Blood purification device

Abstract

Provided is a blood purification device. The pre-filling operation before treatment and the blood return operation after treatment are efficiently performed. The present invention is provided with: a liquid supply passage (11), one end of which is connected to a dialysate supply passage (4A) of a dialysate circuit and the other end of which is connected to a venous passage (3A) of a blood circuit; and a supply / discharge passage (12), one end of which is connected to the artery passage (3B) of the blood circuit, and the other end of which is switchably connected to the dialysate supply passage (4A) or the dialysate discharge passage (4B) of the dialysate circuit. In a state in which a circulation path is formed in which the tips of an arterial passage (3B) and a venous passage (3A) are connected to each other during a pre-charging operation, dialysate is supplied to a blood circuit via the feed passage (11), and the feed / discharge passage (12) is connected to the dialysate discharge passage (4B), and in a state in which a circulation path is formed in which the tips of the arterial passage (3B) and the venous passage (3A) are connected to each other, the feed / discharge passage (12) is connected to the dialysate discharge passage (4B). Dialysate is discharged from the dialysate supply path (4A) to the dialysate discharge path (4B) via the supply and discharge path (12) for supplying dialysate to a blood circuit.

Description

Technical Field

[0001] This invention relates to a blood purification device, and more specifically, to a blood purification device capable of efficiently performing pre-treatment priming and post-treatment blood return procedures. Background Technology

[0002] Previously, blood purification devices were known to include: a blood circuit comprising an arterial passage and a venous passage connected to a blood purifier; a dialysate circuit comprising a dialysate supply passage and a dialysate discharge passage connected to the blood purifier; a blood pump disposed in the arterial passage; and a dialysate supply and recovery unit disposed in the dialysate circuit for supplying and recovering dialysate relative to the blood purifier (Patent Documents 1, 2, 3).

[0003] In such a blood purification device, a pre-filling operation and a blood return operation are required. The pre-filling operation circulates the pre-filling fluid in the blood purifier and blood circuit before blood purification treatment, and the blood return operation returns the blood remaining in the blood purifier and blood circuit to the patient after treatment.

[0004] The blood purification device of the aforementioned patent document 1 has a fluid supply passage between the dialysate supply passage and the arterial passage. During the pre-filling operation, the dialysate in the dialysate supply passage is supplied to the arterial passage as pre-filling fluid through the fluid supply passage, so that the dialysate circulates in the blood circuit.

[0005] In addition, in the blood purification device of Patent Document 1, during the blood return operation, the dialysate in the dialysate supply passage is also supplied to the arterial passage through the aforementioned fluid supply passage, thereby squeezing the blood out of the blood circuit through the dialysate and returning blood to the patient.

[0006] In addition, in the blood purification device of Patent Document 1, when fluid is replenished during treatment, the dialysate in the dialysate supply passage is also supplied to the arterial passage through the aforementioned fluid supply passage, thereby replenishing the patient with dialysate.

[0007] In contrast, the blood purification device of Patent Document 2 has the following configuration: a fluid supply passage is provided between the dialysate supply passage and the arterial passage, and during pre-filling operation, the front ends of the arterial passage and the venous passage are directly connected (7th embodiment, Figures 23 and 24), or a Y-shaped tube is installed (9th embodiment, Figures 28 and 29) to connect it to the dialysate discharge passage.

[0008] With this configuration, dialysate from the dialysate supply pathway is supplied to the arterial pathway via the aforementioned fluid supply pathway, allowing it to circulate in the blood circuit, and then discharged from the front end of the arterial and venous pathways to the dialysate discharge pathway.

[0009] In addition, the blood purification device of Patent Document 3 has a blood return passage as a fluid supply passage between the dialysate supply passage and the upstream side of the blood pump in the arterial passage, and a fluid replenishment passage as a fluid supply passage between the dialysate supply passage and the upstream side of the blood purifier in the arterial passage downstream of the blood pump (pre-dilution method) or between the venous passage downstream of the blood purifier (post-dilution method).

[0010] In this configuration, during pre-filling, dialysate is supplied from the replenishment pathway and circulated in the blood circuit, and discharged from the arterial and venous pathways to the dialysate discharge pathway.

[0011] Existing technical documents

[0012] Patent documents

[0013] Patent Document 1: Japanese Patent No. 4091873

[0014] Patent Document 2: Japanese Patent No. 6685374

[0015] Patent Document 3: Japanese Patent Application Publication No. 2024-35694 Summary of the Invention

[0016] However, in the blood purification device of Patent Document 1, during the pre-filling operation, the dialysate supplied to the blood circuit flows out from the front end of the arterial and venous access channels. Therefore, there is a problem that the work of medical personnel, such as the need for containers to collect the outflowing dialysate, becomes complicated.

[0017] Furthermore, in the case of the blood purification device in Patent Document 2, if the front ends of the arterial and venous access channels are not directly connected to the dialysate discharge channel during the pre-filling operation, a Y-shaped tube that can be connected to each access channel must be attached to the blood circuit, which increases the material cost.

[0018] Furthermore, in the blood purification device of Patent Document 3, dialysate is supplied from a common fluid supply channel during pre-filling, blood return, and fluid replenishment, but in reality, the supply location of dialysate in the blood circuit is different during blood return and fluid replenishment.

[0019] That is, in the blood purification device of Patent Document 3, in addition to the blood return passage that supplies dialysate to the upstream side of the blood pump, a fluid replenishment passage that supplies dialysate to the downstream side of the blood pump via an arterial or venous passage is also provided for fluid replenishment.

[0020] The blood circuit can be attached to and detached from the blood purification device for each patient, and the connection between the dialysate circuit and the blood circuit is made via a connection port.

