WO2004096321A1 - Procede de nettoyage d'un circuit du flux sanguin dans un dialyseur - Google Patents

Procede de nettoyage d'un circuit du flux sanguin dans un dialyseur Download PDF

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Publication number
WO2004096321A1
WO2004096321A1 PCT/JP2004/005903 JP2004005903W WO2004096321A1 WO 2004096321 A1 WO2004096321 A1 WO 2004096321A1 JP 2004005903 W JP2004005903 W JP 2004005903W WO 2004096321 A1 WO2004096321 A1 WO 2004096321A1
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WO
WIPO (PCT)
Prior art keywords
blood
dialyzer
blood flow
liquid
header
Prior art date
Application number
PCT/JP2004/005903
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English (en)
Japanese (ja)
Inventor
Makoto Nakagawa
Tsuneo Deguchi
Keiko Omura
Original Assignee
Teijin Pharma Limited
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 Teijin Pharma Limited filed Critical Teijin Pharma Limited
Publication of WO2004096321A1 publication Critical patent/WO2004096321A1/fr

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Classifications

    • 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
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3643—Priming, rinsing before or after use
    • 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
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3643—Priming, rinsing before or after use
    • A61M1/3644—Mode of operation
    • 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
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3643—Priming, rinsing before or after use
    • A61M1/3644—Mode of operation
    • A61M1/3646—Expelling the residual body fluid after use, e.g. back to the body

