JP4259167B2 - Continuous blood purification device - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a continuous blood purification device that assists or substitutes for organ functions of a living body by purifying blood taken out of a body from a blood vessel and supplying useful substances thereto.
[0002]
[Prior art]
Conventionally, hemodialysis and blood filtration have been performed in order to improve a serious condition such as a patient with renal failure or a patient with hyperhydration due to postoperative drug injection. Whether to use dialysis or filtration for the treatment of patients is determined and selected as appropriate by the clinician in consideration of the condition of each patient, and an alternative method of dialysis or filtration is adopted. However, in recent years, it has been recognized that so-called continuous blood purification therapy (CHDF), which combines dialysis and filtration, can minimize adverse effects on patients and is rapidly becoming popular. CHDF is a method that gradually returns the patient to normal over a long period of time because the balance of fluids of the patient changes suddenly and adversely affects the patient's condition if treatment with dialysis and filtration is performed in a short time. The dialysate is used at a flow rate as low as about one-tenth that of normal hemodialysis therapy.
[0003]
CHDF does not require special facilities such as hemodialysis and can be performed quickly at night or in an emergency, and it can be performed without trouble in the installation place even in a place surrounded by many devices such as operating rooms and ICU. Because it is possible, it can be said that blood purification therapy is available at any time and place. On the other hand, when managing critically ill patients, it is possible to quickly deal with troubles due to errors in dialysate flow rate and replacement fluid flow rate, and replacement of blood filters. Since doctors have to be on the bedside 24 hours a day so that they can respond, many facilities refrain from CHDF due to a lack of medical staff.
However, recently, a CHDF dedicated bedside console has been developed, and the accuracy of various monitors and flow rate adjustment mechanisms has been improved, so it is possible to prevent problems during the implementation of CHDF, and to improve the safety for patients and the burden on medical staff. There is a dramatic improvement in terms of mitigation.
[0004]
In such a continuous blood purification apparatus used for CHDF, a weight sensor is used as a means for measuring the amount of dialysate and the amount of replacement fluid entering and exiting the blood circulation path (consisting of a blood circuit and a blood purifier). There is a weight measurement method that uses a weighing container and a capacity measurement method that uses a weighing container.
However, although the accuracy of the flow rate adjustment mechanism has improved, in the gravimetric method, since the liquid weight is measured by separate weighing scales, there is an error between the dialysate flow rate and the replacement fluid flow rate due to variations in the weighing scales. Has drawbacks.
In addition, the capacity measurement method requires a measuring container for each liquid, and performs measurement while calibrating each roller pump (for example, Patent Document 1). Therefore, calibration is performed to eliminate variations between pumps. It is necessary to frequently perform calibration, and it is necessary to open and close the valve during calibration.
[0005]
[Patent Document 1]
JP-A-8-191889 (paragraph number 0014, lines 23-28, paragraph number 0016, lines 23-28)
[0006]
[Problems to be solved by the invention]
The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a continuous blood purification apparatus in which an error between a dialysate flow rate and a replacement fluid flow rate is extremely small, and the number of pump calibrations is greatly improved. To do. It is another object of the present invention to provide a continuous blood purification device that can efficiently and appropriately warm fresh dialysate and replacement fluid before use.
