JP5985224B2 - Peritoneal dialysis machine - Google Patents

Description

  The present invention relates to a peritoneal dialysis apparatus that can be performed by a patient at home (at home) or the like. In particular, the present invention relates to a peritoneal dialysis device that can also be applied to pediatric patients.

Peritoneal dialysis (continuous ambulatory peritoneal dialysis, hereinafter also referred to as “CAPD”) is easy to return to society because patients can exchange dialysate containers (bags) at home or at work. ing.
In recent years, peritoneal dialysis treatment has been performed for children using a peritoneal dialysis device.
(See Patent Document 1).

JP 2002-325840 A

  In children, the volume of peritoneal dialysis fluid injected is much less than in adults. When peritoneal dialysis therapy is performed on children using such a peritoneal dialysis device, a volume of peritoneal dialysis fluid with a mode applicable to children that can accurately inject and drain a small amount of peritoneal dialysis fluid Is required.

  However, since the number of peritoneal dialysis patients in children is very small, there is a problem that peritoneal dialysis devices having a mode applicable to children have hardly been developed.

  Therefore, the present invention has been made in view of the above problems, and an object of the present invention is to provide a peritoneal dialysis apparatus having a mode applicable to children.

  In order to solve the above-described problems and achieve the object, a dialysate circuit including at least one dialysate container filled with dialysate and at least one drainage container for collecting dialysate, and the dialysate Starting from a container or from the drainage container as an end point, liquid feeding means for feeding dialysate, input means for inputting dialysis conditions, display means for displaying the input dialysis conditions and operating procedures, A peritoneal dialysis apparatus that has a control unit and supplies peritoneal dialysis by supplying dialysate to the patient side by the liquid feeding means and collecting the drainage, and the dialysis set by the input means A priming operation is enabled during the therapeutic operation of the peritoneal dialysis device based on conditions.

  In addition, preferably, either an adult mode or a pediatric mode can be selected.

  In the present invention, a peritoneal dialysis device having a function applicable to children can be provided.

1 is an external perspective view showing a peritoneal dialysis device of the present invention together with a cassette 8. FIG. It is a figure which shows typically embodiment of the peritoneal dialysis apparatus of this invention. 3 is an external perspective view showing a flow path switching unit and a clamper 240 of the cassette 8. FIG. It is a three-dimensional exploded view of a cassette. It is a related figure of the heating circuit of the cassette 8, and a heater. (a) is a schematic diagram in which the dialysate is fed into the abdominal cavity, and (b) is a schematic diagram in which the drainage is in a liquid feed state. It is a block diagram of a dialysis machine body. It is the figure which showed the display screen which changes sequentially in the display part. It is the figure which showed the display screen which changes sequentially in the display part. It is the figure which showed the display screen which changes sequentially in the display part. It is the figure which showed the display screen which changes sequentially in the display part. It is the figure which showed the display screen which changes sequentially in the display part. It is the figure which showed the display screen which changes sequentially in the display part. It is the figure which showed the display screen when the drainage line obstruct | occludes in the display part. It is a display screen figure of priming mode. It is a display screen figure at the time of parameter setting.

  Hereinafter, the peritoneal dialysis apparatus of the present invention will be described in detail based on the preferred embodiments shown in the accompanying drawings. However, the embodiments described below are preferred specific examples of the present invention, and therefore various technically preferred embodiments. However, the scope of the present invention is not limited to these embodiments unless otherwise specified in the following description.

First, FIG. 1 is an external perspective view showing the peritoneal dialysis apparatus of the present invention together with a disposable cassette (circuit for peritoneal dialysis) 8, and FIG. 2 is a schematic diagram showing the overall configuration.
In both figures, the peritoneal dialysis apparatus 1 includes a dialysis apparatus main body 2 and a cassette 8 for the peritoneal dialysis apparatus that is detachably attached to the dialysis apparatus main body 2.
Further, in FIG. 1, the dialysis machine main body 2 has a cassette mounting portion 21 having an opening 21 a shown by a two-dot chain line for mounting the cassette 8 from the front, and a state in which the cassette mounting portion 21 is closed and opened. The lid member 22, which is rotated with the gripping portion 22a at the position shown by the solid line and the broken line, the display unit 23, the operation unit 24a for performing the treatment start operation, and the operation for performing the treatment stop operation Part 24b.

The shapes and colors of the operation unit 24a and the operation unit 24b are different from each other so that they can be easily distinguished from each other. The start operation unit (start button) 24a has one convex portion and a stop operation unit ( The stop button 24b has two convex portions.
The display unit 23 is composed of, for example, a touch panel provided with a liquid crystal (LCD) panel or the like, and displays various information necessary for dialysis by pressing the touch panel and instructions for operating the apparatus from a speaker 400a shown in broken lines. Operate with the voice guide to ensure operability and convenience. Air bubbles are mixed in the sensor 16a for detecting the closed state of the lid member 22 as indicated by the solid line, the sensor 16b for detecting that the cassette 8 is loaded, and the connection tube 85 connected to the cassette 8. A bubble sensor 14a is provided at the position shown in the figure. Further, the cover of the main body 2 is provided with a hook portion 2a so as to be accommodated, and the liquid is reliably fed by hooking the tube to the hook portion 2a. On the other hand, the dialysis machine main body 2 has a main base portion 200 and a sub base portion 201 shown in broken lines as mounting base portions, each provided with a resin cover as shown, and the main base portion 200 and the sub base portion 201 being 1 It is made of an aluminum metal plate with a thickness of ˜2 mm, and the weight is reduced by drilling large holes everywhere. A lightweight resin cover is fixed to these bases. Further, for example, a memory card 204 having a storage capacity of 100 megabytes or more is provided so as to be able to be loaded into the card reader 203 shown by a broken line from the back of the apparatus. It is configured so that specification changes can be made quickly. In addition, patient data is recorded on the memory card 204, so that individual patients can be handled. Further, a shielding plate 202 is provided on the right side of the cassette mounting portion 21 shown in the two-dot chain line, so as to be movable in the direction of the arrow shown in the broken line, thereby preventing mechanical interference with the connection tube 85 of the cassette 8. By doing so, the cassette 8 can be set at the loading position. On the other hand, the cassette 8 includes a cassette main body 81 that is detachable from the cassette mounting portion 21 of the dialyzer main body 2, a lower main body frame 811 that is continuously formed from the cassette main body 81, and a gap 86 from the lower main body frame 811. And an upper main body frame 812 provided so as to face each other. Further, the cassette body 81 is integrally formed with a liquid feeding diaphragm 87, a heating unit 83, and a flow path switching unit as shown in the figure, and the diaphragm 87 is surrounded by a flange member 815. Has been.

