below.

[0054] In some embodiments, the gas collecting cavity is, for example, the gas collecting cavity described in patent WO2024017065A1; in this application, the entire text of patent document WO2024017065A1 is cited here.

[0055] It should be noted that in the present application, the dialysis pathway L2 includes a dialysate regeneration path, so both are identified by the reference number L2 in the figures.

[0056] In the treatment mode of the dialysis device (as shown in FIG9 ), an arterial puncture needle is connected to the distal end of arterial blood line L1 via a connector, and a drive device 23, such as a peristaltic blood pump, is provided midway therefrom. Meanwhile, a venous puncture needle is connected to the distal end of venous blood line L3 via a connector, and a drip chamber / venous pot or a gas collection chamber 80 that also functions as a drip chamber is connected midway thereto. Furthermore, during dialysis treatment, the arterial puncture needle and the venous puncture needle are inserted into the target arterial and venous vessels of the patient's body, respectively. When the blood pump is activated, the patient's blood flows through arterial blood line L1 to dialysis device 30. The blood is then purified by dialysis device 30, debubbled in the drip chamber / venous pot, and returned to the patient's body via venous blood line L3. In other words, the patient's blood is circulated from the distal end of arterial blood line L1 to the distal end of venous blood line L3 in the extracorporeal circulation loop, while being purified by dialysis device 30.

[0057] The dialysis device 30 is provided on the blood circuit and is used to purify the fluid flowing in the arterial blood line L1. The dialysis device 30 includes a dialysate output end connected to the input end of the waste liquid passage of the dialysate regeneration flow path L2, and a dialysate input end connected to the output end of the regeneration fluid pipeline of the dialysate regeneration flow path L2.

[0058] In an embodiment, the dialysis device 30 includes a dialyzer (the dialysis device 30 is also referred to as a dialyzer, and in subsequent embodiments, the dialyzer is also labeled 30). The dialyzer 30 includes a dialysate chamber, a blood chamber, and a semi-permeable membrane, etc. The membrane separates the dialysate chamber and the blood chamber from each other. In a commonly used capillary dialyzer, the blood chamber is formed by the entire internal volume of the hollow fibers, and the dialysate chamber is formed by the inner cavity of the shell of the dialyzer 30 surrounding the hollow fibers. In an embodiment, the top end of the dialyzer 30 is connected to the arterial blood line L1, and the bottom end of the dialyzer 30 is connected to the venous blood line L3. The type of the dialyzer 30 can include a hemodialyzer, a hemodiafilter, a hemofilter, a plasma separator, a blood plasma component separator, and other instruments of various specifications or uses. As long as the instrument can separate toxins or molecular components in the blood, the present application can be used. In an embodiment, the top end of the dialyzer 30 is connected to the arterial blood line L1 , and the bottom end of the dialyzer 30 is connected to the venous blood line L3 .

[0059] The driving device 23 is provided on the arterial blood line L1 and is located in the blood circuit, and is used to drive the fluid to flow in the arterial blood line L1, the dialysis device 30, and the venous blood line L3; in an embodiment, the driving device 23 includes but is not limited to a peristaltic pump, a pneumatic diaphragm pump, or a pressure pump, which is used to provide power to the fluid in the pipeline so that the fluid circulates in a preset flow direction. Here, in an application scenario for medical purposes, the driving device 23 may not directly contact the fluid, but only apply pressure to the pipeline and drive the fluid to flow. The preferred embodiment of the driving device is a non-contact pump device such as a peristaltic pump or a pneumatic diaphragm pump. More specifically, the peristaltic pump is, for example, a blood pump. The forward and reverse rotation (reversal) of the peristaltic pump will cause the flow direction of the fluid in the circulation loop to be different. In dialysis operations, the driving device 23 is also called a blood pump.

[0060] In one embodiment, the portable dialysis device includes multiple drive devices, such as a blood pump located in the blood circuit, a dialysate pump 46 located in the dialysate regeneration flow path L2, and a secondary circulation pump 68. The dialysate regeneration flow path L2 also includes an ultrafiltration pump 51 and a supplemental fluid pump 74, which will be described in detail below.

[0061] It should be understood that the driving device 23 can drive the fluid in the pipeline at different positions in the pipeline, and its flow rate may change due to factors such as pipeline resistance, temperature, and pressure in the direction of fluid flow. However, in the embodiment provided in the present application for application in the field of hemodialysis, the driving device 23 is arranged on the circulation loop, especially on the arterial blood line L1 of the blood circuit.

[0062] The control device 90 is used to execute a treatment mode to purify the fluid flowing in the blood circuit and then input it into the human body. In an embodiment, the control device 90 is, for example, a controller or system processor of a hemodialysis device, which outputs corresponding control instructions through a program written into the system processor; or receives trigger instructions input by an operator through an input device such as a touch screen to execute relevant control instructions. In one embodiment of the portable dialysis device of the present application, the control device 90 is a main control board disposed on the second mounting surface 111, as shown in Figure 26.

[0063] As shown in FIG2 , the dialysate regeneration flow path L2 includes a waste liquid path, a secondary circulation device L2-4, an adsorption device 70, and a regeneration liquid pipeline L2-7. In one embodiment, the input end of the waste liquid path L2-1 of the dialysate regeneration flow path L2 is connected to the outlet of the dialysate waste liquid through a pipeline valve 40; the output end of the waste liquid path L2-1 is connected to the secondary circulation device, and the input end of the secondary circulation device is connected to the outlet of the waste liquid path L2-1, for metabolic circulation (also referred to as secondary circulation) of the input dialysate waste liquid for primary toxin treatment; the input end of the adsorption device 70 is connected to the output end of the secondary circulation device, for secondary toxin treatment of the waste liquid after the primary toxin treatment of the secondary circulation device to generate regeneration liquid; the inlet of the regeneration liquid pipeline L2-7 is connected to the adsorption device 70 for outputting the regeneration liquid, which is finally input into the dialyzer 30 through a pipeline valve 78.

[0064] In one embodiment, a preparation such as enzyme-loaded microspheres can be added to the secondary circulation device, and the preparation is circulated in the circulation line by the drive of the drive device 46 of the dialysate pump 46. Specifically, the dialysis waste liquid to be processed containing a high concentration of target molecules enters the secondary circulation device through the inlet, and the target molecule preparation is decomposed into corresponding products. The reaction filter 67 provided in the secondary circulation device continuously separates the treated liquid and traps the preparation in the secondary circulation device. The treated liquid flows out of the secondary circulation device through the reaction filter 67 and is then processed by the adsorption module 70 to produce a dialysis regeneration liquid. After adding a supplementary liquid in the regeneration liquid pipeline, for example, potassium, calcium, and magnesium ions, pH buffers, etc., it is used again for the process of dialysis. In certain embodiments, the reaction filter 67 can also be referred to as a metabolic filtration module or a metabolic filter (in each embodiment of the present application, the reaction filter, metabolic filtration module, and metabolic filter are all labeled 67). In one embodiment, the supplementary liquid can be a regeneration liquid supplemented with electrolyte ions such as potassium, calcium, and magnesium and adjusts the pH value. Specifically, the replenishing solution includes, for example, cations such as potassium, calcium, and magnesium ions, and anions such as chloride, acetate, and citrate. For example, the replenishing solution is a prefabricated sterile, pyrogen-free solution. The replenishing solution container 75 contains 1-3 L of the prefabricated sterile, pyrogen-free solution. The 1-3 L replenishing solution contains 20-50 mM potassium ions, 20-50 mM calcium ions, 10-25 mM magnesium ions, and chloride, acetate, and citrate ions.

[0065] In some embodiments, the adsorption device 70 is used to adsorb toxin molecules in dialysis wastewater. The adsorption device includes at least one of an activated carbon layer, a cation exchange material layer, and an anion exchange material layer. Please refer to Figure 5 for a schematic structural diagram of an adsorption device according to one embodiment of the present application. As shown, the adsorption device is an adsorption column comprising an activated carbon layer, a cation exchange material layer, and an anion exchange material layer. As shown in Figure 5, the adsorption device includes four material layers. In terms of the flow direction of the dialysis wastewater, the first material layer is an activated carbon layer, the second material layer located downstream of the activated carbon layer is a cation exchange material layer, the third material layer located downstream of the cation exchange material layer is an anion exchange material layer, and the fourth material layer located downstream of the anion exchange material layer is an activated carbon layer. The cation exchange material is a cation exchange resin or zirconium phosphate, and the anion exchange material is an anion exchange resin, zirconium oxide, or sodium zirconium carbonate. In other examples, the adsorption device may include multiple cation exchange material layers and / or anion exchange material layers, or may include only one activated carbon layer.

[0066] It should be noted that, in other embodiments, the adsorption device 70 may further include other material layers such as urease. For example, the adsorption device includes six material layers. According to the flow direction of the dialysis waste liquid, the first material layer is an activated carbon layer, the second material layer is a zirconium phosphate layer, the third material layer is a urease layer, the fourth material layer is a zirconium phosphate layer, the fifth material layer is a zirconium oxide layer, and the sixth material layer is an activated carbon layer.

[0067] In one embodiment, the adsorption device shown in FIG5 is located downstream of the secondary circulation device and is used to adsorb toxins such as ammonium ions formed after the decomposition of creatinine, phosphate, and urea, as well as potassium, calcium, magnesium, and other ions in the dialysis wastewater.

[0068] In another embodiment, the adsorption device includes a first adsorption device and a second adsorption device. Please refer to Figure 6, which shows a schematic diagram of the principle of the portable dialysis device of the present application in another embodiment. As shown in the figure, the first adsorption device 701 is located upstream of the secondary circulation device. In other words, the output end of the first adsorption device 701 is connected to the input end of the secondary circulation device through a pipeline, and the second adsorption device 702 is located downstream of the secondary circulation device. In other words, the input end of the second adsorption device 702 is connected to the output end of the secondary circulation device through a pipeline. In this embodiment, the first adsorption device 701 and the second adsorption device 702 can be independent consumables. The structure of the first adsorption device is shown in Figure 5, which is mainly used to adsorb potassium, calcium, magnesium and other ions in the dialysis waste liquid. The structure of the second adsorption device is also as shown in Figure 5, but its column is larger than the column of the first adsorption device. It is mainly used to adsorb toxins such as ammonium ions formed after the decomposition of creatinine, phosphate and urea, and also adsorbs potassium, calcium, magnesium and other ions.

[0069] In another embodiment, the adsorption device 70' includes a first adsorption device 701' and a second adsorption device 702'. Please refer to Figure 7, which is a schematic structural diagram of the adsorption device of the present application in another embodiment. As shown in the figure, the first adsorption device 701' and the second adsorption device 702' are integrated together, but the first adsorption device 701' and the second adsorption device 702' are separated from each other and independent of each other in terms of pipeline connection, that is, the first adsorption device 701' is still located upstream of the secondary circulation device, and the second adsorption device 702' is still located downstream of the secondary circulation device. It should be noted that the adsorption materials in the first adsorption device 701' and the second adsorption device 702' are the same, but the filler amount, filler ratio, or column size may be different. For example, the column of the first adsorption device 701' is smaller than the column of the second adsorption device 702'.

[0070] In one embodiment, the present application provides a portable box in which the above-mentioned arterial blood line L1, dialysate regeneration flow path L2, venous blood line L3, dialysis device 30, and part of the control device 90 are arranged, so that the dialysis equipment is small and convenient, and more suitable for the needs of home hemodialysis.

[0071] In one embodiment, the present application provides a portable box for arranging the purification circuit, dialysis device, drive device, control device, and part or main part of the dialysate regeneration circulation system shown in Figure 2 in the portable box, so as to make the dialysis equipment small and convenient, and more suitable for the needs of home hemodialysis.

[0072] Please refer to Figure 8, which shows a schematic diagram of the open state of the portable dialysis device of the present application in one embodiment. As shown in the figure, the portable case includes an upper case 10 and a lower case 11. The upper case 10 and the lower case 11 define an internal space. The upper case 10 can move relative to the lower case 11 and can enable the case to be opened or closed. In an embodiment, the upper case 10 and the lower case 11 are movably connected by a hinge on one side. When the upper case 10 and the lower case 11 are closed, the first mounting surface 101, the second mounting surface 111, and the components / parts and pipelines respectively arranged on the first mounting surface 101 and the second mounting surface 111 can be enclosed in the internal space thereof, so that the case can be moved or carried.

[0073] In this embodiment, the first mounting surface 101 includes a fluid channel integrated board 13 that connects the blood circuit and the dialysate circuit. The fluid channel integrated board 13 is provided with multiple channels for fluid circulation. The channels include, for example, the venous line L1, arterial line L3, and the waste liquid passage and regeneration liquid pipeline L2 in the dialysate regeneration circulation system shown in FIG2 . The channels for fluid circulation in the fluid channel integrated board 13 have interfaces or ports for connecting to external liquid containers, which are used to connect to circuits, containers, or devices external to the fluid channel integrated board 13 through external pipelines. In this embodiment, the external liquid container includes an ultrafiltration container 52, a replenishing liquid container 75, a prefabricated liquid container 45, an adsorption device 70, a hollow fiber filter, and / or a microsphere recovery bag, etc., and the driving device includes, for example, a blood pump 23, a dialysate pump 46, an ultrafiltration pump 51, a replenishing liquid pump 74, a metabolic circulation pump 68, an air pump 65 and other driving devices. The device is also, for example, various sensor devices in the purification circuit or the dialysate circuit for detecting flow, temperature, pressure, the presence of sodium, the presence of ammonia, pH level, leaked blood, closed or air bubbles; or various valve devices for switching passages or opening and closing passages.

[0074] In one embodiment, the fluid containers mounted on the flow channel integrated board 13 include a dialyzer 30, a collection container 60 (in subsequent embodiments, the collection container is also referred to as a reaction pot, and the reaction pot is also labeled 60), a metabolic filter 67, an arterial pot 24, or a venous pot 81. The flow channel integrated board 13 is provided with a mounting structure for mounting the fluid containers. The mounting structure, for example, is a snap-fit ​​structure. The fluid container holder 102 is snap-fitted to the flow channel integrated board 13 and connects to the corresponding internal channels of the flow channel integrated board 13. As shown in FIG8 , the dialyzer 30 can be snap-fitted to one side of the flow channel integrated board 13, and the metabolic filter 67 can be snap-fitted to the other side. The dialyzer 30, the flow channel integrated board 13, and the metabolic filter 67 are generally shaped like an "H." When the portable case is opened, the dialyzer 30 is perpendicular to the horizontal plane at 90 degrees. The multiple fluid containers located on the first mounting surface 101 are also vertically upright relative to the horizontal plane.

[0075] In the embodiment shown in Figure 8, by opening multiple channels in the flow channel integrated board 13, the pipelines / lines of various functions can be independently connected to the various components in their circuits, and these pipelines / lines can be integrated into one board, which not only simplifies the line access operation, but more importantly, simplifies the space in the portable box.

[0076] Please refer to Figures 9 and 10. Figure 9 shows an application diagram of a portable dialysis device in one embodiment of the present application. Figure 10 shows a structural diagram of a portable dialysis device in one embodiment of the present application without a flow channel box. As shown in the figure, the portable dialysis device includes a portable case, a first mounting surface 101, a pipeline, and a second mounting surface 102.

[0077] The portable case includes an upper case 10 and a lower case 11. The upper case 10 and the lower case 11 define an interior space. The upper case 10 is movable relative to the lower case 11, allowing the case to be opened or closed. In one embodiment, the upper case 10 and the lower case 11 are movably connected by a hinge on one side. When the upper case 10 and the lower case 11 are closed, the first mounting surface 101, the second mounting surface 102, and the components respectively disposed on the first mounting surface 101 and the second mounting surface 102 are enclosed in the interior space, facilitating the case to be moved or carried.

[0078] In one embodiment, the portable case is provided with a handle 14, which is disposed on the exterior side of the upper case 10 or the lower case 11. For example, the handle 14 is disposed on the side of the portable case opposite the hinge. As shown in FIG8 , the handle 14 is disposed on the exterior side of the lower case 11. In one embodiment, a locking structure (not shown) is further disposed between the upper case 10 and the lower case 11. When the upper case 10 and the lower case 11 are closed, the user can lock the two and lift the handle 14 to move or carry the portable case.

[0079] In one embodiment, a support arm is provided between the lower box body 11 and the upper box body 10 for maintaining the first mounting surface 101 at a preset angle relative to the second mounting surface 102 when the portable box body is in the open state (not shown in Figure 8, refer to the example of Figure 23). In one example, the support arm is two pairs of folding arms, which are respectively provided on the left and right sides of the portable box body. Specifically, one end of each pair of folding arms is fixed to the inner wall of the lower box body 11, and the other end is fixed to the inner wall of the upper box body 10. When the box body is opened, the two pairs of folding arms maintain the unfolded state of the lower box body 11 and the upper box body 10 through their own damping characteristics, that is, maintain the first mounting surface 101 at a preset angle relative to the second mounting surface 102, for example, an angle of 70°-110°. However, this is not limited to this. In other embodiments, the first mounting surface 101 can also be at other preset angles relative to the second mounting surface 102, such as 30°, 10°, etc. For example, when the portable box is opened, the first mounting surface 101 can also be parallel to the horizontal plane.

[0080] In one embodiment, the first mounting surface 101 is located in the upper box 10. When the portable box is opened, it is in an upright position with an angle of 70°-110° to the horizontal plane, for example, preferably in a vertical position of about 90°.

[0081] In one embodiment, the first mounting surface 101 is located in the upper case 10 and is in an upright position at an angle of 70°-110° to the horizontal plane when the portable case is opened. A plurality of fluid containers are mounted on the first mounting surface 101, and the plurality of fluid containers can be in an upright position when the portable case is opened. In a preferred embodiment, when the portable case is opened and is perpendicular to the horizontal plane at approximately 90°, the plurality of fluid containers located on the first mounting surface 101 are also in an upright position relative to the horizontal plane. In one embodiment, the plurality of fluid containers are detachably mounted on the first mounting surface 101, and the plurality of fluid containers mounted on the first mounting surface 101 include an arterial pot 24 connected to the blood circuit, a venous pot 81, a dialyzer 30, or a collection container 60 connected to the dialysate circuit, and / or a metabolic filter 67, etc.

[0082] In the embodiment shown in Figure 8, the flow channel integrated plate includes a flow channel box. It can also be understood that the flow channel box is a part of the flow channel integrated plate, or the entire flow channel integrated plate can also be called the flow channel box. To facilitate the subsequent description in combination with the diagram, in each embodiment of the present application, the flow channel integrated plate and the flow channel box are marked with the number 13 in the diagram.

