Personal hemodialysis device

Abstract

To provide a console that is hygienic and safe, and can return as much blood as possible. [Solution] When the hemodialysis machine body 100 detects a supply abnormality in the supply abnormality detection unit 505, and the chamber empty determination unit 84 determines that the dialysate chamber 31 supplying dialysate to the dialysate introduction line is empty, the machine controls the machine to deliver the dialysate contained in the dialysate chamber 31 whose dialysate concentration is unsuitable. If the concentration of the dialysate calculated by the concentration calculation unit 503 is unsuitable, the machine controls the machine to stop delivering the dialysate.

Description

Technical Field

[0001] The present invention relates to a personal hemodialysis device that purifies a patient's blood while performing extracorporeal circulation.

Background Art

[0002] When dialysis cannot be continued with a personal hemodialysis device, for example, when the liquid supply pressure in the personal hemodialysis device decreases, or when a power outage occurs and water supply becomes impossible, it is required to perform emergency blood return under such circumstances to appropriately return the blood in the blood circuit to the patient and prevent blood loss.

[0003] In addition, in a personal hemodialysis device, dialysis fluid is prepared by mixing RO (Reverse Osmosis) water, stock solution A, and stock solution B at a predetermined ratio within the personal hemodialysis device.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] When emergency blood return is required during the preparation of dialysis fluid in a personal hemodialysis device, the personal hemodialysis device is usually in a state where dialysis fluid with an inappropriate concentration during preparation is accumulated inside. Conventionally, no means has been proposed to perform emergency blood return to the patient hygienically, safely, and power-savingly without drawing in air and without leaving blood in the blood circuit. In addition, although it is preferable to return as much blood as possible, no means has been proposed to increase the blood return volume as much as possible.

[0006] An object of the present invention is to provide a personal hemodialysis device that is hygienic and safe and can return as much blood as possible. [Means for solving the problem]

[0007] The present invention relates to a personal hemodialysis apparatus comprising a plurality of dialysate chambers, wherein dialysate is prepared in the dialysate chambers, and includes a dialysate introduction line, one end of which is connected to each of the dialysate chambers and the other end of which is connected to a dialyzer that purifies blood, through which dialysate flows from the dialysate chamber to the dialyzer; a dialysate discharge line, one end of which is connected to the dialyzer and the other end of which is connected to each of the dialysate chambers, through which dialysate flows from the dialyzer to the dialysate chamber; and a dialysate discharge line, one end of which is connected to the dialysate discharge line The personal hemodialysis machine includes a drain line connected to the dialysate outlet line for discharging the dialysate flowing through the dialysate outlet line, a pump provided in the drain line, a supply abnormality detection unit for detecting abnormalities in the supply of RO water to the dialysate chamber, a load control unit for controlling the opening and closing of valves included in the personal hemodialysis machine and the operation of the pump, a chamber empty determination unit for determining when the dialysate has finished being discharged from the dialysate chamber, and a concentration calculation unit provided in the dialysate inlet line for calculating the concentration of the dialysate flowing through the dialysate inlet line, wherein the supply abnormality detection unit is supplying If an abnormality is detected, the load control unit controls the opening and closing of the valve and rotates the pump so that the dialysate contained in the dialysate chamber supplying dialysate to the dialysate introduction line is sent to the dialyzer via the dialysate introduction line. If the chamber empty determination unit determines that the dialysate chamber supplying dialysate to the dialysate introduction line is empty, the load control unit controls the opening and closing of the valve so that the dialysate contained in the dialysate chamber supplying dialysate to the dialysate introduction line is stopped from being sent to the dialyzer via the dialysate introduction line, and controls the opening and closing of the valve so that the dialysate contained in the other dialysate chambers is sent to the dialyzer via the dialysate introduction line. If the concentration of the dialysate calculated by the concentration calculation unit becomes unsuitable, the load control unit controls the opening and closing of the valve so that the dialysate contained in the other dialysate chambers is stopped from being sent to the dialyzer via the dialysate introduction line.

[0008] The personal hemodialysis apparatus of the present invention further comprises a pressure sensor provided in the dialysate discharge line, and the chamber empty determination unit may determine whether the dialysate chamber is empty based on the detection result of the pressure sensor.

[0009] The present invention relates to a personal hemodialysis apparatus comprising a plurality of dialysate chambers, wherein dialysate is prepared in the dialysate chambers, and includes a dialysate introduction line, one end of which is connected to each of the dialysate chambers and the other end of which is connected to a dialyzer that purifies blood, through which dialysate flows from the dialysate chamber to the dialyzer; a dialysate discharge line, one end of which is connected to the dialyzer and the other end of which is connected to each of the dialysate chambers, through which dialysate flows from the dialyzer to the dialysate chamber; and a dialysate discharge line, one end of which is connected to the dialysate discharge line. , a drain line that removes water by draining from the dialysate outlet line, a pump provided on the drain line, a blood circuit with one end connected to the patient's artery and the other end connected to the patient's vein via the dialyzer, a replenishment fluid line with one end connected to the dialysate inlet line and the other end connected to the blood circuit, through which replenishment fluid flows to the blood circuit, a supply abnormality detection unit that detects abnormalities in the supply of RO water supplied to the dialysate chamber, a load control unit that controls the opening and closing of valves and the operation of the pump included in the personal hemodialysis machine, and the dialysate chamber The load control unit comprises a chamber empty determination unit that determines when the discharge of dialysate from the valve has finished, and a concentration calculation unit provided in the dialysate introduction line that calculates the concentration of the dialysate flowing through the dialysate introduction line. When the supply abnormality detection unit detects a supply abnormality, the load control unit controls the opening and closing of the valve and rotates the pump so that the dialysate contained in the dialysate chamber that supplies dialysate to the dialysate introduction line is sent to the blood circuit via the replenishment fluid line. When the chamber empty determination unit determines that the dialysate chamber that supplies dialysate to the dialysate introduction line is empty, the load control unit controls the opening and closing of the valve so that the dialysate contained in the dialysate chamber that supplies dialysate to the dialysate introduction line is stopped from being sent to the blood circuit via the replenishment fluid line, and controls the opening and closing of the valve so that the dialysate contained in the other dialysate chambers is sent to the blood circuit via the replenishment fluid line. When the concentration of the dialysate calculated by the concentration calculation unit becomes unsuitable, the load control unit controls the opening and closing of the valve.The valve is controlled to stop the dialysis fluid contained in the other dialysis fluid chamber from being delivered to the blood circuit via the replacement fluid line.

[0010] The personal hemodialysis apparatus of the present invention further comprises a pressure sensor provided in the replacement fluid line, and the chamber empty determination unit may determine whether the dialysate chamber is empty based on the detection result of the pressure sensor. [Effects of the Invention]

[0011] According to the present invention, it is possible to provide a personal hemodialysis console and a personal hemodialysis apparatus that are hygienic and safe and can return as much blood as possible. [Brief explanation of the drawing]

[0012] [Figure 1] Figure 1 shows the overall configuration of a personal hemodialysis device according to one embodiment of the present invention. [Figure 2A] Figure 2A is a diagram showing some of the lines and valves of a personal hemodialysis machine in Embodiment 1. [Figure 2B] Figure 2B is an illustrative diagram of a personal hemodialysis machine used when performing the first stage of emergency blood return in Embodiment 1. [Figure 2C] Figure 2C is an illustrative diagram of a personal hemodialysis machine used when performing the second stage of emergency blood return in Embodiment 1. [Figure 3A] Figure 3A shows the process of injecting RO water during the preparation of dialysate. [Figure 3B] Figure 3B shows the process of injecting stock solution A during the preparation of the dialysate. [Figure 3C] Figure 3C shows the process of injecting stock solution B during the preparation of dialysate. [Figure 4] Figure 4 is a block diagram illustrating the overview of the various components of the personal hemodialysis device according to this embodiment. [Figure 5A]FIG. 5A is a diagram showing a partial extraction of the lines and valves of the personal hemodialysis device in Embodiment 2. [Figure 5B] FIG. 5B is an image diagram of the personal hemodialysis device when performing the first-stage emergency blood return in Embodiment 2. [Figure 5C] FIG. 5C is an image diagram of the personal hemodialysis device when performing the second-stage emergency blood return in Embodiment 2.

