Object liquid purifier

The target liquid purification device addresses the inefficiencies of existing dialysis methods by using a porous membrane and flow rate control to accurately measure target substance concentrations without blood sampling, reducing fluid usage and ensuring safe, efficient dialysis.

JP2025128837APending Publication Date: 2025-09-03PHYSIOLOGAS TECH INC
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Patent Information

Application Number
JP2024025785
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2024-02-22
Publication Date
2025-09-03

AI Technical Summary

Technical Problem

Existing dialysis methods require large amounts of dialysis fluid and replacement fluid, complicating the process and posing safety and efficiency challenges due to blood sampling or short contact times with porous membranes, which hinder accurate concentration measurement of target substances.

Method used

A target liquid purification device with a porous membrane separation system, concentration sensor, and flow rate control, allowing for accurate measurement of target substance concentration without blood sampling, by ensuring prolonged contact time with the membrane and controlled fluid flow rates.

Benefits of technology

The device efficiently reduces the total amount of dialysis fluid used, ensures safe operation without blood sampling, and accurately measures target substance concentrations, facilitating reliable dialysis with minimal fluid usage.

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Abstract

To provide an object liquid purifier that allows dialysis to be performed in a reliable manner, and allows the concentration of an object substance in blood to be measured accurately while reducing a total amount of dialysis solution used in the dialysis without needing to collect blood, which is structured to be simple and so safe as not to affect a human body.SOLUTION: An object liquid purifier includes: a body part 1; a concentration measuring device 2; a control device 3; and a notification device 4. The body part 1 includes a separation device 100, an unpurified object liquid passage 11, a purified object liquid passage 12, a filtration dialysis drainage passage 21, a dialysis solution passage 412, a drainage passage 24, a first flow rate adjusting device 36, and a concentration sensor 35 for outputting a signal according to the concentration of an object substance in the object liquid. The concentration measuring device 2 measures the concentration of the object substance in the object liquid on the basis of the output signal of the concentration sensor 35.SELECTED DRAWING: Figure 1
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Description

[Technical Field]

[0001] The present invention relates to a device for purifying a target liquid. [Background technology]

[0002] BACKGROUND ART In the past, from the viewpoint of reducing the total amount of dialysate used in dialysis methods, blood purification methods involving partial regeneration using adsorbents have been proposed (see, for example, Patent Document 1). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] U.S. Patent No. 9,302,038 Summary of the Invention [Problem to be solved by the invention]

[0004] However, the dialysis fluid used in the dialysis method disclosed in Patent Document 1 requires a replacement fluid to be supplied during dialysis, which results in a problem that the total amount of dialysis is still large and also requires a large amount of replacement fluid, and is therefore insufficient from the perspective of reducing the total amount of dialysis fluid.

[0005] Furthermore, reducing the total volume of dialysis fluid generally poses the problem of insufficient dialysis. From the perspective of reducing the total volume of dialysis fluid, it is conceivable to measure the concentration of a target substance in the target fluid (blood) during purification (during dialysis) in order to determine whether dialysis has been performed sufficiently. One method involves directly inserting a measuring device that measures the target substance into the human body. However, inserting a measuring device into the human body complicates the device or dialysis method from a safety standpoint, posing safety and efficiency challenges.

[0006] Another possible method is to collect blood during dialysis without using a measuring device. However, this method requires that blood be collected during dialysis through a separate fluid passage connected to a separate dialysis device, which complicates the device or dialysis method from a safety standpoint, posing safety and efficiency challenges.

[0007] Another possible method is to install a measuring device inside the dialysis machine. However, this method has the problem that the blood only comes into contact with the porous membrane for a short period of time during dialysis, resulting in a difference in concentration before and after passing through the porous membrane, making it impossible to accurately measure the concentration of the target substance in the blood.

[0008] Therefore, the present invention aims to provide a target fluid purification device that can reliably perform dialysis, reduce the total amount of dialysis fluid used in dialysis, has a simple structure that does not require blood sampling and is safe enough to not affect the human body, and can accurately measure the concentration of a target substance in the blood. [Means for solving the problem]

[0009] In order to achieve the above object, the present invention has the following specific features.

[0010] The target liquid purification device of the present invention is A target liquid purification device for removing at least one target substance from an unpurified target liquid, comprising: a separation device comprising a porous membrane having a pore size that allows the target substance contained in the unpurified target liquid to pass through, and a first portion and a second portion separated by the porous membrane, wherein the unpurified target liquid containing the target substance is passed through the porous membrane from the first portion and introduced into the second portion to produce a dialysis filtrate, and the target substance contained in the unpurified target liquid is removed by the passage, thereby producing a purified target liquid; an unpurified liquid passage for introducing the unpurified liquid into the first portion of the separation device; a liquid to be purified passage for leading the liquid to be purified from the first portion of the separation device; a dialysate passageway for delivering the dialysate from the outlet of the second portion of the separation device; a drainage passage for disposing of the dialysis fluid from the dialysis fluid passage as a drainage fluid; a dialysate passage for introducing dialysate into an introduction portion provided upstream of the outlet portion of the second portion; a concentration sensor provided in at least one of the dialysate passage and the drainage passage, the concentration sensor outputting a signal corresponding to the concentration of the target substance in the dialysate; a flow rate adjusting device provided in at least one of the dialysis fluid passage and the discharge passage, which adjusts the flow rate of the dialysis fluid; and a concentration measuring device that measures the concentration of the target substance based on the output signal of the concentration sensor during the period when the flow rate adjusting device controls the flow rate of the dialysis fluid to be equal to or lower than the flow rate of the unpurified target fluid.

