Runner box of dialysis equipment and portable dialysis equipmentTechnical FieldThe application relates to the technical field of medical equipment, in particular to a runner box of dialysis equipment and portable dialysis equipment.
BackgroundDialysis includes hemodialysis and peritoneal dialysis, which refers to the process of drawing blood out of the body, removing toxins from the blood by various physical and chemical means, and returning the blood back into the body. Hemodialysis is a process of withdrawing blood outside the body, passing through a permeable membrane and a hollow fiber membrane of a hemodialysis machine, removing metabolic waste, impurities and excessive moisture from the blood, and then delivering the purified blood back into the body. End Stage Renal Disease (ESRD) patients currently undergoing global hemodialysis treatment have exceeded 360 ten thousand and have increased year by year. Peritoneal dialysis is a treatment for renal failure, which involves injecting a dialysate into the abdominal cavity, and removing metabolic waste and excess water from the blood by peritoneal filtration in the body. Taking hemodialysis as an example, most of the patients worldwide need to be treated in a dialysis center at present, three times a week for about 4 hours, fatigue is often caused by the fact that the patients are tired after the patients are in the same way and the patients are treated, and the daily treatment causes the loss rate of more than 80 percent. .
While home hemodialysis (Home Hemodialysis, HHD) has been increasingly developed in recent years to treat patients at home. HHD has no time and place restrictions, allowing the patient to schedule treatment according to actual needs and times in a more comfortable and relaxed environment, giving the patient more flexibility and convenience. Meanwhile, HHD requires the patient or his family to learn to operate the equipment and process related transactions, improving patient autonomy.
But for dialysis devices currently aimed at home hemodialysis, e.g. company Nxstage MEDICAL INC in the united statesOutset MEDICAL INC companyAnd British Quanta Dialysis Technologies, LTD CoThe sc+ brand dialysis device uses a large amount of water during treatment, requires additional water treatment equipment, and thus the overall device is still large in volume and weight, and is still unsatisfactory in terms of convenience of operation and cost control.
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 to be solved.
Disclosure of Invention
In view of the above-mentioned drawbacks of the related art, an object of the present application is to provide a flow channel box of a dialysis device and a portable dialysis device, so as to solve the technical problems of complicated operation, larger size, and the like of the dialysis device in the prior art.
To achieve the above and other related objects, a first aspect of the present application provides a flow path cartridge of a dialysis apparatus, comprising a cartridge body detachably mounted on a body of the dialysis apparatus, wherein a plurality of fluid channels for controlling a fluid to flow forward or backward by air pressure are provided in the cartridge body, at least one first pneumatic interface is provided on a side surface of the body of the dialysis apparatus, which is correspondingly combined with the cartridge body, the first pneumatic interface is used for interfacing with a second pneumatic interface of the dialysis apparatus to communicate with a pneumatic system of the dialysis apparatus, and a plurality of fluid interfaces for communicating with a liquid line outside the cartridge are further provided on the cartridge body.
The second aspect of the application discloses a portable dialysis device comprising a portable case comprising a lower case and an upper case openable and closable relative to the lower case, the upper case and the lower case defining an internal space, the upper case and the lower case being closed in a transport or non-operating state, the upper case being upwardly opened relative to the lower case in an operating state, a first mounting surface located in the upper case and forming an angle of 70 DEG to 110 DEG with a horizontal surface in the open state of the portable case, the first mounting surface being provided with a plurality of fluid containers which can be in an erect state in the open state of the portable case, a conduit provided in the internal space defined by the portable case and including a blood circuit for connecting a human body and a dialysate circuit for connecting the blood circuit, a portion of the conduit communicating the plurality of fluid containers, a second mounting surface located in the lower case and forming an angle of 70 DEG to 110 DEG with the horizontal surface in the open state of the portable case, the second mounting surface being provided with a plurality of fluid containers for driving the fluid circulation device in the open state of the portable case.
In summary, in the dialysis device provided by the application, the plurality of fluid channels for controlling the fluid to flow forward or backward through the air pressure are arranged in the box body of the flow channel box, and the at least one first pneumatic interface which is in butt joint with the second pneumatic interface of the dialysis device is arranged on the box body of the flow channel box, so that after the user butts the flow channel box with the second pneumatic interface, the pneumatic system in the dialysis device can control the fluid in the fluid channels to flow forward or backward through the air pressure. In other words, the flow channel box body is integrated with a plurality of pumps and valves, and the pneumatic system can control the pumps and valves to control the fluid to flow in the fluid channel in the forward direction or the reverse direction by utilizing the air pressure through the second pneumatic interface, so that the application greatly reduces the complexity of operation and the operation threshold, and the dialysis equipment has higher integration level and smaller equipment volume, thereby being particularly beneficial to the dialysis treatment in the scenes of first aid, travel, rescue and relief work, home, and the like.
In addition, the portable dialysis equipment provided by the application has the advantages that the core components such as a dialyzer, a pump device, a pipeline, a sensor and the like in the dialysis operation are arranged in the portable box body in a reasonable arrangement mode, and the dialysis operation can be completed based on various modularized functions provided by the portable box body through the design of a blood circuit and a dialysis liquid circuit, and the portable dialysis equipment is unfolded when in use and is closed when in transportation or not in use, so that the operation threshold and the equipment volume are greatly reduced.
DrawingsThe specific features of the application are set forth in the appended claims. The features and advantages of the application that are related to the present application will be better understood by reference to the exemplary embodiments and the drawings described in detail below. The drawings are briefly described as follows:
Fig. 1 is a schematic view showing the constitution of a portable dialysis apparatus according to the present application in one embodiment.
Fig. 2 shows a schematic diagram of the circuitry and principle of the portable dialysis device according to an embodiment of the present application.
Fig. 3 shows a schematic view of the venous pitcher and the air collection chamber of the blood circuit of the present application in one embodiment.
Fig. 4 shows a schematic view of an air collection chamber of another construction for a blood circuit according to the application in another embodiment.
Fig. 5 is a schematic structural diagram of an adsorption device according to an embodiment of the application.
Fig. 6 shows a schematic diagram of a portable dialysis device according to the application in a further embodiment.
Fig. 7 is a schematic structural view of an adsorption device according to another embodiment of the application.
Fig. 8 shows a schematic view of the portable dialysis device of the present application in an open state in one embodiment.
Fig. 9 shows a schematic view of the application of the portable dialysis device according to an embodiment of the present application.
Fig. 10 is a schematic view showing a structure of the portable dialysis device according to the present application with the flow path cartridge removed.
Fig. 11 is a schematic view of a front view of a flow channel box according to an embodiment of the application.
Fig. 12 is a schematic view showing the structure of the back view of the flow channel box according to an embodiment of the application.
Fig. 13a is a schematic view showing a partial structure of a cartridge body according to an embodiment of the present application.
Fig. 13b shows a cross-section of A-A in fig. 13 a.
FIG. 14 is a schematic view showing the structure of the gas collecting chamber according to the present application in one embodiment.
Fig. 15 shows a schematic structural view of the gas collecting chamber according to the present application in another embodiment.
Fig. 16 shows a schematic structure of the gas collecting chamber according to the present application in yet another embodiment.
Fig. 17 shows a schematic structure of the gas collecting chamber according to the present application in a further embodiment.
FIG. 18 shows a schematic diagram of the reaction kettle application of the metabolic cycle device according to one embodiment of the present application.
Fig. 19a and 19b are schematic views showing the structure of the metabolic circulation device according to the present application in one embodiment.
Fig. 20 shows a schematic flow of fluid in a flushing embodiment of the blood circuit of the present application.
Fig. 21 shows a schematic diagram of a pneumatic system in an embodiment of the application.
Fig. 22 shows a schematic diagram of a pneumatic system in another embodiment of the application.
Fig. 23 shows a schematic configuration of a portable dialysis device of the present application in another embodiment.
Fig. 24 is a schematic view showing the layout of components on the first and second mounting surfaces in the portable dialysis device of fig. 23.
Fig. 25 is a schematic rear view of the first mounting surface of the portable dialysis device of fig. 23.
Fig. 26 is a schematic rear view of the second mounting surface of the portable dialysis device of fig. 23.
Detailed DescriptionFurther advantages and effects of the present application will become apparent to those skilled in the art from the disclosure of the present application, which is described by the following specific examples.
As described in the background art, although home hemodialysis has advantages such as flexibility and convenience over conventional hemodialysis, dialysis apparatuses for home hemodialysis tend to be larger in size, lower in integration, and lower in convenience of operation.
In the related art, in order to reduce the number of lines that a user needs to connect before dialysis, the integration of dialysis equipment and the convenience of operation are improved. The pump in the dialysate circuit of the dialysis device is provided as a membrane pump, and the fluid chamber (also referred to as a fluid chamber) in the membrane pump and the membrane sealing the fluid chamber are integrated on a platen comprising the fluid chamber and the membrane, and correspondingly the drive chamber (also referred to as a gas chamber) of the membrane pump is provided in an undetachable manner on the dialysis device. Prior to dialysis, the user secures a platen as a disposable consumable to the dialysis apparatus, during which the membrane of the platen needs to be covered over the gas cavity in a strictly airtight manner to form the drive chamber of the membrane pump. Subsequently, when the dialysis apparatus is performing dialysis, the pneumatic system in the dialysis apparatus controls the membrane to deform downward or upward by introducing positive pressure air flow or negative pressure air flow into the air chamber, thereby controlling the fluid chamber to push or suck fluid (e.g., dialysate or the like).
Thus, the integration and convenience of the dialysis apparatus can be improved to some extent. However, the pressure plate is fixed on the dialysis equipment by a user before operation, and due to uncertainty of manual operation, tightness between the membrane of the pressure plate and a gas cavity on the dialysis equipment is difficult to ensure, for example, pressure leakage is indicated because the membrane does not cover a driver tightly due to careless operation, and normal operation of the dialysis equipment is affected. Furthermore, in the case of improper manual operation, aged deformation of a seal ring on dialysis equipment after long-term use, accidental damage to a membrane in a pressure plate, or the like, the membrane and the gas chamber cannot maintain good sealing performance, and thus the actual amount of sucked or pushed liquid may not be in accordance with a theoretical value or desired treatment control.
In view of this, the present application proposes a flow channel box of a dialysis device and a portable dialysis device, in which, a plurality of fluid channels for controlling fluid to flow forward or backward through air pressure are provided inside a box body of the flow channel box, and a plurality of independent first air interfaces respectively interfacing with a plurality of second air interfaces of the dialysis device are provided on the box body of the flow channel box, so that after a user interfaces the flow channel box with the second air interfaces, a pneumatic system in the dialysis device can control fluid in the fluid channels to flow forward or backward through air pressure, thereby greatly reducing complexity of operation and operation threshold, and the dialysis device has a higher integration level, which is particularly beneficial to dialysis treatment in first aid, travel, rescue and relief, home and other scenes.
In the present application, the portable dialysis device includes, but is not limited to, a blood purification device, an extracorporeal circulation removal system, an extracorporeal enrichment removal device, a hemodialysis device, a plasmapheresis device, an extracorporeal peritoneal dialysis device, or an extracorporeal membrane lung oxygenation device. Wherein the blood purification devices include, but are not limited to, hemodialysis (HD), hemofiltration (HF), hemodiafiltration (HDF), hemodiafiltration (HP), blood substitution (PE), immunoadsorption (IA) and continuous blood purification (CRRT), peritoneal Dialysis (PD), etc.
In some embodiments, the portable dialysis device may also be a component module that is grafted onto other extracorporeal circulation devices, such as an artificial liver, an artificial kidney, a hemodialysis device, a peritoneal dialysis device, a plasmapheresis device, a plasma purification device, a blood lipid purification device, a molecular adsorption recirculation system, an extracorporeal membrane oxygenation device, a leukocyte removal device, an extracorporeal circulation life support system, and the like. In other words, the portable dialysis device described in the present application may be used as a medical device or treatment device alone, or may be integrated into other medical devices or devices that involve extracorporeal treatment of blood or other body fluids to form a new device.
In one embodiment, the portable dialysis device adopts a dialysis device in a dialysate circulation regeneration mode, namely a dialysate regeneration type dialysis machine, and comprises a dialysate regeneration type hemodialysis machine and a dialysate regeneration type peritoneal dialysis machine, wherein the greatest benefit of the dialysis machine is that the regeneration liquid can be obtained without a water source and a water treatment system, so that the portable dialysis device is small and portable and is suitable for home dialysis treatment. The "regeneration liquid" refers to a dialysis waste liquid after the exchange of the dialysis liquid with blood or abdominal liquid, and is treated (such as catalytic decomposition and adsorption treatment) by adopting an adsorption material and enzyme, so that part or most of toxins or toxic molecules in the dialysis waste liquid are removed, and beneficial or necessary molecules such as potassium, calcium, magnesium and the like are supplemented, so that the formed dialysis waste liquid regeneration liquid is called as regeneration liquid for short. The regenerated liquid can be regarded as fresh dialysis liquid, and is exchanged with blood or peritoneal liquid again, and the regenerated liquid is repeatedly circulated in this way to continuously remove toxins in the blood or the peritoneal liquid, so that the treatment purpose is achieved.
In another embodiment, the portable dialysis device may also be a single-pass dialysis device, in which case the dialysate used by the dialysis device is non-regenerative.
In the following embodiments of the present application, a portable dialysis apparatus will be described as an example of a hemodialysis apparatus employing a dialysate circulation regeneration mode.
Referring to fig. 1 and 2, fig. 1 is a schematic diagram of the composition structure of a portable dialysis device according to an embodiment of the present application, and fig. 2 is a schematic diagram of the circuit and principle of the portable dialysis device according to an embodiment of the present application, wherein the portable dialysis device comprises an arterial blood circuit L1, a dialysate regeneration flow path L2, a venous blood circuit L3, a dialysis device 30, and a control device 90.
The arterial blood line L1 is used to access a first portion of the body (e.g., a human arterial blood vessel) through the arterial end 20, the dialysate regeneration flow path L2 is in communication with the dialysis device 30, and the venous blood line L3 is used to access a second portion of the body (e.g., a human venous blood vessel). In some embodiments, the first and second portions of the body may be the same site, such as in cases where the vascular condition of some patients is not good, such as in single needle dialysis or in the case of PICC central venous catheters.
Referring to fig. 3 and 4 in combination with fig. 2, fig. 3 is a schematic view of a venous bottle and an air collecting chamber in a blood circuit according to an embodiment of the present application, fig. 4 is a schematic view of an air collecting chamber with another structure in another embodiment of the blood circuit according to the present application, and 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 for enriching air in the blood circuit when fluid in the blood circuit flows from the venous blood line L3 to the arterial blood line L1, and in an embodiment, the blood circuit includes an arterial blood line L1 in communication with a dialysis device 30, a dialysis path (dialysate regeneration path in the figure) L2, and a venous blood line L3 in communication with the dialysis device 30.
In the following fig. 20, the venous end of the arterial blood line L1 and the venous end 86 of the venous blood line L3 are connected to each other so that the arterial blood line L1 and the venous blood line L3 constitute a closed circulation circuit. In the present application, the circulation circuit may be used as a priming circuit in a priming process, as a flushing circuit in a flushing process, and as a draining circuit in a draining process, as will be described in detail later.
In some embodiments, such as the one described in patent WO2024017065A1, and in the present application, patent document WO2024017065A1 is incorporated herein in its entirety.
In the present application, the dialysis passage L2 includes a dialysate regeneration passage, and is indicated by reference numeral L2 in the drawings.
In the treatment mode of the dialysis apparatus (as shown in fig. 9), the arterial-side puncture needle is connected at the front end of the arterial blood line L1 by a connector, and a driving device 23 such as a peristaltic blood pump is provided at the middle thereof, and on the other hand, the venous-side puncture needle is connected at the front end of the venous blood line L3 by a connector, and a drip/venous pot or a gas collection chamber 80 having a venous pot function is connected at the middle thereof. In addition, during dialysis treatment, the arterial puncture needle and the venous puncture needle are respectively inserted into a target arterial blood vessel and a target venous blood vessel of a patient's body, and if the blood pump is driven, the patient's blood reaches the dialysis apparatus 30 through the arterial blood line L1, and then the blood is purified by the dialysis apparatus 30, and the blood is returned to the patient's body through the venous blood line L3 while being defoamed in the drip chamber/venous pot. That is, the blood of the patient is purified by the dialysis device 30 while being extracorporeal-circulated from the front end of the arterial blood line L1 to the front end of the venous blood line L3 of the circulation circuit.
The dialysis device 30 is provided in the blood circuit, and is configured to purify the fluid flowing through the arterial blood line L1, and the dialysis device 30 includes a dialysate output port connected to an input port of the waste liquid passage of the dialysate regeneration flow path L2, and a dialysate input port connected to an output port of the dialysate line of the dialysate regeneration flow path L2.
In an embodiment, the dialysis device 30 comprises a dialyzer (the dialysis device 30 is also referred to as a dialyzer, in the following embodiments the reference number of the dialyzer is also 30), the dialyzer 30 comprising a dialysate chamber, a blood chamber and a semi-permeable membrane or the like, which separates the dialysate chamber and the blood chamber from each other, which in a commonly used capillary-type dialyzer is formed by the entire inner volume of the hollow fibers, the dialysate chamber being formed by the inner cavity of the housing of the dialyzer 30 surrounding the hollow fibers. In an embodiment, the top end of the dialyzer 30 communicates with the arterial blood line L1 and the bottom end of the dialyzer 30 communicates with the venous blood line L3. The type of the dialyzer 30 may include various specifications or applications of the device such as a hemodiafiltration device, a hemofiltration device, a plasma separator, a blood plasma component separator, etc., as long as the device capable of separating toxins or molecular components in blood uses the present application. In an embodiment, the top end of the dialyzer 30 communicates with the arterial blood line L1 and the bottom end of the dialyzer 30 communicates with the venous blood line L3.
The driving device 23 is disposed on the arterial blood line L1 and in the blood circuit for driving fluid to flow in the arterial blood line L1, the dialysis device 30, and the venous blood line L3, and in an embodiment, the driving device 23 includes, but is not limited to, a peristaltic pump, a pneumatic diaphragm pump, or a pressure pump for powering the fluid in the line to circulate the fluid in compliance with a preset flow direction. In this case, in the medical application, the driving device 23 may apply pressure only to the tube and drive the fluid to flow, instead of directly contacting the fluid, and the driving device is preferably a non-contact pump device such as a peristaltic pump or a pneumatic diaphragm pump, and more specifically, the peristaltic pump is, for example, a blood pump. The positive and negative rotation (reversal) of the peristaltic pump causes the flow direction of the fluid in the circulation loop to be different. In dialysis, the drive device 23 is also called a blood pump.
