WO2019119412A1 - Dispositif pour mesurer le temps de remplissage d'un système à chambre d'équilibrage, dispositif de détection d'anomalie dans un système à chambre d'équilibrage, module de chambre d'équilibrage, système de dialyse et procédé correspondant - Google Patents

Dispositif pour mesurer le temps de remplissage d'un système à chambre d'équilibrage, dispositif de détection d'anomalie dans un système à chambre d'équilibrage, module de chambre d'équilibrage, système de dialyse et procédé correspondant Download PDF

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Publication number
WO2019119412A1
WO2019119412A1 PCT/CN2017/117987 CN2017117987W WO2019119412A1 WO 2019119412 A1 WO2019119412 A1 WO 2019119412A1 CN 2017117987 W CN2017117987 W CN 2017117987W WO 2019119412 A1 WO2019119412 A1 WO 2019119412A1
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WO
WIPO (PCT)
Prior art keywords
chamber
filling time
balancing chamber
filling
abnormity
Prior art date
Application number
PCT/CN2017/117987
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English (en)
Inventor
Joseph JOR
Original Assignee
Fresenius Medical Care Deutschland Gmbh
Fresenius Medical Care R & D (Shanghai) Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Medical Care Deutschland Gmbh, Fresenius Medical Care R & D (Shanghai) Co., Ltd. filed Critical Fresenius Medical Care Deutschland Gmbh
Priority to JP2020534366A priority Critical patent/JP7379336B2/ja
Priority to PCT/CN2017/117987 priority patent/WO2019119412A1/fr
Priority to CN201780097936.2A priority patent/CN112867517A/zh
Publication of WO2019119412A1 publication Critical patent/WO2019119412A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1621—Constructional aspects thereof
    • A61M1/1635—Constructional aspects thereof with volume chamber balancing devices between used and fresh dialysis fluid
    • A61M1/1639—Constructional aspects thereof with volume chamber balancing devices between used and fresh dialysis fluid linked by membranes