[0007]
[Means for Solving the Problems]
In order to solve the above-mentioned problems, the present inventors, as a result of intensive studies, adopt a flexible container containing a dialysate storage container and a replacement fluid storage container in a weight measurement method with a small number of calibrations. By weighing the flexible container with a weigh scale, it is possible to measure the amount of dialysate and replacement fluid supplied, so that variations between weigh scales can be eliminated, and if the used dialysate is heated appropriately The inventors have conceived that the dialysate and the replacement fluid can be heated by the used dialysate contained in a flexible container, and the present invention has been completed. That is, the present invention includes a blood purifier and a blood circuit, a dialysate circuit, a dialysate container, a replacement fluid container, and a water removal line, and the blood purifier can purify blood continuously. The dialysate circuit downstream of the filter is provided with a filtration pump and a sealed flexible container in this order. The flexible container is connected to a flexible dialyzer that communicates with the dialysate container via a dialysate supply line. A fluid storage container and a flexible fluid replacement container that communicates with the fluid replacement container via the fluid replacement supply line are accommodated, and the dialysate liquid pump provided in the dialysate supply line causes the dialysate fluid storage container to pass the dialysate fluid storage container. The dialysate is supplied from the dialysate storage container to the blood purifier, and the replacement fluid reservoir provided in the replacement fluid supply line is used to store the replacement fluid from the replacement fluid container. The replacement fluid is supplied to the container, and the replacement fluid is supplied from the replacement fluid storage container to the blood circuit downstream of the blood purifier, and the weight of the container is measured in the flexible container. A weigh scale is provided, and a weigh scale is provided for measuring the amount of used dialysate discharged from the flexible container in the dewatering line, and the measured weight of the flexible container and discharge of the used dialysate The present invention relates to a continuous blood purification apparatus in which the amount of dialysate supplied to the dialysate storage container, the amount of replacement fluid supplied to the replacement fluid storage container, and the amount of water removal are calculated based on the amount.
[0008]
Here, the dewatering line is preferably provided with an opening / closing valve between the filtration pump and the flexible container, and between the opening / closing valve and the flexible container. In addition, a heater is provided between the filtration pump and the on-off valve so that the used dialysate flowing into the flexible container can be heated, and the heated used dialysate contained in the flexible container is used. The dialysate and the replacement fluid may be heated.
In the blood purification apparatus of the present invention, the spent dialysate stored in a flexible container is drained by the dialysate or the replacement fluid supplied to the dialysate storage container or the replacement fluid storage container, respectively. If the used dialysate flowing into the container is heated, the dialysate storage container contained in the flexible container and the replacement fluid stored in the flexible container are heated and exchanged with the heated used dialysate. It can be heated.
In the present invention, the term “used dialysate” refers to a liquid that flows into a flexible container from a downstream dialysate circuit, and includes a filtrate and a cleaning liquid.
[0009]
DETAILED DESCRIPTION OF THE INVENTION
Next, embodiments of the present invention will be described with reference to the drawings.
FIG. 1 is a schematic explanatory view of a continuous blood purification apparatus of the present invention, and FIGS. 2 to 4 are flow charts of continuous hemodialysis and continuous blood filtration performed using the continuous blood purification apparatus of the present invention, respectively. It is a flow figure and a flow figure of continuous hemofiltration dialysis.
As shown in FIG. 1, the continuous blood purification apparatus of the present invention includes a blood purification device 1, blood circuits 21 and 22, dialysate circuits 35 and 36, a dialysate container 3, and a replacement fluid container 4. The dialysate circuit 36 downstream of the vessel 1 is provided with a filtration pump 37 and a sealed flexible container 5 in this order. The flexible container 5 includes a flexible dialysate storage container 34 that communicates with the dialysate container 3 via the dialysate supply line 31, and a flexible replacement fluid storage container that communicates with the replacement fluid container 4 via the replacement fluid supply line 41. 44 is accommodated, and dialysate is supplied to the dialysate reservoir 34 and the blood purifier 1 by the dialysate pump 32, and the blood circuit 22 downstream of the replacement fluid reservoir 44 and the blood purifier 1 by the replacement fluid pump 42. A replacement fluid is supplied to the tube. The flexible container 5 is provided with a weighing scale 51 so that the weight of the flexible container 5 is measured.
[0010]
In FIG. 1, the blood circulation path includes a blood passage of the blood purifier 1, an upstream blood circuit 21 and a downstream blood circuit 22, and the upstream and downstream blood circuits 21, 22 have blood pumps 23, respectively. And the on-off valve V1 is provided.
On the other hand, the dialysate flow path includes a dialysate supply line 31 that connects the dialysate container 3 and the dialysate reservoir 34, a dialysate circuit 35 on the upstream side, a dialysate passage of the blood purifier 1, and a dialysate on the downstream side. The downstream dialysate circuit 36 is provided with a filtration pump 37 and a sealed flexible container 5 in this order. The flexible container 5 accommodates a dialysate storage container 34 and a replacement fluid storage container 44. The dialysate supply line 31 is provided with an on-off valve V 2, a dialysate pump 32, and a pressure sensor 33 in order from the upstream side, and the upstream dialysate circuit 35 has a dialysis between the on-off valve V 2 and the dialysate pump 32. The liquid supply line 31 is connected. The upstream dialysate circuit 35 is provided with an on-off valve V3. The downstream dialysate circuit 36 may be provided with an on-off valve V4.