In one embodiment, the portable dialysis device includes a plurality of drive means, including, for example, a blood pump in the blood circuit, a dialysate pump 46 in the dialysate regeneration flow path L2, and a secondary circulation pump 68, etc. The dialysate regeneration flow path L2 further includes an ultrafiltration pump 51, a replenishment liquid pump 74, and the like, which will be described in detail later.
It should be understood that the driving device 23 may be disposed at different positions in the pipeline to drive the fluid in the pipeline, and the flow speed may be changed according to the flow direction of the fluid due to factors such as pipeline resistance, temperature, pressure, etc., but in the embodiment of the present application applied to the hemodialysis field, the driving device 23 is disposed on the circulation circuit, particularly, on the arterial blood line L1 of the blood circuit.
The control device 90 is used for performing a treatment mode to perform a purification treatment on the fluid flowing in the blood circuit and then inputting the purified fluid into a human body. In an embodiment, the control device 90 is, for example, a controller of a hemodialysis apparatus or a system processor, and outputs a corresponding control instruction by writing a program in the system processor, or receives a trigger instruction input by an operator through an input device such as a touch screen to execute the related control instruction. In an embodiment of the portable dialysis device of the present application, the control means 90 is a main control board disposed on the second mounting surface 111, as shown in fig. 26, for example.
As shown in fig. 2, 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 line L2-7. In an embodiment, the input end of the waste liquid channel L2-1 of the dialysate regeneration flow channel L2 is communicated with the outlet of the dialysate through a pipeline valve 40, the output end of the waste liquid channel L2-1 is communicated with the secondary circulation device, the input end of the secondary circulation device is communicated with the outlet of the waste liquid channel L2-1 and is used for performing metabolic circulation (also called secondary circulation) on the input dialysate waste liquid to perform primary toxin treatment, the input end of the adsorption device 70 is communicated with the output end of the secondary circulation device and is used for performing secondary toxin treatment on the waste liquid subjected to primary toxin treatment by the secondary circulation device to generate regenerated liquid, and the input end of the regenerated liquid pipeline L2-7 is communicated with the adsorption device 70 and is used for outputting the regenerated liquid and finally inputting the regenerated liquid into the dialyzer 30 through a pipeline valve 78.
In one embodiment, a preparation such as enzyme-loaded microspheres may be added to the secondary circulation device, the preparation circulates in the circulation pipeline by driving the driving device 46 of the dialysate pump 46, specifically, the to-be-treated dialysis waste liquid containing high concentration target molecules enters the secondary circulation device through the inlet, the target molecule preparation is decomposed into corresponding products, the reaction filter 67 arranged in the secondary circulation device continuously separates the treated liquid, the preparation is trapped in the secondary circulation device, the treated liquid flows out of the secondary circulation device through the reaction filter 67 and is treated by the adsorption module 70 to generate dialysis regeneration liquid, and after the replenishing liquid such as potassium calcium magnesium ions, PH buffering agent and the like is added in the regeneration liquid pipeline, the dialysis regeneration liquid is reused in the dialysis process. In some embodiments, the reaction filter 67 may also be referred to as a metabolic filter module or metabolic filter (in embodiments of the present application, the reaction filter, metabolic filter module, and metabolic filter are labeled 67). In one embodiment, the replenishing solution may replenish electrolyte ions such as potassium, calcium, magnesium and the like for the regenerated solution and adjust the pH value. Specifically, the replenishing liquid includes, for example, cations such as potassium ion, calcium ion, magnesium ion, and anions such as chloride ion, acetate ion, citrate ion. For example, the replenishment solution is a preformed sterile pyrogen-free solution. The replenishment liquid container 75 contains 1 to 3L of a pre-prepared sterile pyrogen-free solution, and 1 to 3L of the replenishment liquid contains 20 to 50mM of potassium ions, 20 to 50mM of calcium ions, 10 to 25mM of magnesium ions, and further contains chloride ions, acetate ions, citrate ions, and the like.
In some embodiments, the adsorption device 70 is used to adsorb toxin molecules in the dialysis waste fluid. The adsorption device comprises at least one of an activated carbon layer, a cation exchange material layer and an anion exchange material layer. Referring to fig. 5, a schematic structural diagram of an adsorption device according to an embodiment of the application is shown, wherein 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 fig. 5, the adsorption device includes four material layers, wherein according to the flow direction of the dialysis waste liquid, 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 cation exchange resin or zirconium phosphate, and the anion exchange material is anion exchange resin, zirconium oxide or sodium zirconium carbonate. In other examples, the adsorption device may include multiple layers of cation exchange material and/or anion exchange material, or may include only one layer of activated carbon.
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 comprises six material layers, 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.
In one embodiment, an adsorption device as shown in fig. 5 is located downstream of the secondary circulation device, and is used for adsorbing toxins such as ammonium ions formed by decomposition of creatinine, phosphate and urea, and adsorbing potassium, calcium and magnesium ions in the dialysis waste liquid.
In another embodiment, the adsorption device comprises a first adsorption device and a second adsorption device. Referring to fig. 6, which is a schematic diagram of a portable dialysis device according to another embodiment of the present application, as shown in the drawing, 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 may be separate consumables. The first adsorption device is shown in fig. 5, and is mainly used for adsorbing potassium, calcium, magnesium and other ions in the dialysis waste liquid. The second adsorption device is also shown in fig. 5, but the column is larger than that of the first adsorption device, and is mainly used for adsorbing toxins such as ammonium ions formed by decomposing creatinine, phosphate and urea, and simultaneously adsorbing potassium, calcium, magnesium and the like.
In yet another embodiment, the adsorption device 70' includes a first adsorption device 701' and a second adsorption device 702'. Referring to fig. 7, there is shown a schematic structural diagram of an adsorption apparatus according to another embodiment of the present application, wherein the first adsorption apparatus 701 'and the second adsorption apparatus 702' are integrated together as shown, but the first adsorption apparatus 701 'and the second adsorption apparatus 702' are separated from each other and are independent from each other in piping connection, i.e. the first adsorption apparatus 701 'is still located upstream of the secondary circulation apparatus, and the second adsorption apparatus 702' is still located downstream of the secondary circulation apparatus. The adsorption materials in the first adsorption device 701 'and the second adsorption device 702' are the same, but the amount of filler, the ratio of filler, or the 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'.
In one embodiment, the present application provides a portable case in which the arterial blood line L1, the dialysate regeneration flow path L2, the venous blood line L3, the dialysis device 30, and a part of the control device 90 are disposed, so that the dialysis apparatus is small and convenient, and is more suitable for the needs of home hemodialysis.
In one embodiment, the present application provides a portable case for distributing a part or a main part of the purification circuit, the dialysis device, the driving device, the control device, and the dialysate regeneration circulation system illustrated in fig. 2 in the portable case, so that the dialysis apparatus is small and convenient, and is more suitable for the needs of home hemodialysis.
Referring to fig. 8, an open state of the portable dialysis device according to an embodiment of the present application is shown, wherein the portable case includes an upper case 10 and a lower case 11, the upper case 10 and the lower case 11 define an inner space, and the upper case 10 is movable relative to the lower case 11 and can be opened or closed. In an embodiment, the upper case 10 and the lower case 11 are movably connected by a hinge at one side, and the first mounting surface 101, the second mounting surface 111, and components/parts and pipes provided on the first mounting surface 101 and the second mounting surface 111, respectively, may be enclosed in the inner space thereof when the upper case 10 and the lower case 11 are closed, so as to move or carry the case.
In this embodiment, the first mounting surface 101 includes a flow channel integration plate 13 that communicates with the blood circuit and the dialysate circuit, and a plurality of channels through which fluid flows are provided in the flow channel integration plate 13. The channels include, for example, a plurality of channels or paths through which fluid flows, such as a venous line L1, an arterial line L3, and a waste liquid path and a regenerated liquid line L2 in the dialysate regeneration circulation system shown in fig. 2. The channel for fluid circulation in the flow channel integrated plate 13 is provided with an interface or a connection port for communicating an external liquid container, and is used for communicating a line or a container or a device which is externally arranged on the flow channel integrated plate 13 through an external pipeline. In this embodiment, the external liquid container includes an ultrafiltration container 52, a replenishment liquid container 75, a pre-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 replenishment liquid pump 74, a metabolic circulation pump 68, an air pump 65, etc., and various sensor devices for detecting the flow rate, temperature, pressure, presence of sodium, presence of ammonia, pH level, leaked blood, closed or air bubbles in a purification circuit or a dialysate circuit, or various valve devices for switching the passage or opening and closing the passage.
In one embodiment, the fluid containers provided in the flow path integration plate 13 are dialyzers 30, collection containers 60 (in the following embodiments, collection containers are also referred to as reaction kettles, which are also numbered 60), metabolic filters 67, arterial kettles 24, venous kettles 81, or the like. The flow channel integrated plate 13 is provided with a mounting structure for mounting the fluid container, for example, a clamping structure, and the fluid container support 102 is mounted on the flow channel integrated plate 13 in a clamping manner and is communicated with corresponding internal channels in the flow channel integrated plate 13. As shown in fig. 8, the dialyzer 30 may be mounted on one side of the flow path integrated plate 13 in a snap-fit manner, and the metabolic filter 67 may be mounted on the other side of the flow path integrated plate, wherein the dialyzer 30, the flow path integrated plate 13, and the metabolic filter 67 are substantially shaped as "H", so that when the portable case is opened and is in a vertical state of 90 ° with respect to the horizontal plane, the plurality of fluid containers on the first mounting surface 101 are also in a vertical state of standing with respect to the horizontal plane.
In the embodiment shown in fig. 8, by providing a plurality of channels in the flow passage integration plate 13, the pipes/lines of each function can be butted against each element in its circuit independently of each other, and these pipes/lines can be integrated in one plate, not only simplifying the access operation of the lines, but also, importantly, the space in the portable case.
Referring to fig. 9 and 10, fig. 9 is a schematic diagram illustrating an application of the portable dialysis device according to an embodiment of the present application, and fig. 10 is a schematic diagram illustrating a structure of the portable dialysis device according to an embodiment of the present application with a flow path box removed, wherein the portable dialysis device includes a portable housing, a first mounting surface 101, a pipeline, and a second mounting surface 102.
The portable case includes an upper case 10 and a lower case 11, the upper case 10 and the lower case 11 define an inner space, and the upper case 10 is movable with respect to the lower case 11 and can be opened or closed. In an embodiment, the upper case 10 and the lower case 11 are movably connected by a hinge at one side, and the first mounting surface 101, the second mounting surface 102, and the components respectively provided on the first mounting surface 101 and the second mounting surface 102 may be enclosed in the inner space thereof when the upper case 10 and the lower case 11 are closed, so that the case can be moved or carried.
In one embodiment, the portable case is provided with a handle 14, and the handle 14 is disposed on an outer side surface of the upper case 10 or the lower case 11. For example, the handle 14 is provided on the opposite side of the portable case to the hinge. As shown in fig. 8, the handle 14 is disposed on an outer side surface of the lower case 11. In an embodiment, a lock structure (not shown) is further disposed between the upper case 10 and the lower case 11, so that when the upper case 10 and the lower case 11 are closed, a user can lock them and lift the handle 14 to move or carry the portable case.
In an embodiment, a support arm (not shown in fig. 8, refer to the example of fig. 23) for maintaining the first mounting surface 101 at a predetermined angle with respect to the second mounting surface 102 in the opened state of the portable case is provided between the lower case 11 and the upper case 10, and in an example, the support arm is two pairs of folding arms respectively provided at left and right sides of the portable case, specifically, one end of each pair of folding arms is fixed to an inner wall of the lower case 11 and the other end is fixed to an inner wall of the upper case 10, and when the case is opened, the two pairs of folding arms maintain the opened state of the lower case 11 and the upper case 10 by having a damping characteristic of themselves, that is, maintain the first mounting surface 101 at a predetermined angle with respect to the second mounting surface 102, for example, an angle of 70 ° to 110 °. However, the present invention is not limited thereto, and in other embodiments, the first mounting surface 101 may also have other predetermined angles, for example, 30 °,10 °, etc., with respect to the second mounting surface 102, and for example, the first mounting surface 101 may also be parallel to the horizontal plane when the portable case is opened.
In one embodiment, the first mounting surface 101 is located within the upper housing 10. An erect condition, such as preferably a vertical condition of about 90 degrees, with an angle of 70 to 110 degrees with the horizontal in the open condition of the portable case.
In an embodiment, the first mounting surface 101 is located in the upper case 10 and forms an angle of 70 ° -110 ° with the horizontal plane in the opened state of the portable case, and the first mounting surface 101 is provided with a plurality of fluid containers, which may be in an erect state in the opened state of the portable case. In a preferred embodiment, when the portable case is in an open position at about 90 ° to the horizontal, the plurality of fluid containers on the first mounting surface 101 are also in an upright position with respect to the horizontal. In an embodiment, the plurality of fluid containers are removably mounted on the first mounting surface 101, and the plurality of fluid containers mounted on the first mounting surface 101 include an arterial pitcher 24, a venous pitcher 81, a dialyzer 30, or a pooling container 60 in communication with a dialysate circuit, and/or a metabolic filter 67, etc.
In the embodiment shown in fig. 8, the flow channel integrated plate includes a flow channel box, it may also be understood that the flow channel box is a part of the flow channel integrated plate, or the flow channel integrated plate may be formed as a whole as a flow channel box, for convenience of developing the following description in conjunction with the drawings, and in each embodiment of the present application, reference numerals of the flow channel integrated plate and the flow channel box in the drawings are denoted by reference numeral 13.
In an embodiment, the first mounting surface 101 is an integral part of the upper case 10, for example, the first mounting surface 101 may be an inner side surface of the upper case 10, for example, a planar portion including an inner wall of the upper case 10 and a peripheral arc or curved surface. For example, the flow path box 13 may be provided on an inner side surface of the upper case 10, and the flow path box 13 will be described in detail later. As also shown in fig. 10, a plurality of contact and non-contact sensors (such as a blood leakage sensor 41, a venous-side pressure sensor 21, a dialysate outlet pressure sensor 79, a liquid level sensor 61, a color sensor 62, a temperature sensor 76, a conductivity sensor 77, an ammonia sensor 73, a pressure sensor 66, etc.) or interfaces of the sensors, a heating device 47 for heating the dialysate, or a fluid container (such as an arterial kettle 24, a venous kettle 81, or a reaction kettle 60 communicating with a dialysate circuit, and/or a reaction filter 67, etc.) may be provided on the inner side of the upper case 10.
In the example of fig. 10, the heating device 47 is provided on the first mounting surface 101, and correspondingly, a metal device (e.g., a stainless steel metal sheet) is provided on the surface of the flow path box 13, and the heating device 47 directly contacts the metal device to transfer heat to the dialysate in the flow path box 13.
In one embodiment, the first mounting surface 101 is a separate component, such as a plate having a flat surface, and is detachably fixed in the upper case 10 by a bracket 102. In the present embodiment, the plate body is fixed in the upper case 10 by, for example, screws or engagement, so that the first mounting surface 101 is in an upright state along with the upper case 10 in a state in which the upper case 10 is opened/closed, the flow path box 13 and the fluid container mounted on the first mounting surface 101 are also in an upright state or a vertical state, and the flow path box 13 and the fluid container are fixed to the plate body.
In one embodiment, the fluid container is removably mounted to the first mounting surface 101 by a bracket 102. It should be understood that the removable means that the fluid container is attached to the first mounting surface 101 or removed from the first mounting surface 101 by means of adhesion, engagement, screw locking, etc. without damaging the first mounting surface 101 or the fastening structure or the fluid container.
In one embodiment, the flow channel box 13 is detachably mounted on the first mounting surface 101 by a bracket 102. Wherein, the flow channel box 13 is a consumable. For example, the flow cell 13 is a disposable consumable, and the flow cell 13 needs to be sterilized by ethylene oxide when shipped from the factory. For another example, the flow channel box 13 may be reused for a preset number of times or a preset time after being treated and stored in a sterilizing manner.
In an embodiment, some or all of the pumps of fluid in FIG. 2 (e.g., blood pump 23, supplemental pump 75, secondary circulation pump 68, dialysate pump 46, etc.), or the valves in FIG. 2 (e.g., venous valve 22, arterial valve 84, vent valves 82 and 64, dialysate outlet valve 40, dialysate inlet valve 78, etc.), may be integrated into the flow cassette 13. After the flow cassette 13 is in communication with the portable dialysis device, the pneumatic system of the dialysis device independently manipulates pumps and valves of various fluids to control the flow of fluids (e.g., blood, dialysate, pre-fluid, or ultrafiltrate, etc.) in the flow cassette 13. For example, before the dialysis treatment starts, the whole blood circuit (L1 and L3) and the dialysate circuit L2 are filled with the dialysate by the dialysate pump 46 integrated in the flow path cartridge 13.
In this regard, the present application provides a flow channel box in an embodiment, please refer to fig. 9 and 10 in conjunction with fig. 11 to 13b, wherein fig. 11 and 12 show schematic structural views of the flow channel box in a front view and a rear view, respectively, fig. 13a shows a partial structural view of a box body in an embodiment, and fig. 13b shows a cross-sectional view of A-A in fig. 13 a. In an embodiment, the cartridge body is arranged in a snap-fit manner on the body of the dialysis device by means of a bracket 102. The body of the dialysis equipment comprises the portable box body, and the box body is arranged on the portable box body in a clamping mode.
In a further embodiment, the cartridge body is arranged in a plug-in manner on the body of the dialysis device. In a further embodiment, the cartridge body of the flow cassette 13 is arranged on the body of the dialysis device by clamping means, wherein the clamping means may be nut clamping means, wedge clamping means, locking means, spring clamping means or the like.