[0011] In the target liquid purification device having the above-described configuration, a replenishment liquid passage for introducing replenishment liquid into the target liquid purification device; The substitution fluid passage is preferably configured to introduce the substitution fluid into at least one of the unpurified fluid passage, the purified fluid passage, and the dialysate passage.

[0012] In the target liquid purification device having the configuration described above, the drain passage is configured to branch off from the dialysate passage and discard a first liquid that is a part of the dialysate as drainage; The dialysate filtrate passage is preferably configured to introduce, as the dialysate, a second liquid, which is the remainder of the dialysate filtrate, into an inlet of the dialysate passage.

[0013] In the target liquid purification device having the configuration described above, a replenishment liquid passage for introducing replenishment liquid into the target liquid purification device; The substitution fluid passage is preferably configured to introduce the substitution fluid into at least one of the unpurified fluid passage, the purified fluid passage, the filtered dialysate passage, and the dialysate passage.

[0014] In the target liquid purification device having the configuration described above, a regeneration unit that is provided in the dialysis fluid passage between a branch point of the discharge passage and an introduction section of the dialysis fluid passage, the regeneration unit having an adsorbent that adsorbs the target substances, and that brings the second fluid introduced from the dialysis fluid passage into contact with the adsorbent to remove at least one of the target substances from the second fluid and generate a regeneration fluid having a reduced concentration of the target substances; The regeneration unit is preferably configured to introduce the regenerated fluid as a dialysate into an inlet of the dialysate passage.

[0015] In the target liquid purification device having the configuration described above, a replenishment liquid passage for introducing replenishment liquid into the target liquid purification device; The substitution fluid passage is preferably configured to introduce the substitution fluid into at least one of the unpurified fluid passage, the purified fluid passage, the filtered dialysate passage, and the dialysate passage.

[0016] In the target liquid purification device having the configuration described above, It is preferable that the apparatus further comprises a waste liquid flow rate regulator that regulates the flow rate of the first liquid, and a replenisher liquid flow rate regulator that regulates the flow rate of the replenisher liquid.

[0017] In the target liquid purification device having the configuration described above, an anomaly detection device that detects an anomaly based on a time-series variation in the concentration of the target substance; It is preferable that the system further comprises an alarm device that notifies of an abnormality detected by the abnormality detection device. [Effects of the Invention]

[0018] In the subject fluid purification device having any of the above configurations, the concentration sensor and the flow rate regulator are provided in at least one of the dialysate passage and the drain passage, so that the degree of purification of the subject fluid can be estimated without separately sampling blood.

[0019] The concentration measuring device measures the concentration of the target substance based on the output signal of the concentration sensor during the period when the flow rate adjusting device controls the flow rate of the dialysis fluid to be equal to or lower than the flow rate of the unpurified target fluid. Therefore, when the concentration measuring device measures the concentration of the target substance in the target fluid (such as blood), the unpurified target fluid is in contact with the porous membrane for a long period of time. This results in the concentration of the target substance in the unpurified target fluid being approximately the same as the concentration of the target substance in the dialysis fluid. Therefore, the concentration of the target substance in the unpurified target fluid can be measured efficiently, safely, and accurately without having to separately collect blood or insert a concentration measuring device into the human body. [Brief explanation of the drawings]

[0020] [Figure 1] FIG. 1 is a diagram illustrating the configuration of a target liquid purification device according to the present invention. [Figure 2] 1 is a diagram illustrating the configuration of a main body of a target liquid purification device according to a first embodiment of the present invention; [Figure 3] FIG. 4 is a structural explanatory diagram of a main body of a target liquid purification device according to a second embodiment of the present invention. [Figure 4] FIG. 10 is a structural explanatory diagram of a main body of a target liquid purification device according to a third embodiment of the present invention. [Figure 5] FIG. 10 is a structural explanatory diagram of a main body of a target liquid purification device according to a fourth embodiment of the present invention. [Figure 6] FIG. 10 is a diagram showing the concentration of urea nitrogen in the unpurified target liquid and the concentration of urea nitrogen in the first liquid for each flow rate of the replenisher liquid in the target liquid purification device according to the embodiment of the present invention. [Figure 7] FIG. 10 is a diagram showing the relationship between QD (flow rate of replenishment liquid) and CDO (urea nitrogen concentration in the first liquid) in the subject liquid purification device according to the embodiment of the present invention. [Figure 8A]10 is a diagram showing the relationship between the urea nitrogen concentration and the position of the separation device as seen from the unpurified object liquid passage when the flow rate of the replenisher liquid is 500 mL / min in the object liquid purification device according to the embodiment of the present invention. FIG. [Figure 8B] 10 is a diagram showing the relationship between the urea nitrogen concentration and the position of the separation device as seen from the unpurified object liquid passage when the flow rate of the replenisher liquid is 230 mL / min in the object liquid purification device according to the embodiment of the present invention. FIG. [Figure 8C] 10 is a diagram showing the relationship between the urea nitrogen concentration and the position of the separation device as seen from the unpurified object liquid passage when the flow rate of the replenisher liquid is 150 mL / min in the object liquid purification device according to the embodiment of the present invention. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0021] (First embodiment) The target fluid purification device according to a first embodiment of the present invention, shown in FIG. 1, includes a main body 1, a concentration measuring device 2, a control device 3, and an alarm device 4. FIG. 2 is a schematic diagram of the main body 1 in FIG. 1 according to the first embodiment. As shown in FIG. 2, the main body 1 includes a separation device 100, an unpurified target fluid passage 11, a purified target fluid passage 12, a filtered dialysate passage 21, a dialysate passage 412, a drainage passage 24, a first flow rate adjustment device 36, and a concentration sensor 35 that outputs a signal corresponding to the concentration of a target substance in the target fluid. The concentration measuring device 2 measures the concentration of the target substance in the target fluid based on the output signal of the concentration sensor 35.

