Closed-loop circulation type bladder irrigation system
The closed-loop bladder irrigation system addresses the challenges of infection risk, medication overuse, and medical staff workload by utilizing a controlled catheter system with filtration and sterilization, and intelligent fluid management, resulting in improved treatment efficiency and patient safety.
Patent Information
- Application Number
- PCT/KR2023/020623
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-11-22
- Filing Date
- 2023-12-14
- Publication Date
- 2025-05-30
AI Technical Summary
Existing bladder irrigation systems pose risks of infection due to frequent replacement of irrigation solutions and urine bags, require excessive use of hemostatic agents and antibiotics, and increase the workload of medical staff, particularly in settings with limited medical personnel.
A closed-loop bladder irrigation system that includes a catheter with separate passages for fluid injection and discharge, a pump to control fluid flow, a filter and sterilization unit to process discharged fluids, and a control unit to manage the system's operations, including authentication of cleaning solution cartridges and management of valve and pump operations to maintain optimal pressure and flow rates.
The system reduces the risk of infection by minimizing the need for irrigation solution and urine bag replacements, optimizes the use of hemostatic agents and antibiotics, and alleviates the workload of medical staff by automating many processes, thereby enhancing treatment efficiency and patient safety.
Smart Images

Figure KR2023020623_30052025_PF_FP_ABST
Abstract
Description
Closed loop bladder irrigation system
[0001] The present disclosure relates to a closed-loop bladder cleaning system, and more particularly, to a closed-loop bladder cleaning system in which a cleaning solution is injected into a bladder to clean the bladder and then the cleaning solution is filtered and sterilized to remove foreign substances such as blood clots and then re-injected into the bladder to clean the bladder. In particular, the present disclosure relates to a home-use closed-loop bladder cleaning system, a closed-loop bladder cleaning algorithm, and a clogging prevention algorithm for a closed-loop bladder cleaning system.
[0002] Bladder irrigation can be performed to relieve the condition of urethral obstruction due to blood clots, pus, mucus, etc. accumulated in the bladder, which prevents urine from being discharged, or to stop bleeding in the bladder or prevent and treat infection by injecting drugs such as hemostatic agents or antibiotics into the bladder.
[0003] At this time, an opening may be formed at one end of a catheter (or urinary catheter) inserted into the bladder so that a cleaning solution or drug can be injected into the bladder, and an opening may be formed to suck up urine or blood clots in the bladder, and a connecting portion may be formed at the other end of the catheter to connect a cleaning solution syringe for injecting a cleaning solution or drug, a balloon syringe for inflating a balloon to fix the catheter in the bladder, and a urine bag for storing urine or blood clots discharged from the bladder. The connecting portions form independent paths at different parts and can be connected to various syringes or urine bags.
[0004] Using a bladder irrigation device of this type, a catheter (urinary tube) is inserted into the bladder through the urethra, and then the balloon is inflated to secure the catheter in the bladder. Then, a cleaning solution or medication is injected into the bladder through the inserted catheter to stop any bleeding within the bladder. Furthermore, bladder irrigation can be performed by draining any urine or clots within the bladder into a urine bag. This type of bladder irrigation can be referred to as continuous bladder irrigation.
[0005] In addition, a bladder irrigation method that involves injecting a cleaning solution into the bladder through a catheter using a syringe without connecting a urine bag to the catheter, performing bladder irrigation until the injected cleaning solution is clear, and then connecting a urine bag to the catheter can be called intermittent bladder irrigation (tidal bladder irrigation).
[0006] When performing bladder irrigation using the aforementioned bladder irrigation device, the irrigation syringe or urine bag connected to the catheter's connector must be replaced periodically. For example, the volume of irrigation solution required for bladder irrigation may be larger than the volume of irrigation solution in the irrigation syringe connected to the catheter's connector. In this case, if the irrigation solution connected to the catheter is completely depleted during bladder irrigation, it must be replaced with a new irrigation solution. Furthermore, the urine bag must be replaced if it fills with urine or blood clots discharged from the bladder.
[0007] As mentioned above, if the cleaning solution or urine bag connected to the catheter's connector is periodically replaced, the catheter's connector may be exposed to the external environment, increasing the risk of infection. Furthermore, if hemostatic agents or antibiotics are injected alongside the cleaning solution during bladder irrigation for hemostasis or therapeutic purposes, the continued addition of the cleaning solution may lower the concentration of the hemostatic agent or antibiotic, potentially reducing the therapeutic effect. Therefore, additional hemostatic agents or antibiotics may be required. Furthermore, the workload of specialized personnel, such as the medical staff performing the bladder irrigation, may increase.
[0008] Therefore, there is a need for the introduction of a bladder irrigation system that can reduce the risk of infection by reducing the number of times the irrigation solution or urine bag connected to the catheter's connection is replaced during bladder irrigation, reduce the amount of hemostatic agents or antibiotics used, increase the treatment effect, and relieve the workload of professional management personnel such as medical staff performing bladder irrigation.
[0009] Additionally, bladder irrigation is a high-risk specialized procedure that must be performed multiple times by medical professionals or other specialized management personnel, and the risk may increase in patients in the acute phase due to a lack of medical personnel.
[0010] Therefore, there is a need to introduce a bladder irrigation system that applies a bladder irrigation algorithm to reduce the number of specialized bladder irrigation management personnel, relieve workload, and provide high-quality treatment to patients, thereby lowering the risk of the procedure.
[0011] Furthermore, during bladder irrigation, the catheter may become continuously blocked as foreign substances, such as urine or blood clots, are discharged along with the catheter. In this case, each time the catheter becomes blocked, the medical staff may need to perform manual irrigation using a cleaning solution connected to the catheter to clear the blockage. This increases the workload of the medical staff and increases the risk of the procedure for the patient.
[0012] Therefore, there is a need to introduce a bladder irrigation system that uses a mechanical device driven by an algorithm to relieve or prevent catheter blockage in order to relieve the workload of medical staff and reduce the risk of patient procedures.
[0013] According to one embodiment of the present disclosure, a home closed-loop bladder cleaning system comprises: a catheter including a cleaning solution storage unit, a first passage corresponding to a conduit through which a first fluid discharged from the cleaning solution storage unit moves to a bladder, and a second passage corresponding to a conduit through which a second fluid discharged from the bladder moves to the cleaning solution storage unit; the first fluid includes at least one of a cleaning solution or a treatment solution, and the second fluid may include a cleaning solution and a foreign substance; a pump controlling the flow rate and direction of the first fluid and the second fluid flowing in the catheter; the pump may include a first pump installed on the first passage and a second pump installed on the second passage; a filter unit for filtering the foreign substance included in the second fluid discharged from the bladder; and a control electrically connected to the cleaning solution storage unit and the pump. The control unit may control the first pump to inject the first fluid contained in the washing solution storage unit into the bladder through the first passage, and may control the second pump to inject the second fluid contained in the bladder into the washing solution storage unit through the second passage and through the filter unit.
[0014] According to one embodiment, the detergent storage unit includes a cartridge coupling unit that couples with a detergent cartridge containing the detergent, wherein the coupling portion of the detergent cartridge has a first shape, and the coupling portion of the cartridge coupling unit has a second shape, wherein the first shape and the second shape correspond to each other in a shape-specific manner, and based on the first shape and the second shape, the detergent cartridge and the cartridge coupling unit can be coupled to each other in a shape-specific manner.
[0015] According to one embodiment, the detergent storage unit further includes a detergent authenticating means, and the detergent authenticating means may include at least one of an RFID tag reader, a barcode or QR code reader, an NFC reader, a hologram, or a pattern reader. The control unit identifies a genuine authentication mark included in a detergent cartridge containing the detergent through the detergent authenticating means, and the genuine authentication mark may include at least one of an RFID tag, a barcode or QR code, an NFC reader, a hologram, or a pattern. Based on the identification result, it is possible to determine whether the detergent cartridge is genuine.
[0016] According to one embodiment, the detergent storage unit may further include an opening / closing device for a detergent inlet. The control unit may control the opening / closing device to open the detergent inlet if the detergent cartridge is determined to be genuine based on the identification result, and may control the opening / closing device to not open the detergent inlet if the detergent cartridge is determined to be not genuine based on the identification result.
[0017] According to one embodiment, the cleaning solution storage unit may include a cartridge coupling unit coupled with a cleaning solution cartridge containing the cleaning solution, and a valve for controlling the flow rates of the first fluid and the second fluid flowing in the catheter. The control unit may identify the type of the cleaning solution based on the cleaning solution cartridge coupled to the cartridge coupling unit, calculate a required pressure range within the bladder based on the type of the cleaning solution, and control at least one of the pump or the valve so that the pressure within the bladder is included within the required pressure range.
[0018] According to one embodiment, the valve may include a first valve located on the first passage and a second valve located on the second passage. The control unit may control the first valve and the second valve so that an opening / closing ratio of the first valve is smaller than an opening / closing ratio of the second valve when the pressure within the bladder exceeds the required pressure range, and may control the first valve and the second valve so that an opening / closing ratio of the first valve is larger than an opening / closing ratio of the second valve when the pressure within the bladder is lower than the required pressure range.
[0019] According to one embodiment, the system may further include a flow sensor for measuring the flow rates of the first fluid and the second fluid, and a communication unit. The control unit may measure the flow rates of the first fluid and the second fluid through the flow sensor, and if the flow rate value is lower than a set value based on the measurement result, determine that the catheter is clogged, and transmit information related to the clogging of the catheter to an external device through the communication unit.
[0020] According to one embodiment, the cleaning solution storage unit may be formed integrally with the catheter.
[0021] According to one embodiment, the detergent storage unit may include a cartridge coupling unit coupled with a detergent cartridge containing the detergent. The control unit may identify a concentration of the detergent based on the detergent cartridge coupled to the cartridge coupling unit, and control the first pump and the second pump to control the flow rates of the first fluid and the second fluid based on the concentration of the detergent.
[0022] A closed-loop urinary bladder irrigation system according to one embodiment of the present disclosure can reduce the risk of infection by reducing the number of times the irrigation solution or urinary bladder bag is replaced, reduce the amount of hemostatic agent or antibiotic used, increase the treatment effect, and relieve the workload of professional management personnel such as medical staff performing bladder irrigation.
[0023] A closed-loop bladder irrigation system according to an embodiment of the present disclosure can reduce the number of specialized bladder irrigation management personnel, relieve work overload, and provide high-quality treatment to patients, thereby reducing the risk of treatment to patients.
[0024] According to an embodiment of the present disclosure, a closed-loop bladder irrigation system can operate a mechanical device to which an algorithm for removing blockage of a catheter or predicting blockage is applied, thereby relieving the workload of medical staff and reducing the risk of treatment for patients.
[0025] In addition, various effects may be provided directly or indirectly through the present disclosure.
[0026] Figure 1 illustrates a schematic diagram of a closed-loop bladder irrigation system according to one embodiment.
[0027] FIG. 2 illustrates a block diagram of the system of FIG. 1 according to one embodiment.
[0028] Figure 3 illustrates a block diagram of a detergent storage unit according to one embodiment.
[0029] FIG. 4 is a conceptual diagram illustrating a pre-cleaning algorithm for preparing a user's (patient's) bladder before the system cleans it according to one embodiment.
[0030] FIG. 5 is a conceptual diagram illustrating a cleaning algorithm for cleaning a bladder of a user (patient) according to an embodiment of the present invention.
[0031] FIG. 6 is a flowchart for explaining a blockage detection algorithm operated by a system according to one embodiment.
[0032] Figure 7 is a flowchart for explaining a control algorithm for the type of cleaning solution (by disease) driven by a system according to one embodiment.
[0033] FIGS. 8A and 8B are flowcharts illustrating an algorithm for maintaining intravesical pressure within a required pressure range by a system according to one embodiment.
[0034] FIGS. 9A and 9B are flowcharts illustrating a pulse fluid algorithm driven by a system according to one embodiment.
[0035] Figure 10 is a flowchart illustrating a flow control algorithm driven by a system according to one embodiment.
[0036] Figure 11 illustrates a flowchart of an operation in which a catheter blockage continuous relief algorithm is driven according to one embodiment.
[0037] Figure 12 illustrates a flowchart of an operation for gradually increasing intravesical pressure according to an algorithm for continuously clearing catheter blockage according to one embodiment.
[0038] Figure 13 illustrates a flowchart of an operation for gradually increasing the pulse rate of a pump according to an algorithm for continuously clearing catheter blockages according to one embodiment.
[0039] FIG. 14 illustrates a flowchart of an operation for gradually increasing the amount of drug administered to a catheter according to an algorithm for continuously clearing catheter blockage according to one embodiment.
[0040] FIG. 15 illustrates a flowchart of an operation for re-changing the perfusion direction according to an algorithm for continuously clearing catheter blockage according to one embodiment.
[0041] FIG. 16 illustrates a flowchart of a method for controlling reverse perfusion based on flow rate changes according to a catheter blockage prevention algorithm according to one embodiment.
[0042] FIG. 17 illustrates a flowchart of a method for controlling reverse perfusion based on a perfusion control drive cycle according to a catheter blockage prevention algorithm according to one embodiment.
[0043] FIG. 18 illustrates a flowchart of operations for providing notification when a catheter is blocked or expected to block, according to one embodiment.
[0044] FIG. 19 is a schematic diagram illustrating how a home system according to one embodiment is connected to a patient's catheter for bladder irrigation.
[0045] FIG. 20a is a schematic drawing of the shape of the main body of a 3-way connector according to one embodiment, and FIG. 20b is a schematic drawing of the shape of the handle portion of the 3-way connector according to one embodiment.
[0046] Fig. 21 is a schematic drawing of the shape of the entire connector in which the main body portion and the handle portion of the connector are combined according to one embodiment.
[0047] FIG. 22 is a schematic diagram of a system including a device for managing a home system according to one embodiment and a device for managing a washing system within a hospital.
[0048] Figure 23 is a schematic diagram of a UI / UX screen of an application for managing a home system according to one embodiment.
[0049] Figure 24 is a schematic diagram of a UI / UX screen of a second electronic device used in a hospital according to one embodiment.
[0050] In connection with the description of the drawings, the same or similar reference numerals may be used for identical or similar components.
[0051] Since the embodiments described in this specification are intended to clearly explain the idea of the present invention to a person having ordinary skill in the art to which the present invention pertains, the present invention is not limited to the embodiments described in this specification, and the scope of the present invention should be interpreted to include modified or altered examples that do not depart from the idea of the present invention.
[0052] The terms used in this specification have been selected from widely used terms, as much as possible, considering their functions in the present invention. However, these terms may vary depending on the intentions of those skilled in the art, customs, or the emergence of new technologies. However, if a specific term is defined and used with an arbitrary meaning, the meaning of that term will be described separately. Therefore, the terms used in this specification should be interpreted based on their actual meaning and the overall content of this specification, rather than simply their names.
[0053] In this specification, if it is determined that a specific description of the configuration or function of a public notice related to the present invention may obscure the gist of the present invention, a detailed description thereof will be omitted as necessary.
[0054] Hereinafter, various embodiments of the present invention will be described with reference to the attached drawings. However, this is not intended to limit the present invention to specific embodiments, and it should be understood that the present invention encompasses various modifications, equivalents, and / or alternatives of the embodiments.
[0055]
[0056] 1. Definition and necessity of introduction of a closed-loop bladder irrigation system.
[0057] The closed circulatory bladder washing system (hereinafter, “system”) of the present specification may mean a system equipped with both a closed system in which bladder washing is performed without disconnecting the connection between the catheter and the washing solution of the system for bladder washing, and a circulatory system in which washing solution is injected into the bladder, the washing solution discharged from the bladder is filtered and sterilized to remove foreign substances such as blood clots, and then is injected back into the bladder to wash the bladder.
[0058] For reference, conventional bladder irrigation systems require periodic replacement of the irrigation solution connected to the catheter during bladder irrigation. This exposure of the connection between the catheter and the irrigation solution to the external environment can pose a risk of infection. Such systems are referred to as open systems.
[0059] Furthermore, to perform bladder irrigation, a irrigation solution is injected into the bladder through a catheter. The irrigation solution (or solution) containing urine or foreign substances such as blood clots is discharged from the bladder. Instead of undergoing a process such as a filter or sterilization unit before being reintroduced into the bladder, the irrigation solution accumulates in a urine bag, thereby performing bladder irrigation. Because the irrigation solution does not circulate, continuous replacement of the irrigation solution is necessary to perform bladder irrigation, and this can increase the use of therapeutic medications. Such a system can be referred to as a non-circulating system.
[0060] In addition, bladder irrigation is a high-risk specialized procedure that must be performed multiple times by medical professionals or other specialized management personnel. This can lead to an overload of medical personnel due to a shortage of medical personnel, and the risk of acute patients not receiving quality services can increase.
[0061] Additionally, during bladder irrigation, catheter blockages frequently occur due to foreign substances such as blood clots within the bladder, making it difficult to proceed smoothly. In these cases, medical staff must manually wash the catheter to clear the blockage, increasing their workload.
[0062] Therefore, it may be necessary to introduce a closed bladder irrigation system that can perform bladder irrigation by applying an algorithm that reduces the risk of infection that may occur during bladder irrigation, relieves the workload of specialized medical personnel performing bladder irrigation, and relieves and prevents catheter blockage.
