Purification circuit, method of flushing purification circuit, and dialysis apparatus
Patent Information
- Application Number
- CN202380044381.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-07-20
- Filing Date
- 2023-07-06
- Publication Date
- 2025-01-24
AI Technical Summary
Existing hemodialysis systems are too large and cumbersome, complicated to operate, require cumbersome water treatment and power supply, and require complex modifications and professional training for home use, which limits the development of home hemodialysis.
A purification loop system was designed, including pipelines, a drive device, and a gas collection chamber. By using reverse flow and the gas collection chamber, pre-charging and purging operations are realized, simplifying the operation process of the equipment. Furthermore, the pre-charging and purging modes are simplified by switching between the upright and inverted states of the liquid storage container.
It simplifies the operation process of hemodialysis equipment, reduces the learning cost, minimizes the need for home environment modifications, and improves the ease of use and safety of the equipment.
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Figure CN119365224A_ABST
Abstract
Description
Purification circuit, method for flushing purification circuit, and dialysis device Technical Field
[0001] The present application relates to the field of medical device technology, and in particular to a purification circuit, a method for flushing a purification circuit, a system for pre-filling and emptying a purification circuit, and a dialysis device. Background Art
[0002] Blood purification refers to the process of removing blood from the body, removing toxins through various physical and chemical methods, and then returning it to the body. Hemodialysis involves drawing blood from the body, passing it through the permeable membranes and hollow fiber membranes of a hemodialysis machine, removing metabolic waste, impurities, and excess water, and then returning the purified blood to the body. Currently, the number of end-stage renal disease (ESRD) patients receiving hemodialysis treatment worldwide exceeds 3.6 million, and the number continues to increase annually.
[0003] Currently, the vast majority of patients worldwide need to visit dialysis centers for treatment three times a week, each visit lasting approximately four hours. Patients are often exhausted from the travel and treatment, and this daily treatment has led to unemployment rates exceeding 80%. During the COVID-19 outbreak, this necessary outing actually increased the risk of infection. In the United States, more than 15,000 ESRD patients died from COVID-19 in 2020. Home hemodialysis (HHD) allows patients to enjoy treatment in both space and time, allowing them to flexibly arrange their daily routines, including normal work, caring for family members, or socializing. Consequently, home hemodialysis (HHD) is gaining increasing attention in the industry. For example, the US Centers for Disease Control and Prevention (CMS) has specifically encouraged and subsidized HHD through the ESRD Treatment Choices (ETC) Model.
[0004] However, current hemodialysis systems are generally unsuitable for home use. One reason for this is that dialysis equipment is too large and heavy, typically weighing up to 60-80 kg, and requires an additional water treatment system. The dialysis machines currently widely used in dialysis centers are single-pass dialysis machines, which consume an average of 500 liters of tap water or 120 liters of purified water per treatment. The dialysis equipment also requires a significant amount of heat to heat 120 liters of cold water, resulting in significant energy consumption. Current equipment requires extensive modifications to a home's plumbing and electrical systems to meet the requirements of dialysis equipment. Single-pass dialysis machines require complex flow balancing technology to ensure accurate dehydration and ultrafiltration, resulting in extremely high manufacturing costs and high prices. Patients must purchase a separate, expensive dialysis machine and water treatment system. Even if some families adopt HHD treatment, the operation of these machines still follows the same tedious and complex procedures as those in dialysis centers. Patients or their families require approximately 100 hours of training, equivalent to nurse training, which greatly increases the difficulty for ordinary people to master the relevant procedures. Of course, this also greatly limits the development of HHD.
[0005] Summary of the Invention
[0006] In view of the shortcomings of the above-mentioned related technologies, the purpose of this application is to provide a purification circuit, a method for flushing a purification circuit, a system for pre-filling and emptying a purification circuit, and a dialysis device to solve the problems of complex operation of the equipment in the prior art.
[0007] To achieve the above-mentioned objectives and other related objectives, the first aspect of the present application provides a purification circuit, comprising a pipeline, a driving device arranged on the pipeline, and an air collecting chamber connected to the pipeline, wherein the air collecting chamber includes a reverse air collecting chamber for enriching the gas in the purification circuit when the fluid in the purification circuit flows in reverse.
[0008] The second aspect of the present application discloses a method for flushing a purification circuit, wherein the purification circuit includes a first circuit for accessing a human arterial blood vessel, a driving device arranged on the first circuit, a dialysis device connected to the first circuit, and a second circuit connected to the dialysis device; the method includes the following steps: setting an air collecting chamber on the second circuit, and connecting the arterial end of the first circuit to the venous end of the second circuit; and allowing the pre-filled liquid applied to the purification circuit to flow from the second circuit to the first circuit, so that the gas pre-stored in the dialysis device and / or the first circuit is enriched in the air collecting chamber.
[0009] The third aspect of the present application discloses a dialysis device, comprising: a purification circuit, comprising a first circuit, a dialysis passage connected to the first circuit, and a second circuit connected to the dialysis passage; wherein, an air collecting chamber is provided on the second circuit; the air collecting chamber is used to enrich the gas in the purification circuit when the fluid in the purification circuit flows from the second circuit to the first circuit; a driving device, provided on the first circuit, for driving the fluid to flow forward or reversely in the purification circuit; a dialysis device, provided on the dialysis passage, for purifying the fluid flowing in the purification circuit, and forming a fluid flow path for the flow of patient fluid and a dialysate flow path for the flow of dialysate through a built-in purification membrane for purifying the fluid; a control device, for executing a flushing mode to flush the purification circuit and enrich the gas in the purification circuit in the air collecting chamber; or for purifying the fluid flowing in the purification circuit and inputting it into the human body after executing a treatment mode.
[0010] The fourth aspect of the present application discloses a system for pre-filling and emptying a purification circuit, comprising: a liquid storage container for storing pre-filled liquid and recovering emptied waste liquid, comprising a container body, and a first interface and a second interface provided on the container body for serving as liquid and / or gas inlets and outlets; 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; a circulation circuit, one end of which is connected to the first interface and the other end is connected to the second interface; a driving device, provided on the circulation circuit between the first interface and the second interface, for driving the fluid to flow forward or reverse in the circulation circuit.
[0011] The fifth aspect of the present application discloses a dialysis device, a liquid storage container for storing pre-filled liquid and recovering emptied waste liquid, comprising a container body, and a first interface and a second interface provided on the container body for serving as liquid and / or gas inlet and outlet; 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; a circulation loop comprises a first circuit and a second circuit connected to the first circuit, in the pre-filling mode or the emptying mode of the circulation loop, the input end of the first circuit is connected to the output end of the second circuit, the first interface is connected to the first section in the circulation loop, and the first interface is connected to the second section in the circulation loop; in the treatment mode, the The input end of the first circuit is connected to the first part of the human body, and the output end of the second circuit is connected to the second part; the driving device is provided on the first circuit and is located between the second section and the first section of the circulation loop, and is used to drive the fluid to flow in the circulation loop; the dialysis device is used to purify the fluid flowing in the circulation loop and form a fluid flow path for the flow of patient fluid and a dialysate flow path for the flow of dialysate through a built-in purification membrane for fluid purification; the control device is used to execute a pre-filling mode to pre-fill the circulation loop, to execute a treatment mode to purify the fluid flowing in the circulation loop and then input it into the human body, or to execute an emptying mode to recover the waste liquid in the circulation loop by discharging it into the liquid storage container.
[0012] In summary, the purification circuit, the method for flushing the purification circuit, and the dialysis equipment proposed in the present application adopt the purification circuit of the present application that adds an air collecting chamber on the second line, so that during the flushing operation, the dialysis device can be flushed and exhausted even without turning the dialysis device upside down. The present application reversely drives the fluid in the pipeline and adds an air collecting chamber downstream of the dialyzer device. When the liquid flows from the venous end through the venous pot to the air collecting chamber and flows to the bottom of the dialysis device, the air collecting chamber can be enriched with a certain amount of gas. Since the gas in the air collecting chamber will preferentially flow out from its top, the gas in the air collecting chamber can be discharged in a timely manner in the treatment mode.
[0013] In addition, the system of pre-filling and emptying purification circuit proposed in the present application can realize the two operations of pre-filling and emptying by connecting to a liquid storage container in the circulation loop and cooperating with the working mode of the driving device, or the upright or inverted state of the liquid storage container, that is, in the pre-filling mode, the outlet of the liquid in the liquid storage container is at a low position; and in the emptying mode, the outlet of the gas in the liquid storage container is at a high position; compared with the conventional operation in the prior art, the system structure of the present application is simple, the operation is convenient, and the learning cost is low. The operator does not need to repeatedly invert the dialyzer for continuous circulation pre-filling. Moreover, the application of the system of the present application enables more scientific treatment of medical waste such as pipelines and waste liquids after emptying. BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The specific features of the invention involved in this application are shown in the appended claims. The features and advantages of the invention involved in this application can be better understood by referring to the exemplary embodiments described in detail below and the accompanying drawings. A brief description of the drawings is as follows:
[0015] FIG1 is a schematic diagram showing a principle of a system for pre-filling and emptying a purification circuit according to an embodiment of the present invention.
[0016] FIG. 2 is a schematic diagram showing the positions of the first and second interfaces in one embodiment of the present application.
[0017] FIG3 is a schematic diagram showing the positions of the first and second interfaces in another embodiment of the present application.
[0018] FIG. 4 is a schematic diagram showing the positions of the first and second interfaces in yet another embodiment of the present application.
[0019] 5a to 5c are schematic diagrams showing the positions of the first and second interfaces in some embodiments of the present application.
[0020] FIG6 is a schematic diagram showing the fluid flow in a pre-filling mode embodiment of the present application.
[0021] FIG. 7 is a schematic diagram showing the fluid flow direction in an embodiment of the present application in an emptying mode.
[0022] FIG8 is a schematic diagram showing the fluid flow direction in another embodiment of the emptying mode of the present application.
[0023] FIG. 9 is a schematic diagram showing the positions of the first and second interfaces in another embodiment of the present application.
[0024] FIG10 is a schematic diagram showing the fluid flow in another pre-filling mode embodiment of the present application.
[0025] FIG. 11 is a schematic diagram showing the fluid flow direction in yet another embodiment of the emptying mode of the present application.
[0026] FIG. 12 is a schematic diagram showing a first valve component and a second valve component in one embodiment of the present application.
[0027] FIG13 is a schematic diagram showing a liquid storage container connected to a circulation loop in one embodiment of the present application.
[0028] FIG14 is a schematic diagram showing a liquid storage container connected to a circulation loop in one embodiment of the present application.
[0029] 15a to 15c are schematic diagrams showing different working states of the flow channel switching valve component in one embodiment of the present application.
[0030] FIG16 is a schematic diagram showing the working state of the flow channel switching valve component in another embodiment of the present application.
[0031] 17a to 17c are schematic diagrams showing different working states of the flow channel switching valve component in one embodiment of the present application.
[0032] FIG18 is a schematic diagram showing a dialysis device according to an embodiment of the present application.
[0033] FIG19 is a schematic diagram showing an embodiment of the dialysis device of the present application in a treatment mode.
[0034] FIG20 is a schematic diagram showing the principle of a purification circuit in one embodiment of the present application.
[0035] FIG21 is a schematic diagram showing the gas collecting chamber and its connection relationship in the purification circuit of the present application.
[0036] FIG. 22 is a schematic diagram showing the fluid flow of the purification circuit of the present application in a flushing embodiment.
[0037] FIG. 23 is a schematic diagram showing the fluid flow of the purification circuit of the present application in a treatment embodiment.
[0038] FIG. 24 is a schematic diagram showing a purification circuit of the present application in an embodiment using another structure of a gas collecting chamber.
[0039] FIG25 is a schematic diagram showing a purification circuit of the present application in another embodiment adopting a gas collecting chamber with another structure.
[0040] FIG26 is a schematic structural diagram of the gas collecting chamber of the present application in one embodiment.
[0041] FIG. 27 is a schematic diagram showing a gas collecting cavity of the present application in an embodiment that is substantially A-shaped or inverted V-shaped.
[0042] FIG. 28 is a schematic diagram showing a gas collection cavity of the present application in an embodiment of a substantially inverted U-shaped or N-shaped structure.
[0043] FIG. 29 is a schematic diagram showing a gas collecting cavity of the present application having a substantially V-shaped internal structure in one embodiment. DETAILED DESCRIPTION
[0044] The following describes the implementation of the present application through specific embodiments. People familiar with this technology can easily understand other advantages and effects of the present application from the contents disclosed in this specification.
[0045] In the following description, reference is made to the accompanying drawings, which describe several embodiments of the present application. It should be understood that other embodiments may also be used, and that mechanical, structural, electrical, and operational changes may be made without departing from the spirit and scope of the present application. The following detailed description should not be considered restrictive, and the scope of the embodiments of the present application is limited only by the claims of the disclosed patents. The terms used herein are only for the purpose of describing specific embodiments and are not intended to limit the present application. Spatially related terms, such as "upper", "lower", "left", "right", "below", "below", "lower", "above", "upper", etc., may be used in the text to illustrate the relationship between one element or feature shown in the figure and another element or feature.
[0046] Although in some instances the terms first, second etc. are used to describe various elements or parameters in this article, these elements or parameters should not be limited by these terms. These terms are only used to distinguish an element or parameter from another element or parameter. For example, the first interface can be referred to as the second interface, and similarly, the second interface can be referred to as the first interface, without departing from the scope of the various described embodiments. The first interface and the second interface are both describing an interface, but unless the context clearly indicates otherwise, they are not the same interface. Similar situations also include the first connecting member and the second valve part, or the first connecting member and the second valve part.
[0047] Furthermore, as used herein, the singular forms "a", "an", and "the" are intended to include the plural forms as well, unless the context indicates otherwise. It should be further understood that the terms "comprise", "include" indicate the presence of the described features, steps, operations, elements, components, items, kinds, and / or groups, but do not exclude the presence, occurrence, or addition of one or more other features, steps, operations, elements, components, items, kinds, and / or groups. The terms "or" and "and / or" used herein are interpreted as inclusive, or mean any one or any combination. Thus, "A, B, or C" or "A, B, and / or C" means "any of the following: A; B; C; A and B; A and C; B and C; A, B, and C". Exceptions to this definition occur only when the combination of elements, functions, steps, or operations is inherently mutually exclusive in some way.
[0048] In the treatment preparation procedure using hemodialysis equipment, one or more bags of priming liquid (usually saline or saline buffer) are generally required to prime the pipeline and expel bubbles in the pipeline and dialyzer. In most designs and schemes, there is a special "interface" on the arterial side of the blood pipeline to connect to the above-mentioned priming liquid bag. This interface is often upstream of the blood pump and located between the arterial interface and the blood pump. The operation process is to connect the priming liquid bag and the interface, start the blood pump, and the flow direction of the saline is from the arterial end, through the dialyzer, and delivered to the venous end. In some designs or operating guidelines, a waste liquid bag is also used, and the pre-filled saline flows directly into the waste liquid bag. In the above operation, the process of priming the pipeline is called "priming" in practice.
[0049] After that, it is necessary to enter the "flushing" procedure, connect the arterial end and the venous end of the blood line, and turn the dialyzer upside down so that the saline flows from bottom to top, and continue to circulate and flush to empty the bubbles in the dialyzer. This process is called "flushing" in practice. Because in most dialysis equipment and consumables, most arterial and venous pots with conical containers are placed vertically, such as pre-filled liquid (usually saline or saline buffer) or blood and other fluids flow from top to bottom, so that gas or bubbles will be enriched in the upper space of the arterial or venous pot. If the bubbles or gas in the arterial pot need to be removed, the traditional operation method is for medical staff to turn the arterial pot upside down, and the way to remove bubbles from the venous pot is to use a degassing pump to exhaust the air. During this process, the liquid level in the venous pot will be raised.
[0050] As mentioned above, dialysis equipment typically requires priming the dialysis tubing and dialyzer with priming fluid during operation. However, since the dialyzer contains approximately 8,000-10,000 tiny hollow fibers, a single priming operation cannot completely expel all bubbles, and residual bubbles can affect the dialyzer's exchange efficiency. Therefore, after priming, medical personnel must connect the arterial and venous ends of the tubing and invert the dialyzer so that the fluid flowing through the dialyzer flows from bottom to top. This cycle of flushing lasts approximately five minutes. Furthermore, the adsorption columns in the water circuit also require flushing after priming, which increases operational costs and learning curves. For example, when priming the tubing, medical personnel must invert the arterial chamber to keep the fluid level high. Another example is that after priming, medical personnel often need to adjust the fluid level by opening and closing the vent on the venous chamber. While some dialysis equipment has an electronic adjustment mechanism, medical personnel still need to manually adjust the fluid level in the venous chamber based on experience. If the blood pump is reversed without turning the dialyzer upside down, the bubbles will escape from the top of the arterial pot to the blood pump, then escape to the top of the venous pot and finally flow into the dialyzer.
[0051] In most dialysis equipment, after blood return, the water does not need to be drained, or it can only be drained manually by a nurse. The process of draining the line is called "draining" in practice. During this process, the arterial and venous ends of the blood line still need to be connected. The residual water not only increases the weight of medical waste but also increases the risk of contamination. Therefore, a better approach is to separate solid waste from liquid waste, dispose of solid waste in a centralized manner, and direct liquid waste into the wastewater pipeline.
[0052] The above operations are still cumbersome and complicated, especially compared with home hemodialysis (HHD), and increase the difficulty for ordinary people to master the relevant operations. As mentioned above, when using dialysis equipment for blood purification, the conventional operation process includes pipeline connection, pre-filling, flushing, treatment, blood return, emptying of water and disconnection of pipelines and discarding. The technical solution provided by this application will involve the explanation of the processes of "pre-filling", "emptying" and "flushing" in subsequent embodiments. To this end, this application provides a system for pre-filling and emptying a purification circuit and a dialysis device and dialysis equipment suitable for the system. This application also provides a purification circuit, a method for flushing a purification circuit, and a dialysis device, which will be described in detail later.
[0053] In view of the above problems, the present application proposes a system for pre-filling and emptying a purification circuit, which is applied to the field of hemodialysis in various modes and medical scenarios such as hospital treatment and home treatment, especially in blood purification equipment, such as blood purification systems or hemodialysis machines. Of course, the system for pre-filling and emptying a purification circuit of the present application can also be applied to the field of peritoneal dialysis (PD). Peritoneal dialysis is the process of injecting dialysate into the abdominal cavity and using the peritoneum in the body to filter and remove metabolic waste and excess water from the blood. It is one of the treatments for renal failure other than hemodialysis. Before membrane dialysis, the extracorporeal circulation circuit also needs to be pre-filled and flushed, and the extracorporeal circulation circuit needs to be emptied after the treatment.