[0022] The separation device 100 is separated into a first section 110 and a second section 120 by a porous membrane 102. The porous membrane 102 has a pore size that allows passage of target substances contained in the unpurified target fluid F11 (e.g., blood, plasma, dialysis effluent, hemofiltrate). The "target substances" include, for example, at least one ion selected from potassium ions, ammonium ions, calcium ions, magnesium ions, phosphate ions, bicarbonate ions, and organic acid ions, as well as pathogenic substances that accumulate in the body during illness, such as urea, creatinine, uric acid, peptides, and proteins. The separation device 100 is configured to pass the unpurified target fluid F11 containing the target substances from the first section 110 through the porous membrane 102 and introduce it into the second section 120 to produce a dialysis fluid F21, and to remove the target substances contained in the unpurified target fluid F11 through this passage to produce a purified target fluid F12. The fluid moving from the first section 110 to the second section 120 is the dehydrated fluid F0.

[0023] Here, the "dehydration fluid" refers to excess water contained in the body. It is preferable that this water is excreted during the purification of the target fluid. The amount of dehydration fluid F0 usually varies from person to person and is calculated using a predetermined calculation method based on the user's weight, meal frequency, height, etc. For a normal person (e.g., a person weighing 60 kg or less), it is preferable that the flow rate of dehydration fluid F0 per hour be 1000 mL or less.

[0024] The unpurified target liquid passage 11 is configured to introduce the unpurified target liquid F11 drawn out from the patient's body into a first section 110 of the separation device 100. The purification target liquid passage 12 is configured to lead the purification target liquid F12 out of the first section 110 of the separation device 100 and introduce it into the patient's body. The separation device 100 is configured, for example, by a dialyzer, and the first section 110 is the internal space of hollow fibers made of dialysis membranes, and the second section 120, as described below, is the space around the hollow fibers through which dialysis fluid and / or regenerated fluid flows.

[0025] In this embodiment, the separation device 100 is configured as a "countercurrent separation device" in which the flow direction of the unpurified target liquid F1 in the first section 110 and the flow direction of the regenerated liquid F22 in the second section 120 are opposite or in opposite directions, but in other embodiments, the separation device 100 may be configured as a "parallel current separation device" in which the flow direction of the unpurified target liquid F11 in the first section 110 and the flow direction of the regenerated liquid F22 in the second section 120 are parallel or in the same direction.

[0026] The dialysate filtrate passage 21 allows the dialysate filtrate F21 to be discharged from the second portion 120 of the separation device 100. The drain passage 24 allows the dialysate filtrate F21 introduced from the dialysate filtrate passage 21 to be discarded as drain F41.

[0027] The dialysate passage 412 is configured to directly introduce the dialysate F41 into an introduction port provided upstream of the outlet port of the second section 120. Here, the "dialysate" means, for example, fresh dialysate.

[0028] The first flow rate adjustment device 36 is, for example, a flow rate adjustment valve, a pump, or a mass flow controller, and is provided in at least one of the dialysate passage 21 and the discharge passage 24. The first flow rate adjustment device 36 adjusts the flow rate of the dialysate F21. In particular, the first flow rate adjustment device 36 is provided to control the flow rate of the dialysate F21 to be equal to or lower than the flow rate of the unpurified target fluid F11.

[0029] The concentration sensor 35 outputs a signal corresponding to the concentration of a target substance in the target fluid and is provided in at least one of the dialysate passage 21 and the drain passage 24. Different types of concentration sensors 35 may be provided to measure the respective concentrations of multiple target substances. By providing the concentration sensor 35 in a passage through which the dialysate F21 passes, the concentration of the target substance in the unpurified target fluid F11 can be estimated without providing a concentration sensor 35 inside the human body. Furthermore, as will be described later in the results section, the concentration sensor 35 measures the concentration of the target substance while the first flow control device 36 controls the flow rate of the dialysate F21 to be equal to or lower than the flow rate of the unpurified target fluid F11. Therefore, the concentration of the target substance present in the dialysate F21 or the drain F211 can be referred to as the concentration of the target substance in the unpurified target fluid F11. Since the composition of the unpurified target fluid can be determined based on the results measured by the concentration sensor 35, the target fluid purification device of the present invention can adjust the flow rate of each fluid in the target fluid purification device based on the concentration of the target substance. Furthermore, the degree of purification can be quantified, and purification of the target fluid can be terminated at an appropriate timing. For these reasons, purification of the target fluid is possible without adding more dialysate or substitution fluid than necessary.