[0021] In the case of the blood purification device in Patent Document 3, in order to connect the blood return passage and the fluid replenishment passage, there are connection ports at two points in the dialysate supply passage, and in order to drain the fluid during pre-filling, there is a connection port at one point in the dialysate discharge passage, for a total of three connection ports.

[0022] Similarly, in the blood purification device of Patent Document 2, in order to drain the fluid during pre-filling, two connection ports are required when the front ends of the venous and arterial access are directly connected to the dialysate discharge access without using a Y-shaped tube.

[0023] Thus, with the addition of multiple connection ports, not only are additional ports added, but also additional passages, on / off valves, filters, etc., increasing the number of components and thus leading to an increase in the cost of the blood purification device.

[0024] Furthermore, in the blood purification devices of Patent Documents 2 and 3, the front ends of the arterial and venous access channels are connected to the connection port in order to drain the fluid during pre-filling. However, although the connection port is thoroughly cleaned after treatment, it is an open part and there is a risk of contamination after cleaning.

[0025] Therefore, it is desirable to avoid connecting the sterilized blood circuits to the patient's venous or arterial access points to such connection ports before starting treatment.

[0026] In view of these issues, the present invention provides a blood purification device that can efficiently perform pre-filling and refilling operations, while also reducing the cost of materials and devices and preventing contamination of the blood circuit before treatment.

[0027] That is, the blood purification device 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 disposed in the arterial passage; and a dialysate supply and discharge unit disposed in the dialysate circuit for supplying and discharging dialysate from the blood purifier. The blood purification device circulates blood from the arterial passage to the venous passage via the blood purifier to perform blood purification treatment.

[0028] The blood purification device includes: a fluid supply passage, one end of which is connected to the dialysate supply passage, and the other end of which is connected to the arterial or venous passage; a supply and drainage passage, one end of which is connected to the arterial passage, and the other end of which is connected to both the dialysate supply passage and the dialysate drainage passage; and a switching unit for switching the supply and drainage of dialysate in the blood circuits of the supply and drainage passages.

[0029] During the pre-treatment filling process, once a circulatory path connecting the front ends of the aforementioned arterial and venous access routes is established, dialysate is supplied from the dialysate supply route to the blood circuit via the aforementioned supply route, and the dialysate is discharged from the blood circuit via the aforementioned supply and drainage routes to the aforementioned dialysate discharge route.

[0030] In the post-treatment blood return procedure, dialysate is supplied to the blood circuit from the dialysate supply passage via the aforementioned supply and drainage passages, and blood is returned from the front end of the aforementioned arterial and venous passages.

[0031] According to the invention of claim 1, the pre-filling of the dialysis fluid is performed via a supply and drainage passage that is pre-connected to the dialysis fluid circuit and remains connected during treatment. Therefore, there is no need to attach or detach the front end of the arterial or venous passage of the blood circuit relative to the dialysis fluid drainage passage. In addition, there is no need to attach the tube connected to the dialysis fluid drainage passage to the blood circuit.

[0032] In addition, the supply and drainage pathways can be used for both fluid supply and drainage, thus reducing the need for additional connection ports and eliminating the need to connect the front ends of arterial and venous access pathways to the connection ports.

[0033] This allows for efficient pre-filling and refilling procedures, while also reducing material and equipment costs and preventing contamination of the blood circuit before treatment. Attached Figure Description

[0034] Figure 1 This is a circuit diagram of the dialysate circuit and the blood circuit of the dialysis device in this embodiment.

[0035] Figure 2 It is a diagram illustrating the flow of dialysate and the pre-filling process during hemodialysis treatment.

[0036] Figure 3 It is a diagram illustrating the pre-filling process.

[0037] Figure 4 It is a diagram illustrating the pre-filling process.

[0038] Figure 5 It is a diagram illustrating the process of blood return operations.

[0039] Figure 6 It is a diagram illustrating the process of blood return operations.

[0040] Figure 7 It is a diagram illustrating the process of blood return operations.

[0041] Figure 8 It is a diagram illustrating the process of blood return operations.

[0042] (Symbol Explanation)

[0043] 1: Dialysis device; 2: Dialyzer; 3: Blood circuit; 3A: Venous access; 3B: Arterial access; 4: Dialysis fluid circuit; 4A: Dialysis fluid supply access; 4B: Dialysis fluid discharge access; 11: Fluid supply access; 12: Supply and discharge access; 13: Connecting unit; 23: Blood pump. Detailed Implementation

[0044] The present invention will now be described with reference to the illustrated embodiments. Figure 1 A dialysis apparatus 1, which performs hemodialysis as a blood purification treatment, is shown. It includes a dialyzer 2 as a blood purifier, a blood circuit 3 connected to the dialyzer 2 and allowing blood to flow, and a dialysate circuit 4 connected to the dialyzer 2 and allowing dialysate to flow. The dialysis apparatus 1 is controlled by a control unit (not shown).

[0045] The dialysis device 1 described above has a frame 5, indicated by a dashed line, which houses the dialysate circuit 4. Each time a dialysis treatment is performed, a sterilized new dialyzer 2 and a blood circuit 3 are installed on the outside of the frame 5.

[0046] In addition, before dialysis treatment, such as Figures 2-4 As shown, a pre-filling operation is performed to allow the pre-filling fluid to circulate in the installed dialyzer 2 and the blood circuit 3. Furthermore, in this embodiment, dialysate circulating in the dialysate circuit 4 is used as the pre-filling fluid.