[0054] Please refer to Figure 1, which is a schematic diagram of the principle of the system for pre-filling and emptying the purification circuit of the present application in one embodiment. As shown in the figure, the system for pre-filling and emptying the purification circuit of the present application includes a liquid storage container 1, a circulation circuit 2, and a driving device 3.
[0055] The liquid storage container 1 is used to store pre-filled liquid and recover emptied waste liquid. It includes a container body 10, and a first interface and a second interface provided on the container body 10 for serving as the inlet and outlet of liquid and / or gas. The first interface and the second interface both serve as the inlet and outlet of the fluid in the container body. In Figure 1, the first interface is labeled 11, and the second interface is labeled 12.
[0056] In the present application, the liquid storage container can be switched between upright and inverted states, that is, the state of placing the liquid storage container upright is upright, and the state of placing the liquid storage container upside down is inverted. In order to switch between the two states more simply, a mechanism for placing the liquid storage container upright or inverted is also included. In one embodiment, the mechanism is, for example, a plate or a frame for placing the liquid storage container, and a structure for fixing the liquid storage container and a positioning structure for positioning the upright state and the inverted state are provided on the plate or the frame, so that the liquid storage container can be stabilized in the upright state when it is placed upright, or can be stabilized in the inverted state when it is inverted.
[0057] In the present application, the liquid storage container has two working modes in the system of pre-filling and emptying the purification circuit, that is, 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 is at a lower height so that the pre-filled liquid in the liquid storage container preferentially enters the pipeline in the circulation loop from the second interface, while in the emptying mode, the first interface 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. In the present application, the switching between the pre-filling mode and the emptying mode can be achieved by adjusting the flow direction of the fluid and / or switching the liquid storage container upright or inverted, which will be described in detail later.
[0058] In one embodiment, the liquid storage container is a soft pre-filled liquid bag, such as a liquid bag made of medical plastic; in another embodiment, the liquid storage container is a rigid pre-filled liquid bottle, such as a liquid bottle or jar made of glass. To facilitate observation of the liquid content within the container, in some embodiments, the container body is made of a transparent material and may be marked with volume graduations.
[0059] In the present application, the "priming liquid" refers to the liquid used for pre-filling the blood purification control device. In an embodiment, the liquid is, for example, physiological saline or physiological buffer.
[0060] In the present application, the liquid storage container has a first interface and a second interface at different heights, so that when the liquid storage container is in an upright state or an inverted state, the first interface and the second interface are not at the same height. For example, when the liquid storage container is in an upright state, the first interface is located at a high position, and the second interface is located at a low position. Correspondingly, when the liquid storage container is in an inverted state, the first interface is located at a low position, and the second interface is located at a high position. In a specific implementation, based on the requirements of the configuration of the pipeline connected to the circulation loop, the first interface and the second interface can be in mutually symmetrical positions, or can be relatively staggered, such as a left-and-right configuration.
[0061] In one embodiment, the first interface is located at a high position in the container body; the second interface is located at a low position in the container body. In one example, referring to Figure 2, which shows a schematic diagram of the positions of the first and second interfaces in one embodiment of the present application, the liquid storage container 1 is in an upright position as shown in the figure. The first interface 11 is an opening at the top of the container body 10; the second interface 12 is an opening at the bottom of the container body 10. The first interface 11 and the second interface 12 are either openings or openings formed using tubular joints.
[0062] In another example, please refer to Figure 3, which shows a schematic diagram of the positions of the first and second interfaces in another embodiment of the present application. As shown in the figure, when the liquid storage container is in an upright position, the first interface 11 is a long tube that extends into the interior space of the container body 10 and is located at a first height. The second interface 12 is an opening at the bottom of the container body 10. When the liquid storage container is in an upright position, the first height is higher than the opening. In a specific implementation, the first height can be designed to different lengths based on the space in the container body and the amount of flushing liquid required to be stored. The second interface is an opening or an opening made using a tubular joint.
[0063] In another example, please refer to FIG4 , which shows a schematic diagram of the positions of the first and second interfaces in another embodiment of the present application. As shown in the figure, when the liquid storage container is in an upright state, the first interface 11 is a pipe extending into the interior space of the container body 10 and located at a first height; the second interface 12 is a pipe extending into the interior space of the container body 10 and located at a second height, and when the liquid storage container is in an upright state, the first height is higher than the second height. For example, the first interface is a long pipe and the second interface is a short pipe, so that there is a height difference between the two, so as to form two first and second interfaces at different heights. This different height allows the levels of the first and second interfaces to be interchangeable when the liquid storage container is in an upright state and an inverted state.
[0064] In another embodiment, when the liquid storage container is in an upright position, in order to ensure that in the emptying mode, the gas located in the container body can be preferentially discharged from the liquid storage container into the circulation loop pipeline, the structure of the liquid storage container is as shown in Figures 2 to 4 above. Please refer to Figures 5a to 5c, which are schematic diagrams of the positions of the first and second interfaces in some embodiments of the present application. As shown in the figure, when the liquid storage container is in an upright position, its first interface 11 is located above the liquid level of the pre-filled liquid 13 in the container body 10 when it is full of liquid.
[0065] One end of the circulation loop 2 is connected to the first interface 11 of the liquid storage container 1, and the other end is connected to the second interface 12 of the liquid storage container 1, thereby incorporating the liquid storage container 1 into the circulation loop; in this application, the circulation loop refers to a purification loop used for pre-filling and emptying. It should be understood that in the flushing procedure, the circulation loop can also be regarded as a flushing loop.
[0066] Still taking hemodialysis as an example, the purification circuit described in the system of the present application is a vascular access system for extracorporeal blood circulation established by puncturing with a needle to obtain blood and return the treated blood during the blood purification and hemodialysis process. In the purification circuit of the present application, the pipeline used can be set as a blood delivery pipeline, a liquid medicine delivery pipeline, or a dedicated pipeline for a peristaltic pump. The pipeline materials include but are not limited to soft polyvinyl chloride plastics, high-performance polyolefin thermoplastic elastomers (TPE), nano-biomedical materials, resin materials, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyether urethane (PEU), polyurethane (PU), polyester (PET), etc.
[0067] It should be understood that "conduit" or "tubing" disclosed in this application means that components can be fluidically coupled to each other so as to provide a path for transferring fluid (i.e., saline, blood, or plasma, etc.) between these components. "Conduit" as used herein broadly includes tubes, pipes, hoses, catheters, or other structures having one or more lumens adapted to transfer fluid between two ends. Typically, tubes are elongated cylindrical structures with some flexibility, but the geometry and rigidity can vary. In some embodiments, multiple components can also be coupled by virtue of physical proximity, become a single structure as a whole, or be formed from the same material.
[0068] The loop is used to represent a unit formed by hardware or structure including pipelines, devices connected or associated in the pipelines, such as containers, drive devices, dialysis devices, etc., and a fluid circulation path connected end to end including the aforementioned hardware or structures, such as fluids in the pipelines, and pre-filled fluids added to the pipelines.
[0069] In certain embodiments of the present application, the circulation loop includes a first line, a second line, and a dialysate line disposed between the first line and the second line for communicating with a dialysis device.
[0070] In an embodiment where the dialysis device is a hemodialysis device, the first circuit is an arterial blood circuit, and the second circuit is a venous blood circuit. The arterial blood circuit includes an arterial end inserted into a human artery and an arterial line connecting the arterial end to the dialysis device. A drive device is provided on the arterial line. In some cases, an arterial pot is also provided on the line before the arterial line connects to the dialysis device. The arterial line also includes necessary components or assemblies, such as an arterial pressure sensor, an arterial valve, a hydrophobic filter, a heparin syringe, and a heparin pump.
[0071] The venous blood circuit includes a venous end inserted into the human venous blood vessels, and a venous line connecting the venous end and the dialysis device. A venous pot is provided on the venous line. In some cases, the venous line is also provided with necessary elements or components such as a venous pressure sensor, a hydrophobic filter, a venous pot three-way valve, an exhaust line connected to the venous pot, a liquid level sensor, an air sensor, a venous valve / clamp, and a photoelectric sensor.
[0072] It should be noted that in the “priming”, “flushing” and “emptying” operation modes, the arterial end of the arterial blood line and the venous end of the venous blood line need to be connected / communicated to form a circulation loop.
[0073] The dialysate circuit includes a dialysate inlet and a dialysate outlet, which are used to input the dialysate into the dialysis device and output it after treatment. It should be understood that the dialysate circuit also includes necessary valves, sensors and other necessary elements or components.
[0074] Referring again to FIG1 , the driving device 3 is disposed on the circulation loop 2 between the first interface 11 and the second interface 12 and is configured to drive a fluid (e.g., priming fluid or blood) to flow in a forward or reverse direction within the circulation loop 2. It should be noted that during hemodialysis treatment, the direction in which the dialysis device drives blood from the arterial end to the venous end is forward flow.
[0075] In an embodiment, the driving device includes but is not limited to a peristaltic pump, a pneumatic diaphragm pump, or a pressure pump, which is used to provide power to the fluid in the pipeline so that the fluid circulates in a preset flow direction. Here, in an application scenario for medical purposes, the driving device should not directly contact the fluid, but only apply pressure to the pipeline and drive the fluid to flow. In the application examples of hemodialysis or membrane dialysis, the preferred embodiment of the driving device is a non-contact pump device such as a peristaltic pump or a pneumatic diaphragm pump. More specifically, the peristaltic pump is, for example, a dialysis pump or a blood pump. The forward and reverse (reversal) of the peristaltic pump will cause the flow direction of the fluid in the circulation loop to be different. In the application example where the circulation loop is a waterway, the driving device can be a contact-type driving pump or the like to drive the fluid to flow in the circulation loop in a forward or reverse direction.
[0076] It should be understood that the driving device can drive the fluid in the pipeline at different positions in the pipeline, and its flow rate may change due to factors such as pipeline resistance, temperature, and pressure in the direction of fluid flow. However, in the embodiment of the present application applied to the field of dialysis, the driving device is arranged on the circulation loop, especially on the pipeline near the second interface, that is, on the arterial blood line of the purification circuit.
[0077] In actual scenarios, the drive device can control the fluid flow rate in the pipeline based on application requirements. During the above-mentioned hemodialysis process of purifying blood, the blood drawn from the human body is controlled by the blood pump to introduce the processed blood into the circulation loop at a flow rate within a preset range to ensure patient safety. The drive device controls the fluid flow rate to ensure the dynamic balance of the total amount of fluid in the pipeline. The pressure in the pipeline during the circulation can be maintained at a constant value or a fluctuation range determined by the constant value. This can avoid problems such as pipe rupture, negative pressure suction, and destruction of fluid components such as red blood cell rupture caused by pressure changes in the pipeline. Therefore, the circulation is sustainable.
[0078] To sum up, the system of the pre-filling and emptying purification circuit of the present application can realize the two operations of pre-filling and emptying by connecting to a liquid storage container in the circulation loop and cooperating with the working mode of the driving device, or the upright or inverted state of the liquid storage container, that is, in the pre-filling mode, the outlet of the liquid in the liquid storage container is at a low position; and in the emptying mode, the outlet of the gas in the liquid storage container is at a high position; compared with the conventional operation in the prior art, the system structure of the present application is simple, the operation is convenient, and the learning cost is low. The operator does not need to repeatedly invert the dialyzer for continuous circulation pre-filling. Moreover, the application of the system of the present application enables more scientific and reasonable treatment of medical waste such as pipelines and waste liquids after emptying.
[0079] Please refer to Figure 6, which is a schematic diagram of the fluid flow in a pre-filling mode embodiment of the present application. As shown in the figure, in the pre-filling mode, the driving device 3 is in a forward rotation state to drive the pre-filling liquid in the liquid storage container 1 to flow from the second interface 12 into the circulation loop 2.
[0080] In this embodiment, when the system starts the pre-filling mode, the liquid storage container 1 is in an upright state, that is, the second interface 12 is at the bottom of the container body 10 (i.e., the low position), and the first interface 11 is at the top of the container body 10 (i.e., the high position). The driving device 3, such as the peristaltic pump, rotates forward to drive the fluid in the circulation loop 2 to flow in the forward direction. That is, the liquid, such as the pre-filled liquid, in the liquid storage container 1 flows from the second interface 12 at the low position to the pipeline of the circulation loop 2, and flows forward all the way through the circulation loop 2, and finally from the high position. The first interface 11 flows into the liquid storage container. Prior to this, the gas originally stored in the pipeline in the circulation loop 2 (or the processing device connected to the pipeline, such as a dialyzer) will enter the liquid storage container 1 from the first interface 11 earlier than the liquid such as the pre-filled liquid due to the positive drive of the driving device 3. In this embodiment, since liquid is easier to flow out from the second interface 12 located at a lower position than gas, and the gas is retained above the liquid surface, the gas in the circulation loop 2 can also be enriched in the liquid storage container 1 during pre-filling.
[0081] Please refer to Figure 7, which is a schematic diagram of the fluid flow direction in an emptying mode embodiment of the present application. As shown in the figure, in the emptying mode, the driving device 3 is in a reverse state to drive the gas in the liquid storage container 1 to be discharged from the first interface 11 into the circulation loop 2.
[0082] In this embodiment, when the system starts the emptying mode, the liquid storage container 1 is in an upright state, that is, the second interface 12 is at the bottom of the container body 10 (that is, the low position), and the first interface 11 is at the top of the container body 10 (that is, the high position). For example, the driving device 3 of the peristaltic pump is reversed (reversed) to drive the fluid in the circulation loop 2 to flow in the opposite direction. That is, the gas originally enriched in the liquid storage container 1 preferentially flows from the first interface 11 located at a high position to the pipeline of the circulation loop 2, and the liquid originally existing in the pipeline of the circulation loop 2 will flow into the liquid storage container 1 from the second interface 12 located at a low position, and continue for a period of time, so that the liquid in the pipeline of the circulation loop 2 enters the liquid storage container 1, and then the driving device is stopped and the passage of the second interface is closed, thereby completing the operation of recovering the emptied waste liquid.
[0083] Please refer to Figure 8, which shows a schematic diagram of the fluid flow in another embodiment of the emptying mode of the present application. As shown in the figure, in the emptying mode, the liquid storage container 1 is in an inverted state and the driving device 3 is in a forward rotation state to drive the gas in the liquid storage container to be discharged from the second port 12 into the circulation loop 2. The inverted state of the liquid storage container changes the height relationship of the first and second ports; in this embodiment, when the liquid storage container 1 is in an inverted state, the first port 11 is in a low position and the second port 12 is in a high position.
[0084] In this embodiment, when the system starts the emptying mode, the liquid storage container 1 is in an inverted state, that is, the first interface 11 is at the bottom of the container body 10 (that is, the low position), and the second interface 12 is at the top of the container body 10 (that is, the high position). For example, the driving device 3 of the peristaltic pump rotates forward, driving the fluid in the circulation loop 2 to flow forward, that is, the gas originally enriched in the liquid storage container 1 preferentially flows from the second interface 12 located at a high position to the pipeline of the circulation loop 2, and the liquid originally existing in the pipeline of the circulation loop 2 will flow into the liquid storage container from the first interface 11 located at a low position, and continue for a period of time, so that the liquid in the pipeline of the circulation loop 2 enters the liquid storage container 1, and then the driving device 3 is stopped and the passage of the first interface 11 is closed, thereby completing the operation of recovering the emptied waste liquid.
[0085] In the present application, the liquid storage container has a first interface and a second interface. When the liquid storage container is in an upright state, the first interface and the second interface of the liquid storage container are both located at a low position in the container body. Correspondingly, when the liquid storage container is in an inverted state, the first interface and the second interface of the liquid storage container are both located at a high position in the container body. In a specific implementation, based on the requirements of the pipeline configuration connected to the circulation loop, the first interface and the second interface can be in mutually symmetrical positions, or can be relatively staggered, such as a front-and-back configuration.
[0086] Please refer to Figure 9, which shows a schematic diagram of the positions of the first and second interfaces in another embodiment of the present application. As shown in the figure, with the liquid storage container in an upright position, the first interface 11 and the second interface 12 are openings formed in the bottom of the container body 10. The first interface 11 and the second interface 12 are openings or openings formed using tubular joints. The drive device 3 is disposed on the circulation circuit, specifically on the pipeline adjacent to the second interface, i.e., on the arterial blood line of the purification circuit.
[0087] Please refer to Figure 10, which is a schematic diagram of the fluid flow in another pre-filling mode embodiment of the present application. As shown in the figure, in the pre-filling mode, the driving device 3 is in a forward rotation state to drive the pre-filling liquid in the liquid storage container 1 to flow from the second interface 12 into the circulation loop 2.
[0088] In this embodiment, when the system starts the pre-filling mode, the liquid storage container 1 is in an upright state, that is, the first interface 11 and the second interface 12 are both at the bottom of the container body 10 (i.e., at a low position), and the driving device 3 of the peristaltic pump, for example, rotates forward, driving the fluid in the circulation loop 2 to flow forward, that is, the liquid in the liquid storage container 1, for example, the pre-filled liquid, flows from the second interface 12 located at a low position to the pipeline of the circulation loop 2, and flows forward all the way through the circulation loop 2, and finally flows into the liquid storage container 1 from the first interface 11 located at a low position. Prior to this, the gas originally stored in the pipeline of the circulation loop 2 (or the processing device connected to the pipeline, such as a dialyzer) will enter the liquid storage container 1 from the first interface 11 earlier than the liquid, such as the pre-filled liquid, due to the forward drive of the driving device 3. In this embodiment, since the mass of the gas is smaller than that of the liquid, the gas will float up and be retained above the liquid surface, so that the gas in the circulation loop 2 can also be enriched in the liquid storage container 1 during pre-filling.
[0089] Please refer to Figure 11, which shows a schematic diagram of the fluid flow in another embodiment of the emptying mode of the present application. As shown in the figure, in the emptying mode, the liquid storage container 1 is in an inverted state and the driving device 3 is in a forward rotation state to drive the gas in the liquid storage container 1 to be discharged from the second port 12 into the circulation loop 2. In this embodiment, the inverted state of the liquid storage container 1 causes both the first and second ports to be located at a high position.