[0063]
[0064] 2. Bladder washing method using a closed-loop bladder washing system
[0065] According to one embodiment of the present application, a closed-loop bladder washing system may be a bladder washing system designed to resolve problems that may arise when performing bladder washing using existing bladder washing systems (or devices). As mentioned above, the problems may include hygiene issues such as infections that may arise due to periodic replacement of washing solutions during bladder washing, problems of decreased therapeutic efficacy and increased dosage of therapeutic drugs due to increased usage of washing solutions, and problems of work overload for specialized personnel such as medical staff. However, the problems may not be limited to the examples mentioned above.
[0066] Figure 1 illustrates a schematic diagram of a closed-loop bladder irrigation system according to one embodiment.
[0067] Referring to FIG. 1, the system can perform bladder washing in a cyclic manner by injecting washing solution from a washing solution storage unit (101) into a bladder (102) through a catheter (110), filtering and sterilizing the washing solution (or solution) containing foreign substances such as urine and blood clots discharged from the bladder (102) using a filter unit (151) and a sterilizing unit (161), and then re-injecting the treated washing solution (or solution) into the bladder (102).
[0068] According to one embodiment, the system may include a catheter (110) including a first passage (111) and a second passage (112), a pump (120) including a first pump (121) and a second pump (122), a valve (130) including a first valve (131) and a second valve (132), a flow sensor (140) including a first flow sensor (141) and a second flow sensor (142), a filter unit (151), and a sterilization unit (161). The system is not limited to the components illustrated in FIG. 1, and some components may be added or omitted.
[0069] According to one embodiment, the cleaning solution storage unit (101) may contain a cleaning solution. The cleaning solution may be a cleaning solution for bladder washing, and at least one of the type, concentration, dosage, or mixing ratio of the cleaning solution may be determined based on at least one of the disease, treatment, bladder capacity, or health condition of the patient undergoing bladder washing. The mixing ratio may refer to a mixing ratio for each of the multiple cleaning solutions when multiple cleaning solutions are required for bladder washing.
[0070] According to one embodiment, the first pump (121) can generate a flow of fluid by applying pressure to the fluid inside the catheter (110). The first pump (121) can perform a bidirectional pump function, and can, for example, cause the fluid (e.g., a cleaning solution, urine, a hemostatic agent, an antibiotic, etc.) inside the catheter (110) to flow in a first direction (171) or a second direction (172).
[0071] According to one embodiment, the cleaning solution may be discharged from the cleaning solution storage unit (101). For example, the first pump (121) may apply pressure to cause the cleaning solution stored in the cleaning solution storage unit (101) to flow in the first direction (171) through the first passage (111).
[0072] According to one embodiment, the first valve (131) can control the flow rate of the fluid flowing inside the first passage (111) of the catheter (110). For example, the first valve (131) can control the flow rate of the fluid by controlling the opening / closing ratio. Increasing the opening / closing ratio of the first valve (131) can increase the flow rate of the fluid, and decreasing the opening / closing ratio can decrease the flow rate of the fluid.
[0073] According to one embodiment, the pressure inside the bladder (102) can be controlled by controlling the opening / closing rate of the first valve (131), and the shape of the fluid flow inside the bladder (102) can be controlled. For example, the pressure inside the bladder (102) can be controlled by controlling the opening / closing rate of the first valve (131) and the opening / closing rate of the second valve (132), and the shape of the fluid flow inside the bladder (102) can be controlled. For example, when the opening / closing rate of the first valve (131) is controlled to be smaller than the opening / closing rate of the second valve (132), the amount of fluid discharged (or discharged) from the bladder (102) can be smaller than the amount of fluid flowing into the bladder (102). In this case, the pressure inside the bladder (102) can be maintained at an appropriate level, while the fluid inside the bladder (102) can form a reservoir. The above-described appropriate level may be understood as a level similar to or reduced from the pressure inside the bladder (102) before controlling the first valve (131) and the second valve (132). For another example, when the opening / closing rate of the first valve (131) is controlled to be greater than the opening / closing rate of the second valve (132), the amount of fluid discharged (or discharged) from the bladder (102) may be greater than the amount of fluid flowing into the bladder (102). In this case, the pressure inside the bladder (102) may increase, and the fluid inside the bladder (102) may form a vortex.
[0074] According to one embodiment, the first flow sensor (141) can measure the flow rate of the fluid flowing inside the first passage (111) of the catheter (110). The system can determine whether the first passage (111) of the catheter (110) is clogged or expected to be clogged based on the flow rate data of the fluid flow rate measured by the first flow sensor (141). For example, the system can determine that the catheter is clogged or expected to be clogged if the flow rate value of the fluid is lower than a reference value based on the flow rate data measured by the first flow sensor (141). The expected clogging state may mean that the catheter is not currently clogged but is expected to be clogged soon.
[0075] According to one embodiment, the catheter (110) includes a first passage (111) and a second passage (112), and as illustrated in FIG. 1, the first passage (111) and the second passage (112) are physically separated to form respective flow paths and can be inserted into the bladder (102). The physical forms of the first passage (111) and the second passage (112) of the catheter (110) illustrated in FIG. 1 may be conceptually illustrated to explain the present system and may not be limited to the forms illustrated in FIG. 1. For example, although not illustrated in FIG. 1, the catheter (110) may be manufactured in the form of a single tube in which the first passage (111) and the second passage (112) each form a flow path but are physically connected. For example, the single tube may form two independent flow path tubes that are not internally connected, and the flow path tubes may be arranged in a form that is parallel to each other. As another example, one of the above-described euro pipes may be arranged such that the other surrounds the outer shell of the inner shell.
[0076] According to one embodiment, fluid (e.g., washing solution, urine, blood clot, hemostatic agent, antibiotic, etc.) inside the bladder (102) can be discharged from the bladder (102) and controlled through a second pump (122).
[0077] According to one embodiment, the second flow sensor (142) can measure the flow rate of the fluid flowing inside the second passage (112) of the catheter (110). The system can determine whether the second passage (112) of the catheter (110) is blocked or expected to be blocked based on the flow rate data on the flow rate of the fluid measured through the second flow sensor (142).
[0078] According to one embodiment, the fluid discharged (or discharged) from the bladder (102) may sequentially pass through the filter unit (151) and the sterilization unit (161) along the second passage (112) and then flow into the cleaning solution storage unit (101).
[0079] According to one embodiment, the filter unit (151) may perform a function of filtering foreign substances (or impurities, waste) in the fluid discharged (or discharged) from the bladder (102). The filter unit (151) may adopt a cross flow method. The filter unit (151) may include a nano filter. The type of filter of the filter unit (151) may be determined based on at least one of the patient's disease, treatment, and health condition. The filter may be a disposable filter. The filter may be a disposable filter, and the filter replacement cycle may be determined based on at least one of the patient's disease, treatment, and health condition.
[0080] According to one embodiment, the sterilizing unit (161) may perform a function of sterilizing a fluid that has passed through the filter unit (151). For example, although the fluid discharged (or discharged) from the bladder (102) has passed through the filter unit (151), there may be foreign substances (or impurities, waste) that have not been filtered out. Therefore, the sterilizing unit (161) may minimize foreign substances in the fluid by performing ultraviolet (UV) sterilization on the fluid that has passed through the filter unit (151).
[0081]
[0082] 2.1 Device configuration of a closed-loop bladder irrigation system
[0083] FIG. 2 illustrates a block diagram of a closed-loop bladder washing system (100) illustrated in FIG. 1 according to one embodiment.
[0084] Referring to FIG. 2, a closed-loop urinary bladder cleaning system (100) (hereinafter, “system”) may include a cleaning solution storage unit (101), a catheter (110), a pump (120), a valve (130), a filter unit (151), a sterilization unit (161), a control unit (201), a sensing unit (203), a cooling device (205), and a communication unit (207).
[0085] According to one embodiment, the sensing unit (203) may include a temperature sensor (203-1), a pressure sensor (203-2), and a flow sensor (140). The sensing unit (203) may be located on the first passage (111) or the second passage (112) of the catheter (110), and may be distinguished from the sensing unit (307 of FIG. 3) provided in the cleaning solution storage unit (101). Although not shown in FIG. 1, the temperature sensor (203-1) may be located on the first passage (111) or the second passage (112) of the catheter (110), and may be located in each of the first passage (111) and the second passage (112). The flow sensor (140), as shown in FIG. 1, may include a first flow sensor (141) and a second flow sensor (142). The catheter (110) may include a first passage (111) and a second passage (112), as illustrated in FIG. 1. The pump (120) may include a first pump (121) and a second pump (122), as illustrated in FIG. 1. The valve (130) may include a first valve (131) and a second valve (132), as illustrated in FIG. 1. The components of the system (100) are not limited to those illustrated in FIG. 2, and some components may be omitted or added.
[0086]
[0087] 2.1.1 Control and Communication Unit
[0088] Referring to FIG. 2, a control unit (201) according to an embodiment may include a CPU (Central Processing Unit), a ROM (Read-Only Memory) storing a control program for controlling the system (100), and a RAM (Random Access Memory) used as a memory area for storing signals or data input from the outside of the system (100) or for control performed in the system (100). The CPU may include at least one of a single core processor, a dual core processor, a triple core processor, or a quad core processor. The CPU, the ROM, and the RAM may be electrically and / or operatively connected to each other through an internal bus.
[0089] According to one embodiment, the control unit (201) may be electrically and / or operatively connected to the cleaning solution storage unit (101), the pump (120), the valve (130), the filter unit (151), the sterilizing unit (161), the sensing unit (203), the cooling device (205), and the communication unit (207). The meaning of being electrically and / or operatively connected may mean a connected state so as to be able to transmit and receive various data.
[0090] According to one embodiment, the control unit (201) can transmit commands to control components of the system (100) (e.g., the cleaning solution storage unit (101), the pump (120), the valve (130), the filter unit (151), the sterilizing unit (161), the sensing unit (203), the cooling device (205), and the communication unit (207)), and can receive data acquired by the components from the components. The control unit (201) can analyze and process the received data, and control the components based on the results of analyzing and processing the received data.
[0091] Referring to FIG. 2, a communication unit (207) according to one embodiment may include a communication module (or communication circuit) to transmit and receive data with an external device (e.g., a server, a terminal, etc.) using a wireless access technology according to a communication protocol. The external device may refer to a terminal including a smartphone or tablet PC, or may refer to a server capable of analyzing or storing data.
[0092] According to one embodiment, the communication module may include at least one of a wireless LAN module and a short-range communication module. The wireless LAN module may be connected to the Internet at a location where a wireless access point (AP) is installed under the control of the control unit (201). The short-range communication module may be capable of wirelessly performing short-range communication between the system (100) and the external device under the control of the control unit (201). The short-range communication method may include Bluetooth, infrared communication (IrDA), NFC, etc.
[0093]
[0094] 2.1.2 Pumps and valves
[0095] Referring to FIGS. 1 and 2, a pump (120) according to one embodiment can control the flow or direction of a fluid (e.g., a cleaning solution, urine, a hemostatic agent, an antibiotic, etc.) flowing inside a catheter (110). The pump (120) may include a bidirectional pump that can control the flow of the fluid in both directions. For example, the control unit (201) may control the flow of a fluid flowing in a first direction (171) inside the catheter (101) to flow in a second direction (172). The bidirectional may refer to the first direction (171) and the second direction (172). The first direction (171) may refer to a direction from the cleaning solution storage unit (101) to the bladder (102), and the second direction (172) may refer to a direction from the bladder (102) to the cleaning solution storage unit (101).
[0096] According to one embodiment, the pump (120) may include a first pump (121) and a second pump (122). The first pump (121) may be positioned on a first passage (111) of the catheter (110), and the second pump (122) may be positioned on a second passage (112).
[0097] Referring to FIGS. 1 and 2, a valve (130) according to one embodiment can control the flow rate of a fluid (e.g., a cleaning solution, urine, a hemostatic agent, an antibiotic, etc.) flowing inside a catheter (110). For example, the valve (130) can control the flow rate of the fluid by controlling the opening / closing rate. For example, when the opening / closing rate of the valve (130) increases, the flow rate of the fluid increases, and when the opening / closing rate of the valve (130) decreases, the flow rate of the fluid can decrease.
[0098] According to one embodiment, the valve (130) may include a first valve (131) and a second valve (132). The first valve (131) may be located on a first passage (111) of the catheter (110), and the second valve (132) may be located on a second passage (112) of the catheter (110).
[0099] According to one embodiment, the control unit (201) can control the pressure inside the bladder (102) and the shape of the fluid flow inside the bladder (102) by controlling the opening / closing ratios of the first valve (131) and the second valve (132), respectively. For example, the control unit (201) can control the opening / closing ratio of the first valve (131) to be greater than the opening / closing ratio of the second valve (132). In this case, the amount of fluid flowing into the bladder (102) can be greater than the amount of fluid discharged (or discharged) from the bladder (102). Therefore, the pressure inside the bladder (102) can increase compared to before controlling the first valve (121) and the second valve (122), and the fluid inside the bladder (102) can form a vortex. For another example, the control unit (201) may control the opening / closing rate of the first valve (131) to be smaller than the opening / closing rate of the second valve (132). In this case, the amount of fluid flowing into the bladder (102) may be smaller than the amount of fluid discharged (or discharged) from the bladder (102). Therefore, the pressure inside the bladder (102) may be similar to or reduced than before controlling the first valve (121) and the second valve (122), and the fluid inside the bladder (102) may form a reservoir.
[0100]
[0101] 2.1.3 Detergent storage compartment
[0102] Referring to FIGS. 1 and 3, a cleaning fluid storage unit (101) according to one embodiment may include a control unit (301), a cleaning fluid inlet (303), a cleaning fluid cartridge module (305), and a sensing unit (307). The cleaning fluid cartridge module (305) may include a cartridge coupling unit (305-1) and a genuine product authentication module (305-2). The sensing unit (307) may include a temperature sensor (307-1), a temperature display unit identification unit (307-2), and a contamination sensor (307-2). The sensing unit (307) is a component included in the cleaning solution storage unit (101), and can be physically installed on the cleaning solution storage unit (101), and can be distinguished from the sensing unit (207) that can be located in at least one of the first passage (111) or the second passage (112) of the catheter (110) other than the cleaning solution storage unit (101).
[0103] According to one embodiment, the control unit (301) of FIG. 3 may be a separate configuration distinct from the control unit (201) of FIG. 2. However, at least some of the functional description of the control unit (201) of FIG. 2 may be understood to be equally applicable to the function of the control unit (301) of FIG. 3.
[0104] According to one embodiment, the control unit (301) may be electrically and / or operatively connected to the detergent inlet (303), the detergent cartridge module (305), the sensing unit (307), and the cooling device (309). The meaning of being electrically and / or operatively connected may mean a connected state so as to be able to transmit and receive various data.
[0105] According to one embodiment, the control unit (301) can transmit commands to control components of the detergent storage unit (101) (e.g., detergent inlet (303), detergent cartridge module (305), sensing unit (307), and cooling device (309)) and receive data acquired by the components from the components. The control unit (301) can analyze and process the received data and control the components based on the results of analyzing and processing the received data.
[0106] According to one embodiment, the cleaning solution inlet (303) can be controlled by the control unit (301) to discharge or not discharge the cleaning solution in the cleaning solution storage unit (101) from the cleaning solution storage unit (101) to the catheter (110). For example, the control unit (301) can open the cleaning solution inlet (303) so that the cleaning solution in the cleaning solution storage unit (101) is discharged into the first passage (111) of the catheter (110). As another example, the control unit (301) can close the cleaning solution inlet (303) so that the cleaning solution in the cleaning solution storage unit (101) is not discharged into the first passage (111) of the catheter (110). The operation of opening the cleaning solution inlet (303) can mean an operation of opening the cleaning solution inlet (303) by controlling the opening / closing device of the cleaning solution inlet (303).
[0107] According to one embodiment, the cleaning solution cartridge module (305) may include a cartridge coupling portion (305-1) to which a cleaning solution cartridge can be coupled. The cleaning solution of the system (100) may be provided in the form of a cleaning solution cartridge so as to confirm whether the cleaning solution is genuine as a consumable. The cartridge coupling portion (305-1) may be shape-specifically coupled to the cleaning solution cartridge so as to confirm whether the cleaning solution provided to the system (100) is genuine. For example, only cleaning solution cartridges that can be shape-specifically coupled to the cartridge coupling portion (305-1) of the cleaning solution storage unit (101) can be coupled to the cartridge coupling portion (305-1), thereby forcing the use of genuine cleaning solution.
[0108] According to one embodiment, the cleaning solution cartridge module (305) may include a genuine product authentication module (305-2). The genuine product authentication module (305-2) may perform a function of verifying whether the cleaning solution used in the system (100) is genuine. For example, the control unit (301) may, through the genuine product authentication module (305-2), cause the cleaning solution to be discharged from the cleaning solution storage unit (101) to the first passage (111) of the catheter (110) only when the cleaning solution cartridge coupled to the cleaning solution storage unit (101) is genuine.