[0047] Furthermore, after dialysis treatment, such as Figures 5-8 As shown, during dialysis treatment, a blood return procedure is performed to return the blood remaining in the dialyzer 2 and blood circuit 3 to the patient.

[0048] The dialyzer 2 described above has a structure in which numerous hollow filaments 2a, which serve as blood purification membranes, are housed inside a cylindrical shell 2b. The inner side of the hollow filaments 2a is connected to the blood circuit 3 to allow blood to flow, and the outer side of the hollow filaments 2a inside the shell 2b is connected to the dialysate circuit 4. The dialysate flows in the opposite direction to the blood. During dialysis treatment, hemodialysis is performed between the blood flowing through the inner side of the hollow filaments 2a and the dialysate flowing through the outer side.

[0049] The aforementioned blood circuit 3 includes a venous passage 3A for returning blood from the dialyzer 2 to the patient, and an arterial passage 3B for supplying blood drained from the patient to the dialyzer 2. A rehydration passage 11a, which branches off from the venous passage 3A to form the fluid supply passage 11, and a blood return passage 12a, which branches off from the arterial passage 3B to form the blood supply and drainage passage 12, is also provided. These passages are constructed from tubes made of an elastic resin, including silicone rubber.

[0050] One end of the arterial access 3B is connected to the dialyzer 2. A drip chamber 24 is provided between this end and the branch position of the blood return access 12a. A connector 21 for mounting a puncture needle for puncturing the patient is provided at the front end of the other end.

[0051] Additionally, a first clamp 22 and a blood pump 23 are provided on the outside of the frame 5. The arterial passage 3B is held by a plurality of retainers (not shown) provided on the outside of the frame 5, such that the first clamp 22 is located between the front end and the branch position of the blood return passage 12a, and the blood pump 23 is located between the branch position of the blood return passage 12a and the drip chamber 24.

[0052] Thus, a first clamp 22 and a blood pump 23 are provided in the arterial access 3B. The first clamp 22 clamps the tube constituting the arterial access 3B to cut off the flow of liquid in the tube.

[0053] In addition, the blood pump 23 mentioned above includes a roller pump that can rotate in both directions by sequentially squeezing the tube constituting the arterial passage 3B with multiple rollers. By rotating in the forward direction, it can deliver the blood from the front end of the arterial passage 3B to the dialyzer 2. By rotating in the reverse direction, it can deliver the blood in the opposite direction. When stopped, any roller flattens the tube and cuts off the flow of liquid in the tube.

[0054] One end of the aforementioned intravenous access 3A is connected to the aforementioned dialyzer 2, and at the front end of the other end, a connector 25 is provided for mounting a puncture needle for puncturing the patient. Between the connector 25 and the branch position of the fluid infusion access 11a, the infusion chamber 26 is located near the branch position.

[0055] In addition, a second clamp 27 is provided on the outside of the frame 5, and the second clamp 27 is positioned in the intravenous access 3A near the front end between the front end and the drip chamber 26.

[0056] Then, during the pre-charging operation, such as Figure 2 As shown, a circulatory path is formed by connecting the connector 21 at the front end of the arterial passage 3B and the connector 25 at the front end of the venous passage 3A to the connecting unit 13 containing the cylindrical component.

[0057] Regarding the aforementioned connecting unit 13, arterial access 3B, and venous access 3A, prepare sterilized new products.

[0058] The replenishment passage 11a, which constitutes the above-mentioned fluid supply passage 11, is branched from the connection end of the dialyzer 2 in the above-mentioned intravenous passage 3A between the drip chamber 26 and the fluid supply passage 11a. The replenishment passage 11a is connected to the fluid supply connection port (fluid supply port 11c) located on the outside of the frame 5, thereby connecting to the dialysate circuit 4.

[0059] Furthermore, regarding the rehydration pathway 11a of the aforementioned blood circuit 3, as a post-dilution method, it branches from the venous pathway 3A, but in the case of rehydration via the pre-dilution method, it can branch from the aforementioned arterial pathway 3B.

[0060] The blood return passage 12a that constitutes the blood supply and drainage passage 12 is branched out from the location where the first clamp 22 is located in the arterial passage 3B and the location where the blood pump 23 is located.

[0061] By connecting the blood return passage 12a to the supply and drainage connection port (supply and drainage port 12c) located on the outside of the frame 5, it is connected to the dialysate circuit 4.

[0062] In addition, the blood return passage 12a is installed on the third clamp 28 located on the outside of the frame 5 in a state of being connected to the supply and drainage port 12c. The third clamp 28 clamps the tube constituting the blood return passage 12a and cuts off the flow of liquid in the tube.

[0063] The aforementioned dialysate circuit 4 includes: a dialysate supply passage 4A for supplying fresh dialysate to the dialyzer 2; and a dialysate discharge passage 4B for recovering used dialysate that has passed through the dialyzer 2. Furthermore, as a dialysate supply and recovery unit, it includes: a first dialysate chamber 31 and a second dialysate chamber 32 of the same shape for containing dialysate; and a delivery pump 33 disposed in the dialysate discharge passage 4B. The passages constituting these dialysate circuits 4 are also constructed from flexible resin tubing, similar to those constituting the blood circuit 3.

[0064] The interior of the first and second dialysate chambers 31 and 32 is divided into two chambers by elastic membranes 31a and 32a, forming supply chambers 31A and 32A for containing fresh dialysate and recovery chambers 31B and 32B for containing used dialysate.

[0065] In the aforementioned supply chambers 31A and 32A, the aforementioned dialysate supply passage 4A and the water supply passage 4C connected to the purified water supply unit (not shown) are respectively branched. Supply valves V1 and V2 are provided in the branch passages of the water supply passage 4C, and supply valves V3 and V4 are provided in the branch passages of the dialysate supply passage 4A.