[0090] In this embodiment, when the system starts the emptying mode, the liquid storage container 1 is in an inverted state, that is, the first interface 11 and the second interface 12 are at the top of the container body 10 (that is, at a high position), and the driving device 3 of the peristaltic pump, for example, rotates forward, driving the fluid in the circulation loop 2 to flow forward, that is, the gas originally enriched in the liquid storage container 1 preferentially flows from the second interface 12 located at a high position to the pipeline of the circulation loop 2, and the liquid originally existing in the pipeline of the circulation loop 2 will flow from the first interface 11 located at a high position into the liquid storage container 1, and continue for a period of time, so that the liquid in the pipeline of the circulation loop 2 enters the liquid storage container 1, and then the driving device 3 is stopped and the passage of the first interface 11 is closed, thereby completing the operation of recovering the emptied waste liquid.
[0091] In the embodiments shown in Figures 2 to 11 above, in order to facilitate the control of the flow or stop (blocking) of the fluid flowing through the first interface and the second interface, the system of the pre-filling and emptying purification circuit of the present application further includes a first valve component for blocking or conducting the first interface, and a second valve component for blocking or conducting the second interface. Please refer to Figure 12, which shows a schematic diagram of the first valve component and the second valve component in one embodiment of the present application. As shown in the figure, the first valve component 23 is arranged on the pipeline of the circulation circuit and is adjacent to the first interface 11, and the second valve component 24 is arranged on the pipeline of the circulation circuit and is adjacent to the second interface 12. In this embodiment, the first valve component 23 or the second valve component 24 is, for example, a manual valve component or an electric valve component. The manual valve component is, for example, a clamping valve similar to a venous clamp or an arterial clamp, or other mechanical components, and the electric valve component is, for example, a solenoid valve.
[0092] In one embodiment, the liquid storage container is connected to the circulation loop in a branch manner. More specifically, the first interface and the second interface of the liquid storage container are respectively connected to different sections in the circulation loop through two parallel branches, and when the passage of the above sections is blocked, they are connected to the circulation loop to realize storage of pre-filled liquid and recovery of emptied waste liquid. Please refer to Figure 13, which shows a schematic diagram of the liquid storage container connected to the circulation loop in one embodiment of the present application. As shown in the figure, the circulation loop includes a first branch 20, a second branch 21, and a main loop 22 connected end to end, wherein the first end of the first branch 20 is connected to the first interface 11, and the second end of the first branch 20 is connected to the first section 221 of the main loop 22; the first end of the second branch 21 is connected to the second interface 12, and the second end of the second branch 21 is connected to the second section 222 of the main loop 22; a third valve member 25 (i.e., V34 in the figure) for blocking or conducting the fluid passage is provided between the first section 221 and the second section 222 of the main loop 22.
[0093] As shown in Figure 13, point a is located upstream of the main circuit 22, and point b is located downstream of the main circuit 22. The liquid storage container 1 has two inlets and outlets, with point c located at a high position and point d located at a low position. The pipeline from point c to point a is the first branch 20, and the pipeline from point d to point b is the second branch 21. The pipeline between the first section 221 and the second section 222 of the main circuit 22 is the pipeline from point a to point b, and the third valve member 25 is disposed in this pipeline. After the priming and flushing operations are completed, the first branch 20 and the second branch 21 can be blocked by the valve members disposed in the first branch 20 and the second branch 21, respectively, and the third valve member 25 can be opened, thereby opening the pipeline from point a to point b. Of course, in the application example of hemodialysis, the input end of the main circuit 22 is connected to the arterial output end, and the output end of the main circuit 22 is connected to the venous input end, thereby forming a vascular pathway for the extracorporeal blood circulation of hemodialysis.
[0094] In this embodiment, the first interface 11 of the liquid storage container 1 is connected to the first section 221 of the main circuit 22 through the first branch 20, and the second interface 12 of the liquid storage container 1 is connected to the second section 222 of the main circuit 22 through the second branch 21. When the passage between the first section 221 and the second section 222 of the main circuit 22 is blocked by the third valve member 25, the liquid storage container 1, the second branch 21, the main circuit 22, and the first branch 20 form a circulation loop, and when the driving device 3 is working, the fluid in the circulation loop flows in different directions according to the forward or reverse rotation of the driving device 3.
[0095] In one embodiment, when the system starts the priming mode, the liquid storage container is in an upright position, that is, the second interface is at the bottom of the container body (i.e., the lower position), and the first interface is at the top of the container body (i.e., the higher position). The driving device, such as a peristaltic pump, rotates forward, driving the fluid in the circulation loop to flow in the forward direction. That is, the liquid in the liquid storage container, such as the priming liquid, flows from the second interface at the lower position through the second branch to the main loop of the circulation loop, and flows forward all the way through the main loop, and finally flows into the liquid storage container from the first interface at the higher position through the first branch. Prior to this, the gas originally stored in the pipeline of the main loop (or the treatment device connected to the main loop, such as a dialyzer) will enter the liquid storage container from the first interface earlier than the liquid, such as the priming liquid, due to the forward driving of the driving device. In this embodiment, since the liquid is more likely to flow out from the second interface at the lower position than the gas, the gas is retained above the liquid surface, thereby enriching the gas in the circulation loop in the liquid storage container during the priming process.
[0096] In an embodiment of an emptying mode, when the system starts the emptying mode, the liquid storage container is in an upright state, that is, the second interface is at the bottom of the container body (that is, the low position), and the first interface is at the top of the container body (that is, the high position), for example, the driving device of the peristaltic pump is reversed (inverted), driving the fluid in the circulation loop to flow in the opposite direction, that is, the gas originally enriched in the liquid storage container preferentially flows from the first interface located at a high position through the first branch to the main loop of the circulation loop, and the liquid originally present in the pipeline of the main loop will flow into the liquid storage container from the second interface located at a low position through the second branch, for a period of time, so that the liquid in the main loop of the circulation loop enters the liquid storage container, and then the driving device is stopped and the passage of the second interface is closed, thereby completing the operation of recovering the emptied waste liquid.
[0097] In another embodiment of the emptying mode, when the system starts the emptying mode, the liquid storage container is in an inverted state, that is, the first interface is at the bottom of the container body (that is, the low position), and the second interface is at the top of the container body (that is, the high position). For example, the driving device of the peristaltic pump rotates forward, driving the fluid in the circulation loop to flow forward, that is, the gas originally enriched in the liquid storage container preferentially flows from the second interface located at a high position through the second branch to the main loop of the circulation loop, and the liquid originally existing in the main loop of the circulation loop will flow into the liquid storage container from the first interface located at a low position through the first branch, for a period of time, so that the liquid in the main loop of the circulation loop enters the liquid storage container, and then the driving device is stopped and the passage of the first interface is closed, thereby completing the operation of recovering the emptied waste liquid.
[0098] In another embodiment, in order to simplify the system configuration, the valves provided on the first branch and the second branch can be eliminated, and the same purpose can be achieved by a single valve. Please refer to FIG14, which shows a schematic diagram of the connection of the liquid storage container to the circulation loop in one embodiment of the present application. As shown in the figure, in this embodiment, the circulation loop 22 is further provided with a fourth valve 26 (i.e., V33 in the figure) for blocking or connecting the first branch 20 and the second branch 21. The fourth valve 26 is used to switch the state of blocking or connecting the first branch 20 and the second branch 21, thereby enabling the first branch 20 and the second branch 21 to be connected to the main loop 22 of the circulation loop, or to block the first branch 20 and the second branch 21 during the treatment phase.
[0099] In one embodiment, the fourth valve component 26 (i.e., V33 in the figure) is a flow channel switching valve component that can switch the flow state; please refer to Figures 15a to 15c, which respectively show schematic diagrams of different working states of the flow channel switching valve component in one embodiment of the present application. Among them, Figure 15a shows the first state of the flow channel switching valve component, Figure 15b shows the second state of the flow channel switching valve component, and Figure 15c shows the third state of the flow channel switching valve component. As shown in the figure, the first state of the flow channel switching valve component is used to conduct the first branch 20 and the second branch 21, and block the passage between the first section 221 and the second section 222 of the main circuit (i.e., the passage between point a and point b); the second state of the flow channel switching valve component is used to block the first branch 20 and the second branch 21. branch 21, and conducts the passage between the first section 221 and the second section 222 of the main circuit (i.e., the passage between point a and point b); the third state of the flow channel switching valve component is used to conduct the first end of the first branch 20 and the second end of the second branch 21 (i.e., conduction between point c and point b), the first end of the second branch 21 and the second end of the first branch 20 (i.e., conduction between point d and point a), and block the passage between the first section 221 and the second section 222 of the main circuit 22 (i.e., blocking the passage between point a and point b).
[0100] In the embodiment shown in Figure 15a, when the flow channel switching valve is in the first state, the pipeline from point a to point c is connected, and the pipeline from point b to d is connected. At this time, the driving device is started, the liquid in the liquid storage container can be drawn out, and the gas in the flow channel can be discharged into the liquid storage container. In the subsequent flushing process, small bubbles can also be continuously discharged.
[0101] In the embodiment shown in Figure 15b, when the flow channel switching valve component is in the second state, the passages between point a to point c and point b to point d are blocked, and the third valve component (i.e., V34 in Figure 14) between point a and point b of the main circuit conducts the fluid passage.
[0102] In the embodiment shown in Figure 15c, when the flow channel switching valve component is in three states, the passage from point a to point d is connected, and the passage from point b to point c is connected. The third valve component (i.e., V34 in Figure 14) between point a and point b of the main circuit blocks the fluid passage. At this time, the gas in the liquid storage container can be sucked into the pipeline, and the liquid in the main circuit in the pipeline can be discharged into the liquid storage container.
[0103] In an embodiment, the flow channel switching valve component, such as the disc component shown in Figures 15a, b, and c, has two independent flow channels disposed therein, wherein the two ports of each flow channel are used to connect the first or second branch circuit and the main circuit. In actual applications, the flow channel switching valve component further includes a sealing portion for ensuring the tightness of the connection when connecting the first or second branch circuit, or the main circuit. In different states as shown in Figures 15a, b, and c, the flow channel switching valve component, which is a disc component, achieves connection or blocking of the target passage by switching different angles.
[0104] In one embodiment, the flow channel switching valve component is a manual valve component that switches between three states by means of a device; or in another embodiment, the flow channel switching valve component is an electric valve component that automatically switches between the first, second, or third states according to a driver program, and the driver program can be written into the system processor to output corresponding control instructions by a control device.
[0105] In yet another embodiment, in order to further simplify the system configuration, the two valves provided on the first branch, the second branch, and the main circuit can be integrated into one valve, and the same purpose can be achieved by one valve. Please refer to FIG16, which is a schematic diagram of the working state of the flow path switching valve in another embodiment of the present application. As shown in the figure, the circulation circuit includes a first branch 20, a second branch 21, and a main circuit 22 connected end to end. The intersection of the first branch 20, the second branch 21, and the main circuit 22 connected end to end is provided with a flow path switching valve (V3 in FIG16) that can switch the flow state. 4), the first state of the flow channel switching valve component is used to connect the first branch 20 to the first section 221 of the main circuit 22 and the second branch 21 to the second section 222 of the main circuit 22, and to block the passage between the first section 221 and the second section 222 of the main circuit 22; the second state of the flow channel switching valve component is used to block the first branch 20 from the first section 221 of the main circuit 22 and the second branch 21 from the second section 222 of the main circuit 22, and to open the passage between the first section 221 and the second section 222 of the main circuit 22. In this embodiment, the third state of the flow channel switching valve component (V34 in the figure) is used to connect the first branch 20 to the second section 222 of the main circuit 22 and the second branch 21 to the first section 221 of the main circuit 22, and to block the passage between the first section 221 and the second section 222 of the main circuit 22.
[0106] Please refer to Figures 17a to 17c, which respectively illustrate different operating states of the flow channel switching valve component in one embodiment of the present application. Figure 17a shows the flow channel switching valve component in a first state, Figure 17b shows the flow channel switching valve component in a second state, and Figure 17c shows the flow channel switching valve component in a third state.
[0107] In the embodiment shown in Figure 17a, the first state of the flow channel switching valve component is used to connect the first branch 20 and the second branch 21, and block the passages between the first section 221 and the second section 222 of the main circuit 22; that is, the passage between point c and point a and the passage between point d and point b are connected, and the passage between point a and point b is blocked.
[0108] In the embodiment shown in FIG17 b , the second state of the flow channel switching valve member is used to block the first branch 20 and the second branch 21 and open the passages of the first section 221 and the second section 222 of the main circuit 22. That is, the passage between point a and point b is opened, and the passage between point c and point a and the passage between point d and point b are blocked.
[0109] In the embodiment shown in Figure 17c, the third state of the flow channel switching valve component is used to connect the first end of the first branch 20 and the second end of the second branch 21, and the first end of the second branch 21 and the second end of the first branch 20, and block the passage between the first section 221 and the second section 222 of the main circuit 22, that is, connect the passage between point c and point b and the passage between point a and point d, and block the passage from point a to point b.
[0110] In an embodiment, the flow channel switching valve component, such as the disc component shown in Figures 17a, b, and c, has three independent flow channels disposed therein, wherein two ports of each flow channel are used to connect the target branch circuit and the main circuit interface. In actual applications, the flow channel switching valve component further includes a sealing portion for ensuring the tightness of the interface when connecting the first or second branch circuit, or the main circuit. In different states as shown in Figures 17a, b, and c, the flow channel switching valve component, which is a disc component, achieves connection or blocking of the target channel by switching different angles.
[0111] In one embodiment, the flow channel switching valve component is a manual valve component that switches between three states by means of a device; or in another embodiment, the flow channel switching valve component is an electric valve component that automatically switches between the first, second, or third states according to a driver program, and the driver program can be written into the system processor to output corresponding control instructions by a control device.
[0112] In other embodiments of the present application, the circulation circuit may also include a blood circuit / blood circuit, a water circuit, or a metabolic circulation circuit. Wherein, the metabolic circulation circuit is, for example, a metabolic circulation circuit used in the metabolic circulation of hemodialysis and peritoneal dialysis. In some embodiments, the metabolic circulation circuit is, for example, a circuit or a circuit system or a circuit in a circulation treatment system constituted by the “metabolic circulation module” described in patent document WO2022036739A1 or / and patent document WO2022036738A1; in this application, the full text of patent documents WO2022036739A1 and WO2022036738A1 is cited hereby.
[0113] The present application also provides a method for pre-filling and emptying a purification circuit, which is applied to the field of hemodialysis in various modes and medical scenarios such as hospital treatment and home treatment, and is particularly applied in blood purification equipment, such as in a blood purification system or a hemodialysis machine. Of course, the system for pre-filling and emptying the purification circuit of the present application can also be applied to the field of peritoneal dialysis. Peritoneal dialysis is the process of injecting dialysate into the abdominal cavity and using the peritoneum in the body to filter and remove metabolic waste and excess water from the blood. It is one of the therapies for renal failure other than hemodialysis, and the extracorporeal circulation circuit also needs to be pre-filled and flushed before membrane dialysis. As mentioned above, the purification circuit in the method for pre-filling and emptying the purification circuit of the present application can also be a blood circuit / blood circuit, a water circuit, or a metabolic circulation circuit. Among them, the metabolic circulation circuit is, for example, a metabolic circulation circuit used in the metabolic circulation of hemodialysis and peritoneal dialysis.
[0114] In an embodiment, the purification circuit includes an arterial blood line for accessing a human artery, a drive device provided on the arterial blood line, a dialysis device connected to the arterial blood line, and a venous blood line connected to the dialysis device. In an embodiment, the purification circuit is configured as described in the embodiment shown in FIG. 18 above, and further description thereof will be omitted. The method for priming and emptying the purification circuit includes the following steps:
[0115] A liquid storage container for storing pre-filled liquid and recovering emptied waste liquid is provided on the purification circuit. In the embodiment, the implementation method of the liquid storage container, the connection method with the blood circuit / circulation circuit / main circuit, and the working principle are as described in the embodiments of Figures 1 to 17 above, and will not be repeated here.
[0116] 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.
[0117] In one embodiment of the priming mode of the dialysis device, when the priming mode is executed, the driving device is in a forward rotation state to drive the priming liquid in the liquid storage container to flow from the second interface into the circulation loop. In this embodiment, the method described in the embodiment shown in Figure 6 above is adopted and will not be repeated here.
[0118] In another embodiment of the pre-filling mode, in the pre-filling mode, the driving device is in a forward rotation state to drive the pre-filled liquid in the liquid storage container to flow from the second interface into the circulation loop. In the embodiment, the method is as described in the embodiment shown in Figure 10 above, and no further details are given here.
[0119] In one embodiment of the emptying mode, the driving device is in a reverse state to drive the gas in the liquid storage container to be discharged from the first interface into the circulation loop. In this embodiment, the method is as described in the embodiment shown in Figure 7 above, and no further details are given here.
[0120] In another embodiment of the emptying mode, the liquid storage container is in an inverted position and the drive device is in a forward rotation state to drive the gas in the liquid storage container to be discharged from the second port into the circulation loop. The inverted state of the liquid storage container changes the height relationship of the first and second ports; in this embodiment, when the liquid storage container is in an inverted position, the first port is in a lower position and the second port is in a higher position. In this embodiment, the method described in the embodiment shown in Figure 8 above is adopted and will not be further described here.
[0121] In another embodiment of the emptying mode, the liquid storage container is in an inverted state and the driving device is in a forward rotation state to drive the gas in the liquid storage container to be discharged from the second port into the circulation loop. In this embodiment, the inverted liquid storage container causes both the first and second ports to be in a high position. In this embodiment, the method described in the embodiment shown in Figure 11 above is adopted and will not be repeated here.
[0122] The present application also provides a dialysis device for dialysis treatment, which is suitable for home hemodialysis (HHD) treatment scenarios and hospital hemodialysis scenarios. Please refer to Figure 18, which shows a schematic diagram of the dialysis device of the present application in one embodiment. As shown in the figure, the dialysis device includes: a liquid storage container 1, a circulation loop 2, a drive device 3, and a control device 4. When the dialysis device of the present application is actually used, its operation process includes several processes, which are roughly divided into pipeline connection, pre-filling, flushing, treatment, blood return, emptying water, and disconnecting the pipeline and discarding. In the following embodiments, the dialysis device provided by the present application will be used to illustrate the processes of "pre-filling", "emptying", and "flushing" in subsequent embodiments. The description of the following embodiments will take the dialysis device as a hemodialysis device as an example for explanation.
[0123] The liquid storage container 1 is used to store pre-filled liquid and recover emptied waste liquid. The liquid storage container 1 includes a container body 10, and a first interface 11 and a second interface 12 provided on the container body for serving as liquid and / or gas inlet and outlet; in the pre-filling mode, the outlet of the liquid in the liquid storage container 1 is at a low position; in the emptying mode, the outlet of the gas in the liquid storage container 1 is at a high position; in the various embodiments provided in the present application, the implementation method of the liquid storage container, the connection method with the blood circuit / circulation circuit / main circuit, and the working principle are as described in the aforementioned embodiments of Figures 1 to 17, and will not be repeated here.