Mode for Carrying Out the Invention

[0013] A preferred embodiment of the personal hemodialysis device 1 of the present invention will be described with reference to the drawings. The personal hemodialysis device 1 is a device that purifies the blood of patients with renal failure and drug poisoning, removes excess water in the blood, and replenishes water, that is, replenishes fluid, in the blood as necessary.

[0014] The overall configuration of the personal hemodialysis device 1 will be described with reference to FIG. 1. FIG. 1 is a diagram showing the overall configuration of the personal hemodialysis device 1 of the present embodiment. The personal hemodialysis device 1 includes a blood circuit 20, a dialysate circuit 30, a replenishing fluid line 38, and a console 100 as the hemodialysis device main body. In the console 100, a part of the blood circuit 20, a part of the dialysate circuit 30, a heater 40, a chemical solution pump 231, a replenishing fluid pump 39, a control unit 50, an operation unit 70, and a display unit 80 are arranged. FIG. 1 is a diagram showing a partial extraction of the lines and valves arranged in the console 100. FIG. 1 and each of the figures described below do not show all the lines, valves, and components arranged in the console 100. In any configuration, a configuration in which the technology of the present disclosure can be implemented is included in the embodiments of the present disclosure.

[0015] In the personal hemodialysis device 1, the dialysate is not supplied from the outside to the console 100 as a previously appropriately prepared dialysate, but is prepared in the console 100. The preparation of the dialysate in the console 100 will be described later.

[0016] The dialyzer 10, which is a component for purifying blood, includes a cylindrical container body 11 and a dialysis membrane (not shown) housed inside the container body 11. The inside of the container body 11 is partitioned by the dialysis membrane into a blood-side flow path and a dialysate-side flow path. These are not shown in any figure. In the container body 11, a blood inlet 111 and a blood outlet 112 that communicate with the blood-side flow path, and a dialysate inlet 113 and a dialysate outlet 114 that communicate with the dialysate-side flow path, are formed.

[0017] The blood circuit 20 includes an arterial line 21, a venous line 22, and a drug line 23. Additionally, an overflow line 24 may be provided. The arterial line 21, the venous line 22, and the drug line 23 are each mainly composed of a flexible tube through which liquid can flow.

[0018] The tubes constituting the arterial line 21, the venous line 22, and the drug line 23 are formed of a flexible tube such as polyvinyl chloride or silicon, for example. The outer diameter of the tube can be, for example, 5.5 mm, and the inner diameter can be, for example, 3.3 mm. The hardness of the tube can be, for example, in the range of 50 or more and 85 or less according to JIS K7215.

[0019] One end side of the arterial line 21 is connected to the artery of the dialysis subject, that is, the dialysis patient, and the other end side is connected to the blood inlet 111 of the dialyzer 10.

[0020] A part of the arterial line 21 is arranged in the console 100. A blood pump 212 is arranged at the portion of the console 100 through which the arterial line 21 passes.

[0021] The blood pump 212 sends out liquids such as blood and priming liquid inside the arterial line 21 by squeezing the tube constituting the arterial line 21 with rollers.

[0022] One end side of the venous line 22 is connected to the blood outlet 112 of the dialyzer 10, and the other end side is connected to the vein of the subject.

[0023] A venous chamber 222 is positioned in the middle of the venous line 22. The venous chamber 222 is positioned between the dialyzer 10 and the hemodialysis machine body 100 in the venous line 22. The venous chamber 222 stores a predetermined amount of blood, for example, 20 ml. A venous clamp 112d is also positioned between the venous chamber 222 and the patient-side end of the venous line 22.

[0024] The drug line 23 supplies the necessary drugs to the arterial line 21 during hemodialysis. One end of the drug line 23 is connected to a drug solution pump 231 that delivers the drugs, and the other end is connected between the blood pump 212 and the dialyzer 10 in the arterial line 21.

[0025] If an overflow line 24 is provided, one end of the overflow line 24 is connected to the venous chamber 222 at its proximal end. The overflow line 24 is a line for discharging saline solution and air flowing through the venous line 22 to the outside during the priming process. An overflow clamp 241 is placed on the overflow line 24. The overflow clamp 241 opens and closes the flow path of the overflow line 24.

[0026] In the blood circuit 20, blood drawn from the subject's artery is pumped by a blood pump 212 through the arterial line 21 and introduced into the blood flow path of the dialyzer 10. The blood introduced into the dialyzer 10 is purified by dialysate flowing through the dialysate circuit 30 (described later) via a dialysis membrane. The purified blood in the dialyzer 10 is returned to the subject's vein through the venous line 22.

[0027] In this embodiment, the dialysate circuit 30 is composed of a so-called sealed volume control type dialysate circuit 30. The dialysate circuit 30 includes a dialysate chamber 31, a stock solution supply line 32, a dialysate introduction line 33, a dialysate outlet line 34, a first drain line 35, a second drain line 36 as a drain line, a water removal / reverse filtration pump 37 as a pump, a circulation pump line 90, and a circulation pump 92. The dialysate circuit 30 in this embodiment includes a plurality of dialysate chambers as the dialysate chamber 31, such as a first dialysate chamber 31A and a second dialysate chamber 31B. In the following description, when there is no need to particularly distinguish between the first dialysate chamber 31A and the second dialysate chamber 31B, the first dialysate chamber 31A and the second dialysate chamber 31B together will simply be referred to as the dialysate chamber 31.

[0028] The dialysate chamber 31 comprises a rigid container 311 capable of holding a certain volume of dialysate, and a flexible diaphragm 312 that partitions the inside of the container 311. The certain volume can be, for example, 300 ml or more and 500 ml or less. The aforementioned flexible diaphragm is also called a diaphragm. The inside of the dialysate chamber is partitioned by the diaphragm 312 into a fluid supply section 313 and a drainage section 314.

[0029] The fluid supply and containment section 313 of the first dialysate chamber 31A is referred to as the first fluid supply and containment section 313A, and the fluid supply and containment section 313 of the second dialysate chamber 31B is referred to as the second fluid supply and containment section 313B. The drain fluid containment section 314 of the first dialysate chamber 31A is referred to as the first drain fluid containment section 314A, and the drain fluid containment section 314 of the second dialysate chamber 31B is referred to as the second drain fluid containment section 314B.

[0030] The base end of the concentrate supply line 32 is connected to an RO water tank, a concentrate A tank, and a concentrate B tank (not shown), and the tip end is connected to the dialysate chamber 31. The concentrate supply line 32 supplies RO water, concentrate A, and concentrate B, which are the raw materials for dialysate, to the first fluid supply storage section 313A and the second fluid supply storage section 313B of the dialysate chamber 31. When there is no need to distinguish between concentrate A and concentrate B, or when referring to both concentrate A and concentrate B, the terms concentrate or dialysate concentrate are used instead of concentrate A and concentrate B.

[0031] The dialysate introduction line 33 connects the dialysate chamber 31 to the dialysate inlet 113 of the dialyzer 10. The dialysate introduction line 33 introduces the dialysate contained in the first fluid delivery section 313A and the second fluid delivery section 313B of the dialysate chamber 31 into the dialysate side flow path of the dialyzer 10.

[0032] The dialysate outlet line 34 connects the dialysate outlet 114 of the dialyzer 10 to the dialysate chamber 31. The dialysate outlet line 34 leads the dialysate discharged from the dialyzer 10 to the first drainage container 314A and the second drainage container 314B of the dialysate chamber 31.

[0033] The proximal end of the first drainage line 35 is connected to the dialysate chamber 31 and discharges the dialysate contained in the first drainage storage section 314A and the second drainage storage section 314B.

[0034] The second drainage line 36 has its proximal end connected to the dialysate outlet line 34 and discharges the dialysate flowing through the dialysate outlet line 34.

[0035] The ultrafiltration / reverse filtration pump 37 is located in the second drain line 36. The ultrafiltration / reverse filtration pump 37 consists of a pump that is driven to deliver dialysate from inside the second drain line 36 in a direction that flows towards the discharge side (forward direction) and in a direction that flows towards the dialysate outlet line 34 (reverse direction). The direction in which dialysate flows towards the discharge side is called the ultrafiltration direction. The direction in which dialysate flows towards the dialysate outlet line 34 is called the reverse filtration direction.

[0036] The circulating pump line 90 is positioned to bypass the dialysate outlet line 34.