[0066] On the other hand, in the above-mentioned recovery chambers 31B and 32B, the dialysate discharge passage 4B and the drain passage 4D connected to the waste liquid piping (not shown) are respectively branched. Recovery valves V5 and V6 are provided in the branch passages of the dialysate discharge passage 4B, and drain valves V7 and V8 are provided in the branch passages of the drain passage 4D.

[0067] In the middle of the aforementioned water supply passage 4C, there are supply sources 34 and 35 for A stock solution and B stock solution, which are used as dialysis fluid, and a water supply pump 36 is installed on its upstream side.

[0068] In the aforementioned dialysate supply passage 4A, there are a first dialysate filter F1, a second dialysate filter F2 including an endotoxin removal filter for purifying dialysate, a first flow regulating valve VA1 and a ninth on / off valve V9 controlled by a control unit.

[0069] A supply branch passage 11b is branched from the second dialysate filter F2 and the first flow regulating valve VA1, which is connected to the replenishment passage 11a and forms the supply passage 11. In the supply branch passage 11b, a second flow regulating valve VA2 controlled by the control unit and a tenth on / off valve V10 serving as the supply on / off valve are provided. The front end of the supply branch passage 11b is connected to the supply port 11c.

[0070] Therefore, when fluid resuscitation is performed during treatment, the flow rate of dialysate supplied from dialysate supply passage 4A to dialyzer 2 and the flow rate of dialysate supplied from dialysate supply branch passage 11b to blood circuit 3 can be adjusted by controlling the opening of the first flow regulating valve VA1 of dialysate supply passage 4A and the second flow regulating valve VA2 of dialysate supply branch passage 11b.

[0071] In addition, the fluid supply branch passage 11b branches off from the dialysate supply passage 4A downstream of the first dialysate filter F1 and the second dialysate filter F2, supplying purified dialysate to the blood circuit 3.

[0072] In the dialysate discharge passage 4B, there is an 11th on / off valve V11 controlled by the control unit and the aforementioned delivery pump 33. In a position adjacent to the downstream side of the delivery pump 33, between the dialysate discharge passage 4D and the discharge passage 4D, there is a water removal passage 37, and a water removal pump 38 is installed in the water removal passage 37.

[0073] The aforementioned dehydration pump 38 is a piston pump capable of accurately delivering a specified amount of fluid each time, and can switch the delivery direction in both directions. The forward direction is the direction in which used dialysate is delivered from the dialysate discharge passage 4B to the drain passage 4D via the dehydration passage 37 for dehydration during dialysis treatment. Moreover, by switching the forward and reverse directions, fluid can be delivered in the opposite direction, i.e., from the drain passage 4D to the dialysate discharge passage 4B.

[0074] Furthermore, in the dialysate circuit 4, a first bypass passage 41 is provided between the dialysate supply passage 4A and the dialysate discharge passage 4B. The first bypass passage 41 is provided with a 12th on / off valve V12, which is controlled by the control unit, and a 13th on / off valve V13, which is controlled by the control unit.

[0075] One end of the first bypass passage 41 is connected between the first flow regulating 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 liquid delivery pump 33 in the dialysate discharge passage 4B.

[0076] The supply and drainage branch passage 12b, which is connected to the blood return passage 12a and forms the supply and drainage passage 12, branches off from the 12th on-off valve V12 and the 13th on-off valve V13 in the first bypass passage 41. A 14th on-off valve V14 controlled by the control unit is provided in the supply and drainage branch passage 12b. The front end of the supply and drainage branch passage 12b is connected to the supply and drainage port 12c.

[0077] According to this configuration, when the 12th on / off valve V12 of the first bypass passage 41 is opened, the 13th on / off valve V13 is closed, and the 14th on / off valve V14 of the supply / drainage branch passage 12b is opened, the blood circuit 3 is connected to the dialysate supply passage 4A via the supply / drainage passage 12, and purified dialysate can be supplied to the blood circuit 3 for blood return.

[0078] Conversely, when the 12th on / off valve V12 is closed and the 13th on / off valve V13 and the 14th on / off valve V14 are opened, the blood circuit 3 is connected to the dialysate discharge passage 4B via the supply and discharge passage 12, and can discharge fluid from the blood circuit 3.

[0079] That is, these constitute the switching unit of the present invention, which switches the supply and discharge of dialysate to the blood circuit 3 in the above-mentioned supply and discharge passage 12.

[0080] In addition, a second bypass passage 42 is provided downstream of the water supply pump 36 in the above-mentioned water supply passage 4C. The second bypass passage 42 further branches into a first branch passage 42a and a second branch passage 42b.

[0081] The first branch passage 42a is connected between the connection position of the first bypass passage 41 in the dialysate discharge passage 4B and the delivery pump 33, and the second branch passage 42b is connected between the water removal pump 38 in the water removal passage 37 and the connection position of the discharge passage 4D.

[0082] In addition, a 15th on / off valve V15 controlled by a control unit is provided in the first branch passage 42a, and a 16th on / off valve V16 controlled by a control unit is provided in the second branch passage 42b.

[0083] Therefore, by opening the aforementioned 15th on / off valve V15, purified water can flow in large flow from the water supply passage 4C into the recovery chambers 31B and 32B via the liquid delivery pump 33.

[0084] In addition, by opening the 16th on / off valve V16 and switching the delivery direction of the dewatering pump 38 to the opposite direction to deliver liquid, clean water can be added to the dialysate flowing into the recovery chambers 31B and 32B via the dewatering passage 37 with a small flow rate and high precision.

