Blood purification device

Abstract

To efficiently perform priming work before treatment and blood-return work after treatment.SOLUTION: A blood purification device includes: a fluid supply passage 11 having one end connected to a dialysis fluid supply passage 4A of a dialysis fluid circuit and the other end connected to a venous passage 3A of a blood circuit; and a supply-discharge passage 12 having one end connected to an arterial passage 3B of the blood circuit and the other end switchably connected to the dialysis fluid supply passage 4A or a dialysis fluid discharge passage 4B of the dialysis fluid circuit. During priming work, in a state where a circulation path is formed by connecting respective distal ends of the arterial passage 3A and the venous passage 3A, dialysis fluid is supplied to the blood circuit via the fluid supply passage 11, and the supply-discharge passage 12 is connected to the dialysis fluid discharge passage 4B. During blood-return work, dialysis fluid is supplied from the dialysis fluid supply passage 4A to the blood circuit, and the dialysis fluid is discharged to the dialysis fluid discharge passage 4B via the supply-discharge passage 12.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present invention relates to a blood purification apparatus, and more particularly to a blood purification apparatus that can efficiently perform a priming operation before treatment and a blood return operation after treatment. [Background technology]

[0002] Conventionally, blood purification devices have been known that include a blood circuit consisting of an arterial passage and a venous passage connected to a blood purifier, a dialysate circuit consisting of a dialysate supply passage and a dialysate discharge passage connected to the blood purifier, a blood pump provided in the arterial passage, and dialysate supply / recovery means provided in the dialysate circuit for supplying and recovering dialysate to and from the blood purifier (Patent Documents 1, 2, and 3). Such blood purification devices require a priming step in which a priming solution is circulated through the blood purifier and blood circuit before blood purification treatment, and a blood return step in which blood remaining in the blood purifier and blood circuit is returned to the patient after treatment. The blood purification device of Patent Document 1 is provided with a fluid supply passage between the dialysate supply passage and the arterial passage, and during priming, the dialysate in the dialysate supply passage is supplied as a priming fluid to the arterial passage via the fluid supply passage, thereby circulating the dialysate in the blood circuit. Furthermore, when returning blood using the blood purification device of Patent Document 1, the dialysate in the dialysate supply passage is supplied to the arterial passage via the above-mentioned fluid supply passage, so that the blood in the blood circuit is pushed out by the dialysate and returned to the patient. Furthermore, in the blood purification device of Patent Document 1, when fluid replacement is performed during treatment, the dialysate in the dialysate supply passage is supplied to the arterial passage via the above-mentioned fluid supply passage, thereby replacing the dialysate with the patient. In contrast, the blood purification device of Patent Document 2 is provided with a fluid supply passage between the dialysate supply passage and the arterial passage, and is configured such that, during priming, the ends of the arterial passage and the venous passage are directly connected (Seventh Example, Figures 23 and 24) or are connected to the dialysate discharge passage by attaching a Y-shaped tube (Ninth Example, Figures 28 and 29). With this configuration, the dialysate in the dialysate supply passage is supplied to the arterial passage via the above-mentioned fluid supply passage, circulating in the blood circuit, and is discharged from the ends of the arterial passage and the venous passage to the dialysate discharge passage. Furthermore, the blood purification device of Patent Document 3 is provided with a blood return passage as a fluid supply passage between the dialysate supply passage and the arterial passage upstream of the blood pump, and a fluid replacement passage as a fluid supply passage between the dialysate supply passage and the arterial passage downstream of the blood pump upstream of the blood purifier (pre-dilution system) or between the dialysate supply passage and the venous passage downstream of the blood purifier (post-dilution system). In such a configuration, during priming, the dialysate is supplied from the fluid replacement passageway and circulated through the blood circuit, and is discharged from the ends of the arterial and venous passageways into the dialysate discharge passageway. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 4091873 [Patent Document 2] Patent No. 6685374 [Patent Document 3] Japanese Patent Application Laid-Open No. 2024-35694 Summary of the Invention [Problem to be solved by the invention]

[0004] However, in the blood purification device of Patent Document 1, the dialysate supplied to the blood circuit is caused to flow out from the ends of the arterial and venous passages during the priming operation, which requires a container to collect the outflowing dialysate, complicating the work of medical personnel. Furthermore, in the case of the blood purification device of Patent Document 2, if the ends of the arterial and venous passages are not directly connected to the dialysate discharge passage during the priming operation, a Y-shaped tube connectable to each passage must be attached to the blood circuit, which poses a problem of increased material costs. Furthermore, in the blood purification device of Patent Document 1, the dialysate is supplied from a common fluid supply passage for priming, blood return, and fluid replacement, but in reality, the supply positions of the dialysate in the blood circuit are different for blood return and fluid replacement. That is, in the blood purification device of Patent Document 3, in addition to a blood return passage that supplies dialysate to the upstream side of the blood pump, a fluid replacement passage is provided that supplies dialysate to the arterial or venous passage downstream of the blood pump for fluid replacement. The blood circuit is detachable from the blood purification device so that it can be replaced for each patient, and the passages between the dialysate circuit and the blood circuit are connected via a connection port. In the case of the blood purification device of Patent Document 3, connection ports are provided at two locations in the dialysate supply passage to connect the blood return passage and the fluid replacement passage, and a connection port is provided at one location in the dialysate discharge passage for draining the dialysate during priming, for a total of three connection ports. Similarly, in the blood purification device of Patent Document 2, if the ends of the venous passage and the arterial passage are connected directly to the dialysate discharge passage without using a Y-shaped tube for drainage during priming, two connection ports are required. Increasing the number of connection ports in this way requires the addition of not only ports but also passages, on-off valves, filters, etc., which increases the number of parts and leads to an increase in the cost of the blood purification device. Furthermore, in the blood purification devices of Patent Documents 2 and 3, the ends of the arterial and venous passages are connected to connection ports for drainage during priming. Although the connection ports are thoroughly washed after treatment, they are exposed to the outside and therefore may become contaminated after washing. Therefore, it is desirable to avoid connecting the ends of the venous and arterial passages of the sterilized blood circuit that are to be connected to the patient to such connection ports as much as possible before connecting to the patient and starting treatment. In view of these problems, the present invention provides a blood purification device that can efficiently perform priming and blood return procedures, reduces the costs of materials and equipment, and prevents contamination of the blood circuit before treatment. [Means for solving the problem]

