Device for measuring the fill time of a balance chamber system, device for detecting an anomaly in a balance chamber system, balance chamber module, dialysis system and corresponding method

Abstract

An apparatus for detecting an anomaly in a balancing chamber system (1) is provided, wherein the apparatus comprises an inflow monitor configured to measure a first filling time of a first chamber (4) of the balancing chamber (2) or a second filling time of a second chamber (5) of the balancing chamber (2), and an analysis evaluator (27) configured to compare the first filling time to a first predetermined value or range or to compare the second filling time to a second predetermined value or range to detect an anomaly in the balancing chamber system (1). Furthermore, an apparatus for measuring a filling time of a balancing chamber system (1), a balancing chamber module, a dialysis system and a method for detecting an anomaly in a balancing chamber system (1) are provided. An anomaly can be reliably and simply detected and identified.

Description

Technical Field

[0001] The present invention relates to an apparatus for measuring the filling time of a balance chamber system, an apparatus for detecting abnormalities in a balance chamber system, a balance chamber module, a dialysis system, and a method for detecting abnormalities in a balance chamber system. Background Technology

[0002] Dialysis is widely used for certain kidney diseases, such as uremia or kidney failure. A common machine used for hemodialysis is called a hemodialysis machine.

[0003] In hemodialysis treatment, it is essential to ensure that sufficient fresh dialysate flows into the dialyzer of the hemodialysis machine. Conventional hemodialysis machines, including at least one, preferably two, balance chambers, control the circulation rate of the balance chambers to achieve the desired flow rate within a predetermined chamber volume.

[0004] The flow rate may also decrease undetected when the loading pressure used for the balancing chamber drops or an anomaly occurs (e.g., blockage in the inflow and / or outflow paths). One known method is to detect the amplitude and timing of the current rise pulse to indicate whether sufficient loading pressure has been generated and whether fluid has filled the balancing chamber.

[0005] However, this method requires higher pressure in the hydraulic circuit and may not be usable when limiting loading pressure. Furthermore, it places higher pressure on the hydraulic piping system. Summary of the Invention

[0006] In view of the problems existing in the prior art, the object of the present invention is to provide an apparatus for measuring the filling time of a balance chamber system, an apparatus for detecting abnormalities in a balance chamber system, a corresponding balance chamber module, a corresponding dialysis system, and a corresponding method.

[0007] To achieve the above objective, according to a first aspect of the present invention, an apparatus for measuring the filling time of a balancing cavity system is provided, wherein the apparatus comprises: an inflow monitor configured to measure a first filling time of a first cavity of the balancing cavity or a second filling time of a second cavity of the balancing cavity; and a storage module configured to receive the first filling time or the second filling time.

[0008] According to a second aspect of the present invention, an apparatus for measuring the filling time of a balancing cavity system is provided, wherein the apparatus comprises: a monitor configured to monitor a first filling process of a first cavity of a balancing cavity or a second filling process of a second cavity of a balancing cavity and generate monitoring data; a processing module configured to receive the monitoring data from the monitor to calculate a first filling time of the first filling process or a second filling time of the second filling process; and a storage module configured to receive the first filling time or the second filling time.

[0009] According to a third aspect of the invention, an apparatus for detecting anomalies in a balancing cavity system is provided, wherein the apparatus comprises: an inflow monitor configured to measure a first filling time of a first cavity of the balancing cavity or a second filling time of a second cavity of the balancing cavity; and an analysis evaluator configured to compare the first filling time with a first predetermined value or range or the second filling time with a second predetermined value or range to detect anomalies in the balancing cavity system.

[0010] According to an optional embodiment of the present invention, the balancing cavity system includes at least one balancing cavity divided into a first cavity and a second cavity by a flexible partition wall.

[0011] According to an optional embodiment of the present invention, an anomaly is detected if a first deviation between the first filling time and a first predetermined value exceeds a first predetermined range; or an anomaly is detected if a second deviation between the second filling time and a second predetermined value exceeds a second predetermined range.