[0124] In certain embodiments of the present application, the circulation loop includes a first circuit, a second circuit, and a dialysate circuit disposed between the first circuit and the second circuit for communicating with a dialysis device. In an embodiment where the dialysis device is a hemodialysis device, the first circuit is an arterial blood circuit and the second circuit is a venous blood circuit. For example, the circulation circuit 2 includes an arterial blood line L1 and a venous blood line L3 connected to the arterial blood line L1. In the pre-filling mode or the emptying mode of the circulation circuit 2, the input end of the arterial blood line L1 is connected to the output end of the venous blood line L3, the first interface 11 is connected to the first section of the circulation circuit 2 (i.e., the position shown by point a in Figure 18), and the second interface 12 is connected to the second section of the circulation circuit 2 (i.e., the position shown by point b in Figure 18); in the treatment mode, the input end of the arterial blood line L1 is connected to the human artery, and the output end of the venous blood line L3 is connected to the human venous blood; in the various embodiments provided in this application, the circulation circuit refers to a pre-filling and emptying purification circuit, i.e., the circulation circuit described in the aforementioned embodiments of Figures 1 to 17; it should be understood that in the flushing procedure, the circulation circuit is also a flushing circuit, and the input end of the arterial blood line L1 is connected to the output end of the venous blood line L3.
[0125] As shown in FIG. 18 , the circulation circuit 2 includes an arterial blood line L1 , a venous blood line L3 , and a dialysate line L2 disposed between the arterial blood line L1 and the venous blood line L3 for communicating with the dialysis device 6 .
[0126] Among them, the arterial blood line L1 includes an arterial end 50 that intervenes in the human artery and an arterial pipeline connecting the arterial end 50 and the dialysis device 6. A driving device 3 is provided on the arterial pipeline. In some cases, an arterial pot 53 is also provided on the line before the arterial pipeline is connected to the dialysis device 6; the arterial pipeline is also provided with necessary elements or components such as an arterial pressure sensor 52, an arterial valve 51, a hydrophobic filter, a heparin syringe, and a heparin pump.
[0127] The venous blood line L3 includes a venous end 90 that intervenes in the human body's venous blood vessels, and a venous line connecting the venous end 90 and the dialysis device 6. A venous pot 93 is provided on the venous line. In some cases, the venous line is also provided with a venous pressure sensor 92, a hydrophobic filter, a valve device 80 located on the exhaust line L4 (for example, a venous pot three-way valve), an exhaust line L4 connected to the venous pot, a liquid level sensor, a sensor 81 located on the exhaust line L4 (for example, an air sensor), a venous valve 91, a photoelectric sensor and other necessary elements or components.
[0128] It should be noted that in the “priming”, “flushing” and “emptying” operation modes, the arterial end 50 of the arterial blood line L1 and the venous end 90 of the venous blood line L3 need to be connected / communicated to form a circulation loop.
[0129] The driving device 3 is provided on the arterial blood line L1 and is located between the second section and the first section of the circulation loop 2, and is used to drive the fluid to flow in the circulation loop 2. In each embodiment provided in the present application, the driving device 3 is provided on the arterial blood line L1, and is particularly provided between the second interface 12 of the liquid storage container 1 and the dialysis device 6, so that the driving device 3 is provided on the circulation loop 2 between the first interface 11 and the second interface 12, and is used to drive the fluid (such as priming liquid or blood) to flow forward or reverse in the circulation loop 2. The implementation method and working principle of the driving device 3 are as described above for the embodiments of Figures 1 to 17, and will not be repeated here.
[0130] The dialysis device 6 is used to purify the fluid (blood) flowing in the circulation loop 2, and forms a fluid (blood) flow path for the patient's fluid (blood) to flow and a dialysate flow path for the dialysate to flow through a built-in purification membrane for purifying the fluid (blood); in an embodiment, the dialysis device 6 includes a dialyzer, and the dialyzer includes a dialysate chamber, a blood chamber and a semi-permeable membrane, etc., and the membrane separates the dialysate chamber and the blood chamber from each other. In the commonly used capillary dialyzer, the blood chamber is formed by the entire internal volume of the hollow fiber, and the dialysate chamber is formed by the inner cavity of the dialyzer shell surrounding the hollow fiber. In an embodiment, the top end of the dialyzer is connected to the arterial blood line L1, and the bottom end of the dialyzer is connected to the venous blood line L3.
[0131] The dialysate line L2 includes a dialysate inlet 60 and a dialysate outlet 61 connected to the dialyzer, which are used to input the dialysate into the dialysis device 6 and output it after treatment. It should be understood that the dialysate line L2 also includes necessary valves, sensors and other necessary elements or components.
[0132] The control device 4 is configured to execute a pre-filling mode to pre-fill the circulation circuit, execute a treatment mode to purify the fluid (blood) flowing in the circulation circuit and then inject it into the human body, or execute an emptying mode to recycle the waste fluid in the circulation circuit by discharging it into the liquid storage container. In an embodiment, the control device 4 is, for example, a controller or system processor of a dialysis device, which outputs corresponding control instructions through a program written into the system processor; or receives trigger instructions input by an operator to execute relevant control instructions.
[0133] FIG19 is a schematic diagram of an embodiment of the dialysis device of the present application in a treatment mode. As shown in the figure, in the treatment mode of the dialysis device, the input end of the arterial blood line L1 is connected to a first portion of the human body, and the output end of the venous blood line L3 is connected to a second portion of the human body. In this embodiment, an arterial puncture needle is connected to the front end of the arterial blood line L1 via a connector, and a driving device 3, such as a peristaltic blood pump, is provided midway therethrough. Meanwhile, a venous puncture needle is connected to the front end of the venous blood line L3 via a connector, and a drip chamber / venous pot is connected midway therethrough. Furthermore, during dialysis treatment, the arterial puncture needle and the venous puncture needle are respectively inserted into the target artery (i.e., the first portion of the human body) and the target vein (i.e., the second portion of the human body) of the patient's body. When the blood pump is activated, the patient's blood flows through the arterial blood line L1 to the dialysis device 6. The blood is then purified by the dialysis device 6, de-bubbled in the drip chamber / venous pot 93, and returned to the patient's body via the venous blood line L3. That is, the patient's blood is purified by the dialysis device 6 while being extracorporeally circulated from the distal end of the arterial blood line L1 to the distal end of the venous blood line L3 of the circulation circuit 2 .
[0134] In one embodiment of the priming mode of the dialysis device, when the dialysis device is in the priming mode, the driving device is in a forward rotation state to drive the priming liquid in the liquid storage container to flow from the second interface into the circulation loop. In this embodiment, the method described in the embodiment shown in Figure 6 above is adopted and will not be repeated here.
[0135] In another embodiment of the priming mode of the dialysis device, in the priming mode, the driving device is in a forward rotation state to drive the priming liquid in the liquid storage container to flow from the second interface into the circulation loop. In this embodiment, the method is as described in the embodiment shown in Figure 10 above, and no further details are given here.
[0136] In one embodiment of the evacuation mode of the dialysis device, in the evacuation mode, the driving device is in a reverse state to drive the gas in the liquid storage container to be discharged from the first interface into the circulation loop. In this embodiment, the method is as described in the embodiment shown in Figure 7 above, and no further details are given here.
[0137] In another embodiment of the evacuation mode of the dialysis device, in the evacuation mode, the liquid storage container is in an inverted state and the drive device is in a forward rotation state to drive the gas in the liquid storage container to be discharged from the second interface into the circulation loop. The inverted state of the liquid storage container changes the height relationship of the first and second interfaces; in this embodiment, when the liquid storage container is in an inverted state, the first interface is in a low position and the second interface is in a high position. In this embodiment, the method described in the embodiment shown in Figure 8 above is adopted and will not be repeated here.
[0138] In another embodiment of the evacuation mode of the dialysis device, in the evacuation mode, the liquid storage container is in an inverted state and the drive device is in a forward rotation state to drive the gas in the liquid storage container to be discharged from the second interface into the circulation loop. In this embodiment, the inverted liquid storage container causes both the first and second interfaces to be located at a high position. In this embodiment, the method described in the embodiment shown in Figure 11 above is adopted and will not be further described here.
[0139] In summary, the dialysis device of the present application can realize the two operations of pre-filling and emptying by being connected to a liquid storage container in the circulation loop and cooperating with the working mode of the driving device, or the upright or inverted state of the liquid storage container, that is, in the pre-filling mode, the outlet of the liquid in the liquid storage container is at a low position; and in the emptying mode, the outlet of the gas in the liquid storage container is at a high position; compared with the conventional operation in the prior art, the system structure of the present application is simple, the operation is convenient, and the learning cost is low. The operator does not need to repeatedly invert the dialyzer for continuous circulation and pre-filling. Moreover, the application of the dialysis device of the present application enables more scientific treatment of medical waste such as pipelines and waste liquids after emptying.
[0140] In another aspect, the present application further provides a purification circuit, comprising a pipeline, a drive device, and a gas collecting chamber. The pipeline constitutes a fluid passage of the purification circuit, and the drive device is disposed on the pipeline to drive the fluid in the pipeline to flow forward or reversely in the pipeline. The gas collecting chamber is connected to the pipeline, and the gas collecting chamber includes a reverse gas collecting chamber for enriching gas in the purification circuit when the fluid in the purification circuit flows in reverse.
[0141] In one embodiment, the gas collection chamber includes a reverse gas collection chamber and a forward gas collection chamber. The forward gas collection chamber is used to enrich gas in the purification circuit when the fluid in the purification circuit flows in a forward direction. For example, in an example where the purification circuit is applied to a dialysis device, the forward gas collection chamber is, for example, an arterial or venous chamber, so as to enrich bubbles or gas entrained in a fluid such as a flushing fluid or blood when the fluid flows in a forward direction.
[0142] In an embodiment, when the fluid in the purification circuit flows in a forward direction, the reverse plenum is located downstream of the forward plenum. In other words, with the forward flow of the fluid as the reference for upstream and downstream, in one embodiment, the forward plenum is located upstream and the reverse plenum is located downstream; in another embodiment, the reverse plenum is located upstream and the forward plenum is located downstream.
[0143] In another embodiment, the reverse gas collecting chamber and the forward gas collecting chamber can be one gas collecting chamber, that is, the gas collecting chamber is a bidirectional gas collecting chamber that can collect bubbles or gases in the enriched fluid regardless of whether the liquid moves forward or backward. That is, the reverse gas collecting chamber and the forward gas collecting chamber are the same cavity, and the cavity includes a liquid storage space located in the lower part of the cavity and a gas collecting space located in the upper part of the cavity. A first interface for connecting to the upstream of the pipeline and a second interface for connecting to the downstream of the pipeline are opened on opposite sides of the bottom end of the liquid storage space of the cavity.
[0144] In this embodiment, the gas collecting chamber includes a liquid storage space located in the lower part of the chamber and a gas collecting space located in the upper part of the chamber. That is, the gas collecting chamber is divided into two spaces according to function, the upper gas collecting space is used to collect gas, and the lower liquid storage space is used to collect liquid passing through the gas collecting chamber, that is, there is a gas-liquid separation layer in the gas collecting chamber, and a first interface and a second interface are provided on the gas collecting chamber. The liquid flows from the first interface through the internal space of the gas collecting chamber to the second interface. The shortest flow distance of the liquid is controlled by designing the internal structure of the gas collecting chamber and the relative positions of the first interface and the second interface, so that the bubbles in the liquid can float up and escape and achieve the purpose of gas-liquid interface separation. In the structural diagrams of several gas collecting chambers shown in Figures 26 to 29 below, the horizontal dotted line in the figure is used to represent the gas-liquid interface, that is, the lower side of the gas-liquid interface is the liquid storage space, and the lower side of the gas-liquid interface is the gas collecting space.
[0145] The inlet and outlet of the gas collection chamber are both located at the bottom end of the liquid storage space. In this embodiment, the first interface is connected to the bottom interface of the dialysis device on the dialysis pathway, and the second interface is connected to the venous pot on the venous blood line. When the fluid in the purification circuit is driven in the forward direction, the first interface is the inlet and the second interface is the outlet; conversely, when the fluid in the purification circuit is driven in the reverse direction, the second interface is the inlet and the first interface is the outlet.
[0146] In other embodiments of the present application, the purification circuit includes a blood circuit, a water circuit, an enrichment circuit, or a metabolic circuit. Wherein, the metabolic circuit is, for example, a metabolic circuit used in the metabolic circuit of hemodialysis and peritoneal dialysis. In some embodiments, the metabolic circuit is, for example, a circuit or circuit system or a circuit in a circulation treatment system constituted by the “metabolic circulation module” described in patent document WO2022036739A1 or / and patent document WO2022036738A1; in this application, the full text of patent documents WO2022036739A1 and WO2022036738A1 is hereby cited.
[0147] The purification circuit of the present application can be applied to the field of hemodialysis in various modes and medical scenarios such as hospital treatment and home treatment, especially in blood purification equipment, such as blood purification systems or hemodialysis machines. Of course, the purification circuit of the present application can also be applied to the field of peritoneal dialysis. Peritoneal dialysis is the process of injecting dialysate into the abdominal cavity and using the peritoneum in the body to filter and remove metabolic waste and excess water from the blood. It is one of the treatments for renal failure other than hemodialysis. Before membrane dialysis, the extracorporeal circulation circuit also needs to be flushed. The description of the following embodiments will be temporarily explained by taking the dialysis equipment applied by the purification circuit as a hemodialysis equipment as an example.
[0148] Please refer to Figure 20, which is a schematic diagram of the principle of the purification circuit of the present application in one embodiment. As shown in the figure, the purification circuit of the present application includes an arterial blood line L1 as a first line, a dialysis pathway (the pathway of the dialysis device 6 is included in the figure), and a venous blood line L3 as a second line. The arterial end 50 of the arterial blood line L1 and the venous end 90 of the venous blood line L3 are connected to each other, so that the arterial blood line L1, the dialysis pathway, and the venous blood line L3 constitute a circulation loop, namely a purification loop. In the present application, the circulation loop can be used as a priming loop in the priming procedure; in the flushing procedure, the circulation loop is also a flushing loop; in the emptying procedure, the circulation loop is also an emptying loop. In the embodiment in which the dialysis device described later is a hemodialysis device, for the sake of convenience, the following will be described using the example in which the first line is the arterial blood line L1 and the second line is the venous blood line L3 as an example.
[0149] It should be noted that a liquid storage container 1 is also provided on the purification circuit. The liquid storage container 1 is used to store pre-filled liquid and recover emptied waste liquid, and includes a container body 10, and an inlet and outlet provided on the container body 10 for pre-filled liquid or recovery of waste liquid. In one embodiment, the liquid storage container 1 is a soft pre-filled liquid bag, such as a liquid bag made of medical plastic; in another embodiment, the liquid storage container 1 is a hard pre-filled liquid bottle, such as a liquid bottle or jar made of glass. In order to facilitate the observation of the content of the liquid in the container body, in some embodiments, the container body 10 is made of a transparent material, and the surface is marked with a volume scale line. In this application, the "pre-filled liquid" refers to the pre-filled liquid used in the blood purification control device, which can be used to flush the purification circuit. In the embodiment, the liquid is, for example, physiological saline, physiological buffer, or enzyme-loaded microsphere solution.
[0150] In one embodiment, the liquid storage container is connected to the circulation loop in a branch manner. More specifically, the two interfaces of the liquid storage container are respectively connected to different sections in the circulation loop through two parallel branches, and are connected to the circulation loop when the passage of the above sections is blocked, so as to realize storage of pre-filled liquid and recovery of emptied waste liquid.
[0151] Still taking hemodialysis as an example, the purification circuit described in the system of the present application is a vascular access system for extracorporeal blood circulation established by puncturing with a needle to obtain blood and return the treated blood during the blood purification and hemodialysis process. In the purification circuit of the present application, the pipeline used can be set as a blood delivery pipeline, a liquid medicine delivery pipeline, or a dedicated pipeline for a peristaltic pump. The pipeline materials include but are not limited to soft polyvinyl chloride plastics, high-performance polyolefin thermoplastic elastomers (TPE), nano-biomedical materials, resin materials, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyether urethane (PEU), polyurethane (PU), polyester (PET), etc.
[0152] It should be understood that "conduit" or "tubing" disclosed in this application means that components can be fluidically coupled to each other so as to provide a path for transferring fluid (i.e., saline, blood, or plasma, etc.) between these components. "Conduit" as used herein broadly includes tubes, pipes, hoses, catheters, or other structures having one or more lumens adapted to transfer fluid between two ends. Typically, tubes are elongated cylindrical structures with some flexibility, but the geometry and rigidity can vary. In some embodiments, multiple components can also be coupled by virtue of physical proximity, become a single structure as a whole, or be formed from the same material.
[0153] The loop is used to represent a unit formed by hardware or structure including pipelines, devices connected or associated in the pipelines, such as containers, drive devices, dialysis devices, etc., and a path including the aforementioned hardware or structures, such as fluids in the pipelines, and pre-filled fluids added to the pipelines.
[0154] In certain embodiments of the present application, the purification circuit includes an arterial blood line for accessing a human arterial vessel (i.e., the arterial blood line L1 as the first line in FIG. 20 above), a dialysis pathway connected to the arterial blood line (i.e., the pathway including the dialysis device in FIG. 20 above), and a venous blood line connected to the dialysis pathway (i.e., the arterial blood line L3 as the second line in FIG. 20 above).
[0155] Among them, the arterial blood line L1 includes an arterial end 50 that intervenes in the human artery (the first part of the human body) and an arterial pipeline connecting the arterial end 50 and the dialysis device 6. A driving device 3 is provided on the arterial pipeline. In some cases, an arterial pot is also provided on the line before the arterial pipeline is connected to the dialysis device 6; the arterial pipeline is also provided with necessary elements or components such as an arterial pressure sensor, a hydrophobic filter, a heparin syringe, and a heparin pump.
[0156] The venous blood line L3 includes a venous end 90 that intervenes in the human venous blood vessels (the second part of the human body), and a venous pipeline connecting the venous end 90 and the dialysis device 6. A venous pot is provided on the venous pipeline. In some cases, the venous pipeline is also provided with a venous pressure sensor, a hydrophobic filter, a venous pot three-way valve, an exhaust pipeline connected to the venous pot, a liquid level sensor, an air sensor, a venous valve such as a venous clamp, a photoelectric sensor and other necessary elements or components.