Definitions

  • the present invention relates to a device for measuring filling time of a balancing chamber system, a device for detecting an abnormity in the balancing chamber system, a balancing chamber module, a dialysis system and a method for detecting the abnormity in the balancing chamber system.
  • a dialysis treatment is widely used for some kidney diseases, such as uremia or renal failure.
  • a common machine used for blood dialysis treatment is called as a hemodialysis machine.
  • the conventional hemodialysis machine comprising at least one, preferably two balancing chambers controls balancing chamber cycle rate to achieve a desirable flow rate at a preset chamber volume.
  • the flow rate When a loading pressure for the balancing chamber drops or there is an abnormity, such as a blockage in the inflow path and/or the outflow path, the flow rate also may drop but undetected.
  • One of known methods is to detect current rising pulse amplitude and timing to indicate whether a sufficient loading pressure and fluid filling into the balancing chamber are generated.
  • an object of the present invention is to provide a device for measuring filling time of a balancing chamber system, a device for detecting an abnormity in the balancing chamber system, a corresponding balancing chamber module, a corresponding dialysis system and a corresponding method.
  • a device for measuring filling time of a balancing chamber system comprising an inflow monitoring means configured to measure a first filling time of a first chamber of a balancing chamber or a second filling time of a second chamber of the balancing chamber, and a memory module configured to receive the first filling time or the second filling time.
  • a device for measuring filling time of a balancing chamber system comprising: a monitoring means configured to monitor a first filling process of a first chamber of a balancing chamber or a second filling process of a second chamber of the balancing chamber, and generate a monitoring data; a processing module configured to receive the monitoring data from the monitoring means to calculate a first filling time of the first filling process or a second filling time of the second filling process; a memory module configured to receive the first filling time or the second filling time.
  • a device for detecting an abnormity in a balancing chamber system comprising: an inflow monitoring means configured to measure a first filling time of a first chamber of a balancing chamber or a second filling time of a second chamber of the balancing chamber; and an evaluating means configured to compare the first filling time with a first predetermined value or range or compare the second filling time with a second predetermined value or range to detect the abnormity in the balancing chamber system.
  • the balancing chamber system comprises at least one balancing chamber which is divided by a flexible separating wall into the first chamber and the second chamber.
  • the abnormity is detected if a first deviation of the first filling time from the first predetermined value is out of a first predetermined range; or the abnormity is detected if a second deviation of the second filling time from the second predetermined value is out of a second predetermined range.
  • the inflow monitoring means is disposed on a first filling flow path of the balancing chamber system; or the inflow monitoring means is disposed on a second filling flow path of the balancing chamber system.
  • the inflow monitoring means is disposed on a first discharging flow path of the balancing chamber system; or the inflow monitoring means is disposed on a second discharging flow path of the balancing chamber system.
  • the inflow monitoring means comprises a pair of electrodes across a first electrically insulated check valve which is fluidly connected with a first filling port of the first chamber so as to only allow fresh fluid to flow into the first chamber; or the inflow monitoring means comprises a pair of electrodes across a second electrically insulated check valve which is fluidly connected with a second filling port of the second chamber so as to only allow used fluid to flow into the second chamber.
  • the device further comprises an indicating module configured to generate an abnormal signal if the abnormity is detected.
  • a balancing chamber module wherein the balancing chamber module comprises the devices for measuring the filling time of the balancing chamber system or the device for detecting the abnormity in the balancing chamber system.
  • a dialysis system wherein the dialysis system comprises the balancing chamber module.
  • a method for detecting an abnormity in a balancing chamber system comprises the following steps: measuring a first filling time of a first chamber of a balancing chamber or a second filling time of a second chamber of the balancing chamber; 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 the abnormity in the balancing chamber system.
  • the abnormity exists in a second discharging flow path if the first filling time of the first chamber is below the first predetermined range; or the abnormity exists in a first discharging flow path or a first filling flow path if the first filling time of the first chamber is above the first predetermined range.
  • the abnormity exists in a first discharging flow path if the second filling time of the second chamber is below the second predetermined range; or the abnormity exists in a second filling flow path or a second discharging flow path if the second filling time of the second chamber is above the second predetermined range.
  • the method further comprises generating an abnormal signal if the abnormity is detected, which indicates the insufficient discharge of a chamber.
  • an abnormal signal is generated until the abnormity is detected for predetermined number of times according to a predetermined criterion.
  • the abnormity in the balancing chamber system can be detected and identified reliably and simply.
  • Fig. 1 schematically illustrates a method and a device for detecting an abnormity in a balancing chamber system of a hemodialysis machine by taking a single-balancing chamber system as an example
  • Fig. 2 shows a relationship between a filling time of the first chamber and a loading pressure according to an exemplary embodiment of the present invention
  • Fig. 3 shows a relationship between a normalized filling time and a normalized flow rate of the fluid filling into the first chamber for indicating problems of the fresh or used dialysate flow path.