Next, in FIG. 2, the peritoneal dialysis device 1 includes a dialysate circuit unit 3, and the dialysate circuit unit 3 supplies dialysate to be injected (injected) into the peritoneum (intraperitoneal) of the patient K. A plurality of dialysate bags (dialysate containers) 4 to be accommodated (accommodated), an additional dialysate bag 5 to accommodate dialysate having different concentrations, and a drainage fluid for recovering dialysate drained from the peritoneum of patient K It is prepared to connect the tank (drainage container) 6 and a dialysis catheter (catheter tube) 7 placed in the peritoneum of the patient K. Here, the dialysate circuit unit 3 includes a liquid injection tube circuit (line) 31, an additional liquid injection tube circuit (line) 32, a liquid injection / drainage tube circuit (line) 33, and a liquid discharge tube circuit (line). 34). Furthermore, the dialysate circuit unit 3 includes a switching cassette circuit 82 provided in the cassette body 81 of the cassette 8, a heating cassette circuit 83, and a bypass circuit (patient side tube circuit) 84. The circuit 82 includes a liquid injection circuit 821, an additional liquid injection circuit 822, a liquid injection / drainage circuit 823, and a liquid discharge circuit 824.

  3 is an external perspective view showing the flow path switching unit and the clamper (clamp) 240 of the cassette 8 in FIG. 3. One end of the liquid injection circuit 821, one end of the additional liquid injection circuit 822, and other parts of the liquid injection / drainage circuit 823 Connection tubes 85a, 85b, 85c, and 85d are connected to the other end of the drainage circuit 824. In FIG. 2, a plurality of branch tube circuits 35 are branched and connected to one end side of the injection tube circuit 31, and one end of each branch tube circuit 35 is connected to the dialysate bag 4. The other end of the tube circuit 31 is connected to one end of the liquid injection circuit 821 via a connection tube 85a.

  One end of the additional tube circuit 32 is connected to the additional dialysate bag 5, and the other end of the additional tube circuit 32 is connected to one end of the additional liquid injection circuit 822 via the connection tube 85b.

One end of the liquid injection / drainage tube circuit 33 is connected to the other end of the liquid injection / drainage circuit 823 via the connection tube 85c, and the other end of the liquid injection / drainage tube circuit 33 is dialyzed. The catheter 7 is connected via a transfer tube set 36. One end of the drainage tube circuit 34 is connected to the other end of the drainage circuit 824 via a connection tube 85 d, and the other end of the drainage tube circuit 34 is connected to the drainage tank 6.

  The liquid injection tube circuit 31, the additional liquid injection tube circuit 32, the liquid injection / drainage tube circuit 33, and the liquid discharge tube circuit 34 connected to the switching cassette circuit 82 forming the flow path switching unit are used for the cassette 8 to dialyze the cassette 8. When mounted on the main body 2, it is located on the front surface or the front side surface of the dialyzer main body 2.

  Each branch tube circuit 35, additional liquid injection tube circuit 32, liquid injection / drainage tube circuit 33, and liquid discharge tube circuit 34 are each provided with a clamp (channel opening / closing means) 37 that opens and closes the flow path. ing.

  Next, in the three-dimensional exploded view of the cassette 8 in FIG. 4, in the figure, components that have already been described are denoted by the same reference numerals and description thereof is omitted, and between the two divided heating cassette circuits 831 and 832 A gap 86 is formed, and when the cassette body 81 is mounted on the cassette mounting portion 21 of the dialyzer body 2, the heating means 9 is provided on both sides (upper surface and lower surface) of each of the divided heating cassette circuits 831 and 832. Heaters (heating units) are located, and each of the divided heating cassette circuits 831 and 832 is configured to be heated while being sandwiched by the corresponding heaters.

  The cassette body 81 is provided with the switching cassette circuit 82 shown in FIG. 1, and the switching cassette circuit 82 includes the liquid injection circuit 821, the additional liquid injection circuit 822, and the liquid injection / drainage shown in FIG. A circuit 823 and a drain circuit 824 are included. The other end of the additional liquid injection circuit 822 communicates with the liquid injection circuit 821, and one end of the liquid discharge circuit 824 communicates with the vicinity of the other end of the liquid injection circuit 821.

  Further, when the cassette body 81 is mounted on the cassette mounting portion 21 of the dialyzer body 2, the switching cassette circuit 82 switches between the injection circuit state and the drain circuit state due to the blockage by the clamper 240 of FIG. It is configured to be able to.

  Here, the liquid injection circuit state means that the liquid injection circuit 821 (or the additional liquid injection circuit 822) and the liquid injection / drainage circuit 823 communicate with each other so that the dialysate bag 4 (or the additional dialysate bag 5) is dialyzed. This refers to a state in which the catheter 7 is communicated, in other words, a state for injecting dialysate into the peritoneum of the patient K (a state in which injection is possible).

  Further, the drainage circuit state is a state in which the injection / drainage circuit 823 and the drainage circuit 824 communicate with each other so that the dialysis catheter 7 and the drainage tank 6 communicate with each other, in other words, dialysis from within the peritoneum of the patient K. This refers to a state for draining the liquid (a state where the liquid can be drained). Further, the cassette body 81 is provided with a heating cassette circuit 83 shown in FIG. The heating cassette circuit 83 includes two sheet-like divided heating cassette circuits 831 and 832 arranged to face each other.

  One end of the lower divided heating cassette circuit 831 communicates with the other end of the liquid injection circuit 821, and the other end of the lower divided heating cassette circuit 831 is connected to the upper divided heating cassette via the connection pipe 833. The circuit 832 communicates with one end. The other end of the upper divided heating cassette circuit 832 communicates with one end of the liquid injection / drainage circuit 823.

  Accordingly, the dialysate sequentially flows in the lower divided heating cassette circuit 831 and the upper divided heating cassette circuit 832 in this order.

  In the present invention, the dialysate may be divided and flow into the lower divided warming cassette circuit 831 and the upper divided warming cassette circuit 832 and then merged.

