JP3106722B2 - Peritoneal dialysis machine - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a peritoneal dialysis apparatus for performing dialysis using the peritoneum by repeating the steps of injecting, storing, and draining a dialysate into the peritoneal cavity of a patient, and in particular, while the patient is asleep. The present invention relates to a peritoneal dialysis apparatus that automatically changes the dialysate several times.

[0002]

2. Description of the Related Art In general, as one method for purifying blood of a patient with renal failure, a dialysate is injected into the abdominal cavity of the patient, and harmful substances in the blood are transferred into the dialysate through the peritoneum by a concentration gradient. There is a peritoneal dialysis method in which the operation of discharging the dialysate after the operation is repeated. Conventionally, in peritoneal dialysis, a method in which a patient himself uses a head to inject / drain fluid for exchange of dialysate,
There were two methods of automatically changing the dialysate by machine. The former is called continuous portable peritoneal dialysis (CAPD), in which the patient himself carries out an operation of injecting and discharging dialysate contained in a bag by carrying a catheter provided on the abdominal wall. Normally, the dialysate is exchanged about four times a day, but the patient can move freely except at the time of exchange, and can be treated at home, which is an advantageous method for rehabilitation of the patient. The latter also
When the apparatus is set, the apparatus automatically injects and discharges the dialysate while automatically controlling the apparatus, and has been used for temporarily performing peritoneal dialysis. However, recently, attention has been paid to a method of performing dialysis using a device while a CAPD patient is sleeping at night. In other words, the dialysate is automatically replaced several times while the patient is asleep, thereby eliminating the need for daytime dialysate replacement and reducing the burden on the patient.

[0003]

When the dialysate is automatically changed while the patient is asleep, an abnormal condition occurs during the operation, particularly when the dialysate tube is bent or obstructed, resulting in dialysis. When the liquid injection / discharge is not performed normally, it is necessary to automatically detect this and issue an alarm to urge the operator (patient) of the apparatus to correct the abnormal state. This is because if left as it is, dialysis will not be performed until wake-up, and dialysis must be performed again after wake-up. The conventional apparatus does not have a sufficient mechanism for detecting such an abnormality, and it is particularly difficult to detect an abnormality in drainage. Further, even if the drainage abnormality can be detected, a complicated operation must be performed to subsequently perform dialysis, and the patient who is asleep needs to wake up and perform a complicated operation. Therefore, there was a problem that sleep could be hindered for a long time. It is an object of the present invention to accurately detect abnormalities during dialysis operation, particularly abnormalities in drainage, and to perform dialysis by automatically correcting the abnormal state even if an abnormality occurs, and automatically taking over the state before the abnormality. It is to provide a peritoneal dialysis device.

[0004]

According to the present invention, there is provided a liquid injection means for injecting a predetermined amount of dialysate into the abdominal cavity of a patient, a drainage means for discharging dialysate stored in the peritoneal cavity for a predetermined time, and Means for measuring the weight of the dialysate to be drained, and at least control means for monitoring and controlling the execution of the liquid injection means and the liquid drainage means, wherein the control means performs each of the liquid injection / storage and drainage steps in advance. In a peritoneal dialysis device that can be automatically repeated under set control conditions, the lower limit of the drainage amount, which is the sum of the previous actual drainage amount of the dialysate and the specified value represented by the following equation (1) Setting, and comparing the lower limit and the actual drainage amount of the dialysate measured, if the latter value does not reach the former value, it is determined that the drainage process is abnormal. It has a function of issuing an alarm signal, and receives the alarm signal It has a display means for indicating the occurrence location of the means or even abnormal state notifies the occurrence of the abnormal condition related to peritoneal dialysis apparatus according to claim.

[Equation 1] Total dialysate injection amount / number of replacement times × alarm value (I) (where the alarm value is selected from the range of 0.5 to 1). Indicates the number of times the dialysate has been drained at the total dialysate injection volume of.