[0012] According to an optional embodiment of the present invention, the inflow monitor is disposed on the first filling flow path of the balancing cavity system; or the inflow monitor is disposed on the second filling flow path of the balancing cavity system.

[0013] According to an optional embodiment of the present invention, the inflow monitor is disposed on the first discharge flow path of the balancing chamber system; or the inflow monitor is disposed on the second discharge flow path of the balancing chamber system.

[0014] According to an optional embodiment of the invention, the inflow monitor includes a pair of electrodes disposed across a first electrically insulating check valve, the first electrically insulating check valve being fluidly connected to a first filling port of a first chamber, thereby allowing only fresh fluid to flow into the first chamber; or the inflow monitor includes a pair of electrodes disposed across a second electrically insulating check valve, the second electrically insulating check valve being fluidly connected to a second filling port of a second chamber, thereby allowing only waste fluid to flow into the second chamber.

[0015] According to an optional embodiment of the present invention, the device further includes an indication module configured to generate an abnormal signal when an abnormality is detected.

[0016] According to a fourth aspect of the present invention, a balancing cavity module is provided, wherein the balancing cavity module includes the means for measuring the filling time of the balancing cavity system or the means for detecting abnormalities in the balancing cavity system.

[0017] According to a fifth aspect of the present invention, a dialysis system is provided, wherein the dialysis system includes the balance chamber module.

[0018] According to a sixth aspect of the present invention, a method for detecting an anomaly in a balanced cavity system is provided, wherein the method includes the steps of: measuring a first filling time of a first cavity of a balanced cavity or a second filling time of a second cavity of a balanced cavity; and comparing the first filling time with a first predetermined value or range, or comparing the second filling time with a second predetermined value or range, to detect an anomaly in the balanced cavity system.

[0019] According to an optional embodiment of the present invention, if the first filling time of the first cavity is lower than a first predetermined range, an anomaly exists in the second discharge flow path; or if the first filling time of the first cavity is higher than the first predetermined range, an anomaly exists in the first discharge flow path or the first filling flow path.

[0020] According to an optional embodiment of the present invention, if the second filling time of the second cavity is lower than a second predetermined range, an anomaly exists in the first discharge flow path; or if the second filling time of the second cavity is higher than a second predetermined range, an anomaly exists in the second filling flow path or the second discharge flow path.

[0021] According to an optional embodiment of the present invention, the method further includes: if an anomaly is detected, generating an anomaly signal indicating that the cavity is not discharging sufficiently.

[0022] According to an optional embodiment of the present invention, an abnormal signal is generated only when the number of abnormalities detected according to a predetermined standard reaches a predetermined number.

[0023] According to the present invention, abnormalities in a balanced cavity system can be reliably and easily detected and identified. Attached Figure Description

[0024] The invention and its advantages will be further understood by reading the following detailed description of some preferred exemplary embodiments with reference to the accompanying drawings. The drawings include:

[0025] Figure 1 Taking a single balance chamber system as an example, a method and apparatus for detecting abnormalities in the balance chamber system of a hemodialysis machine are schematically illustrated.

[0026] Figure 2The relationship between the filling time and loading pressure of the first cavity according to an exemplary embodiment of the present invention is shown; and

[0027] Figure 3 The relationship between standardized filling time and standardized flow rate of fluid filled into the first chamber is shown to indicate the flow path of fresh dialysate or waste dialysate. Detailed Implementation

[0028] Some exemplary embodiments of the invention will be described in more detail below with reference to the accompanying drawings to better understand the basic ideas of the invention.

[0029] Figure 1 A method and apparatus for detecting abnormalities in a balance chamber system are schematically illustrated, using a single balance chamber system of a hemodialysis machine as an example. Furthermore, refer to... Figure 1 Describes an apparatus for measuring the filling time of a balanced cavity system.

[0030] like Figure 1 As shown, the balancing chamber system 1 includes a single balancing chamber (BC) 2, which is divided into a first chamber 4 and a second chamber 5 by a movable partition wall 3. The movable partition wall 3 is preferably constructed as a flexible membrane.