[0083] In one embodiment, the first mounting surface 101 is an integral part of the upper housing 10. For example, the first mounting surface 101 may be the inner side of the upper housing 10, such as including the planar portion of the inner wall of the upper housing 10 and the surrounding curved or curved portions. For example, the flow channel box 13 may be mounted on the inner side of the upper housing 10. The flow channel box 13 will be described in detail later. As shown in Figure 10, multiple contact sensors and non-contact sensors for monitoring the operating status of the device (such as the blood leakage sensor 41, the venous pressure sensor 21, the dialysate outlet pressure sensor 79, the liquid level sensor 61, the color sensor 62, the temperature sensor 76, the conductivity sensor 77, the ammonia sensor 73, the pressure sensor 66, etc.) or sensor interfaces, the heating device 47 for heating the dialysate, or fluid containers (such as the arterial pot 24, the venous pot 81, or the reaction pot 60 connected to the dialysate circuit, and / or the reaction filter 67) may be mounted on the inner side of the upper housing 10.

[0084] In the example of Figure 10, the heating device 47 is arranged on the first mounting surface 101, and correspondingly, a metal device (such as a stainless steel metal sheet) is provided on the surface of the flow channel box 13, and the heating device 47 is in direct contact with the metal device to transfer heat to the dialysate in the flow channel box 13.

[0085] In one embodiment, the first mounting surface 101 is an independent component, such as a flat plate, which is detachably fixed to the upper case 10 via a bracket 102. In this embodiment, the plate is fixed to the upper case 10, for example, by screws or snap-fitting, so that when the upper case 10 is flipped open, the first mounting surface 101 is upright along with the upper case 10, and the flow channel box 13 and the fluid container mounted on the first mounting surface 101 are also upright or vertical, and the flow channel box 13 and the fluid container are fixed to the plate.

[0086] In one embodiment, the fluid container is detachably mounted on the first mounting surface 101 via a bracket 102. It should be understood that the detachable manner refers to mounting or removing the fluid container on or from the first mounting surface 101 by bonding, snapping, screwing, or other means that does not damage the first mounting surface 101, the fixed structure, or the fluid container.

[0087] In one embodiment, the flow channel box 13 is detachably mounted on the first mounting surface 101 via a bracket 102. The flow channel box 13 is a consumable. For example, the flow channel box 13 is a disposable consumable and requires ethylene oxide sterilization upon shipment. Alternatively, after disinfection and sterilization and preservation, the flow channel box 13 can be reused a predetermined number of times or for a predetermined period of time.

[0088] In one embodiment, some or all of the fluid pumps (e.g., blood pump 23, supplemental fluid pump 75, secondary circulation pump 68, dialysate pump 46, etc.) or valves (e.g., venous valve 22, arterial valve 84, exhaust valves 82 and 64, dialysate outlet valve 40, dialysate inlet valve 78, etc.) shown in FIG2 may be integrated into the flow box 13. After the flow box 13 is connected to the portable dialysis device, the pneumatic system of the dialysis device independently controls the pumps and valves of the various fluids to control the flow of fluids (e.g., blood, dialysate, preformed fluid, or ultrafiltrate) in the flow box 13. For example, before the start of dialysis treatment, the preformed fluid is pumped out by the dialysate pump 46 integrated in the flow box 13 to fill the entire blood circuit (L1 and L3) and the dialysate circuit L2.

[0089] Here, the present application provides a flow channel box in one embodiment. Please continue to refer to Figures 9 and 10 in conjunction with Figures 11 to 13b. Figures 11 and 12 are respectively schematic structural diagrams of the flow channel box in one embodiment of the present application from the front and back perspectives. Figure 13a is a schematic partial structural diagram of the box body in one embodiment of the present application, and Figure 13b is a cross-sectional view of AA in Figure 13a. In one embodiment, the box body is arranged on the body of the dialysis device in a snap-fit ​​manner through a bracket 102. The body of the dialysis device includes the portable case, and the box body is arranged on the portable case in a snap-fit ​​manner.

[0090] In another embodiment, the box body is arranged on the body of the dialysis device in a plug-in manner. In yet another embodiment, the box body of the flow channel box 13 is arranged on the body of the dialysis device by a clamping device, wherein the clamping device can be a nut clamping device, a wedge clamping device, a locking device, or a spring clamping device.

[0091] Among them, the box body is provided with at least one first pneumatic interface 1322 on one side of the body of the dialysis device correspondingly combined therewith, and the dialysis device is correspondingly provided with a second pneumatic interface 103 connected to the pneumatic system. In one example, the box body is provided with a first pneumatic interface 1322, and correspondingly, the dialysis device is provided with a second pneumatic interface 103 connected to the pneumatic system, and the first pneumatic interface 1322 is connected to the second pneumatic interface 103. For example, the dialysis device includes a plurality of flow channel boxes 13, and each flow channel box 13 has only one pneumatic element in the box body, and the pneumatic element is connected to the first pneumatic interface 1322. As shown in Figure 13a, the box body includes three pneumatic elements, and the first pneumatic interface 1322 can be connected to the three pneumatic elements respectively through a shunt pipeline. In another example, two first pneumatic interfaces 1322 are provided on the box body, and correspondingly, two second pneumatic interfaces 103 connected to the pneumatic system are provided on the dialysis device. After the first pneumatic interface 1322 is connected to the second pneumatic interface 103, one first pneumatic interface 1322 is used to introduce positive pressure gas into the flow channel box 13, and the other is used to introduce negative pressure gas into the flow channel box 13. Each first pneumatic interface 1322 can be connected to multiple pneumatic components via a shunt pipeline. It should be noted that the structure of the shunt pipeline can be designed according to the number of first pneumatic interfaces 1322 provided on the box body and the number of pneumatic components.

[0092] In one embodiment, the box body is provided with a plurality of independent first pneumatic interfaces 1322 (as shown in FIG12 , there are 10 first pneumatic interfaces 1322 on the back of the box body) on one side of the body of the dialysis device. Correspondingly, the dialysis device is provided with a plurality of independent second pneumatic interfaces 103 connected to the pneumatic system. After the first pneumatic interface 1322 of the box body is connected to the second pneumatic interface 103, the pneumatic system can drive the fluid to flow in the box body. In this embodiment, one pneumatic element is connected to an independent first pneumatic interface 1322, so that the pneumatic system can control the various pneumatic elements in the flow channel box 13. Further, for ease of description and understanding, in this application, the side of the box body corresponding to the body of the dialysis device is the back side, and it should be understood that the side of the box body away from the back side is the front side. Correspondingly, the side of the front side of the flow channel box 13 body is the front side, as shown in FIG11 , and the side of the back side of the flow channel box 13 body is the rear side or back side, as shown in FIG11 .

[0093] In a specific embodiment, as shown in Figures 9, 10 and 12, the box body is arranged on the first mounting surface 101 of the dialysis device. A plurality of independent second pneumatic interfaces 103 are provided on the first mounting surface 101, and the side surface where the box body is combined with the first mounting surface 101 has a plurality of independent first pneumatic interfaces 1322. The box body can be connected to or disconnected from the second pneumatic interface 103. It should be noted that the box body can be mounted on the first mounting surface 101 in parallel, as shown in Figure 9, or can be mounted on the first mounting surface 101 vertically or at a preset angle to the first mounting surface 101. It is only necessary to ensure that when the dialysis device is in working condition, the box body of the flow channel box 13 is in an upright position at an angle of 70°-110° to the horizontal plane. In a preferred embodiment, when the dialysis device is in working condition, the flow channel box 13 body is in a vertical position of approximately 90° to the horizontal plane.

[0094] By connecting the multiple independent first pneumatic interfaces 1322 of the box body to the multiple independent second pneumatic interfaces 103 one by one, the pneumatic system independently controls the pump or valve corresponding to each first pneumatic interface 1322 to control the flow of fluid in the box body. It should be noted that, although in the embodiments shown in Figures 10 and 12, the number of the first pneumatic interface 1322 and the second pneumatic interface 103 are both ten for example, this is not limited to this. The number of the first pneumatic interface 1322 and the second pneumatic interface 103 can be equal to the total number of pumps and valves in the box body; the number of the first pneumatic interface 1322 and the second pneumatic interface 103 can also be greater than the total number of pumps and valves in the box body. For example, the box body also includes a first pneumatic interface 1322 connected to one or more gas-liquid separation chambers in the box body; the number of the first pneumatic interface 1322 and the second pneumatic interface 103 can also be less than the total number of pumps and valves in the box body. For example, the first pneumatic interface 1322 mentioned above can be connected to multiple pumps and / or valves through a diversion pipeline in the box body.

[0095] In the case where the flow channel box 13 is defined as a consumable, the male and female interfaces are often inserted into and out of the male interface multiple times, which often causes the female interface to be gradually expanded and the sealing of the interface to be weakened. For this reason, in one embodiment of the present application, the first pneumatic interface 1322 is designed as a female interface, and the second pneumatic interface 103, which is permanently located in the body of the dialysis device, is designed as a male interface corresponding to the female interface. In this way, since the flow channel box 13 is discarded after a single use or a limited number of uses, even if the female interface is expanded and deformed due to multiple plugging and unplugging operations, it will not affect the subsequent sealed connection between the new flow channel box 13 and the second pneumatic interface 103, thereby ensuring the long-term use of the second pneumatic interface 103.

[0096] Of course, without considering the weakening of the sealing performance, for example, in other embodiments, the first pneumatic interface 1322 may also be a male interface, and the second pneumatic interface 103 may be a female interface corresponding to the male interface.

[0097] In one embodiment, the interior of the box body is provided with a plurality of fluid channels 1313 for controlling the forward or reverse flow of the fluid by air pressure. The fluid channels 1313 are used for the flow of the fluid. The fluid channels 1313 can be connected through the ports of the fluid channels 1313 (e.g., the inlet or outlet in FIG13 ). In one embodiment, the box body may include at least one of the blood channel (L1 and L3) and the dialysate regeneration channel L2. For example, the box body includes a blood channel and a dialysate regeneration channel, and then the box body can be directly connected to the human vein, human artery, dialyzer 30, etc. through external pipelines. For another example, in order to simplify the complexity of the arrangement of the fluid channels 1313 in the box body, the box body may also include only a part of the blood channel or only a part of the dialysate regeneration channel.

[0098] Furthermore, it should be understood that the “channel” disclosed in the present application refers to the fact that the pumps and valves in the box body can be fluidically connected to each other so as to provide a path for transferring fluid (i.e., blood, saline, dialysate, etc.) between these components. Among them, the blood channel in the box body is a channel for transferring fluid between the components in the blood circuit, and the dialysate regeneration channel in the box body is a channel for transferring fluid between the components in the dialysate regeneration flow path L2. Since the channel itself can be made of soft / flexible material, its shape will be limited by the structure of the box body or the position of the pump and valve in actual layout, presenting different wiring / piping forms. In order to further clarify the connection relationship between the channel and each pump and valve, please refer to the connection relationship shown in the schematic diagram described in Figure 2 or Figure 6, which is specifically stated here.

[0099] In one embodiment, the interior of the box body is provided with a plurality of fluid "channels" for controlling the forward or reverse flow of the fluid by air pressure. The channels are formed inside the box body by one-time molding processes such as injection molding, blow molding, stamping, subtractive molding, or additive molding (such as 3D printing) and have a certain rigidity. Please refer to the cross-sectional structure shown in the subsequent Figure 13. In other words, the cavity structure and side wall material of the "channel" are the same material as the box body. For example, in one embodiment, the box body is injection molded by PMMA, PVC or PC plastic.

[0100] In one embodiment, the box body of the flow channel box 13 includes a pneumatic element, which is connected to the first pneumatic interface 1322 and the fluid channel 1313 for controlling the forward or reverse flow of the fluid in the fluid channel 1313 using the positive pressure gas and negative pressure gas introduced through the first pneumatic interface 1322.

[0101] In one embodiment, the pneumatic component includes a pneumatic fluid pump and a pneumatic fluid valve. The pneumatic fluid pump is used to push and discharge fluid into the fluid channel 1313 using positive pressure gas introduced through the first pneumatic interface 1322, and to draw fluid from the fluid channel 1313 using negative pressure gas introduced through the first pneumatic interface 1322. The pneumatic fluid valve is used to open or close the fluid channel 1313. For example, the pneumatic fluid valve uses positive pressure gas introduced through the first pneumatic interface 1322 to close the fluid channel 1313, and uses negative pressure gas introduced through the first pneumatic interface 1322 to open the fluid channel 1313. During the process of the cartridge body drawing fluid, the pneumatic fluid valve on the inlet side opens the fluid channel 1313, and the fluid is then drawn from the inlet through the fluid channel 1313 into the pneumatic fluid pump. During the process of pushing and discharging the fluid from the box body, the pneumatic fluid valve on the outlet side opens the fluid channel 1313, and the fluid is pushed out of the pneumatic fluid pump and discharged at the outlet through the fluid channel 1313. It should be noted that, although the present application uses the example of the pneumatic components including the pneumatic fluid pump and the pneumatic fluid valve for explanation, in other embodiments, the box body may also include only the pneumatic fluid pump, for example, the valve may be an external pinch valve. The box body may also include only the pneumatic fluid valve, for example, the pump may be an external peristaltic pump.

[0102] The pneumatic fluid pump and the pneumatic fluid valve in the box body can not only realize the functions of traditional pumps and valves, but also reduce the size of the portable dialysis device and improve the integration of the portable dialysis device.

[0103] In one specific embodiment, the pneumatic element includes a fluid cavity, a pneumatic diaphragm, and a gas cavity. The portion of the box body shown in Figures 13a and 13b includes three pneumatic elements, each of which includes a fluid cavity (1310, 1314), a pneumatic diaphragm 133, and a gas cavity (1320, 1324). It should be noted that the three pneumatic elements can share a single pneumatic diaphragm as shown in Figures 13a and 13b. In other embodiments, one or two pneumatic elements can share a single pneumatic diaphragm.

[0104] The fluid cavity is in communication with the fluid channel 1313. In one embodiment, the cartridge body includes a flow channel plate 131, and the fluid cavity and the fluid channel 1313 are disposed on the flow channel plate 131. Specifically, the fluid cavity and the fluid channel 1313 are formed by a plurality of recesses, grooves, openings, and other structures reserved on the flow channel plate 131. In one embodiment, the flow channel plate 131 is injection molded from PMMA, PVC, or PC plastic.

[0105] In one embodiment, the fluid chamber is formed inside the flow channel plate 131. The inside of the flow channel plate 131 is the side of the flow channel plate 131 that is closest to the pneumatic diaphragm 133. As shown in FIG13b , the fluid chamber includes a valve fluid chamber 1314 and a pump fluid chamber 1310. The valve fluid chamber 1314 and the pump fluid chamber 1310 are connected via the fluid channel 1313. However, this is not limiting. In other embodiments, the fluid chamber may include only the pump fluid chamber 1310 or the valve fluid chamber 1314. It should be understood that the number of fluid chambers in the box body is equal to the total number of pumps and valves that need to be integrated in the box body, that is, the total number of valve fluid chambers 1314 and pump fluid chambers 1310 is equal to the total number of pumps and valves that need to be integrated in the box body. In the following embodiments, the fluid chamber including the pump fluid chamber 1310 and the valve fluid chamber 1314 is used as an example for description.

[0106] In one example, the fluid cavity is a cavity formed by being recessed on the inner side of the flow channel plate 131 in a direction away from the pneumatic diaphragm 133. The recessed surface of the fluid cavity can be in an arc-shaped, curved, or other shape. The size of the pump fluid cavity 1310 can be equal to or different from the size of the valve fluid cavity 1314. For example, as shown in Figures 13a and 13b, the size of the pump fluid cavity 1310 is larger than the size of the valve fluid cavity 1314. The smaller size of the valve fluid cavity 1314 facilitates the opening and closing of the valve.

[0107] In one embodiment, as shown in Figures 13a and 13b, the fluid channel 1313 connects the valve fluid chamber 1314 and the pump fluid chamber 1310. The fluid channel 1313 has an opening on one side that connects to each of the fluid chambers. In one example, the opening of the fluid channel 1313 in the fluid chamber conforms to the slope of the chamber wall so that turbulence is not generated when the fluid enters the fluid chamber. In other words, the opening of the fluid channel 1313 in the fluid chamber is opened on the chamber wall of the fluid chamber. For example, as shown in Figures 13a and 13b, the opening of the fluid channel 1313 connecting to the pump fluid chamber 1310 is opened on the curved chamber wall of the pump fluid chamber 1310. For another example, the opening of the fluid channel 1313 connecting to the inlet valve fluid chamber 1314 is opened on the plane portion of the chamber wall of the inlet valve fluid chamber 1314.

[0108] In one embodiment, the first surface of the pneumatic diaphragm 133 covers the fluid cavity. The first surface is the surface facing the flow channel plate 131, and the second surface is the surface facing away from the flow channel plate 131. When the pneumatic component is a pneumatic fluid pump, the first surface of the pneumatic diaphragm 133 covers the fluid cavity, and is used to change the volume of the fluid cavity when subjected to pressure, causing the fluid cavity to push fluid into the fluid channel 1313 or to cause the fluid cavity to draw fluid from the fluid channel 1313. When the pneumatic component is a pneumatic fluid valve, the first surface of the pneumatic diaphragm 133 covers the fluid cavity, and is used to change the volume of the fluid cavity when subjected to pressure, causing the fluid channel 1313 to be opened or closed.

[0109] In one embodiment, the pneumatic diaphragm 133 is made of silicone rubber or PVC soft film. When the pneumatic diaphragm 133 is deformed by force, it can return to its original state / shape after the force is removed. When the pneumatic diaphragm 133 is deformed downward by force, the pressure within the fluid cavity is positive. Alternatively, when the pneumatic diaphragm 133 is deformed upward by force, the pressure within the fluid cavity is negative.

[0110] In one embodiment, the number of pneumatic diaphragms 133 in the cartridge body can be one or more. For example, as shown in FIG11 , multiple fluid chambers in the cartridge body are covered by one pneumatic diaphragm 133. In another example, each fluid chamber is covered by an independent pneumatic diaphragm 133.

[0111] In the present application, the forward flow of the fluid in the box body is taken as an example to describe the use of air pressure to control the box body to pump and push the fluid. Wherein, the forward flow of the fluid is from the valve fluid chamber 1314 at the inlet 1311 toward the pump fluid chamber 1310. For example, when the portable dialysis device is in treatment mode or when performing a treatment operation, the dialysate flows from the valve fluid chamber 1314 at the inlet toward the pump fluid chamber 1310. As shown in Figure 2, the dialysate flows forward along the direction of the dotted arrow under the action of multiple pumps and valves, that is, it flows forward under the action of multiple pumps and valves integrated in the box body. The reverse flow of the fluid is from the valve fluid chamber 1314 at the outlet toward the pump fluid chamber 1310. For example, when the portable dialysis device is performing a flushing operation, the fluid flows from the valve fluid chamber 1314 at the outlet toward the pump fluid chamber 1310.