[0005] That is, the blood purification device according to the invention of claim 1 comprises a blood circuit having an arterial passage and a venous passage connected to a blood purifier, a dialysate circuit having a dialysate supply passage and a dialysate discharge passage connected to the blood purifier, a blood pump provided in the arterial passage, and a dialysate supply / discharge means provided in the dialysate circuit for supplying and discharging dialysate to and from the blood purifier, and performs blood purification therapy by circulating blood from the arterial passage to the venous passage via the blood purifier, a supply passage having one end connected to the dialysate supply passage and the other end connected to the arterial passage or the venous passage; a supply / discharge passage having one end connected to the arterial passage and the other end connected to the dialysate supply passage and the dialysate discharge passage; and a switching means for switching between supplying and discharging the dialysate to / from the blood circuit in the supply / discharge passage, In a priming operation before treatment, in a state in which a circulation path is formed by connecting the ends of the arterial passage and the venous passage, the dialysate is supplied from the dialysate supply passage to the blood circuit via the dialysate supply passage, and the dialysate is discharged from the blood circuit to the dialysate discharge passage via the supply / discharge passage, In the blood return operation after treatment, the dialysate is supplied from the dialysate supply passage to the blood circuit via the supply and discharge passages, and blood is returned from the ends of the arterial and venous passages. [Effects of the Invention]

[0006] According to the invention of claim 1, the drainage during priming is performed through the supply and discharge passages that are connected to the dialysate circuit in advance and remain connected during treatment, so there is no need to attach or detach the ends of the arterial and venous passages of the blood circuit to or from the dialysate discharge passage, and there is no need to attach a tube to the blood circuit to connect to the dialysate discharge passage. Furthermore, since the supply and discharge passages are used for both supplying and discharging fluid, the number of connection ports is reduced and there is no need to connect the ends of arterial and venous passages to the connection ports. This allows the priming and blood return procedures to be carried out efficiently, reduces the cost of materials and equipment, and prevents contamination of the blood circuit before treatment. [Brief explanation of the drawings]

[0007] [Figure 1] FIG. 2 is a circuit diagram of the dialysate circuit and blood circuit of the dialysis device according to the present embodiment. [Figure 2] FIG. 2 is a diagram illustrating the flow of dialysate and the procedure of the priming operation when performing hemodialysis treatment. [Figure 3] FIG. 4 is a diagram illustrating the procedure of a priming operation. [Figure 4] FIG. 4 is a diagram illustrating the procedure of a priming operation. [Figure 5] FIG. 1 is a diagram illustrating the steps of the blood return procedure. [Figure 6] FIG. 1 is a diagram illustrating the steps of the blood return procedure. [Figure 7] FIG. 1 is a diagram illustrating the steps of the blood return procedure. [Figure 8] FIG. 1 is a diagram illustrating the steps of the blood return procedure. DETAILED DESCRIPTION OF THE INVENTION

[0008] The present invention will be described below with reference to the illustrated embodiments. Fig. 1 shows a dialysis machine 1 as a blood purification device that performs hemodialysis as a blood purification treatment, and includes a dialyzer 2 as a blood purifier, a blood circuit 3 connected to the dialyzer 2 to circulate blood, and a dialysate circuit 4 connected to the dialyzer 2 to circulate dialysate. The dialysis machine 1 is controlled by control means (not shown). The dialysis device 1 is provided with a housing 5 shown by the dashed line that houses the dialysis fluid circuit 4, and a new sterilized dialyzer 2 and blood circuit 3 are attached to the outside of the housing 5 each time a dialysis treatment is performed. 2 to 4, before dialysis treatment, a priming operation is performed in which a priming fluid is circulated through the attached dialyzer 2 and the blood circuit 3. In this embodiment, the dialysis fluid circulating through the dialysis fluid circuit 4 is used as the priming fluid. Furthermore, after the dialysis treatment, as shown in Figs. 5 to 8, a blood return operation is carried out to return the blood remaining in the dialyzer 2 and blood circuit 3 during the dialysis treatment to the patient.

[0009] The dialyzer 2 has a configuration in which countless hollow fibers 2a serving as blood purification membranes are housed inside a cylindrical housing 2b. The inside of the hollow fibers 2a communicates with a blood circuit 3 through which blood flows, and the outside of the hollow fibers 2a in the housing 2b communicates with a dialysate circuit 4 through which dialysate flows in the opposite direction to the blood. During dialysis treatment, hemodialysis is carried out between the blood flowing inside the hollow fibers 2a and the dialysate flowing outside.