Definitions

  • the present invention relates to a mechanism that enables repeated use of a blood circuit and a dialyzer.
  • the present invention relates to a method for cleaning a dialysis machine having a function. For details, immediately after dialysis,
  • the present invention also relates to a method for washing a dialyzer by discharging blood components remaining in a blood flow path from an extracorporeal circuit by dialysate transported by reverse filtration.
  • dialyzer regenerator In the United States, it is common to repeatedly use dialyzers by washing and sterilizing them with a dedicated dialyzer regenerator. However, blood circuits are rarely used repeatedly after being washed and sterilized. US Axis Limited has developed a dialysis machine that can be used repeatedly with the dialyzer and blood circuit cleaned and sterilized while the dialyzer and blood circuit are attached to the dialyzer. In this device, dialysate or clean water that has passed through a dialysate filter that removes endotoxin is reverse-filtered and transported to the blood channel in the filter, and the blood channel is used as a closed circuit. The blood flow path is washed by repeating circulation and drainage (Special Table 2 0 0 2-5 0 3 1 1 5 gazette).
  • the blood component remaining in the blood channel is blood It may clog or clot during internal circulation in the circuit and clog the blood flow path. If clots or clots of blood components are clogged in the dialyzer membrane or blood circuit of the dialyzer, the performance of dialysis treatment may be reduced, which hinders continuous use of the extracorporeal circuit. In addition, agglomerates or clots of blood components can become clogged with parts such as solenoid valves and reverse valves in the device, causing malfunction of the device. Therefore, it was a problem to clean the blood flow path so as not to cause aggregation and coagulation of blood components.
  • physiological saline is flowed from the upstream side of the blood flow path to return blood to the patient.
  • the judgment of the end of the blood return is based on the time when the blood is sufficiently returned to the patient or the predetermined amount of physiological saline is flowed while visually confirming the blood flow path. According to this standard, blood components hardly remain in the blood flow path.
  • the dialysate is reverse filtered and transported in the dialyzer and moved to the blood flow path, and the blood pump rotates in the reverse direction, and the blood flow side of the blood flow path
  • the blood is returned to the patient by sending dialysate to both the vein and the vein.
  • the determination of the return of blood is done by measuring the blood component concentration in the blood flow path close to the connection site with the patient by optical measurement etc. It is based on the point when the value falls below a certain value.
  • blood circuits and The dialyzer is generally discarded after every dialysis. Therefore, even if some blood components remain in the blood flow path at the end of blood return, the dialysis machine will not be adversely affected.
  • blood and dialysate may be mixed in the process of reverse filtration in the dialyzer, and blood components may remain in the blood flow channel after completion of blood return. is there.
  • the remaining blood components may depend on the patient's condition or the amount of blood returned.
  • the remaining blood components in the blood flow path cause aggregation and coagulation of the components in the blood flow path.
  • An object of the present invention is to solve the above-mentioned problems and to provide a method for cleaning a dialysis apparatus for safely and repeatedly using a blood circuit and a dialyzer for a long period of time. Disclosure of the invention
  • the present invention is a method for washing a blood flow path of a dialysis apparatus having a function of repeatedly using a blood flow path, and includes a step of discharging blood components from the blood flow path to the outside of the dialysis apparatus immediately after dialysis is completed.
  • the present invention provides a cleaning method characterized by comprising: Brief Description of Drawings
  • FIG. 1 is an example of a schematic configuration diagram of a dialysis apparatus that performs the cleaning method of the present invention.
  • FIG. 2 is a flowchart of the steps after the end of dialysis including the cleaning method of the present invention.
  • FIG. 3 is a photograph observing the cleaning effect of the cleaning method of the present invention over time in Example 2.
  • FIG. 4 is a photograph observing the cleaning effect of the cleaning method of Example 3 over time.
  • the washing method of the present invention can be used in the following dialysis machine. That is,
  • a dialysis machine equipped with an air pump that can pressurize the bubble removal container installed in the blood flow path.
  • the blood flow path refers to a blood circuit and a portion of the dialyzer through which blood flows.
  • the present invention comprises the following first aspect, second aspect, and third aspect.
  • the first aspect of the present invention is characterized by having a step of discharging blood components from the blood flow path to the outside of the dialyzer immediately after completion of dialysis (hereinafter sometimes referred to as “preliminary washing step”). It is a cleaning method.
  • a second aspect of the present invention is a blood flow path cleaning method for a dialysis apparatus having a function of repeatedly using a blood flow path, and includes the following step 1. Also, in the second embodiment, the following steps 2 and 3 can be further included.
  • step consisting of step 1 or the step consisting of steps 1 to 3 may be referred to as a “main cleaning step”.
  • Step 1 above is a step of flowing fluid in both the arterial and venous side headers of the dialyzer at the same time, and Step 2 above is greater in the arterial header direction and in the venous side header direction.
  • the above-described step 3 is a step of flowing more liquid in the vein-side header direction than in the artery-side header direction.
  • a third aspect of the present invention is a blood flow path cleaning method of a dialysis apparatus having a function of repeatedly using a blood flow path, the step of discharging blood components from the blood flow path immediately after the completion of dialysis, And a cleaning method comprising the main cleaning step.
  • blood components remaining in the blood channel are directed from one side of the blood channel to the other by introducing a liquid through the dialyzer, or without going through the dialyzer.
  • introducing the liquid in one direction it is discharged from the blood flow path to the outside of the dialyzer via the patient connector connection port and then the drainage pipe in the device.