Wherein, the corresponding combination of the box body is provided with at least one first pneumatic interface 1322 at one side of the body of the dialysis equipment, and the dialysis equipment is provided with a second pneumatic interface 103 communicated with the pneumatic system. In an example, a first pneumatic interface 1322 is provided on the cartridge body, and correspondingly, a second pneumatic interface 103 is provided on the dialysis device, which communicates with the pneumatic system, the first pneumatic interface 1322 communicating with the second pneumatic interface 103. For example, the dialysis device comprises a plurality of flow cassette 13, with only one pneumatic element in the cassette body of each flow cassette 13, which pneumatic element communicates with the first pneumatic interface 1322. As also shown in fig. 13a, the box body includes 3 pneumatic elements therein, and the first pneumatic interface 1322 may be respectively communicated with the 3 pneumatic elements through a split line. In another example, two first pneumatic interfaces 1322 are disposed on the cartridge body, and correspondingly, two second pneumatic interfaces 103 that are communicated with the pneumatic system are disposed on the dialysis device, where after the first pneumatic interfaces 1322 are communicated with the second pneumatic interfaces 103, one first pneumatic interface 1322 is used for introducing positive pressure gas into the flow channel cartridge 13, and the other first pneumatic interface 1322 is used for introducing negative pressure gas into the flow channel cartridge 13, and each first pneumatic interface 1322 may be respectively communicated with a plurality of pneumatic elements through a split pipeline. It should be noted that the structure of the shunt pipeline may be designed according to the number of the first air interfaces 1322 and the number of the air elements provided on the box body.
In an embodiment, a plurality of independent first pneumatic interfaces 1322 (as shown in fig. 12, 10 first pneumatic interfaces 1322 on the back of the cartridge body) are disposed on a side surface of the cartridge body corresponding to the body of the dialysis apparatus, and correspondingly, a plurality of independent second pneumatic interfaces 103 communicated with the pneumatic system are disposed on the dialysis apparatus, and after the first pneumatic interfaces 1322 of the cartridge body are correspondingly communicated with the second pneumatic interfaces 103, the pneumatic system can drive fluid to flow in the cartridge body. In this embodiment, one pneumatic element is correspondingly connected to one independent first pneumatic interface 1322, so that the pneumatic system is convenient for controlling each pneumatic element in the flow channel box 13. Further, for convenience of description and understanding, in the present application, a side of the cartridge body corresponding to the body coupled to the dialysis apparatus is a rear side, and it is understood that a side of the cartridge body remote from the rear side is a front side. Correspondingly, one side of the front surface of the flow channel box 13 body is a front side, as shown in fig. 11, and one side of the back surface of the flow channel box 13 body is a back side or a back surface, as shown in fig. 11.
In a specific embodiment, as shown in fig. 9,10 and 12, the cartridge body is disposed on the first mounting surface 101 of the dialysis device. The first mounting surface 101 is provided with a plurality of independent second pneumatic interfaces 103, and the side surface of the box body combined with the first mounting surface 101 is provided with a plurality of independent first pneumatic interfaces 1322. The cartridge body may be in communication with the second pneumatic interface 103 or may be out of communication with the second pneumatic interface 103. It should be noted that, the cartridge body may be mounted on the first mounting surface 101 in parallel, as shown in fig. 9, or may be mounted on the first mounting surface 101 vertically or at a preset angle with respect to the first mounting surface 101, so long as it is ensured that the cartridge body of the flow channel cartridge 13 is in an upright state with an included angle of 70 ° -110 ° with respect to the horizontal plane in the operating state of the dialysis apparatus. In the preferred embodiment, the body of the flow cassette 13 is oriented approximately 90 ° perpendicular to the horizontal when the dialysis apparatus is in operation.
By communicating the plurality of independent first pneumatic interfaces 1322 of the cartridge body with the plurality of independent second pneumatic interfaces 103 in a one-to-one correspondence, the pneumatic system independently operates the pump, or valve, to which each first pneumatic interface 1322 corresponds, so as to control the flow of fluid in the cartridge body. It should be noted that, although in the embodiment shown in fig. 10 and 12, the number of the first pneumatic interfaces 1322 and the second pneumatic interfaces 103 is ten, the number of the first pneumatic interfaces 1322 and the second pneumatic interfaces 103 may be equal to the total number of the pumps and the valves in the box body, the number of the first pneumatic interfaces 1322 and the second pneumatic interfaces 103 may be greater than the total number of the pumps and the valves in the box body, for example, the box body may further include the first pneumatic interfaces 1322 in communication with one or more gas-liquid separation cavities in the box body, and the number of the first pneumatic interfaces 1322 and the second pneumatic interfaces 103 may be smaller than the total number of the pumps and the valves in the box body, for example, the first pneumatic interfaces 1322 may be in communication with a plurality of pumps and/or valves through the split-flow pipes in the box body.
In the case that the flow channel box 13 is defined as a consumable material, in the operation of multiple plugging operations of the male and female connectors, the female connectors are gradually enlarged due to multiple plugging operations of the male connectors, so that the tightness of the connectors is weakened, to this end, in an embodiment of the application, the first pneumatic interface 1322 is designed as a female interface and the second pneumatic interface 103, which is located long-term 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 disposed of after one use or a limited number of uses, even if the female connector is deformed by multiple plugging operations, the sealing connection between the second pneumatic connector 103 and the new flow channel box 13 will not be affected, and thus the long-term use of the second pneumatic connector 103 is ensured.
Of course, the first pneumatic interface 1322 may be a male interface and the second pneumatic interface 103 may be a female interface corresponding to the male interface, regardless of the reduced tightness.
In one embodiment, the cartridge body is internally provided with a plurality of fluid channels 1313 for controlling the flow of fluid in a forward or reverse direction by air pressure. Wherein the fluid channel 1313 is configured to allow the fluid to flow. The fluid channels 1313 may communicate with each other through ports (e.g., inlets or outlets in fig. 13) of each fluid channel 1313. In an embodiment, the cartridge body may include at least one of a blood path channel (L1 and L3), a dialysate regeneration channel L2. For example, the cartridge body includes a blood path passage and a dialysate regeneration passage therein, and thus the cartridge body may be directly communicated with a vein of a human body, an artery of a human body, a dialyzer 30, etc. through an external pipe. As another example, to simplify the complexity of the arrangement of the fluid channels 1313 in the cartridge body, it is also possible to include only a portion of the blood path channels or only a portion of the dialysate regeneration channels in the cartridge body.
Further, it should be understood that the "channels" disclosed herein refer to pumps and valves in the cartridge body that may be fluidly coupled to one another to provide a path for transferring fluids (i.e., blood, saline, dialysate, etc.) between these components. The blood path channel in the cartridge body is a channel for transferring fluid between the components in the blood circuit, and the dialysate regeneration channel in the cartridge body is a channel for transferring fluid between the components in the dialysate regeneration flow path L2. Since the channels themselves may be of soft/flexible material, the shape of the channels may be limited by the structure of the box body or the positions of the pumps and valves to present different wiring/piping patterns when actually arranged, and in order to further define the communication relationship between the channels and the respective pumps and valves, the connection relationship shown in the schematic diagrams described with reference to fig. 2 or fig. 6 is described in detail herein.
In an embodiment, the inside of the box body is provided with a plurality of fluid "channels" for controlling the fluid to flow forward or backward through air pressure, which are channels having a certain rigidity and formed inside the box body by injection molding, blow molding, stamping, material reduction, or material addition (such as 3D printing) processes, and please refer to the cross-sectional structure shown in fig. 13 later, in other words, the cavity structure and the material of the side walls of the "channels" are the same as the material of the box body, for example, in an embodiment, the box body is injection molded by PMMA, PVC or PC plastic.
In an embodiment, the cartridge body of the flow channel cartridge 13 includes a pneumatic element, and the pneumatic element is in communication with the first pneumatic interface 1322 and the fluid channel 1313, and is used for controlling the fluid to flow in the positive direction or the reverse direction in the fluid channel 1313 by using the positive pressure gas and the negative pressure gas that are introduced by the first pneumatic interface 1322.
In an embodiment, the pneumatic element comprises a pneumatic fluid pump and a pneumatic fluid valve. The pneumatic fluid pump is used for pushing fluid into the fluid channel 1313 by positive pressure gas introduced by the first pneumatic interface 1322 and sucking fluid from the fluid channel 1313 by negative pressure gas introduced by the first pneumatic interface 1322. The pneumatic fluid valve is used for turning on or off the fluid channel 1313, for example, the pneumatic fluid valve uses positive pressure gas introduced by the first pneumatic interface 1322 to turn off the fluid channel 1313, and uses negative pressure gas introduced by the first pneumatic interface 1322 to turn on the fluid channel 1313. During pumping of the cartridge body, the pneumatic fluid valve on the inlet side opens the fluid channel 1313 and fluid is then pumped from the inlet through the fluid channel 1313 into the pneumatic fluid pump. During the pushing out of the cartridge body, the pneumatic fluid valve on the outlet side opens the fluid passage 1313, and the fluid is pushed out of the pneumatic fluid pump and discharged at the outlet via the fluid passage 1313. It should be noted that, although the present application is described by taking the pneumatic element including a pneumatic fluid pump and a pneumatic fluid valve as an example, in other embodiments, the cartridge body may include only a pneumatic fluid pump, for example, the valve may be an external pinch valve. The cartridge body may also include only pneumatic fluid valves therein, for example, the pump may be a peripheral peristaltic pump.
The pneumatic fluid pump and the pneumatic fluid valve in the box body not only can realize the functions of the traditional pump and the valve, but also can reduce the size of the portable dialysis equipment and improve the integration level of the portable dialysis equipment.
In a specific embodiment, the pneumatic element includes a fluid chamber, a pneumatic diaphragm, and a gas chamber. The partial cartridge body shown in fig. 13a and 13b includes three pneumatic elements, each including a fluid chamber (1310, 1314), a pneumatic diaphragm 133, and a gas chamber (1320, 1324). It should be noted that, as shown in fig. 13a and 13b, the three pneumatic elements may share one pneumatic diaphragm, and in other embodiments, one pneumatic element or two pneumatic elements may share one pneumatic diaphragm.
The fluid cavity communicates with the fluid channel 1313. In one embodiment, the cartridge body includes a flow field plate 131, and the fluid chamber and the fluid channel 1313 are disposed on the flow field plate 131. Specifically, the fluid cavity and the fluid channel 1313 are formed by a plurality of recesses, grooves, openings, and the like reserved on the runner plate 131. In one embodiment, the runner plate 131 is injection molded from PMMA, PVC or PC plastic.
In one embodiment, the fluid chamber is formed inside the flow field plate 131. Wherein, the inner side of the flow channel plate 131 is the side of the flow channel plate 131 close to the pneumatic diaphragm 133. As shown in fig. 13b, the fluid chambers include a valve fluid chamber 1314 and a pump fluid chamber 1310. The valve fluid chamber 1314 and the pump fluid chamber 1310 are in communication via the fluid passageway 1313. However, this is not limiting and in other embodiments the fluid chamber may include only the pump fluid chamber 1310 or the valve fluid chamber 1314. It should be appreciated that the number of fluid chambers in the cartridge body is equal to the total number of pumps and valves in the cartridge body that need to be integrated, i.e., the total number of valve fluid chambers 1314, and pump fluid chambers 1310 is equal to the total number of pumps and valves in the cartridge body that need to be integrated. In the following embodiments, the fluid chambers are illustrated as including a pump fluid chamber 1310 and a valve fluid chamber 1314.
In an example, the fluid chamber is a chamber recessed in the inner side of the flow channel plate 131 toward a direction away from the air-operated diaphragm 133. The concave surface of the fluid chamber may be arcuate, curvilinear, or the like. The pump fluid chamber 1310 may be the same size as the valve fluid chamber 1314 or may be different size than the valve fluid chamber 1314. For example, as shown in fig. 13a and 13b, the pump fluid chamber 1310 is sized larger than the valve fluid chamber 1314. The smaller size of the valve fluid chamber 1314 facilitates opening and closing of the valve.
In one embodiment, as shown in fig. 13a and 13b, the fluid passageway 1313 communicates between the valve fluid chamber 1314 and the pump fluid chamber 1310. Wherein a side of the fluid channel 1313 communicating with each of the fluid chambers has an opening. In one example, the opening of the fluid channel 1313 in the fluid chamber is a chamber wall slope compliant opening such that turbulence is not created as fluid enters the fluid chamber. In other words, the opening of the fluid channel 1313 in the fluid chamber is open on the chamber wall of the fluid chamber. For example, as shown in fig. 13a and 13b, the opening of the fluid channel 1313 communicating with the pump fluid chamber 1310 is formed in a chamber wall of the pump fluid chamber 1310 having an arc surface. For another example, the opening of the fluid passageway 1313 in communication with the inlet valve fluid chamber 1314 is formed in a wall of a planar portion of the inlet valve fluid chamber 1314.
In one embodiment, the first surface of the pneumatic diaphragm 133 overlies the fluid chamber. Wherein the first surface is a surface thereof facing the flow field plate 131, and the second surface is a surface thereof facing away from the flow field plate 131. When the pneumatic element is a pneumatic fluid pump, the first surface of the pneumatic diaphragm 133 overlies the fluid chamber for changing the volume of the fluid chamber when subjected to pressure to push the fluid chamber into the fluid channel 1313 or to draw fluid from the fluid channel 1313. When the pneumatic element is a pneumatic fluid valve, the first surface of the pneumatic diaphragm 133 overlies the fluid chamber for changing the volume of the fluid chamber to turn the fluid channel 1313 on or off when subjected to pressure.
In one embodiment, the pneumatic diaphragm 133 is made of silicone rubber or PVC flexible film. The pneumatic diaphragm 133 is deformed by force and the pneumatic diaphragm 133 returns to its original state/shape after the force is removed. Wherein the cavity pressure in the fluid cavity is positive pressure when the pneumatic diaphragm 133 is deformed downward by force. As another example, the chamber pressure in the fluid chamber is negative as the pneumatic diaphragm 133 is forced to deform upward.
In an embodiment, the number of the air-operated diaphragms 133 in the case body may be one or more. For example, as shown in fig. 11, a plurality of fluid chambers in the cartridge body are covered with one air-operated diaphragm 133. As another example, each fluid chamber is covered by a separate pneumatic diaphragm 133.
In the present application, the case where the fluid flows in the forward direction in the cartridge body is taken as an example, the suction and the pushing of the fluid by the air pressure control cartridge body will be described. Wherein the positive fluid flow is from the valve fluid chamber 1314 at the inlet 1311 towards the pump fluid chamber 1310, e.g. the dialysis fluid flows from the valve fluid chamber 1314 at the inlet towards the pump fluid chamber 1310 in a treatment mode or when performing a treatment operation, as shown in fig. 2, the dialysis fluid flows positively under the action of a plurality of pumps and valves, i.e. under the action of a plurality of pumps and valves integrated in the cartridge body, in the direction of the dashed arrow. The reverse flow of fluid is from the valve fluid chamber 1314 at the outlet toward the pump fluid chamber 1310, e.g., the portable dialysis device flows from the valve fluid chamber 1314 at the outlet toward the pump fluid chamber 1310 when performing a flushing operation.
With continued reference to fig. 13b, during the pumping of the cartridge body, first, the pneumatic system positive pressure on the upper side of the pneumatic diaphragm 133 at the valve fluid chamber 1314 of the outlet position, where the valve fluid chamber 1314 is closed, the pneumatic diaphragm 133 is forced downward. The pneumatic system then applies negative pressure to the upper sides of the inlet-positioned valve fluid chamber 1314 and the pneumatic diaphragm 133 at the pump fluid chamber 1310, both the inlet-positioned valve fluid chamber 1314 and the pneumatic diaphragm 133 at the pump fluid chamber 1310 being forced upward, the inlet-positioned valve fluid chamber 1314 being open and fluid being drawn from the inlet 1311 through the fluid passageway 1313, the inlet-positioned valve fluid chamber 1314 into the pump fluid chamber 1310. During the fluid pushing out of the cartridge body, first, the pneumatic system makes the upper side of the pneumatic diaphragm 133 at the valve fluid chamber 1314 at the outlet position negative pressure, the pneumatic diaphragm 133 is forced to deform upwards, and the valve fluid chamber 1314 at the outlet 1312 position is opened. The pneumatic system then applies positive pressure to the upper sides of the pneumatic diaphragm 133 at the inlet position valve fluid chamber 1314 and pump fluid chamber 1310, the inlet position valve fluid chamber 1314 and pump fluid chamber 1310 being forced downward by the pneumatic diaphragm 133, the inlet position valve fluid chamber 1314 being closed and fluid in pump fluid chamber 1310 being expelled through the fluid passageway 1313 at the outlet 1312.
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 fig. 13b, the valve fluid chamber 1314 at the outlet position of the flow channel plate 131 is located at the lower side of the pneumatic diaphragm 133, covered by the first surface of the pneumatic diaphragm 133, and the valve gas chamber 1324 corresponding to the valve fluid chamber 1314 is located at the upper side of the pneumatic diaphragm 133, covered by the second surface of the pneumatic diaphragm 133. The gas cavity is provided with a gas hole 1321 for communicating with the first pneumatic interface 1322, and the positive pressure gas flow or the negative pressure gas flow provided by the gas hole 1321 is used for driving the pneumatic diaphragm 133 to change the cavity pressure in the fluid cavity.
In an embodiment, the cartridge body comprises an air channel plate 132, the air channel plate 132 being combined with the flow channel plate 131 and the pneumatic diaphragm 133 of the pneumatic element. In one embodiment, the airway plate 132, when combined with the flow channel plate 131, sandwiches the pneumatic diaphragm 133. In one embodiment, the airway plate 132 is injection molded from PMMA, PVC, or PC plastic. The airway plate 132 is provided with a plurality of recesses, grooves, openings, etc.
In one embodiment, the gas chamber is disposed on the airway plate 132. Specifically, the gas chamber is formed inside the airway plate 132. The gas cavity is formed by a plurality of recesses, grooves, openings, etc. reserved in the airway plate 132. In one embodiment, the gas chambers are uniformly aligned with the number and location of the fluid chambers, in other words, the gas chambers include a valve gas chamber 1324 corresponding to the valve fluid chamber 1314, a pump gas chamber 1320 corresponding to the pump fluid chamber 1310, each set of the valve fluid chamber 1314, the valve gas chamber 1324, and the pneumatic diaphragm 133 therebetween form the pneumatic fluid valve described above, and each set of the pump fluid chamber 1310, the pump gas chamber 1320, and the pneumatic diaphragm 133 therebetween form the pneumatic fluid pump described above.