  • Fig. 1 schematically illustrates a method and a device for detecting an abnormity in a balancing chamber system, herein a single-balancing chamber system of a hemodialysis machine being taken as an example. Further, a device for measuring filling time of the balancing chamber system is described with reference to Fig. 1.
  • the balancing chamber system 1 comprises a single balancing chamber (BC) 2 which is divided by a displaceable partition wall 3 into a first chamber 4 and a second chamber 5.
  • the displaceable partition wall 3 is preferably configured as a flexible membrane.
  • 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 disposed at a first inlet 6 and a first outlet 7 of the first chamber 4 respectively.
  • the second inlet valve 38 and the first outlet valve 34 are disposed at a second inlet 12 and a second outlet 13 of the second chamber 5 respectively.
  • a fresh dialysate supply unit 8 may be fluidly connected with the first inlet valve 37 through a first filling flow path 9.
  • An end of a first discharging flow path 17 is fluidly connected with the first outlet valve 34.
  • the other end of the first discharging flow path 17 is connected with a draining part (not shown) .
  • the other end of the first discharging flow path 17 is shown herein schematically as being connected to a drain flow resistance simulation unit 18 and finally leading to a weight scale 19 which may be used for measuring actual amount of fluid displaced from the second chamber 5.
  • the drain flow resistance simulation unit 18 may be used for simulating a possible abnormity in the first discharging flow path 17.
  • An end of a second filling flow path 15 is fluidly connected with the second inlet valve 38, and an end of a second discharging flow path 10 is fluidly connected with the second outlet valve 33.
  • the other end of the second discharging flow path 10 is to be fluidly connected with a dialysate chamber of a dialyzer 28, and the other end of the second filling flow path 15 is to be fluidly connected with the dialysate chamber of the dialyzer 28 via a used-dialysate transmitting unit 14 (shown only schematically) , such as a gear pump, which connections are shown schematically by dashed lines in Fig. 1.
  • a fresh dialysate may be supplied from the fresh dialysate supply unit 8 into the first chamber 4 via the first filling flow path 9, the first inlet valve 37 and the first inlet 6 while the first outlet valve 34 is opened and both the second inlet valve 38 and the second outlet valve 33 are closed.
  • the fresh dialysate is filled into the first chamber 4 and a used dialysate is displaced from the second chamber 5 by a pressure applied on the displaceable partition wall 3 by the fresh dialysate. This means that the first inlet 6 and the first outlet 13 are fluidly communicated indirectly via the displaceable partition wall 3 in the first process.
  • the used dialysate may be filled from the dialyzer 28 into the second chamber 5 by means of the used-dialysate transmitting unit 14 while the second outlet valve 33 is opened and both the first inlet valve 37 and the first outlet valve 34 are closed.
  • the used dialysate is filled into the second chamber 5 and the fresh dialysate is displaced from the first chamber 4 by a pressure applied on the displaceable partition wall 3 by the used dialysate. This means that the second inlet 12 and the second outlet 7 are fluidly communicated indirectly via the displaceable partition wall 3 in the second process.
  • the other end of the second discharging flow path 10 is shown herein schematically as being connected to a dialysate flow resistance simulation unit 11 which may be used for simulating a possible abnormity in the second discharging flow path 10.
  • a flow pressure adjusting means 16 For controlling a pressure, i.e., a flow pressure, within the second chamber 5 to adjust a differential pressure across the displaceable partition wall 3, a flow pressure adjusting means 16, such as a valve, is disposed across the used-dialysate transmitting unit 14.
  • dialysate flow resistance simulation unit 11 may be connected with the used-dialysate transmitting unit 14, as shown in Fig. 1.
  • the used dialysate is actually the fresh dialysate, which is possible for testing.
  • other kinds of fluids also may be used for testing.
  • a filling time of the first chamber 4 may reflect flow characteristic of the balancing chamber system 1.
  • the filling time may be dependent on a total volume of the first chamber 4 and the second chamber 5, the differential pressure across the displaceable partition wall 3, dialysate flow resistance of the first discharging flow path 17, drain flow resistance of the second discharging flow path 10, filling flow resistance of the first filling flow path 9 and other factors.
  • these factors are either constant or can be determined, for example, the total volume of the first chamber 4 and the second chamber 5 is known and constant.
  • the reference filling time also may change with the differential pressure across the displaceable partition wall 3, and thus it is necessary to determine the differential pressure.
  • the differential pressure measuring device comprises a first pressure measuring means 20 for measuring a pressure, i.e. a loading pressure of the fresh dialysate filling into the first chamber 4 and a second pressure measuring means 24 for measuring a pressure, i.e., a flow pressure of the used dialysate within the second chamber 5.
  • the first pressure measuring means 20 may be incorporated into the fresh dialysate supply unit 8. More specifically, the fresh dialysate supply unit 8 also may set the loading pressure. As an alternative embodiment, the first pressure measuring means 20 also may be disposed at the first filling flow path 9.
  • the second pressure measuring means 24 may be disposed at the second filling flow path 15.
  • the flow pressure may be set by the flow pressure adjusting means 16.
  • the differential pressure across the displaceable partition wall 3 can be determined by the loading pressure which is measured by the first pressure measuring means 20 and minus the counter pressure which is measured by a third pressure measuring means 21 disposed in the first discharging flow path 17.
  • the differential pressure across the displaceable partition wall 3 also can be determined by the flow pressure which is generated by the flow pressure adjusting means 16 against the dialysate flow resistance simulation unit 11, then individually measured by means of the second pressure measuring means 24 disposed in second filling flow path 15 and a fourth pressure measuring means 25 disposed in the second discharging flow path 10.