[0037] The circulation pump 92 is located in the circulation pump line 90. The circulation pump 92 can facilitate the flow of dialysate in the dialysate circuit 30, among other things.

[0038] The heater 40 heats the dialysate flowing through the dialysate circuit 30 to a predetermined temperature.

[0039] The replacement fluid line 38 is a line for directly supplying dialysate as replacement fluid to the blood circuit 20. The upstream side of the replacement fluid line 38 is connected between the dialysate chamber 31 in the dialysate inlet line 33 of the dialysate circuit 30 and the dialysate inlet 113 of the dialyzer 10.

[0040] A replenishment clamp is provided in the replenishment liquid line 38. The replenishment clamp provided in the replenishment liquid line 38 during pre-dilution is replenishment liquid clamp 381, and the replenishment liquid clamp provided in the replenishment liquid line 38 during post-dilution is replenishment liquid clamp 382.

[0041] As shown by the solid line in Figure 1, if the downstream side of the replacement fluid line 38 is connected between the blood pump 212 and the dialyzer 10 in the arterial line 21, it becomes a pre-dilution type hemodiafiltration. As shown by the dashed line in Figure 1, if the downstream side of the replacement fluid line 38 is connected to the venous chamber 222 in the venous line 22, it becomes a post-dilution type hemodiafiltration.

[0042] The control unit 50 is composed of an information processing device, such as a computer. The control unit 50 controls the operation of the entire personal hemodialysis machine 1 by executing a control program in the information processing device. The control unit 50 controls and operates the personal hemodialysis machine 1 by executing control programs for various processes. Specifically, the control unit 50 controls the operation of various pumps, clamps, and heaters 40, etc., arranged in the blood circuit 20 and dialysate circuit 30, to execute various processes performed by the personal hemodialysis machine 1. These various processes include, for example, the priming process, blood withdrawal process, dialysis process, fluid replacement process, and blood return process.

[0043] In the various processes of the personal hemodialysis device 1 of this embodiment, for example, the priming process, blood withdrawal process, dialysis process, and blood return process are performed in this order, and the total execution time for all these processes is approximately 4 to 5 hours.

[0044] The priming process is a preparatory process that involves washing and purifying the blood circuit 20 and dialyzer 10. The blood withdrawal process is the process of filling the blood circuit 20 with the patient's blood after puncture and circulating it outside the body. The dialysis process follows the blood withdrawal process and involves dialysis to purify the blood. The fluid replacement process is a process of rapid fluid replacement performed during dialysis treatment, such as when blood pressure drops. The blood return process is the process of returning the blood in the blood circuit 20 back into the patient's body.

[0045] The above describes an example of a personal hemodialysis machine 1. Below, with reference to Figure 2A, the arrangement of lines and valves in the console 100 of this embodiment will be described in more detail. Figure 2A is a diagram showing some of the lines and valves arranged in the console 100. Figure 2A and the following diagrams mainly show parts related to the dialysate chamber 31. Furthermore, there are differences in the configuration between the personal hemodialysis machine 1 described with reference to Figure 1 and the personal hemodialysis machine 1 described below with reference to Figure 2A and other figures.

[0046] (Configuration related to the preparation of dialysate) The configuration for preparing dialysate in a personal hemodialysis machine 1 will now be described. In this embodiment, dialysate is prepared in the console 100. Specifically, dialysate is prepared in each dialysate chamber 31, and the prepared dialysate is stored in the dialysate chamber 31. Dialysate is prepared, for example, by mixing RO water, stock solution A, and stock solution B.

[0047] The personal hemodialysis machine 1 includes an RO water line L10, a degassing pump P1, a first solenoid valve SV1, and a third solenoid valve SV3 as components for preparing the dialysate. In Figure 2A and other figures, open valves are drawn in white and closed valves are drawn in black. First, RO water is supplied from one end of the RO water line L10. The other end of the RO water line L10 is connected to each dialysate chamber 31 via a solenoid valve. More specifically, the other end of the RO water line L10 branches into two at the junction J14 before being connected to each dialysate chamber 31. One of the branches is connected to the first fluid supply container 313A via the first solenoid valve SV1. The other branch is connected to the second fluid supply container 313B via the third solenoid valve SV3.

[0048] The degassing pump P1 is installed in the RO water line L10.

[0049] The personal hemodialysis machine 1 further includes a stock solution line L11, a stock solution tank A TA, a stock solution tank B TB, a solenoid valve SVA for stock solution A, a solenoid valve SVB for stock solution B, and a stock solution pump P2.

[0050] One end of the concentrate line L11 is connected to concentrate tank A TA and concentrate tank B TB. More specifically, one end of concentrate line L11 is connected to concentrate tank A TA via solenoid valve SVA for concentrate A, and to concentrate tank B TB via solenoid valve SVB for concentrate B. The point in concentrate line L11 where concentrate tank A TA and concentrate tank B TB are connected is called the junction point J16.

[0051] The other end of the stock solution line L11 is connected to the upstream side of junction point J14 in the RO water line L10. The point in the RO water line L10 where the other end of the stock solution line L11 is connected is called junction point J12.

[0052] The concentrate pump P2 is located downstream of the junction J16 in the concentrate line L11.

[0053] The personal hemodialysis machine 1 is further equipped with an auxiliary RO water line L12 and an auxiliary line solenoid valve SVC.

[0054] One end of the auxiliary RO water line L12 is connected to the RO water line L10, downstream of the degassing pump P1 and upstream of the connection point J12. The point on the RO water line L10 where the auxiliary RO water line L12 is connected is called the connection point J10.

[0055] The other end of the auxiliary RO water line L12 is connected to junction J16.

[0056] The auxiliary line solenoid valve SVC is installed in the auxiliary RO water line L12.

[0057] The preparation of the dialysate will be explained in more detail with reference to Figures 3A to 3C. Figures 3A to 3C are diagrams that extract and show the parts of Figure 2A that are particularly relevant to the preparation of the dialysate. The preparation of the dialysate is performed, for example, by injecting concentrate A, concentrate B, and RO water in a set ratio into a dialysate chamber 31 with a volume of 300 ml. The injection is performed in the order of RO water, concentrate A, RO water, concentrate B, and RO water. If concentrate A and concentrate B are mixed directly, they may react and form compounds. During the injection process of concentrate A and concentrate B, it is necessary to prevent them from mixing directly in the line. In other words, contact between concentrate A and concentrate B in the line is to be avoided.

[0058] The preparation of the dialysate is completed when predetermined amounts of each fluid are injected into the dialysate chamber 31 and mixed together. The console 100 in this embodiment is equipped with two dialysate chambers 31. The dialysate is prepared by switching between each dialysate chamber 31 alternately. The procedure for preparing the dialysate will be described below, using the preparation of the dialysate in the second dialysate chamber 31B as an example.

[0059] The following explanation describes the open solenoid valves for each solenoid valve shown in Figures 3A to 3C. As mentioned earlier, in the drawings, open valves are drawn in white and closed valves are drawn in black.

[0060] (RO water injection) The injection of RO water will be explained with reference to Figure 3A. In preparing the dialysate, RO water is first injected into the second fluid supply container 313B. The third solenoid valve SV3 and the auxiliary line solenoid valve SVC are opened. The degassing pump P1 and the stock pump P2 are activated. As a result, RO water is injected into the second fluid supply container 313B as shown in flow F11. Specifically, the RO water is injected into the second fluid supply container 313B by the flow through the RO water line L10 and the third solenoid valve SV3, and by the flow through the auxiliary RO water line L12, the auxiliary line solenoid valve SVC, and the stock line L11.

[0061] (Injection of undiluted solution A) The injection of concentrate A will be explained with reference to Figure 3B. After the injection of RO water as described above, concentrate A is injected. During the injection of concentrate A, RO water is also injected via the RO water line L10.

[0062] The third solenoid valve SV3 and the solenoid valve SVA for concentrate A are opened. The degassing pump P1 and the concentrate pump P4 are activated. As a result, concentrate A is injected into the second liquid supply container 313B as shown in flow F15. Specifically, concentrate A is injected into the second liquid supply container 313B by the flow through the solenoid valve SVA for concentrate A, the concentrate line L11, the RO water line L10, and the third solenoid valve SV3.

[0063] Furthermore, as shown in flow F13, RO water is injected into the second liquid supply container 313B by the flow through the RO water line L10 and the third solenoid valve SV3.