The air cavity is provided with an air hole 1321 for communicating with an external air passage, and the air hole 1321 provides positive pressure air flow or negative pressure air flow to drive the pneumatic diaphragm 133 to change the volume of the fluid cavity. In an embodiment, each gas chamber has a gas hole 1321, the pneumatic system of the dialysis device provides a positive pressure gas flow or a negative pressure gas flow through the gas hole 1321 into each gas chamber in the cartridge body, the pneumatic diaphragm 133 is forced to deform downward when the positive pressure gas flow is in the gas chamber, and the pneumatic diaphragm 133 is forced to deform upward when the negative pressure gas flow is in the gas chamber.
For this purpose, a first pneumatic interface 1322 is also provided on the outside of the airway plate 132, which communicates with the air holes 1321. In other words, the valve gas chamber 1324 and the pump gas chamber 1320 are respectively correspondingly connected to a separate first pneumatic interface 1322, so that the valve gas chamber 1324 and the pump gas chamber 1320 can be respectively connected to the pneumatic system of the portable dialysis device through the first pneumatic interface 1322, so that the pneumatic system can control each gas chamber to control the fluid to flow in the forward direction or the reverse direction in the fluid channel 1313 of the cartridge body.
In an embodiment, the cartridge body further includes a gas passage 1323, the gas passage 1323 is disposed in the gas passage plate 132, and the gas vent 1321 communicates with the first pneumatic interface 1322 through the gas passage plate 132.
In one embodiment, the flow channel plate 131 and the air channel plate 132 may be bonded together by bonding, welding, fastening, or screwing, etc., and the pneumatic diaphragm 133 is clamped between the flow channel plate 131 and the air channel plate 132. The three of the flow path plate 131, the air-operated diaphragm 133, and the air passage plate 132 are fixedly combined together in advance, so that the air tightness between the air-operated diaphragm 133 and the flow path plate 131 and the air passage plate 132 can be ensured to ensure the air tightness of the air drive.
In another embodiment, the pneumatic diaphragm 133 is bonded to the flow path plate 131 and/or the airway plate 132 by bonding or welding.
In an embodiment, the flow box 13 body further comprises a sealing ring 134 to seal between the pneumatic diaphragm 133 and the fluid chamber and/or the gas chamber. The sealing ring 134 may be provided on the pneumatic diaphragm 133 by adhesion or the like, or may be integrally formed with the pneumatic diaphragm 133.
In one embodiment, as shown in fig. 13b, the sealing rings 134 are located on both sides of each pump/valve, and the sealing rings 134 can seal between the pneumatic diaphragm 133 and the fluid chamber and between the pneumatic diaphragm 133 and the gas chamber. However, the present invention is not limited thereto, and in other embodiments, the flow channel box 13 may further include only a sealing ring 134 for sealing disposed between the pneumatic diaphragm 133 and the flow channel plate 131, or only a sealing ring 134 for sealing disposed between the pneumatic diaphragm 133 and the air channel plate 132. Wherein, the sealing ring 134 is made of silicon rubber, isobutyl rubber, ethylene propylene rubber, nitrile rubber, fluororubber or polyurethane rubber.
In an embodiment, the air channel plate 132 and/or the flow channel plate 131 are further provided with a groove structure for placing the sealing ring 134. For example, the groove structure is a rectangular groove, a V-groove, a semicircular groove, a dovetail groove, or a triangular groove.
It should be noted that although the pump and the valve integrated in the body of the flow cassette 13 are described with respect to the partial flow cassette 13 structure of fig. 13b as an example, it should be understood that according to the configuration of the inlet valve, the outlet valve, and the pump shown in fig. 13b, it is possible to integrate partial devices (e.g., partial lines, valves, and pumps) in the blood circuit and/or the dialysate circuit in the cassette body according to the embodiment shown in fig. 2 or fig. 6.
In one embodiment, the cartridge body further includes a gas-liquid separation chamber (e.g., the venous pot and the reaction pot 60 of fig. 2) in communication with the fluid channel 1313 for separating and exhausting the gas within the fluid channel 1313. In other embodiments, the gas-liquid separation chamber may also be referred to as a gas collection chamber.
In an embodiment, the gas-liquid separation chamber is in communication with the first pneumatic interface 1322, and the gas is introduced into the gas-liquid separation chamber when the first pneumatic interface 1322 is introduced with positive pressure gas, or is discharged from the gas-liquid separation chamber when the first pneumatic interface 1322 is introduced with negative pressure gas. In other words, the first pneumatic interface 1322 is filled with positive pressure gas when the gas-liquid separation chamber needs to be filled with gas, and the first pneumatic interface 1322 is filled with negative pressure gas when the gas-liquid separation chamber needs to be exhausted.
Further, the flow channel box 13 further includes an atmosphere interface, and the gas-liquid separation cavity is communicated with the atmosphere interface, and the atmosphere interface is used for discharging the gas in the gas-liquid separation cavity. In an embodiment, the flow channel box 13 further comprises a hydrophobic and breathable membrane, and the gas in the gas-liquid separation cavity is discharged from the atmosphere interface through the hydrophobic and breathable membrane.
In an embodiment, the cartridge body further comprises a one-way fluid valve in communication with the fluid channel 1313, pneumatic element, or fluid interface for allowing one-way fluid flow within the fluid channel 1313.
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.
In an embodiment, the cartridge body further comprises a sensor interface and/or a heating device interface. The sensor interfaces include, but are not limited to, pressure sensor interfaces, color sensor interfaces, ammonia sensor interfaces, temperature sensor interfaces, liquid level sensor interfaces, blood leakage sensor interfaces, conductivity sensor interfaces, air sensor interfaces. Such as shown in fig. 11, the cartridge body is provided with an ammonia sensor interface 135 and a catalytic unit injection port 136.
It should be noted that although the foregoing embodiments have been described by taking the case where the fluid passage 1313 is provided in the flow path plate 131 and the gas passage 1323 is provided in the gas path plate 132 as an example. However, the present invention is not limited thereto, and in other embodiments, a portion of the fluid channels 1313 may be disposed in the air channel plate 132, and a portion of the gas channels 1323 may be disposed in the flow channel plate 131. The dimensions and shapes of the flow channel plate 131 and the air channel plate 132 may be the same or different, e.g. in order to integrate a large number of channels in the air channel plate 132, the dimensions of the air channel plate 132 are larger than the dimensions of the flow channel plate 131.
As mentioned above, pumps and valves in the portable dialysis device are integrated in the body of the flow cassette 13. Therefore, the box body is also provided with a plurality of fluid interfaces for communicating with liquid pipelines outside the box, and the fluid interfaces are used for communicating with the liquid pipelines outside so as to communicate the flow channel in the flow channel box 13 body with veins and arteries of a human body and a liquid container outside the flow channel box 13 body. In certain embodiments, the liquid container may also be referred to as a fluid container. The external liquid containers include ultrafiltration containers 52, make-up liquid containers 75, preformed liquid containers, and/or adsorption devices, among others. In an embodiment, the fluid interface is provided on at least one side of the cartridge body, in other words, the fluid interface may be provided on any side of the flow box 13 body, for example, on the front, rear, left, right, top, or bottom side of the flow box 13 body. In one example, as illustrated in fig. 11 and 12, the fluid ports are provided on the top, bottom, and front sides of the cartridge body and connect the corresponding lines.
The fluid interface comprises an arterial interface capable of being connected with an arterial line of an artery of a patient, a venous interface capable of being connected with a venous line of a vein of the patient, a replenishing liquid interface capable of being connected with a replenishing liquid passage, a prefabricated liquid interface capable of being connected with a prefabricated liquid passage, an adsorption interface capable of being connected with an adsorption device, or/and an ultrafiltration interface capable of being connected with an ultrafiltration passage. In some embodiments, the fluid interface may further include a replenishment liquid interface for connecting with a replenishment liquid branch L2-8 in the dialysate regeneration flow path L2 for delivering a replenishment liquid, an ammonia sensor gas interface 135 for connecting with an ammonia sensor for detecting an ammonia content in the dialysate regeneration flow path L2, and a catalytic unit injection port 136 connected with the sample adding device S or the 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 an enzyme preparation is injected into the dialysate regeneration flow path L2, for example, an enzyme preparation is injected into the secondary circulation flow path in the dialysate regeneration flow path L2 through the catalytic unit injection port. In one embodiment, the ammonia sensor needs to be inserted into the protective fluid after the dialysis treatment is completed to prevent damage to the sensor's sensing elements. In other embodiments, the make-up fluid passage may also be referred to as a make-up fluid bypass, the ultrafiltration passage may also be referred to as an ultrafiltration bypass, and the pre-fluid passage may also be referred to as a pre-fluid bypass.
In one embodiment, as shown in fig. 11, the ammonia sensor interface 135 and the catalytic unit injection port 136 are disposed on the front surface of the cartridge body and along with the corresponding fluid channel 1313 inside the cartridge body, but not limited thereto, and in other embodiments, the ammonia sensor interface 135 and the catalytic unit injection port 136 may be disposed on the upper side, the left side, the right side, etc. of the cartridge body.
In the embodiment shown in fig. 11 and 12, the cartridge body has integrated thereon a dialyzer 30 and/or a reaction filter 67. For example, as shown in fig. 11, the cartridge body has the dialyzer 30 and the reaction filter 67 integrated thereon, the dialyzer 30 being located on the left side of the cartridge body, and the reaction filter 67 being located on the right side of the cartridge body.
Here, in some embodiments, a bracket (not shown) supporting the dialyzer 30 and/or the reaction filter 67 is also provided on the first surface of the cartridge body. The holder of the dialyzer 30 or the holder of the reaction filter 67 comprises at least one groove structure in which the dialyzer 30 or the reaction filter 67 is clamped. In a possible embodiment, the support of the dialyzer 30 or the support of the reaction filter 67 each comprises two groove structures. Although the present application is described by taking the rack as a groove structure, the present application is not limited thereto, and in other embodiments, the rack may be other structures capable of supporting the dialyzer 30 or the reaction filter 67.
In one embodiment, the dialyzer 30 and/or the reaction filter 67 communicates with the fluid channel 1313 inside the cartridge body via tubing integrally formed on the cartridge body. For example, as shown in fig. 11, a plurality of L-shaped or inverted L-shaped pipes for communicating the dialyzer 30 and/or the reaction filter 67 with the fluid passage 1313 inside the cartridge body are integrally formed with the cartridge body at both upper and lower sides of the cartridge body. In other embodiments, the dialyzer 30 and/or the reaction filter 67 are disposed on the cartridge body, and a fluid interface for communicating with the dialyzer 30 and/or the reaction filter 67 is preset on the cartridge body, and the dialyzer 30 and/or the reaction filter 67 is communicated with the fluid channel 1313 inside the cartridge body through a pipeline for communicating with the fluid interface. For example, a user may place the tubing in communication with the dialyzer 30 and/or the reaction filter 67 with the corresponding fluid interface while using the flow cassette 13.
In the operating state of the dialysis apparatus, the dialyzer 30 and/or the reaction filter 67 of the cartridge body are/is in an upright state with an angle of 70 ° to 110 ° with respect to the horizontal plane. In other words, the standing state is at an angle of 70 ° -110 ° to the horizontal with respect to the dialyzer 30 and/or the reaction filter 67 of the cartridge body in the open state of the portable case. In a preferred embodiment, the dialyzer 30 and the reaction filter 67 of the cartridge body are oriented at about 90 ° to the horizontal when the dialysis apparatus is in operation.
In summary, the dialyzer 30 and/or the reaction filter 67 are integrated in the cartridge body in advance, so that convenience of user operation can be improved, and sealability and safety of the portable dialysis apparatus can be improved.
In an embodiment, the tubing in the portable dialysis device is disposed in an interior space defined by the portable housing. The pipeline is used for connecting a blood circuit of a human body and a dialysate circuit used for connecting the blood circuit. The tubing is located outside of the flow cassette 13. One end of the pipeline is communicated with the runner box 13, for example, is communicated with a fluid interface of the runner box 13 body. The other end of the pipeline is communicated with devices such as veins, arteries, blood pumps, adsorption devices, ultrafiltration containers 52, prefabricated liquid, replenishing liquid or pressure sensors of a human body.
In an embodiment, the tube may be integrally formed with the cartridge body. In other embodiments, the tubing may also be in communication with the cartridge body by a user between hemodialysis performed by the dialysis apparatus.
In one embodiment, the lines include a venous line for communicating with a vein of a human body, an arterial line for communicating with an artery of a human body, a blood pump line for communicating with a blood pump, an adsorption device line for communicating with an adsorption device, an ultrafiltration line L2-2 for communicating with an ultrafiltration vessel 52, a pre-preparation line L2-3 for communicating with a pre-preparation, a replenishment line L2-8 for communicating with a replenishment solution, and a pressure sensor line for communicating with a pressure sensor.
In one embodiment, the tubing may be made of silicone rubber or PVC. For example, the blood pump tube is made of the silicone rubber material, and the venous line, the arterial line, the adsorption device line, the ultrafiltration line, the pre-fluid line, the replenishment fluid line, the pressure sensor line, and the like are all made of PVC materials. In use, blood from the arterial end of the body enters the dialyzer 30 from the upper end of the dialyzer 30 in communication with the cartridge body via tubing and is output from the lower end of the dialyzer 30 to the venous end 86 of the body, in which embodiment the dialyzer 30 further comprises an inlet and an outlet for dialysate which communicate with the dialysis circuit L2/the dialysate regeneration flow path L2.
On this basis, the cartridge body is integrated with a dialysate regeneration flow path L2. The dialysate regeneration flow path L2 communicates with the dialyzer 30, the dialysate waste liquid of the dialyzer 30 flows into the dialysate regeneration flow path L2 from a dialysate input end, and the purified regeneration liquid flows into the dialyzer 30 from a dialysate output end.
In one embodiment, the dialysate regeneration flow path L2 comprises a waste liquid path L2-1, a secondary circulation flow path L2-4 and a regeneration liquid pipeline L2-7. Further, the dialysate regeneration flow path L2 may further include at least one of an ultrafiltration branch L2-2, a pre-fluid bypass L2-3, a gas branch L2-5, and a replenishment fluid branch L2-8. The secondary circulation device comprises the gas branch L2-5 and a secondary circulation flow path L2-4.
The dialysate regeneration flow path L2 according to the present application is integrated with the cartridge body, and means that a pump and a valve in the dialysate regeneration flow path L2, and a line connecting the pump and the valve may be provided inside the cartridge body, and a fluid container (for example, the ultrafiltration container 52, the preformed fluid bag 45, the replenishment fluid container 75, and/or the reaction filter 67) and/or an adsorption device in the dialysate regeneration flow path L2 may be connected to the fluid channel 1313 inside the cartridge body through an external line. For example, the reaction filter 67 is provided outside the cartridge body to communicate with the fluid passage 1313 inside the cartridge body through an external pipe.
In the following embodiments, please continue to refer to the schematic diagrams shown in fig. 2 and 6 in combination with fig. 9 to 13b.
In one embodiment, the input of the waste liquid path L2-1 communicates with the dialyzer 30 to obtain the waste liquid for dialysis from the dialyzer 30. In an embodiment, the dialyzer 30 is used for purifying blood flowing in a blood circuit, and forms a blood flow path through which blood of a patient flows and a dialysate flow path through which dialysate flows by a built-in purification membrane for purifying blood.
In this embodiment, a venous pot 81 is also provided on the side adjacent to the dialyzer 30, for example a venous pot 81 is provided vertically adjacent to the right side of the dialyzer 30. A liquid level sensor for detecting the liquid level of the venous kettle 81 is mounted on the first mounting surface 101, the liquid level sensor is disposed on the venous kettle and is used for detecting the liquid level in the venous kettle, a gas collecting kettle 80 (as shown in fig. 3) is disposed between the venous kettle and the dialyzer 30 and is used for collecting gas from the venous kettle 81, in this embodiment, an inlet of the venous kettle 81 is located at an upper side, and an inlet is located at an upper side and is communicated with the gas collecting kettle 80 through a pipeline. The gas collection kettle 81 may also be referred to as a gas collection chamber 80 in some embodiments (as in fig. 4).
In the treatment mode or treatment operation, as shown in fig. 3, the dialysis device drives the flow of blood from the arterial end to the venous end 86 in a forward direction, i.e. when the fluid in the blood circuit is driven in the forward direction, the fluid flowing through the arterial blood line L1 flows via the dialysis channel L2 from the first port into the gas collection chamber 80 (gas collection pot) and fills the gas collection chamber 80 and then flows from the second port to the venous blood line L3.
In the embodiment shown in fig. 3, a venous bottle 81 is also in communication with the line between the air collection chamber 80 and the venous end 86 of the venous blood line L3, in this embodiment the venous bottle 81 and the air collection chamber 80 are two separate elements connected in series on the venous blood line L3. The venous pot 81 is used for observing instillation and collecting gas from a pipeline, so that the section of the conventional venous pot 81 is generally in an inverted trapezoid or cone-shaped structure, and the top end of the conventional venous pot 81 is generally provided with an exhaust pipeline, and venous pot valves 82, venous pressure sensors 83 and the like arranged on the exhaust pipeline. In the treatment mode or in the treatment operation, when the fluid in the blood circuit is driven positively, the gas enriched in the gas collection chamber 80 flows into the venous pot 81 preferentially over the liquid entering the gas collection chamber 80 so as to be discharged from the venous pot 81 through a discharge line L4 provided on the venous pot 81.
In the embodiment shown in fig. 4, it is also conceivable to integrate the above-mentioned venous jug 81 and the air collecting chamber 80 into one component which functions as both the air collecting chamber 80 and the venous jug, which air collecting chamber 80 is different from the structure of a conventional venous jug having a generally inverted trapezoidal or conical configuration in cross section, also referred to as the air collecting chamber 80 in the subsequent embodiments for convenience of description. In this embodiment, the gas collecting chamber 80 includes a liquid storage space located at a lower portion of the chamber and a gas collecting space located at an upper portion of the chamber. That is, the gas collecting chamber 80 is functionally divided into two spaces, the upper gas collecting space is used for collecting gas, the lower liquid storage space is used for collecting liquid passing through the gas collecting chamber 80, that is, a gas-liquid separation layer is arranged in the gas collecting chamber 80, a first interface and a second interface are arranged on the gas collecting chamber 80, liquid flows from the first interface to the second interface through the inner space of the gas collecting chamber 80, and the shortest flowing distance of the flowing liquid is controlled by designing the inner structure of the gas collecting chamber 80 and the relative positions of the first interface and the second interface, so that bubbles in the liquid float upwards and escape, and the purpose of gas-liquid interface separation is achieved.