[0109] According to one embodiment, the genuine product authentication module (305-2) may include an RFID tag reader, a barcode or QR code reader, an NFC reader, a hologram / pattern reader, a color identification module, a keying interface, etc. For example, an RFID tag may be embedded in the cleaning solution cartridge, a barcode or QR code may be printed on it, an NFC chip may be embedded on it, or a hologram or pattern may be printed on it, and the RFID tag, the barcode or QR code, the NFC chip, or the hologram or pattern may be identified by the RFID tag reader, the barcode or QR code reader, the NFC reader, or the hologram reader of the genuine product authentication module (305-2), so that only when the cleaning solution cartridge is identified as genuine, the cleaning solution may be discharged from the cleaning solution storage unit (101) to the first passage (111).
[0110] According to one embodiment, the cleaning solution cartridge coupled to the cartridge coupling portion (305-1) may be provided with a temperature display unit. The cleaning solution of the system (100) needs to be maintained at a low temperature for the purpose of hemostasis within the bladder (102). Therefore, the cleaning solution cartridge may be provided with a temperature display unit that displays the temperature. For example, when the temperature of the cleaning solution cartridge is an appropriate temperature (e.g., 10 to 15°C), the temperature may be displayed through the temperature display unit, or a temperature color band indicating a specific temperature may be displayed through thermochromic paint or ink.
[0111] According to one embodiment, the cleaning solution storage unit (101) may include a cooling device (309). The cooling device (309) may perform a function of cooling the temperature of the cleaning solution in the cleaning solution storage unit (101) to an appropriate temperature (e.g., 10 to 15°C). The cooling device (309) may be located inside the cleaning solution storage unit (101). The cooling device (309) of FIG. 3 performs a function of cooling the temperature of the cleaning solution to an appropriate temperature (e.g., 10 to 15°C) similar to the cooling device (205) of FIG. 2, but the location where the cooling device is installed may be different. For example, the cooling device (205) of FIG. 2 may be positioned in at least one of the first passage (111) or the second passage (112) of the catheter (110), and may be manufactured in a form that surrounds at least a portion of the outer shell of the catheter (110). The cooling device (205) may be operated based on temperature data measured by the temperature sensor (203-1) of the sensing unit (203) while the fluid flows inside the catheter (110) after the cleaning solution is discharged from the cleaning solution storage unit (101) into the first passage (111). For example, the temperature sensor (203-1) may periodically or selectively measure the temperature of the fluid inside the catheter (110), and when the measured temperature is not the appropriate temperature, the cooling device (205) may control the temperature so that the temperature becomes the appropriate temperature. On the other hand, the cooling device (309) of FIG. 3 may be located inside the cleaning solution storage unit (101). For example, the cooling device (309) may be located at the center of the cleaning solution storage unit (101) to uniformly cool the cleaning solution from the center.
[0112] According to one embodiment, both the cooling device (205) of FIG. 2 and the cooling device (309) of FIG. 3 may have a function of not only cooling the temperature of the cleaning solution but also heating the temperature of the cleaning solution.
[0113] According to one embodiment, the control unit (301) can detect the temperature of the cleaning liquid in the cleaning liquid storage unit (301) through the temperature sensor (307-1) of the sensing unit (307) or the temperature display unit identification unit (307-2), and when the detected temperature is lower than the appropriate temperature, the cleaning liquid can be heated until the temperature of the cleaning liquid reaches the appropriate temperature, and when the detected temperature is higher than the appropriate temperature, the cleaning liquid can be cooled until the temperature of the cleaning liquid reaches the appropriate temperature. The temperature sensor (307-1) can be installed in the cleaning liquid storage unit (101), can detect the temperature of the cleaning liquid in the cleaning liquid storage unit (101), and can transmit the detected temperature information to the control unit (301). The temperature display unit identification unit (307-2) can detect the temperature displayed on the temperature display unit provided in the cleaning liquid cartridge, and can transmit the detected temperature information to the control unit (301).
[0114] According to one embodiment, the control unit (301) can detect the temperature of the cleaning solution in the cleaning solution storage unit (301) through the temperature sensor (307-1) of the sensing unit (307) or the temperature display unit identification unit (307-2), and can open the cleaning solution inlet (303) only when the temperature of the cleaning solution corresponds to the appropriate temperature, and when the temperature of the cleaning solution does not correspond to the appropriate temperature, the temperature of the cleaning solution is controlled to the appropriate temperature through the cooling device (309), and then the cleaning solution inlet (303) can be opened.
[0115]
[0116] 2.1.4 Sensing unit
[0117] Referring to FIGS. 1 and 2, the sensing unit (203) may include a temperature sensor (203-1), a pressure sensor (203-2), and a flow sensor (140). The temperature sensor (203-1) may be installed on the catheter (110) rather than on the cleaning solution storage unit (101). For example, the temperature sensor (203-1) may be installed in at least one of the first passage (111) or the second passage (112) of the catheter (110). The temperature sensor (203-1) may measure the temperature of the fluid flowing inside the catheter (110). The temperature sensor (203-1) may transmit data on the measured temperature to the control unit (201).
[0118] According to one embodiment, the pressure sensor (203-2) may be installed on the catheter (110) rather than the cleaning solution storage unit (101). At least one pressure sensor (203-2) may be installed. For example, the pressure sensors (203-2) may be installed on each of the first passage (111) and the second passage (112). The pressure sensor (203-2) may measure the pressure inside the bladder (102). The pressure sensor (203-2) may transmit data on the measured pressure to the control unit (201).
[0119] According to one embodiment, the flow sensor (140) may include a first flow sensor (141) and a second flow sensor (142). The flow sensor (140) may measure the flow rate and flow velocity of a fluid flowing inside the catheter (110). The flow sensor (140) may measure the flow rate of a fluid injected into the bladder (102) and discharged (or discharged) from the bladder (102), and may provide the measured flow rate data to the control unit (201). The flow sensor (104) may be composed of a Hall Effect Sensor Circuit and a turbine wheel, and may measure the flow rate by measuring the number of times the blades of the turbine wheel rotate.
[0120] Referring to FIGS. 1 and 3, the sensing unit (307) may include a temperature sensor (307-1), a temperature display unit identification unit (307-2), and a contamination sensor (307). The temperature sensor (307-1) may be installed on the cleaning solution storage unit (101) rather than on the catheter (110). The temperature sensor (307-1) may measure the temperature of the cleaning solution in the cleaning solution storage unit (101). The temperature sensor (307-1) may transmit data on the measured temperature to the control unit (301).
[0121] According to one embodiment, the temperature display identification unit (307-2) can detect the temperature displayed on the temperature display unit provided in the cleaning solution cartridge and transmit the detected temperature information to the control unit (301).
[0122] According to one embodiment, the contamination sensor (307-3) can detect the contamination level of the cleaning solution inside the cleaning solution storage unit (101) and transmit the detected contamination level information to the control unit (301). The control unit (301) can open the cleaning solution inlet (303) only when the contamination level of the cleaning solution inside the cleaning solution storage unit (101) falls within a normal range.
[0123]
[0124] 2.1.5 Catheter (detachable or integral)
[0125] According to one embodiment, the catheter (110) may be manufactured in a form that is detachable from the system (100) or in an integrated form. The first passage (111) and the second passage (112) of the catheter (110) may be manufactured in a form that is detachable from the cleaning solution storage unit (101) of the system (100). For example, the detachable form may include a form in which the connection portion between the catheter (110) and the system (100) is connected through a screw-shaped bolt and nut fastening structure, a fastening method between a protrusion and a receiving groove, etc. In addition, a rubber packing member may be added to the connection portion to prevent the cleaning solution from leaking from the connection portion.
[0126] According to one embodiment, the connection between the catheter (110) and the system (100) may be manufactured as an integral part, and a separate connection member (e.g., a rubber packing member) may be omitted at the connection portion between the catheter (110) and the system (100).
[0127]
[0128] 2.2 Workflow of a closed-loop bladder irrigation system
[0129] 2.2.1 Overview
[0130] A closed-loop urinary bladder cleaning system (100) according to one embodiment of the present application can provide a bladder cleaning function to patients suffering from diseases such as benign prostatic hyperplasia, bladder cancer, bladder stones, urolithiasis, cystitis, neurogenic bladder, spinal cord injury, etc., and to patients who have undergone surgeries such as benign prostatic hyperplasia surgery, transurethral cystectomy, total cystectomy, and artificial bladder surgery, transurethral urolithiasis surgery, transurethral cystolithiasis surgery, etc.
[0131] The irrigation solution injected into a patient's bladder can be of various types depending on the patient's condition or degree of improvement, bladder size, the pressure to be maintained within the bladder, and the flow rate of the irrigation solution. This is because the medication contained in the irrigation solution and introduced into the bladder can have various parameters (e.g., flow rate, intravesical pressure, etc.) that vary depending on the patient's characteristics, including the pressure to be maintained within the bladder. In particular, intravesical pressure is a critical parameter related to drug absorption and user pain, and therefore, its control can be crucial.
[0132] That is, depending on the individual characteristics of the patient, the closed-loop bladder washing system (100) according to one embodiment of the present application can be provided to wash the patient's bladder according to various driving algorithms or to allow the drug contained in the washing solution to be absorbed into the bladder.
[0133] To this end, the system (100) can generate signals for controlling the cleaning solution storage unit (101), pump (120), valve (130), filter unit (141), sterilization unit (161), and cooling device (205) based on the data acquired from the sensing unit (203), and can drive an algorithm for cleaning the patient's bladder according to the generated control signals.
[0134]
[0135] 2.2.2 Pre-washing algorithm
[0136] FIG. 4 is a conceptual diagram for explaining a pre-washing algorithm for preparing a system (100) before washing a bladder of a user (patient) according to one embodiment.
[0137] A system (100) according to one embodiment may be driven to wash a patient's bladder according to various algorithms. More specifically, the system (100) according to one embodiment may drive a pre-washing algorithm to obtain information on the patient's bladder capacity and appropriate intra-bladder pressure prior to performing a washing algorithm for injecting and discharging a washing solution into the bladder to discharge foreign substances such as blood clots within the bladder and to allow the medicinal solution within the washing solution to be absorbed into the bladder.
[0138] More specifically, the system (100) of the present disclosure is an algorithm that is performed to set the bladder of each user to fit the device before performing bladder washing.
[0139] Referring to FIG. 4, the pre-washing algorithm driven by the system (100) of the present disclosure may include a bladder emptying step (410), a bladder injection volume versus discharge volume confirmation step (420), a flow rate confirmation step (430), and a bladder capacity confirmation step (440).
[0140] More specifically, the bladder emptying step (410) included in the pre-washing algorithm may be a step for removing residual urine in the bladder after the system (100) is connected to a patient (e.g., a catheter is inserted into the patient's bladder, installed, etc.). More specifically, the system (100) may remove residual urine in the bladder by reverse perfusion (e.g., driving the pump (120) in the opposite direction of the forward direction (hereinafter, 'reverse direction')) for a predetermined period of time. More specifically, the system (100) may control a valve so that the washing solution cannot escape (e.g., so that the fluid in the second passage cannot flow) before driving the bladder washing algorithm. Thereafter, the system (100) may drive the pump in reverse so that the fluid flows from the bladder to the first passage for a predetermined period of time.
[0141] Meanwhile, the predetermined time here may be, for example, 2 to 5 seconds, but is not limited thereto.
[0142] In another embodiment, the system (100) can control the pump (120) through the flow sensor (140) so that the flow rate through reverse perfusion continues until it becomes 0. In another embodiment, the system (100) can control the pump (120) through the flow sensor (140) so that the condition in which the flow rate through reverse perfusion becomes 0 and there is no further flow rate for a predetermined period of time (e.g., 2 to 3 seconds) is maintained.
[0143] That is, in the example described above, the system (100) can drive the pump (120) in reverse to terminate the bladder emptying step (410) according to at least one of a predetermined condition, for example, when the flow rate becomes 0 through the flow rate sensor (140), or when the flow rate remains 0 through the flow rate sensor (140) for a predetermined period of time.
[0144] In one embodiment, the system (100) may, in response to completion of the bladder emptying step (410), initiate a bladder infusion volume versus discharge volume verification step (420).
[0145] More specifically, the step of checking the output volume compared to the bladder infusion volume can be performed by slowly injecting and discharging a small amount of effective irrigation solution (irrigation solution) to check the output volume compared to the bladder infusion volume. In other words, the ratio of the output volume to the infusion volume can be checked.
[0146] More specifically, the system (100) may generate a signal to control the pump (120) to inject a predetermined first volume of cleaning solution into the bladder. Accordingly, in response to the first predetermined volume of cleaning solution being injected into the bladder, the system (100) may generate a signal to control the pump (120) to discharge the predetermined first volume of cleaning solution. Here, the signal to control the pump (120) to discharge the cleaning solution may include a signal to control the pump to drive in the opposite direction to when it is injected.
[0147] The system (100) may generate a signal to control the pump (120) to inject a second predetermined volume of cleaning solution into the bladder in response to the discharge of a first predetermined volume of cleaning solution after it has been injected. In this case, the system (100) may generate a signal to control the reverse operation of the pump (120) so that the second predetermined volume of cleaning solution can be discharged in response to the injection of the second predetermined volume of cleaning solution into the bladder.
[0148] Meanwhile, the step (420) of checking the discharge capacity compared to the bladder injection capacity driven by the present system (100) may include a first step for injecting and then discharging a first predetermined volume of cleaning solution, a second step for injecting and then discharging a second predetermined volume of cleaning solution, etc. In other words, in addition to the first predetermined volume and the second predetermined volume, the step of injecting and discharging an additional predetermined volume may be further included.
[0149] For example, the predetermined first volume may be determined to have a volume of 30 cc, the predetermined second volume may be determined to have a volume of 50 cc, the predetermined third volume may be determined to have a volume of 70 cc, and the predetermined fourth volume may be determined to have a volume of 100 cc. In other words, the predetermined n+1 volume may be determined to have a larger volume than the predetermined n volume. Here, the predetermined volume may be determined as an optimal value for confirming the output volume compared to the infusion volume into the patient's bladder, for example, as a value determined experimentally or empirically.
[0150] Meanwhile, the system (100) according to one embodiment can control the pump to inject and discharge a predetermined volume. In this case, the system can control the pump (120) to inject the predetermined volume and continue to maintain the flow rate through the reverse perfusion until it becomes 0 through the flow sensor (140), rather than the predetermined volume. That is, the system (100) can obtain the first flow rate data of the first fluid flowing in the catheter (110) through the flow rate sensor (142) and identify the discharged amount compared to the injected amount of the washing solution based on the processing of the first flow rate data. Accordingly, the step of confirming the discharged amount compared to the injected amount in the bladder of the system (100) can be a step to confirm the discharged amount compared to the injected amount based on the difference between the injected and discharged volumes of the washing solution, and to confirm the volume additionally generated due to reasons such as urine generated other than the washing solution injected into the patient's bladder.
[0151] Meanwhile, the present system (100) can obtain first flow rate data of the first fluid flowing in the catheter (110) through the flow rate sensor (142) and stop the operation of the pump if the first flow rate data is the same predetermined condition as in the bladder emptying step described above.
[0152]
[0153] Meanwhile, the present system (100) can obtain information on the patient's discharge volume compared to the injected volume through the step (420) of checking the discharge volume compared to the injected volume in the bladder. Thereafter, the present system (100) can prepare to run the subsequent pre-washing algorithm by running the bladder emptying step (410). That is, the present system (100) can perform the bladder emptying step (410) before the flow rate checking step (430) which will be described in detail below, and can perform the bladder emptying step (410) before the bladder capacity checking step (440).
[0154] According to one embodiment, the system (100) may drive the flow rate verification step (430) in response to driving the bladder emptying step (410) after the bladder injection volume versus output volume verification step (420). In another embodiment, the system (100) may drive the flow rate verification step (430) in response to driving the bladder emptying step (410) without performing the bladder injection volume versus output volume verification step (420).
[0155] That is, the present system (100) may be intended to prevent the user (patient) from experiencing discomfort, pain, etc. by controlling the flow rate of the cleaning solution injected into the patient's bladder.
[0156] The present system (100) can perform the flow rate verification step (430) by injecting a predetermined amount into the bladder for a predetermined time and then discharging it. More specifically, the flow rate verification step (430) of the present system (100) can verify the maximum flow rate of the cleaning solution flowing into the bladder in response to receiving input from the patient, including information about discomfort or pain, by injecting a predetermined amount into the bladder for another predetermined time.
[0157] That is, the present system (100) can inject and discharge a pre-determined amount of washing solution into the bladder within a pre-determined first time, a pre-determined second time, and a pre-determined third time, and in this case, in response to receiving an input including information about discomfort or pain from the patient for a specific time, the maximum flow rate of the washing solution flowing into the bladder can be confirmed.
[0158] In another embodiment, the flow rate checking step (430) of the present system (100) may generate a signal to control the pump (120) to inject the cleaning solution at a predetermined first flow rate for a predetermined capacity and discharge the predetermined capacity at the predetermined first flow rate.
[0159] Thereafter, the system (100) can repeatedly perform intravesical injection and discharge for a predetermined volume at a predetermined second flow rate. Here, "repeatedly" may mean that the injection and discharge are performed at different flow rates. Meanwhile, the system (100) can continuously receive user input including information about discomfort or pain from the patient (user) while performing the aforementioned flow rate confirmation step (430).
