Detailed Description
Preferred embodiments of the present invention will be described below with reference to the accompanying drawings. Note that the same elements are denoted by the same reference numerals, and redundant description thereof is omitted. The positional relationship between the upper, lower, left, and right sides is not limited unless otherwise specified. The dimensional ratios in the drawings are not limited to the illustrated ratios. The following embodiments are illustrative of the present invention, and the present invention is not limited to these embodiments.
Fig. 1 is an explanatory diagram showing an outline of the configuration of an ascites treatment device 1 as a body cavity fluid treatment device according to the present embodiment. The ascites treatment apparatus 1 is an apparatus for filtering raw ascites extracted from a patient and stored in araw ascites bag 10 and removing water from the filtered ascites to generate concentrated ascites.
The ascites treating apparatus 1 includes afilter 11, afirst line 12, asecond line 13, athird line 14, afourth line 15, a firstpressure measuring device 16, a second pressure measuring device 17, apump 18, a first opening/closing device 19, an upstream opening/closing device 21, acontrol device 50, and the like. The ascites treatment apparatus 1 is divided into a filtration system (filtration section) 2 for performing filtration treatment and a concentration system (concentration section) 3 for performing concentration treatment (see fig. 2). The ascites treatment apparatus 1 according to the present embodiment further includes an air-supply pump 160, a bubble detection means 170, and a backflow prevention opening/closing device 22 (see fig. 1 and the like).
Thefilter 11 is, for example, cylindrical, and hasliquid inlets 11a and 11b at both ends in the longitudinal direction and twoliquid inlets 11c and 11d on the side surface. Thefilter 11 is provided with afiltration membrane 70 such as a hollow fiber membrane, and thefiltration membrane 70 can selectively remove a specific substance in the abdominal water, for example, by removing a predetermined causative substance such as bacteria or cancer cells and passing a predetermined useful component such as albumin. The inner region of thefiltration membrane 70 communicates with theliquid inlet ports 11a and 11b, and the outer region of thefiltration membrane 70 communicates with theliquid inlet ports 11c and 11 d.
Afirst line 12 connects theraw ascites bag 10 with thefilter 11. The downstream end of thefirst line 12 is connected to aliquid inlet 11a of thefilter 11.
Thesecond line 13 connects thefilter 11 to a later-describedconcentrator 110 of theconcentration system 3. The upstream end of thesecond line 13 is connected to a fluid inlet (outlet of ascites filtered by the filter 11) 11c of thefilter 11.
One end of thethird line 14 is connected to theliquid inlet 11b of thefilter 11. The other end of thethird line 14 is connected to, for example, a drain portion not shown.
One end of thefourth line 15 is connected to theliquid inlet 11d of thefilter 11. The other end of thefourth line 15 is open to the atmosphere. In addition, soft tubes are used for the first tofourth lines 12 to 15.
Here, the connection of the first to fourth pipelines may be reversed. That is, the first line may be connected to theliquid passage port 11c, the second line may be connected to theliquid passage port 11a, the third line may be connected to theliquid passage port 11d, and the fourth line may be connected to theliquid passage port 11 b. In general, from the viewpoint of priming, the filter used for blood purification reduces the priming amount of blood by flowing blood to the inside of the filtration membrane and then filtering the blood to the outside, but in the case of a body cavity fluid treatment, a treatment method according to the amount and composition of the body cavity fluid may be appropriately selected. For example, in the case of filtration from the inside toward the outside of thefiltration membrane 70 of thefilter 11, a cleaning effect in the case of membrane cleaning (circulation of a cleaning liquid from the outside toward the inside of the filtration membrane 70) performed in the case of clogging of the membrane can be expected, and in the case of filtration from the outside toward the inside of thefiltration membrane 70 of thefilter 11, the surface area of thefiltration membrane 70 is larger than in the case of flow from the inside toward the outside, and therefore, contribution to improvement of the membrane life of thefilter 11 can be expected.