[0157] It should be noted that in the “priming”, “flushing” and “emptying” operation modes, the arterial end of the arterial blood line and the venous end of the venous blood line need to be connected / communicated to form a circulation loop.
[0158] The dialysis pathway refers to a pathway through the dialysis device, including an inlet from the top of the dialysis device and an outlet from the bottom of the dialysis device. The dialysis device is also provided with a dialysis circuit. The dialysate circuit includes a dialysate inlet and a dialysate outlet, which are used to input the dialysate into the dialysis device and output it after treatment. It should be understood that the dialysate circuit also includes necessary valves, sensors and other necessary elements or components.
[0159] The driving device 3 is provided on the arterial blood line L1 and is used to drive a fluid (e.g., priming fluid or blood) to flow in a forward or reverse direction in the circulation loop. It should be noted that during hemodialysis treatment, the dialysis device drives blood from the arterial end 50 to the venous end 90 in a forward flow direction.
[0160] In an embodiment, the driving device includes but is not limited to a peristaltic pump or a pressure pump, which is used to provide power to the fluid in the pipeline so that the fluid circulates in a predetermined flow direction. In this application scenario for medical purposes, the driving device should not directly contact the fluid, but only apply pressure to the pipeline and drive the fluid to flow. The preferred embodiment of the driving device is a peristaltic pump, more specifically, the peristaltic pump is, for example, a dialysis pump or a blood pump. The forward and reverse rotation (reversal) of the peristaltic pump will cause the flow direction of the fluid in the circulation loop to be different.
[0161] It should be understood that the driving device can drive the fluid in the pipeline at different positions in the pipeline, and its flow rate may change due to factors such as pipeline resistance, temperature, and pressure in the direction of fluid flow. However, in the embodiment of the present application applied to the field of dialysis, the driving device is arranged on the circulation loop, especially on the arterial blood line of the purification circuit.
[0162] In the present application, a gas collection chamber 7 is provided on the venous blood line L3; this chamber is used to collect gases from the purification circuit as the fluid in the purification circuit flows from the venous blood line L3 to the arterial blood line L1. It should be noted that the gas collection chamber 7 provided on the venous blood line L3 is not a traditional intravenous evacuator. Traditional intravenous evacuators are used to observe the dripping status and collect gases from the pipeline during forward flow (i.e., flow from the arterial end to the venous end) of fluids such as blood or saline. Therefore, traditional intravenous evacuators generally have an inverted trapezoidal or conical cross-section, and are typically equipped with an exhaust line at the top, along with components such as an intravenous evacuator valve and a sensor. The gas collection chamber 7 in the present application, on the other hand, collects gases / bubbles from the purification circuit into the chamber when fluid flows from the venous blood line L3 to the arterial blood line L1 (i.e., reverse flow). This is achieved through the design of its inlet and outlet, which will be described in detail later.
[0163] In summary, the present application adds a purification circuit of an air collecting chamber to the venous blood line, so that during the flushing operation, the final flushing and exhaust of the dialysis can be achieved even without turning the dialysis device upside down. The present application reversely drives the fluid in the pipeline and adds an air collecting chamber downstream of the dialyzer device. When the liquid flows from the venous end through the venous pot to the air collecting chamber and then to the bottom of the dialysis device, the air collecting chamber can be enriched with a certain amount of gas. Since the gas in the air collecting chamber will preferentially flow out from its top, the gas in the air collecting chamber can be discharged in a timely manner in the treatment mode.
[0164] In one embodiment, the inner diameter of the gas collection chamber is larger than the inner diameter of the tubing in the venous blood line, so as to be able to accommodate and enrich the gas / bubbles in the tubing.
[0165] In one embodiment, the volume of the gas collecting chamber is larger than the volume of the stored gas in the purification circuit in the initial state (the initial state is the state before flushing and after the priming is completed, which will be described in the specification) to ensure that all gases originally retained in the purification circuit (including the gas retained in the dialysis device) can be enriched in a normal pressure environment. The "initial state" refers to the state before the purification circuit is flushed, or the state after the purification circuit is priming and the flushing operation has not yet been performed. The "stored gas" refers to the gas remaining in the dialysis device in the above-mentioned initial state; or the gas remaining in the dialysis device and the residual gas in the venous pot in the above-mentioned initial state; or the gas remaining in the dialysis device and the residual gas in the venous pot and the residual gas in the arterial pot in the above-mentioned initial state.
[0166] Please refer to Figure 21, which shows a schematic diagram of the gas collecting chamber and its connection relationship in the purification circuit of the present application. As shown in the figure, in one embodiment provided by the present application, the gas collecting chamber 7 has a first interface 70 for connecting to the dialysis pathway through a pipeline and a second interface 71 for connecting to the venous end of the venous blood line through a pipeline, wherein the first interface 70 is located at the bottom end of the gas collecting chamber 7 and the second interface 71 is located at the top end of the gas collecting chamber 7. In this embodiment, the gas collecting chamber 7 has two interfaces, a first interface 70 at the bottom and a second interface 71 at the top. The first interface 70 is used to connect to the bottom end of the dialysis device 6, and the second interface 71 is used to connect to the venous pot in the venous blood line. When the fluid in the pipeline is driven in reverse, the fluid enters the gas collecting chamber 7 from the second interface 71 on the upper side, and the liquid in the fluid will preferentially flow out from the first interface 70 at the bottom, thereby causing the gas carried by the fluid to be retained in the gas collecting chamber 7.
[0167] During the flushing operation, when the fluid in the purification circuit is driven in reverse, the liquid and / or gas passing through the venous blood line L3 flows from the second interface 71 into the gas collecting chamber 7, and flows from the first interface 70 to the dialysis passage, so that the gas carried in the liquid is enriched in the gas collecting chamber 7.
[0168] Please refer to FIG. 22 , which shows a schematic diagram of the fluid flow in the purification circuit of the present application during a flushing embodiment. As shown in the figure, during the flushing operation, the arterial end 50 of the arterial blood line L1 is connected to the venous end 90 of the venous blood line L3, and the fluid in the purification circuit flows in a reverse direction. Gas stored in the dialysis device on the dialysis access rises to the top of the arterial blood line L1 and the venous blood line L3, and is concentrated in the gas collection chamber 7. Liquid entering the gas collection chamber 7 flows from the first port 70 of the gas collection chamber 7 to the bottom of the dialysis device 6 on the dialysis access. Since the gas in the purification circuit is concentrated in the gas collection chamber 7 during the flushing mode, during the treatment phase, i.e., when the fluid in the purification circuit is driven in the forward direction, the gas originally concentrated in the gas collection chamber 7 preferentially flows along the venous blood line L3 into the venous pot 93, and is then discharged through the exhaust pipe L4 of the venous pot 93.
[0169] In one embodiment, an arterial pot 53 is connected to the pipeline between the dialysis access and the arterial end 50 of the arterial blood line L1 for observing the dripping situation in the treatment mode. The cross section of the arterial pot 53 is generally in an inverted trapezoidal or conical structure.
[0170] Please refer to Figure 23, which is a schematic diagram of the fluid flow direction of the purification circuit of the present application in a treatment embodiment. As shown in the figure, in treatment mode or during treatment operation, the dialysis device drives the blood to flow from the arterial end 50 to the venous end 90 in a forward flow; that is, when the fluid in the purification circuit is driven in the forward direction, the liquid passing through the arterial blood line L1 flows into the gas collecting chamber 7 from the first interface 70 through the dialysis pathway, and after filling the gas collecting chamber 7, flows from the second interface 71 to the venous blood line L3.
[0171] In one embodiment, a venous trap 93 is connected to the pipeline between the gas collection chamber 7 and the venous end 90 of the venous blood line L3. In this embodiment, the venous trap 93 and the gas collection chamber 7 are two independent components connected in series to the venous blood line L3. The venous trap 93 is used to monitor the infusion status and collect gas from the pipeline. Therefore, the cross-section of a traditional venous trap is generally an inverted trapezoidal or conical structure. The top of the traditional venous trap is usually equipped with an exhaust pipeline, as well as components such as a venous trap valve, a venous pressure sensor, and a hydrophobic filter. In treatment mode or during treatment operation, when the fluid in the purification circuit is driven forward, the gas enriched in the gas collection chamber 7 flows into the venous trap 93 preferentially over the liquid entering the gas collection chamber 7, and is discharged from the venous trap 93 through the exhaust pipeline L4 provided on the venous trap 93.
[0172] In one embodiment, it is also possible to consider integrating the aforementioned intravenous pot and gas collection chamber into a component that serves both functions as a gas collection chamber and an intravenous pot. For ease of description, this will also be referred to as a gas collection chamber in subsequent embodiments. The gas collection chamber differs from the structure of a conventional intravenous pot, which generally has an inverted trapezoidal or conical cross-section. In this embodiment, the gas collection chamber includes a liquid storage space located in the lower portion of the chamber and a gas collection space located in the upper portion of the chamber. That is, the gas collection chamber is functionally divided into two spaces: the upper gas collection space is used to collect gas, and the lower liquid storage space is used to collect liquid passing through the gas collection chamber. That is, the gas collection chamber has a gas-liquid separation layer, and a first interface and a second interface are provided on the gas collection chamber. The liquid flows from the first interface through the internal space of the gas collection chamber to the second interface. By designing the internal structure of the gas collection chamber and the relative positions of the first and second interfaces, the shortest flow distance of the liquid is controlled, so that bubbles in the liquid can float up and escape, achieving the purpose of gas-liquid interface separation. In the structural diagrams of several gas collecting cavities shown in the following Figures 26 to 29, the horizontal dotted line in the figure is used to represent the gas-liquid interface, that is, the lower side of the gas-liquid interface is the liquid storage space, and the lower side of the gas-liquid interface is the gas collecting space.
[0173] In one embodiment, a third interface can be directly provided on the top of the gas collecting chamber for connecting to the exhaust pipe, for example, a valve device for controlling the exhaust is provided on the exhaust pipe. In one example, the exhaust pipe is provided with components such as a hydrophobic filter, a static pressure sensor, a solenoid valve, and / or a hydrophobic filter.
[0174] Please refer to Figure 24, which shows a schematic diagram of an alternative structure of a plenum chamber in one embodiment of the purification circuit of the present application. As shown, to facilitate the participation of liquid within a liquid storage space 72 in the circulation process of the purification circuit, a first port 70 for connecting to the dialysis pathway via a pipeline and a second port 71 for connecting to the venous end 90 of the venous blood line L3 via a pipeline are provided on opposite sides of the bottom end of the liquid storage space 72. In other words, the inlet and outlet of the plenum chamber 7 are both located at the bottom end of the liquid storage space 72. In this embodiment, the first port 70 connects to the bottom port of the dialysis device 6 on the dialysis pathway, and the second port 71 connects to the venous ureter of the venous blood line L3. When the fluid in the purification circuit is driven in the forward direction, the first port 70 serves as the inlet, and the second port 71 serves as the outlet. Conversely, when the fluid in the purification circuit is driven in the reverse direction, the second port 71 serves as the inlet, and the first port 70 serves as the outlet.
[0175] As shown in FIG24 , in an embodiment of a flushing operation, the arterial end 50 of the arterial blood line L1 is connected to the venous end 90 of the venous blood line L3, and the fluid in the purification circuit flows in the reverse direction. The gas in the dialysis device 6 on the dialysis pathway floats to the top thereof, and flows in sequence along the arterial blood line L1 and the venous blood line L3, and enters the gas collecting chamber 7 through the second interface 71 of the gas collecting chamber 7. Since the mass of the gas is smaller than that of the liquid, the gas will float up and be retained above the liquid surface. Therefore, the gas in the purification circuit can be enriched in the gas collecting space 73 in the gas collecting chamber 7 while flushing. The liquid entering the gas collecting chamber 7 flows in from the second interface 71 of the gas collecting chamber 7 and flows out through the first interface 70 to flow to the bottom end of the dialysis device 6 on the dialysis pathway.
[0176] In order to increase the flow resistance or generate turbulence for the fluid flowing through the liquid storage space 72 in the gas collecting chamber 7, so that the gas in the fluid is enriched in the gas collecting space 73 located on the upper side, the liquid flowing from one of the first interface 70 or the second interface 71 through the liquid storage space 72 to the other interface undergoes multiple flow direction changes in the liquid storage space 72. In an embodiment, for example, by providing an isolation portion or an isolation structure between the first interface 70 and the second interface 71, the fluid flowing from the first interface 70 to the second interface 71, or from the second interface 71 to the first interface 70, undergoes a flow direction change, increases the flow resistance of the fluid or generates turbulence, and thereby enables the gas / bubbles carried in the fluid to be enriched above the liquid surface of the liquid storage space 72. It should be understood that the isolation portion or isolation structure is not completely isolated in space. In order to ensure the flow between the first interface 70 and the second interface 71, the isolation portion or isolation structure may also be referred to as an obstruction portion or obstruction structure, or an interference portion or interference structure, etc.
[0177] Please refer to Figure 25, which shows a schematic diagram of another embodiment of the purification circuit of the present application using another structure of the gas collection chamber. In the embodiment shown in the figure, the pipeline between the dialysis device 6 and the venous end 90 of the venous blood line L3 is also connected to the gas collection chamber 7, which also serves as a venous pot. In this embodiment, the gas collection chamber 7 includes a liquid storage space 72 located in the lower part of the cavity and a gas collection space 73 located in the upper part of the cavity. In other words, the gas collection chamber 7 is divided into two spaces according to function: the upper gas collection space is used to collect gas, and the lower liquid storage space is used to collect liquid passing through the gas collection chamber. In one embodiment, the top of the gas collection chamber 7 can be directly provided with an opening for connecting to the exhaust pipeline L4. For example, a valve device 80 for controlling exhaust is provided on the exhaust pipeline. In one example, the exhaust pipeline is provided with components such as a hydrophobic filter, a static pressure sensor, a solenoid valve, and / or a hydrophobic filter.
[0178] In an embodiment of treatment operation as shown in Figure 25, in treatment mode or during treatment operation, when the fluid in the purification circuit is driven forward, the fluid such as blood flows from the arterial blood line L1 into the dialysis device 6 for blood purification treatment, flows into the venous blood line L3, and enters from the first interface 70 of the gas collecting chamber 7, and the liquid such as blood flows from the second interface 71 in the liquid storage space 72 to the venous end 90 of the venous blood line L3, and the bubbles of the liquid such as blood will be enriched in the gas collecting space 73 on the upper side of the gas collecting chamber 7, and discharged through the exhaust line L4 in time according to the detection of the sensor.
[0179] Please refer to Figure 26, which shows a schematic diagram of the structure of the gas collection chamber of the present application in one embodiment. As shown in the figure, in this embodiment, the liquid storage space 72 includes a first extension portion 720 and a second extension portion 721 extending downward, respectively, and an isolation portion 722 located between the first extension portion 720 and the second extension portion 721; wherein the first interface 70 is opened at the bottom end of the first extension portion 720; the second interface 71 is opened at the bottom end of the second extension portion 721, and the isolation portion 722 is higher than the first interface 70 and the second interface 71. In this embodiment, in order to ensure that the inlet and outlet of the liquid storage space 72 are both at the lowest position, the first interface 70 and the second interface 71 are respectively set at the bottom ends of the first extension portion 720 and the second extension portion 721 extending downward, so that no matter whether the fluid flows from the first interface 70 to the second interface 71 or from the second interface 71 to the first interface 70, the fluid flows from the bottom to the top in the gas collection chamber 7. In this embodiment, the first extension portion 720 and the second extension portion 721 of the liquid storage space 72 both extend downward. It should be understood that the "downward extension" includes, for example, a vertical downward extension as shown in FIG. 28 , and may also include, for example, an inclined downward extension as shown in FIG. 27 .
[0180] In another embodiment, one of the first extension portion and the second extension portion of the liquid storage space extends horizontally, and the other extension portion extends downward, so that the first extension portion and the second extension portion have an incident angle. In specific practice, the angle of the incident angle can be designed accordingly according to parameters such as the actual fluid flow rate, bubble content, or fluid flow rate.
[0181] In an embodiment, the length of the first extension portion with the first interface or the second extension portion with the second interface is related to the flow rate, bubble content, or fluid flow rate of the fluid in the liquid storage space; or the length of the isolation portion located between the first extension portion and the second extension portion is related to the flow rate, bubble content, or fluid flow rate of the fluid in the liquid storage space; or the shortest flow distance of the fluid flowing from one interface of the first interface or the second interface to the other interface is related to the flow rate, bubble content, or fluid flow rate of the fluid.
[0182] In an embodiment, a fluid, such as a liquid, flows from a first extension portion having a first interface through the internal space of a gas collecting chamber to a second extension portion having a second interface. The internal structure of the gas collecting chamber and the relative positions of the first interface and the second interface are designed to control the shortest flow distance of the liquid so that the bubbles in the liquid can float up and escape and achieve the purpose of gas-liquid interface separation. The shortest flow distance of the liquid is related to the bubble content, flow rate, or flow rate of the liquid. For example, the higher the bubble content in the liquid, or the faster the flow rate, or the larger the flow rate, in practice, the longer the shortest flow distance of the liquid needs to be designed. Corresponding to different embodiments, for example, in one example, when the bubble content in the liquid is higher, or the flow rate is faster, the length of the first extension part or the second extension part is longer; in another example, when the bubble content in the liquid is higher, or the flow rate is faster, or the flow rate is larger, the length of the isolation part located between the first extension part and the second extension part is longer; in yet another example, when the bubble content in the liquid is higher, or the flow rate is faster, or the flow rate is larger, the shortest flow distance of the fluid flowing from one interface of the first interface or the second interface to the other interface needs to be longer.
[0183] In this embodiment, in order to adjust the flow resistance of the fluid passing through the gas collecting chamber or to generate turbulence, or to adjust the flow rate of the fluid passing through the gas collecting chamber, so as to facilitate the gas / bubbles carried in the fluid to be enriched above the liquid level of the liquid storage space, the length of the first extension part and / or the second extension part can be appropriately increased or shortened in actual application; of course, the above purpose can also be achieved by changing the length of the isolation part between the first extension part and the second extension part. In some embodiments, the isolation part is a stepped structure relative to the first extension part and / or the second extension part; the isolation part is an arched structure relative to the first extension part and / or the second extension part; or the isolation part is a baffle structure extending upward from the bottom of the gas collecting chamber; for example, the gas collecting chamber is roughly A-shaped, inverted V-shaped, inverted U-shaped, n-shaped, or "mountain"-shaped, etc., with a bottom extension part. For example, Figure 27 shows a schematic diagram of a plenum chamber that is roughly A-shaped or inverted V-shaped, wherein the partition is positioned higher relative to the first and second extensions, forming a trapezoidal or stepped structure; or Figure 28 shows a schematic diagram of a plenum chamber that is roughly inverted U-shaped or N-shaped; or Figure 29 shows a schematic diagram of a plenum chamber interior that is roughly chevron-shaped. As shown in Figure 29, the partition 722 provided within the plenum chamber is a baffle structure extending upward from the bottom of the plenum chamber. The left and right portions separated by this baffle structure constitute the first extension 720 and the second extension 721. The first interface 70 and the second interface 71 form opposite sides of the plenum chamber bottom. The partition 722 is an arched structure relative to the first extension 720 and / or the second extension 721, which is not shown. It should be understood that the aforementioned arched structure can be achieved by changing the bottom surface of the liquid storage space shown in Figure 28 to an upwardly arched arc, so that the first extension, partition, and second extension form a bridge-shaped arch.