[0005] The alarm means is preferably a means for surely informing a patient, particularly a sleeping patient, of an alarm, and preferably can easily identify the location of the abnormal condition. Examples of such an alarm unit include a unit that generates an alarm sound and blinks a drain alarm lamp and a temperature alarm lamp that indicate a location where an abnormality has occurred. Further, instead of the alarm sound or following the generation of the alarm sound, the location of the abnormality and / or the content of the cause of the abnormality may be notified by artificially created voice. When the patient hears the alarm, the patient refers to the display means such as an alarm lamp to check for an abnormal location or what kind of abnormality is occurring, and takes action to correct the abnormality. For example, the drainage becomes normal by correcting an abnormal condition such as blockage of the drainage tube, and when the drainage amount reaches the drainage lower limit value, the device further extends the drainage for a predetermined time from this point. After the liquid is sufficiently drained, the draining step is completed. Then, the process proceeds to the next step. In this way, the device operates automatically, so even if a drainage abnormality occurs, the patient only needs to investigate the cause of the abnormality and make it normal, and perform special operation of the device (for example, pressing the restart switch). There is no.

In the peritoneal dialysis apparatus of the present invention, when a container (for example, a bag) containing a peritoneal dialysis solution is heated by the heating section, the temperature is heated to a set temperature, preferably about the body temperature, by a temperature controller. If the set temperature is out of the allowable range, for example, when the temperature exceeds the set temperature ± 2 ° C., it is preferable to issue an alarm. The set temperature is set by a temperature controller, for example, in a temperature range of 0 to 43 ° C. However, if an excessive temperature rise, for example, a temperature of 43 ° C. or higher, is detected, it is preferable to provide an excessive rise prevention device for shutting off a heater power supply for heating.

Next, an example of a peritoneal dialysis apparatus used in the present invention will be described with reference to the drawings. However, the peritoneal dialysis device of the present invention is not limited to the following drawings. 1 is a basic configuration of the peritoneal dialysis device of the present invention, FIG. 2 is a control panel provided on the front of the control unit of the peritoneal dialysis device, FIG. 3 is a control panel provided on the side of the control unit of the peritoneal dialysis device, and FIG. An operation panel provided on the rear surface of the peritoneal dialysis device, FIG. 5 is an embodiment in which the peritoneal dialysis device of the present invention is mounted on a gantry (however, a dialysate infusion and drainage bag is not shown), and FIG. It is a figure which shows the electric block diagram of the peritoneal dialysis apparatus of this invention, respectively. As shown in FIG. 1 or 2, in the peritoneal dialysis apparatus A, the dialysate-containing bags 1a to 1d are positioned above the patient W, and the drainage bag is positioned below the patient W;
This allows the dialysate to flow due to a height difference, that is, a drop. A warming section B for storing and heating the bags 1a to 1d containing the dialysate, and a drainage measuring section C for placing the drainage bag 2 for storing the used dialysate and measuring the weight thereof.
Dialysis fluid-containing bags 1a to 1d, a liquid feed pipe circuit D for connecting the patient W and the drainage bag 2, and a control unit E for controlling the liquid feed pipe circuit D. The liquid feed pipes L1 to L4 on the dialysate containing bags 1a to 1d side, the liquid feed pipe L5 on the patient W side, the liquid feed pipes L6 on the drainage bag 2 side, and the liquid on the dialysate containing bags 1a to 1d side. Connecting pipe J1 connecting connecting pipes L1 to L4, and connecting pipe J1 and liquid feeding pipe L on patient W side
5. Connecting pipe J for connecting liquid feeding pipe L6 on drainage bag 2 side
Consists of two. These liquid feeding tubes L1 to L6 are formed of elastic tubes. The control unit E includes injectable liquid clamps K1 to K4 provided in the liquid feed pipes L1 to L4 on the dialysate-containing bags 1a to 1d side, a patient clamp K5 provided in the liquid feed pipe L5 on the patient W side, and drainage. Liquid feed pipe L6 on liquid bag 2 side
Drainage clamps K6 provided on the
It comprises a control device S capable of controlling K6. The clamps K1 to K6 open and close the liquid supply pipes L1 to L6.
In this mechanism, the liquid feed pipes L1 to L6 are always closed by a spring by pressing the liquid feed pipes L1 to L6, and the electromagnet is actuated to move the tube hold against the spring to open the pipe. The clamps K1 to K6 are, for example, as shown in FIG.
The control panel SP includes a clamp opening / closing switch 21 for opening and closing the clamps K1 to K6 (all the clamps can be opened and closed by pressing the switch), and a preparation switch for flushing (preparation by pressing the switch). Mode) 22, a start switch 23 for activating the device, a stop switch 24 for stopping the device,
A mode display unit 25 for displaying the state of preparation, drainage, injection, and storage, an injection number display unit 26 for displaying the number of injections, a drainage failure alarm lamp (not shown), and a heater alarm lamp (not shown). Z) can be provided. Also, in FIG.
An indicator lamp for displaying an open state is provided near each of the clamps K1 to K6.