[0085] use Figure 2 The flow of dialysate during hemodialysis treatment in a dialysis apparatus 1 having the above-described configuration will be explained. Figure 2 In the diagram, thick lines represent the parts where the dialysate flows. Additionally, white lines represent open valves and clamps, while black lines represent closed valves and clamps.

[0086] In the first dialysate chamber 31, the third on / off valve V3 and the fifth on / off valve V5 are in the open state, the ninth on / off valve V9 and the eleventh on / off valve V11 are open, the dialysate circuit 4 is connected 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.

[0087] Thus, a closed loop is formed by the supply chamber 31A of the first dialysate chamber 31, the dialysate supply passage 4A, the outer side of the hollow wire 2a inside the shell 2b of the dialyzer 2, the dialysate discharge passage 4B, and the recovery chamber 32B of the second dialysate chamber 32.

[0088] In this state, purified water, as well as raw solutions A and B, flow through the open second on / off valve V2 and are supplied to the supply chamber 32A of the second dialysate chamber 32 in a prescribed ratio from the purified water supply unit and the supply sources 34 and 35 of solutions A and B via the aforementioned water supply passage 4C. The solutions are mixed inside the supply chamber 32A to prepare fresh dialysate.

[0089] At this time, when purified water and raw solution flow into the supply chamber 32A, the elastic membrane 32a deforms, the volume of the supply chamber 32A expands, and the volume of the recovery chamber 32B decreases. As a result, the used dialysate flows from the recovery chamber 32B through the opened 8th on / off valve V8 and is discharged through the drainage passage 4D.

[0090] On the other hand, in the first dialysate chamber 31, with the prepared fresh dialysate contained in the supply chamber 31A, the delivery pump 33 operates, thereby delivering the fresh dialysate to the dialyzer 2 via the dialysate supply passage 4A, and the used dialysate that has passed through the dialyzer 2 is contained in the recovery chamber 31B via the dialysate discharge passage 4B. Thus, the dialysate moves from the supply chamber 31A to the recovery chamber 31B, and the volume of the recovery chamber 31B increases.

[0091] Then, when a specified amount of dialysate is transported from the supply chamber 31A of the first dialysate chamber 31 to the recovery chamber 31B, the opening and closing states of the supply valves V1 and V2, the drain valves V7 and V8, the supply valves V3 and V4, and the recovery valves V5 and V6 provided in the first and second dialysate chambers 31 and 32 are switched.

[0092] Therefore, in the second dialysate chamber 32, fresh dialysate is supplied to the dialyzer 2 from the supply chamber 32A, and the used dialysate is recycled to the recovery chamber 32B. On the other hand, in the first dialysate chamber 31, fresh dialysate is contained in the supply chamber 31A, and the used dialysate is discharged from the recovery chamber 31B to the drainage passage 4D.

[0093] Then, by alternating and repeating the above actions, fresh dialysate can be continuously supplied to dialyzer 2 through dialysate circuit 4, and used dialysate can be recovered, and hemodialysis can be performed between dialyzer 2 and blood flowing in blood circuit 3.

[0094] In addition, during the dehydration process of removing water from the patient's blood during dialysis treatment, the control unit causes the dehydration pump 38, which is installed in the dehydration passage 37, to deliver fluid in the positive direction, so that the used dialysate flowing in the dialysate discharge passage 4B is discharged through the dehydration passage 37 to the discharge passage 4D at a preset dehydration rate.

[0095] Thus, a closed loop is formed by the supply chambers 31A and 32A, the dialysate supply passage 4A, the outside of the hollow wire 2a inside the dialyzer 2 housing 2b, the dialysate discharge passage 4B, and the recovery chambers 31B and 32B. The loop is filled with dialysate, thereby removing an amount of water from the blood flowing inside the hollow wire 2a of the dialyzer 2, corresponding to the amount of used dialysate discharged by the dehydration pump 38.

[0096] Furthermore, during dialysis treatment, when replenishing the patient with dialysate, the control unit controls the opening of the first flow regulating valve VA1 of the dialysate supply passage 4A and the second flow regulating valve VA2 of the supply branch passage 11b. In addition, the 10 on / off valve V10 of the supply branch passage 11b is opened to supply fresh dialysate to the dialyzer 2, and a predetermined amount of fresh dialysate is supplied from the dialysate supply passage 4A to the blood circuit 3 via the supply passage 11 to replenish the patient's fluids.

[0097] Next, use Figures 2-4 The pre-filling operation of the dialysis apparatus 1 in this embodiment will be described. In the following description, the parts where the dialysate flows are indicated by thick lines. In addition, open valves and clamps are indicated by white, and closed valves and clamps are indicated by black.

[0098] Figure 2 This illustrates the action of allowing the dialysate to flow through the outer portion of the hollow wire 2a within the housing 2b connected to the dialysate circuit 4 in the dialyzer 2.

[0099] First, the new and sterilized dialyzer 2 is supported on the frame 5 of the dialysis device 1, and one end of the arterial passage 3B and venous passage 3A of the new and sterilized blood circuit 3 is connected to the dialyzer 2. Multiple retainers (not shown) are used to hold the arterial passage 3B and venous passage 3A outside the frame 5 and are installed.

[0100] Furthermore, by means of a new and sterilized connecting unit 13 attached to the blood circuit, the front end of the arterial passage 3B and the front end of the venous passage 3A of the blood circuit 3 are connected, so that the blood circuit 3 becomes a circulatory path.