[0031] The balancing chamber 2 is equipped with a first inlet valve 37, a first outlet valve 34, a second inlet valve 38, and a second outlet valve 33. The first inlet valve 37 and the second outlet valve 33 are respectively located at the first inlet 6 and the first outlet 7 of the first chamber 4. The second inlet valve 38 and the first outlet valve 34 are respectively located at the second inlet 12 and the second outlet 13 of the second chamber 5.

[0032] The fresh dialysate supply unit 8 (shown schematically only) is fluidly connected to the first inlet valve 37 via the first fill flow path 9. One end of the first discharge flow path 17 is fluidly connected to the first outlet valve 34. In an actual balancing chamber system, the other end of the first discharge flow path 17 is connected to a discharge component (not shown). However, the other end of the first discharge flow path 17 is schematically shown here as connected to the discharge flow resistance simulation unit 18, and ultimately leads to a weighing scale 19, which can be used to measure the actual amount of fluid expelled from the second chamber 5. The discharge flow resistance simulation unit 18 can be used to simulate possible anomalies in the first discharge flow path 17.

[0033] One end of the second filling flow path 15 is fluidly connected to the second inlet valve 38, and one end of the second discharge flow path 10 is fluidly connected to the second outlet valve 33. In an actual balancing chamber system, the other end of the second discharge flow path 10 is used to fluidly connect to the dialysate chamber of the dialyzer 28, and the other end of the second filling flow path 15 is used to fluidly connect to the dialysate chamber of the dialyzer 28 via a waste dialysate delivery unit 14 (shown schematically only), for example, a gear pump. These connections are in... Figure 1 The middle part is schematically shown by a dashed line.

[0034] In the first phase of actual operation, with the first outlet valve 34 open and the second inlet valve 38 and the second outlet valve 33 closed, fresh dialysate can be supplied from the fresh dialysate supply unit 8 to the first chamber 4 via the first filling flow path 9, the first inlet valve 37, and the first inlet 6. During this first phase, fresh dialysate is filled into the first chamber 4, and waste dialysate is expelled from the second chamber 5 by the pressure exerted by the fresh dialysate on the movable partition wall 3. This means that during the first phase, the first inlet 6 and the first outlet 13 are indirectly fluidly connected via the movable partition wall 3.

[0035] In the subsequent second process, with the second outlet valve 33 open and the first inlet valve 37 and the first outlet valve 34 closed, waste dialysate can be filled from the dialyzer 28 into the second chamber 5 via the waste dialysate delivery unit 14. During this second process, waste dialysate is filled into the second chamber 5, and fresh dialysate is expelled from the first chamber 4 by the pressure exerted by the waste dialysate on the movable partition wall 3. This means that during the second process, the second inlet 12 and the second outlet 7 are indirectly fluidly connected via the movable partition wall 3.

[0036] However, for testing purposes, the other end of the second discharge flow path 10 is schematically shown here as being connected to a dialysate flow resistance simulation unit 11, which can be used to simulate possible anomalies in the second discharge flow path 10.

[0037] In order to control the pressure in the second chamber 5, i.e. the flow pressure, to adjust the pressure difference between the two sides of the movable partition wall 3, a flow pressure regulator 16, such as a valve, is provided across the waste dialysate delivery unit 14.

[0038] For testing purposes only, the dialysate flow resistance simulation unit 11 can be connected to the waste dialysate delivery unit 14, such as... Figure 1 As shown. In this case, the waste dialysate is actually fresh dialysate, which can be used for testing. Of course, other types of fluids can also be used for testing.

[0039] The operation of the first inlet valve 37, the first outlet valve 34, the second inlet valve 38, the second outlet valve 33, the fresh dialysate supply unit 8, the waste dialysate conveying unit 14, etc., under the control of the controller (not shown), is well known in the prior art, so more detailed operation is omitted here.

[0040] Obviously, if some fluid path components of the balance chamber system 1, such as the first discharge flow path 17 and / or the second discharge flow path 10, malfunction, there may not be enough dialysate flowing into the dialyzer 28 of the hemodialysis machine, which could negatively affect the treatment outcome.