The replacement fluid flow path includes a replacement fluid supply line 41 that connects the replacement fluid container 4 and the replacement fluid storage container 44 and a replacement fluid line 45 that connects the replacement fluid storage container 44 and the blood circuit 22 on the downstream side. An on-off valve V5, a replacement fluid pump 42, and a pressure sensor 43 are provided in order from the upstream side, and an on-off valve V6 is provided in the replacement fluid line 45.
In the downstream dialysate circuit 36, a heater 38 is preferably provided between the filtration pump 37 and the on-off valve V4, and a water removal line 6 is connected between the on-off valve V4 and the flexible container 5. (However, the water removal line 6 may be provided between the heater 38 and the on-off valve V7). The water removal line 6 is provided with an on-off valve V7 and a weigh scale 61 for measuring the water removal amount. The water removal line 6 may be provided with a thermometer 62 for measuring the temperature of the used dialysate discharged from the flexible container 5.
The pressure sensors 33 and 43 measure the internal pressures of the dialysate storage container 34 and the replacement fluid storage container 44, respectively. When a sudden increase in internal pressure is detected, the pumps 32 and 42 are stopped, and the on-off valves V2 and V5 are closed. When a sudden decrease in internal pressure is detected, the pumps 32 and 42 are stopped to prevent idling. In addition, as the on-off valves V1 to V7, an electric type is usually used.
[0011]
The flexible container 5 is a so-called bag-shaped container formed of a flexible plastic sheet such as polyethylene or polypropylene, and a flexible dialysate formed of the same material as the flexible container 5 is contained therein. A storage container 34 and a flexible replacement fluid storage container 44 are accommodated. Therefore, in a state where the flexible container 5 is filled with the used dialysate, the amount of dialysate supplied to the dialysate storage container 34 and the replacement fluid supplied to the replacement fluid storage container 44 are opened by opening the on-off valve V7. The amount can be confirmed by measuring the amount of used dialysate discharged from the flexible container 5 through the water removal line 6 and the weight of the flexible container 5. That is, the amount of dialysate supplied to the dialysate storage container 34 and the replacement fluid storage from the amount of used dialysate discharged by the weight scale 61 and the increase / decrease in the weight of the flexible container 5 measured by the weight scale 51. The amount of replacement fluid supplied to the container 44 can be confirmed.
Further, there is no particular limitation as long as it is between the filtration pump 37 and the flexible container 5, but preferably a heater 38 is provided between the filtration pump 37 and the open / close valve V7 to warm the used dialysate to an appropriate temperature. If possible, the dialysate in the dialysate reservoir 34 and the replacement fluid in the replacement fluid reservoir 44 are heated by heat exchange with the used dialysate heated by the heater 38 and stored in the flexible container 5. be able to.
[0012]
Next, the use of the continuous blood purification apparatus of the present invention will be described.
When performing continuous hemodialysis using the continuous blood purification apparatus of the present invention, the CHD flow diagram shown in FIG. 2 is followed.
With the flexible container 5 filled with spent dialysate (not necessarily full), the dialysate reservoir 34 is empty, and the on-off valves V1-V7 are closed, the on-off valve V2, When V7 is opened and the dialysate pump 32 is driven, dialysate is supplied from the dialysate container 3 to the dialysate storage container 34 through the dialysate supply line 31, while when the flexible container 5 is full, The spent dialysate in the container 5 is discharged to the outside through the dialysate circuit 36 and the water removal line 6 on the downstream side. Therefore, at this time, if the amount of the used dialysate discharged is measured by the weight meter 61 and the weight of the flexible container 5 is measured by the weight meter 51, the dialysate pump 32 supplies the dialysate storage container 34. Since the amount of dialysate per unit time is known, the dialysate pump 32 can be calibrated by comparing it with the set flow rate. When the dialysate reservoir 34 is full, the pressure sensor 33 detects a sudden increase in internal pressure, receives the internal pressure rapid increase signal, stops the dialysate pump 32, and closes the on-off valve V2.