[0101] In addition, arterial access 3B is installed on blood pump 23 and set in first clamp 22, so that the front end of blood return access 12a is connected to supply and drainage port 12c and connected to supply and drainage branch access 12b of dialysate circuit 4, and blood return access 12a is set in third clamp 28.

[0102] The intravenous access 3A is set in the second clamp 27, so that the front end of the fluid replenishment access 11a is connected to the fluid supply port 11c and connected to the fluid supply branch access 11b of the dialysate circuit 4.

[0103] Additionally, in dialysate circuit 4, valves V9 (9th) and V11 (11th) are open and connected to dialyzer 2, while valves V10 (10th), V12 (12th), V13 (13th), V14 (14th), V15 (15th), and V16 (16th) are closed.

[0104] When the pre-charge operation of the control unit begins from this state, the control unit activates the liquid delivery pump 33. Figure 2 In the same state as during dialysis treatment, fresh dialysate contained in the supply chamber 31A of the first dialysate chamber 31 flows through the dialysate supply passage 4A.

[0105] Therefore, fresh dialysate flows into dialyzer 2 from dialysate supply passage 4A, and the dialysate that has passed through dialyzer 2 is discharged into dialysate discharge passage 4B. Thus, dialysate flows outside the hollow wire 2a inside the shell 2b of dialyzer 2.

[0106] Next, Figure 3 The action of allowing dialysate to flow through the blood circuit 3 and the inner portion of the hollow wire 2a connected to the blood circuit 3 in the dialyzer 2 is shown.

[0107] from Figure 2 In the state shown, the control unit closes the 9th on / off valve V9 of the dialysate supply passage 4A and the 11th on / off valve V11 of the dialysate discharge passage 4B, and opens the 10th on / off valve V10 of the supply branch passage 11b, the 14th on / off valve V14 of the supply and discharge branch passage 12b, the 13th on / off valve V13 of the first bypass passage 41, and the 15th on / off valve V15 of the first branch passage 42a of the second bypass passage 42. The 12th on / off valve V12, which serves as the supply on / off valve, remains closed.

[0108] Thus, the blood circuit 3 is connected to the dialysate discharge passage 4B via the supply and discharge passage 12.

[0109] Then, in blood circuit 3, all clamps 22, 27, and 28 (numbers 1-3) are opened.

[0110] In addition, the control unit activates the delivery pump 33 of the dialysate discharge passage 4B and adjusts the first and second flow regulating valves VA1 and VA2 to ensure that all the dialysate flows into the supply branch passage 11b, so that all the dialysate in the dialysate supply passage 4A circulates in the replenishment passage 11a.

[0111] As a result, in Figure 3 In this state, due to the action of the liquid delivery pump 33, 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, and the purified water flows into the recovery chamber 31B of the first dialysate chamber 31.

[0112] As a result, the fresh dialysate contained in the supply chamber 31A of the first dialysate chamber 31 is discharged, and after the dialysate flows through the dialysate supply passage 4A and the fluid supply passage 11, it flows into the venous passage 3A of the blood circuit 3.

[0113] On the other hand, in the blood circuit 3, the control unit reverses the blood pump 23 and delivers fluid to the front end of the arterial passage 3B in the opposite direction to the dialysis treatment. In addition, the flow rate is set to be lower than the flow rate from the above-mentioned fluid replenishment passage 11a into the venous passage 3A.

[0114] For example, when the flow rate of dialysate flowing from the supply channel 11 into the replenishment channel 11a is set to 600 ml / min and the flow rate of the blood pump 23 is set to 300 ml / min, the blood pump 23 delivers 300 ml / min of dialysate from the venous channel 3A through the dialyzer 2 to the front end of the arterial channel 3B, and the remaining 300 ml / min of dialysate flows to the front end of the venous channel 3A.

[0115] Thus, the dialysate flowing in the opposite direction passes over the blood pump 23 and is discharged from the blood return passage 12a. In addition, the dialysate flowing towards the front end of the venous passage 3A passes over the connecting unit 13 that connects the front 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 area of ​​the blood circuit 3, including the fluid replenishment passage 11a and the blood return passage 12a.

[0116] In this way, the dialysate discharged from the blood return passage 12a flows through the supply and discharge branch passage 12b, passes through the first bypass passage 41, flows in the dialysate discharge passage 4B, and is recovered to the recovery chamber 31B of the first dialysate chamber 31.

[0117] In this way, the dialysate is discharged from the blood circuit 3 through the supply and drainage passage 12 to the dialysate discharge passage 4B. Therefore, compared with the case where the dialysate is discharged from the front ends of the venous passage 3A and the arterial passage 3B, there is no need for drainage treatment, and there is no need for materials such as Y-shaped tubes.

[0118] Furthermore, instead of directly connecting the connectors 21, 25 of the front ends of the venous access 3A and the arterial access 3B to the connection port for drainage in order to drain the blood circuit 3, or connecting them to the dialysate drainage passage 4B via a Y-shaped tube or the like, the front ends of the venous access 3A and the arterial access 3B are connected by a sterilized connection unit 13, thus not compromising cleanliness.

[0119] Figure 4 The action of circulating the dialysate in the blood circuit 3 and removing air bubbles from the blood circuit 3 through the drip chambers 24 and 26 is shown.

[0120] from Figure 3In this state, the control unit closes the 10th on / off valve V10 of the supply branch passage 11b and the 14th on / off valve V14 of the supply / drainage branch passage 12b, and opens the 12th on / off valve V12 of the first bypass passage 41. Then, the 3rd clamp 28 of the blood return passage 12a is closed.

[0121] In the dialysate circuit 4, as during dialysis treatment, dialysate is supplied and discharged in the first and second dialysate chambers 31 and 32. However, the dialysate in the dialysate supply passage 4A does not pass through the dialyzer 2, but flows through the first bypass passage 41 to the dialysate discharge passage 4B.