The firstpressure measuring device 16 is provided to be able to measure the pressure in thefirst line 12 and measure the pressure on the primary side (inlet side) of thefiltration membrane 70 of thefilter 11. Here, in the case where the pressure value can be grasped without measuring the pressure value by utilizing the head pressure between theoriginal ascites bag 10 and thefilter 11, the firstpressure measuring device 16 can be omitted. The second pressure measuring device 17 is provided to be able to measure the pressure in thefourth line 15 and measure the pressure on the secondary side (outlet side) of thefiltration membrane 70 of thefilter 11. The pressure measurement results of the firstpressure measurement device 16 and the second pressure measurement device 17 are output to thecontrol device 50. Here, the second pressure measuring device 17 may be disposed on thesecond line 13, and the disposition is not limited as long as the secondary side (outlet side) of thefiltration membrane 70 of thefilter 11 can be measured.
Apump 18 is arranged in thesecond line 13. Thepump 18 is, for example, a tube pump capable of forward rotation and reverse rotation for pressurizing ascites in a delivery tube by treating the tube. Thepump 18 is also used to close thesecond line 13 when stopped, and functions also as an opening/closing device (flow rate adjustment device).
The first opening/closing device 19 is, for example, an opening/closing valve, and is provided in thethird line 14.
The upstream opening/closing device 21 is, for example, an opening/closing valve, and is provided in thefirst line 12.
The open/close device for preventingbackflow 22 is a device for preventing backflow of ascites toward thefilter 11 during the recirculation treatment of ascites or the recovery treatment of ascites. The opening/closing device 22 for preventing backflow according to the present embodiment is disposed on thefilter 11 side of thesecond line 13 with respect to the junction with thecirculation line 114.
The other end of thefourth line 15 is connected to theair feed pump 160. The air-supply pump 160 can be used when filtered ascites (ascites after filtration) remaining on the outlet side of thefiltration membrane 70 of thefilter 11 or the like is collected through thesecond line 13. Theair feed pump 160 supplies gas (atmospheric air) to the outlet side of thefiltration membrane 70 to push out the filtered ascites on the outlet side of thefiltration membrane 70 to thesecond line 13.
Thebubble detecting unit 170 is configured to include a gas detecting device (see fig. 1 and the like) that detects bubbles in the ascites flowing through theconcentrate line 112 or thecirculation line 114. A single gas detection device may be provided acrossconcentrate line 112 and recycleline 114.
Thecontrol device 50 is, for example, a microcomputer having a CPU, a memory, and the like. Thecontrol device 50 can control the operations of the respective devices such as thepump 18, the first opening/closing device 19, the upstream opening/closing device 21, the firstpressure measurement device 16, the second pressure measurement device 17, the pump of the recovery device, and theconcentration system 3, and the operations of the devices such as theconcentration pump 115 described later, and execute ascites treatment. Thecontrol device 50 receives measurement results and the like of the liquidamount measuring device 150 described later. Thecontrol device 50 executes a liquid recovery process described later. Thecontrol device 50 can execute a program stored in advance in a memory, for example, to perform ascites treatment.
Theconcentration system 3 includes aconcentrator 110, aconcentrated ascites bag 111 as a concentrated ascites reservoir, aconcentration line 112, adrain line 113, acirculation line 114, aconcentration pump 115, a thirdpressure measuring device 117, a fourthpressure measuring device 118, and the like, and further includes a liquidamount measuring device 150. Although not particularly shown, for example, an air intake port for sending air from the outside into thesecond line 13 and a valve for opening and closing the air intake port may be provided in the thirdpressure measurement device 117.
Theconcentrator 110 has, for example, a cylindrical shape. Theconcentrator 110 hasliquid inlets 110a and 110b at both ends in the longitudinal direction, and twoliquid inlets 110c and 110d on the side surface. For example, theliquid passage 110a of theconcentrator 110 is connected to thesecond line 13.