[0010] The blood circuit 3 includes a venous passage 3A that returns blood from the dialyzer 2 to the patient, and an arterial passage 3B that supplies blood removed from the patient to the dialyzer 2. A fluid replacement passage 11a that constitutes the fluid supply passage 11 branches off from the venous passage 3A, and a blood return passage 12a that constitutes the supply / drain passage 12 branches off from the arterial passage 3B. These passages are made of elastic resin tubes made of silicone rubber or the like. One end of the arterial passage 3B is connected to the dialyzer 2, and a drip chamber 24 is provided between the one end and the branching point of the blood return passage 12a. A connector 21 for attaching a puncture needle to be inserted into the patient is provided at the tip of the other end. In addition, a first clamp 22 and a blood pump 23 are provided on the outside of the housing 5, and the arterial passage 3B is held by a plurality of holders (not shown) provided on the outside of the housing 5 so that the first clamp 22 is located between the tip and the branching position of the blood return passage 12a, and the blood pump 23 is located between the branching position of the blood return passage 12a and the drip chamber 24. In this way, the arterial passage 3B is provided with the first clamp 22 and the blood pump 23, and the first clamp 22 clamps the tube that constitutes the arterial passage 3B to block the flow of fluid within the tube. The blood pump 23 is a roller pump that can rotate forward and backward and uses multiple rollers to sequentially squeeze the tube that forms the arterial passage 3B to send the liquid. When rotated forward, the liquid is sent from the tip of the arterial passage 3B toward the dialyzer 2, and when rotated reversely, the liquid is sent in the opposite direction. When the pump is stopped, one of the rollers crushes the tube, blocking the flow of liquid through the tube.

[0011] One end of the venous passage 3A is connected to the dialyzer 2, and the other end has a connector 25 at the tip for attaching a puncture needle to be inserted into the patient. A drip chamber 26 is provided between the connector 25 and the branching position of the replacement fluid passage 11a, close to the branching position. A second clamp 27 is provided on the outside of the housing 5, and the venous passage 3A is positioned at a position near the tip between the tip and the drip chamber 26 by the second clamp 27. During the priming operation, as shown in FIG. 2, the connector 21 at the tip of the arterial passage 3B and the connector 25 at the tip of the venous passage 3A are connected by inserting them into connecting means 13 made of a tubular member, thereby forming a circulation path. The connecting means 13, together with the arterial passage 3B and the venous passage 3A, are prepared as new sterilized items.

[0012] The fluid replacement passage 11a constituting the fluid supply passage 11 is provided by branching off from between the connection end of the venous passage 3A with the dialyzer 2 and the drip chamber 26, and is connected to the dialysis fluid circuit 4 by connecting the fluid replacement passage 11a to a fluid supply connection port (fluid supply port 11c) provided on the outside of the housing 5. The fluid replacement passage 11a of the blood circuit 3 is branched off from the venous passage 3A as a post-dilution system, but can be branched off from the arterial passage 3B when fluid replacement is performed by a pre-dilution system. The blood return passage 12a constituting the supply / discharge passage 12 is provided branching off from the arterial passage 3B between the position where the first clamp 22 is provided and the position where the blood pump 23 is provided. The blood return passage 12a is connected to a supply / discharge connection port (supply / discharge port 12c) provided on the outside of the housing 5, thereby being connected to the dialysate circuit 4. In addition, the blood return passage 12a is attached to a third clamp 28 provided on the outside of the housing 5 while connected to the supply / discharge port 12c, and the third clamp 28 clamps the tube that constitutes the blood return passage 12, thereby blocking the flow of liquid within the tube.

[0013] The dialysate circuit 4 includes a dialysate supply passage 4A that supplies fresh dialysate to the dialyzer 2, and a dialysate discharge passage 4B that collects used dialysate that has passed through the dialyzer 2. The dialysate supply and recovery means includes a first dialysate chamber 31 and a second dialysate chamber 32 that are identical in shape and contain dialysate, and a dialysate pump 33 provided in the dialysate discharge passage 4B. Similar to the passages that make up the blood circuit 3, these passages that make up the dialysate circuit 4 are also made of elastic resin tubes. The inside of the first and second dialysis fluid chambers 31, 32 is divided into two compartments by elastic membranes 31a, 32a, forming supply chambers 31A, 32A for storing fresh dialysis fluid and collection chambers 31B, 32B for storing used dialysis fluid. The supply chambers 31A and 32A are connected to the dialysis fluid supply passage 4A and a water supply passage 4C connected to a purified water supply means (not shown) which branch off from each other. Fluid supply valves V1 and V2 are provided in the branched passages of the water supply passage 4C, and supply valves V3 and V4 are provided in the branched passages of the dialysis fluid supply passage 4A. On the other hand, the recovery chambers 31B and 32B are respectively connected to the dialysate discharge passage 4B and a drain passage 4D connected to a waste fluid pipe (not shown) that branch off, and recovery valves V5 and V6 are provided on the branched passages of the dialysate discharge passage 4B, and drain valves V7 and V8 are provided on the branched passages of the drain passage 4D. A liquid A supply source 34 and a liquid B supply source 35 are connected to the water supply passage 4C, and supply the A and B concentrates, which are the concentrates of the dialysis fluid, respectively. A water supply pump 36 is provided upstream of these sources.