[0013]
Next, the on-off valve V1 is opened, the blood pump 23 is driven to circulate blood in the blood circulation path, the on-off valve V2 is closed, the on-off valves V3, V4 are opened, and the dialysate pump 32 is reversely driven ( When the dialysate is rotated in the reverse direction when the dialysate is supplied to the dialysate reservoir 34 and the filtration pump 37 is driven, the dialysate in the dialysate reservoir 34 passes through the dialysate circuit 35 on the upstream side and the blood purifier 1. After the hemodialysis, the used dialysate is supplied to the flexible container 5 through the dialysate circuit 36 on the downstream side, except for the equivalent amount of water removal. At this time, the amount of the used dialysate flowing into the downstream dialysate circuit 36 is determined by the flow rate of the filtration pump 37. Therefore, when water removal is necessary, the flow rate of the filtration pump 37 is set larger than the flow rate of the dialysate pump 32. The difference between the flow rate of the filtration pump 37 and the flow rate of the dialysate pump 32 is the water removal amount, and the water in the removed blood (used dialysate) does not enter the full flexible container 5 and is removed. It is discharged through the line 6 and weighed with a weigh scale 61. When the dialysate storage container 34 becomes empty, the negative pressure is detected by the pressure sensor 33, the negative pressure signal is received, the dialysate pump 32 is stopped, and the on-off valves V3 and V4 are closed. Thereafter, the same operation may be repeated.
In addition, if the amount of the used dialysate discharged through the water removal line 6 is measured with the weigh scale 61 at a predetermined time after the start of CHD, the filtration pump 37 can be used when the flexible container 5 is full. The amount of used dialysate per unit time supplied to the flexible container 5 is equal to the amount of dialysate per unit time discharged from the flexible container 5 by the dialysate pump 32. By comparing the liquid discharge amount and the set flow rate of the filtration pump 37, the filtration pump 32 can be calibrated.
[0014]
When performing continuous blood filtration, follow the CHF flow diagram shown in FIG.
The flexible container 5 is filled with the used dialysate (not necessarily full), the replacement fluid storage container 44 is empty, and the on-off valves V1 to V7 are closed, and the on-off valves V5 and V7 are closed. When the replacement fluid pump 42 is driven, the replacement fluid is supplied from the replacement fluid container 4 to the replacement fluid storage container 44 through the replacement fluid supply line 41. On the other hand, when the flexible container 5 is full, the flexible container 5 is used. The dialyzed fluid is discharged to the outside through the downstream dialysate circuit 36 and the water removal line 6. Therefore, at this time, if the amount of the used dialysate discharged is measured by the weighing scale 61 and the weight of the flexible container 5 is measured by the weighing scale 51, the unit supplied to the replacement fluid storage container 44 by the replacement fluid pump 42 Since the amount of the replacement fluid per time is known, the replacement fluid pump 42 can be calibrated by comparing with the set flow rate. When the replacement fluid storage container 44 becomes full, the pressure sensor 43 detects a sudden increase in internal pressure, receives the internal pressure rapid increase signal, stops the replacement fluid pump 42, and closes the on-off valve V5.
[0015]
Next, the on-off valve V1 is opened, the blood pump 23 is driven to circulate blood in the blood circulation path, the on-off valve V5 is closed, the on-off valve V6 is opened, and the replacement fluid pump 42 is reversely driven (the replacement fluid is replaced with the replacement fluid). When the filtration pump 37 is driven, the replacement fluid in the replacement fluid storage container 44 is supplied to the downstream blood circuit 22 through the upstream replacement fluid circuit 45. At this time, since the flow rate of the filtration pump 37 is normally set to be larger than the flow rate of the replacement fluid pump 42, the water in the blood filtered by the filtration pump 37 (used dialysate) and the replacement fluid discharged from the replacement fluid storage container 44 While the same amount is supplied to the flexible container 5, the remaining spent dialysate is discharged through the dewatering line 6 and weighed by a weigh scale 61. When the replacement fluid storage container 44 becomes empty, the negative pressure is detected by the pressure sensor 43, the negative pressure signal is received, the replacement fluid pump 42 is stopped, and the on-off valve V6 is closed. Thereafter, the same operation may be repeated.