[0112] Continuing with FIG13b , during the process of pumping fluid from the cartridge body, the pneumatic system first applies positive pressure to the upper side of the pneumatic diaphragm 133 in the valve fluid chamber 1314 at the outlet, causing the pneumatic diaphragm 133 to deform downward under the force, closing the valve fluid chamber 1314 at the outlet. Then, the pneumatic system applies negative pressure to the upper sides of the pneumatic diaphragms 133 in the valve fluid chamber 1314 at the inlet and the pump fluid chamber 1310, causing both the pneumatic diaphragms 133 at the inlet and pump fluid chambers 1310 to deform upward under the force, opening the valve fluid chamber 1314 at the inlet. Fluid is then pumped from the inlet 1311 through the fluid passage 1313 and the valve fluid chamber 1314 at the inlet into the pump fluid chamber 1310. During the process of pushing and discharging the fluid from the cartridge body, first, the pneumatic system applies negative pressure to the upper side of the pneumatic diaphragm 133 at the valve fluid chamber 1314 at the outlet position, causing the pneumatic diaphragm 133 to deform upward under the force, and the valve fluid chamber 1314 at the outlet position 1312 is opened. Then, the pneumatic system applies positive pressure to the upper sides of the pneumatic diaphragms 133 at the valve fluid chamber 1314 and the pump fluid chamber 1310 at the inlet position, causing both the pneumatic diaphragms 133 at the valve fluid chamber 1314 and the pump fluid chamber 1310 to deform downward under the force, closing the valve fluid chamber 1314 at the inlet position, and the fluid in the pump fluid chamber 1310 is discharged from the outlet 1312 through the fluid channel 1313.

[0113] The gas cavity is covered by the second surface of the pneumatic diaphragm 133. In other words, the upper side of the pneumatic diaphragm 133 is the gas cavity, and the lower side of the pneumatic diaphragm 133 is the corresponding fluid cavity. For example, as shown in Figure 13b, the valve fluid cavity 1314 at the outlet position on the flow channel plate 131 is located on the lower side of the pneumatic diaphragm 133 and is covered by the first surface of the pneumatic diaphragm 133. The valve gas cavity 1324 corresponding to the valve fluid cavity 1314 is located on the upper side of the pneumatic diaphragm 133 and is covered by the second surface of the pneumatic diaphragm 133. The gas cavity is provided with an air hole 1321 for connecting to the first pneumatic interface 1322. The positive pressure airflow or negative pressure airflow provided by the air hole 1321 drives the pneumatic diaphragm 133 to change the cavity pressure within the fluid cavity.

[0114] In one embodiment, the box body includes an airway plate 132, which is coupled to the flow plate 131 and the pneumatic diaphragm 133 of the pneumatic element. In one embodiment, after the airway plate 132 and the flow plate 131 are coupled, the two sandwich the pneumatic diaphragm 133. In one embodiment, the airway plate 132 is injection molded from PMMA, PVC, or PC plastic. The airway plate 132 has multiple recesses, grooves, openings, and other structures.

[0115] In one embodiment, the gas cavity is provided on the airway plate 132. Specifically, the gas cavity is formed on the inner side of the airway plate 132. The gas cavity is formed by a plurality of recesses, grooves, openings and other structures reserved on the airway plate 132. In one embodiment, the number and position of the gas cavity and the fluid cavity are in one-to-one correspondence. In other words, the gas cavity includes a valve gas cavity 1324 corresponding to the valve fluid cavity 1314, and a pump gas cavity 1320 corresponding to the pump fluid cavity 1310. Each group of valve fluid cavity 1314, valve gas cavity 1324 and the pneumatic diaphragm 133 therebetween constitute the pneumatic fluid valve described above, and each group of pump fluid cavity 1310, pump gas cavity 1320 and the pneumatic diaphragm 133 therebetween constitutes the pneumatic fluid pump described above.

[0116] The gas cavity is provided with an air hole 1321 for connecting to an external gas passage. The positive or negative pressure airflow provided by the air hole 1321 drives the pneumatic diaphragm 133 to change the volume of the fluid cavity. In one embodiment, each gas cavity has an air hole 1321. The pneumatic system of the dialysis device provides positive or negative pressure airflow to each gas cavity in the cartridge body through the air hole 1321. When the air cavity is under positive pressure, the pneumatic diaphragm 133 is forced to deform downward. When the air cavity is under negative pressure, the pneumatic diaphragm 133 is forced to deform upward.

[0117] To this end, a first pneumatic interface 1322 is further provided on the outer side of the airway plate 132, communicating with the air holes 1321. In other words, the valve gas chamber 1324 and the pump gas chamber 1320 are each connected to an independent first pneumatic interface 1322. Furthermore, the valve gas chamber 1324 and the pump gas chamber 1320 can be connected to the pneumatic system of the portable dialysis device through the first pneumatic interface 1322, so that the pneumatic system can manipulate each gas chamber to control the forward or reverse flow of the fluid in the fluid channel 1313 of the cartridge body.

[0118] In one embodiment, the box body further includes a gas channel 1323 , which is disposed in the airway plate 132 , and the air hole 1321 is communicated with the first pneumatic interface 1322 through the airway plate 132 .

[0119] In one embodiment, the flow channel plate 131 and the air channel plate 132 can be joined together by bonding, welding, snapping, or screwing, and the pneumatic diaphragm 133 can be clamped between the flow channel plate 131 and the air channel plate 132. By pre-fixing the flow channel plate 131, the pneumatic diaphragm 133, and the air channel plate 132 together, the sealing between the pneumatic diaphragm 133 and the flow channel plate 131 and the air channel plate 132 can be ensured, thereby ensuring the airtightness of the pneumatic drive.

[0120] In another embodiment, the pneumatic diaphragm 133 is combined with the flow channel plate 131 and / or the air channel plate 132 by bonding or welding.

[0121] In one embodiment, the flow channel box 13 body further includes a sealing ring 134 to achieve a seal between the pneumatic diaphragm 133 and the fluid chamber and / or the gas chamber. The sealing ring 134 can be attached to the pneumatic diaphragm 133 by gluing or other methods, or can be integrally formed with the pneumatic diaphragm 133.

[0122] In one embodiment, as shown in Figure 13b, the sealing ring 134 is located on both sides of each pump / valve. The sealing ring 134 can achieve a seal between the pneumatic diaphragm 133 and the fluid chamber, and between the pneumatic diaphragm 133 and the gas chamber. However, this is not limiting. In other embodiments, the flow channel box 13 body may include only the sealing ring 134 for sealing disposed between the pneumatic diaphragm 133 and the flow channel plate 131, or only the sealing ring 134 for sealing disposed between the pneumatic diaphragm 133 and the air channel plate 132. The sealing ring 134 is made of silicone rubber, isobutyl rubber, ethylene propylene rubber, nitrile rubber, fluororubber, or polyurethane rubber.

[0123] In one embodiment, the airway plate 132 and / or the flow channel plate 131 are further provided with a groove structure for accommodating the sealing ring 134. For example, the groove structure is a rectangular groove, a V-shaped groove, a semicircular groove, a dovetail groove, or a triangular groove.

[0124] It should be noted that although this application uses the partial flow channel box 13 structure of Figure 13b as an example to illustrate the pump and valve integrated in the flow channel box 13 body, it should be understood that according to the structure of the inlet valve, outlet valve, and pump shown in Figure 13b, some devices in the blood circuit and / or dialysate circuit (such as part of the pipeline, valve and pump) can be integrated into the box body according to the embodiment shown in Figure 2 or Figure 6.

[0125] In one embodiment, the cartridge body further includes a gas-liquid separation chamber (e.g., the intravenous pot and the reaction pot 60 in FIG. 2 ), which is in communication with the fluid channel 1313 and is configured to separate and discharge gas within the fluid channel 1313. In other embodiments, the gas-liquid separation chamber may also be referred to as a gas collecting chamber.

[0126] In one embodiment, the gas-liquid separation chamber is connected to the first pneumatic interface 1322. When positive-pressure gas is introduced into the first pneumatic interface 1322, gas is introduced into the gas-liquid separation chamber, or when negative-pressure gas is introduced into the first pneumatic interface 1322, gas is exhausted from the gas-liquid separation chamber. In other words, when it is necessary to add gas to the gas-liquid separation chamber, positive-pressure gas is introduced into the first pneumatic interface 1322, and when it is necessary to exhaust gas from the gas-liquid separation chamber, negative-pressure gas is introduced into the first pneumatic interface 1322.

[0127] Furthermore, the flow channel box 13 further includes an atmospheric port, the gas-liquid separation chamber being in communication with the atmospheric port, and the atmospheric port being used to discharge gas from the gas-liquid separation chamber. In one embodiment, the flow channel box 13 further includes a hydrophobic breathable membrane, and the gas from the gas-liquid separation chamber is discharged from the atmospheric port through the hydrophobic breathable membrane.

[0128] In one embodiment, the cartridge body further includes a one-way fluid valve, which is in communication with the fluid channel 1313 , the pneumatic element, or the fluid interface, and is configured to allow the fluid to flow in one direction within the fluid channel 1313 .

[0129] In some embodiments, the one-way fluid valve, sensor interface, and / or heating device interface may be disposed in the airway plate 132 or in the flow channel plate 131 .

[0130] In one embodiment, the cartridge body further includes a sensor interface and / or a heating device interface. These sensor interfaces include, but are not limited to, a pressure sensor interface, a color sensor interface, an ammonia sensor interface, a temperature sensor interface, a liquid level sensor interface, a blood leakage sensor interface, a conductivity sensor interface, and an air sensor interface. For example, as shown in FIG11 , the cartridge body is provided with an ammonia sensor interface 135 and a catalytic unit injection port 136.

[0131] It should be noted that although the aforementioned embodiments illustrate the fluid channels 1313 disposed in the flow channel plate 131 and the gas channels 1323 disposed in the air channel plate 132, this is not limiting. In other embodiments, some of the fluid channels 1313 may be disposed in the air channel plate 132, and some of the gas channels 1323 may be disposed in the flow channel plate 131. The flow channel plate 131 and the air channel plate 132 may have the same or different sizes and shapes. For example, in order to integrate a large number of channels in the air channel plate 132, the size of the air channel plate 132 may be larger than that of the flow channel plate 131.

[0132] As mentioned above, the pump and valve of the portable dialysis device are integrated into the flow channel box 13 body. Therefore, the box body is also provided with multiple fluid interfaces for connecting to external liquid pipelines. The fluid interfaces are used to connect to external liquid pipelines to connect the flow channels in the flow channel box 13 body with human veins, arteries, and liquid containers external to the flow channel box 13 body. In certain embodiments, the liquid containers may also be referred to as fluid containers. The external liquid containers include ultrafiltration containers 52, replenishing liquid containers 75, prefabricated liquid containers, and / or adsorption devices. In one embodiment, the fluid interfaces are provided on at least one side of the box body. In other words, the fluid interfaces can be provided on any side of the flow channel box 13 body, for example, on the front, back, left, right, top, or bottom side of the flow channel box 13 body. In one example, as shown in Figures 11 and 12, the fluid interfaces are provided on the top, bottom, and front sides of the box body and connected to corresponding pipelines.

[0133] The fluid interfaces include an arterial interface for connecting to an arterial line of a patient's artery, a venous interface for connecting to a venous line of a patient's vein, a supplemental interface for connecting to a supplemental fluid pathway, a preformed fluid interface for connecting to a preformed fluid pathway, an adsorption interface for connecting to an adsorption device, and / or an ultrafiltration interface for connecting to an ultrafiltration pathway. In certain embodiments, the fluid interfaces may further include a supplemental interface, an ammonia sensor gas interface 135, and a catalytic unit injection port 136. The supplemental interface is configured to connect to a supplemental fluid branch L2-8 in the dialysate regeneration flow path L2 for transporting supplemental fluid, the ammonia sensor gas interface is configured to connect to an ammonia sensor for detecting ammonia content in the dialysate regeneration flow path L2, and the catalytic unit injection port is configured to connect to a sample addition device S or a reaction pot 60 in the secondary circulation flow path L2-4. For example, the catalytic unit injection port is an enzyme preparation injection port, through which the enzyme preparation is injected into the dialysate regeneration flow path L2, for example, the enzyme preparation is injected into the secondary circulation flow path of the dialysate regeneration flow path L2 through the catalytic unit injection port. In one embodiment, after the dialysis treatment is completed, the ammonia sensor needs to be inserted into a protective solution to prevent damage to the sensor's sensitive components. It should be noted that in other embodiments, the replenishing fluid path may also be referred to as a replenishing fluid branch, the ultrafiltration path may also be referred to as an ultrafiltration branch, and the pre-prepared fluid path may also be referred to as a pre-prepared fluid bypass.

[0134] In one embodiment, as shown in FIG11 , the ammonia sensor interface 135 and the catalytic unit injection port 136 are disposed on the front of the box body together with the corresponding fluid channel 1313 inside the box body, but the present invention is not limited thereto. In other embodiments, the ammonia sensor interface 135 and the catalytic unit injection port 136 may also be disposed at other positions such as the upper side, left side, or right side of the box body.

[0135] In the embodiments shown in Figures 11 and 12, the cassette body is integrated with a dialyzer 30 and / or a reaction filter 67. For example, as shown in Figure 11, the cassette body is integrated with a dialyzer 30 and the reaction filter 67, the dialyzer 30 is located on the left side of the cassette body, and the reaction filter 67 is located on the right side of the cassette body.

[0136] Here, in certain embodiments, a bracket (not shown) supporting the dialyzer 30 and / or the reaction filter 67 is further provided on the first surface of the box body. The bracket of the dialyzer 30 or the bracket of the reaction filter 67 includes at least one groove structure, and the dialyzer 30 or the reaction filter 67 is stuck in the groove structure. In a feasible embodiment, the bracket of the dialyzer 30 or the bracket of the reaction filter 67 includes two groove structures. Although the present application is described with the bracket being a groove structure as an example, it is not limited thereto. In other embodiments, the bracket may also be other structures capable of supporting the dialyzer 30 or the reaction filter 67.

[0137] In one embodiment, the dialyzer 30 and / or reaction filter 67 are connected to the fluid channel 1313 inside the box body by a pipeline integrally formed on the box body. For example, as shown in Figure 11, a plurality of L-shaped or inverted L-shaped pipelines located on the upper and lower sides of the box body are integrally formed with the box body, and the L-shaped or inverted L-shaped pipelines are used to connect the dialyzer 30 and / or reaction filter 67 to the fluid channel 1313 inside the box body. In other embodiments, the dialyzer 30 and / or reaction filter 67 are arranged on the box body, and the box body is preset with a fluid interface for connecting the dialyzer 30 and / or reaction filter 67, and the dialyzer 30 and / or reaction filter 67 are connected to the fluid channel 1313 inside the box body by a pipeline connected to the fluid interface. For example, when using the flow channel box 13, the user connects the pipeline to the dialyzer 30 and / or reaction filter 67 and the corresponding fluid interface.

[0138] It should be noted that when the dialysis device is in operation, the dialyzer 30 and / or the reaction filter 67 of the cassette body are in an upright position at an angle of 70°-110° to the horizontal plane. In other words, when the portable case is opened, the dialyzer 30 and / or the reaction filter 67 of the cassette body are in an upright position at an angle of 70°-110° to the horizontal plane. In a preferred embodiment, when the dialysis device is in operation, the dialyzer 30 and the reaction filter 67 of the cassette body are in a vertical position of approximately 90° to the horizontal plane.

[0139] In summary, pre-integrating the dialyzer 30 and / or the reaction filter 67 on the box body can improve the convenience of user operation and improve the sealing and safety of the portable dialysis device.

[0140] In one embodiment, the tubing in the portable dialysis device is disposed within the interior space defined by the portable housing. The tubing is used to connect the human blood circuit and the dialysate circuit connected to the blood circuit. The tubing is located outside the flow channel box 13. One end of the tubing is connected to the flow channel box 13, for example, to a fluid interface within the flow channel box 13. The other end of the tubing is connected to a human vein, artery, blood pump, adsorption device, ultrafiltration container 52, preformed fluid, supplemental fluid, or pressure sensor.

[0141] In one embodiment, the pipeline can be integrally formed with the box body. In other embodiments, the pipeline can also be connected to the box body by a user between hemodialysis sessions on the dialysis device.

[0142] In one embodiment, the pipeline includes a venous pipeline for connecting to human veins, an arterial pipeline for connecting to human arteries, a blood pump pipeline for connecting to a blood pump, an adsorption device pipeline for connecting to an adsorption device, an ultrafiltration pipeline L2-2 for connecting to an ultrafiltration container 52, a preformed liquid pipeline L2-3 for connecting to a preformed liquid, a supplementary liquid pipeline L2-8 for connecting to a supplementary liquid, and a pressure sensor pipeline for connecting to a pressure sensor.

[0143] In one embodiment, the tubing can be made of materials such as silicone rubber or PVC. For example, the blood pump tubing is made of the silicone rubber material, and the venous tubing, arterial tubing, adsorption device tubing, ultrafiltration tubing, preformed liquid tubing, supplemental liquid tubing, pressure sensor tubing, etc. are all made of PVC. During use of the portable dialysis device, blood from the human arterial end enters the dialyzer 30 from the upper end of the dialyzer 30, which is connected to the cartridge body via a tubing, and is output from the lower end of the dialyzer 30 to the human venous end 86. In this embodiment, the dialyzer 30 also includes a dialysate inlet and outlet, which are connected to the dialysis pathway L2 / dialysate regeneration flow path L2.

[0144] On this basis, the cassette body is integrated with a dialysate regeneration flow path L2. The dialysate regeneration flow path L2 is connected to the dialyzer 30. The dialysate waste of the dialyzer 30 flows into the dialysate regeneration flow path L2 from the dialysate input end, and the purified regenerated fluid flows into the dialyzer 30 from the dialysate output end.

[0145] In one embodiment, the dialysate regeneration circuit L2 includes a waste liquid channel L2-1, a secondary circulation circuit L2-4, and a regeneration liquid pipeline L2-7. Furthermore, the dialysate regeneration circuit L2 may also include at least one of an ultrafiltration branch L2-2, a preformed liquid bypass L2-3, a gas branch L2-5, and a supplemental liquid branch L2-8. The secondary circulation device includes the gas branch L2-5 and the secondary circulation circuit L2-4.

[0146] It should be noted that the dialysate regeneration flow path L2 described in this application is integrated with the cartridge body, which means that the pump and valve in the dialysate regeneration flow path L2, as well as the interconnected pipelines between the pump and the valve, can be disposed inside the cartridge body, and the fluid containers (e.g., the ultrafiltration container 52, the prefabricated fluid bag 45, the supplemental fluid container 75, and / or the reaction filter 67, etc.) and / or adsorption devices in the dialysate regeneration flow path L2 can be connected to the fluid channel 1313 inside the cartridge body via external pipelines. For example, the reaction filter 67 is disposed outside the cartridge body and is connected to the fluid channel 1313 inside the cartridge body via external pipelines.

[0147] In the following embodiments, please continue to refer to the principle diagrams shown in FIG. 2 and FIG. 6 in conjunction with FIG. 9 to FIG. 13 b .

[0148] In one embodiment, the input end of the waste liquid passage L2-1 is connected to the dialyzer 30 to obtain dialysate waste from the dialyzer 30. In an embodiment, the dialyzer 30 is used to purify blood flowing in the blood circuit and forms a blood flow path for the patient's blood and a dialysate flow path for the dialysate through a built-in purification membrane for blood purification.