[0160] For example, a user may transmit user input regarding the discomfort or pain to the system (100) via a user terminal. Accordingly, in response to receiving the user input via the communication unit (207) of the system (100), the system (100) may set a maximum flow rate for a specific flow rate at the time the user input was received. The maximum flow rate here is set for all algorithms described in detail below, and the system (100) may control the pump (120) and valve (130) so that the flow rate does not exceed the maximum flow rate.
[0161] Meanwhile, the reception of user input through the user terminal described above is exemplary, and in another embodiment, the system (100) may include a display (not shown) to output various data and / or UI / UX. Here, the display (not shown) may be provided as an integral part with an input device capable of receiving user input, and may also be used as an input device for inputting user operations. That is, the system (100) may set the maximum flow rate based on user input regarding discomfort or pain through the display (not shown). However, the present invention is not limited thereto.
[0162] The present system (100) can perform a bladder emptying step (410) in response to completion of the flow rate verification step (430).
[0163] Meanwhile, the system (100) according to one embodiment may perform the bladder capacity verification step (440) in response to the bladder emptying step (410) being performed after the flow rate verification step (430). In another embodiment, the system (100) may perform the bladder capacity verification (440) in response to the bladder emptying step (410) being performed without performing the bladder injection capacity versus discharge capacity verification step (420) and / or the flow rate verification step (430).
[0164] The present system (100) can inject a cleaning solution (irrigation solution) into the bladder in a forward direction up to the bladder's limit capacity in order to check bladder capacity. That is, the present system (100) can check the amount of cleaning solution injected before receiving user input regarding discomfort or pain from the user, and in response to receiving the user input, check the limit capacity (441).
[0165] More specifically, the system (100) can drive the pump forward to inject a cleaning solution into the bladder after a bladder emptying step, and in response to receiving a user input regarding discomfort or pain from the user, drive the pump in reverse, acquire first flow rate data of the first fluid flowing in the catheter (110) through the flow sensor (142), and identify the cumulative volume of the cleaning solution in the bladder until the input is received based on processing the first flow rate data.
[0166] In addition, the present system (100) may be capable of checking not only bladder capacity but also the intra-bladder pressure that causes pain to each user. For example, the present system (100) may, in response to a user input indicating that the user feels discomfort while injecting a cleansing solution into the bladder, check the maximum pressure based on the intra-bladder pressure acquired from the pressure sensor (203-2). Here, the maximum pressure is set for all algorithms described in detail below, and the present system (100) may control the pump (120) and the valve (130) so that the intra-bladder pressure does not exceed the maximum pressure.
[0167] Meanwhile, in the case of a patient (user) who does not feel a feeling of fullness, discomfort, etc., the present system (100) can perform the bladder capacity confirmation step (440) by injecting only a predetermined amount into the bladder of the patient. In this case, the present system (100) can stop the injection of the predetermined amount in response to the pressure in the bladder of the patient reaching the predetermined pressure through the pressure sensor (203-2), and confirm the maximum bladder capacity of the patient.
[0168] Thereafter, the system (100) can perform a bladder emptying step (410) to discharge all of the cleaning solution injected into the patient's bladder. Accordingly, the system (100) can operate a cleaning algorithm for bladder cleaning.
[0169] Meanwhile, the present system (100) can control the pump (120) and valve (130) so that the maximum bladder capacity of the patient is set for all algorithms described in detail below and the amount of cleaning solution injected into the bladder does not exceed the maximum capacity. However, the present invention is not limited thereto.
[0170] According to one embodiment, the system (100) can determine the ratio of the amount of discharged fluid to the amount injected, the maximum flow rate of the intravesical infusion solution, and the maximum bladder capacity of the user (patient) based on the execution of the pre-cleaning algorithm. However, this is not limited thereto. In other embodiments, it is understood that the system (100) may further include or omit various processes in the pre-cleaning algorithm.
[0171]
[0172] 2.2.3 Cleaning Algorithm
[0173] According to one embodiment, the system (100) can check the ratio of the discharged amount to the injected amount, the maximum flow rate of the intravesical injected cleaning solution, and the maximum bladder capacity of the user (patient) according to whether the pre-cleaning algorithm is run. However, the present invention is not limited thereto. In another embodiment, the system (100) may further include additional steps in addition to the bladder emptying step (410), the step of checking the discharged amount to the intravesical injected amount (420), the step of checking the flow rate (430), and the step of checking the bladder capacity (440) described above in the pre-cleaning algorithm, and at least one of the above-described steps may be omitted.
[0174] According to one embodiment, the present system (100) can, in response to driving the pre-washing algorithm described above, drive the washing algorithm based on the ratio of the obtained injection amount to the discharge amount, the maximum flow rate of the intravesical washing solution, and the maximum bladder capacity of the user (patient).
[0175]
[0176] FIG. 5 is a conceptual diagram for explaining a washing algorithm for washing the bladder of a user (patient) by a system (100) according to one embodiment.
[0177] A system (100) according to an embodiment may be driven to wash a patient's bladder according to various algorithms. More specifically, the system (100) according to an embodiment may perform a washing algorithm to discharge foreign substances such as blood clots in the bladder by injecting and discharging a washing solution into the bladder and to allow the medicinal solution in the washing solution to be absorbed into the bladder. More specifically, the washing algorithm performed by the present system (100) may be performed after the driving is completed according to the above-described pre-washing algorithm, and in the case of an existing patient, since the ratio of the patient's acquired injection amount to the discharged amount, the maximum flow rate of the washing solution injected into the bladder, and the user's (patient's) maximum bladder capacity are already obtained in advance, only the bladder emptying step (410) among the pre-washing algorithms may be performed and the washing algorithm may be performed.
[0178] Referring to FIG. 5, the pre-washing algorithm driven by the system (100) of the present disclosure may include a first bladder emptying step (510), a first washing step (520), a second washing step (530), a second bladder emptying step (540), and a tube washing step (550).
[0179] More specifically, the first bladder emptying step (510) among the cleaning algorithms driven by the present system (100) can be applied in the same manner as the bladder emptying step (410) performed in the pre-cleaning algorithm described above, for example. Specifically, the bladder emptying step (410) and the first bladder emptying step (510) can be named a safety mode for the safety of the user by preventing the limit capacity or pressure from being exceeded when injecting the cleaning solution in the case where there is a liquid such as residual cleaning solution or urine in the bladder, but is not limited thereto.
[0180] Meanwhile, it can be understood that the first bladder emptying step (510) among the cleaning algorithms driven by the present system (100) according to one embodiment may be omitted if the bladder emptying step (410) is performed after the bladder capacity confirmation step (440) of the pre-cleaning algorithm.
[0181] According to one embodiment, the system (100) may operate a first irrigation step (520) in response to the completion of the first bladder emptying step (510) or the pre-irrigation algorithm terminating with the bladder emptying step (410). Meanwhile, the first irrigation step (520) may be referred to as a short irrigation step since it injects and discharges a smaller volume of irrigating solution than the second irrigation step (530) described in detail below, but is not limited thereto.
[0182] More specifically, the present system (100) can generate a signal to control the pump (120) to inject a predetermined volume of cleaning solution (hereinafter referred to as a “first cleaning volume”) through forward perfusion. Thereafter, the present system (100) can generate a signal to control the pump (120) to discharge the first cleaning solution through reverse perfusion in response to the first cleaning solution being injected. Here, the process of the present system (100) injecting and discharging the first cleaning solution is referred to as one cycle.
[0183] In this case, the present system (100) can perform the above cycle at least twice. For example, the present system (100) can perform the first washing step (520) by repeating the first washing capacity of the washing liquid for six cycles.
[0184] More specifically, the present system (100) can inject and discharge a cleaning solution having a capacity of 50 cc at a flow rate of 1 L / min. Here, the present system (100) can perform the first cleaning step (520) of the above-described cycle at least once or more repeatedly. Meanwhile, the present system (100) can discharge only the cleaning solution having the first cleaning capacity based on data acquired from the flow sensor (140) during the process of injecting and discharging the cleaning solution having the first cleaning capacity, even when discharging.
[0185] Meanwhile, the volume of the cleaning solution injected into the bladder of the patient and the volume of the cleaning solution discharged may be different. For example, when the first cleaning volume of cleaning solution is injected and the first cleaning volume of cleaning solution is discharged, there may be cases where the same volume as the first cleaning volume is not discharged. This may occur depending on the type of catheter installed in the bladder. In this case, the present system (100) may generate a control signal to drive the pump (120) in the reverse direction for a predetermined period of time even when the first cleaning volume of cleaning solution is not discharged. Thereafter, the present system (100) may terminate the discharge (stop driving the pump) even when the first cleaning volume of cleaning solution is not discharged for the predetermined period of time (for example, when a predetermined condition in the bladder emptying step described above is met).
[0186] That is, when the system (100) injects the first washing liquid and discharges the first washing liquid, if the first washing liquid is not completely discharged, the discharge can be performed only for a predetermined time and one cycle can be completed.
[0187] Meanwhile, the system (100) can calculate the amount of washing solution in the bladder for the safety of the patient while performing the first washing step (520). More specifically, the system (100) can calculate the amount of washing solution injected and discharged through the flow sensor (140). That is, since the amount of washing solution discharged may be less than the amount of washing solution injected, the system (100) can accumulate and calculate the amount of washing solution remaining in the bladder.
[0188] At this time, the system (100) may generate a signal to control the pump (120) to discharge the washing solution within the bladder, if the amount of the accumulated washing solution is greater than the first predetermined capacity, and to terminate the first washing step (520). Thereafter, the system (100) may restart the first washing step (520) in response to the residual washing solution within the bladder being calculated to be less than the second predetermined capacity through the discharge. For example, the system (100) may terminate the first washing step (520) in response to the cumulative amount remaining within the bladder being greater than 300 cc during the first washing step (520) and to control the pump (120) to discharge the residual washing solution within the bladder. Thereafter, the first washing step (520) may be restarted in response to the residual washing solution within the bladder being calculated to be less than 100 cc. However, the present invention is not limited thereto.
[0189] According to one embodiment, the system (100) may perform a second irrigation step (530) in response to the first irrigation step (520) having cycled a predetermined number of times (e.g., 6 times). The second irrigation step (520) may be referred to as a full bladder irrigation step because it injects and discharges a larger volume of irrigating solution than the first irrigation step (520) described above, but is not limited thereto.
[0190] The system (100), in response to the completion of the first washing step (520), may generate a signal to control the pump (120) to inject into the bladder a larger volume (e.g., 200 cc) (hereinafter referred to as a “second washing volume”) than the first washing volume injected and discharged in the first washing step (520). Thereafter, the system (100), in response to the entirety of the second washing volume being injected into the bladder, may control the pump (120) to inject the first washing volume and control the pump (120) to discharge the first washing volume.
[0191] That is, the second washing step (520) can be understood as the system (100) performing the first washing step (520) in a state where the second washing volume has been fully injected into the bladder. Referring to FIG. 5, the second washing step (520) performs the injection and discharge of the first washing volume in three cycles after the second washing volume has been injected, but is not limited thereto.
[0192] More specifically, the present system (100) can control the pump (120) to inject a 200 cc volume of cleaning solution at a flow rate of 1 L / min and to inject and discharge a 50 cc volume of cleaning solution at a flow rate of 1 L / min. Here, the present system (100) can perform the first cleaning step (520) of the above-described cycle at least once after the second cleaning volume is injected.
[0193] Meanwhile, the present system (100) can calculate the volume of residual washing solution in the bladder through a flow sensor (140) during the process of injecting the washing solution of the second washing volume and injecting and discharging the washing solution of the first washing volume.
[0194] Accordingly, the system (100) may, in response to the residual cleaning solution in the bladder being greater than the third predetermined volume while operating the second cleaning step (530), discharge the residual cleaning solution in the bladder so that the residual cleaning solution in the bladder becomes less than the third predetermined volume. Thereafter, the system (100) may, in response to the residual cleaning solution in the bladder becoming less than the third predetermined volume, perform the injection and discharge of the cleaning solution of the first cleaning volume. Here, the third predetermined volume may be, for example, 300 to 400 cc, but may be determined based on the patient's maximum bladder capacity through a pre-cleaning algorithm.
[0195] Meanwhile, in another embodiment, the system (100) may, in response to the residual washing solution in the bladder being greater than a third predetermined volume while operating the second washing step (530), discharge the residual washing solution in the bladder so that the residual washing solution in the bladder becomes less than a fourth predetermined volume. Here, the fourth predetermined volume may be set to, for example, 150 cc or 200 cc, which may be determined based on the patient's maximum bladder capacity as described above.
[0196] Meanwhile, the system (100) can calculate the total amount of cleaning solution injected into the bladder through the flow sensor (140). In this case, the system (100) can terminate the second cleaning step (530) in response to the total amount of cumulative cleaning solution injected into the bladder exceeding a predetermined ratio of the cleaning solution equipped in the system (1000). Meanwhile, the predetermined ratio may mean, for example, 90%, but is not limited thereto, and may be determined as a ratio that is effective for the treatment of a patient determined empirically or experimentally.
[0197] According to one embodiment, the present system (100) may perform a second bladder emptying step (540) in response to the completion of the second washing step (530). Here, the second bladder emptying step (540) may be operated in the same manner as the bladder emptying step (410) described above.
[0198] However, since the bladder is usually distended when the second washing step (530) is completed, there is a possibility that residual washing fluid may exist within the bladder. Accordingly, the present system (100) may terminate the second bladder emptying step (540) in response to a predetermined amount of residual washing fluid within the bladder (e.g., 100 cc) or a discharge flow rate obtained through a flow sensor (140) being 0.
[0199] Thereafter, the system (100) may drive the tube cleaning step (550) in response to the end of the second bladder emptying step (540). Here, the tube cleaning step (550) may perform tube cleaning using a cleaning solution excluding the amount used for bladder cleaning from the total amount of bladder cleaning solution installed in the system (100). That is, for example, when the installed cleaning solution is 1 L and the cleaning solution injected into the bladder through the first cleaning step (520) and the second cleaning step (530) is 900 cc, the system (100) may perform tube cleaning based on the remaining 100 cc.
[0200] Meanwhile, the system (100) can calculate the residual bladder cleaning fluid based on the cumulative amount of cleaning fluid injected into the bladder and discharged while operating the cleaning algorithm. That is, the system (100) can operate an emergency discharge mode when the residual bladder cleaning fluid exceeds the caution capacity. The emergency discharge mode can generate a signal to control the pump (120) so that the residual bladder cleaning fluid becomes smaller than the caution capacity, for example. Meanwhile, the caution capacity here can be set according to, for example, the patient's maximum capacity, but is not limited thereto. For example, the caution capacity can be determined to have a range of 200 cc to 500 cc.
[0201] Meanwhile, the injection and discharge speeds of the cleaning solution in the first washing step (520) and the second washing step (530) may be determined, for example, to inject or discharge a volume of 50 cc for 3 seconds. However, if the injection of the volume of 50 cc for 3 seconds is faster than the maximum flow rate at which the patient feels pain, the system (100) may control the pump (120) to be less than the maximum flow rate through the pre-washing algorithm.
[0202] Meanwhile, in the description of the above-described pre-washing algorithm and washing algorithm, for the convenience of explanation, an embodiment was described in which the washing solution is injected and discharged in one direction by controlling the valve when the bladder emptying step included in the above-described pre-washing algorithm and washing algorithm is performed.
[0203] In more detail, the pre-washing algorithm and the bladder emptying step included in the washing algorithm are described as controlling a valve to prevent the fluid in the second passage from flowing through the washing solution injected into the bladder through the first passage, and controlling a pump to discharge the washing solution in the bladder in the opposite direction (reverse direction) to the injection of the washing solution using the first passage. However, this is not limited thereto.
[0204] That is, the pre-washing algorithm and the washing algorithm described above can control the valve and the pump so that the fluid in the first passage cannot flow so that the washing solution in the bladder can be discharged (in the reverse direction of the injection direction) using the first passage (the passage into which the washing solution is injected) after the present system (100) controls the pump (120) so that the washing solution in the bladder can be injected using the first passage, and also so that the washing solution in the bladder can be discharged using the second passage.
[0205] In addition, the pre-washing algorithm and the washing algorithm described above can control the valve and the pump so that the washing solution in the bladder is discharged (in the reverse direction of the injection direction) using the first passage (the passage into which the washing solution is injected) after the system (100) controls the pump (120) to inject the washing solution using the second passage, and can also control the valve and the pump so that the fluid in the first passage cannot flow so that the washing solution in the bladder can be discharged using the second passage.
[0206] Likewise, the steps of injecting the washing solution into the bladder and draining the washing solution included in the pre-washing algorithm and / or the washing algorithm may all be applied as described above.
[0207] For example, in the step of checking the discharge volume compared to the bladder injection volume included in the pre-washing algorithm, after injecting the washing solution into the bladder using the first passage and / or the second passage, the present system (100) can control the valve and / or the pump so that the washing solution can be discharged using the first passage and / or the second passage opposite to the passage through which it was injected. That is, it can be understood that there are no restrictions on the direction and / or passage of the washing solution injection and / or the passage used (the first passage and / or the second passage) as long as the purpose of injecting and discharging the washing solution into the bladder can be achieved.