The control device S further includes timers T1 to T3 for controlling the opening and closing times of the clamps K1 to K6. Timer T1 is an injection timer for setting the injection time, and timer T2
Is a drainage timer for setting the drainage time from the patient W, T3 is a storage timer for setting the storage time, and the like. These timers are provided, for example, on a side panel on the side of the control unit as shown in FIG. The control device S also has a drainage residual timer (a timer for setting a drainage time from the abdominal cavity after the last storage) 51, for example, as shown in FIG.
A residual liquid discharge switch (a switch for selecting whether to perform liquid discharge after the last storage) 52, a preparation timer (a timer for setting a flushing time) 53, a liquid injection number selection switch 54,
A changeover switch (a switch for switching the operation of the clamp) and a drainage amount alarm setting knob (a knob for setting an alarm setting value of a drainage failure alarm. The alarm setting value is a percentage of the peritoneal dialysis solution injection amount, for example, 50 to 100%. Can be set in the range of.) 61 etc. are provided. Further, the control device S serves as a reference value for issuing an alarm signal based on the prescribed value of the formula (I) set by the drainage amount alarm setting knob 61 and the weight of the dialysate injected and discharged, for example. The lower limit of the drainage amount is calculated, and the calculated lower limit is compared with the measured amount of dialysate actually discharged. If the latter value does not reach the former value, the drainage process is abnormal. It has a function of issuing an alarm signal to a means for judging that the state is a state and notifying the patient of the occurrence of an abnormal state, and executing the notifying means. The control device S is a control device capable of performing each of the above-described controls, for example, a device having a built-in microcomputer.

The heating section B comprises, for example, a heater 14 provided with an opening / closing door 11 as shown in FIG. 5 and a substantially triangular heater 12 provided therein.
2 is provided with a planar heater on both inclined surfaces, and the dialysate-containing bags 1a to 1d are brought into contact with the planar heater. The bags 1a to 1d have a heater 12
Are provided, and these are indicated by 1a to 1d. In the above-described example, four dialysis fluid bags are connected, but in the present invention, this number can be set arbitrarily as needed, and may be more or less than four. If it is a large capacity bag, it may be one.

[0010] The peritoneal dialysis apparatus of the present invention can be used, for example, mounted on a gantry 3 as shown in FIG. The gantry 3 includes an upper plate 10 on which the heating unit B is mounted, a lower plate 4 on which a weighing scale 5 for measuring the weight of the dialysate, a middle plate 6 on which the control unit E is mounted, and these plates , And the height of each plate is adjustable. A slide table 7 that can be pulled out is provided in the middle plate 6. The weight scale 5 places all the dialysate bags and measures the weight before the start of the dialysis, measures the total injection amount, and measures the weight of the drained liquid after the start of the dialysis.