Theconcentrator 110 includes aconcentration membrane 120 such as a hollow fiber membrane, and theconcentration membrane 120 removes water from the filtered ascites supplied from thesecond line 13, for example, to concentrate the filtered ascites. The inner region of the concentratingmembrane 120 communicates with theliquid inlets 110a and 110b, and the outer region of the concentratingmembrane 120 communicates with theliquid inlets 110c and 110 d. In the present embodiment, theliquid passage port 110d is closed, but may communicate with thedrain line 113.
Theconcentrated ascites bag 111 is a container capable of collecting and storing concentrated ascites concentrated by theconcentrator 110. Theconcentration line 112 connects the liquid passingport 110b of theconcentrator 110 with theconcentrated ascites bag 111. One end of thedrain line 113 is connected to theliquid inlet 110c of theconcentrator 110, and the other end is connected to a drain unit, not shown.
Thecirculation line 114 connects, for example, theconcentrate bag 111 with thesecond line 13. Thecirculation line 114 is connected to thesecond line 13 at a position upstream of the pump 18 (on thefilter 11 side). An opening/closing device 119 including, for example, an opening/closing valve is provided in thecirculation line 114. For example, soft tubes are used for theconcentrate line 112, thedrain line 113, and thecirculation line 114.
Theconcentration pump 115 is disposed, for example, on the downstream side of theconcentrator 110 of theconcentration line 112, and delivers the concentrated ascites to theconcentrated ascites bag 111. Theconcentration pump 115 uses, for example, a tube pump.
The thirdpressure measuring device 117 is provided to be able to measure the pressure in thesecond line 13, for example, and measure the pressure on the primary side (inlet side) of theconcentration membrane 120 of theconcentrator 110. The fourthpressure measuring device 118 is provided in thedrain line 113, and measures the pressure on the secondary side (outlet side) of theconcentration membrane 120 of theconcentrator 110. The pressure measurement results of the thirdpressure measurement device 117 and the fourthpressure measurement device 118 are output to thecontrol device 50. Thecontrol device 50 can control the operations of the respective devices of theconcentration system 3, such as theconcentration pump 115, thepump 18, the thirdpressure measurement device 117, and the fourthpressure measurement device 118, and execute ascites treatment. In addition, when the pressure value can be grasped without measuring the pressure value by the head pressure between the concentrator 110 and the end of thedrain line 113, the fourthpressure measuring device 118 can be omitted.
In theconcentration system 3, a means (recirculation means) for recirculating the concentrated ascites stored in theconcentrated ascites bag 111 to theconcentrator 110 is constituted. For example, in the ascites treatment apparatus 1 of the present embodiment, therecirculation apparatus 62 is constituted by theaforementioned circulation line 114, theconcentration pump 115, thepump 18, and the like. Theconcentration pump 115 may be disposed in thedrain line 113.
The fluidamount measuring device 150 measures the fluid amount of the concentrated ascites stored in theconcentrated ascites bag 111. The specific configuration of the liquidamount measuring device 150 is not particularly limited, and for example, it may be configured to include a weight scale capable of measuring the weight of theconcentrated ascites bag 111 storing the concentrated ascites, and calculate the pump flow rate by multiplying the time based on the flow rate of theconcentration pump 115 controlled based on the measured value of the weight scale.
When the liquidamount measuring device 150 is a device having a weight as described above, the liquid amount in theconcentrate bag 111 can be controlled based on the measured value of the weight.
Alternatively, the amount of the concentrated ascites stored in theconcentrated ascites bag 111 can be calculated from the known weight of theconcentrated ascites bag 111 and the weight per unit volume of the concentrated ascites by using a weight in the same manner as described above. For example, the volume may be measured by measuring the capacity of the concentrated abdominal water bag 111 (for example, using an ultrasonic sensor, an electrostatic capacitance sensor, or the like, not shown), and the volume may be converted into the weight. In addition to calculating the amount of the concentrated ascites based on the weight as described above, the volume may be calculated from the result of the volume measurement, and the control may be performed based on the calculated volume. In this case, the amount of liquid in theconcentrated ascites bag 111 is controlled based on the increase/decrease amount of the volume.