[0208] As another example, in the second washing step (520) included in the washing algorithm, the process of injecting the washing solution of the second washing volume and injecting and discharging the first washing solution may include valve control, such that while the first washing solution is being injected, the valve is controlled so that the fluid in the second passage cannot flow, and when discharging after the first washing solution is injected, the fluid may be discharged through the first passage, or the valve may be controlled so that the fluid in the first passage cannot flow through additional valve control, and the first washing solution may be discharged through the second passage. Meanwhile, in this case, the present system (100) may repeatedly inject and discharge the fluid (washing solution) in the bladder into and out of the bladder through forward and / or reverse control of the pump without valve control.
[0209]
[0210] 2.2.4. Blockage Detection Algorithm
[0211] According to one embodiment, the present system (100) can continuously run an algorithm for detecting that the catheter (110) is blocked by a blood clot or foreign substance in the patient's bladder while running the pre-washing algorithm and / or the washing algorithm described above.
[0212] More specifically, in the case of a patient who needs to undergo bladder washing, blood clots may occur due to surgery and / or inflammation of the bladder, and such blood clots may block the pipe or catheter (110) of the system (100), making it difficult for the washing algorithm to proceed smoothly. Accordingly, the system (100) may execute an algorithm capable of preventing or resolving blockage by executing a blockage detection algorithm during the operation of the algorithm described below, as well as a pre-washing algorithm or a washing algorithm.
[0213]
[0214] FIG. 6 is a flowchart for explaining a blockage detection algorithm driven by a system (100) according to one embodiment.
[0215] Referring to FIG. 6, the system (100) according to one embodiment can identify a first flow rate value and a second flow rate value or an intra-bladder pressure value (610). Furthermore, the system can determine whether a blockage is detected (620) in response to the completion of step 610. Furthermore, the system (100) can identify a blockage detection based on the performance of step 620 (630). Meanwhile, if a blockage is not detected based on the performance of step 620, the system (100) can re-perform from step 610.
[0216] More specifically, the present system (100) can identify a first flow rate value of the cleaning solution injected into the catheter (110) inserted into the bladder based on the flow rate sensor (140). In addition, the present system (100) can identify a second flow rate value of the cleaning solution discharged from the catheter (110) inserted into the bladder based on the flow rate sensor (140). In another embodiment, the present system (100) according to one embodiment can identify a pressure value within the bladder based on the pressure sensor (203-2). Meanwhile, the present system (100) can identify the residual cleaning solution in the bladder compared to the maximum bladder capacity, which can replace the pressure value within the bladder, using only the flow rate sensor (140) without using the pressure sensor (203-2).
[0217] According to one embodiment, the system (100) can determine whether a blockage is detected in response to identifying the first flow rate value and the second flow rate value or the pressure value within the bladder (620).
[0218] More specifically, the system (100) can detect at least one abnormality during algorithm operation. For example, the abnormality may refer to a state in which the system (100) is highly confident of being blocked or is determined to be blocked.
[0219] The present system (100) can detect an abnormality in response to, for example, a decrease in a first flow rate value (injection amount) by a preset first value. In addition, the present system (100) can detect an abnormality in response to a decrease in a second flow rate value (discharge amount) by a preset second value.
[0220] More specifically, since the first flow rate value represents the volume of the cleaning solution injected into the bladder per unit time, a decrease in the first flow rate value can be determined with high reliability as indicating the presence of a blood clot or foreign substance in the tube or outlet injected into the bladder. In addition, since the second flow rate value represents the volume of the cleaning solution discharged from the bladder per unit time, a decrease in the second flow rate value can be determined with high reliability as indicating the presence of a blood clot or foreign substance in the tube or inlet discharged from the bladder.
[0221] Meanwhile, the present system (100) can identify the circulating amount of the cleaning solution based on the flow sensor (141, 142). For example, the circulating amount may refer to the volume of the cleaning solution circulated per unit time through the pipe of the present system (100) per unit time based on the first flow rate value and the second flow rate value. That is, the present system (100) drives the pump (120) at the intended flow rate, but if a blockage is detected due to accumulation of a blood clot or foreign substance in the pipe or catheter (110), smooth circulation of the cleaning solution may not be possible. Accordingly, the present system (100) can determine with high reliability that a blood clot or foreign substance exists in the passage through which the cleaning solution circulates in response to a decrease in the circulating amount (e.g., the second flow rate value - the first flow rate value) by a preset third value.
[0222] In another embodiment, the system (100) can determine with high reliability that a blood clot or foreign substance is present in the pipe (channel) through which the cleaning fluid flows, based on the pressure identified by the pressure sensor (203-2) within the bladder or within the pipe through which the cleaning fluid flows, in response to the identified pressure increasing by a preset fourth value. However, the present invention is not limited thereto.
[0223] Accordingly, the system (100) can determine whether a blockage is detected in response to the detection of at least one abnormality among the above-described abnormalities (620). That is, if at least one abnormality is detected, the system (100) can identify that a blockage has been detected (630), and if no abnormality is detected, the system can continuously monitor the first flow rate value and the second flow rate value or the intravesical pressure value until at least one abnormality is detected (610).
[0224] Meanwhile, the present system (100) can continuously operate the aforementioned blockage detection algorithm even while operating the algorithm described below or the pre-cleaning algorithm and the cleaning algorithm. Accordingly, the present system (100) can operate the blockage removal algorithm in response to the blockage detection algorithm identifying the blockage, or can remove the blockage through the bladder pressure control algorithm described below.
[0225]
[0226] 2.2.5 Disease-specific control algorithms
[0227] As described above, various types of cleaning solutions may be applied to the patient's bladder depending on the patient's disease or the degree of improvement of the disease, the size of the bladder, the pressure to be maintained within the bladder, and the flow rate of the cleaning solution. In particular, the present system (100) can control specific parameters (e.g., flow rate or pressure) depending on the type of cleaning solution by operating various cleaning algorithms depending on the type of cleaning solution.
[0228] FIG. 7 is a flowchart for explaining a control algorithm for the type of cleaning solution (by disease) driven by a system (100) according to one embodiment.
[0229] Referring to FIG. 7, the system (100) according to one embodiment can identify the type of cleaning solution (710). More specifically, the system (100) can identify the type of cleaning solution in response to receiving information about the cleaning solution cartridge received from the cleaning solution cartridge (305).
[0230] Accordingly, the present system (100) can calculate the required pressure range for absorption of the cleaning solution based on a table containing information on the required pressure range for the cleaning solution stored in the control unit (210) according to the type of the identified cleaning solution (720). Meanwhile, the table may further include information on the required pressure range for the cleaning solution, drug concentration information, required flow rate range information, etc.
[0231] The present system (100) can identify a first flow rate value and a second flow rate value or pressure value in response to calculating a pressure range that must be maintained within the bladder of the cleaning solution based on the table (730) depending on the type of cleaning solution. Accordingly, the present system (100) can generate a signal for controlling the pump (120) and / or the valve (130) so that the identified first flow rate value and second flow rate value or pressure value are maintained within the required pressure range of the identified cleaning solution.
[0232] Meanwhile, the present system (100) can identify drug concentration information of the cleaning solution based on a table, depending on the type of cleaning solution. Here, the drug concentration of the cleaning solution may refer to the concentration of a coagulant that prevents the occurrence of thrombosis, but this is merely an example and is not limited thereto.
[0233] In this case, the present system (100) can control the pump (120) and / or the valve (130) to control the flow rate of the cleaning solution according to the concentration of the identified cleaning solution. That is, the present system (100) can increase the driving speed of the pump (120) or decrease the opening / closing amount of the valve (130) to increase the flow rate of the cleaning solution, and can decrease the driving speed of the pump (120) or increase the opening / closing amount of the valve (130) to decrease the flow rate of the cleaning solution.
[0234]
[0235] 2.2.6 Intravesical pressure control algorithm
[0236] FIGS. 8A and 8B are flowcharts illustrating an algorithm for maintaining intravesical pressure within a required pressure range by a system (100) according to one embodiment.
[0237] Referring to FIG. 8A, the system (100) according to one embodiment can identify a required pressure range to be maintained within the bladder depending on the type of cleaning solution (810). In addition, the system (100) can determine whether the current bladder pressure identified based on the pressure sensor (203-2) is within the required pressure range (820).
[0238] In addition, the system (100) can generate a control signal to reduce the driving speed of the pump (120) when the current bladder pressure identified in step 820 is outside the required pressure range and is in excess of the required pressure range, since there is a need to reduce the pressure (840). Meanwhile, the system (100) can generate a control signal to increase the driving speed of the pump (120) when the current bladder pressure identified in step 820 is outside the required pressure range and is in excess of the required pressure range, since there is a need to increase the pressure (850). Meanwhile, the system (100) can continuously monitor the current bladder pressure to maintain the pressure in the bladder within the required pressure range according to the cleaning solution, and can drive a pump control algorithm to maintain the pressure in the bladder within the required pressure range.
[0239] Referring to FIG. 8b, the system (100) according to one embodiment can identify a required pressure range to be maintained within the bladder depending on the type of cleaning solution (810). In addition, the system (100) can determine whether the current bladder pressure identified based on the pressure sensor (203-2) is within the required pressure range (820).
[0240] In addition, if the current bladder pressure identified in step 820 is outside the required pressure range and is in excess of the required pressure range, the system (100) may generate a control signal to increase the opening / closing rate of the second valve (132) installed in the direction of discharging the cleaning solution in the bladder, since there is a need to reduce the pressure (860). Meanwhile, if the current bladder pressure identified in step 820 is outside the required pressure range and is in excess of the required pressure range, the system (100) may generate a control signal to increase the opening / closing rate of the first valve (131) installed in the direction of injecting the cleaning solution into the bladder, since there is a need to increase the pressure (850). Meanwhile, the system (100) may continuously monitor the current bladder pressure to maintain the pressure in the bladder within the required pressure range according to the cleaning solution, and may drive a valve control algorithm to maintain the pressure in the bladder within the required pressure range.
[0241] Meanwhile, the pump (120) control algorithm and the valve (130) control algorithm described in FIGS. 8a and 8b can be appropriately applied depending on the operating state of the system (100) to maintain the pressure in the bladder.
[0242] More specifically, in the present system (100), when the driving speed of the pump (120) is increased to increase the intravesical pressure, there is a possibility that the flow rate of the cleaning solution may become higher than the patient's maximum flow rate. To prevent this, the present system (100) increases the driving speed of the pump (120) to increase the intravesical pressure, while increasing the opening / closing rate of the first valve (131) and the second valve (132), thereby improving the intravesical pressure while reducing the flow rate.
[0243] In another embodiment, when the system (100) reduces the driving speed of the pump (120) to reduce the pressure in the bladder, there is a possibility that the catheter may be blocked by foreign substances such as blood clots as the flow rate of the cleaning solution slows down, so that the pressure in the bladder can be reduced along with the increase in the flow rate by reducing the opening / closing rate of the first valve (131) and the second valve (132). However, the present invention is not limited thereto.
[0244]
[0245] 2.2.7 Pulsed Fluid Algorithm
[0246] According to one embodiment, the system (100) can, in response to the identification of a blockage, operate an algorithm for clearing the blockage. More specifically, the system (100) can identify a blockage based on the blockage detection algorithm described above when a foreign substance, such as a blood clot, occurs within a pipe through which the cleaning solution flows or at the inlet and outlet of the cleaning solution within the bladder. Accordingly, the system (100) can, in response to the identification of a blockage, operate a blockage clearing algorithm.
[0247] Meanwhile, the present system (100) can clear a blockage through a pulse fluid algorithm using a pulse fluid before driving the blockage clearing algorithm or when a blockage is not cleared according to the blockage clearing algorithm and blockage detection is continuously identified.
[0248] More specifically, pulsed fluid may mean, for example, that the system (100) increases the operating speed of the pump (120) for a predetermined period of time, thereby increasing the flow rate and / or pressure of the cleaning solution instantaneously. That is, the system (100) may generate a signal that controls the pump (120) to generate the pulsed fluid. It can be understood that the pulsed fluid algorithm described below is an additional embodiment of the system (100), and that only controlling the pump (120) to generate the aforementioned pulsed fluid may be included in the pulsed fluid algorithm.
[0249]
[0250] FIGS. 9A and 9B are flowcharts illustrating a pulse fluid algorithm driven by a system (100) according to one embodiment.
[0251] Referring to FIG. 9A, the system (100) may generate a signal to control the pump (120) to generate pulsed fluid in response to the identification of a condition for generating pulsed fluid. Here, the condition for generating pulsed fluid may include, for example, a case where a blockage is not cleared according to a blockage clearing algorithm, a case where a blockage detection is continuously identified, or a case where a blockage clearing algorithm is not run, but this is exemplary and not limited thereto.
[0252] Accordingly, the present system (100) can identify the input of pulsed fluid in response to the generation of a signal for controlling the pump (120) to generate pulsed fluid (910). That is, the present system (100) can determine that the input of pulsed fluid has been identified when a signal for controlling the pump (120) to generate pulsed fluid is generated.
[0253] The present system (100) can reduce the opening / closing rate of the second valve (132) in response to the identified pulse fluid input (920). More specifically, since the second valve (132) is a valve of the outlet through which the cleaning solution in the bladder is discharged, reducing the opening / closing rate of the second valve (132) can have the same effect as if the second valve (132) were closed. Accordingly, as the pressure of the pulse fluid is directly transmitted into the bladder, foreign substances such as blood clots that have settled in the bladder can surface, and foreign substances such as blood clots that have been blocking the outlet can be dispersed. That is, the present system (100) can generate undercurrent in the bladder by reducing the opening / closing rate of the second valve (132) in response to the identified pulse fluid input.
[0254] Thereafter, the system (100) can increase (restore) the opening / closing rate of the second valve (132) to the pre-reduction state in response to the termination of the pulse fluid (940).
[0255] Meanwhile, referring to FIG. 9b, the system (100) can increase the opening / closing rate of the second valve (132) in response to the identified pulse fluid input (950). More specifically, since the second valve (132) is a valve of the outlet through which the cleaning solution in the bladder is discharged, when the opening / closing rate of the second valve (132) increases, the flow rate may decrease but the pressure may increase. Accordingly, the system (100) can relieve the blockage by increasing the pressure capable of discharging foreign substances such as blood clots through the pulse fluid algorithm. Thereafter, the system (100) can reduce (restore) the opening / closing rate of the second valve (132) to the state before the reduction in response to the termination of the pulse fluid (970).
[0256] In another embodiment, the system (100) may, in response to the identified pulse fluid input, reduce the opening / closing rate of the second valve (132) to generate undercurrent in the bladder, and immediately thereafter increase the opening / closing rate of the second valve (132) compared to before the reduction to increase the pressure capable of expelling foreign substances such as blood clots. More specifically, the system (100) may reduce the opening / closing rate of the second valve (132) within the time period in which the pulse fluid is generated, and increase the opening / closing rate of the second valve (132) compared to before the reduction to remove foreign substances such as blood clots in the bladder. However, this is an example and is not limited thereto.
[0257]
[0258] 2.2.8 Washing fluid flow control algorithm
[0259] According to one embodiment, the present system (100) can control specific parameters (e.g., flow rate or pressure) depending on the type of cleaning solution by operating various cleaning algorithms according to the type of cleaning solution. That is, as described above, the concentration of the drug contained in the cleaning solution may vary depending on the type of cleaning solution, and in particular, in the case of cleaning solution with a low drug concentration, there is a need to continuously clean the bladder with a fast flow rate. This may be to efficiently assist the absorption of the drug through osmotic pressure.
[0260] Furthermore, the flow rate of the irrigation solution injected into the bladder is closely related to the risk of blockage caused by foreign substances such as blood clots, drug absorption, and user (patient) discomfort. Specifically, a low flow rate of the irrigation solution increases the likelihood of blockage due to foreign substances and reduces drug absorption. Conversely, a high flow rate of the irrigation solution reduces the likelihood of blockage and enhances drug absorption, but at the cost of increased user discomfort. Therefore, the flow rate of the irrigation solution injected into the bladder must be controlled within a specific range.
[0261]
[0262] FIG. 10 is a flowchart for explaining a flow control algorithm driven by a system (100) according to one embodiment.
[0263] Referring to FIG. 10, the system (100) according to one embodiment can identify the type of cleaning solution (1010). Furthermore, in response to identifying the type of cleaning solution, the system (100) can identify the flow rate per unit time flowing into the bladder (1020). More specifically, the flow rate per unit time flowing into the bladder may refer to, for example, a first flow rate value obtained from a first flow rate sensor (141), but is not limited thereto. For example, it may be replaced with a second flow rate value obtained from a second flow rate sensor (142).
[0264] Meanwhile, the present system (100) can generate a control signal for the pump (120) or valve (130) for flow rate control based on the identified flow rate per unit time (1030). More specifically, the present system (100) can calculate the required flow rate range of the identified cleaning solution according to the above-described table based on the type of the identified cleaning solution. That is, the present system (100) can calculate the required flow rate range determined according to the drug concentration of the cleaning solution, and control the pump (120) or valve (130) so that the flow rate per unit time of the perfused cleaning solution can be maintained within the required flow rate range.
[0265] For example, the system (100) may generate a control signal to reduce the driving speed of the pump (120) when the flow rate per unit time obtained from the flow sensor (140) is outside the required flow rate range of the identified cleaning liquid and exceeds it, since there is a need to reduce the flow rate. On the other hand, the system (100) may generate a control signal to increase the driving speed of the pump (120) when the flow rate per unit time obtained from the flow sensor (140) is outside the required flow rate range of the identified cleaning liquid and is below it, since there is a need to increase the flow rate.