[0030] The concentration sensor 35 is preferably provided downstream of the first flow rate control device 36, but may be provided upstream of the first flow rate control device 36. In addition, both the concentration sensor 35 and the first flow rate control device 36 may be provided in either the dialysate passage 21 or the drainage passage 24, or each may be provided in a different location.

[0031] Typically, during purification of the target fluid, it is difficult to achieve uniformity in the flow of the dialysate, so the flow rate of the dialysate F412 is set to about twice the flow rate of the unpurified target fluid F11. On the other hand, in the present invention, when the concentration measuring device 2 measures the concentration of a target substance, the flow rate of the dialysate F412 is set to the same as or less than the flow rate of the unpurified target fluid F11. In this case, since the unpurified target fluid F11 is in contact with the porous membrane 102 for a long time, the concentration of the unpurified target fluid F11 is approximately the same as the concentration of the dialysis fluid F21. Furthermore, since water can be removed from the unpurified target fluid F11 by the amount that the flow rate of the dialysis fluid F21 is set to be higher than that of the replacement fluid F41, the flow rate of the water removal fluid F0 can also be controlled.

[0032] In the present invention, the flow rate of the dialysate F412 is approximately equal to the sum of the flow rates of the dialysate F21 and the water remover F0. At this time, the dialysate F21 and the regenerated fluid F22 flow through a constant-volume flow path. Therefore, when the flow rate of the dialysate F412 is approximately equal to the flow rates of the dialysate F21 and the water remover F0, the sum of the flow rates of the unpurified target fluid F11 and the purified target fluid F12 and the water remover F0 is equal to the flow rate difference between the dialysate F41 and the dialysate F21.

[0033] In addition to the main body 1 described above, the target liquid purification device of the present invention includes a concentration measuring device 2, a control device 3, and an alarm device 4, as shown in FIG. 1 . The device is comprised of the concentration measuring device 2 and the control device 3, a storage device (memory such as RAM, ROM, EEPROM, SSD, HDD, etc.) that stores and retains programs (software) and data, a processing device (single-core processor, multi-core processor, CPU, etc.) that reads necessary programs and / or data from the storage device and executes predetermined calculations, and I / O circuits, etc. The concentration measuring device 2 and the control device 3 measure the concentration of the target substance based on the signal output by the concentration sensor 35 while controlling the flow rate adjusted by the first flow rate adjustment device 36, as described below, and control the entire target liquid purification device. The control device 3 is provided with an abnormality detection device 301, which detects abnormalities based on the concentration of the target substance measured by the measurement device, as described below.

[0034] The notification device 4 includes an output interface 402. The notification device 4 is an audio output device, an image output device, a personal computer, a mobile phone (smartphone), or any other information terminal device. The notification device 4 is configured to, for example, notify of an abnormality detected by the abnormality detection device 301, and present various information during the purification of the target liquid.

[0035] (Second embodiment) 3 shows a schematic diagram of a second embodiment of the main body 1 in FIG. 1. The second embodiment relates to a target fluid purification device further including a replacement fluid passage 422 for introducing a replacement fluid F42 into the main body 1 of the first embodiment. The replacement fluid passage 422 is configured to introduce the replacement fluid F422 into at least one of the unpurified target fluid passage 11, the purification target fluid passage 12, and the dialysate passage 412. The other configurations are substantially the same as those of the first embodiment, and therefore a description of the overlapping parts will be omitted.

[0036] The replacement fluid passage 422 may be provided in one of the above-described passages, or may be provided in multiple passages simultaneously. For example, the replacement fluid passage 422 may be configured to introduce the replacement fluid F422 into both the unpurified target fluid passage 11 and the dialysate passage 412. The replacement fluid passage 422 is preferably configured to introduce the replacement fluid F422 downstream of the position where the concentration sensor 35 is provided. In this case, when the concentration measuring device 2 measures the concentration of a target substance, the unpurified target fluid F11 contacts the porous membrane 102 for a long period of time, thereby enabling accurate measurement of the concentration of the target substance in the dialysis fluid F21. In addition, without being limited to the above embodiment, the replacement fluid passage 422 may be configured to introduce the replacement fluid F422 downstream of the position where the concentration sensor 35 is provided. In this case, by providing a third flow rate control device 32 (described later) to control the flow rate of the replacement fluid, the unpurified target fluid F11 can be kept in contact with the porous membrane 102 for a long period of time when the concentration measuring device 2 measures the concentration based on the signal from the concentration sensor 35. In addition, by recognizing the flow rate of the dialysis fluid F21 and the flow rate of the replacement fluid F422 and applying an appropriate correction coefficient based on the ratio of these flow rates, the concentration of the target substance in the unpurified target fluid F422 can be accurately measured.