In an embodiment, the top of the air collecting chamber 80 may be directly provided with a third port for communicating with an exhaust pipe L4, for example, a valve device for controlling exhaust is provided on the exhaust pipe, and in an example, a static pressure sensor 83, a solenoid valve 82, or/and a hydrophobic filter is provided on the exhaust pipe L4.
In the embodiment shown in fig. 4, the line between the air collecting chamber 80 and the venous end 86 of the venous blood line L3 is further connected with an air collecting chamber 80 which also serves as a venous pot, and in an embodiment, the top of the air collecting chamber 80 may be directly provided with an opening for communicating with an air exhaust pipe, for example, a valve device 82 for controlling air exhaust is provided on the air exhaust pipe, and in an example, a hydrophobic filter, a static pressure sensor, a solenoid valve 82, or/and a hydrophobic filter is provided on the air exhaust line L4.
In the embodiment shown in fig. 4 in the treatment operation, when the fluid in the blood circuit is driven in the forward direction in the treatment mode or in the treatment operation, the fluid such as blood flows from the arterial blood line L1 into the dialysis device 30 for the blood purification treatment, flows into the venous blood line L3, and enters from the first port of the air collection chamber 80, the fluid such as blood flows from the second port to the venous end 86 of the venous blood line L3 through the liquid storage space, and bubbles of the fluid such as blood are collected in the air collection space at the upper side of the air collection chamber 80 and are discharged through the air discharge line at a proper time according to the detection condition of the sensor.
Referring to fig. 14, a schematic structural diagram of an air collecting chamber according to an embodiment of the present application is shown, in which, in this embodiment, the air collecting chamber 80 includes a liquid storage space 803 located at a lower portion of the chamber and an air collecting space 804 located at an upper portion of the chamber. That is, the gas collecting chamber 80 is functionally divided into two spaces, an upper gas collecting space 804 for collecting gas and a lower liquid storing space 803 for collecting liquid passing through the gas collecting chamber 80. The liquid storage space 803 includes a first extending portion 8031, a second extending portion 8032, and a separating portion 807 located in the first extending portion 8031 and the second extending portion 8032, where the first interface 801 is disposed at a bottom end of the first extending portion 8031, the second interface 802 is disposed at a bottom end of the second extending portion 8032, and the separating portion 807 is higher than the first interface 801 and the second interface 802. In this embodiment, in order to ensure that the inlet and outlet of the liquid storage space 803 are at the lowest positions, the first port 801 and the second port 802 are respectively disposed at the bottom ends of the first extending portion 8031 and the second extending portion 8032 that extend downward, so that the fluid flows upward from the bottom in the gas collection chamber 80, regardless of whether the fluid flows from the first port 801 to the second port 802 or from the second port 802 to the first port 801. In this embodiment, the first extending portion 8031 and the second extending portion 8032 of the liquid storage space 803 extend downward, and it should be understood that the "downward extending" includes, for example, vertical downward extending as shown in fig. 16, and may also include, for example, inclined downward extending as shown in fig. 15, and fig. 15 shows a schematic structural diagram of the air collecting chamber in another embodiment of the present application. Fig. 16 shows a schematic structure of the gas collecting chamber according to the present application in yet another embodiment. Fig. 17 shows a schematic structure of the gas collecting chamber according to the present application in a further embodiment.
In another embodiment, one of the first extending portion 8031 and the second extending portion 8032 of the liquid storage space 803 extends horizontally, and the other extending portion extends downward, so that the first extending portion 8031 and the second extending portion 8032 have an incident angle, and in a specific embodiment, the angle of the incident angle can be adaptively designed according to parameters such as an actual flow rate, a bubble content, or a fluid flow rate of the fluid.
In an embodiment, the length of the first extending portion 8031 provided with the first interface 801 or the second extending portion 8032 provided with the second interface 802 is related to the flow rate, the bubble content, or the fluid flow rate of the fluid in the fluid storage space 803, or the length of the isolation portion 807 provided with the first extending portion 8031 and the second extending portion 8032 is related to the flow rate, the bubble content, or the fluid flow rate of the fluid in the fluid storage space 803, or the shortest flowing 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, the bubble content, or the fluid flow rate of the fluid.
In an embodiment, for example, the fluid such as the liquid flows from the first extending portion 8031 provided with the first interface 801 to the second extending portion 8032 provided with the second interface 802 through the inner space of the gas collecting cavity 80, and the shortest flowing distance of the flowing liquid is controlled by designing the inner structure of the gas collecting cavity 80 and the relative positions of the first interface 801 and the second interface 802, so that the bubbles in the liquid float and escape, and the purpose of separating the gas-liquid interface is achieved, where the shortest flowing distance of the liquid is related to the bubble content, the flow rate, or the flow rate of the liquid, for example, when the bubble content in the liquid is higher, or the flow rate is faster, or the flow rate is higher, in practice, the designed shortest flowing distance of the liquid is longer. In correspondence to different embodiments, for example, in one example, the length of the first extension 8031 or the second extension 8032 is longer as the bubble content in the liquid is higher or the flow rate is faster, in another example, the length of the isolation portion 807 between the first extension 8031 and the second extension 8032 is longer as the bubble content in the liquid is higher or the flow rate is faster or the flow rate is greater, and in yet another example, the shortest flow distance of fluid from one of the first interface 801 or the second interface 802 to the other interface is longer as the bubble content in the liquid is higher or the flow rate is faster or the flow rate is greater.
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 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 may be appropriately increased or shortened in practical application, and of course, the length of the isolation portion 807 between the first extension portion 8031 and the second extension portion 8032 may also be changed to achieve the above purpose. In some embodiments, the isolation portion 807 is stepped with respect to the first extension portion 8031 and/or the second extension portion 8032, the isolation portion 807 is arched with respect 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 collection chamber 80, e.g., the gas collection chamber 80 is generally a-shaped, inverted V-shaped, inverted U-shaped, n-shaped, or "mountain" shaped structure having a bottom extension portion. For example, the air collecting chamber 80 shown in fig. 15 is a schematic view of a substantially a-shaped or inverted V-shaped structure, in which the isolation portion 807 is located at a high position with respect to the first extending portion 8031 and the second extending portion 8032 to form a trapezoid or step-shaped structure, or the air collecting chamber 80 shown in fig. 16 is a schematic view of a substantially inverted U-shaped or n-shaped structure, or the inside of the air collecting chamber 80 shown in fig. 17 is a schematic view of a substantially mountain-shaped structure. As shown in fig. 17, the isolation portion 807 provided inside the gas collecting chamber 80 is a baffle structure extending upward from the bottom of the gas collecting chamber 80, and the left and right portions divided by the baffle structure constitute the first extending portion 8031 and the second extending portion 8032, and the first interface 801 and the second interface 802 respectively form opposite sides of the bottom of the gas collecting chamber 80. The isolation portion 807 is not illustrated in an arch structure with respect to the first extension portion 8031 and/or the second extension portion 8032, and it should be understood that the bottom surface of the liquid storage space 803 illustrated in fig. 16 is changed to an arc that is arched upwards, so that the first extension portion 8031, the isolation portion 807 and the second extension portion 8032 form a bridge hole shape, and the arch structure can be designed.
It should be noted that, in order to better implement gas-liquid separation, in an embodiment of the present application, a cross section of a fluid flowing from one of the first port 801 or the second port 802 to the other port is larger than a cross section of the first port 801 or the second port 802, that is, by designing a structural design of a redundant space for an internal space of the gas collecting cavity 80 or a fluid flow channel, a cross section of a fluid flowing through the path is far larger than a cross section of the port (the first port 801 or the second port 802), so as to reduce a flow velocity of the liquid, increase a gas escape time, for example, when the liquid flows horizontally, a cross section of the liquid increases gradually, a flow velocity decreases gradually, and a flow rate is uniform, so that the gas can escape easily.
In one embodiment, a filter member 805 is disposed in the fluid storage space 803 for filtering fluid flowing between the first port 801 and the second port 802. Specifically, the bottom end of the filter member 805 is adjacent to the first port 801, and the top end of the filter member is adjacent to the second port 802 and is disposed in the gas collection chamber 80 at 30 ° -60 °. Preferably, the inclination angle of the filter member 805 at the gas collection chamber 80 is 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°,60°.. In a preferred embodiment, the inclination angle of the filter member 805 at the gas collection chamber 80 is 45 °. It should be understood that the inclination angle of the filter 805 in the gas collection chamber 80 refers to the angle between the filter 805 and the bottom surface of the gas collection chamber 80. In a specific embodiment, the filter 805 is a screen or a filter membrane.
As mentioned above, the venous kettle and the air collecting cavity 80 are integrated into a component with functions of the air collecting cavity 80 and the venous kettle, so that in order to facilitate the air enriched in the air collecting cavity 80 to be discharged from the air collecting cavity 80 in treatment, an air bag 806 which is communicated with the air collecting cavity 80 and is shown in fig. 14 is arranged at the top of the air collecting space 804, the air bag 806 is a protruding cavity which ensures a small air contact surface and is favorable for being clamped to detect the position of the liquid level or the enriched air quantity or the air pressure in the air collecting cavity, and a detection device for clamping the air bag 806 to detect the position of the liquid level or the enriched air quantity in the air collecting cavity 80 is also included. In a specific example, the detection device is a liquid level detection device, a pressure detection device, a liquid level adjustment device, or the like. In this embodiment, the air bag 806 is further connected to an exhaust pipe L4 for exhausting the air in the cavity (air collecting space), and the exhaust pipe is provided with a valve device for controlling exhaust, and in an example, the exhaust pipe is provided with a hydrophobic filter, a static pressure sensor, an electromagnetic valve, or/and a hydrophobic filter.
In this embodiment, a blood leakage sensor for detecting whether the blood leakage condition occurs in the dialysate circuit is mounted on the first mounting surface 101, and specifically, the blood leakage sensor is used for detecting whether the blood leakage condition exists in a pipeline from the dialysate outlet end in the dialyzer 30.
In the present embodiment, a replenishment liquid pump 74 for adding replenishment liquid to the dialysate circuit is provided on the first mounting surface 101. In the embodiment shown in fig. 2, a replenishing liquid branch line L2-8 for delivering replenishing liquid to the regenerating liquid line L2-7 is arranged on the regenerating liquid line L2-7, and is used for replenishing potassium, calcium and magnesium replenishing liquid through the replenishing liquid branch line L2-8 after urea is removed by the secondary circulation device and other toxins are removed by the adsorption device, so that a dialysis waste liquid regenerating liquid is formed and is reused for dialysis treatment.
In this embodiment, the replenishment liquid branch L2-8 is provided with a container (for example, a replenishment liquid bag) for storing replenishment liquid, and a replenishment liquid pump for delivering the replenishment liquid in the container to the replenishment liquid branch L2-8. The replenishing liquid comprises a potassium-calcium-magnesium replenishing liquid. In an example of the application of the portable dialysis device according to the application, the container for storing the replenishment liquid (for example, a replenishment liquid bag) is an external container, which conveys the replenishment liquid into the dialysate circuit via a line. As shown in fig. 9 and 10, the supplementary fluid bag is provided on the hook 15 of the upper case 10. The replenishment liquid pump for sucking and pushing the replenishment liquid is integrated in the cartridge body. In one embodiment, the hanger 15 is a retractable hanger in order to reduce the volume of the portable dialysis device.
In the present application, the replenishing liquid is a liquid containing one or more than two substances or ions of potassium, calcium, magnesium, sodium, chlorine, bases, glucose and the like, for example, the replenishing liquid is potassium calcium magnesium concentrated liquid, and in some implementation cases, the replenishing liquid can also be called concentrated liquid or dialysis liquid.
In this embodiment, the plurality of fluid containers mounted on the first mounting surface 101 include a reaction pot 60 (or pooling container) and/or a reaction filter 67 (or metabolic filter 67) in communication with the dialysate circuit. In this embodiment, the first mounting surface 101 is provided with a liquid level sensor 61 for detecting the liquid level in the reaction kettle 60. As shown in fig. 9 and 11, the reaction filter 67 is disposed vertically on the right side of the first mounting surface 101. The reaction filter 67 is mounted in the upper case 10 by a bracket provided on the first mounting surface 101. In one embodiment, a reaction kettle 60 is vertically disposed adjacent the left side of the reaction filter 67. A photoelectric sensor or a color sensor 62 for detecting the enzyme preparation content in the reaction kettle 60 is provided on a pipe line on the lower side of the reaction kettle 60. The color sensor 62 is used for detecting the color of the liquid in the reaction kettle 60 to detect the content or concentration of the enzyme-carrying microspheres, or is used as a detection signal for an operator to ensure the correct operation flow and programmed operation of the dialysis equipment. The reaction kettle 60 is a container for holding and pooling at least one fluid, such as a container for pooling the dialysis waste fluid from the dialysis tubing and the enzyme preparation from the loading device S. In one embodiment, the reaction kettle 60 may also be integrated into the cartridge body in communication with the first pneumatic interface 1322. In one embodiment, the reaction filter 67 comprises a Tangential flow filtration module (Tangentil/Cross Flow Filtration Module, TFFM for short), it being understood that the adjustment of the pressure differential for driving the transmembrane can be achieved by controlling the fluid flow rate at the retention module based on the manner in which separation is achieved by the transmembrane pressure differential actuation of the boundary surface in Tangential flow filtration, and in some examples, the Tangential flow filtration module can employ an existing Tangential flow filtration membrane package, such as the Pellicon cartridge ultrafiltration membrane package from MERCK, the leukocyte removal filter from Asahi chemical company, the virus removal filter, the LEOCEED dialyzer, the membrane type plasma component separator, the plasma separator from BRAUN, or the like.
In this embodiment, an air pump (e.g., air pump 65 of fig. 2) for controlling the liquid level in the reaction kettle 60 is integrated with the cartridge body. The first mounting surface 101 is provided with a pressure sensor 66 for detecting the pressure of the fluid in the reaction kettle 60.
Referring to fig. 1,2 and 6, in the embodiment shown in fig. 1,2 and 6, a secondary circulation device is disposed in the dialysate regeneration flow path L2. In one embodiment, the secondary circulation device comprises a reaction kettle 60, a secondary circulation pump 68 and a reaction filter 67. Wherein, the reaction kettle 60, the secondary circulation pump 68 and the secondary circulation flow path formed by the reaction filter 67 can decompose urea molecules in the waste dialysate.
In this embodiment, the secondary circulation device adds the dialysis waste liquid to be treated to the secondary circulation flow path L2-4 to flow and drives the circulation liquid flow through the secondary circulation pump 68, and the liquid flow in the circulation is treated to selectively change the structure or concentration of molecules or molecular combinations in the liquid flow, in the process, the metabolism treatment liquid of the dialysis waste liquid treated in the circulation is led to leave the circulation and the preparation allowance of the mixed enzyme-carrying microspheres is kept in the circulation.
In this embodiment, one end of the secondary circulation flow path L2-4 is connected to the second port 802 of the reaction kettle 60, and the other end is connected to the third port of the reaction kettle 60, so as to form a circulation loop, in this embodiment, the secondary circulation pump 68 is disposed on the secondary circulation flow path L2-4 and is used for driving enzyme-carrying microspheres and dialysis waste liquid mixed in the reaction kettle 60 to circulate in the secondary circulation flow path L2-4, and the metabolic filtration module is disposed on the secondary circulation flow path L2-4 and is used for intercepting the enzyme-carrying microspheres in the secondary circulation flow path L2-4 after toxin treatment is performed on the mixed solution of the enzyme-carrying microspheres and the dialysis waste liquid circulated in the secondary circulation flow path L2-4 and filtering out metabolic treatment solution of the dialysis waste liquid.
In an embodiment, the portable dialysis device further comprises means for controlling the secondary circulation pump 68 to dynamically balance the total amount of fluid in the secondary circulation flow path L2-4 in a secondary circulation mode, i.e. by controlling the flow rate of the dialysis waste liquid introduced into the circulation and the metabolic treatment liquid of the dialysis waste liquid leaving the circulation in any one of the circulation to maintain the dynamic balance of the total amount of fluid in the circulation, the liquid to be treated containing a high concentration of target molecules is introduced into the circulation through the inlet, the target molecules are decomposed into corresponding products by the enzyme-loaded microspheres, the metabolic filtration module in the secondary circulation means continuously separates the treated liquid, the enzyme-loaded microspheres are trapped in the circulation, and the treated liquid flows out of the secondary circulation means through the metabolic filtration module.
In an embodiment, the structure of the gas collection chamber as shown in fig. 14 to 17 may also be used as a reaction kettle in a dialysis fluid regeneration circuit, as shown in fig. 18, which is a schematic diagram of the reaction kettle of the metabolic cycle device according to the present application in an embodiment, as shown in the drawing, in this embodiment, the first port a1 of the reaction kettle 60 is connected to the output end of the waste liquid channel L2-1, and the reaction kettle 60 includes a liquid storage space 601 located in the lower part of the chamber and a gas collection space 600 located in the upper part of the chamber. That is, the reaction kettle 60 is functionally divided into two spaces, an upper gas collecting space 600 for collecting gas, and a lower liquid storing space 601 for collecting liquid passing through the gas collecting chamber 60, that is, a gas-liquid separation layer is provided in the reaction kettle 60, and the liquid in the reaction kettle 60 flows from the second port a2 through the inflow secondary circulation flow path L2-4 and flows from the third port a3 into the reaction kettle 60 again, and of course, in the case that the secondary circulation pump 68 is reversed, the liquid in the reaction kettle 60 flows from the third port a3 through the inflow secondary circulation flow path L2-4 and flows from the second port a2 into the reaction kettle 60 again. In this embodiment, a fourth port a4 is provided at the top of the reaction kettle 60 for communicating with the gas branch L2-5.
In this embodiment, the liquid storage space 601 includes a first extending portion 6011 and a second extending portion 6012 that extend downward, wherein the second interface a2 is disposed at a bottom end of the first extending portion 6011, the third interface a3 is disposed at a bottom end of the second extending portion 6012, and the isolation portion 604 is higher than the second interface a2 and the third interface a3. In this embodiment, in order to ensure that the inlet and outlet of the liquid storage space 600 are at the lowest positions, the second port a2 and the third port a3 are respectively disposed at the bottom ends of the first extension portion 6011 and the second extension portion 6012 that extend downward, so that the fluid flows upward from the bottom in the reaction kettle 60 regardless of whether the fluid flows from the second port a2 to the third port a3 or from the third port a3 to the second port a 2. In this embodiment, the first extension portion 6011 and the second extension portion 6012 of the liquid storage space 601 extend downward, and it should be understood that the "downward extending" extends vertically downward and may also include extending obliquely downward. The reaction pot is generally a-shaped, inverted V-shaped, inverted U-shaped, n-shaped, or "mountain" shaped structure having a shape or configuration of a bottom extension, such as the several gas collection chambers 80 shown in fig. 14 to 17.