  • a filling time measuring device which comprises an inflow monitoring means configured to measure the filling time of the first chamber 4 and a memory module configured to receive the filling time.
  • the filling time as a parameter can be provided to a corresponding means needing the parameter.
  • the filling time measuring device further comprises a conductivity measuring means which is disposed at the first filling flow path 9.
  • the conductivity measuring means comprises a pair of electrodes 22 across a first electrically insulated check valve 23 which is disposed at the first filling flow path 9 so as to only allow the fresh dialysate to flow into the first chamber 4.
  • the conductivity measuring means when the fresh dialysate is flowing into the first chamber 4, the conductivity between the pair of electrodes 22 is high and when the balancing chamber 2 is full and no more fresh dialysate would flow into the first chamber 4, the check valve 23 will be closed and the conductivity between the pair of electrodes 22 will drop. That is to say, the filling time of the first chamber 4 can be obtained by measuring the conductivity between the pair of electrodes 22.
  • the filling time of the first chamber 4 also may be obtained by monitoring filling process of the first chamber 4.
  • another filling time measuring device comprises a monitoring means configured to monitor the filling process of the first chamber 4 and generate a monitoring data, a processing module configured to receive the monitoring data from the monitoring means to calculate the filling time of the filling process, and a memory module configured to receive the filling time.
  • Fig. 2 shows a relationship between the filling time and the loading pressure according to an exemplary embodiment of the present invention.
  • the filling time changes with the loading pressure, more precisely with the differential pressure across the displaceable partition wall 3.
  • the filling time decreases with increasing of the differential pressure across the displaceable partition wall 3.
  • a filling time turning point 26 is reached, further increasing of the differential pressure across the displaceable partition wall 3 has less effect on the filling time.
  • the abnormity in the second discharging flow path 10 can be simulated by the dialysate flow resistance simulation unit 11 and the abnormity in the first discharging flow path 17 can be simulated by the drain flow resistance simulation unit 18. It is found that when the flow resistance of the second discharging flow path 10 and/or the flow resistance of the first discharging flow path 17 changes at the predetermined differential pressure across the displaceable partition wall 3, the filling time also changes.
  • an abnormity is detected if a deviation of the filling time from a predetermined value at the predetermined differential pressure is out of a predetermined range.
  • the 100%normalized filling time is the predetermined value or range obtained in the calibration or POST under a normal balancing chamber loading pressure and a normal flow rate.
  • Scenario 1 an abnormity in a fresh dialysate flow path (illustrated in the left side of the normalized filling time in Fig. 3) .
  • the used dialysate in the second chamber 5 can not be drained completely within a predetermined BC cycle time. In this case, there is some of the used dialysate left in the second chamber 5. Therefore, a less fill volume is left in a subsequent filling of the first chamber 4. As a result, the filling time will be shortened. A decreasing amount of the filling time may be associated with a decreasing amount of the fresh dialysate filling into the balancing chamber 2.
  • Scenario 2 an abnormity in a used-dialysate flow path (illustrated in the right side of the normalized filling time in Fig. 3) .
  • the abnormity in the used-dialysate flow path has direct effect on the differential pressure across the displaceable partition wall 3.
  • the filling time will be extended when the drain flow resistance increases. If the drain flow resistance is too high, filling of the first chamber 4 will be cut off.
  • Fig. 3 only shows possible abnormities detected based on the filling time of the first chamber when the fresh dialysate is filled into the first chamber to displace the used dialysate from the second chamber.
  • some possible abnormities also can be detected based on the filling time of the second chamber when the used dialysate is filled into the second chamber to displace the fresh dialysate from the first chamber.
  • the filing time of the first chamber corresponds to outflow-time of the second chamber and vice versa. Therefore, the abnormity also can be detected based on the outflow-time, which also falls into the scope of the present invention.
  • the measuring means is disposed on a fresh flow path of the balancing chamber system, or disposed on a used flow path of the balancing chamber system.
  • an evaluating means 27 which at least can compare the filling time with the predetermined value or range. As shown in Fig. 1, the evaluating means 27 is illustrated only very schematically for reasons of simplification.
  • a function of the evaluating means 27 also may be achieved by the controller of the balancing chamber system.
  • an indicating module (not shown) which can generate an abnormal signal if the abnormity is detected, which for example indicates insufficient discharge of a chamber.
  • the abnormal signal is generated until the abnormity is detected for predetermined number of times according to a predetermined criterion.
  • the loading pressure and the flow pressure are adjusted according to defined factory calibration procedures.
  • the filling time can normally be used as a parameter to monitor the actual flow rate of the fresh dialysate filling into the balancing chamber in a dialysis treatment. That is to say, the abnormity can then be detected based on the filling time of a chamber.
  • the device for detecting an abnormity in a balancing chamber system may be integrated into the hemodialysis machine.
  • the present invention further provides a balancing chamber module comprising the filling time measuring device or the device for detecting the abnormity in the balancing chamber system and a dialysis system comprising the balancing chamber module.
  • the abnormity can be detected and identified reliably and simply.