[0014] The dialysate supply passage 4A is provided with a first dialysate filter F1 and a second dialysate filter F2, each of which is an endotoxin-cutting filter that purifies the dialysate, as well as a first flow rate adjustment valve VA1 and a ninth opening / closing valve V9, which are controlled by a control means. A fluid supply branch passage 11b, which is connected to the replacement fluid passage 11a to form the fluid supply passage 11, branches off between the second dialysis fluid filter F2 and the first flow rate adjustment valve VA1, and is provided in the fluid supply branch passage 11b with a second flow rate adjustment valve VA2 and a tenth on-off valve V10 as a fluid supply on-off valve, both of which are controlled by a control means. The tip of the fluid supply branch passage 11b is connected to the fluid supply port 11c. As a result, when fluid replacement is performed during treatment, the flow rate of the dialysate supplied from the dialysate supply passage 4A to the dialyzer 2 and the flow rate of the dialysate supplied from the dialysate supply passage 4A to the blood circuit 3 are adjusted by controlling the openings of the first flow rate adjustment valve VA1 of the dialysate supply passage 4A and the second flow rate adjustment valve VA2 of the supply passage 11b. The supply fluid branch passage 11b branches off from the dialysate supply passage 4A downstream of the first dialysate filter F1 and the second dialysate filter F2, and supplies purified dialysate to the blood circuit 3.

[0015] The dialysis fluid discharge passage 4B is provided with an eleventh on-off valve V11 controlled by a control means and the fluid supply pump 33, and a water removal passage 37 is provided adjacent to the downstream side of the fluid supply pump 33 between the drainage passage 4D and the dialysis fluid discharge passage 4B, and a water removal pump 38 is provided in the water removal passage 37. The water removal pump 38 is configured as a so-called piston pump capable of accurately delivering a predetermined amount at a time, and is capable of switching the delivery direction between forward and reverse, with the forward direction being the direction in which used dialysate is delivered from the dialysate discharge passage 4B to the drainage passage 4D via the water removal passage 37 for water removal during dialysis treatment. By switching between forward and reverse, the dialysate can be delivered in the reverse direction, i.e., from the drainage passage 4D to the dialysate discharge passage 4B.

[0016] The dialysate circuit 4 further includes a first bypass passage 41 between the dialysate supply passage 4A and the dialysate discharge passage 4B, and the first bypass passage 41 is provided with a twelfth on-off valve V12 as a supply on-off valve and a thirteenth on-off valve V13 as a discharge on-off valve, both of which are controlled by a control means. One end of the first bypass passage 41 is connected between the first flow rate adjustment valve VA1 and the ninth on-off valve V9 in the dialysate supply passage 4A, and the other end is connected between the eleventh on-off valve V11 and the solution feed pump 33 in the dialysate discharge passage 4B. A supply / discharge branch passage 12b, which is connected to the blood return passage 12a and forms the supply / discharge passage 12, branches off between the 12th on-off valve V12 and the 13th on-off valve V13 in the first bypass passage 41, and is provided with a 14th on-off valve V14 controlled by a control means, and the tip of the supply / discharge branch passage 12b is connected to the supply / discharge port 12c. With this configuration, when the twelfth on-off valve V12 of the first bypass passage 41 is opened, the thirteenth on-off valve V13 is closed, and the fourteenth on-off valve V14 of the supply / discharge branch passage 12b is opened, the blood circuit 3 communicates with the dialysate supply passage 4A via the supply / discharge passage 12, and purified dialysate can be supplied to the blood circuit 3 and returned. Conversely, when the twelfth on-off valve V12 is closed and the thirteenth on-off valve V13 and the fourteenth on-off valve V14 are opened, the blood circuit 3 communicates with the dialysis fluid discharge passage 4B via the supply / discharge passage 12, allowing the dialysate to be discharged from the blood circuit 3. That is, these constitute a switching means for switching between supply and discharge of the dialysis fluid to and from the blood circuit 3 in the supply and discharge passage 12 according to the present invention.

[0017] A second bypass passage 42 is provided by branching off from the water supply passage 4C downstream of the water supply pump 36, and the second bypass passage 42 further branches off into a first branch passage 42a and a second branch passage 42b. The first branch passage 42a is connected between the connection position of the first bypass passage 41 in the dialysis fluid discharge passage 4B and the fluid supply pump 33, and the second branch passage 42b is connected between the connection position of the water removal pump 38 in the water removal passage 37 and the drainage passage 4D. The first branch passage 42a is provided with a fifteenth on-off valve V15 controlled by the control means, and the second branch passage 42b is provided with a sixteenth on-off valve V16 controlled by the control means. As a result, by opening the fifteenth on-off valve V15, the liquid feed pump 33 can cause purified water to flow into the recovery chambers 31B and 32B from the water supply passage 4C at a large flow rate. In addition, by opening the 16th on-off valve V16 and switching the liquid delivery direction of the water removal pump 38 to the reverse direction, purified water can be accurately supplied at a small flow rate through the water removal passage 37 to the dialysis fluid flowing into the recovery chambers 31B and 32B by the liquid delivery pump 33.

[0018] The flow of dialysate during hemodialysis treatment in the dialysis device 1 having the above configuration will be explained using Figure 2. In Figure 2, the area through which the dialysate flows is indicated by a thick line, and open on-off valves and clamps are indicated in white, while closed on-off valves and clamps are indicated in black. In the first dialysate chamber 31, the third on-off valve V3 and the fifth on-off valve V5 are in an open state, the ninth on-off valve V9 and the eleventh on-off valve V11 are open to connect the dialysate circuit 4 to the dialyzer 2, and the tenth on-off valve V10, the twelfth on-off valve V12, the thirteenth on-off valve V13, the fourteenth on-off valve V14, the fifteenth on-off valve V15, and the sixteenth on-off valve V16 are closed. As a result, a sealed circuit is formed by the supply chamber 31A of the first dialysate chamber 31, the dialysate supply passage 4A, the outside of the hollow fibers 2a in the housing 2b of the dialyzer 2, the dialysate discharge passage 4B, and the collection chamber 31B of the second dialysate chamber 31.