  • the liquid is not circulated in the blood channel. In this way, it is possible to minimize aggregation and Z or coagulation of blood components by not circulating the liquid in the blood flow path. As a result, the dialyzer and blood circuit can be effectively washed to withstand repeated use.
  • immediate after completion of dialysis in the first aspect of the present invention means as soon as possible after completion of blood return to the patient (that is, after completion of dialysis).
  • the operator disconnects the blood circuit patient connector from the patient and then connects it to the patient connector port of the device before the fluid in the blood flow path is internally circulated in the blood flow path. It means that there is.
  • the liquid is introduced in one direction from one side of the blood flow path to the other by introducing the liquid through the dialyzer, or without going through the dialyzer. Therefore, when discharging the blood component remaining in the blood channel from the extracorporeal circuit to the outside of the dialyzer, the blood component is connected via the drainage channel of the dialyzer while the blood channel is connected to the dialyzer. Can be discharged out of the dialyzer from the extracorporeal circuit.
  • the liquid is introduced in one direction from one side of the blood flow path to the other by introducing the liquid body through the dialyzer, or without going through the dialyzer.
  • the blood components remaining in the blood flow path are discharged from the extracorporeal circuit to the outside of the dialyzer, all the liquid in the bubble removing container installed in the blood flow path is pressurized by applying pressure to the dialyzer. Can be discharged outside.
  • it is discharged out of the dialyzer by pressurizing and introducing a liquid. It becomes possible.
  • the pressure at the time of the pressurization can be appropriately set.
  • a preferable range is 300 mmHg to 650 mmHg.
  • step of discharging all the liquid in the bubble removing container by pressurization can also be employed in the main cleaning step in the second aspect described later.
  • Steps 1 to 3 in the main cleaning step of the second aspect of the present invention are as follows.
  • the above step 1 is a step of flowing a liquid simultaneously in both directions of the arterial side and the venous side of the dialyzer by rotating the blood pump opposite to that during dialysis.
  • the flow rate of the fluid flowing in the direction of the artery toward the header (A 1) and the flow rate of the fluid flowing in the direction of the vein toward the vein (B 1) can be the same, or either one can be greater than the other.
  • Step 2 is a step of flowing more fluid in the arterial-side header direction than in the venous-side header direction.
  • a 2 is characterized by a larger flow rate (B2) of liquid flowing in the direction of the venous header.
  • B2 flow rate of liquid flowing in the direction of the venous header.
  • the relationship between the flow rates A 2 and B 2 of the liquid flowing in each direction may be any as long as A 2> B 2.
  • step (A2) can be made larger than the flow rate (A1) of the liquid flowing in the direction of the artery side header in step 1 above.
  • the cleaning effect in the direction of the arterial header is higher in step 2 than in step 1 above.
  • Step 3 is a step of flowing more fluid in the vein-side header direction than in the artery-side header direction. In this process, the flow rate of the liquid (B
  • A3 is characterized by a larger fluid flow (A3) in the direction of the arterial header.
  • the relationship between the flow rates A 3 and B 3 of the liquid flowing in each direction is not limited as long as it is A 3 and B 3.
  • the flow rate (B 3) of the liquid flowing in the venous header direction in the above step 3 is the flow rate (B 1) of the liquid flowing in the venous header direction in the above step 1.
  • the venous header cleaning effect is higher in step 3 than in step 1 above.
  • the liquid can be introduced into the blood flow channel 21 and / or the blood flow channel 22 after being introduced into the hollow fiber of the dialyzer by reverse filtration.
  • the liquid can be directly introduced into the hollow fiber of the dialyzer and passed through the hollow fiber, and then introduced into the blood channel 21 and / or the blood channel 22.
  • “introducing into the hollow fiber of the dialyzer by reverse filtration” means that the liquid is transported from the dialysate flow path 1 8 of the dialyzer to the blood flow path 17 of the dialyzer through the dialysis membrane 1.
  • directly introduced into the hollow fiber of the dialyzer and passing through the hollow fiber means that the fluid is transported from the arterial blood channel 21 to the blood channel 17 of the dialyzer, and 2 Means transport to 2.
  • any of the introduction methods can be adopted in the above steps 1 to 3, but in any one or more of the above steps 1 to 3, the former introduction method is adopted, and the other above-mentioned methods are adopted. In any one or more of steps 1 to 3, the latter introduction method can be employed.
  • the order of steps 1, 2, and 3 can be set as appropriate, but the order of step 1, step 2, step 3, or step 1, step 3.
  • the order of step 2 can be given as a preferred order.
  • the execution time of each process can be set as appropriate.
  • the flow rate of the liquid can be appropriately selected from a conventionally known flow rate, and a preferable flow rate is 50 to 500 ml Zmin. .
  • a third aspect of the present invention will be described.
  • a blood flow path washing method for a dialysis apparatus having a function of repeatedly using a blood flow path comprising the preliminary washing step and the main washing step. This is a characteristic cleaning method.
  • the third aspect is a cleaning method having both the preliminary cleaning process in the first aspect and the main cleaning process in the second aspect.
  • the main washing step following the preliminary washing step but following the preliminary washing step, other steps for blood channel washing. It is also possible to adopt the main cleaning step after that. Further, following the main cleaning step, another step for cleaning the blood channel may be employed.
  • the liquid used may be a liquid selected from the group consisting of water, dialysate, purified water, reverse filtration dialysate, and a liquid containing a cleaning agent.
  • the dialysate is a liquid used for dialysis, and refers to both the liquid before use for dialysis and the liquid after use for dialysis.
  • the purified water refers to water from which impurities have been removed by some method, for example, filtration.
  • clean water examples include water filtered through a reverse osmosis membrane (hereinafter sometimes referred to as “RO water”).
  • RO water reverse osmosis membrane
  • the reverse filtration dialysate is obtained by filtering the dialysate before or after use in dialysis to the blood circuit side of the dialyzer using a permeable membrane.