In one embodiment, the first port a1 of the reaction kettle 60 is connected to the output end of the waste liquid channel L2-1 for mixing the added enzyme-carrying microspheres and the dialysis waste liquid for sufficient contact. In this embodiment, the reaction kettle 60 is provided with a sample inlet for adding an enzyme preparation (enzyme-carrying microspheres containing urease). Specifically, the loading port includes a valve or a clip for opening and closing the loading port, and the loading port may be shaped to facilitate connection of the syringe and to provide a certain air tightness. The reaction kettle 60 is, for example, a transparent liquid container, such as a container made of medical grade plastic. In an embodiment of the present application, the reaction kettle 60 may be integrated into the cartridge body.
In certain embodiments, the loading port (as shown at 135 in FIG. 11) in the secondary circulation device is further configured with a loading device S (as shown in FIG. 9) for adding, supplementing or replacing reaction substrates, catalytic units, drugs, and other cofactors or activators to the secondary circulation flow path L2-4. In this example, the sample loading device S may be used as a processing unit, and the catalytic unit, the reaction substrate, the activator, etc. may be added, supplemented, or replaced to the secondary circulation flow path L2-4 by the sample loading device S under manual control or controlled by a computing device, thereby implementing the processing of the fluid. In a practical scenario, the sample adding device S may be further configured to control the concentration of the catalytic unit in the cycle, for example, when the concentration of the target substance in the fluid to be treated is different, the corresponding amount of the catalytic unit added into the pipeline may be controlled to achieve the preset reaction effect. In an embodiment, as shown in fig. 9 and 11, the sample loading port is, for example, a catalytic unit injection port provided on the front side of the cartridge body, for example, the catalytic unit injection port 135 is an enzyme preparation injection port, and the enzyme preparation sample loading device S injects an enzyme preparation into the secondary circulation flow path L2-4 through the enzyme preparation injection port 135.
The sample loading device S may be provided as an injection needle tube or the like communicating with the catalyst unit injection port 135. For example, the sample application device S is an injection needle tube in which an enzyme-carrying microsphere solution is preloaded. Through the sample adding device S, the catalytic unit or the reaction substrate can be added into the secondary circulation flow path L2-4 immediately, that is, into the flow path box 13 body, so as to decompose 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 can be a substance capable of reacting 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 cofactor or activator may be used to assist the catalytic unit in reacting with the target substance, for example, when the catalytic unit is a metalloenzyme requiring a metal ion as a cofactor.
In one example, the loading port 135 may also be configured with a corresponding tap or sealing cap for opening during loading and closing after loading is completed to ensure that the interior of the tubing remains relatively sealed.
In another example, the loading device S may be provided with a permeable member such as a rubber stopper, and a loading port may be formed by injection or puncture at the time of loading, for example, a catalytic unit or a reaction substrate to be loaded in the line may be stored in a syringe, and the rubber stopper may be pierced by the syringe to add the catalytic unit or the reaction substrate to the loading device S.
In an embodiment, the reaction kettle 60 has a collection chamber for mixing the circulating catalytic unit, the fluid balance and the liquid to be treated to bring the catalytic unit into contact with the target substance.
In one embodiment, the reaction kettle 60 may be used to expand the volume of the circulation, and in examples where the fluid is a liquid, the reaction kettle 60 may help better mix the circulating liquid with the circulating catalytic unit, thereby allowing for adequate contact of the target substance with the catalytic unit.
In certain embodiments, the reaction kettle 60 is further configured to provide a sample addition port, a vent port, or a drain port. In this example, the reaction kettle 60 may also be used as an integrated platform for various inlets and outlets or as a mixing station for various liquids.
In one embodiment, by determining the position of the reaction kettle 60 in the pipeline, the fluid in the reaction kettle 60 has a tendency to flow in the circulation direction based on the action of gravity during natural placement, thus the generation of bubbles in the pipeline can be avoided or reduced, and the air outlet and inlet communicated with the air branch L2-5 can be arranged on the collecting device to regulate the internal air pressure of the circulation.
In an embodiment, the first mounting surface 101 is provided with a level sensor for detecting the level of the liquid in the reaction kettle 60, and a signal can be transmitted by the level sensor to determine whether to control the level in the reaction kettle 60.
In one embodiment, the secondary circulation device further comprises a gas branch L2-5 for controlling the amount of liquid in the reaction kettle 60 by exhausting or charging. In this embodiment, the air pump is disposed on the air branch L2-5, and the air pump may be integrated in the case body. The exhaust branch is provided with an exhaust valve or a flow passage switching device for communicating or closing the circulating gas on the exhaust branch, and the exhaust valve is a three-way valve or a four-way valve. The gas branch L2-5 is provided with a hydrophobic filter 63. The exhaust branch is provided with a pressure sensor for detecting the pressure in the chamber of the reaction kettle 60, which may reflect the secondary circulation or/and the downstream fluid pressure conditions.
In an embodiment, the gas branch L2-5 integrated in the box body is communicated with the reaction kettle 60 and the first gas port 1322, and the gas is introduced into the reaction kettle 60 when the first gas port 1322 is introduced with positive pressure gas or is discharged from the reaction kettle 60 when the first gas port 1322 is introduced with negative pressure gas.
In another embodiment, two air pumps, namely a first air pump for degassing and a second air pump for aerating, may be disposed on the air branch L2-5, and an exhaust valve or a flow passage switching device is disposed between the first air pump and the second air pump, and the liquid level and the liquid amount in the reaction kettle 60 are controlled by selectively controlling the first air pump or the second air pump.
In an embodiment, the gas branch L2-5 integrated in the cartridge body may further be in communication with two first gas ports 1322, one first gas port 1322 being used for introducing positive pressure gas and the other first gas port 1322 being used for introducing negative pressure gas.
In an embodiment, the pressure sensor, the air pump and the hydrophobic filter are commonly inherited in the gas branch L2-5 through a three-way or four-way valve or a runner switching device, and the gas branch L2-5 is positioned on the reaction kettle 60. When the air pump is used, the pressure sensor is communicated, the air outlet is communicated when the air pump is required to be inflated, and the air pump is communicated when the air pump is required to be inflated. It should be noted that the air pump may be integrated inside the case body.
In an embodiment, the level sensor may be used to transmit a signal to control the level of the liquid in the reaction kettle 60, or the level sensor or the pressure sensor may be used to determine the level or the gas content of the reaction kettle 60, and then the air pump or the air outlet valve on the air branch L2-5 may be used to automatically control the closing of the air outlet, discharge the gas generated by the reaction in the secondary circulation, or control the total amount of the liquid in the dialysate regeneration circulation. In some embodiments, the total amount of dialysate regeneration cycles and the total amount of regeneration fluid.
In an embodiment, the portable dialysis device further comprises a sensor for detecting the concentration of target molecules in the liquid to be treated in the reaction kettle 60, i.e. by measuring the pH, substrate concentration, or product concentration of the living effluent in the secondary loop, to detect the concentration of target molecules or cumulative throughput, thereby reflecting the use of the downstream adsorption means, e.g. an adsorption column. Further, the concentration of the substance detected by the sensor may be used to display or indicate the OCM (on-LINE CLEARANCE monitoring, or OCM for short) of the target molecule, the concentration of the product molecule, or to reflect or detect the activity of the enzyme by comparing with an empirical or historical or agreed value, and to indicate to the operator if the measured value is far below the historical or preset value, so as to facilitate the addition or replacement of the enzyme preparation.
In an embodiment, the adsorption device externally connected to the portable case is, for example, a dialysate regeneration adsorption column, and the adsorption column contains zirconium phosphate, hydrous zirconium oxide, enzyme-carrying microspheres, activated carbon and other materials. In one embodiment, the cation exchanger layer, the urease layer and the zirconium phosphate layer are arranged in the dialysate regeneration adsorption column, and the dialysate regeneration circulation system is in an operating state, wherein the dialysate sequentially passes through the cation exchanger layer, the urease layer and the zirconium phosphate layer. In another embodiment, the dialysate regeneration adsorption column is a fully mixed layer of cation exchanger, hydrous zirconia, enzyme-carrying microspheres, and activated carbon, and contains a zirconium phosphate layer or a zirconium phosphate containing column downstream. The cation exchanger is used as an adsorbent or exchanger for effectively adsorbing calcium and magnesium ions, such as zirconium phosphate, cation resin and other materials.
The application can realize the design of an HDF treatment mode, namely hemodialysis filtration with the total quantity (of circulating dialysate) dynamically controlled by arranging the gas branch L2-5 in the secondary circulating device. The total amount of liquid in the dialysate circulation is regulated and controlled by dynamically and periodically regulating and controlling the volume or the liquid level of any container in the dialysate circulation, so that periodic filtration and filtering are realized, and molecular convection exchange of the dialyzer is increased.
Assuming a volume of the reaction kettle 60 of about 20-30mL, an exhaust valve, such as a four-way valve, may be connected to an air pump or pressure sensor for degassing or aerating. Under standard conditions, the liquid level in the reaction kettle 60 is low, the air is about 25mL, and the air chamber in the reaction kettle 60 is positive pressure due to the continuous injection of liquid in the dialysis waste liquid path L2-1.
In an embodiment, one HDF process may be split into many identical cycles, or air pump air-in or air-out cycles.
During the degassing cycle (assuming 30 s), the liquid level in the reaction kettle 60 slowly rises during the degassing, the amount of filtered water in the blood on the dialysate side increases, and if the degassing speed of the air pump is 46mL/min, the filtered water is 23mL.
During the gassing cycle (assuming 30 s), the gas pressurization level drops and more dialysate is filtered into the blood, again at a rate of 46ml/min. That is, the increased filtration rate for one cycle (1 min) was 23mL, then the 240min filtration rate was 5.52L for the entire treatment cycle.
In another example of increased filtration, if the aeration period is shortened compared to the de-aeration period, the aeration rate is faster, e.g. 5s to complete aeration, the flow rate is 276ml/min, in which case the treatment time for one period is 35s,240min can be run for 411.4 periods, and the total filtration is 9.45L.
Although the exhaust can be performed by arranging the gas branch line L2-5 in the metabolic cycle device, various devices such as an air pump, a pressure sensor and the like are required to be arranged, so that the complexity of the metabolic cycle device is increased, and the manufacturing cost is further increased.
For this reason, in another embodiment, referring to fig. 19a and 19b, a schematic structure of the metabolic circulation device of the application is shown in an embodiment, as shown in fig. 19a, an air outlet a4 is provided at the top of the reaction kettle 60, and a floating valve ball 605 is suspended in the reaction kettle 60 corresponding to the air outlet a 4. The float valve ball 605 is used to seal the vent a4 as the liquid level in the reaction kettle 60 rises and to open the vent as the liquid level in the reaction kettle 60 falls. Specifically, the gas in the reaction kettle 60 rises and gathers on the top of the reaction kettle 60, the liquid level in the reaction kettle 60 gradually drops as the gas gradually increases, the floating valve ball 605 drops along with the liquid level while the liquid level drops, the vent a4 is opened, the gas is discharged from the vent a4, when the liquid level rises, the floating valve ball 6051 rises along with the liquid level, as shown in fig. 19b, and the floating valve ball 605 seals the vent a4 when it rises to the top of the reaction kettle 60 to prevent the liquid from being discharged from the vent a 4. In this way, both the removal of gases from the reaction kettle 60 and the complexity of the metabolic cycle apparatus, such as the reduction in the placement of electrical components or elements, are reduced.
In the above embodiment, the enzyme preparation is reusable and by the "pre-preparation bypass" described above, an empty pre-preparation bag 45 is inserted in the secondary cycle, the liquid and enzyme-carrying microspheres in the secondary cycle are flushed into the bag, and the enzyme preparation (more dilute enzyme preparation) is stored at low temperature to form the pre-preparation. At the next treatment, the bag is inserted into the secondary circulation flow path and inverted, and the outlet is down, and the enzyme preparation is supplemented to the secondary circulation as the secondary circulation, or a part of the enzyme preparation is supplemented according to the experience value in proper amount, and then the dialysis treatment is continued.
In one embodiment, the separation of the enzyme preparation is achieved by a reaction filter 67, the reaction filter 67 includes a separation component to separate the reaction filter 67 into a first side and a second side, wherein two opposite ends of the first side of the reaction filter 67 are respectively communicated with the inlet and the outlet of the secondary circulation flow path L2-4, and the second side of the reaction filter 67 is communicated with the input end of the adsorption device. In some embodiments, reaction filter 67 may also be referred to as a separation module.
In the present embodiment, the secondary circulation pump 68 provided in the flow path box 13 drives the enzyme-carrying microspheres and the dialysis waste liquid mixed in the reaction pot 60/reaction pot 60 provided in the flow path box 13 to circulate in the secondary circulation flow path L2-4 at a preset flow rate, wherein the preset flow rate is related to at least one of a target substance, a fluid composition, a fluid temperature, a separation assembly structure, a separation assembly material, a metabolic filtration module cavity structure, a pipe diameter, and a fluid exchange efficiency.
In an embodiment, the inlet and outlet of the pipeline in the secondary circulation device are communicated with two ports corresponding to the metabolic filtration module, so that the pipeline and the metabolic filtration module can jointly form a circulating passage, and the secondary circulation pump 68 controls the flow rate of fluid in the pipeline, for example, by controlling the flow rate of the fluid introduced into the secondary circulation device to be equal to the flow rate of the fluid leaving the circulation based on the metabolic filtration module, the total amount of fluid in the pipeline can be dynamically balanced.
The metabolic filter module is connected with the fluid in the pipeline, so that the selective permeation of components in the fluid can be realized based on the metabolic filter module, and the components which can permeate through the metabolic filter module permeate through the separation assembly from one side to the other side, so that the separation effect can be realized. That is, the metabolic filtration module may be regarded as one treatment unit having a selective treatment function for a fluid to be treated (e.g., enzyme-carrying microspheres and dialysis waste liquid mixed in the present application). In some examples, the fluid may further include a catalytic unit, and correspondingly, the metabolic filtration module may be configured as a structure or material that is not permeable to the catalytic unit, so as to achieve the enzyme-carrying microsphere entrapment effect.
Here, the first side and the second side are used for distinguishing the position of the fluid component which can penetrate through the metabolic filter module and the position of the trapped fluid (the liquid containing the enzyme-carrying microspheres), and the position relationship between the first side and the second side is determined by the cavity structure of the metabolic filter module and the separation assembly structure. For example, when the separation component is in a planar structure and is transversely arranged in the metabolic filter module, the first side and the second side are respectively an upper side and a lower side, or when the separation component is in a planar structure and is vertically arranged in the metabolic filter module, the first side and the second side are respectively a left side and a right side.
It should be understood that in the embodiment provided by the application, the cavity in the metabolic filter module, which is communicated with the pipeline, is the first side, and the other cavities in the metabolic filter module are the second side, and in one example, when the metabolic filter module includes a plurality of cavities, for example, the metabolic filter module is divided into a plurality of cavities by a plurality of separation components in the form of plate films in the metabolic filter module, the cavities in the plurality of cavities, which are communicated with the pipeline, are the first side, and the other cavities are the second side.
In certain embodiments, the separation module is a structure or material that is selectively permeable to a portion of the components in the fluid, such as a filter, filtration membrane, microfiltration membrane, porous metal material. In an embodiment, the microfiltration membrane may be integrated in the cartridge body in communication with a secondary circulation pump 68 and a reaction kettle 60 in a secondary circulation flow path.
In certain embodiments, the separation module is a separation membrane, and selective removal of molecules or combinations of molecules from the fluid to be treated (e.g., the mixed enzyme-loaded microspheres and dialysis waste fluid of the present application) is achieved by selective permeation through the separation membrane, e.g., such that the enzyme-loaded microspheres are trapped in the circulation.
In certain embodiments, the separation module is a porous membrane, wherein the porous membrane comprises a microfiltration membrane, an ultrafiltration membrane, or a nanofiltration membrane. Here, the average pore size or molecular weight cut-off (molecular weight cutoff, abbreviated as MWCO) of the porous membrane or reverse osmosis membrane is related to the target substance. In a practical scenario, based on the fluid composition and the determined target substance, a porous membrane suitable for trapping the target substance is selected, for example, when the target substance to be trapped in the fluid is 10nm (i.e. 0.01 μm), then the corresponding separation membrane may employ a nanofiltration membrane or a reverse osmosis membrane to achieve trapping of the target substance. Here, the specific type of the separation membrane may be determined based on the difference in physicochemical properties of the respective components of the fluid and the target substance, and includes, for example, a reverse osmosis membrane (average pore size of 0.0001 to 0.001 μm), a nanofiltration membrane (average pore size of 0.001 to 0.01 μm), an ultrafiltration membrane (average pore size of 0.01 to 0.1 μm), a microfiltration membrane (average pore size of 0.1 to 10 μm), an electrodialysis membrane, an osmotic vaporization membrane, a liquid membrane, a gas separation membrane, an electrode membrane, and the like.
In certain embodiments, the separation membrane effects the entrapment, filtration, or exchange of the catalytic unit and components in the fluid by steric, daonan, or electrostatic effects, adsorption, diffusion, charge-rejection effects, pore effects, or dissolution.
In some embodiments, particularly in dialysis medical applications of the application, the separation membrane is a high purity polymer, is chemically inert, and has good blood and tissue compatibility.
When the target substance is a substance to be trapped by the metabolic filtration module (such as the enzyme-carrying microspheres described in the present application), the average pore size or the molecular weight of the porous membrane or the reverse osmosis membrane is related to the target substance, and in a practical scenario, a membrane suitable for trapping the target substance or for filtering the target substance is selected based on the fluid composition and the determined target substance, for example, when the target substance to be trapped in the fluid has a particle size of 10nm (i.e., 0.01 μm), the corresponding separation membrane may employ a nanofiltration membrane or a reverse osmosis membrane to achieve the trapping of the target substance.