[0266] Meanwhile, the system (100) can generate a signal to control the pump (120) for flow control in response to a case where a blockage is detected according to the blockage detection algorithm described above while step 1030 is being performed or a blockage is detected according to the blockage detection algorithm for a recent predetermined time (1050).
[0267] More specifically, the system (100) may generate a signal to control the pump (120) for flow rate control based on the number of blockages detected during the recent predetermined time based on a blockage detection algorithm, in response to a blockage being detected during the recent predetermined time. This is because, when the drug concentration of the cleaning solution is high, the flow rate of the cleaning solution may cause discomfort to the user, and therefore, a lower required flow rate range may be determined than when the drug concentration of the cleaning solution is low. However, the system (100) may apply a weight proportional to the number of blockage detections within the recent predetermined time based on the number of blockage detections during the recent predetermined time, since a low flow rate may prevent foreign substances such as blood clots from being discharged from the bladder. Accordingly, the system (100) may generate a signal to control the pump (120) or the valve (130) so that the flow rate is applied high.
[0268] Meanwhile, since the weight applied to the flow rate increases in proportion to the number of blockage detections, the present system (100) can generate a signal for controlling the pump (120) or valve (130) so that the flow rate is lower than the maximum flow rate by applying the maximum flow rate obtained through the pre-cleaning algorithm described above.
[0269]
[0270] 2.3 Usage scenarios of closed-loop bladder irrigation systems
[0271] A closed-loop urinary bladder cleaning system (100) according to one embodiment of the present application can provide a bladder cleaning function to patients suffering from diseases such as benign prostatic hyperplasia, bladder cancer, bladder stones, urolithiasis, cystitis, neurogenic bladder, spinal cord injury, etc., and to patients who have undergone surgeries such as benign prostatic hyperplasia surgery, transurethral cystectomy, total cystectomy, and artificial bladder surgery, transurethral urolithiasis surgery, transurethral cystolithiasis surgery, etc.
[0272] According to one embodiment, after the cleaning solution cartridge is coupled to the cartridge coupling portion (305-1) of the cleaning solution storage portion (101), the control portion (301) determines whether the coupled cleaning solution cartridge is genuine through the genuine authentication module (305-2). If the cleaning solution cartridge is determined to be genuine, the cleaning solution of the cleaning solution storage portion (101) may be injected into the bladder (102) through the first passage (111), thereby performing bladder cleaning. Since foreign substances such as blood clots, pus, and urine exist inside the bladder (102), the cleaning solution injected into the bladder (102) and the foreign substances may be discharged from the bladder (102) together through the second passage (112). After the discharged cleaning solution and the foreign substances are filtered and sterilized through the filter unit (151) and the sterilization unit (161), they are injected back into the cleaning solution storage unit (101), and the cleaning solution injected into the cleaning solution storage unit (101) is injected back into the bladder (102) through the first passage (111), thereby continuously performing bladder washing.
[0273]
[0274] 2.3.1 How to manage and inject the detergent
[0275] In one embodiment, one of the reasons for performing bladder irrigation is to control bleeding within the patient's bladder. To achieve this, the temperature of the irrigation solution must be maintained at an appropriate temperature (e.g., 10 to 15°C) to achieve optimal hemostatic effects. Therefore, the irrigation solution for bladder irrigation must be maintained at the appropriate temperature.
[0276] According to one embodiment, the type, concentration, and amount of the cleaning solution to be injected into the system (100) may be determined based on at least one of the patient's disease, treatment, and health condition, and the efficacy of bladder cleaning may vary depending on the quality of the cleaning solution. Accordingly, the system (100) may be operated only when an authenticated cleaning solution cartridge is combined, thereby guaranteeing the efficacy (or quality) of bladder cleaning. For example, the control unit (301) may determine whether the cleaning solution cartridge is genuine through the genuine product authentication module (305-2), and may control the cleaning solution inlet (303) to be opened only when the cleaning solution cartridge is genuine, and to discharge the cleaning solution in the cleaning solution storage unit (101) into the first passage (111) only if it is genuine.
[0277]
[0278] 2.3.1.1 Detergent containers and management
[0279] According to one embodiment, in order to ensure the efficacy of bladder washing, it is important to use an approved washing solution, but the hygiene of the washing solution storage unit (101) where the washing solution is stored may also be important. Therefore, periodic cleaning may be required to maintain the hygiene of the washing solution storage unit (101). The washing solution storage unit (101) may additionally be equipped with a contamination sensor (307-3), and the washing solution storage unit (101) may be periodically cleaned based on contamination information measured through the contamination sensor (307-3). In addition, based on contamination information measured through the contamination sensor (307-3), only when the contamination level of the washing solution storage unit (101) falls within a normal range, the control unit (301) may control to open the washing solution inlet (303) to discharge the washing solution of the washing solution storage unit (101) into the first passage (111).
[0280]
[0281] 2.3.1.2 Storage of cleaning solution (cooling function)
[0282] In one embodiment, as previously mentioned, the temperature of the washing solution must be maintained at an appropriate temperature (e.g., 10 to 15°C) to achieve optimal hemostatic effects. Therefore, the washing solution for bladder washing must be maintained at the appropriate temperature.
[0283] According to one embodiment, when the cleaning solution cartridge is coupled to the cartridge coupling portion (305-1), the control unit (301) can detect the temperature of the cleaning solution contained in the cleaning solution cartridge through the temperature sensor (307-1) or the temperature display identification portion (307-2). If the detected temperature is higher than the appropriate temperature, the control unit (301) can cool the cleaning solution through the cooling device (309) so that the temperature of the cleaning solution becomes the appropriate temperature. For another example, if the detected temperature is lower than the appropriate temperature, the control unit (301) can heat the cleaning solution through the cooling device (309) so that the temperature of the cleaning solution becomes the appropriate temperature.
[0284]
[0285] 2.3.2 Control in case of catheter blockage
[0286] According to one embodiment, while bladder washing is performed through the system (100), the opening (or suction port) of the catheter (110) may become clogged during the process of discharge of waste materials (e.g., urine, blood clots, pus, etc.) in the bladder (102) to the catheter (110). In this case, the system (100) can relieve the clogging of the catheter (110) by operating a clogging prevention algorithm under the control of the control unit (201). The clogging prevention algorithm will be described in detail with reference to FIG. 11.
[0287] Figure 11 illustrates a flowchart of an operation in which a catheter blockage continuous relief algorithm is driven according to one embodiment.
[0288] The operations illustrated in FIG. 11 are not limited to the operation sequence illustrated in FIG. 11, and the operation sequence may be changed or the operations may be performed simultaneously.
[0289] In operation 1101, the control unit (201) can determine (or detect, determine) whether the catheter (110) is clogged. For example, the control unit (201) can determine whether the catheter (110) is clogged based on the flow rate data measured through the flow rate sensor (140) of the sensing unit (203). For example, the control unit (201) can determine that the catheter (110) is clogged when the flow rate data (e.g., flow rate data) of the fluid inside the catheter (110) measured using at least one of the first flow rate sensor (141) and the second flow rate sensor (142) is less than a reference value.
[0290] In operation 1103, the control unit (201) may drive reverse flow control in response to determining that the catheter (110) is blocked. The first direction (171) may mean forward, and the second direction (172) may mean reverse. When starting bladder washing, the default value may be to inject the washing solution in the first direction (171), and when the catheter (110) is blocked, the flow direction of the washing solution may be changed from the first direction (171) to the second direction (172). The control unit (201) may change the flow of the fluid flowing in the first direction (171) through the pump (120) to the second direction (171) in response to determining that the catheter (110) is blocked. The pump (120) may be a bidirectional pump and may change the flow of the fluid by 180 degrees. When controlling the pump (120) to drive reverse flow control, the first pump (121) and the second pump (122) can be controlled simultaneously so that the flow of the fluid is changed.
[0291] In operation 1105, the control unit (201) can determine whether a specified time has elapsed since the reverse flow control was driven. The specified time can be set by the administrator of the system (100) or can be automatically set based on the flow rate data measured by the flow sensor (140). For example, if the flow rate data is below a reference value, it is determined that the degree of blockage of the catheter (110) is severe, and therefore it is determined that a relatively long time will be required for the reverse flow control to resolve the blockage of the catheter (110), and thus the specified time can be automatically set to a relatively long time.
[0292] According to one embodiment, if the specified time has not elapsed since the reverse flow control was driven, the control unit (201) can perform operation 1103, and if the specified time has elapsed since the reverse flow control was driven, the control unit (201) can perform operation 1107.
[0293] In operation 1107, when the specified time has elapsed since the reverse perfusion control was driven, the control unit (201) can measure the flow rate (or flow velocity) of the fluid inside the catheter (110) through the flow sensor (140).
[0294] In operation 1109, the control unit (201) may determine whether the blockage of the catheter (110) persists after driving the reverse perfusion control. For example, if the flow rate (or flow velocity) data measured after the specified time after driving the reverse perfusion control is less than a reference value, the control unit (201) may determine that the blockage of the catheter (110) persists. The reverse perfusion control may be referred to as primary control.
[0295] According to one embodiment, if the blockage of the catheter (110) persists, the control unit (201) may perform operation 1103.
[0296]
[0297] 2.3.3 Catheter blockage continuous relief algorithm
[0298] In operation 1111, if the blockage of the catheter (110) persists, the control unit (201) may execute a blockage persistence clearing algorithm. The blockage persistence clearing algorithm may refer to a method that can be taken in the system (100) to clear the persistent blockage of the catheter (110), and is described in detail in FIGS. 12 to 15. The blockage persistence clearing algorithm may be referred to as secondary control.
[0299] The operations illustrated in FIGS. 12 to 15 are not limited to the order of operations illustrated in FIGS. 12 to 15, and the order of operations may be changed or the operations may be performed simultaneously.
[0300] Figure 12 illustrates a flowchart of an operation for gradually increasing intravesical pressure according to an algorithm for continuously clearing catheter blockage according to one embodiment.
[0301] In operation 1201, the control unit (201) can determine whether the pressure within the bladder (102) is below a threshold pressure. For example, the control unit (201) can measure the pressure within the bladder (102) through a pressure sensor (203-2) and compare the measured value with the threshold pressure. Based on the comparison result, the control unit (201) can determine whether the pressure within the bladder (102) is below the threshold pressure.
[0302] According to one embodiment, when the pressure within the bladder (102) is less than the threshold pressure, the control unit (201) can perform operation 1203, and when the pressure within the bladder (102) is greater than the threshold pressure, the control unit (201) can perform operation 1207.
[0303] In operation 1203, the control unit (201) can determine whether a specified period has elapsed after executing the blockage persistence resolution algorithm. If the specified period has elapsed, the control unit (201) can perform operation 1205, and if the specified period has not elapsed, the control unit (201) can perform operation 1205.
[0304] In operation 1205, the control unit (201) may increase the pressure within the bladder (102) in response to determining that a designated period has elapsed after driving the blockage persistence clearing algorithm. For example, the control unit (201) may increase the pressure within the bladder (102) by controlling the first valve (131) and the second valve (132) in response to determining that a designated period has elapsed after driving the blockage persistence clearing algorithm. In this case, the opening / closing rate of the first valve (131) may be greater than the opening / closing rate of the second valve (132). If the blockage of the catheter (110) continues, the control unit (201) may control the valve (130) to gradually increase the pressure within the bladder (102) up to a critical pressure each time the designated period has elapsed.
[0305] In operation 1207, the control unit (201) can control the valve (130) to increase the pressure in the bladder (102) by one level, and then determine whether the blockage of the catheter (110) continues. For example, the control unit (201) can determine whether the blockage of the catheter (110) continues based on the flow rate data measured by the flow rate sensor (140). If the blockage of the catheter (110) continues, the control unit (201) can perform operation 1201.
[0306]
[0307] Figure 13 illustrates a flowchart of an operation for gradually increasing the pulse rate of a pump according to an algorithm for continuously clearing catheter blockages according to one embodiment.
[0308] In operation 1301, the control unit (201) can determine whether the beat frequency of the pump (120) is less than a threshold beat frequency. For example, the control unit (201) can compare the beat frequency of the pump (120) with the threshold beat frequency, and based on the comparison result, determine whether the beat frequency is less than the threshold beat frequency.
[0309] According to one embodiment, when the pulse period of the pump (120) is less than the threshold pressure, the control unit (201) can perform operation 1303, and when the pulse period of the pump (120) is greater than or equal to the threshold pressure, the control unit (201) can perform operation 1307.
[0310] In operation 1303, the control unit (201) can determine whether a specified period has elapsed after running the blockage persistence resolution algorithm. If the specified period has elapsed, the control unit (201) can perform operation 1305, and if the specified period has not elapsed, the control unit (201) can perform operation 1305.
[0311] In operation 1305, the control unit (201) may increase the pulsation cycle of the pump (140) in response to determining that a designated period has elapsed after driving the blockage persistence clearing algorithm. For example, the control unit (201) may increase the pulsation cycle by controlling the first pump (121) and the second pump (122) in response to determining that a designated period has elapsed after driving the blockage persistence clearing algorithm. If the blockage persistence of the catheter (110) continues, the control unit (201) may control the pump (120) to gradually increase the pulsation cycle of the pump (120) up to a critical pulsation cycle each time the designated period has elapsed.
[0312] In operation 1307, the control unit (201) can control the pump (120) to increase the pulse cycle of the pump (120) by one step, and then determine whether the clogging of the catheter (110) continues. For example, the control unit (201) can determine whether the clogging of the catheter (110) continues based on the flow rate data measured by the flow rate sensor (140). If the clogging of the catheter (110) continues, the control unit (201) can perform operation 1301.
[0313]
[0314] FIG. 14 illustrates a flowchart of an operation for gradually increasing the amount of drug administered to a catheter according to an algorithm for continuously clearing catheter blockage according to one embodiment.
[0315] In operation 1401, the control unit (201) can determine whether the amount of fluid (e.g., a cleaning solution, a hemostatic agent, an antibiotic) discharged from the cleaning solution storage unit (101) into the catheter (110) (e.g., the first passage (111)) is less than a threshold fluid amount. The control unit (201) can determine whether the amount of drug discharged from the cleaning solution storage unit (101) into the catheter (110) (e.g., the first passage (111)) is less than a threshold drug amount. For example, the control unit (201) can measure the amount of the fluid based on the flow rate data of the fluid measured through the flow sensor (140) and compare the measured amount of the fluid with the threshold amount. Based on the comparison result, the control unit (201) can determine whether the amount of the fluid injected and flowing into the catheter (110) is less than a threshold amount.
[0316] According to one embodiment, when the amount of fluid in the catheter (110) is less than the threshold amount, the control unit (201) can perform operation 1403, and when the pressure in the bladder (102) is greater than the threshold pressure, the control unit (201) can perform operation 1407.
[0317] In operation 1403, the control unit (201) can determine whether a specified period has elapsed after running the blockage persistence resolution algorithm. If the specified period has elapsed, the control unit (201) can perform operation 1405, and if the specified period has not elapsed, the control unit (201) can perform operation 1405.
[0318] In operation 1405, the control unit (201) may control the cleaning solution storage unit (101) to increase the amount of fluid flowing in the catheter (110) in response to determining that a designated period has elapsed after driving the blockage maintenance algorithm. For example, the control unit (201) may control the cleaning solution storage unit (101) to discharge a designated amount of cleaning solution from the cleaning solution storage unit (101) into the first passage (111) of the catheter (110). As another example, the control unit (201) may discharge a designated amount of a drug (e.g., a hemostatic agent, an antibiotic, etc.) into the first passage (111) of the catheter (110). If the blockage of the catheter (110) continues, the control unit (201) can control the cleaning solution storage unit (101) to gradually increase the amount of drug (or fluid amount) flowing into the catheter (110) up to a critical drug amount each time the specified cycle elapses.
[0319] In operation 1407, the control unit (201) controls the cleaning solution storage unit (101) to additionally inject a specified amount (or 1 unit amount) of the fluid flowing in the catheter (110), and then determine whether the clogging of the catheter (110) continues. For example, the control unit (201) can determine whether the clogging of the catheter (110) continues based on the flow rate data measured by the flow rate sensor (140). If the clogging of the catheter (110) continues, the control unit (201) can perform operation 1401.
[0320]
[0321] FIG. 15 illustrates a flowchart of an operation for re-changing the perfusion direction according to an algorithm for continuously clearing catheter blockage according to one embodiment.
[0322] In operation 1501, the control unit (201) can determine whether the current state of the system (100) satisfies a specific condition (or a designated condition). The specific condition may include a case where the pressure within the bladder (102) corresponds to a critical pressure, a case where the pulsation cycle of the currently driven pump (120) corresponds to a critical pulsation cycle, and a case where the amount of drug (or fluid) currently injected into the catheter (110) corresponds to a critical drug amount (or fluid amount).
[0323] According to one embodiment, if the current state of the system (100) satisfies the specific condition, the control unit (201) can perform operation 1503, and if the current state of the system (100) does not satisfy the specific condition, the operations of FIGS. 12 to 14 can be performed again until the specific condition is satisfied.