  • the liquid containing the above-mentioned detergent refers to a detergent used for washing the dialysate circuit, blood circuit, and dialyzer.
  • a detergent used for washing the dialysate circuit, blood circuit, and dialyzer.
  • peracetic acid such as Dia 1 o XC-J (manufactured by Japan Air Liquide) -Based cleaning fluids
  • hypochlorite-based products such as AMTEC (manufactured by AMTECH) Examples include cleaning liquid and electrolyzed water.
  • FIG. 1 shows a dialysis apparatus for carrying out the cleaning method of the present invention. The flow of dialysate or RO water in each step of the washing method will be described in order.
  • the arterial patient connector 1 2 and the venous patient connector 1 3 of the blood circuit are disconnected from the puncture needle connected to the patient, and the arterial patient connector 1 2 is the artery of the dialyzer.
  • the side patient connector connection port 14 and the vein side patient connector 13 are connected to the vein side patient connector connection port 15 of the dialysis machine, respectively.
  • Dialysate or RO water is transported to flow path 19 by dialysate transport pump 7a or RO water pump 3 3 and totally filtered by ultrafiltration membrane 3 of ultrafilter 4 and flow path 2 0 Be transported to. At this time, if the pulp 10 is opened and the pulp 1 1 is closed, the filtered dialysate or RO water is transported to the blood flow path 17 of the dialyzer through the dialyzer membrane 1 of the dialyzer 2.
  • the flow path 2 0 to the blood flow path 1 of the dialyzer The reversely filtered dialysate or RO water flowing to 7 is branched into the arterial blood channel 21 and channel 22 and transported.
  • the reversely filtered dialysate or RO water flows to the flow path 2 4 a via the arterial blood flow path 21 and to the flow path 2 4 b to the flow path 2 2 and the venous blood flow path 2 3.
  • the valves 2 6 and 3 4 are opened and the valve 30 is closed, the liquid transported to the flow paths 2 4 a and 2 4 b is discharged from the device via the drain flow path 3 5. The liquid is discharged.
  • the dialysate transport pump 7a or the RO water pump 33 set to a flow rate of 300 m / min and the blood pump 6 set to a flow rate of 100 ml / min.
  • the reverse filtration dialysate flows through the arterial blood flow channel 21 at a flow rate of 100 m 1 per minute and the venous blood flow channel 2 3 at a flow rate of 200 m 1 per minute.
  • the distribution of the feeding of the arterial blood channel 21, the channel 22, and the venous blood channel 23 can be adjusted. (Reverse filtration step, above.)
  • the arterial blood channel 21 the dialyzer blood channel 17, the channel 22, the bubble removal container 16, the venous blood Channel 2
  • the blood remaining in 3 can be washed away with dialysate or RO water. Pressurization process
  • the bubble removal container 16 is filled with the air pump 5 at the same time as the above washing, for example, 60 O mmH g
  • the blood component aggregates or coagulation clots generated during dialysis are combined with the liquid, all via the venous blood channel 2 3 and the channel 2 4 to the drainage channel '3 It is possible to transport to 5. (Pressurization step, above.)
  • dialysate or RO in the blood flow path with reduced residual blood shown in Fig. 1 are 2 4 a, 2 1, 1 7, 2 2, 1 6, 2 3, and 2 4 b
  • valve 26 is opened, valve 30 and pulp 34 are closed, the blood flow path can be closed circuit.
  • the blood pump 6 is operated in the forward or reverse rotation, and after circulating the liquid in the blood flow path for a certain period of time, the blood flow is discharged by, for example, draining via the patient connector connection port of the apparatus. A process of washing the road may be adopted. (Recycle process, above)
  • 8 is a dewatering pump
  • 9 is a gas-liquid separation membrane
  • 18 is a dialysate flow path of the dialyzer
  • 25 is an air flow path
  • 27 is a pressure gauge.
  • FIG. 2 is a flowchart of the steps after the end of dialysis including the cleaning method of the present invention.
  • the flowchart shows an example of the flow of each step of the cleaning method of the present invention from the end of dialysis.
  • the cleaning effect of the cleaning method of the present invention is evaluated by observing the blood channel over time. I was worth it.
  • the washing conditions are shown below.
  • the recirculation step, the reverse filtration step, the water flow step, and the pressurization step in the washing conditions indicate the steps described in Example 1.
  • Preliminary washing process After returning blood, the reverse filtration dialysate was branched into a venous header and an arterial header and washed and drained. The flow rate of the reverse filtration dialysate during washing was 2500 m 1 Zm in, and the washing time was about 7 minutes.
  • the cleaning effect of the conventional cleaning method was evaluated by observing the blood channel over time.
  • the recirculation process, reverse filtration process, water flow process, and pressurization process in the washing conditions indicate the processes described in Example 1.
  • Pre-cleaning step not performed.
  • Example 2 Before washing after returning blood, each part was red, and blood remained as in Example 2.
  • the cleaning effect of the following cleaning method was evaluated by observing the blood channel over time.
  • the recirculation process, reverse filtration process, water flow process, and pressurization process in the washing conditions indicate the processes described in Example 1.
  • Preliminary washing process After returning blood, the reverse filtration dialysate was branched into a venous header and an arterial header and washed and drained.
  • the flow rate of the reverse filtration dialysate at the time of washing was 1 67 to 2500 m 1 Zm in, and the washing time was about 2 minutes.
  • Example 2 Before washing after returning blood, each part was red, and blood remained as in Example 2.
  • the duration of continuous use of a dialysis machine used for repeated continuous use was prolonged, and the frequency of apparatus abnormality in the analyzer was reduced.
  • the present invention it is possible to perform the dialysis without contacting the dialysate containing blood components, and it is possible to provide a safe dialysis apparatus and dialysis method without risk of infection.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un procédé de nettoyage d'un circuit du flux sanguin dans un dialyseur dont une fonction permet l'utilisation répétée et continue du circuit du flux sanguin. Le procédé se caractérise en ce qu'il consiste à décharger les composants du sang du circuit du flux sanguin à l'extérieur du dialyseur, immédiatement après la séance de dialyse.
PCT/JP2004/005903 2003-04-28 2004-04-23 Procede de nettoyage d'un circuit du flux sanguin dans un dialyseur WO2004096321A1 (fr)