[0149] In this embodiment, a venous pot 81 is further provided on a side adjacent to the dialyzer 30, for example, vertically adjacent to the right side of the dialyzer 30. A liquid level sensor for detecting the liquid level of the venous pot 81 is mounted on the first mounting surface 101. The liquid level sensor is provided on the venous pot to detect the liquid level in the venous pot. A gas collection pot 80 (as shown in FIG. 3 ) is provided between the venous pot and the dialyzer 30 to collect gas from the venous pot 81. In this embodiment, the inlet of the venous pot 81 is located on the upper side and is connected to the gas collection pot 80 via a pipeline. In some embodiments (as shown in FIG. 4 ), the gas collection pot 81 can also be referred to as a gas collection chamber 80.

[0150] As shown in FIG3 , in treatment mode or during treatment operation, the dialysis device drives the blood to flow from the arterial end to the venous end 86 in a forward flow direction; that is, when the fluid in the blood circuit is driven in the forward direction, the liquid passing through the arterial blood line L1 flows through the dialysis pathway L2 from the first interface into the gas collecting chamber 80 (gas collecting pot), and after filling the gas collecting chamber 80, flows from the second interface to the venous blood line L3.

[0151] In the embodiment shown in Figure 3, a venous trap 81 is connected to the pipeline between the gas collection chamber 80 and the venous end 86 of the venous blood line L3. In this embodiment, the venous trap 81 and the gas collection chamber 80 are two independent components connected in series to the venous blood line L3. The venous trap 81 is used to monitor the infusion status and collect gas from the pipeline. Therefore, the cross-section of a conventional venous trap 81 is generally an inverted trapezoidal or conical structure. The top of the conventional venous trap 81 is usually equipped with an exhaust pipeline, and components such as a venous trap valve 82 and a venous pressure sensor 83 are installed on this exhaust pipeline. In treatment mode or during treatment operation, when the fluid in the blood circuit is driven forward, the gas enriched in the gas collection chamber 80 flows into the venous trap 81 preferentially over the liquid entering the gas collection chamber 80, and is discharged from the venous trap 81 through the exhaust pipeline L4 provided on the venous trap 81.

[0152] In the embodiment shown in Figure 4 , it is also possible to integrate the aforementioned intravenous pot 81 and gas collection chamber 80 into a single component that serves both functions. For ease of description, this will be referred to as the gas collection chamber 80 in the subsequent embodiments. This gas collection chamber 80 differs from the conventional intravenous pot, which generally has an inverted trapezoidal or conical cross-section. In this embodiment, the gas collection chamber 80 comprises a liquid storage space located in the lower portion of the cavity and a gas collection space located in the upper portion. Specifically, the gas collection chamber 80 is functionally divided into two spaces: the upper gas collection space is used to collect gas, and the lower liquid storage space is used to collect liquid passing through the gas collection chamber 80. This means that the gas collection chamber 80 has a gas-liquid separation layer, and a first interface and a second interface are provided on the gas collection chamber 80. Liquid flows from the first interface through the interior space of the gas collection chamber 80 to the second interface. By designing the internal structure of the gas collection chamber 80 and the relative positions of the first and second interfaces, the minimum flow distance of the flowing liquid is controlled, allowing bubbles in the liquid to float upward and escape, thereby achieving gas-liquid interface separation.

[0153] In one embodiment, a third interface can be directly set on the top of the gas collecting chamber 80 for connecting to the exhaust pipe L4, for example, a valve device for controlling exhaust is set on the exhaust pipe. In one example, the exhaust pipe L4 is provided with a static pressure sensor 83, a solenoid valve 82, and / or a hydrophobic filter and other components.

[0154] In the embodiment shown in Figure 4, the pipeline between the gas collecting chamber 80 and the venous end 86 of the venous blood line L3 is also connected to the gas collecting chamber 80 which also serves as a venous pot. In one embodiment, an opening can be directly provided at the top of the gas collecting chamber 80 for connecting to an exhaust pipe, for example, a valve device 82 for controlling exhaust is provided on the exhaust pipe. In one example, a hydrophobic filter, a static pressure sensor, a solenoid valve 82, or / and a hydrophobic filter and other components are provided on the exhaust pipe L4.

[0155] As shown in FIG4 , in an embodiment of a treatment operation, in treatment mode or during treatment operation, when the fluid in the blood circuit is driven forward, the fluid such as blood flows from the arterial blood line L1 into the dialysis device 30 for blood purification treatment, flows into the venous blood line L3, and enters from the first interface of the gas collecting chamber 80, and the liquid such as blood flows from the second interface in the liquid storage space to the venous end 86 of the venous blood line L3, and the bubbles of the liquid such as blood will be enriched in the gas collecting space on the upper side of the gas collecting chamber 80, and discharged through the exhaust pipe in time according to the detection of the sensor.

[0156] Please refer to Figure 14, which shows a schematic diagram of the structure of the gas collection chamber of the present application in one embodiment. As shown in the figure, in this embodiment, the gas collection chamber 80 includes a liquid storage space 803 located in the lower part of the chamber and a gas collection space 804 located in the upper part of the chamber. That is, the gas collection chamber 80 is divided into two spaces according to function. The upper gas collection space 804 is used to collect gas, and the lower liquid storage space 803 is used to collect liquid passing through the gas collection chamber 80. The liquid storage space 803 includes a first extension portion 8031 ​​and a second extension portion 8032 extending downward, respectively, and an isolation portion 807 located at the first extension portion 8031 ​​and the second extension portion 8032; wherein the first interface 801 is opened at the bottom end of the first extension portion 8031; the second interface 802 is opened at the bottom end of the second extension portion 8032, and the isolation portion 807 is higher than the first interface 801 and the second interface 802. In the present embodiment, in order to ensure that the inlet and outlet of the liquid storage space 803 are both at the lowest position, the first interface 801 and the second interface 802 are respectively arranged at the bottom ends of the first extension part 8031 ​​and the second extension part 8032 extending downward, so that no matter whether the fluid flows from the first interface 801 to the second interface 802 or from the second interface 802 to the first interface 801, in the gas collecting chamber 80, the fluid flows from the bottom upward. In the present embodiment, the first extension part 8031 ​​and the second extension part 8032 of the liquid storage space 803 both extend downward. It should be understood that the "downward extension" includes, for example, a vertical downward extension as shown in Figure 16, and may also include, for example, an inclined downward extension as shown in Figure 15. Figure 15 shows a schematic structural diagram of the gas collecting chamber of the present application in another embodiment. Figure 16 shows a schematic structural diagram of the gas collecting chamber of the present application in yet another embodiment. Figure 17 shows a schematic structural diagram of the gas collecting chamber of the present application in yet another embodiment.

[0157] In another embodiment, one of the first extension portion 8031 ​​and the second extension portion 8032 of the liquid storage space 803 extends horizontally, and the other extension portion extends downward, so that the first extension portion 8031 ​​and the second extension portion 8032 have an incident angle. In a specific embodiment, the angle of the incident angle can be designed accordingly according to actual parameters such as the flow rate, bubble content, or fluid flow rate of the fluid.

[0158] In an embodiment, the length of the first extension portion 8031 ​​having the first interface 801 or the second extension portion 8032 having the second interface 802 is related to the flow rate, bubble content, or fluid flow rate of the fluid in the liquid storage space 803; or the length of the isolation portion 807 located between the first extension portion 8031 ​​and the second extension portion 8032 is related to the flow rate, bubble content, or fluid flow rate of the fluid in the liquid storage space 803; or the shortest flow distance of the fluid flowing from one interface of the first interface 801 or the second interface 802 to the other interface is related to the flow rate, bubble content, or fluid flow rate of the fluid.

[0159] In an embodiment, a fluid such as a liquid flows from a first extension portion 8031 ​​having a first interface 801 through the internal space of the gas collecting cavity 80 to a second extension portion 8032 having a second interface 802. The internal structure of the gas collecting cavity 80 and the relative positions of the first interface 801 and the second interface 802 are designed to control the shortest flow distance of the liquid so that the bubbles in the liquid can float up and escape and achieve the purpose of gas-liquid interface separation. The shortest flow distance of the liquid is related to the bubble content, flow rate, or flow rate of the liquid. For example, the higher the bubble content in the liquid, or the faster the flow rate, or the larger the flow rate, in practice, the longer the shortest flow distance of the liquid needs to be designed. Corresponding to different embodiments, for example, in one example, when the bubble content in the liquid is higher, or the flow rate is faster, the length of the first extension portion 8031 ​​or the second extension portion 8032 is longer; in another example, when the bubble content in the liquid is higher, or the flow rate is faster, or the flow rate is larger, the length of the isolation portion 807 located at the first extension portion 8031 ​​and the second extension portion 8032 is longer; in yet another example, when the bubble content in the liquid is higher, or the flow rate is faster, or the flow rate is larger, the shortest flow distance of the fluid flowing from one interface of the first interface 801 or the second interface 802 to the other interface needs to be longer.

[0160] In this embodiment, in order to adjust the flow resistance of the fluid passing through the gas collecting chamber 80 or to generate turbulence, or to adjust the flow rate of the fluid passing through the gas collecting chamber 80, so as to facilitate the gas / bubbles carried in the fluid to be enriched above the liquid level of the liquid storage space 803, the length of the first extension portion 8031 ​​and / or the second extension portion 8032 can be appropriately increased or shortened in actual applications; of course, the above purpose can also be achieved by changing the length of the isolation portion 807 between the first extension portion 8031 ​​and the second extension portion 8032. In some embodiments, the isolation portion 807 is a stepped structure relative to the first extension portion 8031 ​​and / or the second extension portion 8032; the isolation portion 807 is an arched structure relative to the first extension portion 8031 ​​and / or the second extension portion 8032; or the isolation portion 807 is a baffle structure extending upward from the bottom of the gas collecting chamber 80; for example, the gas collecting chamber 80 is generally A-shaped, inverted V-shaped, inverted U-shaped, n-shaped, or "mountain"-shaped, etc., with a bottom extension portion. For example, FIG15 shows a schematic diagram of the gas collecting chamber 80 being generally A-shaped or inverted V-shaped, wherein the isolation portion 807 is at a high position relative to the first extension portion 8031 ​​and the second extension portion 8032, forming a trapezoidal or stepped structure; or FIG16 shows a schematic diagram of the gas collecting chamber 80 being generally in an inverted U-shaped or n-shaped structure; or FIG17 shows a schematic diagram of the gas collecting chamber 80 having a generally mountain-shaped structure. As shown in Figure 17 , the isolation portion 807 disposed within the gas collection chamber 80 is a baffle structure extending upward from the bottom of the gas collection chamber 80. The left and right portions separated by the baffle structure constitute the first extension portion 8031 ​​and the second extension portion 8032. The first interface 801 and the second interface 802 respectively form opposite sides of the bottom of the gas collection chamber 80. The isolation portion 807 is an arched structure relative to the first extension portion 8031 ​​and / or the second extension portion 8032, which is not shown in the figure. It should be understood that the arched structure design can be achieved by changing the bottom surface of the liquid storage space 803 shown in Figure 16 to an upwardly arched arc, so that the first extension portion 8031, the isolation portion 807, and the second extension portion 8032 form a bridge-shaped arch.

[0161] It should be noted that in order to better achieve gas-liquid separation, in one embodiment of the present application, the path cross-section of the fluid flowing from one of the first interface 801 or the second interface 802 to the other interface is larger than the cross-section of the first interface 801 or the second interface 802, that is, by designing a redundant space structure for the internal space of the gas collecting cavity 80 or the flow channel of the fluid, so that the cross-section of the liquid flow path is much larger than the cross-sectional area of ​​the interface (the first interface 801 or the second interface 802), so as to reduce the liquid flow rate and increase the gas escape time. For example, when the liquid flows horizontally, the horizontal cross-sectional area gradually increases, the flow rate gradually decreases, and the flow rate is consistent, so that the gas can easily escape.

[0162] In one embodiment, a filter element 805 is provided in the liquid storage space 803 for filtering the fluid flowing between the first interface 801 and the second interface 802. Specifically, the bottom end of the filter element 805 is adjacent to the first interface 801, and the top end of the filter element is adjacent to the second interface 802. The filter element 805 is disposed at an angle of 30° to 60° in the gas collection chamber 80. Preferably, the filter element 805 is inclined at an angle of 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44°, 45°, 46°, 47°, 48°, 49°, 50°, 51°, 52°, 53°, 54°, 55°, 56°, 57°, 58°, 59°, or 60° in the gas collection chamber 80. In a preferred embodiment, the filter element 805 is inclined at a 45° angle in the gas collecting chamber 80. It should be understood that the inclination angle of the filter element 805 in the gas collecting chamber 80 refers to the angle between the filter element 805 and the bottom surface of the gas collecting chamber 80. In a specific embodiment, the filter element 805 is a filter screen or a filter membrane.

[0163] As mentioned above, the intravenous pot and the gas collection chamber 80 are integrated into a component that serves both the functions of the gas collection chamber 80 and the intravenous pot. Therefore, to facilitate the discharge of the gas enriched in the gas collection chamber 80 of the present application during treatment, a gas bag 806 is provided at the top of the gas collection space 804 in the gas collection chamber 80, as shown in FIG14 , which is connected to the interior of the gas collection chamber. The gas bag 806 is a protruding cavity that ensures a small air contact surface, which is convenient for being clamped to detect the liquid level position or the amount of enriched gas or the air pressure therein. To cooperate with the gas bag 806, a detection device for clamping the gas bag 806 to detect the liquid level position or the amount of enriched gas in the gas collection chamber 80 is also included. In a specific example, the detection device is a liquid level detection device, a pressure detection device, or a liquid level adjustment device. In this embodiment, the airbag 806 is also connected to an exhaust pipe L4 for removing gas from the cavity (gas collecting space). The exhaust pipe is provided with a valve device for controlling exhaust. In one example, the exhaust pipe is provided with a hydrophobic filter, a static pressure sensor, a solenoid valve, and / or a hydrophobic filter and other components.

[0164] In this embodiment, a blood leakage sensor for detecting whether blood leakage occurs in the dialysate circuit is installed on the first mounting surface 101. Specifically, the blood leakage sensor is used to detect whether blood leakage occurs in the pipeline from the dialysate outlet end of the dialyzer 30.

[0165] In this embodiment, a replenishing fluid pump 74 for adding replenishing fluid to the dialysate circuit is mounted on the first mounting surface 101. In the embodiment shown in FIG2 , a replenishing fluid branch L2-8 is provided on the regeneration fluid line L2-7 for delivering replenishing fluid to the regeneration fluid line L2-7. After urea is removed by the secondary circulation device and other toxins are removed by the adsorption device, potassium, calcium, and magnesium replenishing fluid is replenished through the replenishing fluid branch L2-8 to form the dialysate waste regeneration fluid for further use in dialysis treatment.

[0166] In this embodiment, the replenishing liquid branch L2-8 is provided with a container for storing replenishing liquid (for example, a replenishing liquid bag), and a replenishing liquid pump for transporting the replenishing liquid in the container to the replenishing liquid branch L2-8. The replenishing liquid includes potassium, calcium and magnesium replenishing liquid. In the application example of the portable dialysis device of the present application, the container for storing replenishing liquid (for example, a replenishing liquid bag) is an external container, which transports the replenishing liquid to the dialysate circuit through a pipeline. As shown in Figures 9 and 10, the replenishing liquid bag is arranged on the hook 15 of the upper box body 10. The replenishing liquid pump for sucking and pushing the replenishing liquid is integrated in the box body. In one embodiment, in order to reduce the volume of the portable dialysis device, the hook 15 is a retractable hook.

[0167] In the present application, the supplementary fluid is a liquid containing one or more substances or ions selected from potassium, calcium, magnesium, sodium, chloride, alkali, glucose, etc. For example, the supplementary fluid is a potassium, calcium, and magnesium concentrate; in some implementation scenarios, the supplementary fluid may also be referred to as a concentrate or a dialysate.

[0168] In this embodiment, the multiple fluid containers mounted on the first mounting surface 101 include a reaction pot 60 (or collection container) and / or a reaction filter 67 (or metabolic filter 67) connected to the dialysate circuit. In this embodiment, a liquid level sensor 61 for detecting the liquid level in the reaction pot 60 is mounted on the first mounting surface 101. As shown in Figures 9 and 11, the reaction filter 67 is vertically positioned on the right side of the first mounting surface 101. The reaction filter 67 is mounted in the upper housing 10 via a bracket mounted on the first mounting surface 101. In one embodiment, a reaction pot 60 is vertically positioned adjacent to the left side of the reaction filter 67. A photoelectric sensor or color sensor 62 for detecting the enzyme preparation content in the reaction pot 60 is mounted on the pipeline on the lower side of the reaction pot 60. The color sensor 62 is used to detect the color of the liquid in the reaction pot 60 to determine the content or concentration of enzyme-loaded microspheres, or to serve as a detection signal to indicate whether the operator has added enzyme-loaded microspheres, thereby ensuring the correct operating procedures and programmed operation of the dialysis device. The reaction pot 60 is a container for holding and collecting at least one fluid, such as a container for collecting dialysis waste liquid from the dialysis line and an enzyme preparation from the sampling device S. In one embodiment, the reaction pot 60 can also be integrated into the box body and communicate with the first pneumatic interface 1322. In one embodiment, the reaction filter 67 includes a tangential / cross flow filtration module (TFFM). It should be understood that based on the method of driving separation through the transmembrane pressure difference of the boundary surface in tangential flow filtration, by controlling the fluid flow rate at the retention module, the pressure difference used to drive the transmembrane can be adjusted to adjust the separation efficiency or retention efficiency. In some examples, the tangential flow filtration module can use an existing tangential flow filtration membrane package, such as the Pellicon cassette ultrafiltration membrane package of MERCK, the leukocyte removal filter, virus removal filter of Asahi Kasei, the LEOCEED dialyzer, the membrane-type plasma component separator, the plasma separator of BRAUN, etc.

[0169] In this embodiment, the cartridge body is integrated with an air pump (eg, the air pump 65 in FIG. 2 ) for controlling the liquid level in the reaction pot 60 . A pressure sensor 66 for detecting the fluid pressure in the reaction pot 60 is mounted on the first mounting surface 101 .

[0170] Referring to Figures 1, 2, and 6, in the embodiments shown in Figures 1, 2, and 6, a secondary circulation device is provided in the dialysate regeneration flow path L2. In one embodiment, the secondary circulation device includes a reaction pot 60, a secondary circulation pump 68, and a reaction filter 67. The secondary circulation flow path composed of the reaction pot 60, the secondary circulation pump 68, and the reaction filter 67 can decompose urea molecules in the waste dialysate.

[0171] In this embodiment, the secondary circulation device adds the dialysis waste liquid to be treated into the secondary circulation flow path L2-4 and drives the circulating liquid flow through the secondary circulation pump 68, and treats the liquid flow in the circulation to selectively change the structure or concentration of the molecules or molecular combinations in the liquid flow. In this process, the treated dialysis waste liquid metabolic treatment liquid in the circulation is allowed to leave the circulation and the residual amount of the mixed enzyme-loaded microsphere preparation is retained in the circulation.