  As shown in the plan view of the cassette 8 in FIG. 5 and the rear view of the cassette 8 in FIG. 6, the flow path of each of the divided heating cassette circuits 831 and 832 has a meandering shape. It may be. Thus, by making it meander shape or spiral shape, the flow path of each division | segmentation cassette circuit 831 and 832 becomes long, and it can heat a dialysate reliably.

Further, the cassette body 81 is provided with a diaphragm pump 87 which is kept airtight in a pump chamber which will be described later in order to pump the dialysate by contraction and expansion and to send the dialysate. It is connected in the middle of the circuit 821.

  The diaphragm pump 87 is accommodated in a sealed state by the flange member 815, so that the diaphragm pump 87 contracts when pressurized, and the diaphragm pump 87 expands when decompressed.

The cassette body 81 is provided with the bypass circuit 84 as described above. One end of the bypass circuit 84 is connected to the upstream side of the heating cassette circuit 83, in the present embodiment, in the middle of the liquid injection circuit 821, and the other end of the bypass circuit 84 is connected to the downstream side of the heating cassette circuit 83, this embodiment. In the form, it is connected in the middle of the liquid injection / drainage circuit 823. The bypass circuit 84 connects the upstream side and the downstream side of the heating cassette circuit 83 to form a circulation circuit for cooling the dialysate.

  Further, in order to forcibly cool the dialysate in the bypass circuit 84, forcible cooling means such as a Peltier element may be provided to cool quickly and reliably.

  The switching cassette circuit 82, the heating cassette circuit 83, the bypass circuit 84, and the diaphragm pump 87 are arranged substantially in a plane. Thereby, the thickness of the cassette 8 can be made thinner.

  When the cassette body 81 is mounted on the cassette mounting portion 21 of the dialyzer body 2, the outlet side (downstream side) of the heating cassette circuit 83 can be switched between the final injection circuit state and the return circuit state. It is configured. Here, the final liquid injection circuit state means a state in which the outlet side of the heating cassette circuit 83 communicates with the liquid injection / drainage circuit 823 and does not communicate with the bypass circuit 84. The return circuit state refers to a state in which the outlet side of the heating cassette circuit 83 communicates with the bypass circuit 84 and does not communicate with the liquid injection / drainage circuit 823.

  Furthermore, as shown in the three-dimensional exploded view of the cassette 8 in FIG. 4, first to eighth support protrusions 881 to 888 that form a flow path switching unit at positions corresponding to the switching cassette circuit 82 of the lower body frame 811. Is formed. The first support protrusion 881 supports the vicinity of one end of the liquid injection circuit 821, the second support protrusion 882 supports the additional liquid injection circuit 822, and the third support protrusion 883 is an injection liquid. The fourth support protrusion 884 supports between the diaphragm pump 87 and one end of the bypass circuit 84 in the liquid circuit 821, and supports between the diaphragm pump 87 and one end of the heating cassette circuit 83 in the liquid injection circuit 821. To do. Similarly, the fifth support protrusion 885 supports the drain circuit 824, and the sixth support protrusion 886 is connected to the other end of the heating cassette circuit 83 and the bypass circuit 84 in the liquid injection / drain circuit 823. The seventh support protrusion 887 supports the vicinity of the other end of the liquid injection / drainage circuit 823, and the eighth support protrusion 888 supports the bypass circuit 84. To do.

  The switching cassette circuit 82, the bypass circuit 84, and the diaphragm pump 87 are integrally formed by blow molding. Thereby, joining with another component can be reduced, the quality of the cassette 8 can be improved, and the cost can be reduced.

  Further, each of the divided heating cassette circuits 831 and 832 of the heating cassette circuit 83 is formed by sheet molding. Thereby, manufacture of each division | segmentation heating cassette circuit 831 and 832 becomes easy, and cost can be reduced.

  The switching cassette circuit 82, the bypass circuit 84, and the diaphragm pump 87 are joined to the divided heating cassette circuits 831 and 832 by high-frequency fusion (high-frequency welding) and adhesion.

  Here, in order to form the division heating cassette circuits 831 and 832 by sheet molding, for example, two resin sheets are overlapped, and these are fused in a predetermined pattern. In addition, the part which was not melt | fused forms a flow path.

  The switching cassette circuit 82, the heating cassette circuit 83, the bypass circuit 84, and the diaphragm pump 87 are composed of soft resins such as polyethylene, polypropylene, ethylene-propylene copolymer, and ethylene-vinyl acetate copolymer, respectively. Polyolefin such as coalescence (EVA), polyvinyl chloride, polyvinylidene chloride, polystyrene, polyamide, polyimide, poly- (4-methylpentene-1), ionomer, acrylic resin, polyethylene terephthalate (PET), polybutylene terephthalate (PBT) ) Polyester, styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide and other thermoplastic elastomers, silicone resin, polyurethane, etc. Polymers, blends, polymer alloys and the like, can be used singly or in combination of two or more of these (e.g., a laminate of two or more layers).

  Further, positioning holes 8a and 8a are formed in the cassette body 81 so that positioning is performed by the positioning pins of the sub base 201. Further, an opening 81b that forms part of the flow path switching portion is formed opposite to the first to eighth support protrusions, and the clamper can enter the opening 81b so as to be closed. ing.

  On the other hand, as shown in the heater configuration diagram of FIG. 5, a heating means 9 for heating the heating cassette circuit 83 of the cassette 8 is provided in the dialysis apparatus main body 2. (Layered) lower surface heater 91, plate-shaped (layered) upper surface heater 92, and plate-shaped (layered) intermediate surface heater 93.

  Here, the lower surface heater 91 heats the lower surface of the lower divided heating cassette circuit 831 from below through an aluminum plate 94a as a heat transfer member, and the upper surface heater 92 The upper surface of the divided heating cassette circuit 832 is heated from above via an aluminum plate 94d as a heat transfer member. The intermediate surface heater 93 is located in the gap 86 and heats the upper surface of the lower divided heating cassette circuit 831 from above through an aluminum plate 94b as a heat transfer member, and also performs upper divided heating. The lower surface of the temperature cassette circuit 832 is heated from below through an aluminum plate 94c as a heat transfer member.

  Accordingly, the dialysate inside the lower divided heating cassette circuit 831 is heated while being sandwiched between the lower surface heater 91 and the intermediate surface heater 93, and the dialysis solution inside the upper divided heating cassette circuit 832. The liquid is heated while being sandwiched between the upper surface heater 92 and the intermediate surface heater 93. Therefore, the heating efficiency of the dialysate inside the heating cassette circuit 83 by the heating means 9 is improved, which is advantageous for downsizing and weight reduction of the dialyzer body 2 and the cassette 8.