Applications Claiming Priority (2)

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JP2003123371 2003-04-28
JP2003-123371 2003-04-28

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WO2004096321A1 true WO2004096321A1 (fr) 2004-11-11

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012173161A1 (fr) * 2011-06-15 2012-12-20 ニプロ株式会社 Dispositif de purification de sang et procédé pour amorcer automatiquement un dispositif de purification de sang

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0880346A (ja) * 1994-09-13 1996-03-26 Toray Medical Kk 血液透析方法および装置
JPH1099430A (ja) * 1996-09-26 1998-04-21 Noriaki Tanaka ダイアライザーの再生方法及び再生装置
JP2001017541A (ja) * 1999-07-06 2001-01-23 Saitekku Kk 透析器の再生方法と透析装置

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0880346A (ja) * 1994-09-13 1996-03-26 Toray Medical Kk 血液透析方法および装置
JPH1099430A (ja) * 1996-09-26 1998-04-21 Noriaki Tanaka ダイアライザーの再生方法及び再生装置
JP2001017541A (ja) * 1999-07-06 2001-01-23 Saitekku Kk 透析器の再生方法と透析装置

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012173161A1 (fr) * 2011-06-15 2012-12-20 ニプロ株式会社 Dispositif de purification de sang et procédé pour amorcer automatiquement un dispositif de purification de sang
JPWO2012173161A1 (ja) * 2011-06-15 2015-02-23 ニプロ株式会社 血液浄化装置および血液浄化装置の自動プライミング方法

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