Next, the operation of the peritoneal dialysis apparatus of the present invention will be described below. This apparatus automatically executes the heating of the peritoneal dialysate and the infusion and drainage into the peritoneal cavity at a set time. For infusion and drainage into the abdominal cavity, see “Preparation” “Drainage”
Each mode of “liquid injection” and “storage” is continuously executed as one cycle. (1) “Preparation mode” This is a mode for opening the infusion clamp and the drainage clamp, filling the peritoneal dialysate into the peritoneal perfusion circuit, and checking for the presence or absence of fluid leakage. (2) “Drainage mode” The drainage clamp and the patient-side clamp are opened, and the dialysate in the patient's abdominal cavity is drained for a set time. (3) “Injection mode” The infusion clamp and the patient-side clamp are opened, and the dialysate is injected into the abdominal cavity of the patient for a set time. Various modes of the injection method can be considered depending on the number of injection clamps and the selectable number of injection times. For example, as shown in Table 1 below, the following three types are available. [Type 1] A peritoneal dialysis solution corresponding to each clamp is injected for each bag by opening and closing the four injection clamps in order. [Type 2] A single injection clamp is opened and closed for a predetermined time, thereby injecting a predetermined amount from all the peritoneal dialysis solution bags. [Type 3] An eclectic type of Type 1 and Type 2,
The following two operations can be selected. Two of the four injection clamps are two, and the rest are one.
The peritoneal dialysis solution corresponding to each clamp is infused in a fixed amount for each bag by opening and closing sequentially six times in total. Using only one of the four clamps, a certain amount of liquid is injected in the same manner as in [Type 2].

[0012]

[Table 1]

Next, the operation and action of the peritoneal dialysis apparatus A will be described. First, the slide table 7 is pulled out, and the bags 1a to 1d containing the peritoneal dialysis solution are placed on the slide table 7, respectively.
And stored in the heater 14. In addition, the drainage bag 2 is also connected to the liquid feeding pipe circuit D and is mounted on the mounting portion. Operate the clamp open / close switch 21 to operate all clamps K1 to K6.
Is opened, and the liquid feed pipes L1 to L6 of the liquid feed pipe circuit D are set to the respective clamps K1 to K6. By operating the clamp on / off switch 21 again, all the clamps K1 to K6 are closed, all the tube clamps (not shown) attached to the liquid feed pipes L1 to L4 of the bags 1a to 1d are opened, and the dialysate flows. . Then, the liquid delivery pipe L5 on the patient W side
Is connected to an extension tube (not shown) to allow the dialysate to enter the abdominal cavity of the patient W. Preparation switch 2
2 is operated to perform flushing (short-time circuit cleaning). At this time, a preparation timer (not shown) is activated, the injection clamps K1 to K4 and the drainage clamp K6 are opened (the patient-side clamp K5 is closed), and the dialysate in the dialysate-containing bags 1a to 1d is discharged. Fluid supply pipes L1 to L
4. Flow into the drainage bag via the connecting pipes J1 and J2 and the liquid feeding pipe L6 to clean the inside of the liquid feeding pipe circuit D. By operating the device operation start switch 23, the timers T1 to T3 are operated, and the injection (injection), storage, and discharge (drainage) of the dialysate are repeated (four times in total). At the time of infusion, the timer T1 is operated, and one of the infusion clamps K1 to K4 and the patient side clamp K5 are opened (the drainage clamp K6 is closed), and the dialysate in the dialysate bag 1a to 1d is closed. Is one of the liquid feed pipes L1 to L4 and the connecting pipes J1 to J
2 and to the patient W via the liquid delivery pipe L5. At the time of the first injection, the injection clamp K1 is operated, and at the second time, the injection clamp K2 is sequentially operated like the injection clamp K2. When the infusion of the dialysate is completed by the predetermined time of the timer T1, the timer T2 is operated to close all the clamps K1 to K6, and the dialysate is stored in the abdominal cavity of the patient W. When the storage of the dialysate is completed by the timer T2, the timer T3 operates and the patient-side clamp K5 and the drainage clamp K6 are opened (injection clamps K1 to K4),
The dialysate in the patient W is moved up and down depending on the level.
The liquid flows into the drainage bag via the second and liquid feed pipes L6, and is drained. When the discharge of the dialysate is completed by the predetermined time of the timer T3, the second injection is performed in the same manner, and the above operation is repeatedly performed.