Next, an outline of ascites treatment using the ascites treatment device 1 described above will be described (see fig. 6, fig. 7, and the like).
< filtration and concentration step >
First, the rawabdominal water bag 10 containing ascites extracted from the patient is connected to thefirst line 12. Then, the ascites filtration and concentration step is started. In a state where the first opening/closing device 19 is closed and the upstream opening/closing device 21 and the backflow prevention opening/closing device 22 are opened, thepump 18 is rotated in the forward direction to operate the concentration pump 115 (see fig. 1).
Thereby, the ascites in the originalabdominal water bag 10 is transferred to thefilter 11 through thefirst line 12. The ascites flows into the inlet side (inner region) of thefilter membrane 70 from thefluid inlet 11a of thefilter 11, passes through thefilter membrane 70, and flows out to the outlet side (outer region) of thefilter membrane 70. At this time, a predetermined causative substance is removed from the ascites. The filtered ascites flowing out to the outlet side of thefiltering membrane 70 flows out from thefilter 11 to thesecond line 13, is transferred to theconcentrator 110 through thesecond line 13 and flows into the inlet side of the concentratingmembrane 120 of theconcentrator 110. Here, a part of the moisture, for example, the filtered ascites flows out to the outlet side of theconcentration membrane 120 through theconcentration membrane 120 by a pressure difference (flow rate difference) between thepump 18 and theconcentration pump 115. Thereby, water is removed from the filtrated ascites, and the filtrated ascites is concentrated. The concentrated ascites concentrated by theconcentrator 110 is received in theconcentrated ascites bag 111 through theconcentration line 112.
< reconcentration step >
Thepump 18 and theconcentration pump 115 are operated in a state where the opening/closing device 119 is opened and the opening/closing device forbackflow prevention 22 is closed (see fig. 2). Thereby, the concentrated ascites in theconcentrated ascites bag 111 is transferred to theconcentrator 110 through thecirculation line 114 and thesecond line 13, and returned from theconcentrator 110 to theconcentrated ascites bag 111 through theconcentration line 112 to be circulated. By this, the concentrated ascites is re-concentrated. In the case of a configuration in which the opening/closing device 19 and the upstream opening/closing device 21 can be closed, the opening/closing device 22 for preventing backflow can be omitted.
In the step of filtering and concentrating ascites, the firstpressure measuring device 16 and the second pressure measuring device 17 are operated to monitor the pressure on the inlet side and the pressure on the outlet side of thefiltration membrane 70 of thefilter 11. For example, when the pressure difference (P1 to P2) between the pressure P1 on the inlet side and the pressure P2 on the outlet side of the filtration membrane 70 (the pressure difference between the membranes) in thefilter 11 exceeds a predetermined threshold value D, the upstream opening/closing device 21 may be closed to stop the process of filtering and concentrating ascites, assuming that thefiltration membrane 70 is clogged. The threshold value D is obtained and set in advance by experiments and calculations.
< recovery step >
In the ascites treatment device 1 of the present embodiment, after the filtration treatment and/or concentration treatment of ascites is completed, ascites remaining in the outside of thefilter 11, the inside of the filter line, theconcentrator 110, and the recirculation line are recovered as follows (see fig. 3, fig. 4, and the like).
Herein, the term "filtration line" as used herein refers to a line through which ascites flows when the filtration treatment of ascites is performed. Specifically, the line is connected to the outlet (liquid inlet 11c) of thestrainer 11, and more specifically, the line is connected from thestrainer 11 to theconcentrate bag 111 through theconcentrator 110. In fig. 3, the filtration line is indicated by a bold line and reference FL.