[0041] The filling time of the first chamber 4 can reflect the flow characteristics of the equilibrium chamber system 1. For example, the filling time may be related to the total volume of the first chamber 4 and the second chamber 5, the pressure difference between the two sides of the movable partition wall 3, the dialysate flow resistance of the first discharge flow path 17, the discharge flow resistance of the second discharge flow path 10, the filling flow resistance of the first filling flow path 9, and other factors. For a specific equilibrium chamber system, these factors are constant or determinable; for example, the total volume of the first chamber 4 and the second chamber 5 is known and constant.

[0042] Therefore, this anomaly can be detected based on fill time. More specifically, it can be detected based on the change in actual fill time relative to the baseline fill time.

[0043] As mentioned above, the baseline filling time can also vary with the pressure difference between the two sides of the movable partition wall 3, so the pressure difference needs to be determined.

[0044] To determine the pressure difference between the two sides of the movable partition wall 3, a pressure difference measuring device is provided. According to an exemplary embodiment of the present invention, the pressure difference measuring device includes a first pressure measuring device 20 for measuring the pressure of fresh dialysate filled into the first chamber 4, i.e., the loading pressure, and a second pressure measuring device 24 for measuring the pressure of waste dialysate in the second chamber 5, i.e., the flow pressure.

[0045] According to an exemplary embodiment of the present invention, such as Figure 1 As shown, the first pressure measuring device 20 can be integrated into the fresh dialysate supply unit 8. More specifically, the fresh dialysate supply unit 8 can also be set with a loading pressure. As an alternative embodiment, the first pressure measuring device 20 can also be located at the first filling flow path 9.

[0046] According to an exemplary embodiment of the present invention, such as Figure 1 As shown, the second pressure measuring device 24 can be disposed at the second filling flow path 15. According to another exemplary embodiment of the present invention, the flow pressure can be set by the flow pressure regulator 16.

[0047] The pressure difference between the two sides of the movable partition wall 3 can be determined by subtracting the back pressure measured by the third pressure measuring device 21 located in the first discharge flow path 17 from the loading pressure measured by the first pressure measuring device 20.

[0048] The pressure difference across the movable partition wall 3 can also be determined by the flow pressure generated by the flow pressure regulator 16 relative to the dialysate flow resistance simulation unit 11, which can be measured separately by means of the second pressure measuring device 24 provided in the second filling flow path 15 and the fourth pressure measuring device 25 provided in the second discharge flow path 10.

[0049] A fill time measuring device is provided, comprising an inflow monitor configured to measure the fill time of a first chamber 4 and a storage module configured to receive the fill time. The fill time can be provided as a parameter to a corresponding device that requires such a parameter.

[0050] According to an exemplary embodiment of the present invention, the filling time measuring device further includes a conductivity measuring device disposed at the first filling flow path 9.

[0051] According to an exemplary embodiment of the present invention, the conductivity meter includes a pair of electrodes 22 disposed across a first electrically insulating check valve 23, which is located at a first filling flow path 9, thereby allowing only fresh dialysate to flow into the first chamber 4. For the conductivity meter, the conductivity between the pair of electrodes 22 is high when fresh dialysate flows into the first chamber 4; when the balance chamber 2 is full and no more fresh dialysate flows into the first chamber 4, the check valve 23 closes, and the conductivity between the pair of electrodes 22 decreases. That is, the filling time of the first chamber 4 can be obtained by measuring the conductivity between the pair of electrodes 22.

[0052] Typically, the filling time of the first cavity 4 can also be obtained by monitoring the filling process of the first cavity 4. In this case, another filling time measuring device is provided, which includes: a monitor configured to monitor the filling process of the first cavity 4 and generate monitoring data, a processing module configured to receive monitoring data from the monitor to calculate the filling time of the filling process, and a storage module configured to receive the filling time.