[0184] It should be noted that in order to better achieve gas-liquid separation, in one embodiment of the present application, the path cross-section of the fluid flowing from one of the first interface or the second interface to the other interface is larger than the cross-section of the first interface or the second interface, that is, by designing a redundant space structure for the internal space of the gas collecting cavity or the flow channel of the fluid, so that the cross-section of the liquid flow path is much larger than the cross-sectional area of the interface (the first interface or the second interface), so as to reduce the liquid flow rate and increase the gas escape time. For example, when the liquid flows horizontally, the horizontal cross-sectional area gradually increases, the flow rate gradually decreases, and the flow rate is consistent, so that the gas can easily escape.
[0185] In one embodiment, a filter element 75 is provided in the liquid storage space 72 for filtering the fluid flowing between the first interface 70 and the second interface 71. Specifically, the bottom end of the filter element 75 is adjacent to the first interface 70, and the top end of the filter element 75 is adjacent to the second interface 72, and is arranged in the gas collecting cavity at an angle of 30°-60°. Preferably, the filter element has an inclination angle of 30°, 31°, 32°, 33°, 34°, 35°, 36°, 37°, 38°, 39°, 40°, 41°, 42°, 43°, 44°, 45°, 46°, 47°, 48°, 49°, 50°, 51°, 52°, 53°, 54°, 55°, 56°, 57°, 58°, 59°, or 60° in the gas collecting cavity. In a preferred embodiment, the filter element has an inclination angle of 45° in the gas collecting cavity. It should be understood that the inclination angle of the filter element in the gas collecting chamber refers to the angle between the filter element and the bottom surface of the gas collecting chamber. In a specific embodiment, the filter element is a filter screen or a filter membrane.
[0186] As mentioned above, the above-mentioned intravenous pot and gas collection chamber are integrated into a component that has the functions of both the gas collection chamber and the intravenous pot. Therefore, in order to facilitate the discharge of the gas enriched therein from the gas collection chamber of this application during treatment, as shown in Figure 26, the top of the gas collection space 73 in the gas collection chamber is provided with an air bag 74 connected to the cavity. The air bag 74 is a protruding cavity that ensures a small air contact surface, which is convenient for being clamped to detect the liquid level position or the enriched gas volume or air pressure therein. To cooperate with the air bag 74, a detection device for clamping the air bag 74 to detect the liquid level position or the enriched gas volume in the gas collection chamber is also included. In a specific example, the detection device is a liquid level detection device, a pressure detection device, or a liquid level adjustment device. In this embodiment, the air bag is also connected to an exhaust pipeline for exhausting gas from the cavity (gas collection space). The exhaust pipeline is provided with a valve device for controlling exhaust. In one example, the exhaust pipeline is provided with components such as a hydrophobic filter, a static pressure sensor, a solenoid valve, and / or a hydrophobic filter.
[0187] The present application also provides a method for flushing a purification circuit, which is applied to the field of hemodialysis in various modes and medical scenarios such as hospital treatment and home treatment, and is particularly applied in blood purification equipment, such as in a blood purification system or a hemodialysis machine. Of course, the purification circuit of the present application can also be applied to the field of peritoneal dialysis. Peritoneal dialysis is the process of injecting dialysate into the abdominal cavity and using the peritoneum in the body to filter and remove metabolic waste and excess water from the blood. It is one of the therapies for renal failure other than hemodialysis, and the extracorporeal circulation circuit also needs to be flushed before membrane dialysis. As mentioned above, the purification circuit in the method for flushing a purification circuit of the present application can also be a blood circuit / blood circuit, a water circuit, or a metabolic circulation circuit. Among them, the metabolic circulation circuit is, for example, a metabolic circulation circuit used in the metabolic circulation of hemodialysis and peritoneal dialysis.
[0188] In the present application, the purification circuit includes an arterial blood line for accessing a human artery, a drive device provided on the arterial blood line, a dialysis device connected to the arterial blood line, and a venous blood line connected to the dialysis device; in an embodiment, the purification circuit is in the manner described in the embodiment shown in FIG. 20 above, and will not be described in detail here. The method for flushing the purification circuit includes the following steps:
[0189] An air collecting chamber is provided on the venous blood line, and the arterial end of the arterial blood line is connected to the venous end of the venous blood line; in an embodiment, the structure and working principle of the air collecting chamber are as described in the embodiments shown in Figures 21 to 23 or Figures 24 to 27 above, and will not be repeated here.
[0190] The priming fluid applied to the purification circuit is caused to flow from the venous blood line to the arterial blood line (i.e., reverse driving), so that the gas pre-stored in the dialysis device and / or the arterial blood line is enriched in the gas collecting chamber. In an embodiment, the process of implementing this step is as described in the embodiment shown in Figure 22 above, and will not be repeated here.
[0191] In the step of the priming liquid flowing from the venous blood line to the arterial blood line, the gas stored in the dialysis device floats to the top thereof and passes through the arterial blood line and the venous blood line in sequence and enters from the top of the gas collecting chamber to be enriched in the gas collecting chamber, and the liquid flows from the bottom of the gas collecting chamber to the bottom end of the dialysis device in the manner described in the embodiment shown in Figure 22 above, which will not be repeated here.
[0192] In an embodiment, a venous trap is also connected to the pipeline between the gas collection chamber and the venous end of the venous blood line. This is in the manner described in the embodiment shown in Figure 23 above, and further includes a step of directing the priming fluid or blood applied to the purification circuit from the arterial blood line to the venous blood line (i.e., forward driving), so that the gas enriched in the gas collection chamber flows into the venous trap preferentially over the liquid entering the gas collection chamber, thereby allowing it to be discharged from the venous trap. In an embodiment, this is in the manner described in the embodiment shown in Figure 23 above, and no further details will be given here.
[0193] In an embodiment, the gas collecting chamber includes a liquid storage space located in the lower part of the chamber and a gas collecting space located in the upper part of the chamber. In an embodiment, the embodiment is as described in the embodiment shown in FIG24 above, and no further details are given here.
[0194] A first interface for connecting to the dialysis access via a pipeline and a second interface for connecting to the venous end of the venous blood line via a pipeline are provided on opposite sides of the bottom end of the liquid storage space. In an embodiment, the embodiment is as described in the embodiment shown in Figures 26 to 28 above, and no further details will be given here.
[0195] In the step of the priming liquid flowing from the venous blood line to the arterial blood line, the gas stored in the dialysis device floats to the top thereof and passes through the arterial blood line and the venous blood line in sequence and enters from the second interface of the gas collecting chamber and is enriched in the inner gas collecting space of the gas collecting chamber. The liquid flows from the first interface of the gas collecting chamber to the bottom end of the dialysis pathway. As shown in FIG24 , in an embodiment of a flushing operation, the arterial end of the arterial blood line is connected to the venous end of the venous blood line, and the fluid in the purification circuit is reversely flowed, so that the gas in the dialysis device on the dialysis pathway floats to the top thereof, and flows in sequence along the arterial blood line and the venous blood line, and enters the gas collecting chamber through the second interface of the gas collecting chamber. Since the mass of the gas is smaller than that of the liquid, the gas will float up and be retained above the liquid surface, and thus the gas in the purification circuit can be enriched in the gas collecting space in the gas collecting chamber while flushing, and the liquid entering the gas collecting chamber flows in from the second interface of the gas collecting chamber and flows out through the first interface to flow to the bottom end of the dialysis device on the dialysis pathway.
[0196] In an embodiment, the method further includes causing the priming liquid or blood applied to the purification circuit to flow from the arterial blood line to the venous blood line (positive drive), so that the priming liquid or blood enters from the first interface of the gas collection chamber and flows from the second interface to the venous blood line, and the gas or bubbles carried by the priming liquid or blood are enriched in the gas collection space of the gas collection chamber for discharge. In treatment mode or during treatment operation, when the fluid in the purification circuit is driven in the positive direction, the gas enriched in the gas collection chamber flows into the venous pot preferentially over the liquid entering the gas collection chamber so as to be discharged from the venous pot through the exhaust pipe provided on the venous pot. In an embodiment of treatment operation as shown in Figure 25, in treatment mode or during treatment operation, when the fluid in the purification circuit is driven forward, the fluid, for example, blood, flows from the arterial blood line into the dialysis device for blood purification treatment and then flows into the venous blood line, and enters from the first interface of the gas collecting chamber, and the liquid, for example, blood, flows from the second interface in the liquid storage space to the venous end of the venous blood line, and the bubbles in the liquid, for example, blood, will be enriched in the gas collecting space on the upper side of the gas collecting chamber, and discharged through the exhaust pipe in time according to the detection of the sensor.
[0197] The present application also provides a dialysis device for dialysis treatment, which is suitable for home hemodialysis (HHD) treatment scenarios and hospital hemodialysis scenarios. Please refer to Figure 20 or Figure 24, the dialysis device includes: a purification circuit, a drive device, a dialysis device, and a control device. When the dialysis device of the present application is actually used, its operation process includes several processes, which are roughly divided into pipeline connection, pre-filling, flushing, treatment, blood return, emptying water, and disconnecting the pipeline and discarding. In the following embodiments, the dialysis device provided by the present application will be used to illustrate the process of "flushing" in subsequent embodiments.
[0198] The purification circuit includes a first circuit, a dialysis pathway connected to the first circuit, and a second circuit connected to the dialysis pathway; wherein the second circuit is provided with a gas collecting chamber; the gas collecting chamber is used to enrich the gas in the purification circuit when the fluid in the purification circuit flows from the second circuit to the first circuit; in certain embodiments of the present application, the purification circuit includes a first circuit, a second circuit, and a dialysate circuit provided between the first circuit and the second circuit for connecting to a dialysis device. In an embodiment where the dialysis device is a hemodialysis device, the first circuit is an arterial blood circuit, and the second circuit is a venous blood circuit. As shown in FIG20 or FIG24 , the circulation circuit includes an arterial blood line L1 and a venous blood line L3 connected to the arterial blood line L1. The purification circuit includes an arterial blood line for accessing a first part of a human body (e.g., a human artery), a dialysis access connected to the arterial blood line, and a venous blood line connected to the dialysis access. The venous blood line is for accessing a second part of a human body (e.g., a human venous vessel). The venous blood line is provided with a gas collecting chamber. The gas collecting chamber is used to enrich gas in the purification circuit as the fluid in the purification circuit flows from the venous blood line to the arterial blood line. In an embodiment, the purification circuit includes the arterial blood line L1, the dialysis access (including the access of the dialysis device in the figure), and the venous blood line L3. The venous end of the arterial blood line L1 and the venous end of the venous blood line L3 are interconnected, so that the arterial blood line L1, the dialysis access, and the venous blood line L3 form a circulation circuit, i.e., a purification circuit. In the present application, the circulation loop can serve as a pre-filling loop in a pre-filling procedure; in a flushing procedure, the circulation loop is also a flushing loop; in an emptying procedure, the circulation loop is also an emptying loop.
[0199] In one embodiment, the gas collection chamber is used to collect gas in the purification circuit as the fluid in the purification circuit flows from the venous blood line to the arterial blood line. It should be noted that the gas collection chamber provided on the venous blood line is not a traditional venous trap. Traditional venous traps are used to observe dripping and collect gas from the pipeline when a fluid, such as blood or saline, flows in the forward direction (i.e., from the arterial end to the venous end). Therefore, the cross-section of a traditional venous trap is generally an inverted trapezoidal or conical structure, and the top of a traditional venous trap is usually provided with an exhaust line, a venous trap valve, and other components such as a sensor provided on the exhaust line. The gas collection chamber in the present application, on the other hand, collects gas / bubbles in the purification circuit when the fluid flows from the venous blood line to the arterial blood line (i.e., in the reverse direction or reverse flow). This is achieved by designing the position of its inlet and outlet. The implementation of the gas collection chamber, its connection with the purification circuit / circulation circuit / main circuit, and its operating principle are similar to those described above with respect to the embodiments of Figures 20 to 4 and will not be further described here.
[0200] In another embodiment, it is also possible to consider integrating the above-mentioned intravenous pot and gas collecting chamber into a component that has the functions of both gas collecting chamber and intravenous pot. For the convenience of description, it is also referred to as gas collecting chamber in subsequent embodiments. The gas collecting chamber is different from the structure of a traditional intravenous pot whose cross section is generally in the shape of an inverted trapezoid or a cone. In this embodiment, the gas collecting chamber includes a liquid storage space located in the lower part of the cavity and a gas collecting space located in the upper part of the cavity. That is, the gas collecting chamber is divided into two spaces according to function, the upper gas collecting space is used to collect gas, and the lower liquid storage space is used to collect liquid passing through the gas collecting chamber. In one embodiment, an opening can be directly provided at the top of the gas collecting chamber for connecting to an exhaust pipe, for example, a valve device for controlling exhaust is provided on the exhaust pipe. In one example, components such as a hydrophobic filter, a static pressure sensor, a solenoid valve, or / and a hydrophobic filter are provided on the exhaust pipe.
[0201] In order to facilitate the liquid in the liquid storage space to participate in the circulation process in the purification circuit, a first interface for connecting to the dialysis pathway through a pipeline and a second interface for connecting to the venous end of the venous blood line through a pipeline are provided on opposite sides of the bottom end of the liquid storage space. That is, the inlet and outlet of the gas collecting chamber are both located at the bottom end of the liquid storage space. In this embodiment, the first interface is connected to the bottom interface of the dialysis device on the dialysis pathway, and the second interface is connected to the venous pot on the venous blood line. When the fluid in the purification circuit is driven forward, the first interface is the inlet and the second interface is the outlet; on the contrary, when the fluid in the purification circuit is driven in reverse, the second interface is the inlet and the first interface is the outlet. The implementation method of the gas collecting chamber, the connection method with the purification circuit / circulation circuit / main circuit, and the working principle are as described in the above-mentioned embodiments of Figures 24 to 28, and will not be repeated here.
[0202] The driving device is arranged on the arterial blood line and is used to drive the fluid to flow forward or reversely in the purification circuit; it should be noted that during the hemodialysis treatment process, the dialysis equipment drives the blood to flow from the arterial end to the venous end in a forward flow.
[0203] In an embodiment, the driving device includes but is not limited to a peristaltic pump, a pneumatic diaphragm pump, or a pressure pump, which is used to provide power to the fluid in the pipeline so that the fluid circulates in a preset flow direction. Here, in an application scenario for medical purposes, the driving device should not directly contact the fluid, but only apply pressure to the pipeline and drive the fluid to flow. The preferred embodiment of the driving device is a non-contact pump device such as a peristaltic pump or a pneumatic diaphragm pump. More specifically, the peristaltic pump is, for example, a dialysis pump or a blood pump. The forward and reverse (reversal) rotation of the peristaltic pump will cause the flow direction of the fluid in the circulation loop to be different. In an application example where the circulation loop is a waterway, the driving device can be a contact-type driving pump or the like to drive the fluid to flow in the circulation loop in a forward or reverse direction. In an application example where the circulation loop is a waterway, the driving device can be a contact-type driving pump or the like to drive the fluid to flow in the circulation loop in a forward or reverse direction.
[0204] It should be understood that the driving device can drive the fluid in the pipeline at different positions in the pipeline, and its flow rate may change due to factors such as pipeline resistance, temperature, and pressure in the direction of fluid flow. However, in the embodiment of the present application applied to the field of dialysis, the driving device is arranged on the circulation loop, especially on the arterial blood line of the purification circuit.
[0205] The dialysis device is provided on the dialysis pathway, and is used to purify the blood flowing in the purification circuit, and to form a blood flow path for the patient's blood and a dialysate flow path for the dialysate through a built-in purification membrane for blood purification; in an embodiment, the dialysis device is used to purify the blood flowing in the purification circuit, and to form a blood flow path for the patient's blood and a dialysate flow path for the dialysate through a built-in purification membrane for blood purification; in an embodiment, the dialysis device includes a dialyzer, and the dialyzer includes a dialysate chamber, a blood chamber, and a semi-permeable membrane, etc., the membrane separates the dialysate chamber and the blood chamber from each other. In a commonly used capillary dialyzer, the blood chamber is formed by the entire internal volume of the hollow fibers, and the dialysate chamber is formed by the inner cavity of the dialyzer shell surrounding the hollow fibers. In an embodiment, the top end of the dialyzer is connected to the arterial blood line L1, and the bottom end of the dialyzer is connected to the venous blood line L3.
[0206] The dialysate line L2 includes a dialysate inlet 60 and a dialysate outlet 61 connected to the dialyzer, which are used to input the dialysate into the dialysis device 6 and output it after treatment. It should be understood that the dialysate line L2 also includes necessary valves, sensors and other necessary elements or components.
[0207] In one embodiment, a dialysate regeneration circulation system is further provided between the dialysate inlet 60 and the dialysate outlet 61 of the dialysate line L2, including a waste liquid passage, whose input end is connected to the outlet of the dialysate waste liquid; a metabolic circulation device, whose input end is connected to the outlet of the waste liquid passage, for metabolically circulating the input dialysate waste liquid for primary toxin treatment; an adsorption device, whose input end is connected to the output end of the metabolic circulation device, for performing secondary toxin treatment on the waste liquid after the primary toxin treatment by the metabolic circulation device to generate regeneration liquid; and a regeneration liquid pipeline, whose inlet is connected to the adsorption device for outputting the regeneration liquid. The dialysate regeneration circulation system adds a preparation, such as enzyme-loaded microspheres, to a metabolic circulation device, and the preparation circulates in a circulation pipeline driven by a driving device. Specifically, a dialysate waste liquid to be treated containing a high concentration of target molecules enters the metabolic circulation device through an inlet, and the target molecules are decomposed into corresponding products by the preparation. The metabolic filtration module provided in the metabolic circulation device continuously separates the treated liquid, retains the preparation in the metabolic circulation device, and maintains continuous circulation. The treated liquid flows out of the metabolic circulation device through the metabolic filtration module and is then treated by an adsorption device to produce a dialysate regeneration liquid. After potassium, calcium, and magnesium ions are supplemented in the regeneration liquid pipeline, the liquid is used again in the dialysis process. This solves the problems of low exchange efficiency in the existing perfusion mode, which increases the amount of enzyme used, and loss of enzyme efficiency and safety risks due to enzyme shedding.