[0172] In this embodiment, one end of the secondary circulation flow path L2-4 is connected to the second interface 802 of the reaction pot 60, and the other end is connected to the third interface of the reaction pot 60, thereby forming a circulation loop; in this embodiment, the secondary circulation pump 68 is arranged on the secondary circulation flow path L2-4, and is used to drive the mixed enzyme-loaded microspheres and dialysis waste liquid in the reaction pot 60 to circulate in the secondary circulation flow path L2-4; the metabolic filtration module is arranged on the secondary circulation flow path L2-4, and is used to treat the mixed liquid of enzyme-loaded microspheres and dialysis waste liquid circulating in the secondary circulation flow path L2-4 with toxins, retain the enzyme-loaded microspheres in the secondary circulation flow path L2-4, and filter out the dialysis waste liquid metabolic treatment liquid.

[0173] In one embodiment, the portable dialysis device further includes a device for controlling the secondary circulation pump 68 to dynamically balance the total amount of fluid in the secondary circulation flow path L2-4 in the secondary circulation mode, that is, by controlling the flow rate of the dialysis waste liquid introduced into the circulation and the dialysis waste liquid metabolic treatment liquid leaving the circulation in any circulation to maintain the dynamic balance of the total amount of fluid in the circulation, allowing the liquid to be treated containing a high concentration of target molecules to enter the circulation through the inlet, and the target molecules are decomposed into corresponding products by the enzyme-loaded microspheres. The metabolic filtration module in the secondary circulation device continuously separates the treated liquid and retains the enzyme-loaded microspheres in the circulation, and the treated liquid flows out of the secondary circulation device through the metabolic filtration module.

[0174] In one embodiment, the structure of the gas collecting chamber shown in Figures 14 to 17 can also be used as a reaction pot in the dialysate regeneration circulation pipeline. As shown in Figure 18, it is a schematic diagram of the application of a reaction pot in the metabolic circulation device in one embodiment of the present application. As shown in the figure, in this embodiment, the first interface a1 of the reaction pot 60 is connected to the output end of the waste liquid passage L2-1, and the reaction pot 60 includes a liquid storage space 601 located in the lower part of the cavity and a gas collecting space 600 located in the upper part of the cavity. That is, the reaction pot 60 is functionally divided into two spaces: the upper gas collection space 600 is used to collect gas, and the lower liquid storage space 601 is used to collect liquid passing through the gas collection chamber 60. That is, the reaction pot 60 has a gas-liquid separation layer, and the liquid in the reaction pot 60 flows from the second interface a2 into the secondary circulation flow path L2-4 and then flows into the reaction pot 60 from the third interface a3. Of course, when the secondary circulation pump 68 is reversed, the liquid in the reaction pot 60 flows from the third interface a3 into the secondary circulation flow path L2-4 and then flows into the reaction pot 60 from the second interface a2. In this embodiment, a fourth interface a4 is provided at the top of the reaction pot 60 for connecting to the gas branch L2-5.

[0175] In this embodiment, the liquid storage space 601 includes a first extension portion 6011 and a second extension portion 6012, each extending downward. The second port a2 is located at the bottom end of the first extension portion 6011, and the third port a3 is located at the bottom end of the second extension portion 6012. The isolation portion 604 is higher than the second port a2 and the third port a3. In this embodiment, to ensure that the inlet and outlet of the liquid storage space 600 are both at the lowest possible position, the second port a2 and the third port a3 are located at the bottom ends of the downwardly extending first extension portion 6011 and the second extension portion 6012, respectively. This ensures that, whether the fluid flows from the second port a2 to the third port a3 or from the third port a3 to the second port a2, the fluid in the reaction pot 60 flows upward from the bottom. In this embodiment, the first extension portion 6011 and the second extension portion 6012 of the liquid storage space 601 both extend downward. It should be understood that the term "downward extension" may refer to a vertical downward extension or an inclined downward extension. The reaction pot is generally in the shape of A, inverted V, inverted U, N, or "mountain" with a bottom extension, such as the structures of the several gas collecting chambers 80 shown in Figures 14 to 17.

[0176] In one embodiment, the first interface a1 of the reaction kettle 60 is connected to the output end of the waste liquid passage L2-1, for mixing the added enzyme-loaded microspheres and the dialysis waste liquid to fully contact. In the present embodiment, the reaction kettle 60 is provided with a sample addition port for adding an enzyme preparation (enzyme-loaded microspheres containing urease). Specifically, the sample addition port contains a valve or a clamp for switching and closing the sample addition port, and the shape of the sample addition port can be designed to be easy for syringe connection and has certain air tightness. The reaction kettle 60 is, for example, a transparent liquid container, for example, a container made of medical plastic. In an embodiment of the present application, the reaction kettle 60 can be integrated in the box body.

[0177] In certain embodiments, the sample addition port (as shown by reference numeral 135 in FIG. 11 ) in the secondary circulation device is further provided with a sample addition device S (as shown in FIG. 9 ) for adding, supplementing or replacing reaction substrates, catalytic units, drugs, and other auxiliary factors or activators to the secondary circulation flow path L2-4. In this example, the sample addition device S can be used as a processing unit, and the sample addition device S can be manually controlled or controlled by a computing device to add, supplement or replace catalytic units and reaction substrates, activators, etc. to the secondary circulation flow path L2-4, thereby achieving the processing of the fluid. In actual scenarios, the sample addition device S can also be used to control the concentration of the catalytic unit in the circulation. For example, when the concentration of the target substance in the fluid to be treated is different, the amount of the catalytic unit added to the pipeline can be controlled to achieve a preset reaction effect. In one embodiment, as shown in Figures 9 and 11, the sample addition port is, for example, a catalytic unit injection port provided on the front side of the box body. For example, the catalytic unit injection port 135 is an enzyme preparation injection port, and the enzyme preparation sample addition device S injects the enzyme preparation into the secondary circulation flow path L2-4 through the enzyme preparation injection port 135.

[0178] The sample adding device S can be configured as a device such as an injection needle connected to the injection port 135 of the catalytic unit. For example, the sample adding device S is an injection needle pre-loaded with an enzyme-loaded microsphere solution. Through the sample adding device S, the catalytic unit or reaction substrate can be immediately added to the secondary circulation flow path L2-4, that is, added to the flow channel box 13 body, so as to decompose the urea molecules in the dialysate in the secondary circulation flow path L2-4 to facilitate adsorption by the adsorption device 70; wherein, the reaction substrate can be any component in the fluid to be treated or a substance that can react with any component in the fluid to be treated, and the mutual reaction includes but is not limited to biological reaction, chemical reaction, and physical reaction. The auxiliary factor or activator can be used to assist the catalytic unit in reacting with the target substance, for example, when the catalytic unit is a metal enzyme that requires metal ions as auxiliary factors.

[0179] In one example, the sample addition port 135 may also be configured with a corresponding stopcock or sealing cover, which is used to be opened when adding samples and closed after the addition is completed, so as to ensure that the interior of the pipeline remains relatively sealed.

[0180] In another example, the sample adding device S may be configured with a permeable component such as a rubber stopper, and a sample adding port may be formed by injection or puncture when adding samples. For example, the catalytic unit or reaction substrate to be added to the pipeline is placed in a syringe, and the rubber stopper is pierced by the syringe to add the catalytic unit or reaction substrate to the sample adding device S.

[0181] In an embodiment, the reaction pot 60 has a collecting chamber for mixing the circulating catalytic unit, the fluid surplus and the liquid to be treated, so that the catalytic unit contacts the target substance.

[0182] In one embodiment, the reaction pot 60 can be used to expand the circulation volume. In each example where the fluid is liquid, the reaction pot 60 can help the circulating liquid and the circulating catalytic unit to be better mixed, thereby achieving full contact between the target substance and the catalytic unit.

[0183] In some embodiments, the reaction pot 60 is further configured to include a sample addition port, an air inlet, or a liquid discharge port. In this example, the reaction pot 60 can also serve as an integrated platform for various liquid inlets and outlets or air inlets and outlets and a place for the intersection and mixing of various liquids.

[0184] In one embodiment, by determining the position of the reaction pot 60 in the pipeline, the fluid in the reaction pot 60 tends to flow in the direction of circulation due to gravity when placed naturally. This design can avoid or reduce the generation of bubbles in the pipeline. In this example, the collecting device can also be provided with an exhaust port connected to the gas branch L2-5 to adjust the internal air pressure of the circulation.

[0185] In one embodiment, a liquid level sensor is provided on the first mounting surface 101 for detecting the liquid level in the reaction pot 60 . The liquid level sensor can transmit a signal to decide whether to control the liquid level in the reaction pot 60 .

[0186] In one embodiment, the secondary circulation device further includes a gas branch L2-5, which is used to control the amount of liquid in the reaction pot 60 by exhausting or intake. In this embodiment, an air pump is provided on the gas branch L2-5, and the air pump can be integrated into the box body. An exhaust valve or a flow channel switching device is provided on the exhaust branch, which is used to connect or close the circulating gas on the exhaust branch. The exhaust valve is, for example, a three-way valve or a four-way valve. A hydrophobic filter 63 is provided on the gas branch L2-5. The exhaust branch is provided with a pressure sensor for detecting the pressure in the cavity of the reaction pot 60, and the pressure sensor can reflect the secondary circulation or / and the fluid pressure conditions downstream.

[0187] In one embodiment, the gas branch L2-5 integrated in the box body is connected to the reaction pot 60 and the first pneumatic interface 1322. When positive pressure gas is introduced into the first pneumatic interface 1322, the gas is introduced into the reaction pot 60, or when negative pressure gas is introduced into the first pneumatic interface 1322, the gas is discharged from the reaction pot 60.

[0188] In another embodiment, two air pumps can be provided on the gas branch L2-5, namely a first air pump for degassing and a second air pump for adding gas. An exhaust valve or a flow channel switching device is provided between the first air pump and the second air pump, and the liquid level and liquid volume in the reaction pot 60 are controlled by selectively controlling the first air pump or the second air pump.

[0189] In one embodiment, the gas branch L2-5 integrated in the box body can also be connected to two first pneumatic interfaces 1322, one first pneumatic interface 1322 is used to introduce positive pressure gas, and the other first pneumatic interface 1322 is used to introduce negative pressure gas.

[0190] In an embodiment, the pressure sensor, air pump, and hydrophobic filter are integrated into the gas branch L2-5 via a three-way or four-way valve or a flow channel switching device. This gas branch L2-5 is located on the reaction pot 60. During use, it is connected to the pressure sensor. When rapid exhaust is required, it is connected to the exhaust port. When slow exhaust is required, it is connected to the degassing pump. When air is required, it is connected to the air pump. It should be noted that the air pump can also be integrated into the interior of the cartridge body.

[0191] In an embodiment, the liquid level in the reaction kettle 60 can be controlled by transmitting a signal via the liquid level sensor, or the liquid level or gas content in the reaction kettle 60 can be determined via the liquid level sensor or pressure sensor. The air pump or exhaust valve on the gas branch L2-5 can then be used to automatically control the closing of the exhaust port to discharge the gas generated by the reaction in the secondary cycle, or to control the total amount of liquid in the secondary cycle, or to control the total amount of liquid in the dialysate regeneration cycle. In some embodiments, the total amount of the dialysate regeneration cycle is the total amount of dialysis waste liquid and regeneration liquid.

[0192] In an embodiment, the portable dialysis device further includes a sensor for detecting the concentration of target molecules in the liquid to be treated in the reaction pot 60, that is, by measuring the pH, substrate concentration, or product concentration of the active effluent in the secondary cycle, the concentration of the target molecules or the cumulative treatment volume is detected, thereby reflecting the usage of the downstream adsorption device (e.g., an adsorption column). Furthermore, the concentration of the substance detected by the above-mentioned sensor can be used to display or prompt the concentration of the initial, treated, or remaining target molecules and product molecules (OCM), or by comparing with an empirical value, a historical value, or a predetermined value to reflect or detect the activity of the enzyme. If the measured value is much lower than the historical value or the preset value, the operator is prompted to add or replace the enzyme preparation.

[0193] In one embodiment, the adsorption device connected to the portable box is, for example, a dialysate regeneration adsorption column, which contains materials such as zirconium phosphate, hydrated zirconium oxide, enzyme-loaded microspheres, and activated carbon. In one embodiment, the dialysate regeneration adsorption column is built with a cation exchanger layer, a urease layer, and a zirconium phosphate layer. When the dialysate regeneration circulation system is in operation, the dialysate waste fluid passes through the cation exchanger layer, the urease layer, and the zirconium phosphate layer in sequence. In another embodiment, the dialysate regeneration adsorption column is a fully mixed layer of a cation exchanger, hydrated zirconium oxide, enzyme-loaded microspheres, and activated carbon, and contains a zirconium phosphate layer or a column containing zirconium phosphate downstream. The cation exchanger is an adsorbent or exchanger used to effectively adsorb calcium and magnesium ions, such as zirconium phosphate, cationic resin and other materials.

[0194] By providing gas branches L2-5 within the secondary circulation device, this application enables the design of an HDF treatment mode, namely, hemodiafiltration with dynamic control of the total amount of (circulating dialysate). By dynamically and periodically regulating the volume or liquid level of any container in the dialysate circulation, the total amount of liquid in the dialysate circulation is controlled, thereby achieving periodic filtration and filtration, and increasing molecular convection exchange in the dialyzer.

[0195] Assuming the volume of the reactor 60 is approximately 20-30 mL, an exhaust valve, such as a four-way valve, can be connected to an air pump or pressure sensor for degassing or adding air. Under standard conditions, the liquid level in the reactor 60 is low, with approximately 25 mL of air. Due to the continuous injection of liquid into the dialysis waste liquid passage L2-1, the air chamber in the reactor 60 is under positive pressure.

[0196] In an embodiment, one HDF process can be divided into a plurality of identical cycles, or gas pump gas filling or degassing cycles.

[0197] During the degassing cycle (assuming 30 seconds), the liquid level in the reaction pot 60 slowly rises during the degassing process, and the amount of water in the blood filtered to the dialysate side increases. If the degassing speed of the air pump is 46 ml / min, the filtered water is 23 mL.

[0198] During the regassing cycle (assuming 30 seconds), the pressure level drops, and more dialysate filters into the bloodstream at the same rate of 46 ml / min. This means the filtration rate increases by 23 mL per cycle (1 minute), resulting in a total filtration volume of 5.52 L over the entire 240-minute treatment cycle.

[0199] In another embodiment of increasing the filtration volume, if the gas filling cycle is shorter than the degassing cycle, the gas filling speed is faster, for example, the gas filling is completed in 5 seconds, and the flow rate is 276 ml / min; in this case, the time of one cycle is 35 seconds, and the treatment time of 240 minutes can work 411.4 cycles, and the total filtration volume is 9.45L.

[0200] Although exhaust can be performed by setting up a gas branch L2-5 in the metabolic circulation device, various devices such as an air pump and a pressure sensor need to be set up, which increases the complexity of the metabolic circulation device and further increases the manufacturing cost.

[0201] To this end, in another embodiment, please refer to Figures 19a and 19b, which show a schematic structural diagram of a metabolic circulation device according to one embodiment of the present application. As shown in Figure 19a, a vent a4 is provided at the top of the reactor 60. A floating valve ball 605 is suspended within the reactor 60, corresponding to the vent a4. The floating valve ball 605 is configured to seal the vent a4 as the liquid level within the reactor 60 rises, and to open the vent as the liquid level within the reactor 60 drops. Specifically, gas within the reactor 60 rises and accumulates at the top of the reactor 60. As the gas gradually increases, the liquid level within the reactor 60 gradually drops. As the liquid level drops, the floating valve ball 605 drops with the liquid level, opening the vent a4, allowing gas to be discharged through the vent a4. When the liquid level rises, as shown in Figure 19b, the floating valve ball 605 rises with the liquid level. When the floating valve ball 605 reaches the top of the reactor 60, it seals the vent a4, preventing the liquid from being discharged through the vent a4. In this way, the gas in the reaction pot 60 can be removed and the complexity of the metabolic circulation device can be reduced, such as reducing the setting of electrical components or elements.

[0202] In the above embodiment, the enzyme preparation is reusable. Using the "pre-prepared solution bypass" method described above, an empty pre-prepared solution bag 45 is connected to the secondary circulation. The secondary circulation fluid and enzyme-loaded microspheres are flushed into the bag, and the enzyme preparation (a more diluted enzyme preparation) is stored at low temperatures to form a pre-prepared solution. During the next treatment, the bag is connected to the secondary circulation flow path and inverted with the outlet facing downward. The enzyme preparation is then replenished into the secondary circulation, or a portion of the enzyme preparation is added based on empirical data before continuing the dialysis treatment.

[0203] In one embodiment, enzyme preparation separation is achieved via a reaction filter 67, which includes a separation assembly that separates the reaction filter 67 into a first side and a second side. Opposite ends of the first side of the reaction filter 67 are connected to the inlet and outlet of the secondary circulation flow path L2-4, respectively, while the second side of the reaction filter 67 is connected to the input of the adsorption device. In some embodiments, the reaction filter 67 may also be referred to as a separation module.

[0204] In this embodiment, the secondary circulation pump 68 provided in the flow channel box 13 drives the reaction pot 60 provided in the flow channel box 13 / the enzyme-loaded microspheres and the dialysis waste liquid mixed in the reaction pot 60 to circulate in the secondary circulation flow path L2-4 at a preset flow rate; during this period, the preset flow rate is related to at least one of the target substance, fluid composition, fluid temperature, separation component structure, separation component material, metabolic filtration module cavity structure, pipeline diameter, and fluid exchange efficiency.

[0205] In an embodiment, the inlet and outlet of the pipeline in the secondary circulation device are connected to the two ports corresponding to the metabolic filtration module, so that the pipeline and the metabolic filtration module can jointly form a circulation path. The secondary circulation pump 68 controls the flow rate of the fluid in the pipeline. For example, by controlling the rate of fluid introduced into the secondary circulation device to be equal to the rate of fluid leaving the circulation based on the metabolic filtration module, the total amount of fluid in the pipeline can be dynamically balanced.

[0206] The fluid in the pipeline contacted by the metabolic filtration module can thereby achieve selective permeation of the components in the fluid based on the metabolic filtration module, and make the components that can pass through the metabolic filtration module pass through the separation component from one side to the other side, thereby achieving a separation effect. That is, the metabolic filtration module can be regarded as a processing unit with a selective treatment function for the fluid to be treated (such as the mixed enzyme-loaded microspheres and dialysis waste liquid in this application). In some examples, the fluid may also include a catalytic unit, and correspondingly, the metabolic filtration module can be set to a structure or material that is not permeable to the catalytic unit, so as to achieve the enzyme-loaded microsphere retention effect.