[0053] Without altering the physical flow characteristics of the balancing chamber system, numerous tests were conducted at typical loading pressures (and constant flow pressures) to evaluate the relationship between filling time and the actual flow rate of fresh dialysate filled into balancing chamber 2, which can be calculated from the actual amount of fluid expelled from second chamber 5 and the corresponding filling time. It was found that, under predetermined pressure differential conditions across the movable partition wall 3, the filling time is fairly consistent in each balancing chamber (BC) cycle. Typically, standardized filling times are generated during calibration or POST (Power-On Self-Test) and recorded in memory as predetermined values ​​or ranges.

[0054] Figure 2 The relationship between filling time and loading pressure according to an exemplary embodiment of the present invention is illustrated. Figure 2 As shown, the filling time varies with the loading pressure, and more precisely, with the pressure difference between the two sides of the movable partition wall 3. Specifically, the filling time decreases as the pressure difference between the two sides of the movable partition wall 3 increases. When the filling time inflection point 26 is reached, further increases in the pressure difference between the two sides of the movable partition wall 3 have little effect on the filling time.

[0055] As mentioned above, there is a close correlation between the filling time and the pressure difference between the two sides of the movable partition wall 3. If any anomaly exists in the relevant hydraulic flow path that causes a change in the pressure difference between the two sides of the movable partition wall 3, particularly a decrease, the filling time will change.

[0056] During testing, anomalies in the second discharge flow path 10 can be simulated using the dialysate flow resistance simulation unit 11, and anomalies in the first discharge flow path 17 can be simulated using the discharge flow resistance simulation unit 18. It can be observed that the filling time also changes when the flow resistance of the second discharge flow path 10 and / or the flow resistance of the first discharge flow path 17 varies under a predetermined pressure difference between the two sides of the movable partition wall 3.

[0057] According to an exemplary embodiment of the present invention, if the deviation between the filling time and the predetermined value under a predetermined pressure difference exceeds a predetermined range, an anomaly is detected.

[0058] Based on the deviation of the filling time from the predetermined value or range, the following can be achieved by means of... Figure 3 The two scenarios shown are in Figure 3 In this context, the abnormal filling time deviates from the 100% normalized filling time. Those skilled in the art will understand that the 100% normalized filling time is a predetermined value or range obtained during calibration or POST under normal equilibrium chamber loading pressure and normal flow rate.

[0059] 1) Scenario 1: Abnormalities in the flow path of fresh dialysate (e.g.) Figure 3 (The standardized fill time is shown on the left).

[0060] When the pressure difference between the two sides of the movable partition wall 3 drops to a certain level, the waste dialysate in the second chamber 5 cannot be completely drained within the predetermined BC cycle time. In this case, some waste dialysate remains in the second chamber 5. Therefore, only a small filling volume remains when the first chamber 4 is subsequently filled. Thus, the filling time will be shortened. The reduction in filling time can be related to the reduction in the amount of fresh dialysate filled into the equilibration chamber 2.

[0061] 2) Scenario 2: Anomalies in the flow path of waste dialysate (such as...) Figure 3 (The standardized fill time is shown on the right).

[0062] Abnormalities in the flow path of the waste dialysate directly affect the pressure differential between the two sides of the movable partition wall 3. When the discharge flow resistance increases, the filling time will be prolonged. If the discharge flow resistance is too high, the filling of the first chamber 4 will be terminated.

[0063] Figure 3 Only the possible anomalies detected based on the filling time of the first chamber when fresh dialysate is filled into the first chamber to expel waste dialysate from the second chamber are shown. However, those skilled in the art will understand that some possible anomalies can also be detected based on the filling time of the second chamber when waste dialysate is filled into the second chamber to expel fresh dialysate from the first chamber.

[0064] Those skilled in the art will understand that although the basic idea of ​​the invention has been described using the filling of the first cavity as an example, the basic idea can also be utilized based on the filling time of the second cavity.

[0065] Furthermore, those skilled in the art will understand that the filling time of the first cavity corresponds to the outflow time of the second cavity, and vice versa. Therefore, anomalies can also be detected based on the outflow time, which also falls within the scope of this invention.