[0019] In this state, purified water and undiluted solution A and undiluted solution B are supplied in a predetermined ratio from the purified water supply means and solution A and solution B supply sources 34, 35 to supply chamber 32A of second dialysate chamber 32 through the opened second on-off valve V2 and via the water supply passage 4C, and are mixed inside supply chamber 32A to prepare fresh dialysate. At this time, when purified water or undiluted solution flows into the supply chamber 32A, the elastic membrane 32a deforms and the volume of the supply chamber 32A expands, and accordingly the volume of the collection chamber 32B decreases, so that the used dialysis fluid flows through the opened eighth opening / closing valve V8 from the collection chamber 32B and is drained through the drainage passage 4D. Meanwhile, in the first dialysate chamber 31, when the supply pump 33 is operated with prepared fresh dialysate stored in the supply chamber 31A, the fresh dialysate is sent to the dialyzer 2 via the dialysate supply passage 4A, and the used dialysate that has passed through the dialyzer 2 is stored in the collection chamber 31B via the dialysate discharge passage 4B. As a result, the dialysate moves from the supply chamber 31A to the collection chamber 31B, and the volume of the collection chamber 32B increases.

[0020] When a predetermined amount of dialysis fluid is sent from the supply chamber 31A of the first dialysis fluid chamber 31 to the recovery chamber 31B, the open / close states of the fluid supply valves V1, V2 and drainage valves V7, V8, and the supply valves V3, V4 and recovery valves V5, V6 provided in the first and second dialysis fluid chambers 31, 32 are switched. Then, in the second dialysate chamber 32, fresh dialysate is supplied from the supply chamber 32A to the dialyzer 2, and used dialysate is collected in the collection chamber 32B. Meanwhile, in the first dialysate chamber 31, fresh dialysate is stored in the supply chamber 31A, and used dialysate is drained from the collection chamber 31B to the drain passage 4D. Thereafter, by alternately repeating the above operations, the dialysate circuit 4 can continuously supply fresh dialysate to the dialyzer 2 and collect used dialysate, and hemodialysis is performed in the dialyzer 2 between the dialysate and the blood circulating through the blood circuit 3.

[0021] In addition, when performing a water removal operation to remove water from the patient's blood during dialysis treatment, the control means causes the water removal pump 38 provided in the water removal passage 37 to pump water in the forward direction, and discharges a predetermined amount of used dialysis fluid flowing through the dialysis fluid discharge passage 4B into the drainage passage 4D via the water removal passage 37. As a result, a sealed circuit is formed by the supply chambers 31A, 32A, the dialysate supply passage 4A, the outside of the hollow fibers 2a in the housing 2b of the dialyzer 2, the dialysate discharge passage 4B, and the recovery chambers 31B, 32B, and the circuit is filled with dialysate. Therefore, an amount of water corresponding to the amount of used dialysate discharged by the water removal pump 38 is removed from the blood circulating inside the hollow fibers 2a of the dialyzer 2.

[0022] Furthermore, when a fluid replacement operation is performed to replace dialysate with a patient during dialysis treatment, the control means controls the apertures of the first flow rate adjustment valve VA1 of the dialysate supply passage 4A and the second flow rate adjustment valve VA2 of the replacement fluid passage 11, and also opens the tenth on-off valve V10 of the replacement fluid passage 11b, thereby supplying fresh dialysate to the dialyzer 2 while supplying a predetermined amount of fresh dialysate from the dialysate supply passage 4A to the blood circuit 3 via the replacement fluid passage 11, thereby replacing the fluid with the patient.

[0023] Next, the priming operation using the dialysis device 1 of this embodiment will be described with reference to Figures 2 to 4. In the following description, the part through which the dialysis fluid flows is indicated by a thick line, and open valves and clamps are indicated in white, while closed valves and clamps are indicated in black. FIG. 2 shows the operation of circulating the dialysate around the outside of the hollow fibers 2a in the housing 2b connected to the dialysate circuit 4 in the dialyzer 2. First, a new, sterilized dialyzer 2 is supported on the housing 5 of the dialysis device 1, and one end of the arterial passage 3B and one end of the venous passage 3A of the new, sterilized blood circuit 3 are connected to the dialyzer 2, and the arterial passage 3B and the venous passage 3A are attached to the outside of the housing 5 by being held by a plurality of holders (not shown). Furthermore, the tip of the arterial passage 3B of the blood circuit 3 and the tip of the venous passage 3A are connected by a new, sterilized connecting means 13 attached to the blood circuit, making the blood circuit 3 a circulation path. In addition, the arterial passage 3B is attached to the blood pump 23 and set in the first clamp 22, the tip of the blood return passage 12a is connected to the supply / exhaust port 12c and connected to the supply / exhaust branch passage 12b of the dialysate circuit 4, and the blood return passage 12a is set in the third clamp 28. The venous passage 3A is set in the second clamp 27, and the tip of the replacement fluid passage 11a is connected to the supply / discharge port 11c, which is then connected to the supply branch passage 11b of the dialysate circuit 4. In addition, in the dialysis fluid circuit 4, the ninth on-off valve V9 and the eleventh on-off valve V11 are open and communicate with the dialyzer 2, and the tenth on-off valve V10, the twelfth on-off valve V12, the thirteenth on-off valve V13, the fourteenth on-off valve V14, the fifteenth on-off valve V15, and the sixteenth on-off valve V16 are closed. In this state, when an operation to start the priming operation is performed on the control means, the control means operates the fluid supply pump 33, and in the state shown in FIG. 2, causes the fresh dialysate stored in the supply chamber 31A of the first dialysate chamber 31 to flow through the dialysate supply passage 4A in the same manner as during dialysis treatment. As a result, fresh dialysate flows into the dialyzer 2 from the dialysate supply passage 4A, and the dialysate that has passed through the dialyzer 2 is discharged into the dialysate discharge passage 4B, thereby causing the dialysate to circulate outside the hollow fibers 2a in the housing 2b of the dialyzer 2.