[0064] (RO water injection) After injecting concentrate A, RO water is injected again. This is to avoid contact between concentrate A and concentrate B in the concentrate line L11, as mentioned above. RO water is injected after injecting concentrate A to prevent any concentrate A from remaining in the line. The method of injecting RO water is the same as the RO water injection method explained earlier with reference to Figure 3A.

[0065] (Injection of undiluted solution B) The injection of concentrate B will be explained with reference to Figure 3C. After ensuring that no concentrate A remains in the line, etc., by injecting RO water, concentrate B is injected. During the injection of concentrate B, RO water is also injected via RO water line L10.

[0066] In the injection of concentrate B, unlike the injection of concentrate A described earlier, the solenoid valve SVA for concentrate A is closed and the solenoid valve SVB for concentrate B is opened. Specifically, the third solenoid valve SV3 and the solenoid valve SVB for concentrate B are opened. The degassing pump P1 and the concentrate pump P4 are activated. As a result, concentrate B is injected into the second liquid supply container 313B as shown in flow F17. More specifically, concentrate B is injected into the second liquid supply container 313B by the flow through the solenoid valve SVB for concentrate B, the concentrate line L11, the RO water line L10, and the third solenoid valve SV3.

[0067] Furthermore, as shown in flow F13, RO water is injected into the second liquid supply container 313B by the flow through the RO water line L10 and the third solenoid valve SV3.

[0068] (RO water injection) After injecting the B concentrate, RO water is injected again. This brings the dialysate to the desired concentration, completing the dialysate preparation. The method of injecting the RO water is the same as the RO water injection method explained earlier with reference to Figure 3A.

[0069] (First dialysis fluid chamber) The above describes the preparation of dialysate in the second dialysate chamber 31B. When preparing dialysate in the first dialysate chamber 31A, the third solenoid valve SV3 is closed and the first solenoid valve SV1 is opened. As a result, the liquid flowing through the stock solution supply line 32 flows to the first liquid supply storage unit 313A instead of the second liquid supply storage unit 313B. This prepares dialysate in the first dialysate chamber 31A.

[0070] (Emergency blood return) The emergency blood return procedure in the personal hemodialysis machine 1 of this embodiment will be explained with reference to Figures 2A to 2C and Figure 4. The emergency blood return procedure described below is performed, for example, when the supply of RO water is stopped due to a power outage or a malfunction of the personal hemodialysis machine 1. As explained with reference to Figures 3A to 3B, in the personal hemodialysis machine 1 of this embodiment, the dialysate is prepared in a dialysate chamber 31 provided in the console 100. The console 100 is equipped with two dialysate chambers 31. The dialysate is prepared alternately in the two dialysate chambers 31. Therefore, if a power outage occurs, one of the dialysate chambers 31 may still be in the process of preparing dialysate. In this case, the dialysate chamber 31 will be filled with dialysate of an inappropriate concentration.

[0071] In the personal hemodialysis device 1 of this embodiment, even when inappropriate dialysate is present in the dialysate chamber 31, it is possible to perform as many emergency blood returns as possible in a hygienic, safe, and energy-efficient manner. The following will explain this in detail.

[0072] Before explaining the opening and closing of the solenoid valve during emergency blood return, we will provide a more detailed explanation of the components of the console 100 with reference to Figure 4. Figure 4 is a block diagram showing the components of the console 100. As explained with reference to Figure 1, the console 100 includes a control unit 50, an operation unit 70, and a display unit 80.

[0073] As shown in Figure 4, the control unit 50 includes an emergency device state storage unit 501, a concentration calculation unit 503, a supply abnormality detection unit 505, a load control unit 510, a chamber empty determination unit 84, and a pressure calculation unit 86. The load control unit 510 includes a solenoid valve control unit 513 and a pump control unit 514.

[0074] The emergency device state memory unit 501 is a part that stores the state of the personal hemodialysis machine 1 at the time when emergency blood return becomes necessary.

[0075] The concentration calculation unit 503 is the part that calculates the concentration of the dialysate at a predetermined position in the line of the personal hemodialysis machine 1.

[0076] The supply abnormality detection unit 505 is the part that detects when there is an abnormality in the supply of RO water or other dialysis fluid to the dialysis fluid chamber 31. An abnormality means, for example, that RO water is not supplied, or that the amount of RO water supplied is not the predetermined amount. An abnormality in the supply of RO water may occur, for example, due to a power outage or equipment malfunction.

[0077] The configuration of the supply anomaly detection unit 505 is not particularly limited. The supply anomaly detection unit 505 can be, for example, an RO water flow sensor installed in the RO water line L10.

[0078] The load control unit 510 is the part that controls the operation of each clamp, solenoid valve, pump, etc. included in the personal hemodialysis machine 1 during emergency blood return. The load control unit 510 controls these operations via the solenoid valve control unit 513 and the pump control unit 514.

[0079] The chamber empty determination unit 84 is responsible for determining whether all the dialysate has been discharged from one of the dialysate chambers 31. If the chamber empty determination unit 84 determines that all the dialysate has been discharged, it may control the solenoid valve to switch the dialysate chambers 31 so that dialysate is discharged from the other dialysate chamber 31. Whether or not all the dialysate has been discharged from the dialysate chamber 31 can be determined based on the concentration, flow rate, or pressure of the dialysate in the dialysate circuit 30.

[0080] The pressure calculation unit 86 is the part that measures and calculates the pressure value in the lines included in the hemodialysis machine body 100.

[0081] The display unit 80 is a part that displays various information related to dialysis. The display unit 80 can be, for example, a liquid crystal display. The display unit 80 may also be equipped with a touch panel. The display unit 80 is equipped with a notification unit 82. The notification unit 82 can notify the user of various statuses of the hemodialysis machine body 100 and the completion of emergency blood return.

[0082] The control unit 70 is the part that the user operates to initiate emergency blood return. For example, emergency blood return is initiated when the user presses a button on the control unit 70 or touches a touch panel on the control unit 70.

[0083] (Structure related to emergency blood reinfusion) Referring to Figure 2A, the configuration for emergency blood return in the hemodialysis machine 100 will be explained. In the following explanation, matters explained with reference to Figure 1 will be omitted.

[0084] The personal hemodialysis machine 1 further includes a second solenoid valve SV2, a fourth solenoid valve SV4, a ninth solenoid valve SV9, a concentration sensor S3, and a mixing tank T1 in the dialysate introduction line 33.

[0085] At the end of the dialysate inlet line 33 opposite to the dialysate inlet port 113, the first fluid storage section 313A and the second fluid storage section 313B are connected to the dialysate inlet line 33 via solenoid valves. Specifically, the first fluid storage section 313A is connected to the dialysate inlet line 33 via the second solenoid valve SV2, and the second fluid storage section 313B is connected to the dialysate inlet line 33 via the fourth solenoid valve SV4. The point where the dialysate inlet line 33 branches toward the first fluid storage section 313A and the second fluid storage section 313B is called the junction point J30.

[0086] The mixing tank T1, concentration sensor S3, and ninth solenoid valve SV9 are installed in this order downstream of the junction J30 in the dialysate introduction line 33.

[0087] The mixing tank T1 is a tank for more uniform mixing of the dialysate. The dialysate is prepared in the dialysate chamber 31 of the hemodialysis machine body 100 by mixing each fluid. Therefore, the mixing tank T1 is a tank for mixing the dialysate to make it more uniform before it reaches the dialyzer 10.

[0088] The concentration sensor S3 is a sensor that measures the concentration of the dialysate flowing through the dialysate introduction line 33.

[0089] The personal hemodialysis machine 1 further includes a fifth solenoid valve SV5 to the eighth solenoid valve SV8, a tenth solenoid valve SV10, and a first pressure sensor S1 in the dialysate outlet line 34.

[0090] At the end of the dialysate outlet line 34 opposite to the dialysate outlet 114, the first drainage container 314A and the second drainage container 314B are connected to the dialysate outlet line 34 via solenoid valves. Specifically, the first drainage container 314A is connected to the dialysate outlet line 34 via the fifth solenoid valve SV5, and the second drainage container 314B is connected to the dialysate outlet line 34 via the seventh solenoid valve SV7. The point where the dialysate outlet line 34 branches toward the first drainage container 314A and the second drainage container 314B is called the junction point J32.