In some practical application scenarios, the separation component of the metabolic filtration module can be used for determining the corresponding separation membrane pore diameter and type based on the fact that more than 90% of target substances are trapped, or the retention rate of the separation component on the target substances can be set to be more than 95%, even more than 99% based on higher separation effect requirements, so that the corresponding separation membrane pore diameter and type can be determined.
In some embodiments, the average pore size or molecular weight cut-off of the separation assembly is related to at least one of the catalytic unit, the target substance, and the target product.
In embodiments, the separation assembly may also be configured as a separation membrane of different geometries to accommodate different fluids or to achieve different filtration effects. In certain embodiments, the separation assembly comprises one or more of a planar membrane, a tubular membrane, a rolled membrane, a spiral membrane, and a hollow fiber membrane. The separation membrane may include, for example, a symmetric membrane, an asymmetric membrane, a composite membrane, a multilayer composite membrane, or the like in terms of microstructure.
It should be noted that the positional relationship between the first side and the second side of the corresponding metabolic filtration element may be different based on the different geometries of the separation element, for example, when the separation element is a planar membrane, the first side and the second side are opposite sides of a planar structure barrier, and when the separation element is a hollow fiber membrane, the first side is inside each fiber membrane wall, and the second side is outside each fiber membrane wall.
The angle of flow of the fluid relative to the separation membrane may be set at different angles, for example 0 deg. -90 deg., where when the angle of flow of the fluid relative to the separation membrane is 0 deg., i.e. the fluid flows parallel to the separation membrane surface, for example conventional tangential flow filtration, and when the angle of flow of the fluid relative to the separation membrane is 90 deg., i.e. the fluid flows in a direction perpendicular to the membrane surface, for example conventional dead-end filtration (also known as vertical filtration).
In some embodiments, the flow channels in the metabolic filter module may be configured in a folded round trip form, a spiral form or a flow channel size gradual change form, for example, by folding a planar membrane to increase the contact surface area between the fluid and the planar membrane, and correspondingly, the flow channels are configured in a folded round trip form to match the structural form of the separation membrane, so as to ensure that the separation membrane separates the metabolic filter module to form a first side and a second side.
In some embodiments, the secondary circulation pump 68 controls the flow of fluid in the cartridge body tubing at a predetermined flow rate to cause the catalytic unit to flow from one end of the tubing through the metabolic filtration element to the other end of the tubing, for example, when the metabolic filtration element is TFFM, the flow direction of the fluid is parallel to the separation membrane in TFFM, where a transmembrane pressure differential across the membrane is created across the separation membrane in TFFM to drive the small molecular weight components of the fluid through the separation membrane to the other side, whereby the small molecular weight components that permeate the separation membrane may exit circulation while the trapped catalytic unit or other predetermined trapped macromolecular components are flushed away from the membrane surface under the momentum of the fluid to continue circulation in the tubing. The pressure differential across the membrane in TFFM is related to the preset flow rate, while the continued circulation of the trapped material requires some momentum to overcome the polymerization inhibition between molecules or between molecules and membrane. The driving device controls the flow rate in the pipeline, namely can be used for controlling the pressure difference at two sides of the separation membrane to realize the interception and separation effects and can be used for preventing polymerization inhibition so as to ensure the sustainability of circulation in the pipeline.
The flow rate of the fluid at the metabolic filter module is related to different parameters, for example, based on different characteristics of the fluid, such as fluid density and viscosity, the boundary layer shape of the fluid at the metabolic filter module, such as the surface shape of a separation membrane (i.e. a membrane structure) and the cavity structure of the metabolic filter module, the interaction force between the fluid and the separation membrane, such as the membrane surface roughness determined by a membrane material, and the attractive force between the fluid, the flow rate relationship between the metabolic filter module cavity structure and the pipeline pipe diameter, and the flow rate between the metabolic filter module and the pipeline inlet, may be changed, wherein the preset flow rate is used for determining the flow rate of the fluid at the pipeline inlet flowing to the metabolic filter module, the preset threshold can be used as the initial flow rate at the metabolic filter module, based on the influence parameters of the initial flow rate and the flow rate at the metabolic filter module, the pressure difference for realizing separation can be determined based on controlling the preset flow rate of the fluid in the metabolic filter module, and the trapped macromolecular substances, such as a catalytic unit, are prevented from being blocked on the membrane surface, and thus the macromolecular substances can flow from flowing from the pipeline inlet to the metabolic filter module through the outlet.
In some embodiments, the predetermined flow rate is related to the target product exchange efficiency, for example, in TFFM, the target product needs to be driven to flow to the other side by a pressure difference across the separation membrane after reaching a certain flow rate, thereby leaving the cycle, the pressure difference is related to the flow rate, and when the flow rate is too low, the exchange efficiency of the target product transmembrane flow may decrease, and thus the predetermined flow rate may also be determined by the exchange efficiency.
In an embodiment, the metabolic filter module includes N sub-filter modules, where N is a positive integer greater than 2, and the N sub-filter modules are connected in series or/and parallel. In some embodiments, the N sub-filtration modules are connected in series according to a connection order, and average pore diameters or molecular cut-off amounts corresponding to the separation components of the N sub-filtration modules decrease sequentially.
In some embodiments, the metabolic filtration process is implemented by N cycles, where 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, where N is a positive integer greater than 2.
The N groups of treatment units can be different in treatment type, such as filtering treatment of the fluid to be treated in a first cycle, heating treatment of the fluid to be treated in a second cycle, and catalytic treatment of the fluid to be treated in a third cycle, according to the connection order of the cycles.
Or the N groups of processing units can be the same in type of processing, but respectively correspond to different target substances, for example, the N groups of processing units corresponding to the N cycles are all used for carrying out catalytic processing on the fluid to be processed, and are used for enabling the different target substances to be distributed in the N cycles and respectively contact with different catalytic units.
In certain embodiments, the fluid is introduced into N circulation modules for treatment, wherein the N circulation modules are connected in series or/and parallel, and N is a positive integer greater than or equal to 2 (N is greater than or equal to 2).
In one embodiment, the secondary circulation device has a drain (not shown) for removing enzyme-loaded microspheres from the secondary circulation device. The discharge port is communicated with a storage for storing the discharged enzyme-carrying microspheres. The enzyme-carrying microspheres are discharged from the discharge outlet by centrifugation or membrane filtration, for example by gravity slow filtration or centrifugation, from the secondary circulation device into a reservoir, for example a liquid bag made of medical plastics.
In one embodiment, the secondary circulation device is a re-usable secondary circulation device after sterilization. In this embodiment, the reusable circulation type metabolism module has a non-liquid contact type instant sterilization device, such as a non-contact type sterilization device of ultraviolet rays, gamma rays, etc., or a filtering membrane for bacteria filtration, typically a 0.22um or 0.45um filtering membrane.
In some embodiments, the secondary circulation flow path is a loop or loop system formed by a "metabolic circulation module" described in patent document WO2022036739A1 or/and patent document WO2022036738A1 or a loop in a circulation treatment system, and patent documents WO2022036739A1 and WO2022036738A1 are incorporated herein in their entirety.
In an embodiment, the reaction kettle 60 and the microfiltration membrane in the secondary circulation flow path composed of the reaction kettle 60, the secondary circulation pump 68 and the microfiltration membrane may also be integrated on the cartridge body.
In the present embodiment, in the first mounting surface 101, an ultrafiltration pump 51 for performing ultrafiltration work in the dialysate circuit is provided in the cartridge body. In the embodiment shown in FIG. 2, the waste liquid path L2-1 is connected to an ultrafiltration branch L2-2. In this embodiment, the ultrafiltration branch line L2-2 is provided with an ultrafiltration vessel 52 for storing ultrafiltrate, and an ultrafiltration pump 51 for feeding ultrafiltrate in the ultrafiltration vessel 52 to the waste liquid path L2-1. An ultrafiltration filter 50 may be provided between the ultrafiltration pump 51 and the waste liquid passage L2-1. In an example, as shown in fig. 11, the ultrafiltration container 52 is an external ultrafiltration bag 52, for example, a liquid bag made of medical plastic, and is connected with the pipeline in the portable case of the present application through the pipeline, and the ultrafiltration pump 51 is arranged in the case body and is connected with the external ultrafiltration container 52 through the pipeline connected with the fluid interface.
It should be understood that ultrafiltration is one of the membrane separation techniques that uses pressure as a driving force, and is generally used in the process of buffer replacement, impurity removal, sample separation, and the like. Ultrafiltration is the transport of a liquid through a semipermeable membrane under the action of a certain pressure gradient, called ultrafiltration. In clinical hemodialysis, ultrafiltration refers to the process of transporting moisture from the blood to the dialysate. The amount of liquid ultrafiltered from blood per unit time is called the ultrafiltration rate, in mL/h. Ultrafiltration is one of the important effects of hemodialysis, and through ultrafiltration, fluid retained in a patient in a dialysis interval can be effectively removed, so that the standard weight of the patient is maintained, and an ideal dialysis effect is achieved.
For example, in hemodialysis treatment mode (HD), i.e. standard normal treatment mode, because exchange between molecules is free exchange driven by concentration difference, exchange and toxin removal are achieved, and ultrafiltration branch L2-2 is arranged on waste liquid path L2-1, so that ultrafiltration dehydration can be carried out simultaneously with a certain amount (e.g. 3-4L) of transmembrane flow.
In an embodiment, in the application of the dialysate regeneration circulation system to the circulation of the blood purification device, the ultrafiltration pump 51 continuously pumps out the water in the waste liquid channel L2-1 to form a transmembrane negative pressure, at this time, the dialyzer ultrafilters the water to achieve pressure balance, and finally, the ultrafiltration pump 51 pumps out water, so that the blood loses water, and the purpose of helping the human body to remove the redundant water is achieved. In a practical embodiment, the ultrafiltration pump 51 continuously pumps the dialysis waste liquid in the waste liquid channel L2-1 into the waste liquid bag, and by accurately measuring the flow of the ultrafiltration pump 51, the redundant water in the patient can be accurately pumped out of the body, thereby achieving the purpose of dehydration.
In another embodiment, the ultrafiltration branch L2-2 can also be arranged on the regeneration liquid pipeline L2-7 through the connection of the pipelines, i.e. the ultrafiltration branch L2-2 comprises a first ultrafiltration branch and a second ultrafiltration branch, wherein the first ultrafiltration branch is arranged on the waste liquid channel, the second ultrafiltration branch is arranged on the regeneration liquid pipeline L2-7, in this embodiment, the weighing type ultrafiltration control is adopted, i.e. the double-pump control adopting an upstream pump and a downstream pump is adopted, wherein the upstream pump is arranged on the first ultrafiltration branch, the downstream pump is arranged on the second ultrafiltration branch in the regeneration liquid pipeline L2-7, the container communicated with the second ultrafiltration branch is processed dialysis regeneration liquid, a weighing device is arranged below the ultrafiltration bag, the weighing device can obtain the content of the regeneration liquid in the ultrafiltration bag through weighing, the rotation speed of the upstream pump and the downstream pump is controlled, for example, the rotation speed of the water in the ultrafiltration bag exceeds a preset value (ultrafiltration curve), the rotation speed of the upstream pump is reduced, the rotation speed of the upstream pump is simultaneously increased, and if the rotation speed of the upstream pump exceeds the preset value, the rotation speed of the downstream pump is increased, and conversely, the rotation speed of the upstream pump is adjusted to be lower than the preset value, if the rotation speed is increased.
In the embodiment shown in fig. 2, a leakage sensor 41 is provided in the waste liquid path L2-1. In an embodiment in which the dialysate regeneration circulation system is applied to a blood purification apparatus, the leakage sensor 41 is, for example, a blood leakage sensor that detects leakage of blood, and in an embodiment in which the dialysate regeneration circulation system is applied to a peritoneal dialysis apparatus, the leakage sensor 41 is, for example, a peritoneal fluid leakage sensor.
In the embodiment shown in fig. 2, a pressure sensor 43 for detecting the pressure of the waste dialysate is provided in the waste liquid path L2-1. A hydrophobic filter 42 is provided between the waste liquid path L2-1 and the pressure sensor 43, and the permeability of the hydrophobic filter 42 allows the pressure sensor 43 to detect the waste liquid pressure in the waste liquid path L2-1.
In the embodiment shown in fig. 2, a pre-fluid bypass L2-3 is provided in the waste fluid path L2-1 for priming, purging, or flushing the circulation path of the dialysate regeneration circulation system. In this embodiment, the waste liquid path L2-1 is provided with a shorting valve 44 connected in parallel with the pre-formed liquid bypass L2-3. The shorting valve 44 may be integrated into the cartridge body.
In an embodiment, the pre-made liquid bypass L2-3 is a circulation loop of the dialysate regeneration circulation system, and the pre-filling and the draining can be implemented by connecting to a liquid storage container (for example, a pre-made liquid bag 45, for example, a liquid bag made of medical plastic) in the circulation loop and matching with a working mode of a driving device, or a normal or inverted state of the liquid storage container, that is, in a pre-filling mode, an outlet of liquid in the liquid storage container is in a low position, and in a draining mode, an outlet of gas in the liquid storage container is in a high position.
In this embodiment, the priming and purging system includes a reservoir (i.e., the priming bag 45 shown in FIG. 2), a circulation circuit (i.e., the circulation circuit consisting of the waste liquid path L2-1 and the regeneration liquid line L2-7 in FIG. 2), and a driving device (i.e., the dialysate pump 46 of FIG. 2). The liquid storage container is used for storing priming liquid and recycling emptied waste liquid, and comprises a container body, and a first interface b1 and a second interface b2 which are arranged on the container body and used as liquid or/and gas inlets and outlets, wherein the first interface b1 or the second interface b2 is/are the inlet and outlet of fluid in the container body. In the present application, the "priming solution" refers to a liquid that is used for priming of the blood purification control device, and in some embodiments, the priming solution is physiological saline, physiological buffer, or enzyme-loaded microsphere solution. In certain embodiments, the priming solution may also be referred to as a priming solution. In one example, the preformed fluid is a preformed sterile pyrogen-free solution. The preformed fluid bag 45 contains 3L-5L of a preformed sterile pyrogen-free solution, for example, containing at least one of sodium chloride, sodium bicarbonate, and sodium carbonate. For example, 3L-5L of the pre-mix contains 0.6% -0.9% sodium chloride and 20-80mM sodium bicarbonate or sodium carbonate.
In the embodiment shown in fig. 20, the liquid storage container 45 may be switched between the upright state and the inverted state, i.e., the state in which the liquid storage container is upright and the state in which the liquid storage container is inverted, and further includes a mechanism for arranging or inverting the liquid storage container more simply, in an embodiment, a plate or a frame for arranging the liquid storage container is provided on which a structure for fixing the liquid storage container and a positioning structure for positioning the upright state and the inverted state are provided so that the upright state of the liquid storage container can be stabilized when the liquid storage container is upright or the inverted state thereof can be stabilized when the liquid storage container is inverted.
In this embodiment, the system for pre-filling and emptying the liquid storage container has two working modes, 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-filling liquid in the liquid storage container preferentially enters the pipeline in the circulation loop from the second interface b2, and 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 b 1. In the present application, the switching between the priming mode and the emptying mode may be achieved by adjusting the flow direction of the fluid and/or switching the reservoir to be placed in the normal or inverted position.
In other embodiments, the pre-fluid bypass may also be used in a blood circuit, such as shown in fig. 20, referring to fig. 20, which shows a schematic fluid flow diagram of the blood circuit according to the present application in a flushing embodiment, as shown in the drawing, a bypass including a reservoir 45 is disposed on the arterial blood line L1, and is composed of a valve 451 in communication with a pipeline, a second port b2 of the reservoir 45, a first port b1, and a valve 452, and in the flushing embodiment, the arterial end of the arterial blood line L1 is in communication with the venous end 86 of the venous blood line L3, and the fluid in the blood circuit (pre-fluid in the reservoir) flows reversely, and the gas in the dialysis device floats to the top of the dialysis device on the dialysis channel L2, flows along the arterial blood line L1 and the venous blood line L3 sequentially, and is enriched in the air collecting chamber 80, and the liquid entering the air collecting chamber 80 flows from the first port 801 of the air collecting chamber 80 to the bottom of the dialysis device on the dialysis channel L2. Since in the flushing mode the gas in the blood circuit is enriched in the gas collecting chamber 80, during the treatment phase, i.e. when the fluid in the blood circuit is driven in the forward direction, the gas originally enriched in the gas collecting chamber 80 is preferentially introduced into the venous bottle 81 along the venous blood line L3 and is then discharged via the exhaust line L4 of the venous bottle 81. In the embodiment illustrated in fig. 2, a pressure sensor 83 for detecting the pressure in the venous tank 81 and a discharge valve 82 for discharging the pressure in the venous tank 81 are provided in the discharge pipe L4.
In one embodiment, an arterial kettle 24 is also connected to the line between the dialysis port L2 and the arterial end of the arterial blood line L1 for observing the instillation in the treatment mode, the arterial kettle 24 having a generally inverted trapezoidal or tapered cross-section.
In one embodiment, as shown in fig. 10, the second mounting surface 102 is located in the lower case 11 and is in a horizontal state in a state in which the portable case is opened. A control or monitoring drive device for controlling or monitoring the flow of fluid through the conduit is secured to the second mounting surface 102. Wherein the plurality of control or monitoring devices mounted to the second mounting surface 102 include a blood pump 23 disposed in the blood circuit, a photosensor 87 for detecting whether a venous end 86 in the blood circuit is in blood circulation, a venous clip or valve 84 for controlling blood circulation of the venous end 86 in the blood circuit, and a pressure sensor 85 for arterial end fluid pressure.
In an embodiment, the second mounting surface 102 is an integral part of the lower case 11, for example, the second mounting surface 102 may be an inner side surface of the lower case 11, for example, a planar portion including an inner wall of the lower case 11 and a portion including a peripheral arc surface or curved surface, and the plurality of driving devices are directly fixed on the inner side of the lower case 11. In another embodiment, the second mounting surface 102 is a separate component, such as a plate having a flat surface, and is detachably fixed in the lower case 11. In this embodiment, the plate is fixed in the lower case 11 by, for example, screws or engagement, and the driving device is fixed to the plate.