[0024] Next, FIG. 3 shows the operation of circulating the dialysate through the blood circuit 3 and the inner part of the hollow fibers 2 a connected to the blood circuit 3 in the dialyzer 2 . From the state shown in FIG. 2, the control means closes the ninth on-off valve V9 of the dialysate supply passage 4A and the eleventh on-off valve V11 of the dialysate discharge passage 4B, and opens the tenth on-off valve V10 of the supply fluid branch passage 11b, which are supply on-off valves, the fourteenth on-off valve V14 of the supply / discharge branch passage 12b, the thirteenth on-off valve V13 of the first bypass passage 41, and the fifteenth on-off valve V15 of the first branch passage 42a of the second bypass passage 42, while keeping the twelfth on-off valve V12, which is a supply on-off valve, closed. As a result, the blood circuit 3 is connected to the dialysate discharge passage 4B via the supply / discharge passage 12. Furthermore, in the blood circuit 3, the first to third clamps 22, 27, and 28 are all opened. The control means also operates the fluid pump 33 of the dialysate discharge passage 4B, while adjusting the first and second flow rate control valves VA1 and VA2 so that the entire amount of dialysate flows into the supply fluid branch passage 11b, thereby causing the entire amount of dialysate in the dialysate supply passage 4A to flow into the replacement fluid passage 11a. As a result, in the state shown in FIG. 3, the purified water flows from the water supply passage 4C through the first branch passage 42a of the second bypass passage 42 into the dialysate discharge passage 4B by the action of the fluid supply pump 33, and the purified water flows into the collection chamber 31B of the first dialysate chamber 31. This causes the fresh dialysis fluid contained in the supply chamber 31A of the first dialysis fluid chamber 31 to be discharged, and the dialysis fluid flows through the dialysis fluid supply passage 4A and the fluid supply passage 11, and then flows into the venous passage 3A of the blood circuit 3.

[0025] Meanwhile, in the blood circuit 3, the control means reverses the rotation of the blood pump 23 to send fluid toward the tip of the arterial passage 3B, in the opposite direction to that during dialysis treatment, and the flow rate is set lower than the flow rate flowing from the replacement fluid passage 11a into the venous passage 3A. For example, if the flow rate of the dialysate flowing from the fluid supply passage 11 into the replacement fluid passage 3A is set to 600 ml / min and the flow rate by the blood pump 23 is set to 300 ml / min, the blood pump 23 will send 300 ml / min of dialysate from the venous passage 3A through the dialyzer 2 toward the tip of the arterial passage 3B, but the remaining 300 ml / min of dialysate will flow toward the tip of the venous passage 3A. As a result, the dialysate flowing in the reverse direction is discharged from the blood return passage 12a past the blood pump 23. The dialysate flowing toward the distal end of the venous passage 3A passes through the connecting means 13 that connects the distal ends of the venous passage 3A and the arterial passage 3B, and is discharged from the blood return passage 12a, so that the dialysate circulates throughout the entire blood circuit 3, including the replacement fluid passage 11a and the blood return passage 12a.

[0026] The dialysate discharged from the blood return passage 12a in this manner flows through the supply / discharge branch passage 12b, via the first bypass passage 41, and through the dialysate discharge passage 4B to be collected in the collection chamber 31B of the first dialysate chamber 31. In this way, by discharging the dialysate from the blood circuit 3 through the supply / discharge passage 12 to the dialysate discharge passage 4B, there is no need to treat the drainage, as compared with the case where the dialysate is discharged from each of the ends of the venous passage 3A and the arterial passage 3B, and there is also no need for materials such as a Y-shaped tube. Furthermore, in order to drain the fluid from the blood circuit 3, the connectors 21, 25 at the respective tips of the venous passage 3A and the arterial passage 3B are not directly connected to a drainage connection port or communicated with the dialysate discharge passage 4B via a Y-shaped tube or the like, but the respective tips of the venous passage 3A and the arterial passage 3B are connected by a sterilized connecting means 13, so that cleanliness is not impaired.

[0027] FIG. 4 shows the operation of circulating the dialysate through the blood circuit 3 and removing air bubbles in the blood circuit 3 by the drip chambers 24 and 26. 3, the control means closes the tenth on-off valve V10 of the branched fluid supply passage 11b and the fourteenth on-off valve V14 of the branched supply / discharge passage 12b, and opens the twelfth on-off valve V12 of the first bypass passage 41. Furthermore, the third clamp 28 of the return blood passage 12a is closed. In the dialysate circuit 4, the dialysate is supplied and discharged in the first and second dialysate chambers 31, 32 in the same manner as during dialysis treatment, but the dialysate in the dialysate supply passage 4A does not pass through the dialyzer 2 but flows to the dialysate discharge passage 4B via the first bypass passage 41. Meanwhile, in the blood circuit 3, the control means rotates the blood pump 23 forward or backward to circulate the dialysate through the blood circuit 3, which forms a circulation path. As a result, air bubbles contained in the dialysate are removed by the drip chambers 24 and 26, and the priming process is completed. Once the priming process is completed in this manner, the medical staff can separate the venous passageway 3A and the arterial passageway 3B from the connecting means 13, attach puncture needles 21 and 25 to the tip of each passageway, and insert them into the patient to begin dialysis treatment.