[0122] On the other hand, in the blood circuit 3, the control unit causes the blood pump 23 to rotate forward or reverse, thereby circulating the dialysate in the blood circuit 3 that forms the circulation path. This removes air bubbles contained in the dialysate through the drip chambers 24 and 26, completing the pre-filling operation.

[0123] In this way, after the pre-filling operation is completed, medical personnel can separate the venous access 3A and the arterial access 3B from the aforementioned connecting unit 13, install puncture needles at each end, puncture the patient, and begin dialysis treatment.

[0124] Next, use Figures 5-8 The diagrams illustrate the blood return process after dialysis treatment. Thick lines represent the flow of dialysate, while shaded lines represent residual blood in blood circuit 3.

[0125] like Figure 5 As shown, when the dialysis treatment ends and a command to start the blood return operation is sent to the control unit, the control unit closes the 10th on / off valve V10, which serves as the supply on / off valve, and closes the 9th on / off valve V9 of the dialysate supply passage 4A and the 11th on / off valve V11 of the dialysate discharge passage 4B, cutting off the connection with the dialyzer 2, and opens the 12th on / off valve V12, which serves as the supply on / off valve of the first bypass passage 41, and the 13th on / off valve V13, which serves as the discharge on / off valve.

[0126] Therefore, in Figure 5 In this state, the fourth on / off valve V4 of the second dialysate chamber 32 is opened, connecting the supply chamber 32A with the dialysate supply passage 4A. The sixth on / off valve V6 is opened, connecting the dialysate discharge passage 4B with the recovery chamber 32B. A closed loop is formed by the supply chamber 32A, the dialysate supply passage 4A, the first bypass passage 41, the dialysate discharge passage 4B, and the recovery chamber 32B. When the delivery pump 33 is operated in this state, the dialysate moves from the supply chamber 32A to the recovery chamber 32B.

[0127] In this state, the control unit activates the aforementioned fluid delivery pump 33, opening the 16th on / off valve V16 located in the second branch passage 42b of the second bypass passage 42. This causes the dewatering pump 38 in the dewatering passage 37 to deliver fluid in the reverse direction, supplying purified water from the second bypass passage 42 through the dewatering passage 37 to the dialysate discharge passage 4B in a predetermined amount each time. Simultaneously, the 14th on / off valve V14 located in the supply / discharge branch passage 12b and the 3rd clamp 28 of the blood return passage 12a are opened and closed.

[0128] Therefore, the purified water flowing in from the water removal passage 37 is transported by the liquid delivery pump 33, and... Figure 5 In the above-mentioned state, the dialysate flows from the dialysate discharge passage 4B into the recovery chamber 32B of the second dialysate chamber 32.

[0129] As a result, a closed loop 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. Therefore, the dialysate supplied from the dialysate supply passage 4A, in an amount equal to the purified water delivered by the aforementioned water removal pump 38, overflows from the closed loop and flows from the aforementioned first bypass passage 41 through the supply and discharge branch passage 12b and the blood return passage 12a into the arterial passage 3B of the blood circuit 3.

[0130] On the other hand, in blood circuit 3, such as Figure 5 As shown, when the first clamp 22 is closed and the second clamp 27 is open, the control unit causes the blood pump 23 to rotate in the forward direction and delivers the dialysate flowing in from the blood return passage 12a to the dialyzer 2 in a specified amount.

[0131] Therefore, in Figure 5 In the example, the dialysate flowing from the blood return pathway 12a into the arterial pathway 3B is transported by the blood pump 23 and flows into the dialyzer 2, substantially filling the interior of all the hollow wires 2a of the dialyzer 2.

[0132] In the venous access 3A, which is ahead of the dialyzer 2, the second clamp 27 is opened, so that a amount of blood corresponding to the amount of dialysate flowing into the arterial access 3B is returned to the patient from the front end of the venous access 3A.

[0133] In contrast, in the arterial pathway 3B, the branch position is further anterior (patient side) than that of the aforementioned blood return pathway 12a. The first clamp 22 is closed, thus preventing the flow of dialysate and maintaining the state of residual blood.

[0134] Therefore, in Figure 5 After the state, such as Figure 6 As shown, after closing the second clamp 27, a pre-set small amount of dialysate is supplied from the blood return passage 12a, and after the blood pump 23 delivers the liquid in the positive direction, the blood pump 23 is stopped.

[0135] This results in a small amount of dialysate being pumped from the blood pump 23 toward the dialyzer 2. The amount of dialysate pumped in at this time is defined as such that the elastic tubes forming the pathways can expand and absorb the fluid without applying unnecessary pressure to the arterial pathway 3B or the venous pathway 3A, and that the tubes will not detach or the fluid will leak.

[0136] For example, in the case of Figure 5 When the second clamp 27 is open, and the amount flowing in from the blood return passage 12a is 100ml, it is possible to set the amount pressed in after closing to 4ml.

[0137] Figure 7 This illustrates the action of returning blood to the patient from the anterior end of the branch in arterial pathway 3B, which is located further forward than the branch in blood return pathway 12a.

[0138] from Figure 6 In the state where a specified small amount (e.g., 4 ml) of dialysate is pumped into the dialyzer 2 by the blood pump 23, the third clamp 28 of the blood return pathway 12a is closed, and the first clamp 22 of the arterial pathway 3B is opened.