[0037] The main body 1 may further include a second flow control device 31 that adjusts the flow rate of the first fluid F211 discharged from the target fluid purification device, and a third flow control device 32 that adjusts the flow rate of the replacement fluid F42 introduced into the replacement fluid passage 422. The second flow control device 31 is, for example, a flow control valve or a mass flow controller, and is provided in the drainage passage 24. The third flow control device 32 is, for example, a flow control valve or a mass flow controller, and is provided in the replacement fluid passage 422 or the dialysate passage 412.

[0038] As described below, the second flow control device 31 and the third flow control device 32 may be controlled by the control device 3 to adjust their respective flow rates in accordance with the concentration of the target substance measured by the concentration sensor 35. In this case, the second flow control device 31 and the third flow control device 32 may each be controlled to adjust the flow rates so as to minimize the difference between the amount of the replacement fluid F41 introduced and the amount of the first fluid F211 discharged, or to minimize the difference between the amount of the first fluid F212 discharged and the total amount of the replacement fluid F41 introduced and the amount of the water removed. When controlled in this manner, the unpurified target fluid F11 is in contact with the porous membrane 102 for a long period of time, so that the concentrations of the target substance in the unpurified target fluid F11 and the target substance in the dialysis fluid F21 are approximately equal. Furthermore, because the flow rate of the dialysis fluid F21 is made higher than that of the replacement fluid F41, water can be removed from the unpurified target fluid F11 by the amount corresponding to the amount of water removed, and the flow rate of the water removed fluid F0 can also be controlled.

[0039] (Third embodiment) 4 is a schematic diagram of the main body 1 in FIG. 1 according to a third embodiment. The second embodiment relates to a target fluid purification device further including a branching section at the downstream end of the dialysate passage 21 that branches the filtrate F21 into a first liquid F211 and a second liquid F212. The drainage passage 24 is configured to branch from the dialysate passage 21 and discard the first liquid F211, which is a part of the filtrate F21, as drainage, and the dialysate passage 21 is configured to introduce the second liquid F212, which is the remainder of the filtrate F21, into an inlet section of the dialysate passage 412 as the dialysate F41. That is, the third embodiment relates to a circulating target fluid purification device.

[0040] Furthermore, the third embodiment may further include a replacement fluid passage 422 for introducing the replacement fluid F42 into the main body 1, as in the second embodiment. Here, the replacement fluid passage 422 is configured to introduce the replacement fluid F422 into at least one of the unpurified liquid passage 11, the purified liquid passage 12, and the dialysate passage 412. The other configurations are substantially the same as those of the first or second embodiment, and therefore a description of the overlapping parts will be omitted.

[0041] (Fourth embodiment) FIG. 5 shows a schematic diagram of the main body 1 in FIG. 1 according to a fourth embodiment. The fourth embodiment relates to a target fluid purification device further including a regeneration unit 200 disposed between the branch point of the dialysis fluid passage 21 from the discharge passage 24 and the inlet of the dialysate passage 412. The regeneration unit 200 has an adsorbent that adsorbs target substances. By bringing the second fluid F212 introduced from the dialysis fluid passage 21 into contact with the adsorbent, at least one of the target substances is removed from the second fluid F212, thereby producing a regenerated fluid F22 with a reduced concentration of the target substance. The regeneration unit 200 is configured to introduce the regenerated fluid F22 into the inlet of the dialysate passage 412 as the dialysate F41. Other configurations are substantially similar to those of the third embodiment, and therefore, a description of the overlapping portions will be omitted.

[0042] (Playback section configuration) The regeneration unit 200 has an adsorbent that adsorbs the target substance. The adsorbent may be activated carbon, an adsorbent based on activated carbon, a porous adsorbent, an adsorbent made of cation exchange resin, anion exchange resin, zirconia ceramics, zeolite, or a mixture thereof. The regeneration unit 200 is configured to remove at least a portion of the target substance by bringing a portion of the dialysis filtrate (second liquid F212) into contact with the adsorbent, thereby generating a regenerated liquid F22 in which the concentration of the target substance has been reduced.

[0043] In the fourth embodiment, the second fluid F212 is configured to be introduced into the regeneration section 200. The drain passage 24 branches off from the dialysate passage 21 and is configured to discard the first fluid F211 as a drain, out of the first fluid F211 and the second fluid F212 resulting from separation of the dialysate F21. The flow rate of the drain passage 24 (the discarded amount of the dialysate F21) may be appropriately controlled based on the inflow rate of the substitution fluid (fresh dialysate) into the regeneration fluid passage 22 and / or the outflow rate of the regeneration fluid F22 from the regeneration fluid passage, taking into account the flow rate of the regeneration fluid F22 in the second section 120 of the separation device 100. The regeneration fluid passage 22 is configured to introduce the regeneration fluid F22 from the regeneration section 200 into the second section 120 of the separation device 100.

[0044] In this embodiment, it is preferable that the reproducing unit 200 is configured with at least one reproducing circuit. When there are two or more reproducing circuits, it is preferable that the reproducing circuits are connected in series with each other, but this is not a limitation and they may be connected in parallel.

[0045] In the above embodiments, the second to fourth embodiments have been described as being based on the first embodiment, but the configurations of the respective embodiments may be combined. For example, the configuration of the second embodiment may be combined with the fourth embodiment.