The setting of the dialysate injection amount, injection / drainage time, storage time, etc. in the control device S of the peritoneal dialysis device is different for each patient, so that the doctor or the physician or the like under the doctor's instruction sets these requirements. Other people can do it. When the control device S has a microcomputer or the like, the control device sends the above-mentioned doctor's instructions directly to the control device S via a telephone line.
Or a configuration in which a floppy disk containing a doctor's instruction can be stored in the control device S by inserting a floppy disk. Further, data during the dialysis operation input to the control device S can be stored in a floppy disk, and a new dialysis operation setting condition can be obtained from a doctor based on the data.

[0015]

EXAMPLE A commercially available peritoneal dialysate Perisate (registered trademark)
2,000ml (use 2,000ml bag)
Was used as a dialysate. The four 2,000 ml bags were set in the apparatus and replaced four times a night. The exchange condition of the dialysate was an average water removal amount of 200 ml (the amount of water transferred from the blood to the dialysate in one dialysis). At the end of the fifth dialysis, the dialysate is approximately 1,00
Leave 0 ml in the abdominal cavity and spend the day in that state. The drainage present in the peritoneal cavity was removed before performing the dialysis four times. The lower limit of the amount of drainage at which an alarm is issued is determined by the above equation (I).
It was set based on. That is, the total amount of injected liquid / the number of replacements ×
0.8 = 8,000ml / 4 × 0.8 = 1,600ml
Was set automatically. Tables 2 and 3 below show the dialysate infusion amount, the integrated scheduled drainage amount (predicted value), the alarm amount (integrated value), and the actual drainage amount for each number of times of drainage in this embodiment.

[0016]

[Table 2]

[0017]

[Table 3] In Tables 2 and 3, in the third drainage operation, the actual drainage amount of 4,000 was compared with the lower limit of the drainage amount (alarm amount) of 4,600.
Since the drainage amount is 0, the warning is given by the buzzer sound and the blinking of the warning lamp. Since an alarm was sounded, defective drainage was corrected, and 5,500 ml of drainage was finally performed. It should be noted that no alarm setting is performed for the first discharge only and the fifth discharge remaining due to the remaining amount of drainage because the drainage amount differs depending on the prescription.

[0018]

When the peritoneal dialysis apparatus of the present invention is used, when an abnormality occurs in drainage and the drainage amount falls below a predetermined value, it is reliably detected and an alarm is issued. Then, when the abnormal condition is corrected, the dialysis is automatically performed continuously without operating the apparatus at all, so that even if the dialysis is performed while sleeping at night, the patient is hardly bothered.

[Brief description of the drawings]

FIG. 1 is a diagram showing a basic configuration of a peritoneal dialysis device of the present invention.

FIG. 2 is a view showing one embodiment of a control panel provided in front of a control unit of the peritoneal dialysis apparatus of the present invention.

FIG. 3 is a view showing one embodiment of a control panel provided on a side of a control unit of the peritoneal dialysis apparatus of the present invention.

FIG. 4 is a view showing one embodiment of the back of the control unit of the peritoneal dialysis apparatus of the present invention.

FIG. 5 is a view showing one embodiment in which the peritoneal dialysis device of the present invention is used by mounting it on a gantry (however, a dialysate infusion and drainage bag is not shown).