[0091] The tenth solenoid valve SV10 and the first pressure sensor S1 are installed in this order downstream of the dialysate outlet 114 in the dialysate outlet line 34 and upstream of the junction J32.

[0092] The personal hemodialysis machine 1 is further equipped with a fluid storage tank T11 in the second drainage line 36. The fluid storage tank T11 is located downstream of the water removal / reverse filtration pump 37 in the second drainage line 36. Drainage fluid is stored in the fluid storage tank T11. The drainage fluid stored in the fluid storage tank T11 is used in the event of emergency blood return.

[0093] In the configuration shown in Figure 2A, one end of the second drainage line 36 is connected to the dialysate outlet line 34. More specifically, one end of the second drainage line 36 is connected downstream of the first pressure sensor S1 and upstream of the connection point J32. The point in the dialysate outlet line 34 where one end of the second drainage line 36 is connected is called the connection point J36.

[0094] The personal hemodialysis machine 1 further includes a circulating pump line 90 and a circulating pump 92. One end of the circulating pump line 90 is connected to the downstream side of the first pressure sensor S1 in the dialysate outlet line 34 and to the upstream side of the junction point J36. The point in the dialysate outlet line 34 to which one end of the circulating pump line 90 is connected is called the junction point J38.

[0095] The other end of the circulating pump line 90 is connected to the downstream side of connection point J36 in the dialysate outlet line 34 and to the upstream side of connection point J32. The point in the dialysate outlet line 34 to which the other end of the circulating pump line 90 is connected is called connection point J34.

[0096] The personal hemodialysis machine 1 is equipped with a sixth solenoid valve SV6 and an eighth solenoid valve SV8 in the first drainage line 35. The sixth solenoid valve SV6 is provided in the first drainage line 35, one end of which is connected to the first drainage container 314A. The eighth solenoid valve SV8 is provided in the first drainage line 35, one end of which is connected to the second drainage container 314B.

[0097] (Emergency blood return using automatic reverse filtration function) Referring to Figures 2A to 2C, we will explain emergency blood return using the automatic reverse filtration function. Figure 2A shows an image of the hemodialysis machine 100 immediately before a situation occurs where, for example, the RO water supply pressure drops and the RO water supply becomes impossible. Emergency blood return is necessary when the RO water supply becomes impossible.

[0098] Flows F20, F26, F30, and F32 in Figure 2A show the flow of each liquid immediately before the supply of RO water is interrupted.

[0099] Flow F20 indicates the flow of RO water to the second liquid supply container 313B. Flow F26 indicates the flow of drainage from the second drainage container 314B. Discharge of drainage from the second drainage container 314B occurs in accordance with the supply of RO water or stock solution to the second liquid supply container 313B.

[0100] Flows F20 and F26 above indicate that the dialysate is being prepared in the second fluid delivery and storage section 313B.

[0101] Flow F30 shows the flow of dialysate from the first fluid supply container 313A to the dialyzer 10. Flow F32 shows the flow of dialysate and drainage from the dialyzer 10. Flows F30 and F32 indicate that dialysis is being performed using the dialysate in the first fluid supply container 313A.

[0102] As described above, the state shown in Figure 2A is one in which dialysate of normal concentration is stored in the first dialysate chamber 31A, and dialysis is being performed using the dialysate in the first dialysate chamber 31A.

[0103] In the second dialysate chamber 31B, dialysate is being prepared, and the dialysate stored in the second dialysate chamber 31B is dialysate at an inappropriate concentration.

[0104] In other words, the first dialysate chamber 31A is filled with normal dialysate and is being discharged. On the other hand, the second dialysate chamber 31B is receiving RO water, concentrate A, and concentrate B, and the mixing of the dialysate is not yet complete, so the dialysate is not at the target concentration.

[0105] Here, the emergency device state memory unit 501 stores the state of the hemodialysis machine body 100 immediately before the supply of RO water became unavailable. In the example shown in Figure 2A, the emergency device state memory unit 501 stores that the second solenoid valve SV2 and the fifth solenoid valve SV5 are open. The fact that the second solenoid valve SV2 and the fifth solenoid valve SV5 are open indicates that dialysis is being performed using the dialysate from the first dialysate chamber 31A.

[0106] As mentioned above, the state in which the RO water supply is stopped is a state in which emergency blood return is necessary. In the state shown in Figure 2A, a user of the hemodialysis machine 100, such as a dialysis patient, can press, for example, the "Emergency Blood Return" button displayed on the LCD screen of the control unit 70, which will start emergency blood return in the hemodialysis machine 100.

[0107] Refer to Figures 2B and 2C to explain the procedure for emergency blood return. Emergency blood return is performed in two steps.

[0108] (Phase 1) In the first stage, emergency blood return is performed using one of the multiple dialysate chambers 31 that supplies dialysate to the dialysate inlet line 33. The dialysate chamber 31 that supplies dialysate to the dialysate inlet line 33 is usually a dialysate chamber 31 with a normal concentration of dialysate. This is because it is a dialysate chamber 31 that supplies dialysate to the dialysate inlet line 33 precisely because its concentration is normal.

[0109] (Phase 2) In the second stage, emergency blood return is performed using one of the dialysate chambers 31 other than the one used in the first stage. This other dialysate chamber 31 is one that does not supply dialysate to the dialysate introduction line 33. This other dialysate chamber 31 is usually one in which the dialysate concentration is inappropriate. This is because in dialysate chambers 31 that do not supply dialysate, the dialysate is often still being prepared.

[0110] Figure 2B is an illustrative diagram of personal hemodialysis machine 1 during the first stage of emergency blood return. Figure 2C is an illustrative diagram of personal hemodialysis machine 1 during the second stage of emergency blood return.

[0111] Referring to Figure 2B, the first stage of emergency blood return is described. In the first stage of emergency blood return, the second solenoid valve SV2, the fifth solenoid valve SV5, and the ninth solenoid valve SV9 are opened. All other solenoid valves related to emergency blood return, except for the second solenoid valve SV2, the fifth solenoid valve SV5, and the ninth solenoid valve SV9, are kept closed. The water removal / backfiltration pump 37 is rotated in the opposite direction to normal.

[0112] Flows F30 and F34 in Figure 2B show the flow of dialysate during the first stage of emergency blood return. Flow F30 shows the flow of normal dialysate from the first fluid delivery container 313A towards the dialyzer 10 via the dialysate introduction line 33.

[0113] Flow F34 indicates the flow from the liquid storage tank T11 toward the first drainage container 314A. By reversing the rotation of the water removal / reverse filtration pump 37, the drainage stored in the liquid storage tank T11 flows toward the first drainage container 314A.

[0114] Due to these flows, the dialysate of normal concentration in the first fluid delivery container 313A is back-filtered and flows to the dialyzer 10, and the blood in the blood circuit 20 is returned to the patient. At this time, the clamps on the blood circuit 20 are open.

[0115] Then, if the pressure value of the dialysate outlet line 34 detected by the first pressure sensor S1 exceeds a predetermined threshold, it is determined that all of the dialysate of normal concentration in the first fluid supply storage unit 313A has been discharged from the first fluid supply storage unit 313A.

[0116] Once all the dialysis fluid in the first fluid delivery container 313A has been discharged, the emergency blood return process moves to the second stage.

[0117] The series of operations described above are controlled by the control unit 50. The pressure detected by the first pressure sensor S1 is calculated by the pressure calculation unit 86. In addition, the chamber empty determination unit 84 determines whether all of the dialysate in the first fluid supply storage unit 313A has been discharged.

[0118] Furthermore, the initiation of the first stage of emergency blood return and the transition to the second stage are controlled by various components of the load control unit 510.

[0119] The first stage of emergency blood return is performed by reversing the rotation of the water removal / reverse filtration pump 37. The water removal / reverse filtration pump 37 generally consumes less power than the degassing pump P1 and the circulation pump 92, etc. Therefore, even when performing emergency blood return using a battery as a power source during a power outage, for example, emergency blood return can be reliably performed.

[0120] Blood return can be performed from both the venous and arterial sides by reversing the rotation of the blood pump 212.