[0139] In this state, the control unit reverses the blood pump 23 by the same prescribed small amount, causing the dialysate pumped from the blood pump 23 toward the dialyzer 2 to flow in the opposite direction, so that the blood remaining in the arterial pathway 3B, which is located further forward than the branch position of the blood return pathway 12a, is returned to the patient in the prescribed small amount.

[0140] The amount of blood remaining from the branch position to the tip is more than the amount of dialysate corresponding to the small amount specified above. Therefore, the action of returning a small amount of blood each time is repeated many times.

[0141] That is, again Figure 5 As shown, with the second clamp 27 open, a specified small amount of dialysate flows in from the blood return passage 12a and is delivered in the positive direction by the blood pump 23.

[0142] Then, blood corresponding to the small amount of dialysate flowing in is returned from the anterior end of venous access 3A, and then, as... Figure 6 As shown, with the second clamp 27 closed, a specified small amount of dialysate is allowed to flow in from the blood return passage 12a, and the blood pump 23 delivers the fluid in the positive direction, and then stops it.

[0143] After that, as Figure 7 As shown, with the first clamp 22 open, the blood pump 23 is reversed, causing the same small amount of dialysate to flow in the opposite direction and return blood to the patient from the front end of the arterial access 3B.

[0144] Through repeated such actions Figures 5-7 The action shown in the diagram causes the blood remaining in the arterial pathway 3B from the front end to the blood pump 23 to return to the patient.

[0145] Figure 8 The action is shown to completely return blood from venous access 3A to the patient.

[0146] from Figure 7 The status, control unit and Figure 5 Similarly, the 14th opening / closing valve V14 of the above-mentioned supply and drainage branch passage 12b and the 3rd clamp 28 of the blood return passage 12a are opened, and then the 1st clamp 22 of the arterial passage 3B is closed and the 2nd clamp 27 of the venous passage 3A is opened.

[0147] In this state, the control unit rotates the blood pump 23 forward, delivering dialysate flowing from the blood return passage 12a to the dialyzer 2 and the venous access 3A. As a result, any blood remaining in the venous access 3A is transported to the front end and returned to the patient.

[0148] At this time, the control unit controls the delivery volume of the above-mentioned dewatering pump 38 and blood pump 23 based on the volume of the entire hollow wire 2a of the dialyzer 2, the arterial passage 3B, and the venous passage 3A, and returns the blood remaining in the blood circuit 3 to the patient.

[0149] As described above, in the dialysis apparatus 1 according to this embodiment, during the pre-filling operation, the connector 21 at the front end of the arterial passage 3B and the connector 25 at the front end of the venous passage 3A of the blood circuit 3 are connected by the connecting unit 13 as a circulation path, and dialysate is supplied from the supply passage 11 to pre-fill the dialyzer 2 and the blood circuit 3. The drained fluid during pre-filling is discharged from the supply and discharge passage 12 to the dialysate discharge passage 4B. Therefore, the pre-filling operation can be performed without connecting the front ends of the arterial passage 3B and the venous passage 3A of the blood circuit 3 to the dialysate discharge passage 4B.

[0150] In addition, during the blood return procedure, the dialysate flows from the blood return pathway 12a into the arterial pathway 3B, eliminating the need for a separate fluid supply port for blood return.

[0151] Furthermore, the above embodiments describe the preparation of dialysate in the first and second dialysate chambers 31 and 32, i.e., a personal dialysis device, but it can also be used in a dialysis monitoring device that supplies pre-prepared fresh dialysate through the water supply passage 4C.

Claims

1. A blood purification device, comprising: A blood circuit includes an arterial access and a venous access connected to a blood purifier; a dialysate circuit includes a dialysate supply access and a dialysate discharge access connected to the blood purifier; a blood pump is disposed in the arterial access; and a dialysate supply and discharge unit is disposed in the dialysate circuit to supply and discharge dialysate from the blood purifier. This blood purification device circulates blood from the arterial access to the venous access via the blood purifier for blood purification treatment. Its characteristic is... The blood purification device includes: a fluid supply passage, one end of which is connected to the dialysate supply passage, and the other end of which is connected to the arterial or venous passage; a supply and discharge passage, one end of which is connected to the arterial passage, and the other end of which is connected to both the dialysate supply passage and the dialysate discharge passage; and a switching unit for switching the supply and discharge of dialysate to the blood circuit in the supply and discharge passages. During the pre-treatment filling process, once a circulatory path connecting the front ends of the aforementioned arterial and venous access routes is established, dialysate is supplied from the dialysate supply route to the blood circuit via the aforementioned supply route, and the dialysate is discharged from the blood circuit via the aforementioned supply and drainage routes to the aforementioned dialysate discharge route. In the post-treatment blood return procedure, dialysate is supplied to the blood circuit from the dialysate supply passage via the aforementioned supply and drainage passages, and blood is returned from the front end of the aforementioned arterial and venous passages.

2. The blood purification device according to claim 1, characterized in that, have: The bypass passage is connected at one end to the dialysate supply passage and at the other end to the dialysate discharge passage. The aforementioned switching unit includes a supply on / off valve for opening and closing the aforementioned bypass passage and a liquid supply on / off valve for opening and closing the aforementioned liquid supply passage. One end of the aforementioned supply and drainage pathway is connected between the front end of the aforementioned arterial pathway and the aforementioned blood pump, and the other end of the aforementioned supply and drainage pathway is connected between the aforementioned supply on / off valve of the aforementioned bypass pathway and the other end connected to the aforementioned dialysate drainage pathway. In the aforementioned pre-charging operation, the aforementioned liquid supply valve is opened and the aforementioned supply valve is closed; in the aforementioned blood return operation, the aforementioned supply valve is opened and the aforementioned liquid supply valve is closed.

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