In the embodiment shown in fig. 10, the second mounting surface 102 is provided with 1 drive means, which is a blood pump connected in the blood circuit, and correspondingly the dialysate pump 46 and the secondary circulation pump 68 in the dialysate circuit can be integrated in the cartridge body. In a specific implementation, as shown in fig. 10, the blood pump is disposed on the second mounting surface 102 in a manner of penetrating the second mounting surface 102, that is, in order to facilitate the user to observe the working state of the driving devices, a part of the blood pump penetrates through the second mounting surface 102 and leaks out, so as to connect the blood circuit or the catheter of the dialysis circuit, and also facilitate the user to intuitively observe the working state of the driving devices, where another part of the blood pump is located on the back of the second mounting surface 102, such as a motor tail part of each driving pump. Although the present application is described with the blood pump disposed on the second mounting surface 102 and the dialysate pump 46 and/or the secondary circulation pump 68 integrated on the cartridge body, in other embodiments the dialysate pump 46 and/or the secondary circulation pump 68 may be mounted on the second mounting surface 102.
In one embodiment, the second mounting surface 102 is provided with an arterial end pressure sensor 85 for detecting arterial end pressure in the blood circuit.
In an embodiment, the back surface of the second mounting surface 102 is provided with a power supply device for providing electric power for the portable dialysis device, such as a power switch 113, a battery (not shown) and a power management module (not shown) disposed on the back surface of the second mounting surface. In one example, the power supply devices are located at right and left portions of the back surface of the second mounting surface 102. As shown in fig. 10, a power switch 113 of the power supply device is provided on the second mounting surface 102.
The back surface of the second mounting surface 102 is further provided with a control device (which is arranged on the back surface of the second mounting surface and is displayed) for controlling the working mode of the portable dialysis device, and in this embodiment, the control device is, for example, a main control board of the portable dialysis device. The main control board comprises a controller or a system processor of the hemodialysis equipment, and outputs corresponding control instructions by writing a program in the system processor, or receives trigger instructions input by an operator through an input device such as a touch screen, and outputs related control instructions after calculation, and the control instructions are used for executing related operations such as dialysis treatment, pre-charging, emptying, flushing, dialysis waste liquid circulating filtration and the like.
To facilitate the user to perform related operations on the portable dialysis device, in one embodiment, a touch screen 112 is provided in the upper case 10 or the lower case 11, which can be extended or retracted with respect to the inner space. In one embodiment, the touch screen 112 is disposed in the lower case 11 by a foldable stand. Specifically, the foldable stand includes a connection portion and a folding arm, the connection portion is fixed on the second mounting surface 102 of the lower case 11, a proximal end of the folding arm is connected to the connection portion and can rotate relative to the connection portion to complete folding or unfolding actions, and the touch screen is fixed at a distal end of the folding arm, and is used for pulling out a display screen when a user opens the case so as to enable the user to input an operation instruction or observe an output interface of the dialysis device in related operations such as executing dialysis treatment, pre-filling, emptying, flushing, dialysis waste liquid circulation filtration and the like.
In another embodiment, the touch screen may also be placed in a preset clamping groove on the second mounting surface 102 in the lower case 11, so that when the user opens the case, the display screen is taken out from the clamping groove to input an operation instruction or observe an output interface of the dialysis device in related operations such as performing dialysis treatment, priming, emptying, flushing, and circulating and filtering dialysis waste liquid.
In one embodiment, a pneumatic system is provided in the lower housing 11 that communicates with the second pneumatic interface 103 to operate pumps and/or valves in the cartridge body to cause fluid to flow in either the forward or reverse direction in the fluid channel 1313. In an example, please refer to fig. 21, which is a schematic diagram of a pneumatic system according to an embodiment of the present application, wherein the pneumatic system includes an air pump, a positive pressure chamber, a negative pressure chamber, and a plurality of three-way valves. The air pump comprises a negative pressure cavity, an air pump, a positive pressure cavity, a three-way valve V4, a three-way valve V5 and a valve body, wherein the air inlet of the air pump is used for exhausting air from the negative pressure cavity, the air outlet of the air pump is used for exhausting air to the positive pressure cavity, the three-way valve V4 is arranged in front of the negative pressure cavity and used for adjusting the pressure of the negative pressure cavity to a set value, and the three-way valve V5 is arranged behind the positive pressure cavity and used for adjusting the pressure of the positive pressure cavity to the set value. The three-way valves V8-V12 are respectively connected to each of the second pneumatic interfaces 103, and it should be noted that, in the figure, five three-way valves V8-V12 are only used for illustration, and 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 the three-way valve V4 from the three-way valve V5, in the following embodiments, the three-way valve V5 connected to the positive pressure chamber is referred to as a second three-way valve, and the three-way valve V4 connected to the negative pressure chamber is referred to as a first three-way valve. In another embodiment, the first three-way valve may also be located after the negative pressure chamber and the second three-way valve may also be located before the positive pressure chamber.
The air pressure sensor G6 and the air pressure sensor G7 in fig. 21 are used to measure the pressures of the positive pressure chamber S2 and the negative pressure chamber S3, respectively. If the positive pressure in the positive pressure cavity S2 exceeds the set value, the three-way valve V5 is connected with the atmosphere to release the pressure of the positive pressure cavity S2. The three-way valve V5 may be disposed between the air pump P1 and the positive pressure chamber S2, and if the positive pressure in the positive pressure chamber S2 exceeds a set value, the three-way valve V5 is connected to the atmosphere, and the air pump P1 exhausts to the atmosphere. If the negative pressure in the negative pressure cavity S3 is lower than the set value, the three-way valve V4 is connected with the atmosphere, and the air pump P1 directly extracts air from the external atmosphere. The three-way valve V4 may also be placed before the negative pressure chamber S3, and 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 pressurize the negative pressure chamber S3.
It should be noted that, the three-way valve V4 and the three-way valve V5 in the pneumatic system may be replaced by two-way valves, so as to implement the functions of the three-way valve V4 and the three-way valve V5, respectively. For example, referring to fig. 22, a schematic diagram of a pneumatic system according to another embodiment of the present application is shown, in which a two-way valve V24 is located between the air pump P1 and the negative pressure chamber S3, and a two-way valve V25 is located between the air pump P1 and the positive pressure chamber S2. In order to distinguish the two-way valve V24 from the two-way valve V25, in the following embodiments, the two-way valve V25 connected to the positive pressure chamber is referred to as a second two-way valve, and the two-way valve V24 connected to the negative pressure chamber is referred to as a first two-way valve. In another embodiment, the first two-way valve may also be located after the negative pressure chamber and the second two-way valve may also be located after the positive pressure chamber.
In one embodiment, the portable dialysis device of the present application is used by a user opening the portable housing and communicating the plurality of first pneumatic interfaces 1322 in the flow cassette 13 with the plurality of second pneumatic interfaces 103 on the first mounting surface 101. The external line connected to the fluid port of the flow path box 13 is connected to a device such as a vein, an artery, a preformed fluid bag 45, a replenishing fluid bag, an adsorption device, an ultrafiltration container 52, and/or a blood pump. The portable dialysis device then controls the operation of the various pumps and valves in the flow cassette 13, for example by a pneumatic system, to control the flow of fluid in the fluid channel 1313, either in the forward or reverse direction, by pneumatic pressure. In turn, controls the flow of blood and dialysate in the flow path box 13 and the external piping, and monitors the state of the blood and dialysate using various sensors.
Specifically, referring to fig. 9 to 13b, the blood pump on the second mounting surface controls blood of an artery of the human body to flow into the flow path box 13 through the arterial line, to enter the dialyzer 30 through a part of the arterial blood line L1/a part of the flow path in the flow path box 13, to flow into the flow path box 13 after being purified by the dialyzer 30, and to flow into the venous line through a part of the flow path/a part of the venous blood line L3 in the flow path box 13. Further, the flow channel box 13 is further integrated with a dialysate regeneration flow path L2, a reaction kettle 60, a secondary circulation pump 68 and a microfiltration membrane are arranged in the dialysate regeneration flow path L2, one end of the dialyzer 30 is communicated with the dialysate input end, the other end of the dialyzer 30 is communicated with the dialysate output end, the dialysate in the dialyzer 30 enters the flow channel box 13 through a pipeline communicated with the flow channel box 13, and the pneumatic system controls the valve and the pump in the flow channel box 13 to operate so that the dialysate is subjected to secondary circulation in the dialysate regeneration flow path L2 for toxin treatment. Further, an adsorption column communicating with the cartridge body performs a secondary toxin treatment on the waste liquid before the toxin treatment and/or the waste liquid after the toxin treatment to generate a regeneration liquid, the regeneration liquid flows into a flow passage of the cartridge body through an external pipe, and the regeneration liquid is inputted into the dialyzer 30 through a part of the flow passage/the regeneration liquid pipe. In one embodiment, the pneumatic system controls the forward or reverse flow of the pre-fluid in the flow channels of the flow channel cassette 13 to effect flushing of the flow channels in the cassette body prior to performing dialysis. In one embodiment, a replenishment solution and an enzyme preparation are also injected into a portion of the flow path of the cartridge body during dialysis.
Although the above description has been made with respect to the flow path box 13 by taking the portable dialysis apparatus as an example of the hemodialysis apparatus, the flow path box 13 with integrated pump and valve may be provided in the peritoneal dialysis apparatus in other embodiments.
In summary, the portable dialysis device provided by the present application is configured such that core devices such as a dialyzer 30, a pump device, a valve device, a pipeline, and a sensor are disposed in a portable case in a reasonable layout manner during a dialysis operation, and a plurality of fluid channels 1313 for controlling fluid to flow forward or backward by air pressure are disposed in the case body of the flow channel case 13 (for example, a blood circuit, a part of pipelines in a dialysate circuit, a pump, and a valve are integrated in the flow channel case 13), and a plurality of independent first pneumatic interfaces 1322 for respectively interfacing with a plurality of second pneumatic interfaces 103 of the dialysis device are disposed on the case body of the flow channel case 13, so that after the user interfaces the flow channel case 13 with the second pneumatic interfaces 103, the pneumatic system in the dialysis device can control the fluid in the fluid channels 1313 to flow forward or backward by air pressure, thereby greatly reducing the complexity of operation and the operation threshold, and the integrated dialysis device is smaller, in particular beneficial to, emergency, rescue, and treatment for a user.
In the case that the above-mentioned flow channel box shown in fig. 8 to 13b is omitted, in the following embodiments, the portable dialysis device of the present application greatly reduces the operation threshold and the device volume by arranging core components such as a dialyzer, a pump device, a pipeline, a sensor, etc. in a portable case in a reasonable arrangement manner, and by designing a blood circuit and a dialysate circuit, the dialysis operation can be completed based on various modularized functions provided by the portable case, and the portable dialysis device is unfolded when in use and closed when in transportation or not in use, thereby being particularly beneficial to hemodialysis treatment in scenes such as emergency, travel, rescue, and home.
Referring to fig. 23 to 26, fig. 23 is a schematic view showing the configuration of a portable dialysis apparatus according to another embodiment of the present application, and fig. 24 is a schematic view showing the layout of components on the first and second mounting surfaces of the portable dialysis apparatus shown in fig. 23. Fig. 25 is a schematic rear view of the first mounting surface of the portable dialysis device of fig. 23. Fig. 26 is a schematic rear view of the second mounting surface of the portable dialysis device of fig. 23. As shown, the portable dialysis device includes a portable housing comprising an upper housing 10 and a lower housing 11, a first mounting surface 101, associated tubing, and a second mounting surface 111.
As shown in fig. 24, the first mounting surface 101 is a separate member, such as a plate having a flat surface, and is detachably fixed in the upper case. In this embodiment, the plate body is fixed in the upper case body by, for example, screws or engagement, so that the first mounting surface 101 is in an upright state along with the upper case body 10 in a state in which the upper case body is opened/closed, and a plurality of fluid containers (including the dialyzer 30, the gas collection chamber 80, the venous pot 81, the reaction pot 60, etc.) mounted on the first mounting surface 101 are also in an upright state or a vertical state, and the plurality of fluid containers are fixed to the plate body. In one embodiment, the plurality of fluid containers are removably mounted to the first mounting surface 101. It should be understood that the removable means is to attach the plurality of fluid containers to the first mounting surface 101 or detach the plurality of fluid containers from the first mounting surface 101 by, for example, engaging the bracket 102, screwing, etc., without damaging the first mounting surface or the securing structure or the fluid containers. In the present embodiment, the plurality of fluid containers mounted on the first mounting surface 101 include an arterial pitcher, a venous pitcher 81, a dialyzer 30, or a pooling container 60 (reaction pitcher 60) in communication with a dialysate circuit, and/or a metabolic filter 67, etc. in communication with the blood circuit.
As shown in fig. 24, a dialyzer 30 is mounted on the left side of the first mounting surface, and the dialyzer 30 is vertically fixed to the first mounting surface 101 by engagement with a dialyzer 30 support structure 102, and blood enters the dialyzer 30 from the upper end of the dialyzer 30 and is output from the lower end of the dialyzer 30.
As shown in fig. 25, in this embodiment, an ammonia sensor 73 for detecting the ammonia content in the dialysate circuit is mounted on the back surface of the first mounting surface 101. The back side of the first mounting surface 101 is vertically provided with a conductivity sensor 76 for detecting fluid in the dialysate circuit.
In this embodiment, an air pump 65 for controlling the level or pressure of the reservoir 60 on the dialysate circuit is mounted on the back of the first mounting surface. The air pump 65 is connected to the air branch L2-5 for controlling the amount of liquid in the collecting container by exhausting or intake air. In this embodiment, the degassing pump 65 is connected to a gas inlet and outlet. An exhaust valve or a runner switching device is arranged on the exhaust branch L2-5 and is used for communicating or closing the circulating gas on the exhaust branch L2-5, and the exhaust valve is a three-way valve or a four-way valve. The gas branch L2-5 is provided with a hydrophobic filter. The exhaust branch L2-5 is provided with a pressure sensor for detecting the pressure in the chamber of the collecting vessel, which pressure sensor may reflect metabolic cycles and/or downstream fluid pressure conditions.
In this embodiment, the back surface of the first mounting surface 101 is provided with a plurality of valves (not numbered) for controlling the fluid flow in the pipeline, and a valve member for controlling the fluid flow in the blood circuit or the dialysate circuit or the liquid level in the fluid container, for example, a three-way valve or a four-way valve.
In this embodiment, a control device, such as a control board or a connection port circuit board, for controlling electronic devices, such as a sensor and a pump, located on the first mounting surface 101 is mounted on the back surface of the first mounting surface 101.
In this embodiment, a portion of the dialysate circuit disposed on the first mounting surface 101 has an interface for communicating with an external fluid container. The external liquid container comprises an ultrafiltration container, a replenishing liquid container, a prefabricated liquid container and/or an adsorption device.
In this embodiment, the ultrafiltration pump 51 and the replenishment pump 74 are disposed on the first mounting surface 101 in such a manner as to penetrate the first mounting surface 101, that is, in order to facilitate the user in observing the operation states of the ultrafiltration pump 51 and the replenishment pump 74, a portion of the ultrafiltration pump 51 and the replenishment pump 74 passes through the first mounting surface 101 and leaks out so as to connect the conduit of the ultrafiltration branch or the conduit of the replenishment liquid, while also facilitating the user in intuitively observing the operation states of these driving devices, and another portion of the ultrafiltration pump 51 and the replenishment pump 74 is located on the back surface of the first mounting surface 101, such as the motor tail portion or the like of each of the driving pumps.
As shown in fig. 24 and 26, the second mounting surface 111 is positioned in the lower casing and is in a horizontal state in a state in which the portable casing is opened, and a plurality of driving devices for driving fluid to circulate in the pipeline are fixed to the second mounting surface 111.
In this embodiment, the second mounting surface 111 is a separate component, such as a plate having a flat surface, and is detachably fixed in the lower case 11. In this embodiment, the plate is fixed in the lower case 11 by, for example, screws or engagement, and the plurality of driving devices are fixed to the plate. Specifically, 3 driving devices including the blood pump 23 connected in the blood circuit, the dialysate pump 46 and the metabolic circulation pump 68 provided in the dialysate circuit are provided on the second mounting surface 111. As shown in fig. 24, the blood pump 23 mounted on the second mounting surface 111 is positioned on the leftmost side, the metabolic circulation pump 68 mounted on the second mounting surface 111 is positioned on the rightmost side, and the dialysate pump 46 is positioned between the blood pump 23 and the metabolic circulation pump 68. In a specific implementation, the blood pump 34, the dialysate pump 46, and the metabolic circulation pump 68 are disposed on the second mounting surface 111 in a manner penetrating the second mounting surface 111, that is, in order to facilitate the user in observing the operating states of the driving devices, a portion of the blood pump 23, the dialysate pump 46, and the metabolic circulation pump 68 penetrates the second mounting surface 111 and leaks out, so as to connect the blood circuit or the conduit of the dialysis circuit, while also facilitating the user in visually observing the operating states of the driving devices, and another portion of the blood pump 23, the dialysate pump 46, and the metabolic circulation pump 68 is located on the back of the second mounting surface 111, such as a motor tail portion of each of the driving pumps.
In this embodiment, a photoelectric sensor for detecting whether the blood circulates in the venous side of the blood circuit is mounted on the second mounting surface 111. The second mounting surface 111 is provided with a venous clip or valve element for controlling blood flow from a venous side of the blood circuit.
As shown in the drawing, in the present embodiment, a power supply device (not numbered) for supplying electric power to the portable dialysis device, such as a battery and a power management module, is mounted on the rear surface of the second mounting surface 111, and in the embodiment shown in fig. 6, the power supply device is located on the right side portion and the left side portion of the rear surface of the second mounting surface 111.
In the embodiment shown in fig. 6, the heating device 47 is also provided on the second mounting surface 111 in such a manner as to penetrate the second mounting surface 111, and a portion of the heating device 47 is located on the rear surface of the second mounting surface 111. The back of the second mounting surface 111 is further provided with a control device 90 for controlling the working mode of the portable dialysis device, and in this embodiment, the control device 90 is, for example, a main control board of the portable dialysis device. The main control board comprises a controller or a system processor of the hemodialysis equipment, and outputs corresponding control instructions by writing a program in the system processor, or receives trigger instructions input by an operator through an input device such as a touch screen 112 to execute calculation and then output related control instructions for executing related operations such as dialysis treatment, pre-filling, emptying, flushing, dialysis waste liquid circulating and filtering and the like.
The above embodiments are merely illustrative of the principles of the present application and its effectiveness, and are not intended to limit the application. Modifications and variations may be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the application. Accordingly, it is intended that all equivalent modifications and variations of the application be covered by the claims, which are within the ordinary skill of the art, be within the spirit and scope of the present disclosure.