[0121] Referring to Figure 2C, the second stage of emergency blood return is described. In the second stage, the fourth solenoid valve SV4, the seventh solenoid valve SV7, and the ninth solenoid valve SV9 are switched to the open position. Also, the water removal / reverse filtration pump 37 is rotated in the reverse direction of normal. All solenoid valves related to emergency blood return other than the fourth solenoid valve SV4, the seventh solenoid valve SV7, and the ninth solenoid valve SV9 are kept closed.

[0122] Flows F36, F40, and F42 in Figure 2C show the flow of dialysate during the second stage of emergency blood return. Flow F36 shows the flow of dialysate of normal concentration discharged from the first fluid delivery container 313A in the first stage, through the dialysate introduction line 33 towards the dialyzer 10.

[0123] Flow F40 indicates the flow from the liquid storage tank T11 toward the second drainage container 314B. By reversing the rotation of the water removal / reverse filtration pump 37, the drainage stored in the liquid storage tank T11 flows toward the second drainage container 314B.

[0124] F42 indicates that dialysate of an inappropriate concentration is flowing from the second fluid supply storage section 313B towards the dialysate introduction line 33 and then to the dialyzer 10.

[0125] Thus, in the second stage of emergency blood return, following the normal concentration of dialysate from the first dialysate chamber 31A, dialysate of an inappropriate concentration is backfiltered from the second dialysate chamber 31B and flows toward the dialyzer 10.

[0126] At this point, if the concentration sensor S3 detects a dialysate with an inappropriate concentration, the second stage of emergency blood return is stopped.

[0127] Specifically, if the dialysate concentration detected by the concentration sensor S3 exceeds a predetermined threshold, it is determined that the dialysate is of an abnormal concentration. When an abnormally concentrated dialysate is detected, the blood return operation is terminated. This prevents the patient from receiving dialysate of an inappropriate concentration.

[0128] Furthermore, by using not only the dialysate in the first dialysate chamber 31A, but also the dialysate in the second dialysate chamber 31B, which may have an inappropriate concentration, the maximum amount of blood returned can be ensured.

[0129] Furthermore, emergency blood return can be performed using the power required to operate the water removal / backfiltration pump 37, several solenoid valves, and clamps.

[0130] (Embodiment 2) The personal hemodialysis device 1 of Embodiment 2 will be described with reference to Figures 5A to 5C. Figure 5A is a diagram showing some of the lines and valves of the personal hemodialysis device 1 in Embodiment 2. Figure 5B is an image diagram of the personal hemodialysis device 1 when performing the first stage of emergency blood return in Embodiment 2. Figure 5C is an image diagram of the personal hemodialysis device 1 when performing the second stage of emergency blood return in Embodiment 2. Figure 5A corresponds to Figure 2A in Embodiment 1, Figure 5B corresponds to Figure 2B in Embodiment 1, and Figure 5C corresponds to Figure 2C in Embodiment 1.

[0131] Embodiment 1 involved emergency blood return using an automatic reverse filtration function. Embodiment 2 involved emergency blood return using an online automatic function. The following description will mainly focus on the differences from Embodiment 1. Matters not specifically described can be the same as in Embodiment 1.

[0132] As shown in Figure 5A, the personal hemodialysis apparatus 1 of Embodiment 2 further includes a replacement fluid line 38 in addition to the personal hemodialysis apparatus 1 of Embodiment 1. One end of the replacement fluid line 38 is connected to the dialysate introduction line 33. Specifically, one end of the replacement fluid line 38 is connected downstream of the concentration sensor S3 and upstream of the ninth solenoid valve SV9 in the dialysate introduction line 33. The other end of the replacement fluid line 38 is connected to the blood circuit 20. The other end of the replacement fluid line 38 may be connected to either the arterial line 21 or the venous line 22 in the blood circuit 20.

[0133] The personal hemodialysis machine 1 of Embodiment 2 includes an 11th solenoid valve SV11 and a second pressure sensor S2. The 11th solenoid valve SV11 and the second pressure sensor S2 are installed in the replacement fluid line 38 in this order from the upstream side.

[0134] In the personal hemodialysis device 1 of Embodiment 2, an example of a situation where a power outage occurs and the device is unable to operate, resulting in the inability to supply RO water, will be described.

[0135] Flows F21, F27, F50, F51, and F52 in Figure 5A show the flow of each liquid immediately before the supply of RO water is interrupted.

[0136] Flow F21 indicates the flow of RO water to the first fluid supply container 313A. Flow F27 indicates the flow of drainage from the first drainage container 314A. Drainage from the first drainage container 314A occurs in accordance with the supply of RO water or stock solution to the first fluid supply container 313A. Flows F21 and F27 indicate that dialysate is being prepared in the first fluid supply container 313A.

[0137] Flow F50 shows the flow of dialysate from the second fluid delivery container 313B to the blood circuit 20. Flow F51 shows the flow of dialysate from the second fluid delivery container 313B to the dialyzer 10. Flow F52 shows the flow of dialysate and drainage from the dialyzer 10.

[0138] Flows F50, F51, and F52 indicate that dialysis and online replacement fluid supply (replenishment) are being performed using the dialysate in the second fluid supply container 313B.

[0139] As described above, the state shown in Figure 5A is one in which dialysate of normal concentration is stored in the second fluid supply storage unit 313B, and dialysis is being performed using the dialysate in the second fluid supply storage unit 313B.

[0140] In the first fluid delivery and storage section 313A, dialysate is being prepared, and the dialysate stored in the first fluid delivery and storage section 313A is dialysate of an inappropriate concentration.

[0141] In other words, the second fluid delivery container 313B is filled with normal dialysate and is being discharged. On the other hand, the first fluid delivery container 313A is receiving RO water, concentrate A, and concentrate B, and the dialysate mixing is not yet complete, so the dialysate is not at the target concentration.

[0142] Here, the emergency device state memory unit 501 stores the state of the hemodialysis machine body 100 immediately before the supply of RO water became impossible. In the example shown in Figure 5A, the emergency device state memory unit 501 stores that the first solenoid valve SV1 and the fourth solenoid valve SV4 are open. The fact that the first solenoid valve SV1 and the fourth solenoid valve SV4 are open indicates that dialysis is being performed using the dialysate in the second fluid supply container 313B.

[0143] When the RO water supply is stopped, it indicates that emergency blood return is necessary. In the state shown in Figure 5A, if a user of the hemodialysis machine 100, such as a dialysis patient, presses the "Emergency Blood Return" button displayed on the LCD screen of the control unit 70, the hemodialysis machine 100 will start emergency blood return.

[0144] The operation of emergency blood return will be explained with reference to Figures 5B and 5C. In Embodiment 2, as in Embodiment 1, emergency blood return is performed in two stages. In the first stage, emergency blood return is performed using one of the multiple dialysate chambers 31 that supplies dialysate to the dialysate introduction line 33. The dialysate chamber 31 that supplies dialysate to the dialysate introduction line 33 is usually a dialysate chamber 31 with a normal concentration of dialysate. In the second stage, emergency blood return is performed using one of the multiple dialysate chambers 31 other than the one used in the first stage. This other dialysate chamber 31 is a dialysate chamber 31 that does not supply dialysate to the dialysate introduction line 33. This other dialysate chamber 31 is usually a dialysate chamber 31 with an inappropriate concentration of dialysate.

[0145] Referring to Figure 5B, the first stage of emergency blood return is described. In the first stage of emergency blood return, the fourth solenoid valve SV4, the seventh solenoid valve SV7, and the eleventh solenoid valve SV11 are opened. All other solenoid valves related to emergency blood return, except for the fourth solenoid valve SV4, the seventh solenoid valve SV7, and the eleventh solenoid valve SV11, are kept closed. The ninth solenoid valve SV9, which was open in the state shown in Figure 5A, is closed in the first stage of emergency blood return. The water removal / backfiltration pump 37 is rotated in the opposite direction to normal.

[0146] Flows F50 and F54 in Figure 5B show the flow of dialysate during the first stage of emergency blood return. Flow F50 shows the flow of normal dialysate from the second fluid delivery container 313B to the blood circuit 20 via the dialysate introduction line 33 and the replacement fluid line 38 as replacement fluid.

[0147] Flow F54 indicates the flow from the liquid storage tank T11 toward the second drainage container 314B. By reversing the rotation of the water removal / reverse filtration pump 37, the drainage stored in the liquid storage tank T11 flows toward the second drainage container 314B.