[0208] In one embodiment, the metabolic circulation device includes: a collecting container, a first interface of which is connected to the output end of the waste liquid passage, and is used to mix the added enzyme-loaded microspheres and the dialysis waste liquid to ensure sufficient contact; a metabolic circulation pipeline, one end of which is connected to the second interface of the collecting container, and the other end is connected to the third interface of the collecting container; a metabolic circulation pump, arranged on the metabolic circulation pipeline, for driving the mixed enzyme-loaded microspheres and dialysis waste liquid in the collecting container to circulate in the metabolic circulation pipeline; a metabolic filtration module, arranged on the metabolic circulation pipeline, for treating the mixed liquid of the enzyme-loaded microspheres and dialysis waste liquid circulating in the metabolic circulation pipeline with toxins, retaining the enzyme-loaded microspheres in the metabolic circulation pipeline, and filtering out the dialysis waste liquid metabolic treatment liquid.
[0209] In one embodiment, the dialysate regeneration circulation system also includes a device for controlling the metabolic circulation pump to dynamically balance the total amount of fluid in the metabolic circulation pipeline in the metabolic circulation mode. The device can also be used to control the speed, direction, and / or frequency of the metabolic circulation pump to reduce the deposition of the enzyme-loaded microspheres in the metabolic filtration module.
[0210] The control device is configured to execute a flushing mode to flush the purification circuit and concentrate the gas in the purification circuit in the gas collection chamber; or to execute a treatment mode to purify the blood flowing in the purification circuit and then inject it into the human body. In an embodiment, the control device is, for example, a controller or system processor of a dialysis device, and outputs corresponding control instructions via a program written into the system processor; or receives trigger instructions input by an operator to execute relevant control instructions.
[0211] In the treatment mode of the dialysis device, an arterial puncture needle is connected to the front end of the arterial blood line L1 via a connector, and a driving device such as a peristaltic blood pump is provided midway therefrom. On the other hand, a venous puncture needle is connected to the front end of the venous blood line L3 via a connector, and a drip chamber / venous pot or a gas collecting chamber having the function of a venous pot in the present application is connected midway thereto. In addition, during dialysis treatment, the arterial puncture needle and the venous puncture needle are respectively inserted into the target arterial blood vessel and the target venous blood vessel of the patient's body. If the blood pump is driven, the patient's blood reaches the dialysis device through the arterial blood line L1, and then undergoes blood purification through the dialysis device, while debubbling is performed in the drip chamber / venous pot and the blood is returned to the patient's body through the venous blood line L3. That is, the patient's blood is circulated extracorporeally from the front end of the arterial blood line L1 of the circulation loop to the front end of the venous blood line L3 while being purified through the dialysis device.
[0212] In one embodiment of the flushing mode of the dialysis device, as shown in the flushing operation embodiment of FIG22 , the arterial end of the arterial blood line is connected to the venous end of the venous blood line, and the fluid in the purification circuit is reversed, so that the gas in the dialysis device on the dialysis pathway floats to the top thereof, and flows along the arterial blood line and the venous blood line in sequence, and is enriched in the gas collecting chamber, and the liquid entering the gas collecting chamber flows from the first interface of the gas collecting chamber to the bottom end of the dialysis device on the dialysis pathway. Since the gas in the purification circuit is enriched in the gas collecting chamber in the flushing mode, during the treatment phase, that is, when the fluid in the purification circuit is driven in the forward direction, the gas originally enriched in the gas collecting chamber preferentially enters the venous pot along the venous blood line, and is then discharged through the exhaust pipe L4 of the venous pot.
[0213] In another embodiment of the flushing mode of the dialysis device, as shown in the flushing operation embodiment in Figure 24 above, the arterial end of the arterial blood line is connected to the venous end of the venous blood line, and the fluid in the purification circuit is reversed, and the gas stored in the dialysis device on the dialysis pathway floats to the top thereof, and flows along the arterial blood line and the venous blood line in sequence, and enters the gas collecting chamber through the second interface of the gas collecting chamber. Since the mass of the gas is smaller than that of the liquid, the gas will float up and be retained above the liquid surface, and thus the gas in the purification circuit can also be enriched in the gas collecting space in the gas collecting chamber during flushing, and the liquid entering the gas collecting chamber flows into the second interface of the gas collecting chamber and flows out through the first interface to flow to the bottom end of the dialysis device on the dialysis pathway.
[0214] In summary, the purification circuit, the method for flushing the purification circuit, and the dialysis equipment proposed in the present application adopt the purification circuit of the present application to add an air collecting chamber to the venous blood line, so that during the flushing operation, the final flushing and exhaust of the dialysis can be achieved even without turning the dialysis device upside down. The present application reversely drives the fluid in the pipeline and adds an air collecting chamber downstream of the dialyzer device. When the liquid flows from the venous end through the venous pot to the air collecting chamber and flows to the bottom of the dialysis device, the air collecting chamber can be enriched with a certain amount of gas. Since the gas in the air collecting chamber will preferentially flow out from its top, the gas in the air collecting chamber can be discharged in time in the treatment mode.
[0215] Based on the above examples, this application provides multiple embodiments, which are as follows:
[0216] 1. A system for pre-filling and emptying a purification circuit, comprising:
[0217] A liquid storage container, used for storing pre-filled liquid and recovering emptied waste liquid, comprising a container body, and a first interface and a second interface provided on the container body for serving as liquid and / or gas inlet and outlet; in pre-filling mode, the liquid outlet of the liquid storage container is at a low position; in emptying mode, the gas outlet of the liquid storage container is at a high position;
[0218] a circulation loop, one end of which is connected to the first interface and the other end of which is connected to the second interface;
[0219] The driving device is provided on the circulation loop between the first interface and the second interface, and is used to drive the fluid to flow forward or reverse in the circulation loop.
[0220] 2. A system for pre-filling and emptying a purification circuit according to Example 1, wherein the first interface is located at a high position in the container body; and the second interface is located at a low position in the container body.
[0221] 3. A system for pre-filling and emptying a purification circuit according to Example 2, wherein, in the pre-filling mode, the driving device is in a forward rotation state to drive the pre-filling liquid in the liquid storage container to flow from the second interface into the circulation circuit.
[0222] 4. A system for pre-filling and emptying a purification circuit according to Example 2, wherein, in an emptying mode, the driving device is in a reverse state to drive the gas in the liquid storage container to be discharged from the first interface into the circulation circuit.
[0223] 5. A system for pre-filling and emptying a purification circuit according to Example 2, wherein, in an emptying mode, the liquid storage container is in an inverted state and the driving device is in a forward rotation state to drive the gas in the liquid storage container to be discharged from the second interface into the circulation circuit.
[0224] 6. The system for pre-filling and emptying a purification circuit according to embodiment 2, wherein the first interface is an opening opened at the top of the container body; and the second interface is an opening opened at the bottom of the container body.
[0225] 7. A system for pre-filling and emptying a purification circuit according to Example 2, wherein the first interface is a pipeline extending into the internal space of the container body and located at a first height; the second interface is an opening opened at the bottom of the container body, and when the liquid storage container is in an upright state, the first height is higher than the opening.
[0226] 8. A system for pre-filling and emptying a purification circuit according to Example 2, wherein the first interface is a pipeline extending to the internal space of the container body and located at a first height; the second interface is a pipeline extending to the internal space of the container body and located at a second height, and when the liquid storage container is in an upright state, the first height is higher than the second height.
[0227] 9. A system for pre-filling and emptying a purification circuit according to Example 2, wherein, when the liquid storage container is in an upright position, the first interface is located above the liquid level of the pre-filled liquid in the container body when the container body is fully filled.
[0228] 10. The system for pre-filling and emptying a purification circuit according to embodiment 1, wherein the first interface and the second interface of the liquid storage container are both located at a low position in the container body.
[0229] 11. A system for pre-filling and emptying a purification circuit according to embodiment 10, wherein, in the pre-filling mode, the driving device is in a forward rotation state to drive the pre-filling liquid in the liquid storage container to flow from the second interface into the circulation circuit.
[0230] 12. A system for pre-filling and emptying a purification circuit according to embodiment 10, wherein, in an emptying mode, the liquid storage container is in an inverted state and the driving device is in a forward rotation state to drive the gas in the liquid storage container to be discharged from the second interface into the circulation circuit.
[0231] 13. The system for pre-filling and emptying a purification circuit according to embodiment 1, further comprising a first valve member for blocking or opening the first interface.
[0232] 14. The system for pre-filling and emptying a purification circuit according to embodiment 1, further comprising a second valve member for blocking or opening the second interface.
[0233] 15. A system for pre-filling and emptying a purification circuit according to Example 1, wherein the circulation circuit includes a first branch, a second branch, and a main circuit connected end to end, wherein the first end of the first branch is connected to the first interface, and the second end of the first branch is connected to the first section of the main circuit; the first end of the second branch is connected to the second interface, and the second end of the second branch is connected to the second section of the main circuit; a third valve component for blocking or conducting the fluid passage is provided between the first section and the second section of the main circuit.
[0234] 16. The system for pre-filling and emptying the purification circuit according to embodiment 15, wherein a fourth valve member for blocking or connecting the first branch and the second branch is further provided in the circulation circuit.
[0235] 17. A system for pre-filling and emptying a purification circuit according to Example 16, wherein the fourth valve component is a flow channel switching valve component that can switch the flow state; the first state of the flow channel switching valve component is used to connect the first branch and the second branch, and block the passage between the first section and the second section of the main circuit; the second state of the flow channel switching valve component is used to block the first branch and the second branch, and connect the passage between the first section and the second section of the main circuit; the third state of the flow channel switching valve component is used to connect the first end of the first branch and the second end of the second branch, and the first end of the second branch and the second end of the first branch, and block the passage between the first section and the second section of the main circuit.
[0236] 18. A system for pre-filling and emptying a purification circuit according to Example 1, wherein the circulation circuit includes a first branch, a second branch, and a main circuit connected end to end, and a flow channel switching valve component with switchable flow states is provided at the intersection of the first branch, the second branch, and the main circuit connected end to end, and the first state of the flow channel switching valve component is used to connect the first branch to the first section of the main circuit and the second branch to the second section of the main circuit, and block the passage between the first section and the second section of the main circuit; the second state of the flow channel switching valve component is used to block the first branch from the first section of the main circuit and the second branch from the second section of the main circuit, and connect the passage between the first section and the second section of the main circuit.
[0237] 19. A system for pre-filling and emptying a purification circuit according to Example 18, wherein the third state of the flow channel switching valve is used to connect the first branch to the second section of the main circuit and to connect the second branch to the first section of the main circuit, and to block the passage between the first section and the second section of the main circuit.
[0238] 20. The system for pre-filling and emptying a purification circuit according to embodiment 17 or 18, wherein the flow path switching valve is a manual valve.
[0239] 21. The system for pre-filling and emptying a purification circuit according to embodiment 17 or 18, wherein the flow path switching valve element is an electric valve element that automatically switches between the first, second, or third states according to a driving program.
[0240] 22. The system for priming and emptying a purification circuit according to Example 1, wherein the circulation circuit comprises an arterial blood line, a venous blood line, and a dialysate line arranged between the arterial blood line and the venous blood line for connecting to a dialysis device.
[0241] 23. The system for priming and emptying a purification circuit according to embodiment 1, wherein the liquid storage container is a soft bag or a hard bottle.
[0242] 24. The system for pre-filling and emptying a purification circuit according to embodiment 1, further comprising a mechanism for placing the liquid storage container upright or inverted.
[0243] 25. The system for priming and emptying a purification circuit according to embodiment 1, wherein the driving device is a peristaltic pump or a pneumatic diaphragm pump.
[0244] 26. The system for priming and emptying a purification circuit according to embodiment 1, wherein the priming fluid is physiological saline, physiological buffer, or enzyme-loaded microsphere solution.
[0245] 27. The system for priming and emptying a purification circuit according to embodiment 1, wherein the circulation circuit comprises a blood circuit, a water circuit, an enrichment circulation circuit, or a metabolic circulation circuit.
[0246] 28. A dialysis device, comprising:
[0247] A liquid storage container, used for storing pre-filled liquid and recovering emptied waste liquid, comprising a container body, and a first interface and a second interface provided on the container body for serving as liquid and / or gas inlet and outlet; in pre-filling mode, the liquid outlet of the liquid storage container is at a low position; in emptying mode, the gas outlet of the liquid storage container is at a high position;
[0248] A circulation circuit includes a first circuit and a second circuit connected to the first circuit, wherein in a priming mode or an emptying mode of the circulation circuit, an input end of the first circuit is connected to an output end of the second circuit, the first interface is connected to a first section of the circulation circuit, and the first interface is connected to a second section of the circulation circuit; in a treatment mode, the input end of the first circuit is connected to a first part of the human body, and the output end of the second circuit is connected to a second part;
[0249] a driving device, provided on the first circuit and located between the second section and the first section of the circulation loop, for driving the fluid to flow in the circulation loop;
[0250] a dialysis device for purifying the fluid flowing in the circulation loop and forming a fluid flow path for the flow of patient fluid and a dialysate flow path for the flow of dialysate through a built-in purification membrane for purifying the fluid;
[0251] The control device is used to execute a pre-filling mode to pre-fill the circulation loop, to execute a treatment mode to purify the fluid flowing in the circulation loop and then input it into the human body, or to execute an emptying mode to recover the waste liquid in the circulation loop by discharging it into the liquid storage container.
[0252] 29. The dialysis device according to embodiment 28, wherein the first interface is located at a high position in the container body; and the second interface is located at a low position in the container body.
[0253] 30. The dialysis device according to Example 29, wherein, in the pre-filling mode, the driving device is in a forward rotation state to drive the pre-filling liquid in the liquid storage container to flow from the second interface into the circulation loop.
[0254] 31. The dialysis device according to Example 29, wherein, in the emptying mode, the driving device is in a reverse state to drive the gas in the liquid storage container to be discharged from the first interface into the circulation loop.
[0255] 32. The dialysis device according to Example 29, wherein, in the emptying mode, the liquid storage container is in an inverted state and the driving device is in a forward rotation state to drive the gas in the liquid storage container to be discharged from the second interface into the circulation loop.
[0256] 33. The dialysis device according to Example 29, wherein the first interface is an opening opened at the top of the container body; and the second interface is an opening opened at the bottom of the container body.
[0257] 34. A dialysis device according to Example 29, wherein the first interface is a pipeline extending into the internal space of the container body and located at a first height; the second interface is an opening opened at the bottom of the container body; and when the liquid storage container is in an upright state, the first height is higher than the opening.
[0258] 35. A dialysis device according to Example 29, wherein the first interface is a pipeline extending to the internal space of the container body and located at a first height; the second interface is a pipeline extending to the internal space of the container body and located at a second height, and when the liquid storage container is in an upright state, the first height is higher than the second height.
[0259] 36. The dialysis device according to Example 29, wherein, when the liquid storage container is in an upright position, the first interface is located above the liquid level in the container body when the container body is pre-filled with liquid.
[0260] 37. The dialysis device according to Example 28, wherein the first interface and the second interface of the liquid storage container are both located at a low position in the container body.
[0261] 38. The dialysis device according to embodiment 37, wherein in the priming mode, the driving device is in a forward rotation state to drive the priming liquid in the liquid storage container to flow from the second interface into the circulation loop.
[0262] 39. A dialysis device according to Example 37, wherein, in the emptying mode, the liquid storage container is in an inverted state and the driving device is in a forward rotation state to drive the gas in the liquid storage container to be discharged from the second interface into the circulation loop.
[0263] 40. The dialysis device according to Example 28, further comprising a first valve member for blocking or opening the first interface.
[0264] 41. The dialysis device according to Example 28, further comprising a second valve member for blocking or opening the second interface.
[0265] 42. A dialysis device according to Example 28, wherein the circulation loop includes a first branch, a second branch, and a main loop connected end to end, wherein the first end of the first branch is connected to the first interface, and the second end of the first branch is connected to the first section of the main loop; the first end of the second branch is connected to the second interface, and the second end of the second branch is connected to the second section of the main loop; and a third valve component for blocking or conducting the fluid passage is provided between the first section and the second section of the main loop.
[0266] 43. The dialysis device according to embodiment 42, wherein a fourth valve member for blocking or connecting the first branch and the second branch is further provided in the circulation loop.
[0267] 44. The dialysis device according to Example 43, wherein the fourth valve component is a flow channel switching valve component that can switch the flow state; the first state of the flow channel switching valve component is used to connect the first branch and the second branch, and block the passage between the first section and the second section of the main loop; the second state of the flow channel switching valve component is used to block the first branch and the second branch, and connect the passage between the first section and the second section of the main loop; the third state of the flow channel switching valve component is used to connect the first end of the first branch and the second end of the second branch, and the first end of the second branch and the second end of the first branch, and block the passage between the first section and the second section of the main loop.
[0268] 45. A dialysis device according to Example 28, wherein the circulation loop includes a first branch, a second branch, and a main loop connected end to end, and a flow channel switching valve component with switchable flow states is provided at the intersection of the first branch, the second branch, and the main loop connected end to end, and the first state of the flow channel switching valve component is used to connect the first branch to the first section of the main loop and the second branch to the second section of the main loop, and block the passage between the first section and the second section of the main loop; the second state of the flow channel switching valve component is used to block the first branch from the first section of the main loop and the second branch from the second section of the main loop, and connect the passage between the first section and the second section of the main loop.
[0269] 46. A dialysis device according to Example 45, wherein the third state of the flow channel switching valve is used to connect the first branch to the second section of the main circuit and to connect the second branch to the first section of the main circuit, and to block the passage between the first section and the second section of the main circuit.
[0270] 47. The dialysis device according to embodiment 44 or 45, wherein the flow channel switching valve is a manual valve.
[0271] 48. The dialysis device according to embodiment 44 or 45, wherein the flow channel switching valve component is an electric valve component that automatically switches between the first, second, or third states according to a driving program.
[0272] 49. The dialysis apparatus according to Example 28, wherein the circulation loop further comprises a dialysate line disposed between the first line and the second line for communicating with a dialysis device.
[0273] 50. The dialysis device according to Example 28, wherein the liquid storage container is a soft bag or a hard bottle.