[0028] Next, the blood return process after dialysis treatment will be described with reference to Figures 5 to 8. In these figures, the flow of dialysate is indicated by a thick line, and blood remaining in the blood circuit 3 is indicated by hatching. As shown in FIG. 5, when dialysis treatment is completed and the control means is instructed to start the blood return operation, the control means closes the tenth on-off valve V10, which is a fluid supply on-off valve, and closes the ninth on-off valve V9 in the dialysate supply passage 4A and the eleventh on-off valve V11 in the dialysate discharge passage 4B to cut off communication with the dialyzer 2, and opens the twelfth on-off valve V12, which is a supply on-off valve of the first bypass passage 41, and the thirteenth on-off valve V13, which is a discharge on-off valve. 5, the fourth on-off valve V4 of the second dialysate chamber 32 is opened to connect the supply chamber 32A to the dialysate supply passage 4A, and the sixth on-off valve V6 is opened to connect the dialysate discharge passage 4B to the collection chamber 32B, forming a sealed circuit by the supply chamber 32A, the dialysate supply passage 4A, the first bypass passage 41, the dialysate discharge passage 4B, and the collection chamber 32B. When the solution feed pump 33 is operated in this state, the dialysate moves from the supply chamber 32A to the collection chamber 32B.

[0029] In this state, the control means opens the sixteenth on-off valve V16 provided in the second branch passage 42b of the second bypass passage 42 while keeping the above-mentioned solution feed pump 33 in operation, and causes the water removal pump 38 of the water removal passage 37 to feed solution in the reverse direction, thereby supplying purified water at a predetermined rate from the second bypass passage 42 to the dialysate discharge passage 4B via the water removal passage 37. At the same time, the control means opens the fourteenth on-off valve V14 provided in the supply / discharge branch passage 12b and the third clamp 28 that opens and closes the blood return passage 12a. Then, the purified water flowing in from the water removal passage 37 is sent to the liquid supply pump 33, and flows into the recovery chamber 32B of the second dialysate chamber 32 from the dialysate discharge passage 4B in the state of FIG. As a result, a sealed circuit is formed by the supply chamber 32A of the second dialysate chamber 32, the dialysate supply passage 4A, the first bypass passage 41, the dialysate discharge passage 4B, and the recovery chamber 32B, so that of the dialysate supplied from the dialysate supply passage 4A, an amount of the dialysate equal to the amount of purified water delivered by the water removal pump 38 overflows from the sealed circuit and flows into the arterial passage 3B of the blood circuit 3 from the first bypass passage 41 via the supply / discharge branch passage 12b and the blood return passage 12a.

[0030] On the other hand, in the blood circuit 3, as shown in FIG. 5, the control means closes the first clamp 22 and opens the second clamp 27, and then rotates the blood pump 23 in the normal direction, so that a predetermined amount of the dialysis fluid flowing in from the blood return passage 12a is sent toward the dialyzer 2. As a result, in the example of FIG. 5, the dialysate that has flowed from the blood return passage 12a into the arterial passage 3B is sent to the blood pump 23 and circulates toward the dialyzer 2, so that it substantially fills the interior of all of the hollow fibers 2a of the dialyzer 2. In the venous passage 3A beyond the dialyzer 2, the second clamp 27 is open, so that an amount of blood corresponding to the amount of dialysate flowing into the arterial passage 3B is returned to the patient from the tip of the venous passage 3A. In contrast, the first clamp 22 is closed at the distal end (patient side) of the arterial passage 3B from the branching position of the blood return passage 12a, so that no dialysis fluid flows in and blood remains.

[0031] Therefore, following the state shown in FIG. 5, second clamp 27 is closed as shown in FIG. 6, and then a preset small amount of dialysis fluid is supplied from blood return passage 12a, and the fluid is pumped in the forward direction by blood pump 23, and then blood pump 23 is stopped. As a result, a small amount of dialysate is forced from the blood pump 23 toward the dialyzer 2. The amount of the small amount of dialysate forced in at this time is set to an amount that does not apply unnecessary pressure to the arterial passage 3B or the venous passage 3A, can be absorbed by expanding the elastic tubes that form the passages, and does not cause the tubes to come off or cause liquid leakage. For example, if the amount of blood flowing in from the blood return passage 12a is 100 ml when the second clamp 27 shown in FIG. 5 is open, the amount of blood pushed in after the second clamp 27 is closed can be 4 ml.