[0148] Due to these flows, the dialysate of normal concentration in the second fluid delivery container 313B flows to the blood circuit 20 as replacement fluid, and the blood in the blood circuit 20 is returned to the patient. At this time, the clamps on the blood circuit 20 are open.

[0149] Then, if the pressure value of the replenishment fluid line 38 detected by the second pressure sensor S2 exceeds a predetermined threshold, it is determined that all of the dialysate of normal concentration in the second fluid supply storage unit 313B has been discharged from the second fluid supply storage unit 313B.

[0150] Once all the dialysis fluid in the second fluid delivery container 313B has been discharged, the emergency blood return process moves to the second stage.

[0151] The series of operations described above are controlled by the control unit 50. The pressure detected by the second pressure sensor S2 is calculated by the pressure calculation unit 86. In addition, the chamber empty determination unit 84 determines whether all of the dialysate in the second fluid supply storage unit 313B has been discharged.

[0152] Furthermore, the initiation of the first stage of emergency blood return and the transition to the second stage are controlled by various components of the load control unit 510.

[0153] The first stage of emergency blood return is performed by reversing the rotation of the water removal / reverse filtration pump 37. The water removal / reverse filtration pump 37 generally consumes less power compared to the degassing pump P1 and the circulation pump 92, etc. Therefore, even when performing emergency blood return using a battery as a power source during a power outage, for example, emergency blood return can be reliably performed.

[0154] Blood return can be performed from both the venous and arterial sides by reversing the rotation of the blood pump 212.

[0155] Referring to Figure 5C, the second stage of emergency blood return is described. In the second stage, the second solenoid valve SV2, the fifth solenoid valve SV5, and the eleventh solenoid valve SV11 are switched to the open position. Also, the water removal / reverse filtration pump 37 is rotated in the opposite direction to the normal rotation. All solenoid valves related to emergency blood return other than the second solenoid valve SV2, the fifth solenoid valve SV5, and the eleventh solenoid valve SV11 are kept closed. The ninth solenoid valve SV9 is closed, as in the first stage of emergency blood return.

[0156] Flows F60, F62, and F64 in Figure 5C show the flow of dialysate during the second stage of emergency blood return. Flow F60 shows the flow of dialysate of normal concentration discharged from the second fluid delivery container 313B in the second stage, which is directed towards the blood circuit 20 via the dialysate introduction line 33 and the replacement fluid line 38 as replacement fluid.

[0157] Flow F62 indicates the flow from the liquid storage tank T11 toward the first drainage container 314A. By reversing the rotation of the water removal / reverse filtration pump 37, the drainage stored in the liquid storage tank T11 flows toward the first drainage container 314A.

[0158] Flow F64 indicates that dialysate of an inappropriate concentration flows from the first fluid delivery container 313A through the dialysate introduction line 33 towards the blood circuit 20.

[0159] Thus, in the second stage of emergency blood return, following the dialysate of normal concentration from the second fluid delivery container 313B, dialysate of an inappropriate concentration flows from the first fluid delivery container 313A as replacement fluid towards the replacement fluid line 38 and, consequently, the blood circuit 20.

[0160] At this point, if the concentration sensor S3 detects a dialysate with an inappropriate concentration, the second stage of emergency blood return is stopped.

[0161] Specifically, if the dialysate concentration detected by the concentration sensor S3 exceeds a predetermined threshold, it is determined that the dialysate is of an abnormal concentration. When an abnormally concentrated dialysate is detected, the blood return operation is terminated. This prevents dialysate of an inappropriate concentration from flowing to the patient.

[0162] Furthermore, by using not only the dialysate in the second fluid delivery container 313B, but also the dialysate in the first fluid delivery container 313A that is not at an appropriate concentration, the maximum amount of blood return can be ensured.

[0163] Furthermore, emergency blood return can be performed using the power required to operate the water removal / backfiltration pump 37, several solenoid valves, and clamps.

[0164] As described above, in the personal hemodialysis device of this embodiment, if emergency blood return is required during the preparation of dialysate in the personal hemodialysis device, it is possible to return the maximum amount of blood without drawing in air, in a hygienic manner, and without leaving any blood in the dialysis circuit. Furthermore, it is safe because dialysate of an inappropriate concentration will not flow to the patient. In addition, since only the solenoid valve, the water removal / backfiltration pump, and the clamp need to be operated, emergency blood return to the patient can be performed in a power-saving manner.

[0165] The embodiments of the present invention have been described above. The present invention is not limited to the embodiments described above, and various modifications, variations, and combinations are possible.

[0166] <1> In a personal hemodialysis machine 1 equipped with multiple dialysate chambers 31, in which dialysate is prepared by supplying dialysate concentrate and RO water to the dialysate chambers 31, A dialysate introduction line 33 is provided, with one end connected to each of the dialysate chambers 31 and the other end connected to a dialyzer 10 that purifies blood, through which dialysate flows from the dialysate chamber 31 to the dialyzer 10. A dialysate outlet line 34 is connected at one end to the dialyzer 10 and at the other end to each of the dialysate chambers 31, and the dialysate flows from the dialyzer 10 to the dialysate chamber 31, A second drainage line 36 is connected at one end to the dialysate outlet line 34, and the drainage fluid flows from the dialysate outlet line 34 to remove excess water. A water removal / backfiltration pump 37 is provided in the second drainage line 36, A blood circuit 20 having one end connected to the patient's artery and the other end connected to the patient's vein via the dialyzer 10, A supply abnormality detection unit 505 detects an abnormality in the supply of RO water supplied to the dialysate chamber 31, A load control unit 510 controls the opening and closing of valves included in the personal hemodialysis machine and the operation of the ultrafiltration / reverse filtration pump 37, A chamber empty determination unit 84 that determines when the dialysate has finished being discharged from the dialysate chamber 31, A concentration calculation unit 503 is provided in the dialysate introduction line 33 and calculates the concentration of the dialysate flowing through the dialysate introduction line 33, Equipped with, When the supply abnormality detection unit 505 detects a supply abnormality, the load control unit 510 controls the opening and closing of the valve so that the dialysate contained in the dialysate chamber 31 that supplies dialysate to the dialysate introduction line 33 is sent to the dialyzer 10 via the dialysate introduction line 33, and reverses the rotation of the water removal / reverse filtration pump 37. If the chamber empty determination unit 84 determines that the dialysate chamber 31 supplying dialysate to the dialysate introduction line 33 is empty, the load control unit 510 controls the opening and closing of the valve so that the dialysate contained in the dialysate chamber 31 supplying dialysate to the dialysate introduction line 33 is stopped from being sent to the dialyzer 10 via the dialysate introduction line 33, and controls the opening and closing of the valve so that the dialysate contained in one of the multiple dialysate chambers 31 is sent to the dialyzer 10 via the dialysate introduction line 33. If the concentration of the dialysate calculated by the concentration calculation unit 503 becomes unsuitable, the load control unit 510 controls the opening and closing of the valve so that the dialysate contained in the other dialysate chamber 31 is stopped from being sent to the dialyzer 10 via the dialysate introduction line 33. Personal hemodialysis machine1.

[0167] According to the personal hemodialysis device 1 described above, it is hygienic and safe, and allows for the return of as much blood as possible.

[0168] <2> The dialysate outlet line 34 is further provided with a pressure sensor S1, The chamber empty determination unit 84 determines whether the dialysate chamber 31 is empty based on the detection result of the pressure sensor S1. <1> Personal hemodialysis machine 1 as described above.

[0169] According to the personal hemodialysis device 1 described above, it is possible to easily determine whether the dialysate chamber 31 is empty.