The term "recirculation line" as used herein refers to a line through which ascites flows when the ascites is subjected to a recirculation treatment. Specifically, it refers to the surrounding lines including therecycle line 114, a portion of thesecond line 13, and theconcentrate line 112. In fig. 4, the recirculation line is indicated by a bold line and reference RL.
(stage 0 (concentration stage))
First, in the present embodiment, as the re-concentration step in the stage prior to the recovery step, a predetermined amount of concentrated ascites is recycled in advance to remove water, the predetermined amount being an amount that takes into account the total start-up filling amount of the ascites treatment apparatus 1. As a result, the amount of the concentrated ascites stored in theconcentrated ascites bag 111 is reduced by an amount that takes into account the total priming volume (see fig. 2).
In addition, the priming amount is generally an index indicating how much amount of the patient's blood enters the blood circuit for hemodialysis, and in the present embodiment, corresponds to the amount of ascites stored in theconcentrated ascites bag 111 after the recovery treatment performed after the passage of the residual ascites in the circuit. The amount of the total priming amount may be a known amount input to thecontrol device 50 in advance, or may be a value set by the user.
(stage 1 (recovery stage of filtration line, etc.))
Next, in stage 1 of the ascites collection treatment, ascites remaining outside thefilter 11, the filtration line FL, and inside theconcentrator 110 are collected (step SP 1). Specifically, the air-supply pump 160 is driven to supply air to thefilter 11 through theliquid passage port 11d in a state where the first opening/closing device 19, the upstream opening/closing device 21, and the opening/closing device 119 are closed and the opening/closing device 22 for preventing backflow is opened (see fig. 3). This allows ascites remaining outside thefilter 11, inside the filter line FL and theconcentrator 110 to be collected in the concentrateabdominal water bag 111.
In the middle of the recovery process of the residual ascites, when the bubble detecting means 170 detects the bubble flowing through the concentration line 112 (step SP 2: "YES"), thepump 18 and theconcentration pump 115 are stopped, and the recovery stage of the filtration line FL and the like is ended (step SP 3). Alternatively, step SP2 may be stopped after thepump 18, theconcentration pump 115, and the like are driven to cause a predetermined amount of residual ascites to flow or a predetermined amount of residual ascites to be collected.
(stage 2 (recovery stage of recycle line))
Next, as thestage 2 of the ascites collection treatment, ascites remaining in the recirculation line RL is collected (step SP 4). Specifically, since concentrated ascites remains in thecirculation line 114, the concentrated ascites is mainly recovered (see fig. 4).
In the present embodiment, as thestage 2 of the ascites collecting treatment, thepump 18 is rotated in the reverse direction with at least the open/close device 22 for preventing backflow closed. In this case, for example, air is taken in from an air intake port (not shown) provided in the thirdpressure measuring device 117. Thus, the concentrated ascites remaining in thecirculation line 114 can be returned to theconcentrated ascites bag 111.
In the middle of the recovery process instage 2, when the bubble detecting means 170 detects the bubble flowing through the circulation line 114 (step SP 5: YES), thepump 18 is stopped, and the recovery stage of the recirculation line RL is ended (step SP 6). Alternatively, step SP6 may be terminated after a predetermined amount of ascites is made to flow or a predetermined amount of ascites is collected.
As a result, the ascites collection process (see fig. 6) remaining outside thefilter 11, inside the filtration line, theconcentrator 110, and the recirculation line is completed.
(other examples of stage 2 (recovery stage of recycle line))
The above-mentionedstage 2 of the ascites collection treatment is merely a preferable example, and thestage 2 of the ascites collection treatment can be performed as follows (see fig. 5), for example.