  The clamp means 11 shown in FIG. 3 switches the switching cassette circuit 82 of the cassette 8 to one of a liquid injection circuit state and a liquid discharge circuit state, and the outlet side of the heating cassette circuit 83 is in a final liquid injection circuit state. Or the drain circuit state, or assists the pumping operation of the diaphragm pump 87.

  That is, first to eighth clamps 111 to 118 indicated by arrows are provided in the dialyzer main body 2, and the first clamp 111 cooperates with the first support protrusion 881 of the liquid injection circuit 821. Clamp so that the channel closes near one end. The second clamp 112 cooperates with the second support protrusion 882 to clamp the additional liquid injection circuit 822 so that the flow path is closed. The third clamp 113 cooperates with the third support protrusion 883 to clamp one end of the diaphragm pump 87 and the bypass circuit 84 in the liquid injection circuit 821 so that the flow path is closed. The fourth clamp (pumping control clamp) 114 cooperates with the fourth support protrusion 884 to clamp the diaphragm pump 87 and one end of the heating cassette circuit 83 in the liquid injection circuit 821 so that the flow path is closed. .

  Similarly, the fifth clamp 115 cooperates with the fifth support protrusion 885 to clamp the drain circuit 824 so that the flow path is closed. The sixth clamp 116 cooperates with the sixth support protrusion 886 to clamp the flow path between the other end of the heating cassette circuit 83 and the other end of the bypass circuit 84 in the liquid injection / drainage circuit 823. To do. The seventh clamp 117 cooperates with the seventh support protrusion 887 to clamp the vicinity of the other end of the liquid injection / drainage circuit 823 so that the flow path is closed. The eighth clamp 118 cooperates with the eighth support protrusion 888 to clamp the bypass circuit 84 so that the flow path is closed. Therefore, when the switching cassette circuit 82 is switched to the liquid injection circuit state, the first clamp 111 (or the second clamp 112), the fourth clamp (pumping control clamp) 114, the sixth clamp 116, and the seventh clamp 117 are respectively In addition to switching to the unclamped state, the second clamp 112 (or the first clamp 111), the fifth clamp 115, and the eighth clamp 118 are each switched to the clamped state. When the inside of the chamber 814 is pressurized by the pumping operation means 10, the fourth clamp 114 is switched to the unclamped state and the third clamp 113 is switched to the clamped state. Further, when the pressure in the chamber 814 is reduced by the pumping operation means 10, the fourth clamp 114 is switched to the clamped state and the third clamp 113 is switched to the unclamped state. As a result, the dialysate can be sent from the dialysate bag 4 (or the additional dialysate bag 5) toward the dialysis catheter 7, that is, injected, so that the peritoneal cavity of the dialysate shown in FIG. The liquid can be fed into the inside.

  In addition, when the switching cassette circuit 82 is switched to the drain circuit state and switched, the seventh clamp 117 and the eighth clamp 118 are switched to the unclamped state, and the first clamp 111, the second clamp 112, and the fourth clamp. By switching the 114 and the sixth clamps 116 to the clamped state, respectively, the drainage recovery state shown in FIG.

  Further, when the pressure in the pump chamber is reduced by the pumping operation means, the third clamp 113 is switched to the unclamped state and the fifth clamp 115 is switched to the clamped state. Further, when the inside of the chamber 814 is pressurized by the pumping operation means, the third clamp 113 is switched to the clamped state, and the fifth clamp 115 is switched to the unclamped state, whereby dialysis is performed from the dialysis catheter 7 toward the drainage tank 6. The liquid can be drained.

  The diaphragm pump 87, the third clamp 113, the fourth clamp 114, the fifth clamp 115, and the pumping operation means constitute a liquid feeding means for feeding dialysate.

  Further, when the switching cassette circuit 82 is in the liquid injection circuit state and the outlet side of the heating cassette circuit 83 is in the final liquid injection circuit state, the seventh clamp 117 is in the unclamped state and the eighth clamp 118 is in the clamped state. It has become.

  When the outlet side of the heating cassette circuit 83 is switched to the return circuit state, the first clamp 111, the second clamp 112, and the seventh clamp 117 are switched to the clamped state, and the eighth clamp 118 is switched to the unclamped state. As a result, the dialysate does not flow from the outlet side of the heating cassette circuit 83 toward the dialysis catheter 7 but flows through the bypass circuit 84 toward the diaphragm pump 87. That is, the dialysate circulates between the bypass circuit 87 and the heating cassette circuit 83.

  The seventh clamp 117 and the eighth clamp 118 constitute liquid injection return circuit switching means for switching the outlet side of the heating cassette circuit 83 between the final liquid injection circuit state and the return circuit state.

  Here, when the dialysate is drained, the drainage is collected in the drainage tank 6 via the bypass circuit 84. Thereby, the structure of a flow path can be simplified.

  As described above, by providing the cassette body 81 with the switching cassette circuit 82, the heating cassette circuit 83, the bypass circuit 84, and the diaphragm pump 87, the peritoneal dialysis device 1 can be reduced in size and weight. Therefore, handling such as transportation of the peritoneal dialysis device 1 is facilitated, and a smooth medical practice can be performed.

  In particular, since the dialysate flowing through each of the divided heating cassette circuits 831 and 832 is heated while being sandwiched between the corresponding heaters, the heating efficiency of the dialysate is improved. 1 can be further reduced in size and weight.

  On the other hand, as shown in FIG. 2, the peritoneal dialysis device 1 includes various sensors for temperature control of the dialysate and the like.

  That is, on the downstream side of the heating cassette circuit 83 of the dialyzer main body 2, an outlet for measuring (detecting) the temperature (outlet liquid temperature) of the dialysate flowing on the outlet side (downstream side) of the heating cassette circuit 83. A temperature sensor 12A for liquid temperature is installed, and the temperature (inlet liquid temperature) of the dialysate flowing on the inlet side (upstream side) of the heating cassette circuit 83 is measured (detected) on the upstream side of the heating cassette circuit 83. An inlet liquid temperature sensor 12B is installed.