[0046] (Concentration measurement method) Next, a method for measuring the concentration of a target substance in a target liquid, which is executed in the target liquid purification method in the target liquid purification device common to the first to fourth embodiments having the above configuration, will be described.

[0047] The concentration of the target substance is measured, for example, when a request signal is received via the input interface of the target liquid purification device so that a medical professional or the patient can determine whether the target liquid has been sufficiently purified. Also, for example, as in the fourth embodiment, when the aperture of the fourth flow control device 2013 is adjusted according to the concentration of the target substance, this is done automatically when purification of the target liquid begins or when a specified time has elapsed since the previous concentration measurement.

[0048] When the concentration of a target substance is measured, the output of the first flow control device 36 becomes a value for making the flow rate of the dialysis fluid F21 the same as or less than the flow rate of the unpurified target fluid F11. This prevents the unpurified target fluid F11 from contacting the porous membrane 102 more than necessary, so the concentration of the unpurified target fluid F11 and the concentration of the dialysis fluid F21 are approximately the same. Furthermore, since water can be removed from the unpurified target fluid F11 by the amount that the flow rate of the dialysis fluid F21 is made higher than that of the replacement fluid F41, the flow rate of the water removal fluid F0 can also be controlled.

[0049] When the first flow control device causes the flow rate of the filtered dialysis fluid F21 to be equal to or less than the flow rate of the unpurified target fluid F11, the concentration measuring device 2 measures the concentration of the target substance in the target fluid based on the output signal of the concentration sensor 35.

[0050] The concentration of the target substance may be simultaneously recorded or output to an alarm device, etc. This allows medical personnel and patients to easily grasp the concentration of the target substance during purification of the target liquid and quantitatively determine the degree of purification of the target liquid.

[0051] In addition, when the replacement fluid passage 422 is configured to introduce the replacement fluid F422 downstream of the position where the concentration sensor 35 is provided, the concentration measuring device 2 may be configured to recognize the flow rate of the dialysis fluid F21 and the flow rate of the replacement fluid F422, and apply an appropriate correction coefficient based on the ratio of these flow rates, thereby accurately measuring the concentration of the target substance in the unpurified target fluid F422.

[0052] (Anomaly detection method) In addition to the configuration of the above embodiment, the target liquid purification device of the present invention is equipped with an abnormality detection device 301 that detects abnormalities based on time-series fluctuations in the concentration of the target substance, and an alarm device 4 that alarms abnormalities detected by the abnormality detection device 301.

[0053] The anomaly detection device 301 constitutes part of the control device 3 and is a device that detects anomalies based on the time series of the concentration of a target substance. Here, the time series fluctuation of the concentration of the target substance refers to, for example, information that represents the concentration measured by the concentration measuring device 2 over time. In this case, the values ​​of multiple target substances may be used as the concentration values. Based on the time series information of the concentrations of the multiple target substances, an abnormal value is calculated statistically or using a machine learning method. For example, if the concentration values ​​do not fluctuate, it can be determined that dialysis is not being performed sufficiently. Furthermore, if the amount of a specific substance is higher than other substances, it can be determined that the composition of the replacement fluid and / or dialysis fluid is insufficient.

[0054] The notification device 4 is connected to the target liquid purification device via wireless communication such as a network or wired communication such as a cable. The notification device 4 is, for example, software installed on a personal computer, smartphone, etc. The notification device 4 is carried by, for example, a patient using the target liquid purification device, their family, or a medical professional in charge.

[0055] If an abnormality is detected by the abnormality detection device 301, the output interface 402 of the alarm device 4 will be notified of this. This allows the user to recognize deterioration of the target liquid purification device, and based on this recognition, the target liquid purification can be reliably carried out. Furthermore, since medical personnel can recognize in advance the presence or absence of disease or the risk of disease, this can be beneficial in maintaining the health of the patient of the target liquid purification device. [Example]

[0056] Example 1 is a subject fluid purification device having the configuration of the first embodiment of the present invention. Figure 6 is a graph showing the concentration of urea nitrogen, a subject substance, in the unpurified subject fluid F11 and the first fluid F211 (same as the filtered dialysate F21) when the flow rate of the dialysate F41 in the subject fluid purification device of Example 1 was set to 100, 200, 300, and 450 mL / min. Note that the unpurified subject fluid F11 (blood flow rate) was 250 mL / min. Referring to Figure 6, when the flow rate of the dialysate F41 was higher than the flow rate of the unpurified subject fluid F11 (substitution fluid F41 flow rate: 100, 200 mL / min), the urea nitrogen concentration in the unpurified subject fluid F11 and the urea nitrogen concentration in the first fluid F211 were approximately the same. On the other hand, when the flow rate of the dialysate F41 was higher than the flow rate of the unpurified target fluid F11 (dialysis F41 flow rate: 300, 450 mL / min), the urea nitrogen concentration of the first fluid F211 was lower than the urea nitrogen concentration in the unpurified target fluid F11.

[0057] Here, the removal performance when passing through the target liquid purification device once is expressed as an index called clearance CL. Clearance CL is the urea nitrogen concentration C in the unpurified target liquid F11. BI , urea nitrogen concentration C in the purification target liquid F12 BO , flow rate Q of unpurified target liquid F11 B Using this, it is expressed by the following relational expression (1).