Abstract

Cette invention concerne un dispositif pour détecter une anomalie dans un système à chambre d'équilibrage (1), où le dispositif comprend un moyen de surveillance du flux entrant conçu pour mesurer un premier temps de remplissage d'une première chambre (4) d'une chambre d'équilibrage (2) ou un second temps de remplissage d'une seconde chambre (5) de la chambre d'équilibrage (2), et un moyen d'évaluation (27) conçu pour comparer le premier temps de remplissage à une première valeur ou plage prédéfinie ou pour comparer le second temps de remplissage à une seconde valeur ou plage prédéfinie pour détecter l'anomalie dans le système à chambre d'équilibrage (1). Un dispositif pour mesurer le temps de remplissage d'un système à chambre d'équilibrage (1), un module de chambre d'équilibrage, un système de dialyse et un procédé pour détecter une anomalie dans un système à chambre d'équilibrage (1) sont en outre décrits. L'anomalie peut être détectée et identifiée de manière fiable et simple.
PCT/CN2017/117987 2017-12-22 2017-12-22 Dispositif pour mesurer le temps de remplissage d'un système à chambre d'équilibrage, dispositif de détection d'anomalie dans un système à chambre d'équilibrage, module de chambre d'équilibrage, système de dialyse et procédé correspondant WO2019119412A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2020534366A JP7379336B2 (ja) 2017-12-22 2017-12-22 バランシングチャンバシステムの充填時間を測定するためのデバイス、バランシングチャンバシステムにおける異常を検出するためのデバイス、バランシングチャンバモジュール、透析システム、および対応する方法
PCT/CN2017/117987 WO2019119412A1 (fr) 2017-12-22 2017-12-22 Dispositif pour mesurer le temps de remplissage d'un système à chambre d'équilibrage, dispositif de détection d'anomalie dans un système à chambre d'équilibrage, module de chambre d'équilibrage, système de dialyse et procédé correspondant
CN201780097936.2A CN112867517A (zh) 2017-12-22 2017-12-22 用于测量平衡腔系统的填充时间的装置、用于检测平衡腔系统中的异常的装置、平衡腔模块、透析系统及相应的方法

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PCT/CN2017/117987 WO2019119412A1 (fr) 2017-12-22 2017-12-22 Dispositif pour mesurer le temps de remplissage d'un système à chambre d'équilibrage, dispositif de détection d'anomalie dans un système à chambre d'équilibrage, module de chambre d'équilibrage, système de dialyse et procédé correspondant

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5522998A (en) * 1993-03-18 1996-06-04 Fresenius Ag Hemodialysis apparatus having a single balance chamber and method of dialyzing blood therewith
US20040040620A1 (en) * 2002-08-28 2004-03-04 Helge Brauer Device for carrying fluids for a medical treatment device
CN1604798A (zh) * 2001-12-18 2005-04-06 株式会社Jms 自动血液透析装置及使用该装置的起动方法
CN101232910A (zh) * 2005-07-01 2008-07-30 甘布罗伦迪亚股份公司 一种测试过滤器的装置和方法
CN101687069A (zh) * 2007-06-29 2010-03-31 株式会社Jms 血液透析装置
CN103889479A (zh) * 2011-08-30 2014-06-25 甘布罗伦迪亚股份公司 用于体外流体处理的医疗设备和计算用于输送或收集流体的医疗设备中的设定流速的处理

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19728800C1 (de) * 1997-07-05 1999-02-18 Fresenius Medical Care De Gmbh Vorrichtung zum Fördern von Flüssigkeiten für eine medizinische Behandlungsvorrichtung und Verfahren zur Überwachung der vollständigen Füllung bzw. Entleerung einer von einer beweglichen Trennwand in zwei Teilkammern unterteilten Kammer

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5522998A (en) * 1993-03-18 1996-06-04 Fresenius Ag Hemodialysis apparatus having a single balance chamber and method of dialyzing blood therewith
CN1604798A (zh) * 2001-12-18 2005-04-06 株式会社Jms 自动血液透析装置及使用该装置的起动方法
US20040040620A1 (en) * 2002-08-28 2004-03-04 Helge Brauer Device for carrying fluids for a medical treatment device
CN101232910A (zh) * 2005-07-01 2008-07-30 甘布罗伦迪亚股份公司 一种测试过滤器的装置和方法
CN101687069A (zh) * 2007-06-29 2010-03-31 株式会社Jms 血液透析装置
CN103889479A (zh) * 2011-08-30 2014-06-25 甘布罗伦迪亚股份公司 用于体外流体处理的医疗设备和计算用于输送或收集流体的医疗设备中的设定流速的处理

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JP7379336B2 (ja) 2023-11-14
CN112867517A (zh) 2021-05-28

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