[0032] FIG. 7 shows the operation of returning blood from the distal end side of the branching position of the blood return passage 12a in the arterial passage 3B to the patient. From the state shown in FIG. 6, i.e., a state in which a predetermined small amount (e.g., 4 ml) of dialysis fluid is pushed toward the dialyzer 2 by the blood pump 23, the third clamp 28 of the blood return passage 12a is closed and the first clamp 22 of the arterial passage 3B is opened. In this state, the control means reverses the rotation of the blood pump 23 by the same predetermined small amount, causing the dialysate that had been pushed from the blood pump 23 toward the dialyzer 2 to flow in the opposite direction, and returning to the patient only the predetermined small amount of blood remaining in the arterial passage 3B on the distal side of the branching position of the blood return passage 12a. Since the amount of blood remaining from the branching position to the tip is greater than the predetermined small amount of dialysate, the operation of returning blood in small amounts is repeated multiple times. That is, with second clamp 27 open again as shown in FIG. 5, a predetermined small amount of dialysate is allowed to flow in from blood return passage 12a and is pumped in the forward direction by blood pump 23. Next, blood corresponding to the small amount of dialysate that has flowed in is returned from the tip of the venous passage 3A, and then, with the second clamp 27 closed as shown in Figure 6, a predetermined small amount of dialysate is allowed to flow in from the blood return passage 12a and pumped in the forward direction by the blood pump 23, and then the pumping is stopped. Thereafter, as shown in FIG. 7, with first clamp 22 open, blood pump 23 is reversed to flow the same small amount of dialysate in the opposite direction, returning blood to the patient from the distal end of arterial passage 3B. By repeating the operations shown in FIGS. 5 to 7 multiple times, blood remaining in the arterial passage 3B from the tip to the blood pump 23 is returned to the patient.

[0033] FIG. 8 shows the operation of returning the blood in the venous passage 3A completely to the patient. From the state shown in Figure 7, the control means opens the fourteenth on-off valve V14 of the supply / discharge branch passage 12b and the third clamp 28 of the blood return passage 12a, as in the state shown in Figure 5, and further closes the first clamp 22 of the arterial passage 3B and opens the second clamp 27 of the venous passage 3A. In this state, the control means rotates the blood pump 23 in the normal direction, and the dialysate that has flowed in from the blood return passage 12a is sent toward the dialyzer 2 and the venous passage 3A, thereby sending the blood remaining in the venous passage 3A toward the tip end and returning it to the patient. At this time, the control means controls the amount of fluid sent by the water removal pump 38 and the blood pump 23 according to the volume inside all of the hollow fibers 2a of the dialyzer 2 and the volume inside the arterial passage 3B and venous passage 3A, so as to return the blood remaining in the blood circuit 3 to the patient.

[0034] As described above, according to the dialysis device 1 of this embodiment, in the priming operation, the connector 21 at the tip of the arterial passage 3B of the blood circuit 3 and the connector 25 at the tip of the venous passage 3A are connected by the connecting means 13 to form a circulation path, and the dialysate is supplied from the liquid supply passage 11 to prime the dialyzer 2 and the blood circuit 3. The waste liquid during priming is discharged from the supply / discharge passage 12 to the dialysate discharge passage 4B, so that the priming operation can be performed without connecting the tips of the arterial passage 3B and the venous passage 3A of the blood circuit 3 to the dialysate discharge passage 4B. Furthermore, in the blood return operation, the dialysate is allowed to flow from the blood return passage 12a into the arterial passage 3B, so there is no need to provide a separate liquid supply port for blood return.

[0035] Although the above embodiments have been described as being for so-called personal dialysis devices in which dialysis fluid is prepared in the first and second dialysis fluid chambers 31 and 32, the present invention can also be adopted in so-called dialysis monitoring devices in which pre-prepared fresh dialysis fluid is supplied through the water supply passage 4C. [Explanation of symbols]

[0036] 1 Dialysis machine 2 Dialysis machine 3 Blood Circuit 3A Venous Channel 3B Arterial passage 4 Dialysate circuit 4A Dialysate supply passage 4B Dialysate discharge passage 11 Liquid supply passage 12 Supply and discharge passage 13 Connection means 23 Blood pump

Claims

1. A blood purification device for performing blood purification therapy by circulating blood from the arterial passage to the venous passage via the blood purifier, the device comprising: a blood circuit having an arterial passage and a venous passage connected to a blood purifier; a dialysate circuit having a dialysate supply passage and a dialysate discharge passage connected to the blood purifier; a blood pump provided in the arterial passage; and dialysate supply / discharge means provided in the dialysate circuit for supplying and discharging dialysate to and from the blood purifier, a supply passage having one end connected to the dialysate supply passage and the other end connected to the arterial passage or the venous passage; a supply / discharge passage having one end connected to the arterial passage and the other end connected to the dialysate supply passage and the dialysate discharge passage; and a switching means for switching between supplying and discharging the dialysate to / from the blood circuit in the supply / discharge passage, In a priming operation before treatment, in a state in which a circulation path is formed by connecting the ends of the arterial passage and the venous passage, the dialysate is supplied from the dialysate supply passage to the blood circuit via the dialysate supply passage, and the dialysate is discharged from the blood circuit to the dialysate discharge passage via the supply / discharge passage, In the blood return operation after treatment, the dialysate is supplied from the dialysate supply passage to the blood circuit via the supply and discharge passages, and the blood is returned from the ends of the arterial and venous passages.

2. a bypass passage having one end connected to the dialysate supply passage and the other end connected to the dialysate discharge passage; the switching means includes a supply on-off valve that opens and closes the bypass passage and a liquid supply on-off valve that opens and closes the liquid supply passage, one end of the supply / discharge passage is connected between the tip of the arterial passage and the blood pump, and the other end of the supply / discharge passage is connected between the supply / open / close valve of the bypass passage and the other end connected to the dialysate discharge passage; 2. The blood purification apparatus according to claim 1, wherein the supply valve is opened and the supply valve is closed during the priming operation, and the supply valve is opened and the supply valve is closed during the blood return operation.

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