[0207] Here, the first side and the second side are used to distinguish the locations of the fluid components that can pass through the metabolic filtration module from the retained fluid (the liquid containing the enzyme-loaded microspheres). The positional relationship between the first side and the second side is determined by the structure of the metabolic filtration module cavity and the structure of the separation component. For example, when the separation component is a planar structure and is disposed horizontally in the metabolic filtration module, the first side and the second side are respectively the upper side and the lower side; or when the separation component is a planar structure and is disposed vertically in the metabolic filtration module, the first side and the second side are respectively the left side and the right side.

[0208] It should be understood that in the embodiments provided in the present application, the cavity in the metabolic filtration module that is connected to the pipeline is the first side, and the other cavities in the metabolic filtration module are the second side; in one example, when the metabolic filtration module includes multiple cavities, for example, the metabolic filtration module is divided into multiple cavities by multiple separation components in the form of plate membranes, the cavity in the multiple cavities that is connected to the pipeline is the first side, and the remaining cavities are the second side.

[0209] In certain embodiments, the separation component is a structure or material that is selectively permeable to certain components in the fluid, such as a filter, a filtration membrane, a microfiltration membrane, or a porous metal material. In one embodiment, the microfiltration membrane can be integrated into the cartridge body and communicate with the secondary circulation pump 68 and the reaction vessel 60 in the secondary circulation flow path.

[0210] In certain embodiments, the separation component is a separation membrane, which can selectively remove molecules or molecular combinations from the fluid to be treated (e.g., the mixed enzyme-loaded microspheres and dialysis waste in this application) through the selective permeability of the separation membrane, for example, so that the enzyme-loaded microspheres are retained in the circulation.

[0211] In some embodiments, the separation component is a porous membrane, wherein the porous membrane includes a microfiltration membrane, an ultrafiltration membrane, or a nanofiltration membrane. Here, the average pore size or molecular weight cutoff (MWCO) of the porous membrane or reverse osmosis membrane is related to the target substance. In actual scenarios, based on the fluid components and the determined target substance, a porous membrane suitable for retaining the target substance is selected. For example, when the target substance to be retained in the fluid has a particle size of 10 nm (i.e., 0.01 μm), the corresponding separation membrane can adopt a nanofiltration membrane or a reverse osmosis membrane to achieve the retention of the target substance. Here, the specific type of the separation membrane can be determined based on the differences in the physicochemical properties of the fluid components and the target substance, and includes, for example: reverse osmosis membrane (average pore size 0.0001-0.001 μm), nanofiltration membrane (average pore size 0.001-0.01 μm) ultrafiltration membrane (average pore size 0.01-0.1 μm) microfiltration membrane (average pore size 0.1-10 μm), electrodialysis membrane, permeation vaporization membrane, liquid membrane, gas separation membrane, electrode membrane, etc.

[0212] In certain embodiments, the separation membrane achieves the interception, filtration or exchange of the components in the catalytic unit and the fluid through steric effect, Donan effect or electrostatic effect, adsorption, diffusion, charge repulsion effect, pore effect, or dissolution.

[0213] In some embodiments, especially in the dialysis medical application of the present application, the separation membrane is a high-purity polymer with inactive chemical properties and good blood compatibility and tissue compatibility.

[0214] When the target substance is a substance that needs to be retained by the metabolic filtration module (such as the enzyme-loaded microspheres described in this application), the average pore size or molecular weight cutoff of the porous membrane or reverse osmosis membrane is related to the target substance. In actual scenarios, based on the fluid components and the determined target substance, a membrane that is suitable for retaining the target substance or filtering the target substance is selected. For example, when the target substance to be retained in the fluid has a particle size of 10 nm (i.e., 0.01 μm), the corresponding separation membrane can use a nanofiltration membrane or a reverse osmosis membrane to achieve the retention of the target substance.

[0215] In some practical application scenarios, the separation component of the metabolic filtration module can be used to determine the corresponding separation membrane pore size and type based on its ability to retain more than 90% of the target substance. Alternatively, based on higher separation effect requirements, the separation component can be used to set the retention rate of the target substance to more than 95% or even more than 99% to determine the corresponding separation membrane pore size and type.

[0216] In some embodiments, the average pore size or molecular weight cut-off of the separation component is related to at least one of the catalytic unit, the target substance, and the target product.

[0217] In an embodiment, the separation component can also be configured as a separation membrane of different geometric shapes to adapt to different fluids or achieve different filtration effects. In certain embodiments, the separation component includes one or more of a planar membrane, a tubular membrane, a spiral membrane, a spiral membrane, and a hollow fiber membrane. In terms of microstructure, the separation membrane can include, for example, a symmetric membrane, an asymmetric membrane, a composite membrane, a multilayer composite membrane, etc.

[0218] It should be noted that, based on the different geometric shapes of the separation membranes set in the separation component, the positional relationship between the first side and the second side of the corresponding metabolic filtration module may be different; for example, when the separation component is a planar membrane, the first side and the second side are opposite sides of a planar structure barrier; for example, when the separation component is a hollow fiber membrane, the first side is the inner side of each fiber membrane tube wall, and the second side is the outer side of each fiber membrane tube wall.

[0219] The flow angle of the fluid relative to the separation membrane can be set to different angles, such as 0° to 90°. Here, when the flow angle of the fluid relative to the separation membrane is 0°, the fluid flows parallel to the surface of the separation membrane, such as common tangential flow filtration; when the flow angle of the fluid relative to the separation membrane is 90°, the fluid flows in a direction perpendicular to the membrane surface, such as conventional dead-end filtration (also known as vertical filtration).

[0220] In certain embodiments, the flow channel in the metabolic filtration module can be configured in a folded reciprocating form, a spiral form, or a form with a gradual change in flow channel size. For example, by folding a planar membrane to increase the contact surface area between the fluid and the planar membrane, the flow channel is correspondingly configured in a folded reciprocating form to match the structural form of the separation membrane, thereby ensuring that the separation membrane separates the metabolic filtration module into a first side and a second side.

[0221] In certain embodiments, the secondary circulation pump 68 controls the flow of fluid through the tubing of the cartridge body at a predetermined flow rate, so that the catalytic unit flows from one end of the tubing through the metabolic filtration module to the other end of the tubing. For example, when the metabolic filtration module is a TFFM, the fluid flows parallel to the separation membrane in the TFFM. Here, when the fluid passes through the separation membrane in the TFFM, a transmembrane pressure differential perpendicular to the membrane surface is generated across the membrane, driving low-molecular-weight components in the fluid through the membrane and out the other side. The low-molecular-weight components that permeate the membrane can then exit the circulation, while the retained catalytic unit or other large-molecular components to be retained are flushed off the membrane surface by the fluid momentum and continue to circulate in the tubing. The pressure differential across the membrane in the TFFM is related to the predetermined flow rate. Furthermore, the retained substances require a certain momentum to overcome the inhibition between molecules or between molecules and the membrane in order to continue circulating. The drive device controls the flow rate in the tubing, thereby controlling the pressure differential across the membrane to achieve the desired retention and separation effect, and preventing inhibition, thereby ensuring the sustainability of the circulation in the tubing.

[0222] The fluid flow rate at the metabolic filtration module is related to different parameters, such as different fluid properties such as fluid density and viscosity, the boundary layer shape of the fluid at the metabolic filtration module, such as the surface shape of the separation membrane (i.e., membrane structure) and the cavity structure of the metabolic filtration module, the interaction force between the fluid and the separation membrane, such as the membrane surface roughness determined by the membrane material, the attraction between the membrane and the fluid, and the flow rate relationship between the metabolic filtration module and the pipeline inlet determined by the cavity structure of the metabolic filtration module and the pipeline diameter. The fluid flow rate at the metabolic filtration module may change; here, the preset flow rate is used to determine the fluid flow rate at the pipeline inlet flowing to the metabolic filtration module. The preset threshold value can be used as the initial flow rate at the metabolic filtration module. Based on the initial flow rate and the influencing parameters of the fluid flow rate at the metabolic filtration module, the fluid flow rate in the metabolic filtration module can be determined by controlling the preset flow rate to generate a pressure difference to achieve separation and prevent trapped macromolecules such as catalytic units from being blocked on the membrane surface. As a result, macromolecules can flow from the pipeline inlet through the metabolic filtration module to the pipeline outlet.

[0223] In certain embodiments, the preset flow rate is related to the exchange efficiency of the target product. For example, in TFFM, the target product needs to be driven by the pressure difference on both sides of the separation membrane to flow to the other side after reaching a certain flow rate, thereby leaving the cycle; the pressure difference is related to the flow rate. When the flow rate is too low, the exchange efficiency of the target product flowing across the membrane may decrease. Therefore, the preset flow rate can also be determined by the exchange efficiency.

[0224] In one embodiment, the metabolic filtration module comprises N sub-filtration modules, wherein the N sub-filtration modules are connected in series and / or in parallel, where N is a positive integer greater than 2. In certain embodiments, the N sub-filtration modules are connected in series according to a connection order, and the average pore size or molecular retention capacity corresponding to the separation components of the N sub-filtration modules decreases in sequence.

[0225] In certain embodiments, the metabolic filtration process is implemented by N cycles, and the N groups of secondary circulation modules corresponding to the N cycles respectively process different molecules or molecular combinations in the fluid, so that different components in the fluid are distributed and processed in the N cycles; wherein N is a positive integer greater than 2.

[0226] Here, the N groups of processing units may perform different types of processing. For example, according to the cycle connection order, the fluid to be processed may be filtered in the first cycle, heated in the second cycle, and catalytically processed in the third cycle.

[0227] Alternatively, the processing categories performed by the N groups of processing units may be the same, but correspond to different target substances; for example, the N groups of processing units corresponding to the N cycles are all used to perform catalytic treatment on the fluid to be treated, so that different target substances are distributed in the N cycles and contact different catalytic units respectively.

[0228] In certain embodiments, the fluid is introduced into N circulation modules for treatment, and the N circulation modules are connected in series and / or in parallel, wherein N is a positive integer greater than 2 (N≥2).

[0229] In one embodiment, the secondary circulation device has a discharge port (not shown) for discharging the enzyme-loaded microspheres from the secondary circulation device. The discharge port is connected to a reservoir for storing the discharged enzyme-loaded microspheres. The enzyme-loaded microspheres are discharged from the discharge port by centrifugation or membrane filtration, for example, by slowly filtering by gravity or centrifuging the enzyme-loaded microspheres from the secondary circulation device into a reservoir, such as a liquid bag made of medical plastic.

[0230] In one embodiment, the secondary circulation device is a sterilized, reusable secondary circulation device. In this embodiment, the upstream and downstream piping of the reusable circulating metabolic module contains a non-liquid contact instantaneous sterilization device, such as a non-contact sterilization device such as ultraviolet or gamma ray, or a bacterial filtration membrane, typically a 0.22 μm or 0.45 μm filter membrane.

[0231] In some embodiments, the secondary circulation flow path is, for example, a loop or a loop system or a loop in a circulation treatment system constituted by the "metabolic circulation module" described in patent document WO2022036739A1 or / and patent document WO2022036738A1; in this application, the full text of patent documents WO2022036739A1 and WO2022036738A1 is cited here.

[0232] In one embodiment, the reaction pot 60 and the microfiltration membrane in the secondary circulation flow path composed of the reaction pot 60, the secondary circulation pump 68 and the microfiltration membrane can also be integrated on the box body.

[0233] In this embodiment, an ultrafiltration pump 51 is provided in the box body on the first mounting surface 101 for performing ultrafiltration operations in the dialysate circuit. In the embodiment shown in FIG2 , the waste liquid passage L2-1 is connected to an ultrafiltration branch L2-2. In this embodiment, the ultrafiltration branch L2-2 is provided with an ultrafiltration container 52 for storing ultrafiltrate, and an ultrafiltration pump 51 for transporting the ultrafiltrate in the ultrafiltration container 52 to the waste liquid passage L2-1. An ultrafiltration filter 50 may be provided between the ultrafiltration pump 51 and the waste liquid passage L2-1. In one example, as shown in FIG11 , the ultrafiltration container 52 is, for example, an external ultrafiltration bag 52, such as a liquid bag made of medical plastic, which is connected to the pipeline in the portable box of the present application through a pipeline; the ultrafiltration pump 51 is provided in the box body and is connected to the external ultrafiltration container 52 through a pipeline connected to the fluid interface.

[0234] It should be understood that the ultrafiltration is one of the membrane separation technologies using pressure as the driving force, and is generally used for replacing buffers, removing impurities, separating samples and other processes. Ultrafiltration is the transport of liquid through a semipermeable membrane under a certain pressure gradient, which is called ultrafiltration. In clinical hemodialysis, ultrafiltration refers to the process in which water is transported from blood to dialysate. The amount of liquid ultrafiltered from blood per unit time is called ultrafiltration rate, and the unit is mL / h (milliliters per hour). Ultrafiltration is one of the important functions of hemodialysis. By ultrafiltration, the liquid retained in the patient's body between dialysis periods can be effectively removed, the patient's standard weight can be maintained, and the ideal dialysis effect can be achieved.

[0235] For example, in the hemodialysis treatment mode (HD), that is, the standard normal treatment mode, since the exchange between molecules is a free exchange driven by concentration difference, the purpose of exchange and toxin removal is achieved. Since the ultrafiltration branch L2-2 is set on the waste liquid passage L2-1, ultrafiltration dehydration can be carried out at the same time, which will bring an additional amount of transmembrane flow (for example, 3-4L).

[0236] In one embodiment, when the dialysate regeneration circulation system is applied to the circulation of a blood purification device, the ultrafiltration pump 51 will continuously extract the water in the waste liquid passage L2-1, forming a transmembrane negative pressure. At this time, the dialyzer will ultrafilter more water to achieve pressure balance. Ultimately, the amount of water extracted by the ultrafiltration pump 51 is equal to the amount of water lost by the blood, thereby achieving the purpose of helping the human body remove excess water. In an actual embodiment, the ultrafiltration pump 51 continuously pumps the dialysate waste liquid in the waste liquid passage L2-1 into a waste liquid bag. By accurately measuring the flow rate of the ultrafiltration pump 51, the excess water in the patient's body can be accurately extracted from the body, thereby achieving the purpose of dehydration.

[0237] In another embodiment, the ultrafiltration branch L2-2 can also be set on the regeneration liquid pipeline L2-7 through the connection of the pipeline, that is, the ultrafiltration branch L2-2 includes a first ultrafiltration branch and a second ultrafiltration branch, wherein the first ultrafiltration branch is set on the waste liquid channel, and the second ultrafiltration branch is set on the regeneration liquid pipeline L2-7. In this embodiment, weighing ultrafiltration control is adopted, that is, dual pump control of an upstream pump and a downstream pump is adopted, wherein the upstream pump is set on the first ultrafiltration branch, and the downstream pump is set on the second ultrafiltration branch in the regeneration liquid pipeline L2-7, and the The container connected to the second ultrafiltration branch, such as an ultrafiltration bag, contains treated dialysis regeneration fluid. There is a weighing device under the ultrafiltration bag. The weighing device can obtain the content of the regeneration fluid in the ultrafiltration bag by weighing, and adjust the speed of the upstream pump and the downstream pump by controlling the speed. For example, if the water in the ultrafiltration bag exceeds the preset value (ultrafiltration curve), it means that more water has been ultrafiltered, so the speed of the upstream pump is lowered and the speed of the downstream pump is increased. On the contrary, if the water in the ultrafiltration bag is lower than the preset value (ultrafiltration curve), the speed of the upstream pump can be increased and the speed of the downstream pump can be lowered.

[0238] In the embodiment shown in FIG2 , a leakage sensor 41 is provided in the waste liquid passage L2-1. In an embodiment where the dialysate regeneration circulation system is applied to a blood purification device, the leakage sensor 41 is, for example, a blood leakage sensor for detecting blood leakage; in an embodiment where the dialysate regeneration circulation system is applied to a peritoneal dialysis device, the leakage sensor 41 is, for example, a peritoneal fluid leakage sensor.

[0239] In the embodiment shown in FIG2 , a pressure sensor 43 for detecting the pressure of dialysis waste liquid is provided on the waste liquid passage L2-1. A hydrophobic filter 42 is provided between the waste liquid passage L2-1 and the pressure sensor 43. The permeability of the hydrophobic filter 42 enables the pressure sensor 43 to detect the pressure of the waste liquid in the waste liquid passage L2-1.

[0240] In the embodiment shown in Figure 2, a pre-liquid bypass L2-3 is provided on the waste liquid passage L2-1 for priming, draining, or flushing the dialysate regeneration circulation system. In this embodiment, a short-circuit valve 44 is provided on the waste liquid passage L2-1 in parallel with the pre-liquid bypass L2-3. The short-circuit valve 44 can be integrated into the cartridge body.

[0241] In one embodiment, the prefabricated liquid bypass L2-3 is a circulation loop for prefilling and emptying the dialysate regeneration circulation system. By connecting it to a liquid storage container (for example, a prefabricated liquid bag 45, for example, a liquid bag made of medical plastic) in the circulation loop and cooperating with the working mode of the drive device, or the upright or inverted state of the liquid storage container, the two operations of prefilling and emptying can be achieved, that is, in the prefilling mode, the outlet of the liquid in the liquid storage container is at a low position; and in the emptying mode, the outlet of the gas in the liquid storage container is at a high position; compared with the conventional operation in the prior art, the system structure of the present application is simple, the operation is convenient, and the learning cost is low. Moreover, the application of the system of the present application enables more scientific treatment of medical waste such as pipelines and waste liquids after emptying.

[0242] In this embodiment, the priming and emptying system includes a liquid storage container (i.e., the prefabricated liquid bag 45 shown in FIG2 ), a circulation loop (i.e., the circulation loop composed of the waste liquid passage L2-1 and the regeneration liquid pipeline L2-7 in FIG2 ), and a driving device (i.e., the dialysate pump 46 in FIG2 ). The liquid storage container is used to store the priming liquid and recover the emptied waste liquid, and includes a container body, and a first interface b1 and a second interface b2 provided on the container body for serving as liquid and / or gas inlets and outlets; the first interface b1 or the second interface b2 are both inlets and outlets for the fluid in the container body. In this application, the "priming liquid" refers to the pre-filled liquid used in the blood purification control device. In some embodiments, the priming liquid is physiological saline, physiological buffer, or enzyme-loaded microsphere solution. In certain embodiments, the priming liquid may also be referred to as a prefabricated liquid. In one example, the prefabricated liquid is a prefabricated sterile pyrogen-free solution. The preformed liquid bag 45 contains 3L-5L of a preformed sterile, pyrogen-free solution. For example, the preformed solution contains at least one of sodium chloride, sodium bicarbonate, and sodium carbonate. For example, the 3L-5L preformed solution contains 0.6%-0.9% sodium chloride and 20-80mM sodium bicarbonate or sodium carbonate.

[0243] In the embodiment shown in Figure 20, the liquid storage container 45 can be switched between upright and inverted states, that is, the state of the liquid storage container being placed upright is upright, and the state of the liquid storage container being placed upside down is inverted. In order to switch between the two states more simply, a mechanism for placing the liquid storage container upright or inverted is also included. In one embodiment, the mechanism is, for example, a plate or a frame for placing the liquid storage container, and a structure for fixing the liquid storage container and a positioning structure for positioning the upright state and the inverted state are provided on the plate or the frame, so that the liquid storage container can be stabilized in its upright state when placed upright, or can be stabilized in its inverted state when inverted.