[0058] CL =((C BI -C BO ) / C BI )*Q B (1)

[0059] Here, Q B When the flow rate is 250 mL / min, a CL of 230 to 250 mL / min means that approximately 100% of the urea nitrogen is removed in one pass through the target fluid purification device. Furthermore, the concentration of urea nitrogen in the first fluid F211 at this time can be calculated from the mass balance by dividing the concentration of urea nitrogen in the dialysate F41, the concentration of urea nitrogen in the first fluid F211, and the flow rate of the dialysate F41 by C. DI , C DO , Q Dand is expressed by the following relational expression (2).

[0060] Q B *(C BI -C BO )=Q D *(C DO -C DI ) (2)

[0061] Furthermore, when the overall mass transfer area coefficient KoA is used, the following relational expression (3) is obtained.

[0062] (C BI -C BO ) / (C BI -C DI )= (1-exp(KoA(1 / Q BI -1 / Q BO ))) / (Q BI / Q DI -exp(KoA(1 / Q BI -1 / Q BO ))) ··(3)

[0063] Based on the above equations (1) to (3), C DO At this time, the operating conditions can be calculated as follows: B = 200 mL / min, C BI = 100 mg / dL, in the case of urea nitrogen, KoA can be considered to be about 3000, so the length of the separation device (dialyzer) is 25 cm and the membrane area is 1.5 m 2 Then, Q D When C is changed DO Calculating this, we obtain Figure 7 below.

[0064] Referring to Figure 7, when the flow rate of the dialysate F41 is less than 200 mL / min, which is approximately the same as the flow rate of the unpurified target fluid F11, the first fluid F211 has a concentration of 100 mg / dL, which is approximately the same as the unpurified target fluid F11. This is because the urea nitrogen in the unpurified target fluid F11 moves very quickly through the separation device in the target fluid purification device. In this case, the concentration distribution of urea nitrogen on the unpurified target fluid F11 side and the dialysate F41 side in the target fluid purification device can be calculated as shown in Figure 8 below.

[0065] In FIG. 8, the horizontal axis represents the position in the longitudinal direction of the separation device 100 (0 represents the inflow portion of the unpurified target fluid F11 into the separation device, and 25 represents the outflow portion of the purified target fluid F12), and the vertical axis represents the urea nitrogen concentration. Here, the solid line represents the urea nitrogen concentration on the first portion 110 side, and the dotted line represents the urea nitrogen concentration on the second portion 120 side. Referring to FIG. 8A, when the flow rate of the replacement fluid F41 is 500 mL / min, it can be considered that the urea nitrogen in the unpurified target fluid F11 is substantially 100% removed (the urea nitrogen value at 25 cm is substantially 0). Referring to FIG. 8B, when the flow rate of the dialysate F41 is 230 mL / min, the urea nitrogen is also substantially 100% removed. In this case, the value of the y-intercept, which represents the urea nitrogen concentration of the first fluid F211, is 40 mg / dL when the flow rate of the dialysate F41 is 500 mL / min, which is lower than the urea nitrogen concentration of the unpurified target fluid F11. However, as the flow rate of the dialysate F41 decreases, the urea nitrogen concentration increases. Referring to FIG. 8C , in the graph where the flow rate of the dialysate F41 is 150 mL / min, the urea nitrogen concentrations of the unpurified target fluid F11 and the first fluid F211 are approximately 100 mg / dL and can be considered equivalent. This allows the urea nitrogen concentration of the unpurified target fluid F11 to be determined by determining the urea nitrogen concentration of the first fluid F211 or the filtered dialysate F21, without the need to provide a concentration sensor 35 in the unpurified target fluid F11 (blood). This allows the above-described process to be performed, thereby reducing the total amount of dialysate F41 in the target fluid purification device and ensuring purification.

[0066] Although the results were shown using the value of urea nitrogen, similar results were observed for substances other than urea nitrogen that had high permeability to the separation membrane. Although not specifically shown, similar results were also observed in an example using potassium ions. Therefore, according to the present invention, the concentrations of multiple target substances can be accurately measured, enabling the overall control of the target liquid purification device based on the concentrations.

[0067] As described above, the target fluid purification device of the present invention can reliably control the removal of target substances from the target fluid while reducing the amount of dialysis fluid. Therefore, it can be used for home dialysis, etc. Furthermore, if an abnormality occurs during home dialysis, the abnormality can be communicated to a remote medical professional, etc., thereby providing reliable dialysis treatment. Furthermore, it is possible to provide a target fluid purification device that reliably performs dialysis, reduces the total amount of dialysis fluid used in dialysis, has a simple structure that does not require blood sampling, and is so safe that it does not affect the human body, and can accurately measure the concentration of target substances in blood.