[0274] 51. The dialysis device according to Example 28, further comprising a mechanism for placing the liquid storage container upright or inverted.
[0275] 52. The dialysis device of embodiment 28, wherein the driving device is a peristaltic pump or a pneumatic diaphragm pump.
[0276] 53. The dialysis device according to Example 28, wherein the priming fluid is physiological saline, physiological buffer, or enzyme-loaded microsphere solution.
[0277] 54. The dialysis device of embodiment 28, wherein the circulation circuit comprises a blood circuit, a water circuit, an enrichment circulation circuit, or a metabolic circulation circuit.
[0278] The above embodiments are merely illustrative of the principles and effects of this application and are not intended to limit this application. Anyone skilled in the art may modify or alter the above embodiments without departing from the spirit and scope of this application. Therefore, all equivalent modifications or alterations made by one of ordinary skill in the art without departing from the spirit and technical concepts disclosed in this application shall be covered by the claims of this application.
Claims
1. A purification circuit, characterized in that: It comprises a pipeline, a driving device arranged on the pipeline, and a gas collecting chamber connected to the pipeline, wherein the gas collecting chamber comprises a reverse gas collecting chamber for enriching the gas in the purification circuit when the fluid in the purification circuit flows in reverse direction.
2. The purification circuit according to claim 1, characterized in that: The gas collection chamber further includes a forward gas collection chamber for enriching the gas in the purification circuit when the fluid in the purification circuit flows in the forward direction.
3. The purification circuit according to claim 2, characterized in that: When the fluid in the purification circuit flows in the forward direction, the reverse gas collection chamber is located downstream of the forward gas collection chamber.
4. The purification circuit according to claim 2, characterized in that: When the fluid in the purification circuit flows in the forward direction, the reverse gas collection chamber is located upstream of the forward gas collection chamber.
5. The purification circuit according to claim 2, characterized in that: The reverse gas collecting chamber and the forward gas collecting chamber are the same cavity, and the cavity includes a liquid storage space located in the lower part of the cavity and a gas collecting space located in the upper part of the cavity.
6. The purification circuit according to claim 5, characterized in that: A first interface for communicating with the upstream of the pipeline and a second interface for communicating with the downstream of the pipeline are provided on opposite sides of the bottom of the liquid storage space of the cavity.
7. The purification circuit according to claim 1, characterized in that: The purification circuit includes a blood circuit, a water circuit, an enrichment circulation circuit, or a metabolic circulation circuit.
8. The purification circuit according to claim 2, characterized in that: The purification circuit includes a first circuit, a dialysis passage connected to the first circuit, and a second circuit connected to the dialysis passage; wherein, a gas collecting chamber is provided on the second circuit; the gas collecting chamber is used to enrich the gas in the purification circuit when the fluid in the purification circuit flows from the second circuit to the first circuit.
9. The purification circuit according to claim 8, characterized in that: The inner diameter of the gas collecting cavity is larger than the inner diameter of the pipeline in the second circuit.
10. The purification circuit according to claim 8, characterized in that The inner volume of the gas collecting chamber is larger than the volume of the stored gas in the purification circuit in the initial state.
11. The purification circuit according to claim 8, characterized in that The gas collection chamber has a first interface for connecting to the dialysis path through a pipeline and a second interface for connecting to the venous end of the second line through a pipeline, wherein the first interface is located at the bottom end of the gas collection chamber and the second interface is located at the top end of the gas collection chamber.
12. The purification circuit according to claim 11, characterized in that When the fluid in the purification circuit is driven in reverse, the liquid and / or gas passing through the second line flows from the second interface into the gas collecting chamber, and flows from the first interface to the dialysis pathway, so that the gas carried in the liquid is enriched in the gas collecting chamber.
13. The purification circuit according to claim 11, characterized in that When the fluid in the purification circuit is driven in the forward direction, the liquid passing through the first circuit flows from the first interface into the gas collecting chamber through the dialysis pathway, and flows from the second interface to the second circuit after filling the gas collecting chamber.
14. The purification circuit according to claim 11, characterized in that The arterial end of the first line is connected to the venous end of the second line to enable the fluid in the purification circuit to flow in the reverse direction. The gas stored in the dialysis pathway floats to its top and passes through the first line and the second line in sequence to be enriched in the gas collecting chamber. The liquid flows from the first interface of the gas collecting chamber to the bottom end of the dialysis pathway.
15. The purification circuit according to claim 8, characterized in that An arterial pot is also connected to the pipeline between the dialysis pathway and the arterial end of the first circuit.
16. The purification circuit according to claim 8, characterized in that The pipeline between the gas collecting chamber and the venous end of the second circuit is also connected with a venous pot.
17. The purification circuit according to claim 16, characterized in that When the fluid in the purification circuit is driven in the forward direction, the gas enriched in the gas collecting chamber flows into the venous pot preferentially over the liquid entering the gas collecting chamber so as to be discharged from the venous pot.
18. The purification circuit according to claim 8, characterized in that The gas collecting chamber comprises a liquid storage space located in the lower part of the chamber and a gas collecting space located in the upper part of the chamber.
19. The purification circuit according to claim 18, characterized in that A first interface for connecting to the dialysis pathway through a pipeline and a second interface for connecting to the venous end of the second circuit through a pipeline are provided on opposite sides of the bottom end of the liquid storage space.
20. The purification circuit according to claim 19, characterized in that The liquid flowing from one of the first interface or the second interface through the liquid storage space to the other interface undergoes multiple flow direction changes in the liquid storage space.
21. The purification circuit according to claim 19, characterized in that The liquid storage space includes a first extension part and a second extension part extending downward respectively, and an isolation part located at the first extension part and the second extension part; wherein, the first interface is opened at the bottom end of the first extension part; the second interface is opened at the bottom end of the second extension part, and the isolation part is higher than the first interface and the second interface.
22. The purification circuit according to claim 21, characterized in that The length of the first extension portion with the first interface or the second extension portion with the second interface is related to the flow rate, bubble content, or fluid flow rate of the fluid in the liquid storage space; or the length of the isolation portion located between the first extension portion and the second extension portion is related to the flow rate, bubble content, or fluid flow rate of the fluid in the liquid storage space; or the shortest flow distance of the fluid flowing from one interface of the first interface or the second interface to the other interface is related to the flow rate, bubble content, or fluid flow rate of the fluid.
23. The purification circuit according to claim 21, characterized in that The first extension portion and the second extension portion of the liquid storage space both extend downward.
24. The purification circuit according to claim 21, characterized in that One of the first extension portion and the second extension portion of the liquid storage space extends horizontally, and the other extends downward. The first extension portion and the second extension portion have an incident angle.
25. The purification circuit according to claim 21, characterized in that The isolation portion is a stepped structure relative to the first extension portion and / or the second extension portion; the isolation portion is an arched structure relative to the first extension portion and / or the second extension portion; or the isolation portion is a baffle structure extending upward from the bottom of the gas collecting cavity.
26. The purification circuit according to claim 21, characterized in that A cross section of a path of fluid flowing from one of the first interface or the second interface to the other interface is larger than a cross section of the first interface or the second interface.
27. The purification circuit according to claim 19, characterized in that A filter is provided in the liquid storage space for filtering the fluid flowing between the first interface and the second interface.
28. The purification circuit according to claim 27, characterized in that The bottom end of the filter element is adjacent to the first interface, the top end of the filter element is adjacent to the second interface, and the filter element is arranged in the air collecting cavity at an angle of 30°-60°.
29. The purification circuit according to claim 27, characterized in that The filter element is a filter screen.
30. The purification circuit according to claim 18, characterized in that The gas collecting cavity is in an A-shape, an inverted V-shape, an inverted U-shape, an N-shape, or a mountain-shaped structure.
31. The purification circuit according to claim 18, characterized in that An air bag communicating with the cavity of the air collecting space is provided on the top of the air collecting space.
32. The purification circuit according to claim 31, characterized in that It also includes a detection device for clamping the air bag to detect the liquid level position or the enriched gas amount in the gas collecting cavity.
33. The purification circuit according to claim 32, characterized in that The detection device is a liquid level detection device, a pressure detection device, or a liquid level adjustment device.
34. The purification circuit according to claim 1, 8 or 18, characterized in that The gas collecting space of the gas collecting cavity has a third interface of an exhaust pipeline for exhausting the cavity gas, and the exhaust pipeline is provided with a valve device for controlling the exhaust.
35. The purification circuit according to claim 34, characterized in that The exhaust pipe is provided with a hydrophobic filter, a static pressure sensor, a solenoid valve, and / or a hydrophobic filter.
36. The purification circuit according to claim 1, 8 or 18, characterized in that The second line is provided with a venous valve and / or a photoelectric sensor.
37. The purification circuit according to claim 1, 8 or 18, characterized in that The first line is provided with a hydrophobic filter and / or an arterial pressure sensor.
38. The purification circuit according to claim 1, 8 or 18, characterized in that The fluid is physiological saline, physiological buffer, or enzyme-loaded microsphere solution.
39. A method for flushing a purification circuit, the purification circuit comprising a first circuit for accessing a human artery, a drive device disposed on the first circuit, a dialysis device connected to the first circuit, and a second circuit connected to the dialysis device; characterized in that: The method comprises the following steps: A gas collecting chamber is provided on the second circuit, and the arterial end of the first circuit is connected and communicated with the venous end of the second circuit; and The priming liquid applied to the purification circuit is allowed to flow from the second line to the first line, so that the gas pre-stored in the dialysis device and / or the first line is enriched in the gas collecting chamber.
40. The method for flushing a purification circuit according to claim 39, wherein: In the step of the priming liquid flowing from the second line to the first line, the gas stored in the dialysis device floats to the top thereof and passes through the first line and the second line in sequence and enters from the top of the gas collecting chamber to be enriched in the gas collecting chamber, and the liquid flows from the bottom of the gas collecting chamber to the bottom end of the dialysis device.
41. The method for flushing a purification circuit according to claim 40, characterized in that: The pipeline between the gas collecting chamber and the venous end of the second circuit is also connected with a venous pot.
42. The method for flushing a purification circuit according to claim 41, characterized in that: The method further includes allowing the priming fluid or blood applied to the purification circuit to flow from the first line to the second line, so that the gas enriched in the gas collection chamber flows into the venous pot preferentially over the liquid entering the gas collection chamber so as to be discharged from the venous pot.
43. The method for flushing a purification circuit according to claim 39, wherein: The gas collecting chamber comprises a liquid storage space located in the lower part of the chamber and a gas collecting space located in the upper part of the chamber.
44. The method for flushing a purification circuit according to claim 43, characterized in that: A first interface for connecting to the dialysis pathway through a pipeline and a second interface for connecting to the venous end of the second circuit through a pipeline are provided on opposite sides of the bottom end of the liquid storage space.
45. The method for flushing a purification circuit according to claim 44, characterized in that: In the step of the priming liquid flowing from the second line to the first line, the gas stored in the dialysis device floats to the top thereof and passes through the first line and the second line in sequence and enters from the second interface of the gas collecting chamber and is enriched in the inner gas collecting space of the gas collecting chamber. The liquid flows from the first interface of the gas collecting chamber to the bottom end of the dialysis pathway.
46. The method for flushing a purification circuit according to claim 44, wherein: It also includes allowing the pre-filled liquid or blood applied to the purification circuit to flow from the first line to the second line, so that the pre-filled liquid or blood enters from the first interface of the gas collecting chamber and flows from the second interface to the second line, and the gas or bubbles carried by the pre-filled liquid or blood are enriched in the gas collecting space of the gas collecting chamber for discharge.
47. A dialysis device, characterized in that include: A purification circuit comprising a first circuit, a dialysis pathway connected to the first circuit, and a second circuit connected to the dialysis pathway; wherein the second circuit is provided with a gas collecting chamber; the gas collecting chamber is used to enrich the gas in the purification circuit when the fluid in the purification circuit flows from the second circuit to the first circuit; a driving device, provided on the first circuit, for driving the fluid to flow in the purification circuit in a forward or reverse direction; a dialysis device, provided on the dialysis pathway, for purifying the fluid flowing in the purification circuit, and forming a fluid flow path for the flow of patient fluid and a dialysate flow path for the flow of dialysate through a built-in purification membrane for purifying the fluid; The control device is used to execute a flushing mode to flush the purification circuit and enrich the gas in the purification circuit in the gas collecting chamber; or to execute a treatment mode to purify the fluid flowing in the purification circuit and then input it into the human body.
48. The dialysis device according to claim 47, characterized in that The inner diameter of the gas collecting cavity is larger than the inner diameter of the pipeline in the second circuit.
49. The dialysis device according to claim 47, characterized in that The inner volume of the gas collecting chamber is larger than the volume of the stored gas in the purification circuit in the initial state.
50. The dialysis device according to claim 47, characterized in that The gas collection chamber has a first interface for connecting to the dialysis path through a pipeline and a second interface for connecting to the venous end of the second line through a pipeline, wherein the first interface is located at the bottom end of the gas collection chamber and the second interface is located at the top end of the gas collection chamber.
51. The dialysis device according to claim 50, characterized in that When the fluid in the purification circuit is driven in reverse, the liquid and / or gas passing through the second line flows from the second interface into the gas collecting chamber, and flows from the first interface to the dialysis pathway, so that the gas carried in the liquid is enriched in the gas collecting chamber.
52. The dialysis device according to claim 50, characterized in that When the fluid in the purification circuit is driven in the forward direction, the liquid passing through the first circuit flows from the first interface into the gas collecting chamber through the dialysis pathway, and flows from the second interface to the second circuit after filling the gas collecting chamber.
53. The dialysis device according to claim 50, characterized in that The arterial end of the first line is connected to the venous end of the second line to enable the fluid in the purification circuit to flow in the reverse direction. The gas stored in the dialysis pathway floats to its top and passes through the first line and the second line in sequence to be enriched in the gas collecting chamber. The liquid flows from the first interface of the gas collecting chamber to the bottom end of the dialysis pathway.
54. The dialysis device according to claim 47, characterized in that An arterial pot is also connected to the pipeline between the dialysis pathway and the arterial end of the first circuit.
55. The dialysis device according to claim 47, characterized in that The pipeline between the gas collecting chamber and the venous end of the second circuit is also connected with a venous pot.
56. The dialysis device according to claim 55, characterized in that When the fluid in the purification circuit is driven in the forward direction, the gas enriched in the gas collecting chamber flows into the venous pot preferentially over the liquid entering the gas collecting chamber so as to be discharged from the venous pot.
57. The dialysis device according to claim 47, characterized in that The gas collecting chamber comprises a liquid storage space located in the lower part of the chamber and a gas collecting space located in the upper part of the chamber.
58. The dialysis device according to claim 57, characterized in that A first interface for connecting to the dialysis pathway through a pipeline and a second interface for connecting to the venous end of the second circuit through a pipeline are provided on opposite sides of the bottom end of the liquid storage space.
59. The dialysis device according to claim 58, characterized in that The liquid flowing from one of the first interface or the second interface through the liquid storage space to the other interface undergoes multiple flow direction changes in the liquid storage space.
60. The dialysis device according to claim 58, characterized in that The liquid storage space includes a first extension part and a second extension part extending downward respectively, and an isolation part located at the first extension part and the second extension part; wherein, the first interface is opened at the bottom end of the first extension part; the second interface is opened at the bottom end of the second extension part, and the isolation part is higher than the first interface and the second interface.
61. The dialysis device according to claim 60, characterized in that The length of the first extension portion with the first interface or the second extension portion with the second interface is related to the flow rate, bubble content, or fluid flow rate of the fluid in the liquid storage space; or the length of the isolation portion located between the first extension portion and the second extension portion is related to the flow rate, bubble content, or fluid flow rate of the fluid in the liquid storage space; or the shortest flow distance of the fluid flowing from one interface of the first interface or the second interface to the other interface is related to the flow rate, bubble content, or fluid flow rate of the fluid.
62. The dialysis device according to claim 60, characterized in that The first extension portion and the second extension portion of the liquid storage space both extend downward.
63. The dialysis device according to claim 60, characterized in that One of the first extension portion and the second extension portion of the liquid storage space extends horizontally, and the other extends downward. The first extension portion and the second extension portion have an incident angle.
64. The dialysis device according to claim 60, characterized in that The isolation portion is a stepped structure relative to the first extension portion and / or the second extension portion; the isolation portion is an arched structure relative to the first extension portion and / or the second extension portion; or the isolation portion is a baffle structure extending upward from the bottom of the gas collecting cavity.
65. The dialysis device according to claim 60, characterized in that A cross section of a path of fluid flowing from one of the first interface or the second interface to the other interface is larger than a cross section of the first interface or the second interface.
66. The dialysis device according to claim 58, characterized in that A filter is provided in the liquid storage space for filtering the fluid flowing between the first interface and the second interface.
67. The dialysis device according to claim 66, characterized in that The bottom end of the filter element is adjacent to the first interface, the top end of the filter element is adjacent to the second interface, and the filter element is arranged in the air collecting cavity at an angle of 30°-60°.
68. The dialysis device according to claim 66, characterized in that The filter element is a filter screen.
69. The dialysis device according to claim 57, characterized in that The gas collecting cavity is in an A-shape, an inverted V-shape, an inverted U-shape, an N-shape, or a mountain-shaped structure.
70. The dialysis device according to claim 57, characterized in that An air bag communicating with the cavity of the air collecting space is provided on the top of the air collecting space.
71. The dialysis device according to claim 70, characterized in that It also includes a detection device for clamping the air bag to detect the liquid level position or the enriched gas amount in the gas collecting cavity.
72. The dialysis device according to claim 71, characterized in that The detection device is a liquid level detection device, a pressure detection device, or a liquid level adjustment device.
73. The dialysis device according to claim 47 or 57, characterized in that The gas collecting space of the gas collecting cavity has a third interface of an exhaust pipeline for exhausting the cavity gas, and the exhaust pipeline is provided with a valve device for controlling the exhaust.
74. The dialysis device according to claim 73, characterized in that The exhaust pipe is provided with a hydrophobic filter, a static pressure sensor, a solenoid valve, and / or a hydrophobic filter.
75. The dialysis device according to claim 47 or 57, characterized in that The second line is provided with a venous valve and / or a photoelectric sensor.
76. The dialysis device according to claim 47 or 57, characterized in that The first line is provided with a hydrophobic filter and / or an arterial pressure sensor.
77. The dialysis apparatus according to claim 47, wherein The fluid is physiological saline, physiological buffer, or enzyme-loaded microsphere solution.
78. The dialysis device according to claim 47, characterized in that The purification circuit includes a blood circuit, a water circuit, or a metabolic circulation circuit.