  Here, as the outlet liquid temperature sensor 12A and the inlet liquid temperature sensor 12B, it is preferable to use a thermopile type infrared sensor (non-contact type temperature sensor) having a very fast response speed. Thereby, the temperature of each surface heater 91,92,93 can be controlled with high precision.

  Further, as shown in FIG. 5, each surface heater 91, 92, 93 is provided with a heater temperature sensor 13 such as a thermistor for measuring (detecting) the temperature. Further, the dialyzer main body 2 is provided with bubble sensors 14 for detecting bubbles on the inlet side and the outlet side of the switching cassette circuit 82, respectively. The peritoneal permeation device 1 includes an occlusion sensor that detects occlusion of the circuit and other various sensors (various sensors 16).

Further, as shown in the block diagram of FIG. 7, the peritoneal dialysis apparatus 1 includes a control unit (control means) 15 that controls each of the dialysate injection, drainage control, and display unit control.
The control unit (control means: CPU) 15 includes a control program for the entire apparatus executed by the CPU, a ROM for storing various data, and a RAM for temporarily storing measurement data and various data as a work area. Control is performed to control the entire operation of the dialyzer body 2.

  That is, the control unit 15 includes a CPU (central control unit) 150 and a storage unit 152. The CPU 150 includes a clamp control block 153 that controls the plurality of clamps 111 to 118, and a plurality of surface heaters 91 and 92. , 93 are electrically connected to a heater control unit 154 for controlling the temperature of 93 and a pumping operation control unit 155 for controlling the pumping operation means 10, respectively. Further, the CPU 150 includes an outlet liquid temperature sensor 12A, an inlet liquid temperature sensor 12B, each heater temperature sensor 13, each bubble sensor 14, a display unit 23, and operation units 24a and 24b, respectively. Connected. The CPU 150 is electrically connected to a power supply circuit 156, a battery circuit 157, a sound generation circuit 400, and a cassette loading control unit 301 that controls the cassette loading unit 300. The display unit 23 is electrically connected to a card reader 203 that can be loaded with the memory card. Further, the storage medium reading unit 170 reads a storage medium 170a storing various control programs such as a flexible disk and a CD-ROM. In addition, the external communication unit 171 enables mutual communication with a portable terminal (not shown), a medical site, and the like via a wireless network such as a LAN, the Internet, and infrared rays.

  When the temperature measured by the outlet liquid temperature sensor 12 </ b> A is equal to or higher than a predetermined temperature (39 ° C. in the present embodiment), the controller 15 causes the clamp controller 153 to execute the seventh clamp 117. Is switched to the clamped state, the eighth clamp 118 is controlled to switch to the unclamped state, and the heater control unit 154 switches to the off state in which the driving of the plurality of surface heaters 91, 92, 93 is stopped.

  The outputs (output values) of the surface heaters 91, 92, and 93 are selected based on the temperature control flow of the dialysate and the temperature of the dialysate. That is, the controller 15 determines the temperature of the dialysate to be injected based on the temperature measured by the outlet liquid temperature sensor 12A and the temperature measured by the inlet liquid temperature sensor 12B. The outputs (drives) of the plurality of surface heaters 91, 92, and 93 are controlled so as to be within the temperature range. Then, the clamp control unit 153 controls the first clamp 111 (or the second clamp 112), the fourth clamp 114, the sixth clamp 116, and the seventh clamp 117 to switch to the unclamped state, and the second clamp 112 ( Alternatively, the first clamp 111), the fifth clamp 115, and the eighth clamp 118 are controlled to switch to the clamped state. Thereby, the switching cassette circuit 82 can be switched to the liquid injection circuit state. In addition, the heater control unit 154 performs control so that electric power (output) is supplied to the plurality of surface heaters 91, 92, and 93. Thereby, the heating process which heats the dialysate which flows through the heating cassette circuit 83, in other words, the temperature control flow of the dialysate enters the preheating process.

  When the time T1 has elapsed since the start of power supply to the plurality of surface heaters 91, 92, 93, the preheating process is completed. When this preheating process is completed, the pumping operation control unit 155 controls the pumping operation means 10 to alternately pressurize and depressurize the pump chamber. In addition, the clamp control unit 153 controls the fourth clamp 114 to switch between the clamped state and the unclamped state alternately according to the pressurization and decompression in the chamber 814, and also controls the third clamp 113 to perform the clamp. Switching between the state and the unclamped state is repeated alternately according to the pressurization and decompression in the chamber 814. As a result, the diaphragm pump 87 is pumped (contracted and expanded), and the dialysate is sent from the dialysate bag 4 toward the dialysis catheter 7 and injected.

  When the preheating step is completed, the temperature control flow of the dialysate enters the initial heating step. When the initial warming process ends, the temperature control flow of the dialysate normally enters the warming process. In the normal warming process, the output control of the plurality of surface heaters 91, 92, 93 is the heater output value by P control when the temperature measured by the outlet liquid temperature sensor 12A is less than 33 ° C. Is output to the plurality of surface heaters 91, 92, 93.

  On the other hand, when the temperature measured by the outlet liquid temperature sensor 12A is 33 ° C. or higher and lower than 39 ° C., the output value of the heater by PI control is output to the plurality of surface heaters 91, 92, 93.

  Thereby, output control of the several surface heaters 91, 92, and 93 can be performed with high precision. In the initial heating process or the normal heating process, when the temperature measured by the outlet liquid temperature sensor 12A is 39 ° C. or higher, the clamp controller 153 controls the seventh clamp 117 to switch to the clamped state. At the same time, the eighth clamp 118 is controlled to switch to the unclamped state. Further, the heater control unit 154 stops the supply of electric power to the plurality of surface heaters 91, 92, 93, in other words, turns off the plurality of surface heaters 91, 92, 93. Thereby, the outlet side of the heating cassette circuit 83 can be switched to the return circuit state, and the dialysate flows from the heating cassette circuit 83 toward the bypass circuit 84 without flowing toward the dialysis catheter 7. It returns to the upstream side of the heating cassette circuit 83 through the bypass circuit 84, circulates between the bypass circuit 84 and the heating cassette circuit 83, and the temperature decreases (cools) during that time. That is, the dialysate heating control flow shifts to the cooling step (step 12). Therefore, a dialysis solution having a temperature considerably higher than the body temperature of the patient K (a temperature of 39 ° C. or higher) is not injected into the patient K, and a safe dialysis treatment can be performed.