[0068] It should be noted that the present invention is not limited to the above-described embodiments or examples, and it is clear that the scope of the present invention can be modified or altered within a range that is obvious to those skilled in the art. It is also clear that the scope of the present invention is not limited to the above-described embodiments or examples, but also includes modifications and alterations thereof. [Explanation of symbols]

[0069] 1. Main body 2‥Concentration measuring device 3. Control device 4. Alarm device 11. Unpurified liquid passage 12. Purification target liquid passage 21‥Filtered dialysate passageway 22‥Regeneration liquid passage 24. Drainage passage 31‥Second flow rate adjustment device 32‥Third flow rate adjustment device 35. Concentration sensor 36‥1st flow rate adjustment device 100‥Separation equipment 102‥Porous membrane 110‥1st part 120‥Second part 200‥Reproduction section 201‥Regeneration circuit 202‥Regeneration circuit 221...Regenerated liquid branch passage 222...Regenerated liquid branch passage 301. Anomaly detection device 401...input interface 402: Output interface 412‥Dylysate passage 422‥Refill fluid passage 2011...First circuit (regenerative circuit 201) 2012...Second circuit (regenerative circuit 201) 2013‥4th flow rate adjustment device (regeneration circuit 201) 2021...First circuit (regeneration circuit 202) 2022: Second circuit (regeneration circuit 202) 2023‥4th flow rate adjustment device (regeneration circuit 202) F11...Unpurified liquid F12...Liquid to be purified F21‥Filtration dialysate F211...First liquid (drainage) F212...Second liquid F22‥Regeneration liquid F41: Dialysis fluid F42‥Refill fluid.

Claims

1. 1. A target liquid purification device for removing at least one target substance from an unpurified target liquid, comprising: a separation device comprising a porous membrane having a pore size that allows the target substance contained in the unpurified target liquid to pass through, and a first portion and a second portion separated by the porous membrane, wherein the unpurified target liquid containing the target substance is passed through the porous membrane from the first portion and introduced into the second portion to produce a dialysis filtrate, and the target substance contained in the unpurified target liquid is removed by the passage, thereby producing a purified target liquid; an unpurified liquid passage for introducing the unpurified liquid into the first portion of the separation device; a liquid to be purified passage for leading the liquid to be purified from the first portion of the separation device; a dialysate passageway for delivering the dialysate from the outlet of the second portion of the separation device; a drainage passage for disposing of the dialysis fluid from the dialysis fluid passage as a drainage fluid; a dialysate passage for introducing dialysate into an introduction portion provided upstream of an outlet portion of the second portion; a concentration sensor provided in at least one of the dialysate passage and the drainage passage, the concentration sensor outputting a signal corresponding to the concentration of the target substance in the dialysate; a flow rate adjusting device provided in at least one of the dialysis fluid passage and the discharge passage, which adjusts the flow rate of the dialysis fluid; and a concentration measuring device that measures the concentration of the target substance based on the output signal of the concentration sensor during a period in which the flow rate adjusting device controls the flow rate of the dialysis fluid to be equal to or lower than the flow rate of the unpurified target fluid. Target liquid purification equipment.

2. The target liquid purification device according to claim 1, a replenishment liquid passage for introducing replenishment liquid into the target liquid purification device; The substitution fluid passage is configured to introduce the substitution fluid into at least one of the unpurified fluid passage, the purified fluid passage, and the dialysate passage. Target liquid purification equipment.

3. The target liquid purification device according to claim 1, the drain passage is configured to branch off from the dialysate passage and discard a first liquid that is a part of the dialysate as drainage; The dialysis fluid passage is configured to introduce a second liquid, which is the remainder of the dialysis fluid, as the dialysis fluid into the inlet of the dialysis fluid passage. Target liquid purification equipment.

4. 4. The target liquid purification device according to claim 3, a replenishment liquid passage for introducing replenishment liquid into the target liquid purification device; The substitution fluid passage is configured to introduce the substitution fluid into at least one of the unpurified fluid passage, the purified fluid passage, the filtered dialysate passage, and the dialysate passage. Target liquid purification equipment.

5. 4. The target liquid purification device according to claim 3, a regeneration unit that is provided in the dialysis fluid passage between a branch point of the discharge passage and an introduction section of the dialysis fluid passage, the regeneration unit having an adsorbent that adsorbs the target substances, and that brings the second fluid introduced from the dialysis fluid passage into contact with the adsorbent to remove at least one of the target substances from the second fluid and generate a regeneration fluid having a reduced concentration of the target substances; The regeneration unit is configured to introduce the regenerated fluid as a dialysis fluid into the introduction part of the dialysis fluid passage. Target liquid purification equipment.

6. 6. The target liquid purification device according to claim 5, a replenishment liquid passage for introducing replenishment liquid into the target liquid purification device; The substitution fluid passage is configured to introduce the substitution fluid into at least one of the unpurified fluid passage, the purified fluid passage, the filtered dialysate passage, and the dialysate passage. Target liquid purification equipment.

7. 7. The target liquid purification device according to claim 6, a waste liquid flow rate adjusting device that adjusts the flow rate of the first liquid, and a replenisher liquid flow rate adjusting device that adjusts the flow rate of the replenisher liquid. Target liquid purification equipment.

8. The target liquid purification device according to any one of claims 1 to 7, an anomaly detection device that detects an anomaly based on a time-series variation in the concentration of the target substance; a notification device that notifies of an abnormality detected by the abnormality detection device.

Citation Information

Patent Citations

  • Method and apparatus for limiting diafiltrate waste

    US9302038B2