If the weight of the flexible container 5 is measured by the weigh scale 51 at a predetermined time after the start of CHF, the weight of the flexible container 5, the set flow rate of the replacement fluid pump 42 after calibration, and the filtration pump 37 The filter pump 32 can be calibrated by comparing the set flow rates.
[0016]
When performing continuous hemofiltration dialysis, the CHDF flow diagram shown in FIG. 4 is followed.
The flexible container 5 is filled with the used dialysate (not necessarily filled), the dialysate storage container 34 and the replacement fluid storage container 44 are empty, and the on-off valves V1 to V7 are closed. When the on-off valves V2 and V7 are opened and the dialysate pump 32 is driven, the dialysate is supplied from the dialysate container 3 to the dialysate reservoir 34 through the dialysate supply line 31, while the flexible container 5 is When full, the spent dialysate in the flexible container 5 is discharged to the outside through the downstream dialysate circuit 36 and the water removal line 6. Therefore, at this time, if the amount of the used dialysate discharged is measured by the weight meter 61 and the weight of the flexible container 5 is measured by the weight meter 51, the dialysate pump 32 supplies the dialysate storage container 34. Since the amount of dialysate per unit time is known, the dialysate pump 32 can be calibrated by comparing it with the set flow rate. When the dialysate reservoir 34 is full, the pressure sensor 33 detects a sudden increase in internal pressure, receives the internal pressure rapid increase signal, stops the dialysate pump 32, and closes the on-off valve V2.
[0017]
Next, when the on-off valve V5 is opened and the replacement fluid pump 42 is driven, the replacement fluid is supplied from the replacement fluid container 4 to the replacement fluid storage container 44 through the replacement fluid supply line 41, while the same in the flexible container 5 that is full. An amount of spent dialysate is discharged to the outside through the downstream dialysate circuit 36 and the water removal line 6. Accordingly, at this time, if the amount of the used dialysate discharged is measured by the weigh scale 61, the amount of the replacement fluid per unit time supplied to the replacement fluid storage container 44 by the replacement fluid pump 42 can be known. As a result, calibration of the replacement fluid pump 42 can be performed. When the replacement fluid storage container 44 becomes full, the pressure sensor 43 detects a sudden increase in internal pressure, receives the internal pressure rapid increase signal, stops the replacement fluid pump 42, and closes the on-off valve V5.
[0018]
Next, the on-off valve V1 is opened, the blood pump 23 is driven to circulate blood in the blood circulation path, the on-off valves V2, V5 are closed, the on-off valves V3, V4 are opened, and the dialysate pump 32 is reversed. When driven, the dialysate in the dialysate reservoir 34 is supplied to the blood purifier 1 through the upstream dialysate circuit 35, and after hemodialysis, the used dialysate has an amount equivalent to dewatering. The entire amount is supplied to the flexible container 5 through the dialysate circuit 36 on the downstream side. At this time, the amount of the used dialysate flowing into the downstream dialysate circuit 36 is determined by the flow rate of the filtration pump 37. Therefore, when water removal is necessary, the flow rate of the filtration pump 37 is set larger than the flow rate of the dialysate pump 32. The difference between the flow rate of the filtration pump 37 and the flow rate of the dialysate pump 32 is the water removal amount, and the water in the removed blood (used dialysate) does not enter the full flexible container 5 and is removed. It is discharged through the line 6 and weighed with a weigh scale 61. When performing the replacement fluid, the on-off valve V6 is opened and the replacement fluid pump 42 is driven in reverse. At this time, the replacement fluid in the replacement fluid storage container 44 is supplied to the downstream blood circuit 22 through the upstream replacement fluid circuit 45. At this time, the flow rate of the filtration pump 37 is usually set to be larger than the sum of the flow rate of the dialysate pump 32 and the flow rate of the replacement fluid pump 42. Therefore, the water in the blood filtered by the filtration pump 37 (used dialysate) The same amount as the sum of the dialysate discharged from the dialysate storage container 34 and the replacement fluid discharged from the replacement fluid storage container 44 is supplied to the flexible container 5, while the remaining spent dialysate passes through the water removal line 6. It is discharged through and weighed by a weigh scale 61.