FIG. 6 is a diagram showing an electric block diagram of a peritoneal dialysis device of the present invention.

[Explanation of symbols]

 1a Bag with dialysate (container for drug solution) 1b Bag with dialysate (container for drug solution) 1c Bag with dialysate (container for drug solution) 1d Bag with dialysate (container for drug solution) 2 Bag for drainage (container for drainage) 3) Stand 4 Lower plate 5 Weight scale 6 Middle plate 7 Slide frame 8 Side frame 9 Display panel 10 Upper plate 11 Openable door 12 Heater 13 Side panel 14 Heater 15 Weight scale operation box 21 Clamp open / close switch 22 Preparation switch ( 23 Flushing switch) 23 Device operation start switch 24 Device stop switch 25 Mode display unit 26 Injection count display unit 51 Drainage remaining timer 52 Drainage remaining switch 53 Preparation timer 54 Injection count selection switch 55 Changeover switch 56 Power cord 57 Fuse 58 Heating section power outlet 59 Communication connector 60 Off Change switch 61 Drainage amount alarm setting knob 62 Drainage alarm lamp 61 Temperature alarm lamp A Peritoneal dialysis device B Heating unit C Drainage amount measurement unit D Fluid feeding circuit E Control unit K1 Infusion clamp K2 Infusion clamp K3 Infusion Liquid clamp K4 Injection liquid clamp K5 Patient side clamp K6 Drainage clamp L1 Dialysis solution containing bag side liquid delivery tube L2 Dialysate containing bag side solution delivery tube L3 Dialysate containing bag side solution delivery tube L4 Dialysate containing bag side solution delivery tube L5 Patient side liquid feed pipe L6 Drainage bag side liquid feed pipe J1 Connecting pipe J2 Connecting pipe T1 Injection timer T2 Drainage timer T3 Storage timer W Patient S Clamp control unit SP Control panel

──────────────────────────────────────────────────続 き Continuation of the front page (56) References JP-A 3-13151 (JP, U) JP-A 62-177736 (JP, U) JP-B 55-15219 (JP, B2) JP-B 49- 10119 (JP, B1) (58) Field surveyed (Int. Cl. ⁷ , DB name) A61M 1/14-1/28

Claims (3)

(57) [Claims] 1. A liquid injection means for injecting a predetermined amount of dialysate into the abdominal cavity of a patient, a drainage means for discharging dialysate stored in the peritoneal cavity for a predetermined time, and weighing the dialysate to be discharged And at least control means for monitoring and controlling the execution of the liquid injection means and the liquid discharge means, and the control means automatically controls the respective steps of the liquid injection / storage and the liquid discharge under predetermined control conditions. In a peritoneal dialysis apparatus which can be repeated in the following manner, setting a lower limit value of a drainage amount which is a sum of a previous actual drainage amount of the dialysate and a prescribed value represented by the following equation (1); It has a function to compare the value with the actual amount of dialysate drained, and if the latter value does not reach the former value, determine that the drainage process is abnormal and issue a warning signal. And notifies the patient of the occurrence of the abnormal condition upon receiving the alarm signal. A peritoneal dialysis device, characterized by having means for performing or a display means for indicating a place where an abnormal condition has occurred. [Equation 1] Total dialysate injection amount / number of replacement times × alarm value (I) (where the alarm value is selected from the range of 0.5 to 1) 2. When an abnormality occurs in the drainage process, the operation is automatically advanced by taking over the previous operation only by correcting the abnormal state, and the injection, storage, and drainage are performed under preset control conditions. The peritoneal dialysis device according to claim 1, wherein each step of the liquid is performed. 3. The peritoneal dialysis apparatus according to claim 1, further comprising means for heating the container containing the peritoneal dialysis solution, wherein the abnormal state is generated when the container heating means has an abnormal state. A peritoneal dialysis device comprising means for notifying a patient or means for automatically correcting the abnormal condition.