[0170] <3> In a personal hemodialysis machine 1 equipped with multiple dialysate chambers 31, in which dialysate is prepared by supplying dialysate concentrate and RO water to the dialysate chambers 31, A dialysate introduction line 33 is provided, with one end connected to each of the dialysate chambers 31 and the other end connected to a dialyzer 10 that purifies blood, through which dialysate flows from the dialysate chamber 31 to the dialyzer 10. A dialysate outlet line 34 is connected at one end to the dialyzer 10 and at the other end to each of the dialysate chambers 31, and the dialysate flows from the dialyzer 10 to the dialysate chamber 31, A second drainage line 36 is connected at one end to the dialysate outlet line 34, and the drainage fluid flows from the dialysate outlet line 34 to remove excess water. A water removal / backfiltration pump 37 is provided in the second drainage line 36, A blood circuit 20 having one end connected to the patient's artery and the other end connected to the patient's vein via the dialyzer 10, A replacement fluid line 38 is connected to the dialysis fluid introduction line 33 at one end and to the blood circuit 20 at the other end, and the dialysis fluid flows into the blood circuit 20 as replacement fluid. A supply abnormality detection unit 505 detects an abnormality in the supply of RO water supplied to the dialysate chamber 31, A load control unit 510 controls the opening and closing of valves included in the personal hemodialysis machine and the operation of the water removal / reverse filtration pump, A chamber empty determination unit 84 that determines when the dialysate has finished being discharged from the dialysate chamber 31, A concentration calculation unit 503 is provided in the dialysate introduction line 33 and calculates the concentration of the dialysate flowing through the dialysate introduction line 33, Equipped with, When the supply abnormality detection unit 505 detects a supply abnormality, the load control unit 510 controls the opening and closing of the valve so that the dialysate contained in the dialysate chamber 31 that supplies dialysate to the dialysate introduction line 33 is sent to the blood circuit 20 via the replenishment fluid line 38, and also reverses the rotation of the water removal / reverse filtration pump 37. If the chamber empty determination unit 84 determines that the dialysate chamber 31 supplying dialysate to the dialysate introduction line 33 is empty, the load control unit 510 controls the opening and closing of the valve so that the dialysate contained in the dialysate chamber 31 supplying dialysate to the dialysate introduction line 33 is stopped from being sent to the blood circuit 20 via the replenishment fluid line 38, and controls the opening and closing of the valve so that the dialysate contained in one of the multiple dialysate chambers 31 is sent to the blood circuit 20 via the replenishment fluid line 38. If the concentration of the dialysate calculated by the concentration calculation unit 503 becomes unsuitable, the load control unit 510 controls the opening and closing of the valve so that the dialysate contained in the other dialysate chamber 31 is stopped from being sent to the blood circuit 20 via the replenishment fluid line 38. Personal hemodialysis machine1.

[0171] According to the personal hemodialysis device 1 described above, it is hygienic and safe, and allows for the return of as much blood as possible.

[0172] <4> The replenishment fluid line 38 is further provided with a pressure sensor S2, The chamber empty determination unit 84 determines whether the dialysate chamber 31 is empty based on the detection result of the pressure sensor S2. <3> Personal hemodialysis machine 1 as described above.

[0173] According to the personal hemodialysis device 1 described above, it is possible to easily determine whether the dialysate chamber 31 is empty. [Explanation of Symbols]

[0174] 1 Personal hemodialysis machine 10 Dialyzer 20 Blood circuit 21 Arterial line 22 Venous line 23 Drug lines 24 Overflow line 30 Dialysate circuit 31 Dialysis fluid chamber 31A First Dialysis Fluid Chamber 31B Second Dialysis Fluid Chamber 32. Supply line for undiluted solution, etc. 33 Dialysis fluid infusion line 34 Dialysis fluid outlet line 35. First drainage line 36. Second drainage line 37 Filtration / Back Filtration Pump 38 Refill fluid lines 39 Refill fluid pump 40 Heater 50 Control Unit 70 Operation section 80 Display section 82 Notification Department 84 Chamber empty determination unit 86 Pressure Calculation Unit 90 Circulation pump line 92 Circulation pump 100 Console (Hemodialysis Machine Unit) 111 Blood inlet 112 Blood outlet 113 Dialysis fluid inlet 114 Dialysate outlet 212 Blood pump 222 Venous side chamber 231 Chemical solution pump 241 Overflow Clamp

Claims

1. In a personal hemodialysis machine equipped with multiple dialysate chambers, in which dialysate is prepared by supplying dialysate concentrate and RO water to the dialysate chambers, A dialysate introduction line is provided, with one end connected to each of the dialysate chambers and the other end connected to a dialyzer that purifies blood, through which dialysate flows from the dialysate chamber to the dialyzer. A dialysate outlet line is provided, with one end connected to the dialyzer and the other end connected to each of the dialysate chambers, through which the dialysate flows from the dialyzer to the dialysate chamber. One end is connected to the dialysate outlet line, and the drain line discharges the dialysate flowing through the dialysate outlet line, A pump provided in the drainage line, A supply abnormality detection unit for detecting abnormalities in the supply of RO water to the dialysate chamber, A load control unit that controls the opening and closing of valves and the operation of the pump included in the personal hemodialysis machine, A chamber empty determination unit that determines when the dialysate has finished being discharged from the dialysate chamber, A concentration calculation unit is provided in the dialysate introduction line and calculates the concentration of the dialysate flowing through the dialysate introduction line, Equipped with, When the supply abnormality detection unit detects a supply abnormality, the load control unit controls the opening and closing of the valve and rotates the pump so that the dialysate contained in the dialysate chamber supplying dialysate to the dialysate introduction line is sent to the dialyzer via the dialysate introduction line. If the chamber empty determination unit determines that the dialysate chamber supplying dialysate to the dialysate introduction line is empty, the load control unit controls the opening and closing of the valve so that the dialysate contained in the dialysate chamber supplying dialysate to the dialysate introduction line is stopped from being sent to the dialyzer via the dialysate introduction line, and controls the opening and closing of the valve so that the dialysate contained in one of the plurality of dialysate chambers is sent to the dialyzer via the dialysate introduction line. If the concentration of the dialysate calculated by the concentration calculation unit becomes unsuitable, the load control unit controls the opening and closing of the valve so that the dialysate contained in the other dialysate chamber is stopped from being sent to the dialyzer via the dialysate introduction line. Personal hemodialysis machine.

2. The dialysate outlet line further includes a pressure sensor, The chamber empty determination unit determines whether the dialysis fluid chamber is empty based on the detection result of the pressure sensor. A personal hemodialysis device according to claim 1.

3. In a personal hemodialysis machine equipped with multiple dialysate chambers, in which dialysate is prepared by supplying dialysate concentrate and RO water to the dialysate chambers, A dialysate introduction line is provided, with one end connected to each of the dialysate chambers and the other end connected to a dialyzer that purifies blood, through which dialysate flows from the dialysate chamber to the dialyzer. A dialysate outlet line is provided, with one end connected to the dialyzer and the other end connected to each of the dialysate chambers, through which the dialysate flows from the dialyzer to the dialysate chamber. One end is connected to the dialysate outlet line, and the drain line discharges the dialysate flowing through the dialysate outlet line, A pump provided in the drainage line, A blood circuit having one end connected to the patient's artery and the other end connected to the patient's vein via the dialyzer, A replacement fluid line is provided, with one end connected to the dialysate introduction line and the other end connected to the blood circuit, through which dialysate flows to the blood circuit as replacement fluid. A supply abnormality detection unit for detecting abnormalities in the supply of RO water to the dialysate chamber, A load control unit that controls the opening and closing of valves and the operation of the pump included in the personal hemodialysis machine, A chamber empty determination unit that determines when the dialysate has finished being discharged from the dialysate chamber, A concentration calculation unit is provided in the dialysate introduction line and calculates the concentration of the dialysate flowing through the dialysate introduction line, Equipped with, When the supply abnormality detection unit detects a supply abnormality, the load control unit controls the opening and closing of the valve and rotates the pump so that the dialysate contained in the dialysate chamber supplying dialysate to the dialysate introduction line is sent to the blood circuit via the replenishment fluid line. If the chamber empty determination unit determines that the dialysate chamber supplying dialysate to the dialysate introduction line is empty, the load control unit controls the opening and closing of the valve so that the dialysate contained in the dialysate chamber supplying dialysate to the dialysate introduction line is stopped from being sent to the blood circuit via the replenishment fluid line, and controls the opening and closing of the valve so that the dialysate contained in one of the multiple dialysate chambers is sent to the blood circuit via the replenishment fluid line. If the concentration of the dialysate calculated by the concentration calculation unit becomes unsuitable, the load control unit controls the opening and closing of the valve so that the dialysate contained in the other dialysate chamber is stopped from being sent to the blood circuit via the replenishment fluid line. Personal hemodialysis machine.

4. The aforementioned replenishment fluid line is further equipped with a pressure sensor, The chamber empty determination unit determines whether the dialysis fluid chamber is empty based on the detection result of the pressure sensor. The personal hemodialysis apparatus according to claim 3.

Images