When the replacement fluid storage container 44 becomes empty, the negative pressure is detected by the pressure sensor 43, the negative pressure signal is received, the replacement fluid pump 42 is stopped, and the on-off valve V6 is closed.
When the dialysate storage container 34 becomes empty, the negative pressure is detected by the pressure sensor 33, the negative pressure signal is received, the dialysate pump 32 is stopped, and the on-off valves V3 and V4 are closed. Thereafter, the same operation may be repeated.
[0019]
【The invention's effect】
As is apparent from the above description, the continuous blood purification apparatus of the present invention is designed to perform water removal with a flexible container full, and the amount of water removal is measured with one weighing scale. Therefore, there is no error due to variations between weighing scales and variations between pumps. Accordingly, it is possible to avoid a situation in which the health condition of the patient is hindered due to an error in measuring the water removal amount.
[Brief description of the drawings]
FIG. 1 is a schematic explanatory diagram of a continuous blood purification apparatus of the present invention.
FIG. 2 is a flow diagram of continuous hemodialysis performed using the continuous blood purification apparatus of the present invention.
FIG. 3 is a flow chart of continuous blood filtration performed using the continuous blood purification apparatus of the present invention.
FIG. 4 is a flow diagram of continuous hemofiltration dialysis performed using the continuous blood purification apparatus of the present invention.
[Explanation of symbols]
1 Blood Purifier 21 Upstream Blood Circuit 22 Downstream Blood Circuit 23 Blood Pump 3 Dialysate Container 31 Dialysate Supply Line 32 Dialysate Pump 33 Pressure Sensor 34 Dialysate Storage Container 35 Upstream Dialysate Circuit 36 Downstream Dialysis fluid circuit 37 Filtration pump 38 Heater 4 Fluid replacement container 41 Fluid replacement supply line 42 Fluid replacement pump 43 Pressure sensor 44 Fluid replacement reservoir 45 Fluid replacement line 5 Flexible container (hard container)
51 Weigh scale 6 Water removal line 61 Weigh scale V1 to V7 On-off valve

Claims (3)

A blood purifier comprising a blood purifier and a blood circuit, a dialysate circuit, a dialysate container, a replacement fluid container, and a dewatering line, and capable of continuously purifying blood, wherein the dialysate downstream of the blood purifier The circuit is provided with a filtration pump and a sealed flexible container in this order. The filtration pump allows spent dialysate after dialysis to pass through the dialysate circuit downstream of the blood purifier. Is supplied to the flexible container, and the water removal line is connected between the filtration pump and the flexible container. The flexible container is connected to the dialysate container via the dialysate supply line. A flexible dialysate storage container that communicates with a flexible replacement fluid storage container that communicates with the replacement fluid container via a replacement fluid supply line is accommodated, and the dialysate container provided by the dialysate pump provided in the dialysate supply line To dialysate reservoir The dialysate is also supplied to the blood purifier, and the dialysate is supplied from the dialysate storage container to the blood purifier, and the replacement fluid is supplied from the replacement fluid container to the replacement fluid storage container by a replacement fluid pump provided in the replacement fluid supply line. And the replacement fluid is supplied from the replacement fluid storage container to the blood circuit downstream of the blood purifier, and a weighing scale for measuring the weight of the container is provided in the flexible container. together is above the flexible container in a state of being filled with the used dialysate, by opening the on-off valve provided in the water removal line, which is discharged from the flexible container to the water-removal line A weigh scale for measuring the amount of used dialysate is provided, and the flexible container is measured for its weight and the amount of used dialysate discharged in a state where the flexible container is filled with the used dialysate. Based on The dialysate dialysate amount supplied to the storage container, the replacement fluid replacement fluid amount supplied to the storage container, and ultrafiltration volume, which are calculated continuous blood purification apparatus. The blood purification apparatus according to claim 1, wherein an on-off valve is provided between the filtration pump and the flexible container, and a water removal line is provided between the on-off valve and the flexible container. The blood purification apparatus according to claim 2, wherein a heater is provided between the filtration pump and the on-off valve so that the used dialysate flowing into the flexible container can be heated.

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