  When the temperature measured by the outlet liquid temperature sensor 12A is less than 39 ° C., the clamp controller 153 controls the seventh clamp 117 to switch to the unclamped state, and controls the eighth clamp 118. Switch to the clamped state. Further, the plurality of surface heaters 91, 92, 93 are switched on. Thereby, the exit side of the heating cassette circuit 83 can be returned to the final liquid injection circuit state, and the process proceeds to the initial heating process or the normal heating process again. When a predetermined amount of dialysate is injected (injected) into the peritoneum of patient K, the injection of dialysate is completed.

  After the injection of the dialysate is completed, the clamp controller 154 controls the seventh clamp 117 and the eighth clamp 118 to switch to the unclamped state, and controls the fourth clamp 114 and the sixth clamp 116 to perform the clamp. Switch to state. Thereby, the switching cassette circuit 82 can be switched to the drain circuit state.

  Then, the pumping operation control unit 155 controls the pumping operation means 10 to alternately repeat the depressurization and pressurization of the chamber 814. In addition, the clamp control unit controls the third clamp 113 to alternately switch between the unclamped state and the clamped state according to the decompression and pressurization of the chamber 814, and the fifth clamp 115 is controlled to be in the clamped state. The switching of the unclamped state is repeated alternately in accordance with the decompression and pressurization in the chamber 814. Thereby, the diaphragm pump 87 is pumped, and the dialysate in the peritoneum can be sent from the dialysis catheter 7 toward the drainage tank 6 to be drained.

<User interface>
8 to 13 are diagrams showing display screens that sequentially change in the display unit 23 shown in FIG.

  In the block diagrams of FIGS. 7 and 8, when the power source of the dialyzer body 2 is turned on by a power switch (not shown) and the operation unit 24a is pressed, an initial screen 500 of the device manufacturer name is displayed and a guide is displayed. The screen shifts to a screen 501 displaying the role nurse and sheep (character image) in color. At this time, the self-check of the dialyzer body 2 is performed. Next, the storage unit 152 is initialized by moving the arrow on the screen 502, and at the same time, the voice guide stored by the voice synthesis IC is used. “Let the treatment be done in a bright and clean place. The message “Sho” is generated from the speaker 400a by electronic voice. Following this, the screen is automatically switched to the screen 503. In this screen, treatment pattern, initial drainage volume, injection volume, intraperitoneal retention time, number of cycles, final injection volume, final concentration change, dialysis time, scheduled dialysis end time, total dialysate volume, etc. Parameters required for peritoneal dialysis are displayed as previous data. If this is acceptable, the touch button 506 of “Next” is pressed to advance to the screen of FIG.

  On the screen 507 in FIG. 9, the cassette 8 is displayed with a voice guide so as to be set in the mounting portion of the apparatus. In addition, on the screen 507, a “setting confirmation” touch key 508 appears simultaneously. When the touch key 508 is pressed, the screen moves to a screen 523 in FIG. On the screen 509 after the screen 507, a voice guide is generated, “This is the procedure to insert My Home Pico (registered trademark of Terumo Corporation)” composed of the cassette 8 and piping shown in FIG. Then, the nurse and cassette images are displayed interchangeably. Therefore, when the patient touches the “Next” touch key 510, the screen changes to a screen 511, and the letters “Please close all clamps” and the operation procedure are displayed together with a voice guide and a color still image. When the “next” touch key 512 on this screen 511 is pressed, a screen is displayed on the screen 513 so as to open the lid member 22 toward the front, voice guidance is performed, and the screen is automatically switched to the surface 514. On this screen 514, the state in which the cassette 8 is inserted from above the lid member of the apparatus is displayed as an animated animation in color. Following this, a screen for closing the lid member after loading the cassette is displayed on the screen 515 together with a voice guide, and the screen changes to the screen 516 in FIG. 10 and waits until the cassette is moved to the state of being sandwiched by the three layers of heaters. Following this, the screen 517 is displayed as an animated video together with a voice guide so as to set the connection tube on the hook 2a of the main body, and the screen moves to the screen 518.

  On this screen 518, “Connect a dialysis bag to Pico Set (trademark of Terumo Co., Ltd.) 8” is displayed together with a voice guide, and when “Next” is touched, the screen changes to screen 519 and shows the state of the connection. At the same time, a voice guide is generated. Thereafter, an operation for a necessary connection is instructed by automatically switching to the screens 520, 521, and 522. The screen of FIG. 11 is a screen that is sequentially displayed when the “Setting Confirmation” touch key 508 in the screens 507 and 508 of FIG. 9 is touched. On the screen 523, a message for confirming the connection is displayed together with a voice guide. After the connection is completed, after touching the “Next” touch key 524, the standby screen display of the screen 525 is performed, and after the connection is displayed on the screen 526 and other voices are displayed and voice guidance is given. Then, touch the “setting” touch key on the screen 528 to prepare for dialysis, and press the operation unit 24a to start dialysis. Further, on this screen 528, when the touch key 530 of “up / down arrow” is touched, the items 1 to 5 on the screen are reversed and the touch can be confirmed by touching the touch key of “return”. Further, on the screen 526, an item that the patient needs to explain can be selected with the touch key 530.

  On the other hand, when the “change” touch key 504 on the screen 503 in FIG. 8 is touched, the screen is changed to the screen 531 in FIG. 12, and the “up / down arrow” touch key 533 is touched to set the dialog with the screens 534 to 541. do. Since the display color of these screens 534 to 541 is a single color and the background color does not change, it can be seen that the patient is changing the setting.

  Discharge line blockage, injection line blockage, injection failure, drainage failure, insufficient drainage volume, additional injection line blockage, battery voltage drop, outside temperature drop, peritoneal line blockage, bubble detection, power failure, etc. The contents and the operation procedures corresponding to them are stored in the storage unit 152 in advance. When an abnormality is detected by the bubble sensor 14 and the various sensors 16, the screen automatically displays an abnormal state, and what kind of abnormality has occurred is sequentially displayed on the screen. (Patient) can confirm the response. The injection line blockage, the injection failure detection, and the alarm are performed as follows.

Detection of injection line blockage and injection failure will be described with reference to the flowchart of FIG.
Treatment pattern, storage time, number of cycles, dialysis time, infusion volume (mL) and infusion rate (mL / min) preset by the manufacturer, etc., entered on the setting screens 531 to 541 (usually user) The liquid injection time (minutes) is calculated based on dialysis conditions such as (cannot be set on the setting screen, but can be set by the user on the setting screen). When it is determined that the liquid is injected over a predetermined amount (for example, twice the calculated liquid injection time (minutes)) (step S3), it is displayed on the display unit 23 as a liquid injection failure, and also by voice. Guidance is made as an alarm (step S4-2).