[0244] In this embodiment, the liquid storage container has two working modes in the pre-filling and emptying systems, namely, in the pre-filling mode, the outlet of the liquid in the liquid storage container is at a low position; in the emptying mode, the outlet of the gas in the liquid storage container is at a high position; for example, in the pre-filling mode, the second interface b2 is at a lower height so that the pre-filled liquid in the liquid storage container preferentially enters the pipeline in the circulation loop from the second interface b2, while in the emptying mode, the first interface b1 is at a higher height so that the gas / bubbles in the liquid storage container preferentially enter the pipeline in the circulation loop from the first interface b1. In the present application, the switching between the pre-filling mode and the emptying mode can be achieved by adjusting the flow direction of the fluid and / or switching the liquid storage container upright or inverted.

[0245] In other embodiments, the preformed liquid bypass can also be used in a blood circuit, such as that shown in FIG. 20 . Please refer to FIG. 20 , which is a schematic diagram of the fluid flow direction of the blood circuit of the present application in a flushing embodiment. As shown in the figure, a bypass including a liquid storage container 45 is provided on the arterial blood line L1, which is composed of a valve 451 connected by a pipeline, a second interface b2 of the liquid storage container 45, a first interface b1, and a valve 452. In the embodiment of the flushing operation, the arterial end of the arterial blood line L1 is connected to the venous end 86 of the venous blood line L3, and the fluid in the blood circuit (the preformed liquid in the liquid storage container) flows in the reverse direction. The gas in the dialysis device on the dialysis pathway L2 floats to the top thereof, and flows sequentially along the arterial blood line L1 and the venous blood line L3, and is enriched in the gas collecting chamber 80. The liquid entering the gas collecting chamber 80 flows from the first interface 801 of the gas collecting chamber 80 to the bottom end of the dialysis device on the dialysis pathway L2. During flushing mode, gas in the blood circuit accumulates in the gas collection chamber 80. During the treatment phase, i.e., when the fluid in the blood circuit is driven in the forward direction, the gas originally accumulated in the gas collection chamber 80 preferentially flows along the venous blood line L3 into the venous pot 81 and is then discharged through the exhaust pipe L4 of the venous pot 81. In the embodiment illustrated in FIG2 , the exhaust pipe L4 is provided with a pressure sensor 83 for detecting the pressure within the venous pot 81 and an exhaust valve 82 for releasing the pressure within the venous pot 81.

[0246] In one embodiment, an arterial pot 24 is connected to the pipeline between the dialysis pathway L2 and the arterial end of the arterial blood line L1 for observing the dripping situation in the treatment mode. The cross section of the arterial pot 24 is generally in an inverted trapezoidal or conical structure.

[0247] In one embodiment, as shown in Figure 10 , the second mounting surface 102 is located within the lower case 11 and is horizontal when the portable case is opened. A control or monitoring drive device for controlling or monitoring fluid flow in the pipeline is secured to the second mounting surface 102. The multiple control or monitoring devices mounted on the second mounting surface 102 include a blood pump 23 disposed within the blood circuit, a photoelectric sensor 87 for detecting blood flow at the venous end 86 of the blood circuit, a venous clamp or valve 84 for controlling blood flow at the venous end 86 of the blood circuit, and a pressure sensor 85 for fluid pressure at the arterial end.

[0248] In one embodiment, the second mounting surface 102 is an integral part of the lower housing 11. For example, the second mounting surface 102 may be the inner side surface of the lower housing 11, such as including a flat portion of the inner wall of the lower housing 11 and surrounding curved or arcuate portions. The multiple driving devices are directly fixed to the inner side of the lower housing 11. In another embodiment, the second mounting surface 102 is an independent component, such as a flat plate, which is detachably fixed to the lower housing 11. In this embodiment, the plate is fixed to the lower housing 11, for example, by screws or snap-fitting, and the driving devices are fixed to the plate.

[0249] In the embodiment shown in FIG10 , a drive device is provided on the second mounting surface 102. The drive device is a blood pump connected to the blood circuit. Correspondingly, the dialysate pump 46 and the secondary circulation pump 68 in the dialysate circuit can be integrated into the cartridge body. As shown in FIG10 , in a specific embodiment, the blood pump is provided on the second mounting surface 102 in a manner that penetrates the second mounting surface 102. That is, to facilitate the user to observe the operating status of the drive device, a portion of the blood pump passes through the second mounting surface 102 and leaks out to connect to the catheter of the blood circuit or the dialysate circuit. This also facilitates the user to intuitively observe the operating status of these drive devices. Another portion of the blood pump is located on the back side of the second mounting surface 102, such as the tail of the motor of each drive pump. Although this application uses the example of the blood pump being arranged on the second mounting surface 102 and the dialysate pump 46 and / or the secondary circulation pump 68 being integrated into the box body, in other embodiments, the dialysate pump 46 and / or the secondary circulation pump 68 may also be installed on the second mounting surface 102.

[0250] In one embodiment, an arterial pressure sensor 85 for detecting the arterial pressure in the blood circuit is mounted on the second mounting surface 102 .

[0251] In one embodiment, the back of the second mounting surface 102 is equipped with a power supply device that provides electrical energy to the portable dialysis device. This device includes, for example, a power switch 113, a battery (not shown), and a power management module (not shown). In one example, the power supply device is located on the right and left sides of the back of the second mounting surface 102. As shown in FIG10 , the power switch 113 of the power supply device is located on the second mounting surface 102.

[0252] The back of the second mounting surface 102 is also equipped with a control device for controlling the working mode of the portable dialysis device (displayed on the back of the second mounting surface). In this embodiment, the control device is, for example, a main control board of the portable dialysis device. The main control board includes a controller or system processor of the hemodialysis device, which outputs corresponding control instructions through a program written into the system processor; or receives trigger instructions input by an operator through an input device such as a touch screen, executes calculations and outputs relevant control instructions for performing related operations such as dialysis treatment, priming, emptying, flushing, and filtration of dialysis waste liquid circulation.

[0253] In order to facilitate the user to perform relevant operations on the portable dialysis device, in one embodiment, a touch screen 112 that can be extended or retracted relative to the internal space is provided in the upper box 10 or the lower box 11. In one embodiment, the touch screen 112 is provided in the lower box 11 through a foldable bracket. Specifically, the foldable bracket includes a connecting portion and a folding arm, the connecting portion is fixed on the second mounting surface 102 of the lower box 11, the proximal end of the folding arm is connected to the connecting portion, and can be rotated relative to the connecting portion to complete the folding or unfolding action, and the touch screen is fixed to the distal end of the folding arm, which is used to pull out the display screen when the user opens the box so that the user can input operating instructions or observe the output interface of the dialysis device in performing related operations such as dialysis treatment, pre-filling, emptying, flushing, and dialysis waste liquid circulation filtration.

[0254] In another embodiment, the touch screen can also be placed in a preset card slot on the second mounting surface 102 in the lower box body 11, so that the display screen can be removed from the card slot when the user opens the box body so that the user can input operating instructions or observe the output interface of the dialysis equipment during related operations such as dialysis treatment, priming, emptying, flushing, and dialysis waste liquid circulation filtration.

[0255] In one embodiment, a pneumatic system is provided in the lower box body 11, and the pneumatic system is connected to the second pneumatic interface 103 to control the pump and / or valve in the box body so that the fluid flows forward or reversely in the fluid channel 1313. In one example, please refer to Figure 21, which shows a schematic diagram of the principle of the pneumatic system in one embodiment of the present application. As shown in the figure, the pneumatic system includes an air pump, a positive pressure chamber, a negative pressure chamber, and a plurality of three-way valves. The air inlet of the air pump draws air from the negative pressure chamber, and the air outlet of the air pump exhausts air to the positive pressure chamber. A three-way valve V4 is provided before the negative pressure chamber for adjusting the pressure of the negative pressure chamber to a set value, and a three-way valve V5 is provided after the positive pressure chamber for adjusting the pressure of the positive pressure chamber to a set value. Three-way valves V8-V12 are respectively connected to each of the second pneumatic interfaces 103. It should be noted that the five three-way valves V8-V12 in the figure are for illustration only. In an actual pneumatic system, the number of three-way valves respectively connected to the second pneumatic interfaces 103 is equal to the total number of valves and pumps that need to be controlled by the pneumatic system. In order to distinguish between the three-way valve V4 and the three-way valve V5, in the following embodiments, the three-way valve V5 connected to the positive pressure chamber is referred to as the second three-way valve, and the three-way valve V4 connected to the negative pressure chamber is referred to as the first three-way valve. In another embodiment, the first three-way valve can also be located after the negative pressure chamber, and the second three-way valve can also be located before the positive pressure chamber.

[0256] The air pressure sensor G6 and air pressure sensor G7 in Figure 21 are used to measure the pressure of the positive pressure chamber S2 and the negative pressure chamber S3, respectively. If the positive pressure in the positive pressure chamber S2 exceeds the set value, the three-way valve V5 is connected to the atmosphere to relieve the pressure in the positive pressure chamber S2. The three-way valve V5 can also be placed between the air pump P1 and the positive pressure chamber S2. If the positive pressure in the positive pressure chamber S2 exceeds the set value, the three-way valve V5 is connected to the atmosphere, and the air pump P1 exhausts gas into the atmosphere. If the negative pressure in the negative pressure chamber S3 is lower than the set value, the three-way valve V4 is connected to the atmosphere, and the air pump P1 directly draws gas from the outside atmosphere. The three-way valve V4 can also be placed before the negative pressure chamber S3. If the negative pressure in the negative pressure chamber S3 is lower than the set value, the three-way valve V4 is connected to the atmosphere to increase the pressure in the negative pressure chamber S3.

[0257] It should be noted that the three-way valve V4 and the three-way valve V5 in the pneumatic system can also be replaced by two two-way valves to respectively realize the functions of the three-way valve V4 and the three-way valve V5. For example, please refer to Figure 22, which shows a schematic diagram of the principle of the pneumatic system in another embodiment of the present application. As shown in the figure, the two-way valve V24 is located between the air pump P1 and the negative pressure chamber S3, and the two-way valve V25 is located between the air pump P1 and the positive pressure chamber S2. In order to distinguish between the two-way valve V24 and the two-way valve V25, in the following embodiments, the two-way valve V25 connected to the positive pressure chamber is referred to as the second two-way valve, and the two-way valve V24 connected to the negative pressure chamber is referred to as the first two-way valve. In another embodiment, the first two-way valve can also be located after the negative pressure chamber, and the second two-way valve can also be located after the positive pressure chamber.

[0258] In one embodiment, the use process of the portable dialysis device of the present application is as follows: the user opens the portable case and connects the multiple first pneumatic interfaces 1322 in the flow channel box 13 to the multiple second pneumatic interfaces 103 on the first mounting surface 101. The external pipeline connected to the fluid interface of the flow channel box 13 is connected to the human vein, human artery, prefabricated liquid bag 45, supplementary liquid bag, adsorption device, ultrafiltration container 52, and / or blood pump and other devices. Then the portable dialysis device controls the operation of various pumps and valves in the flow channel box 13, for example, by controlling the operation of the various pumps and valves through the pneumatic system to control the forward or reverse flow of the fluid in the fluid channel 1313 through air pressure. In addition, the flow of blood and dialysate in the flow channel box 13 and the external pipeline is controlled, and the status of blood and dialysate is monitored using various sensors.

[0259] Specifically, referring to Figures 9 to 13b, the blood pump on the second mounting surface controls the blood from the human artery to flow into the flow channel box 13 through the arterial line, enters the dialyzer 30 through the partial arterial blood line L1 / partial flow channel in the flow channel box 13, and the blood purified by the dialyzer 30 flows into the flow channel box 13 and flows into the venous line through the partial flow channel / partial venous blood line L3 in the flow channel box 13. Furthermore, the flow channel box 13 is also integrated with a dialysate regeneration flow path L2, in which a reaction pot 60, a secondary circulation pump 68 and a microfiltration membrane are provided. One end of the dialyzer 30 is connected to the dialysate input end and the other end is connected to the dialysate output end. The dialyzer 30 is connected to the dialysate waste liquid through the pipeline connected to the flow channel box 13. The pneumatic system controls the operation of the valves and pumps in the flow channel box 13 so that the dialysate waste liquid undergoes secondary circulation in the dialysate regeneration flow path L2 for toxin treatment. Furthermore, the adsorption column connected to the cartridge body performs secondary toxin treatment on the waste liquid before and / or after toxin treatment to generate a regeneration liquid. The regeneration liquid flows into the flow channel of the cartridge body through an external pipeline, and the regeneration liquid is input into the dialyzer 30 through a portion of the flow channel / regeneration liquid pipeline. In one embodiment, before dialysis, the pneumatic system controls the forward or reverse flow of the prefabricated liquid in the flow channel of the flow channel box 13 to flush the flow channel in the cartridge body. In one embodiment, during dialysis, a supplemental liquid and an enzyme preparation are also injected into a portion of the flow channel of the cartridge body.

[0260] It should be noted that, although the flow channel box 13 is described above by taking the portable dialysis device as a hemodialysis device as an example, it is not limited to this. In other embodiments, the flow channel box 13 integrating the pump and valve can also be set in a peritoneal dialysis device.

[0261] In summary, the portable dialysis device provided by the present application is arranged in a portable box through a rational layout of core devices such as the dialyzer 30, pump device, valve device, pipeline, sensor, etc. in the dialysis operation, and a plurality of fluid channels 1313 that control the forward or reverse flow of the fluid by air pressure are provided inside the box body of the flow channel box 13 (for example, some pipelines, pumps, and valves in the blood circuit and the dialysate circuit are integrated into the flow channel box 13). In addition, a plurality of independent first pneumatic interfaces 1322 are provided on the box body of the flow channel box 13, which are respectively connected to the plurality of second pneumatic interfaces 103 of the dialysis device. After the user connects the flow channel box 13 to the second pneumatic interface 103, the pneumatic system in the dialysis device can use air pressure to control the forward or reverse flow of the fluid in the fluid channel 1313, thereby greatly reducing the complexity and threshold of operation. In addition, the dialysis device has a higher degree of integration and a smaller device size, which is particularly beneficial for dialysis treatment in scenarios such as emergency, travel, disaster relief, and home.

[0262] The present application further provides an embodiment that omits the flow channel box shown in Figures 8 to 13b above. In the following embodiments, the portable dialysis device of the present application arranges the core components of the dialysis operation, such as dialyzers, pump devices, pipelines, sensors, etc., in a portable box through a rational layout, and through the design of the blood circuit and the dialysate circuit, the dialysis operation can be completed based on the various modular functions provided by a portable box. The portable dialysis device is unfolded when in use and closed when transported or not in use, which greatly reduces the operating threshold and the size of the equipment, and is particularly beneficial for hemodialysis treatment in scenarios such as first aid, travel, disaster relief, and home.

[0263] Please refer to Figures 23 to 26. Figure 23 shows a schematic diagram of the structure of the portable dialysis device of the present application in another embodiment, and Figure 24 shows a schematic diagram of the component layout on the first and second mounting surfaces of the portable dialysis device shown in Figure 23. Figure 25 shows a schematic diagram of the back side of the first mounting surface of the portable dialysis device shown in Figure 23. Figure 26 shows a schematic diagram of the back side of the second mounting surface of the portable dialysis device shown in Figure 23. As shown in the figure, the portable dialysis device includes a portable case consisting of an upper case 10 and a lower case 11, a first mounting surface 101, related pipelines, and a second mounting surface 111.

[0264] As shown in Figure 24, the first mounting surface 101 is an independent component, such as a plate with a flat surface, which is fixed to the upper box body in a detachable manner. In this embodiment, the plate body is fixed to the upper box body by screws or snap-fitting, so that when the upper box body is opened / opened, the first mounting surface 101 is in an upright position along with the upper box body 10, and the multiple fluid containers (including the dialyzer 30, the gas collection chamber 80, the intravenous pot 81 and the reaction pot 60, etc.) installed on the first mounting surface 101 are also in an upright position or vertical position, and the multiple fluid containers are fixed to the plate body. In one embodiment, the multiple fluid containers are mounted on the first mounting surface 101 in a detachable manner. It should be understood that the detachable manner refers to the multiple fluid containers being mounted on or removed from the first mounting surface 101 in a manner that does not damage the first mounting surface or the fixed structure or the fluid containers, such as by snapping on the bracket 102 or screwing. In this embodiment, the multiple fluid containers installed on the first mounting surface 101 include an arterial pot connected to the blood circuit, a venous pot 81, a dialyzer 30, or a collection container 60 (reaction pot 60) connected to the dialysate circuit, and / or a metabolic filter 67, etc.

[0265] As shown in Figure 24, a dialyzer 30 is installed on the left side of the first mounting surface. The dialyzer 30 is fixed to the first mounting surface 101 in a vertically arranged manner using a dialyzer 30 support structure 102. Blood enters the dialyzer 30 from the upper end of the dialyzer 30 and is discharged from the lower end of the dialyzer 30.

[0266] As shown in Figure 25, in this embodiment, an ammonia sensor 73 for detecting ammonia content in the dialysate circuit is installed on the back of the first mounting surface 101. A conductivity sensor 76 for detecting fluid in the dialysate circuit is installed vertically on the back of the first mounting surface 101.

[0267] In the present embodiment, an air pump 65 for controlling the liquid level or pressure of the collecting container 60 on the dialysate circuit is installed on the back side of the first mounting surface. The air pump 65 is connected to the gas branch L2-5, and is used to control the amount of liquid in the collecting container by exhausting or intake. In the present embodiment, the degassing pump 65 is connected to a gas inlet and outlet. An exhaust valve or a flow channel switching device is provided on the exhaust branch L2-5, which is used to connect or close the circulating gas on the exhaust branch L2-5. The exhaust valve is, for example, a three-way valve or a four-way valve. A hydrophobic filter is provided on the gas branch L2-5. The exhaust branch L2-5 is provided with a pressure sensor for detecting the pressure in the cavity of the collecting container. The pressure sensor can reflect the metabolic cycle and / or the fluid pressure conditions downstream.

[0268] In this embodiment, a plurality of valve components (unnumbered) for controlling the flow of fluid in the pipeline, as well as valve components for controlling the flow of fluid in a blood circuit or a dialysate circuit or the liquid level in a fluid container are installed on the back side of the first mounting surface 101. The valve components are, for example, three-way valves or four-way valves.

[0269] In this embodiment, a control device for controlling electronic devices such as sensors and pumps located on the first mounting surface 101 is installed on the back side of the first mounting surface 101. The control device is, for example, a control board or a connection port circuit board.

[0270] In this embodiment, part of the dialysate circuit disposed on the first mounting surface 101 has an interface for connecting to an external liquid container, which includes an ultrafiltration container, a supplementary liquid container, a pre-made liquid container, and / or an adsorption device.