[0066] From an operational perspective, those skilled in the art will understand that measuring the filling time of the balance chamber for fresh fluid inflow is more recommended than measuring the filling time of the balance chamber for waste fluid inflow, because the conductivity of fresh dialysate can be generated more accurately for detection and measurement.

[0067] Therefore, the measuring device is placed on the fresh liquid flow path of the balancing chamber system, or on the waste liquid flow path of the balancing chamber system.

[0068] Furthermore, those skilled in the art will understand that the basic idea can be applied not only to single-balanced cavity systems but also to dual-balanced cavity systems.

[0069] To detect anomalies, an analysis evaluator 27 is provided, which can at least compare the fill time with a predetermined value or range. For example... Figure 1 As shown, for the sake of simplicity, the analysis evaluator 27 is shown only schematically.

[0070] According to an exemplary embodiment of the present invention, the function of the analysis and evaluation unit 27 can also be implemented by the controller of the balancing cavity system.

[0071] According to an exemplary embodiment of the present invention, an indicator module (not shown) is provided that can generate an abnormal signal if an abnormality is detected, such as indicating insufficient discharge of the cavity.

[0072] To avoid false alarms, an anomaly signal is only generated when the number of anomalies detected according to a predetermined standard reaches a predetermined number.

[0073] During the manufacturing process of a hemodialysis machine, the loading pressure and flow pressure are adjusted according to a defined factory calibration procedure. Therefore, the filling time can typically be used as a parameter to monitor the actual flow rate of fresh dialysate filling the balancing chamber during dialysis. In other words, abnormalities can be detected based on the chamber's filling time. Those skilled in the art will understand that devices for detecting abnormalities in the balancing chamber system can be integrated into the hemodialysis machine.

[0074] The present invention also provides a balance chamber module and a dialysis system including the balance chamber module, the balance chamber module including a filling time measuring device or a device for detecting abnormalities in the balance chamber system.

[0075] According to the present invention, anomalies can be detected and identified reliably and simply.

[0076] Although certain embodiments have been described, these embodiments are given by way of example only and are not intended to limit the scope of the invention. The appended claims and their equivalents are intended to cover all modifications, substitutions, and alterations that fall within the scope and spirit of the invention.

Claims

1. A device for detecting anomalies in a balancing cavity system (1), wherein, The device includes: An inflow monitor is configured to measure the first filling time of the first cavity (4) of a single balancing cavity (2) or the second filling time of the second cavity (5) of the same balancing cavity (2); and An analysis and evaluation unit (27) is configured to compare a first fill time with a first predetermined value or range stored in memory, or to compare a second fill time with a second predetermined value or range stored in memory, to detect anomalies in the balance cavity system (1). The balancing cavity (2) is divided into a first cavity (4) and a second cavity (5) by a flexible partition wall (3). The inflow monitor includes a pair of electrodes (22) positioned across a first electrically insulating check valve (23), which is fluidly connected to a first filling port (6) of a first chamber (4), thereby allowing only fresh fluid to flow into the first chamber (4); or the inflow monitor includes a pair of electrodes positioned across a second electrically insulating check valve, which is fluidly connected to a second filling port (12) of a second chamber (5), thereby allowing only waste fluid to flow into the second chamber (5).

2. The apparatus according to claim 1, wherein... If the first deviation between the first filling time and the first predetermined value exceeds the first predetermined range, an anomaly is detected; or An anomaly is detected if the second deviation between the second filling time and the second predetermined value exceeds the second predetermined range.

3. The apparatus according to claim 1 or 2, wherein... The inflow monitor is installed on the first filling flow path (9) of the balancing chamber system (1); or The inflow monitor is set on the second filling flow path (15) of the balance chamber system (1).

4. The apparatus according to claim 1 or 2, wherein, The device further includes: An indicator module is configured to generate an abnormal signal when an anomaly is detected.

5. A balanced cavity module, wherein, The balancing chamber module includes the apparatus according to any one of claims 1 to 4.

6. A dialysis system, wherein, The dialysis system includes the balance chamber module according to claim 5.

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