The injection time (min) is the injection volume (mL) / injection speed (mL / min) + preparation time (min) (for example, about 2 minutes) until the start of injection. Further, when the liquid is returned to a predetermined liquid injection volume (mL) or when liquid injection is performed at a predetermined speed, the display unit 23 displays a normal operation screen on the character.

  Such a liquid injection failure detection mode program and a liquid discharge failure detection mode program storage unit 152 are stored or stored in the storage medium 170a, read by the storage medium reading unit 170, and controlled by the CPU 150. The

  FIG. 13 shows an example of an abnormal state of dialysis when the drainage line is blocked. In order to notify the abnormal state, on the screens 550 to 554, a voice image and a still image or a moving image including characters are displayed, and the background color is displayed as a conspicuous predetermined color such as yellow or orange indicated by hatching in the drawing. In this way, the patient is informed of an abnormal condition.

  On screen 550, the text “Please press the stop switch to stop the alarm sound” is displayed on the alarm (alarm) / instruction screen. Done.

  When the operation unit (stop button) 24b is pressed in accordance with this instruction, a question-type screen is displayed as shown in a screen 551, and one of the obstruction locations (patterns) stored in advance in the storage unit 152 is peritoneal dialysis. It is indicated by an arrow 551a and a circular dot mark 551b of a predetermined color (red) together with a schematic diagram of the line, and a question as to whether or not “pink clamp is closed” is made by voice together with character display.

  If “No” is clicked on the screen 551, the screen shifts to the screen 552, but if “Yes” is clicked, the screen 555 is displayed, and the procedure to be handled is instructed by characters and voices “please open the pink clamp”. When the procedure according to this instruction is executed and “Next” is clicked, the screen shifts to a screen 552.

  If you click "No" on screen 552, the screen will move to screen 554, but if you click "Yes", screen 555 will be displayed, and the procedure to be taken is the text and sound "Please fix the tube crushing and twisting". Indicated by When the procedure according to this instruction is executed and “Next” is clicked, the screen shifts to a screen 554.

  On the screen 554, the user is instructed by characters and voices such as “Please press the start switch.

  In this way, the abnormal content / location is assumed in advance and stored in the storage unit 152 so that it can be sequentially confirmed.

  In each screen, the user can return to the original operation by pressing the operation unit 24a.

  In addition to the blockage of the drainage line shown in FIG. 13, this abnormal state includes the blockage of the injection line during treatment and priming, poor liquid injection, poor drainage and shortage, air bubbles, and additional injection during treatment and priming. There are liquid line blockage, battery backup due to power failure, and outside air temperature drop, and when these abnormalities occur, all of them become background colors with conspicuous colors such as yellow and orange, and at the same time, the abnormality is notified by voice guidance, so there is a trouble. Even if it occurs, it can be easily handled, so it can be used with confidence.

<Selection function for child mode / adult mode>
When a power switch (not shown) is OFF, a switch (not shown) inside the main body is set to the parameter setting mode, and when the power switch is turned ON, a display screen as shown in FIG. Is displayed. On this screen, “Yes” is selected and confirmed from “Children mode” and “Yes / No” (in the case of “Children mode” and “No”, the mode is for adults).
When the infant mode is selected, dialysis conditions are set and input on the screens 531 and 534 to 541 shown in FIG. The initial drainage time and drainage time, which are not shown, are also set.
In the case of the infant mode, the CPU 150 automatically controls various set amounts (initial liquid discharge amount, initial liquid injection amount, liquid supply amount, total liquid discharge amount, total liquid discharge amount, re-drainage amount, The minimum unit of the injection volume for each cycle, the drainage volume for each cycle, the water removal volume for each cycle, the total dialysate volume, the total water removal volume, the Tidal volume, the Tidal volume, etc.) is the default value of 10 mL ( In the adult mode, the minimum unit for each set amount is 50 mL).
It should be noted that the minimum unit of the various set amounts may be set to be 10 mL or less depending on the weight of the infant or child.
In addition, the following dialysis parameter setting can be performed.
<Parameter settings>
Item Setting range (unit) Initial value
Injection rate (mL / min) 50-250 mL (50 mL) 200 mL
Drain rate (mL / min) 50-150mL (50mL) 150mL
Waste liquid deceleration rate (mL / min) 50-150 mL (10 mL) 100 mL
Drainage deceleration start point 50-100% (1%) 80%
Initial drainage occlusion detection point 50-100% (1%) 80%
Blockage detection point 50-100% (1%) 80%
Number of times of occlusion determination 1 to 40 times (1 time) 10 times Number of times of drainage end determination 1 to 120 times (1 time) 3 times Intra-abdominal residual fluid determination value 0 to 200% (1%) 50%
Abdominal residual fluid judgment value (conditioning) 0-200% (1%) 50%