[0271] In this embodiment, the ultrafiltration pump 51 and the replenishing liquid pump 74 are arranged on the first mounting surface 101 in a manner of penetrating the first mounting surface 101, that is, in order to facilitate the user to observe the working status of the above-mentioned ultrafiltration pump 51 and the replenishing liquid pump 74, a part of the ultrafiltration pump 51 and the replenishing liquid pump 74 passes through the first mounting surface 101 and leaks out to connect the conduit of the ultrafiltration branch or the conduit of the replenishing liquid, and it is also beneficial for the user to intuitively observe the working status of these driving devices. The other part of the ultrafiltration pump 51 and the replenishing liquid pump 74 is located on the back of the first mounting surface 101, such as the tail of the motor of each driving pump.

[0272] As shown in FIG. 24 and FIG. 26 , the second mounting surface 111 is located in the lower box and is horizontal when the portable box is opened. A plurality of driving devices for driving the fluid to flow in the pipeline are fixed on the second mounting surface 111 .

[0273] In the present embodiment, the second mounting surface 111 is an independent component, such as a plate with a plane, which is fixed in the lower box body 11 in a detachable manner. In the present embodiment, the plate body is fixed in the lower box body 11 by means of screws or snap-fitting, for example, and the multiple driving devices are fixed on the plate body. Specifically, three driving devices are provided on the second mounting surface 111, including a blood pump 23 connected to the blood circuit, a dialysate pump 46 and a metabolic circulation pump 68 provided in the dialysate circuit. As shown in Figure 24, the blood pump 23 installed on the second mounting surface 111 is located on the leftmost side, the metabolic circulation pump 68 installed on the second mounting surface 111 is located on the rightmost side, and the dialysate pump 46 is located between the blood pump 23 and the metabolic circulation pump 68. In a specific implementation, the blood pump 34, dialysate pump 46, and metabolic circulation pump 68 are arranged on the second mounting surface 111 in a manner of penetrating the second mounting surface 111, that is, in order to facilitate the user to observe the working status of the above-mentioned driving devices, a portion of the blood pump 23, dialysate pump 46, and metabolic circulation pump 68 passes through the second mounting surface 111 and leaks out to connect to the catheter of the blood circuit or the dialysis circuit, and also facilitates the user to intuitively observe the working status of these driving devices. Another portion of the blood pump 23, dialysate pump 46, and metabolic circulation pump 68 is located on the back side of the second mounting surface 111, such as the tail of the motor of each driving pump.

[0274] In this embodiment, a photoelectric sensor for detecting whether blood is flowing through the vein in the blood circuit is mounted on the second mounting surface 111. A venous clamp or valve for controlling blood flow through the vein in the blood circuit is mounted on the second mounting surface 111.

[0275] As shown in the figure, in this embodiment, a power supply device (unnumbered) for providing electrical energy to the portable dialysis device is installed on the back of the second mounting surface 111, such as functional modules such as a battery and a power management module. In the embodiment shown in Figure 6, the power supply device is located on the right and left parts of the back of the second mounting surface 111.

[0276] In the embodiment shown in FIG6 , the heating device 47 is also provided on the second mounting surface 111 in a manner of penetrating the second mounting surface 111, and a portion of the heating device 47 is located on the back of the second mounting surface 111. A control device 90 for controlling the working mode of the portable dialysis device is also provided on the back of the second mounting surface 111. In this embodiment, the control device 90 is, for example, a main control board of the portable dialysis device. The main control board includes a controller or system processor of the hemodialysis device, which outputs corresponding control instructions through a program written into the system processor; or receives trigger instructions input by an operator through an input device such as a touch screen 112 to execute calculations and output relevant control instructions for performing related operations such as dialysis treatment, pre-filling, emptying, flushing, and filtration of dialysis waste liquid circulation.

[0277] The above embodiments are merely illustrative of the principles and effects of this application and are not intended to limit this application. Anyone skilled in the art may modify or alter the above embodiments without departing from the spirit and scope of this application. Therefore, all equivalent modifications or alterations made by one of ordinary skill in the art without departing from the spirit and technical concepts disclosed in this application shall be covered by the claims of this application.

Claims

1. A flow channel box of a dialysis device, characterized in that: The invention comprises a box body which is detachably mounted on the body of the dialysis device, wherein a plurality of fluid channels for controlling the forward or reverse flow of fluid by air pressure are arranged inside the box body, and at least one first pneumatic interface is arranged on a side of the body of the dialysis device corresponding to the box body, and the first pneumatic interface is used to connect with the second pneumatic interface of the dialysis device to connect with the pneumatic system of the dialysis device; and a plurality of fluid interfaces for connecting with liquid pipelines outside the box are also arranged on the box body.

2. The flow channel box according to claim 1, characterized in that: The box body of the flow channel box is arranged on the body of the dialysis device in a snap-fit ​​or plug-in manner, or the box body of the flow channel box is arranged on the body of the dialysis device by a clamping device.

3. The flow channel box according to claim 1, characterized in that: The fluid interface is disposed on at least one side of the box body.

4. The flow channel box according to claim 1, characterized in that: The fluid channel inside the box body includes a blood channel and / or a dialysate channel.

5. The flow channel box according to claim 1, characterized in that: The fluid interface includes an arterial interface that can be connected to an arterial line of a patient's artery, a venous interface that can be connected to a venous line of a patient's vein, a prefabricated liquid interface that can be connected to a prefabricated liquid passage, a supplementary liquid interface that can be connected to a supplementary liquid passage, an adsorption interface that can be connected to an adsorption device, or / and an ultrafiltration interface that can be connected to an ultrafiltration passage.

6. The flow channel box according to claim 1, characterized in that: The fluid interface is used to connect an external liquid container through the liquid pipeline, and the external liquid container includes an ultrafiltration container, a supplementary liquid container, a prefabricated liquid container, and / or an adsorption device.

7. The flow channel box according to claim 1, characterized in that: The side of the box body corresponding to the body combined with the dialysis device is the back side, and the box body is provided with an ammonia sensor interface and / or a catalytic unit injection port.

8. The flow channel box according to claim 1, characterized in that: The box body is integrated with a dialyzer and / or a reaction filter.

9. The flow channel box according to claim 8, characterized in that: The dialyzer and / or reaction filter is connected to the fluid channel inside the box body through a pipeline.

10. The flow channel box according to claim 8, characterized in that: The dialyzer and / or reaction filter is connected to the fluid channel inside the box body through a pipeline integrally formed on the box body.

11. The flow channel box according to claim 8, characterized in that: The dialyzer and the reaction filter are respectively located on the left and right sides of the box body.

12. The flow channel box according to claim 8, characterized in that: When the dialysis device is in working state, the dialyzer and / or reaction filter of the box body is in an upright state with an angle of 70°-110° with the horizontal plane.

13. The flow channel box according to claim 8, characterized in that: The reaction filter comprises a microfiltration membrane.

14. The flow channel box according to claim 1 or 7, characterized in that: The box body is integrated with a dialysate regeneration flow path.

15. The flow channel box according to claim 14, characterized in that: The dialysate regeneration flow path is provided with a secondary circulation flow path consisting of a reaction pot, a secondary circulation pump and a microfiltration membrane.

16. The flow channel box according to claim 15, characterized in that: The injection port of the catalytic unit is an enzyme preparation injection port, and the enzyme preparation injection port is used to inject the enzyme preparation into the secondary circulation flow path.

17. The flow channel box according to claim 1, characterized in that: The box body includes a pneumatic element, which is connected to the first pneumatic interface and the fluid channel and is used to control the forward or reverse flow of the fluid in the fluid channel by using the positive pressure gas and negative pressure gas introduced through the first pneumatic interface.

18. The flow channel box according to claim 17, characterized in that: The pneumatic element includes a pneumatic fluid pump, which is used to push fluid into the fluid channel using the positive pressure gas introduced through the first pneumatic interface, and to draw fluid from the fluid channel using the negative pressure gas introduced through the first pneumatic interface.

19. The flow channel box according to claim 17, characterized in that: The pneumatic element further comprises a pneumatic fluid valve, and the pneumatic fluid valve is used to open or close the fluid channel.

20. The flow channel box according to claim 19, characterized in that: The pneumatic fluid valve is used to close the fluid channel using the positive pressure gas introduced by the first pneumatic interface, and to open the fluid channel using the negative pressure gas introduced by the first pneumatic interface.

21. The flow channel box according to claim 17, characterized in that: The box body also includes a gas-liquid separation chamber, which is communicated with the fluid channel and is used to separate and discharge the gas in the fluid channel.

22. The flow channel box according to claim 21, characterized in that: The gas-liquid separation chamber is connected to the first pneumatic interface. When negative pressure gas is introduced into the first pneumatic interface, gas is discharged from the gas-liquid separation chamber, or when positive pressure gas is introduced into the first pneumatic interface, gas enters the gas-liquid separation chamber.

23. The flow channel box according to claim 21, characterized in that: The flow channel box further comprises an atmospheric interface, and the gas-liquid separation chamber is in communication with the atmospheric interface for discharging the gas in the gas-liquid separation chamber.

24. The flow channel box according to claim 21, characterized in that: The flow channel box also includes a hydrophobic breathable membrane, and the gas in the gas-liquid separation chamber is discharged through the hydrophobic breathable membrane.

25. The flow channel box according to claim 17, characterized in that: The pneumatic components include: a fluid chamber, communicating with the fluid channel; A pneumatic diaphragm, a first surface of which covers the fluid cavity and is used to change the volume of the fluid cavity when subjected to pressure so that the fluid cavity pushes fluid into the fluid channel or the fluid cavity draws fluid from the fluid channel; or so that the fluid channel is opened or closed; The gas cavity is covered by the second surface of the pneumatic diaphragm, and an air hole for connecting to the first pneumatic interface is opened in the gas cavity. The positive pressure airflow or negative pressure airflow provided by the air hole drives the pneumatic diaphragm to change the volume of the fluid cavity.

26. The flow channel box according to claim 1, characterized in that: The box body further includes a one-way fluid valve, which is communicated with the fluid channel, the pneumatic element, or the fluid interface and is used to allow the fluid to flow in one direction in the fluid channel.

27. The flow channel box according to claim 1, characterized in that: The box body also includes a sensor interface and / or a heating device interface.

28. The flow channel box according to claim 25, characterized in that: The box body comprises: A flow channel plate, comprising a fluid cavity of the pneumatic element and a fluid channel connected to the fluid cavity, wherein the fluid cavity is formed inside the flow channel plate body; An airway plate is combined with the flow channel plate and the pneumatic diaphragm of the pneumatic element, the airway plate includes a gas cavity corresponding to the fluid cavity, the gas cavity is formed inside the airway plate body, and the gas cavity is covered by the second surface of the pneumatic diaphragm; a first pneumatic interface connected to the air hole is provided on the outside of the airway plate.

29. The flow channel box according to claim 28, characterized in that: The box body further comprises a gas channel, and the gas hole is communicated with the first pneumatic interface through the gas channel.

30. The flow channel box according to claim 26 or 28, characterized in that: The one-way fluid valve, the sensor interface, the heating device interface and / or a part of the fluid passage communicating with the fluid cavity are arranged in the airway plate.

31. The flow channel box according to claim 26 or 28, characterized in that: The one-way fluid valve, the sensor interface, the heating device interface and / or a part of the gas channel connected to the gas cavity are arranged in the flow channel plate.

32. The flow channel box according to claim 28, characterized in that: The flow channel plate and the air channel plate are combined together by bonding, welding, snapping or screwing to clamp the pneumatic diaphragm between the flow channel plate and the air channel plate.

33. The flow channel box according to claim 28, characterized in that: The pneumatic diaphragm is combined with the flow channel plate and / or the air channel plate by bonding or welding.

34. The flow channel box according to claim 28, characterized in that: The flow channel plate and / or air channel plate is injection molded from PMMA, PVC or PC plastic.

35. The flow channel box according to claim 28, characterized in that: The pneumatic diaphragm is made of silicone rubber or PVC soft film.

36. The flow channel box according to claim 28, characterized in that: It also includes a sealing ring for sealing which is arranged between the pneumatic diaphragm and the flow channel plate.

37. The flow channel box according to claim 28, characterized in that: It also includes a sealing ring for sealing which is arranged between the pneumatic diaphragm and the airway plate.

38. The flow channel box according to claim 36 or 37, characterized in that: The sealing ring and the pneumatic diaphragm are integrally formed.

39. The flow channel box according to claim 36 or 37, characterized in that: The sealing ring is made of silicone rubber, isobutyl rubber, ethylene propylene rubber, nitrile butadiene rubber, fluororubber, or polyurethane rubber.

40. The flow channel box according to claim 36 or 37, characterized in that: The airway plate and / or the flow channel plate is provided with a groove structure for accommodating the sealing ring.

41. The flow channel box according to claim 40, characterized in that: The groove structure is a rectangular groove, a V-shaped groove, a semicircular groove, a dovetail groove, or a triangular groove.

42. The flow channel box according to claim 28, characterized in that: The opening of the fluid channel of the flow channel plate in the fluid cavity is an opening that conforms to the slope of the cavity wall.

43. The flow channel box according to claim 17, characterized in that: One of the pneumatic components is correspondingly connected to an independent first pneumatic interface.

44. The flow channel box according to claim 17, characterized in that: The plurality of pneumatic components are connected to an independent first pneumatic interface.

45. The flow channel box according to claim 1, characterized in that: The first pneumatic interface is a female interface, and the second pneumatic interface is a male interface corresponding to the female interface; or, the first pneumatic interface is a male interface, and the second pneumatic interface is a female interface corresponding to the male interface.

46. ​​A portable dialysis device, characterized in that: include: A portable box, comprising a lower box and an upper box that can be opened and closed relative to the lower box, wherein the upper box and the lower box define an internal space; In the transportation or non-working state, the upper box body and the lower box body are closed; In the working state, the upper box body opens upward relative to the lower box body; A first mounting surface is located in the upper box body and is in an upright state with an angle of 70°-110° with a horizontal plane when the portable box body is opened, and a plurality of fluid containers are mounted on the first mounting surface, and the plurality of fluid containers can be in an upright state when the portable box body is opened; a pipeline, disposed in the internal space defined by the portable case, including a blood circuit for connecting to a human body and a dialysate circuit for connecting to the blood circuit, a portion of the pipeline being connected to the plurality of fluid containers; The second installation surface is located in the lower box and is in a horizontal state when the portable box is opened. A plurality of driving devices for driving the fluid to flow in the pipeline are fixed on the second installation surface.

47. The portable dialysis device according to claim 46, characterized in that The plurality of fluid containers mounted on the first mounting surface include an arterial pot, a dialyzer, and / or a venous pot connected to the blood circuit.

48. The portable dialysis device according to claim 46, characterized in that The partial dialysate circuit disposed on the first mounting surface has an interface for connecting to an external liquid container.

49. The portable dialysis device according to claim 48, characterized in that The external liquid container includes an ultrafiltration container, a supplementary liquid container, a prefabricated liquid container, and / or an adsorption device.

50. The portable dialysis device according to claim 46, characterized in that The first mounting surface is provided with a valve component for controlling the flow of fluid in a blood circuit or a dialysate circuit or the liquid level in a fluid container.

51. The portable dialysis device according to claim 46, characterized in that The plurality of driving devices mounted on the second mounting surface include a blood pump disposed in the blood circuit.

52. The portable dialysis device according to claim 46, characterized in that The plurality of driving devices installed on the second mounting surface include a dialysate pump and / or a metabolic circulation pump arranged in the dialysate circuit.

53. The portable dialysis device according to claim 46, characterized in that The second mounting surface is provided with a heating device for heating the dialysate in the dialysate circuit.

54. The portable dialysis device according to claim 46, characterized in that A control device for controlling the working mode of the portable dialysis device is installed on the second mounting surface.

55. The portable dialysis device according to claim 46, characterized in that The first mounting surface includes a flow channel integrated plate connecting the blood circuit and the dialysate circuit, and the flow channel integrated plate is provided with a plurality of channels for fluid circulation.

56. The portable dialysis device according to claim 55, characterized in that The flow channel integrated plate is provided with a mounting structure for mounting the fluid container, and the fluid container is engaged with the flow channel integrated plate and communicates with the internal channel of the flow channel integrated plate.

57. The portable dialysis device according to claim 55, characterized in that The fluid container installed on the flow channel integrated plate is a dialyzer, a collection container, and / or a metabolic filter.

58. The portable dialysis device according to claim 55, characterized in that The channel for fluid circulation in the flow channel integrated plate has an interface for connecting to an external liquid container.

59. The portable dialysis device according to claim 58, characterized in that The external liquid container includes an ultrafiltration waste liquid bag, a replenishing liquid container, a pre-filled liquid container, an adsorption device, a hollow fiber filter, and / or a microsphere recovery bag.

60. The portable dialysis device according to claim 55, characterized in that The flow channel integrated plate includes a flow channel box, and the flow channel box can be in an upright state when the portable box is opened.

61. The portable dialysis device according to claim 60, characterized in that The flow channel box is detachably mounted on the first mounting surface.

62. The portable dialysis device according to claim 60, characterized in that The first mounting surface is provided with a second pneumatic interface corresponding to the first pneumatic interface on the flow channel box.

63. The portable dialysis device according to claim 60, characterized in that The first mounting surface is provided with a non-contact sensor and a contact sensor for monitoring the running status of the equipment.

64. The portable dialysis device according to claim 60, characterized in that The lower box is provided with a pneumatic system connected with the flow channel box, and the pneumatic system is used to introduce positive pressure gas or negative pressure gas into the flow channel box.

65. The portable dialysis device according to claim 64, characterized in that The pneumatic system includes an air pump, a positive pressure chamber, a negative pressure chamber, a first three-way valve, and a second three-way valve; wherein, the air inlet of the air pump is connected to the negative pressure chamber, and is used to extract air from the negative pressure chamber through the air inlet; the air outlet of the air pump is connected to the positive pressure chamber, and is used to exhaust air into the positive pressure chamber; the first three-way valve is connected to the negative pressure chamber, and is used to adjust the pressure of the negative pressure chamber to a set value; the second three-way valve is connected to the positive pressure chamber, and is used to adjust the pressure of the positive pressure chamber to a set value.

66. The portable dialysis device according to claim 64, characterized in that The pneumatic system includes an air pump, a positive-pressure chamber, a negative-pressure chamber, a first two-way valve, and a second two-way valve; wherein, the air inlet of the air pump is connected to the negative-pressure chamber, and is used to extract air from the negative-pressure chamber through the air inlet; the air outlet of the air pump is connected to the positive-pressure chamber, and is used to exhaust air into the positive-pressure chamber; the first two-way valve is connected to the negative-pressure chamber, and is used to adjust the pressure of the negative-pressure chamber to a set value; and the second two-way valve is connected to the positive-pressure chamber, and is used to adjust the pressure of the positive-pressure chamber to a set value.

67. The portable dialysis device according to claim 46, characterized in that The portable dialysis device is a hemodialysis device or a peritoneal dialysis device.

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