[0324] In operation 1503, if the current state of the system (100) satisfies the specific condition, the control unit (201) can change the direction of the fluid flowing in the catheter (110) (or the perfusion direction). For example, if the current direction of the fluid flowing in the catheter (110) is a first direction (171), and if the current state of the system (100) satisfies the specific condition, the direction of the fluid flowing in the catheter (110) can be changed from the first direction (171) to the second direction (172). For another example, if the current direction of the fluid flowing in the catheter (110) is a second direction (172), and if the current state of the system (100) satisfies the specific condition, the direction of the fluid flowing in the catheter (110) can be changed from the second direction (172) to the first direction (171).
[0325] In operation 1505, the control unit (201) can determine whether the clogging of the catheter (110) persists after the operation of changing the flow direction. For example, the control unit (201) can determine whether the clogging of the catheter (110) persists based on the flow rate data measured through the flow rate sensor (140). If the clogging of the catheter (110) persists, the control unit (201) can perform operation 1501.
[0326]
[0327] 2.3.4 Catheter Clog Prevention Algorithm
[0328] FIG. 16 illustrates a flowchart of a method for controlling reverse perfusion based on flow rate changes according to a catheter blockage prevention algorithm according to one embodiment.
[0329] The operations illustrated in FIG. 16 are not limited to the operation sequence illustrated in FIG. 16, and the operation sequence may be changed or the operations may be performed simultaneously.
[0330] Referring to FIG. 16, the system (100) (or the control unit (201)) can prevent (or prevent) clogging of the catheter (110) by preemptively driving reverse perfusion control as a preventive measure before the catheter (110) is completely clogged.
[0331] In operation 1601, the control unit (201) can detect a change in the flow rate of the fluid flowing within the catheter (110). For example, the control unit (201) can measure the flow rate (or flow rate) of the fluid flowing within the catheter (110) through the flow sensor (140).
[0332] In operation 1603, the control unit (201) can determine whether the flow rate (or flow volume) value is less than a set value or whether the flow rate (or flow volume) value is less than a specified percentage (e.g., 40%, 50%, 60%, 70%, 80%, etc.) of the flow rate (or flow volume) value.
[0333] According to one embodiment, the control unit (201) may determine that the catheter (110) is expected to be blocked within a specified time if the flow rate (or flow rate) value is less than the set value or less than the specified ratio.
[0334] In operation 1605, according to one embodiment, if the flow rate (or flow rate) value is less than the set value or less than the specified ratio, the control unit (201) can drive reverse perfusion control. That is, even if the catheter (110) is not currently clogged, it is expected that the catheter (110) will soon be clogged, and by driving reverse perfusion control, clogging of the catheter (110) can be prevented.
[0335]
[0336] FIG. 17 illustrates a flowchart of a method for controlling reverse perfusion based on a perfusion control drive cycle according to a catheter blockage prevention algorithm according to one embodiment.
[0337] The operations illustrated in FIG. 17 are not limited to the operation sequence illustrated in FIG. 17, and the operation sequence may be changed or the operations may be performed simultaneously.
[0338] Referring to FIG. 17, the system (100) (or the control unit (201)) can prevent (or prevent) clogging of the catheter (110) by preemptively driving reverse perfusion control as a preventive measure before the catheter (110) is completely clogged.
[0339] In operation 1701, the control unit (201) can measure the perfusion control driving time. The perfusion control driving time refers to the time from the start of bladder washing using the system (100) to the present, and may refer to the bladder washing duration.
[0340] In operation 1703, the control unit (201) can determine whether the perfusion control driving time has passed a specified period. The specified period may be a value set by the user or automatically set, and may be a value set in consideration of the expected period of clogging of the catheter (110). If the specified period is set automatically, the specified period may be determined based on at least one of the patient's disease, treatment, blood components, and information (e.g., amount, concentration, type) of the washing solution.
[0341] In operation 1705, if the control unit (201) determines that the perfusion control driving time has passed the specified cycle, the control unit (201) drives reverse perfusion control, that is, if the catheter (110) is not currently blocked, but is expected to be blocked soon, the catheter (110) is driven by reverse perfusion control, thereby preventing blockage of the catheter (110).
[0342]
[0343] 2.3.5 Notification function
[0344] FIG. 18 illustrates a flowchart of operations for providing notification when a catheter is blocked or expected to block, according to one embodiment.
[0345] The operations illustrated in FIG. 18 are not limited to the operation sequence illustrated in FIG. 18, and the operation sequence may be changed or the operations may be performed simultaneously.
[0346] Referring to FIG. 18, when the catheter (110) is blocked or is expected to be blocked, information and an alarm sound related to the catheter blockage or expected blockage can be transmitted to the medical personnel or caregivers around the patient performing bladder irrigation.
[0347] In operation 1801, the control unit (201) can detect a change in the flow rate (or flow rate) based on the flow rate (or flow rate) value of the fluid inside the catheter (110) measured through the flow rate sensor (140).
[0348] In operation 1803, the control unit (201) can determine whether the catheter (110) is clogged or is expected to be clogged based on the flow rate (or flow rate value) of the fluid or a change in the flow rate (or flow rate). Whether the catheter (110) is clogged or is expected to be clogged can be determined using the operations described in FIGS. 11 to 17.
[0349] In operation 1805, if the control unit (201) determines that the catheter (110) is blocked or expected to be blocked, the control unit (201) may transmit information and notification related to the blockage or expected blockage of the catheter (110) to an external device through the communication unit (207), or output them from the system (100) itself.
[0350] According to one embodiment, the information may include the status of the catheter (110) (e.g., degree of blockage), a method of action depending on the degree of blockage of the catheter (110), the status of whether a blockage relief algorithm (e.g., reverse perfusion control (primary control), blockage continuation relief algorithm (secondary control)) is being operated, the direction of perfusion (e.g., first direction (171), second direction (172)), and information on the washing solution (e.g., type, amount, bladder washing progress time, bladder washing remaining time, etc.).
[0351] According to one embodiment, the form of the notification may include sound, visual display (e.g., text, image, video, LED display, etc.), and vibration.
[0352]
[0353] 3. Other features of the closed-loop bladder irrigation system
[0354] 3.1 Sensor - Urine volume measurement and other functions
[0355] The patient's (user's) urine output during bladder irrigation is a crucial factor in assessing the patient's symptoms and / or improvement. However, existing irrigation systems require multiple visits by medical professionals and other specialized personnel, and require analog estimation of urine output. Furthermore, these existing irrigation systems suffer from inaccuracies due to issues such as residual irrigation fluid within the bladder.
[0356] According to one embodiment, the system (100) can calculate the amount of urine discharged from the bladder of a patient (user) based on the first flow rate value and the second flow rate value obtained from the first flow rate sensor (141) and the second flow rate sensor (142). More specifically, the system (100) can calculate the amount of urine additionally discharged from the bladder by accumulating the first flow rate value for the washing solution injected into the bladder and the second flow rate value for the washing solution discharged out of the bladder during the time of driving the washing algorithm after driving the pre-washing algorithm. However, the present invention is not limited thereto.
[0357] In another embodiment, the system (100) can obtain the amount of urine of the patient (user) during the time the cleaning algorithm is in progress based on the total capacity in the cleaning solution storage unit (101) when the cleaning algorithm is completed and the capacity of the newly installed cleaning solution.
[0358] According to one embodiment, a system (100) includes a learning processor for machine learning, capable of training a model composed of an artificial neural network using learning data. The trained artificial neural network may be referred to as a learning model. The learning model may be used to infer result values for new input data other than the learning data, and the inferred values may be used as a basis for making decisions regarding certain actions.
[0359] More specifically, the present system (100) can build a machine learning model by analyzing and processing data based on raw data (here, the raw data can be understood as learning data) including information on urine volume acquired based on the first flow rate value acquired from the first flow rate sensor (141) and the second flow rate value acquired from the second flow rate sensor (142) and contamination data acquired from the contamination sensor (307-3). In order to ensure reliability, the machine learning model can be built by utilizing urine data for existing patient data as raw data. The machine learning model built in this way can be named, for example, a patient status identification model. However, this is an example and is not limited thereto.
[0360] The patient status identification model may be a model trained using the patient's urine volume, contamination data contained in the irrigation solution discharged from the patient's bladder, and the patient's improvement status as input. The contamination data may, for example, include information regarding components not contained in the irrigation solution injected into the patient's bladder. The patient's improvement status may include, for example, improvement, deterioration, and maintenance. However, these are merely examples and are not limiting.
[0361] In another embodiment, the contamination data may be referred to as urine component data. The urine component data may include, for example, the concentration of a specific component. More specifically, the urine component data may include the concentration of glucose, the concentration of creatinine, the concentration of albumin, etc. In this case, it can be understood that the patient condition identification model can perform various diagnoses other than the improvement of the bladder condition of patients who have undergone diseases such as benign prostatic hyperplasia, bladder cancer, bladder stones, urolithiasis, cystitis, neurogenic bladder, spinal cord injury, etc., and surgeries such as benign prostatic hyperplasia surgery, transurethral resection of bladder tumors, total cystectomy and artificial cystoplasty, transurethral urolithotomy, transurethral cystolithiasis surgery, etc.
[0362] Meanwhile, the present system (100) can utilize an encoder and decoder of a neural network model. The present system (100) can input learning data into at least one encoder and obtain at least one vector value as an encoded result value. The encoder and decoder are a type of neural network model, and each can be configured as a DNN (Deep Neural Network), RNN (Recurrent Neural Network), LSTM (Long Short-Term Memory models), BRDNN (Bidirectional Recurrent Deep Neural Network), CNN (Convolutional Neural Networks), etc., but are not limited thereto.
[0363] In another embodiment, the processor of the present system (100) can train a learning model through a deep learning algorithm.
[0364] Deep learning algorithms are a type of machine learning algorithm and refer to modeling techniques developed from artificial neural networks, which are modeled after the human neural network. Artificial neural networks can be structured in a multi-layered hierarchical structure.
[0365] An artificial neural network (ANN) can be structured as a hierarchy that includes an input layer, an output layer, and at least one intermediate layer (or hidden layer) (e.g., a kernel) between the input layer and the output layer. Based on this multi-layer structure, a deep learning algorithm can produce highly reliable results by learning to optimize the weights of the activation function between layers.
[0366] Deep learning algorithms applicable to the processor of the present system (100) according to one embodiment may include, for example, a convolutional neural network (CNN). However, the present invention is not limited thereto. It is understood that other deep learning algorithms may be applied depending on the embodiment.
[0367] Convolutional Neural Networks (CNNs) are characterized by having a structure that extracts data features and identifies patterns of features, unlike techniques that perform a learning process by extracting knowledge from existing data. The convolutional neural network (CNN) can be performed through a convolution process and a pooling process. In other words, the convolutional neural network (CNN) can include an algorithm that is composed of a complex combination of convolutional layers and pooling layers. Here, the convolutional layer performs a process of extracting data features (e.g., a convolution process (convolution process)). The convolution process is a process of identifying features by examining adjacent components of each component in the data and deriving the identified features into a single image, which can effectively reduce the number of parameters as a compression process. The pooling layer performs a process (e.g., a pooling process) that reduces the size of the layer that has undergone the convolution process. The above pooling process can reduce the size of the data, offset noise, and provide consistent features across fine details. For example, the convolutional neural network (CNN) can be utilized in various fields, such as information extraction, sentence classification, and face recognition. Since convolutional neural networks (CNNs) are a well-known technology, a detailed description will be omitted below.
[0368] Meanwhile, the system (100) according to one embodiment can, in response to performing a washing algorithm on a patient, obtain the patient's urine volume and contamination data contained in the washing liquid discharged from the patient. More specifically, the system (100) calculates the patient's urine volume based on the data obtained from the flow sensor (140), and inputs the contamination data obtained from the contamination sensor (307-3) into the patient condition identification model described above to output the patient's condition. However, the present invention is not limited thereto.
[0369]
[0370] 3.2 Filters - Filter Management and Storage
[0371] In accordance with one embodiment, the present system (100) is configured as a closed type, so there is a need for the cleaning solution injected into the bladder to be discharged and then reintroduced. Therefore, the management method of the filter unit (151) for the discharged cleaning solution is important.
[0372] More specifically, the filter unit (151) of the present system (100) may be provided as a replaceable unit and may be arranged so that the discharged cleaning solution can pass through the filter unit (151). The present system (100) may store the replacement time of the filter unit (151) in response to the replacement of the filter unit (151). In addition, the present system (100) may store the usage time for bladder washing through the present system (100) after the replacement of the filter unit (151).
[0373] Accordingly, the system (100) may generate a control signal to provide a filter cycle notification in response to a predetermined value or more based on the number of times the cleaning algorithm has been run and / or the bladder cleaning time after filter replacement. For example, the system (100) may generate a signal to control the display of a filter cycle notification message on the temperature display unit (305-3) of the cleaning solution storage unit (101) in response to the existence of a need to provide a filter cycle notification. However, this is exemplary, and in another embodiment, the system (100) may generate a signal to control the communication unit (207) to display a filter cycle notification message on the user terminal (2201).
[0374] Meanwhile, the system (100) may generate a control signal to display a different filter cycle notification message depending on the number of times the cleaning algorithm is run and / or the bladder cleaning time interval after filter replacement. For example, if the recommended number of uses of the filter unit (151) is 3 times, the system (100) may generate a control signal to display a filter cycle notification message regarding the number of remaining uses when the number of uses is 1 time. As another example, the system (100) may generate a control signal to display a filter cycle notification message regarding the remaining use time when the recommended use time of the filter unit (151) is 10 hours. However, the present invention is not limited thereto.
[0375] In addition, the present system (100) can generate a control signal to stop the operation of the pump (120) in response to the contamination level of the cleaning solution flowing through the contamination level sensor (307-3) being higher than a predetermined standard. For example, the present system (100) can generate different control signals based on the section according to the contamination level of the cleaning solution described above.
[0376] Meanwhile, the filter unit (151) of the present system (100) may be implemented using a reverse osmosis (RO) method, a hollow fiber membrane (UF) method, a nano method (NF), etc. The filter unit (151) may use a conventionally known filter method, or a filter method to be developed in the future. Meanwhile, when the present system (100) performs a blockage prevention algorithm, the pump (120) is driven in the reverse direction, so filtering of the cleaning solution flowing in the reverse direction may be required. The filter unit (151) of the present system (100) may be implemented using a bidirectional (cross flow) filter. However, the present invention is not limited thereto.
[0377]
[0378] 3.3 Sterilization - Sterilization methods and controls
[0379] According to one embodiment, the present system (100) is configured as a closed system, and thus, since the cleaning solution injected into the bladder needs to be discharged and reintroduced, sterilization of the cleaning solution is essential. That is, the present system (100) may include a sterilization unit (161) to remove bacteria in the cleaning solution discharged from the bladder that were not filtered out by the filter unit (151).
[0380] According to one embodiment, the present system (100) may include a sterilizing solution in the washing solution, thereby sterilizing the washing solution discharged from the bladder. In another embodiment, the present system (100) may include a filter unit (151) equipped with a sterilizing-grade filter, thereby simultaneously sterilizing the washing solution and filtering out foreign substances such as blood clots.
[0381] In another embodiment, the system (100) can sterilize the cleaning solution by including a sterilizing unit (161) capable of supplying ultraviolet light (UV) to a passage through which the cleaning solution circulates.
[0382]
[0383] 3.4 Other features
[0384] The irrigating solution injected into a patient's bladder can be of various types depending on the patient's disease or the degree of improvement thereof, the size of the bladder, the pressure to be maintained within the bladder, and the flow rate of the irrigating solution. In particular, if a irrigating solution of a specific high concentration is additionally injected in small amounts and needs to be maintained within the bladder, continuous irrigation can hinder the effectiveness of the irrigating solution.
[0385] According to one embodiment, the system (100) may generate a signal for controlling the pump (120) or the valve (130) in response to the addition of a small amount of cleaning solution for a specific high concentration. More specifically, the system (100) may minimize (e.g., 0) the opening / closing rate of the second valve (132) and maintain the operation of the pump (120) for a predetermined period of time when the cleaning solution for a specific high concentration is additionally added in a small amount.
[0386] In this case, the system (100) can generate a control signal to minimize (e.g., 0) the opening / closing rate of the first valve (131) and stop the operation of the pump (120) when the capacity of the residual washing solution in the bladder becomes the maximum capacity obtained according to the pre-washing algorithm. Accordingly, the washing solution remains in the patient's bladder, allowing the drug to be absorbed into the bladder.
[0387] Meanwhile, if the cleaning solution for the above-described specific high concentration remains in the bladder for a predetermined time (wherein the predetermined time is determined empirically or experimentally for the absorption of the cleaning solution), the present system (100) maximizes the discharge force by maximizing the opening / closing rate of the second valve (132) (e.g., 100), and additionally, removes foreign substances settled in the bladder through the pulse fluid algorithm described above. However, the present invention is not limited thereto.
[0388] Meanwhile, since this system (100) is installed inside a hospital and / or a home, a noise prevention device (not shown) may be additionally installed to prevent noise from occurring during operation.
[0389] A noise prevention device (not shown) according to one embodiment may be provided, for example, for each pump (121, 122) and may be provided in a form that surrounds the pump (121, 122). Meanwhile, a fluid may be provided between the pump (121, 122) and the exterior of the noise prevention device (not shown). Accordingly, the noise prevention device (not shown) may prevent noise generated from the pump (121, 122) by using the fluid.