In a state where the first opening/closing device 19 and the upstream opening/closing device 21 are closed and the opening/closing device 119 is opened, the air-supply pump 160 is driven to supply air to thefilter 11 through theliquid passage port 11 d. Thus, the concentrated ascites remaining in thecirculation line 114 can be returned to theconcentrated ascites bag 111.
In the middle of the recovery process instage 2, if the bubble detection means 170 detects bubbles flowing through thecirculation line 114, theair feed pump 160 is stopped, and the recovery stage of the recirculation line RL is terminated. Alternatively, step SP6 may be terminated after a predetermined amount of ascites is made to flow or a predetermined amount of ascites is collected.
In the above embodiment, the ascites treatment apparatus 1 filters and concentrates the ascites contained in theraw ascites bag 10 and then stores the filtered andconcentrated ascites bag 111, but the ascites may be directly taken out from the patient to thefirst line 12 and filtered and concentrated.
The above embodiment is a preferred example in which the present invention is applied to an ascites treatment device 1 for treating ascites, but the present invention can also be applied to a body cavity fluid treatment device for treating other body cavity fluids such as pleural effusion.
In the above-described embodiment, the ascites after filtration and concentration is collected in theconcentrated ascites bag 111, but this is merely a preferred example. The abdominalwater concentration bag 111 is a kind of container for collecting and storing the concentrated ascites concentrated by theconcentrator 110, and a container other than such a bag may be used for collection.
The air-supply pump 160 is merely a preferable example of an air-supply/liquid-supply unit (fluid-supply unit) that supplies gas or liquid. Instead of theair supply pump 160 for supplying air, a pump for supplying a liquid such as physiological saline may be used. In short, any fluid may be used as long as it can be used for recovery of ascites (body fluid) remaining in the circuit.
In the above-described embodiment, the case where theair supply pump 160 is connected to theliquid inlet 11d of thefilter 11 by using thefourth line 15 to supply air has been exemplified and described (see fig. 1 and the like), but this is merely a preferable example. In addition, for example, if a pump for feeding a liquid such as physiological saline as described above is used as the air/liquid feeding means (fluid supply means), the liquid can pass through thefilter membrane 70, and therefore the liquid feeding pump can be connected to theliquid inlet 11a of thefilter 11. Alternatively, theoriginal ascites 10 may be replaced with a liquid such as a physiological saline solution.
In the above-described embodiment, the ascites is prevented from flowing back toward thefilter 11 by closing the open/close device forbackflow prevention 22 provided in thesecond line 13 at the time of the re-concentration step (see fig. 2) and at the recovery stage of the recirculation line (see fig. 4), but this is merely a preferred example. The backflow prevention valve may be disposed at any position, or a structure in which a certain pump is stopped to prevent backflow may be employed instead of providing the backflow prevention valve.
In the above embodiment, the order of the stage 1 and thestage 2 may be reversed, or the stages may be performed simultaneously.
Next, a second embodiment will be described with reference to fig. 8. The ascites treatment apparatus 1 according to the second embodiment is configured as follows: apump 180 is provided on the primary side (inlet side) of thefiltration membrane 70 of thefilter 11, and ascites is pressurized by thepump 180 and then pushed out toward thefilter 11. In this embodiment, when the concentrated ascites stored in theconcentrated ascites bag 111 is recirculated to theconcentrator 110, the concentrated ascites is recirculated by pressurizing with thepump 23 disposed in thecirculation line 114.
It should be noted that the description of the second embodiment is merely another preferred example different from the first embodiment. In short, the specific configuration of the ascites treatment device 1 is not particularly limited as long as the residual filtered ascites is recovered and the amount of recovered fluid is a predetermined amount regardless of the connection of the respective lines or the position of the pump.
Industrial applicability
The present invention is suitably applied to a body cavity fluid treatment apparatus for filtering a body cavity fluid such as ascites fluid stored in a body cavity of a patient or a body cavity fluid bag and removing water from the filtered body cavity fluid to produce a concentrated body cavity fluid.