<Priming function for additional injection>
FIG. 14 is a diagram showing a screen transition when additional priming is performed during the treatment operation based on the dialysis conditions in which the dialysis apparatus body 2 is set when the infant mode is selected.
When the dialysis machine body 2 of the peritoneal dialysis machine 1 presses the operation unit (stop button) 24b for a predetermined time, for example, about 2 seconds, during a treatment operation based on the set dialysis conditions (during liquid injection operation in FIG. 14), The screen transitions from the screen 560 to the screen 561, and is notified by a voice guide in addition to the character guide and character display “Pause temporarily. Please wait for a while.” When a predetermined time, for example, about 10 seconds elapses, the screen transitions to the screen 562.
When “Next” on the touch panel displayed on this screen 562 is pressed, the screen transitions to the screen 563 under the control of the CPU (control unit) 150 to enter the additional priming mode.
When “addition liquid injection F” on the touch panel displayed on the screen 563 of the additional priming mode is pressed, as in the following 1) to 3), the first clamp 111, the second clamp 112, the third clamp, the fourth clamp, The clamping operations of the fifth clamp 115, the sixth clamp 116, the seventh clamp 117, and the eighth clamp 118 are controlled (see FIG. 6).
1) Under the control of the CPU 150, the second clamp 112 and the third clamp 113 are brought into an unclamped state (clamp release state).
2) At this time, the first clamp 111, the fourth clamp, the fifth clamp 115, the sixth clamp 116, the seventh clamp 117, and the eighth clamp 118 are in a clamped state under the control of the CPU 150.
In this state, under the control of the CPU 150, only the path through which the additional dialysate in the additional liquid injection bag 5 flows into the diaphragm pump 87 through the connection tube 85c by the pumping action of the diaphragm pump 87 is secured. The additional dialysate in 5 flows into the diaphragm pump 87.
3) Next, under the control of the CPU 150, the second clamp 112 and the third clamp 113 are also clamped while the first clamp 111, the fourth clamp, the seventh clamp 117, and the eighth clamp 118 are clamped, With the fifth clamp 115 in an unclamped state (clamp released state), the additional dialysate in the diaphragm pump 87 flows into the drainage tank (or drainage tank) 6 through the connection tube 85c by the pumping action of the diaphragm pump 87. Only the path to be used is ensured, and the additional dialysate in the diaphragm pump 87 flows into the drainage tank (or drainage tank) 6.
Since the connection tube 85c is primed by repeating the operations 1) to 3) a predetermined number of times, for example, about twice, the residual gas due to EOG sterilization does not remain in the connection tube 85c.
When this priming is completed, the screen transitions to the screen 564, and the control of the CPU 150 is performed to return to the screen 561 after the characters and voice guidance “Please wait for a while” are given.

<Priming function for liquid injection>
When the dialysis machine body 2 of the peritoneal dialysis machine 1 presses “Liquid F” on the touch panel displayed on the screen 563 of this additional priming mode during the treatment operation based on the set dialysis conditions, the following 1) to 3) The clamp operations of the first clamp 111, the second clamp 112, the third clamp, the fourth clamp, the fifth clamp 115, the sixth clamp, the seventh clamp 117, and the eighth clamp 118 are controlled as shown in FIG. 6).
1) Under the control of the CPU 150, the first clamp 111 and the third clamp 113 are brought into an unclamped state (clamp release state).
2) At this time, the second clamp 112, the fourth clamp 114, the fifth clamp 115, the sixth clamp 116, the seventh clamp 117, and the eighth clamp 118 are in a clamped state under the control of the CPU 150.
In this state, under the control of the CPU 150, only the path through which the dialysate in the dialysate bag 5 flows into the diaphragm pump 87 through the connection tube 85a by the pumping action of the diaphragm pump 87 is secured. The liquid flows into the diaphragm pump 87.
3) Next, under the control of the CPU 150, the second clamp 112, the fourth clamp 114, the sixth clamp 116, the seventh clamp 117, and the eighth clamp 118 are kept in the clamped state, and the first clamp 111 and the third clamp 113 is also in the clamped state, the fifth clamp 115 is in the unclamped state (clamp released state), and the dialysate in the diaphragm pump 87 is pumped by the diaphragm pump 87 through the connection tube 85c to the drainage tank (or drainage). Only a path for flowing into the liquid tank 6 is secured, and the dialysate in the diaphragm pump 87 flows into the drainage tank (or drainage tank) 6.
By repeating the operations 1) to 3) a predetermined number of times, for example, about twice, the connection tube 85c is primed, so that no residual gas due to EOG sterilization remains in the connection tube 85d.
When this priming is completed, the screen transitions to the screen 564, and the control of the CPU 150 is performed to return to the screen 561 after the characters and voice guidance “Please wait for a while” are given.
This priming effect is great for infants and children who have very little infusion and drainage of peritoneal dialysis fluid.
In the child mode, a so-called child lock function is provided so that the dialyzer body 2 does not stop even if the display screen of the display unit 23 is inadvertently touched or the operation units 24a and 24b are touched. Also good.

Other functions are briefly described below.
<Draining time extension function>
Displayed when the dialysis machine body 2 of the peritoneal dialysis machine 1 is not drained as scheduled during the treatment operation based on the set dialysis conditions, and is temporarily stopped after the set drainage time has elapsed. 14 is displayed together with the “extension button” which is a touch key on the screen displaying the pause, for example, the screen 562 of FIG. Allow the drainage time to be extended.
Thus, the drainage remaining in the abdominal cavity can be reliably drained without remaining.
<Temporary flash function>
When the dialysate that has been set up is replaced with a dialysate bag containing a different concentration of dialysate according to changes in blood pressure, etc., the original concentration of dialysate remaining in the dialysis circuit and the newly connected connection tube In order to allow a predetermined amount, for example, 300 mL of flushing, to be discharged, the dialysis machine body 2 of the peritoneal dialysis machine 1 is undergoing a therapeutic operation based on the set dialysis conditions. 14 is displayed together with “flash” as a touch key on a screen for displaying a pause, for example, a screen 562 in FIG.

  DESCRIPTION OF SYMBOLS 1 Dialysis machine, 2 Dialysis machine main body, 21 Cassette mounting part, 22 Lid member, 23 Display part, 24a, 4b Operation part, 3 Dialysate unit, 31 Injection tube circuit, 32 Injection tube circuit, 3 Drain tube circuit , 35 branch tube circuit, 36 transfer tube set, 37 clamp, 4 dialysate bag, 5 additional dialysate bag, 6 drainage tank, 7 dialysis catheter, 8 cassette, 81 cassette body, 9 heating means, 10 pumping operation means , 101 Air circuit, 102 Branch air circuit, 103 Branch air circuit, 104 Air pressure generator, 105 Vacuum pressure generator, 14 Bubble sensor, 15 Control unit, 16 Various sensors

Claims (1)

A dialysate circuit including at least one dialysate container filled with dialysate and at least one drainage container for collecting dialysate, and starting from the dialysate container, or starting from the drainage container A liquid supply means for supplying dialysate; an input means for inputting dialysis conditions; a display means for displaying the input dialysis conditions and an operation procedure; and a control unit. A peritoneal dialysis device that supplies peritoneal dialysis by supplying the dialysis fluid to the effluent and during the therapeutic operation of the peritoneal dialysis device based on the dialysis conditions set by the input means, allowing priming operation, further are those of any of the adult mode or a pediatric mode can be made selectable, display the input means and the display means that is a touch panel display screen is displayed Yes, the control unit is connected to the operation unit, so that it does not stop even if it touches the display screen of the display unit unexpectedly or touches the operation unit during the infant mode, A peritoneal dialysis device having a child lock function .

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