[0390] In another embodiment, the fluid of the noise reduction device (not shown) may be formed of a solid elastic body to buffer vibrations and noise generated from the pump (121, 122). However, this is not a limitation. That is, the noise reduction device (not shown) may be any noise reduction device known in the past or to be developed in the future.
[0391]
[0392] 4. Home and hospital versions of the closed-loop bladder irrigation system
[0393] 4.1 Home System
[0394] According to an embodiment of the present disclosure, a system is provided that enables bladder irrigation in a patient who has a bladder bag connected to the bladder at home.
[0395] A closed bladder irrigation system used at home may have the same configuration as a bladder irrigation system used in a hospital, but some components may be omitted or added depending on the difference in the usage environment. Therefore, a system used at home is classified as a home system, and a system used in a hospital is classified as a hospital system.
[0396] In one embodiment, the home system may exclude devices that require operation by a medical professional in a hospital system, but may include all the minimal components necessary for bladder irrigation.
[0397] For example, a home system may be configured to operate the cleaning system only for the appropriate cleaning solution so that the appropriate cleaning solution is injected into the cleaning solution storage compartment, and cleaning may be blocked if an unsuitable cleaning solution is injected into the home system.
[0398] The home system may additionally include a cooling device or a sensor to measure the level of contamination in the cleaning solution, if necessary. These devices may be additionally configured based on the diagnosis of a medical professional. The home system may also include a device to control the flow rate or direction of the cleaning solution.
[0399] These devices can be set to default values by healthcare professionals. Healthcare professionals can then set a range within which these default values can be changed at home. Home systems can be used by adjusting settings within these ranges. These settings can be set and modified later in the home system's linked application, and can be remotely adjusted by the hospital.
[0400] In one embodiment, the home system can provide a notification when a blockage is detected within the catheter. For home systems, this notification can be displayed on applications that interface with the home system, or sent to the hospital's management system.
[0401] Additionally, home systems can be implemented with low-noise design methods to minimize noise during system operation.
[0402] In addition to the configurations illustrated, the home system may include additional features or configurations as needed and is not limited to the components disclosed above.
[0403]
[0404] 4.1.1 Utilizing 3-way connectors
[0405] FIG. 19 is a schematic diagram illustrating how a home system according to one embodiment is connected to a patient's catheter for bladder irrigation.
[0406] According to one embodiment of the present disclosure, a catheter (1904) can be inserted into a patient's bladder at home, and a tube of the catheter can be maintained connected to a urine bag (1902). At this time, the home system can be connected to a tube (1903) connecting the catheter (1904) and the urine bag (1902) using a separate connector (1901), thereby enabling irrigation.
[0407] The home system (1905) can be connected to the catheter (1904) to flush the tube connecting to the bladder, and can also be connected to the tube (1903) connected to the urinary bag to flush the tube (1903) connecting to the urinary bag. This flushing method allows the patient to flush the entire tube from the urinary bag (1902) to the bladder at home using the home system.
[0408] According to one embodiment of the present disclosure, the connector (1901) can be maintained in a connected state with the catheter (1904) and the urine bag (1902), and can be separately attached and configured when the cleaning system is in operation. When the connector is connected, the home system can be connected without disconnecting the tube from the catheter even when the cleaning system is used, thereby minimizing the risk of infection and, in particular, preventing accidental infections that may occur at home without the intervention of a medical professional.
[0409] The connector (1901) of the present disclosure can be configured in various forms, and a 3-way connector can be used as one way to enable use of a home system without separately separating the urine bag and catheter.
[0410] FIG. 20 and FIG. 21 are schematic drawings of a 3-way connector according to one embodiment of the present disclosure.
[0411] FIG. 20a is a schematic drawing of the shape of the main body of a 3-way connector according to one embodiment, and FIG. 20b is a schematic drawing of the shape of the handle portion of the 3-way connector according to one embodiment.
[0412] Referring to FIG. 20A, the main body of the connector may include three-way connection means. For example, in a household cleaning system, each connection means may be connected to a urine bag (1902), a catheter (1904) connected to the bladder, and a closed cleaning system (1905). In this case, the catheter (1904) and the urine bag (1902) may be constantly connected to the connector, and the closed cleaning system (1905) may only be connected when the cleaning system is used.
[0413] The main body of the connector includes a connecting portion (2001) to which a handle capable of controlling the connection direction can be connected. Through this connecting portion, the handle portion can be connected to control the connection method of each pipe connected to the connector.
[0414] Referring to FIG. 20b, the handle portion of the connector includes a controller (2002) that allows the user to directly control the direction and a handle coupling portion (2003) that is coupled with the coupling portion (2001) of the main body, and the handle coupling portion (2003) includes holes (2004) that are connected to each pipe.
[0415] In one embodiment, the hole (2004) may be formed in two connecting directions among the connecting pipes. In this case, the connecting pipes may be changed by turning the controller. In this case, a fixing means may be included to fix the hole and the connecting means when they are engaged.
[0416] In one embodiment, the shape of the hole may be a single passage as shown in the drawing, and may be configured differently depending on the shape of the interior of the connected pipe. The shape of the interior of the hole may be determined by the cleaning method of the connected system. These shapes are not limited to those disclosed in the drawing.
[0417] Fig. 21 is a schematic drawing of the shape of the entire connector in which the main body portion and the handle portion of the connector are combined according to one embodiment.
[0418] According to one embodiment of the present disclosure, a coupling means for sealing the tube may be attached to the connecting means.
[0419] According to one embodiment of the present disclosure, the cleaning system can be driven by changing the pipe connected to the household system through the rotation of the handle.
[0420] For example, when irrigation is not required, the catheter connected to the bladder and the urinary bag can be connected via a connector. If bladder irrigation is required during use, the controller (2002) can be used to change the connector to connect the catheter to the system. This allows the bladder to be connected to the system and the bladder to be irrigated. In addition to bladder irrigation, the controller (2002) can be adjusted to connect the tube connected to the urinary bag to the system, allowing irrigation of the tube connected to the urinary bag.
[0421] However, either the bladder or the tube connected to the urinary bag may be washed, and it is not necessary to wash both the bladder and the tube connected to the urinary bag, or to wash them sequentially.
[0422]
[0423] 4.2 Hospital Systems
[0424] Hospital systems can include all the components of a home system. However, unlike home systems, these can be controlled directly from the hospital or through separate control software.
[0425] Hospital systems can be safely and appropriately managed and can include additional features or devices that allow for more functionality to be implemented by medical professionals.
[0426] As an example, the cleaning solution storage unit of a hospital system may additionally be configured with an indicator to display the temperature of the cleaning solution. Furthermore, different control settings may be set for each type or composition of the cleaning solution.
[0427] In one embodiment, a hospital system may have an algorithm that uses a pump to reverse the flow direction of the system to prevent blockages before they are expected. If blockages persist even after this prevention, or if the blockage persists for a preset period of time, an additional resolution algorithm may be activated.
[0428] Additionally, hospital systems may include additional sensors not included in home systems. These sensors may include flow sensors, hydraulic pressure sensors, and other sensors. The sensing values obtained by these sensors can be used in hospital settings to calculate bladder urine volume, for example.
[0429] In one embodiment, a hospital system may include additional functions such as a sterilization function to sterilize the cleaning solution when it is repeatedly used, a replacement notification to periodically replace the filter when it is used, and filter replacement according to disease.
[0430] The components of the hospital system exemplified above are not necessarily limited to hospital systems, but can also be used in home systems. They do not necessarily have to include all of the above functions, and may be implemented by adding only the necessary functions or devices.
[0431]
[0432] 5. Control SW and Platform for Closed Circulation Bladder Irrigation System
[0433] FIG. 22 is a schematic diagram of a system including a device for managing a home system according to one embodiment and a device for managing a washing system within a hospital.
[0434] The entire system may consist of a first electronic device (2201) that manages the home system or a second electronic device (2202) that manages the system within the hospital.
[0435] The first device (2201) and the second electronic device (2202) can separately acquire and store data, and can acquire data by transmitting and receiving data between the first electronic device and the second electronic device.
[0436]
[0437] 5.1 UI / UX of applications dedicated to home systems
[0438] In the case of operating a home system at home, a first electronic device (2201) for managing or controlling the home system may be provided as an application, for example.
[0439] Figure 23 is a schematic diagram of a UI / UX screen of an application for managing a home system according to one embodiment.
[0440] According to one embodiment of the present disclosure, the application includes data on the use of the system, medical data such as diseases, diagnostic information on diseases, etc., so that data related to the washing system can be checked.
[0441] The application may include functionality for modifying the operating settings of the home system. The device may allow for changes to the temperature of the cleaning solution, the flow rate of the cleaning solution, the cleaning cycle, and the cooling device settings. In this case, all settings for the home system must be within the ranges established by the healthcare professional. Therefore, some settings may not be changeable, and different ranges may be set for each patient.
[0442] Additionally, the application may include functionality to receive and transmit notifications when a blockage in the catheter is detected.
[0443] According to one embodiment of the present disclosure, data from the application is transmitted to the hospital system, enabling the acquisition of information related to the patient's current system or condition within the hospital, which can be utilized as supplementary information for patient diagnosis. Conversely, if the patient receives in-patient treatment and the hospital system acquires data related to the patient, the hospital system can transmit this data to the application, allowing the patient to view the medical data at home.
[0444] In addition, the application can provide information related to the use of the hospital or system, such as management of visit schedules, a visit reservation platform, and notifications when consumables are to be purchased.
[0445]
[0446] 5.2 Hospital (Doctor) UI / UX
[0447] In a hospital, a second electronic device (2202) may be used to manage patients visiting the hospital, either using a washing system within the hospital or using a home system.
[0448] Figure 24 is a schematic diagram of a UI / UX screen of a second electronic device used in a hospital according to one embodiment.
[0449] According to one embodiment of the present disclosure, the UI / UX of a second electronic device for hospital use (hereinafter referred to as "hospital UI / UX") can display information such as patient information, diagnosis information, and other medical data, as well as information regarding the operation and settings of a home cleaning system. This allows the hospital to verify whether the home system is operating properly. For example, the hospital can verify whether the home system's settings are appropriately set based on the patient's diagnosis information and provide feedback on the same. Alternatively, the hospital can verify whether the replacement cycle or frequency of consumables is appropriate.
[0450] Additionally, when a patient visits a hospital and diagnostic information is updated, the second electronic device can transmit the acquired data to the first electronic device.
[0451] In addition, the UI / UX for hospitals may include and display functions required for the second electronic device, and is not limited to the UI / UX screen as in the drawings of the present disclosure or the functions disclosed.
[0452]
[0453] 5.3 Medical Platform
[0454] In one embodiment of the present disclosure, since the first electronic device (2201) and the second electronic device (2202) transmit and receive data to each other, appropriate medical data can be provided even when using a home system.
[0455] According to one embodiment of the present disclosure, when data is entered into the second electronic device regarding the dosing and cleaning cycle, the first electronic device can be provided with a notification set by the dosing and cleaning cycle.
[0456] When a blockage or contamination alert is generated in the home system on the first electronic device, information is transmitted to the second electronic device in response, so that the second electronic device can provide remote treatment and update the patient's information on the second electronic device.
[0457] In addition, when replacing consumables at home, by entering the replacement date and information about the consumables into the first electronic device, a notification according to the appropriate replacement cycle set for each consumable is provided to not only the first electronic device but also the second electronic device, so that the patient's condition can be properly maintained through the interaction of the home system, the first electronic device, and the second electronic device.
[0458] Although the embodiments described above have been described by way of limited examples and drawings, those skilled in the art will appreciate that various modifications and variations can be made based on the above teachings. For example, appropriate results can still be achieved even if the described techniques are performed in a different order than described, and / or components of the described systems, structures, devices, circuits, etc. are combined or combined in a different manner than described, or are replaced or substituted with other components or equivalents.
[0459] Therefore, other implementations, other embodiments, and equivalents to the claims also fall within the scope of the claims described below.
[0460] In the specific embodiments of the present disclosure described above, components included in the disclosure are expressed in the singular or plural form, depending on the specific embodiment presented. However, the singular or plural expressions are selected to suit the presented situation for convenience of explanation, and the present disclosure is not limited to singular or plural components. Components expressed in the plural form may be composed of singular elements, or components expressed in the singular form may be composed of plural elements.
[0461] Meanwhile, the embodiments of the present disclosure disclosed in this specification and drawings are merely specific examples to easily explain the technical contents of the present disclosure and help understand the present disclosure, and are not intended to limit the scope of the present disclosure. In other words, it will be apparent to those skilled in the art to which the present disclosure pertains that other modified examples based on the technical idea of the present disclosure are possible. In addition, each embodiment can be combined and operated with each other as needed. For example, parts of one embodiment of the present disclosure and another embodiment can be combined with each other to implement an embodiment not specified in the present specification.
[0462] Meanwhile, the order of description in the drawings explaining the method of the present disclosure does not necessarily correspond to the order of execution, and the order of precedence may be changed or executed in parallel.
[0463] Alternatively, the drawings illustrating the method of the present disclosure may omit some components and include only some components without detracting from the essence of the present disclosure.
[0464] In addition, the method of the present disclosure may be implemented by combining some or all of the contents included in each embodiment within a scope that does not harm the essence of the disclosure.
Claims
1. In a household closed circulation bladder cleaning system, Detergent storage compartment; A catheter including a first passage corresponding to a passage through which a first fluid discharged from the washing solution storage unit moves to the bladder, and a second passage corresponding to a passage through which a second fluid discharged from the bladder moves to the washing solution storage unit, wherein the first fluid includes at least one of a washing solution or a treatment solution, and the second fluid includes a washing solution and a foreign substance; A pump for controlling the flow rate and direction of the first fluid and the second fluid flowing in the catheter, - the pump includes a first pump installed on the first passage and a second pump installed on the second passage; A filter unit for filtering foreign substances contained in the second fluid discharged from the bladder; A control unit electrically connected to the above detergent storage unit and the pump; The above control unit: Controlling the first pump to inject the first fluid contained in the washing liquid storage unit into the bladder through the first passage; A system that controls the second pump to inject the second fluid contained in the bladder through the second passage into the filter unit and into the washing solution storage unit.
2. In paragraph 1, The above detergent storage unit includes a cartridge coupling unit coupled with a detergent cartridge containing the detergent; A system wherein the coupling portion of the above-described cleaning solution cartridge is formed in a first shape, the coupling portion of the above-described cartridge coupling portion is formed in a second shape, the first shape and the second shape correspond to each other in a shape-specific manner, and the cleaning solution cartridge and the above-described cartridge coupling portion are shape-specifically coupled to each other based on the first shape and the second shape.
3. In paragraph 1, The above detergent storage unit further includes a detergent genuine authentication means; - the detergent genuine authentication means includes at least one of an RFID tag reader, a barcode or QR code reader, an NFC reader, a hologram or pattern reader -, The above control unit: Through the above detergent authenticity authentication means, an authenticity authentication mark included in a detergent cartridge containing the detergent is identified, - the authenticity authentication mark includes at least one of an RFID tag, a barcode or QR code, NFC, a hologram or a pattern -; A system for determining whether the detergent cartridge is genuine based on the above identification results.
4. In paragraph 3, The above detergent storage unit further includes an opening / closing device for the detergent inlet; The above control unit: Based on the above identification result, if the detergent cartridge is determined to be genuine, the opening / closing device is controlled so that the detergent inlet is opened. A system for controlling the opening / closing device so that the detergent inlet is not opened if the detergent cartridge is determined to be not genuine based on the above identification result.
5. In paragraph 1, The above detergent storage unit comprises a cartridge coupling unit coupled with a detergent cartridge containing the detergent; and A valve for controlling the flow rate of the first fluid and the second fluid flowing in the catheter; The above control unit: Based on the detergent cartridge coupled to the cartridge coupling portion, the type of detergent is identified, Based on the type of the above cleaning solution, the required pressure range within the bladder is calculated, A system that controls at least one of the pump or the valve so that the pressure within the bladder is within the required pressure range.
6. In paragraph 5, The above valve includes a first valve located on the first passage and a second valve located on the second passage, The above control unit: When the pressure within the bladder exceeds the required pressure range, the first valve and the second valve are controlled so that the opening / closing rate of the first valve is smaller than the opening / closing rate of the second valve. A system that controls the first valve and the second valve so that the opening / closing rate of the first valve is greater than the opening / closing rate of the second valve when the pressure within the bladder is below the required pressure range.
7. In paragraph 1, A flow sensor for measuring the flow rates of the first fluid and the second fluid; and including the Department of Communications; The above control unit: Measure the flow rates of the first fluid and the second fluid through the flow rate sensor, Based on the above measurement results, if the flow rate value is less than the set value, it is determined that the catheter is blocked. A system that transmits information related to blockage of the catheter to an external device through the communication unit.
8. In paragraph 1, A system in which the above-mentioned cleaning solution storage unit is formed integrally including the above-mentioned catheter.
9. In paragraph 1, The above detergent storage unit includes a cartridge coupling unit coupled with a detergent cartridge containing the detergent; The above control unit: Based on the detergent cartridge coupled to the cartridge coupling portion, the concentration of the detergent is identified, A system that controls the first pump and the second pump to control the flow rates of the first fluid and the second fluid based on the concentration of the cleaning solution.
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