JP3131948B2 - 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 device, and more particularly to a peritoneal dialysis device capable of simultaneously and continuously injecting and draining a dialysate in the peritoneum at night or at home.

[0002]

2. Description of the Related Art Continuous peritoneal dialysis (CAPD), continuous hemofiltration (CHF) for patients with acute renal failure and the like are known as treatments for continuous artificial kidneys. In the case of CAPD, the daily clearance of low molecular weight substances such as urea is up to 10 liters / day, even if 2 liters of dialysate are exchanged four times a day and the amount of water removed is 2 liters of drug solution. In CHF using a replacement solution, the amount of the replacement solution required to maintain the blood concentration of urea at 100 mg / dl or less is at least 10 liters / day.
Furthermore, in hemodialysis (HD), which is an intermittent treatment, the blood urea nitrogen (BUN) clearance was set to 150 ml / min,
When the daily clearance is calculated from the accumulated clearance for one week when dialysis is performed for 4 hours a day, it becomes 15.4 liters / day.

[0003] That is, the performance of the existing artificial kidney is at most 10
It is said to be the daily clearance of urea in living kidney at 1515 liters / day, which is far below 170 liters / day of drug solution. And this corresponds to a state in which one kidney is abolished, and more than 4/5 of the remaining kidneys have stopped functioning, and there has been a demand for the development of artificial kidneys that approach the performance of living kidneys as much as possible. Meanwhile, hemodialysis (HD)
In FIG. 5, as shown in FIG. 5, which shows changes in human blood urea nitrogen (BUN) when dialyzed three times a week for 4 hours a day, the BUN value fluctuates greatly. Causes all complications.

[0004]

In order to solve the problems of the existing artificial kidney, it is essential to develop an artificial kidney system by continuous treatment. For that purpose, it is essential to treat the artificial kidney while the patient can be active during the day and treat the artificial kidney while sleeping at night. One of the present inventors made extensive study result to solve the above problems, daytime use the portable peritoneal filtration device compact that combines the filter continuous recirculation peritoneal dialysis shown in FIG. 6, It has been found that a treatment can be carried out intermittently during the night by passing a dialysate on the filtrate side of the filter used during the day shown in FIG. 7 and using the dialyser as a dialyzer, and a patent application has already been filed (Japanese Patent Application No. 2-316652). ). This peritoneal dialysis machine uses a dialyzer consisting of a separation membrane and peritoneal dialysis for continuous hemodialysis treatment day and night, so the daily clearance of urea is significantly improved compared to current HD However, various complications caused by large fluctuations in BUN value were also reduced.

However, since this dialysis apparatus uses a dialyzer comprising a separation membrane, the diffusion efficiency of hemodialysis is reduced, and the clearance of urea and β ₂ -microglobulin in blood is reduced. . An object of the present invention is to provide an apparatus capable of performing artificial kidney treatment with high dialysis efficiency by simultaneously injecting dialysate into the peritoneal cavity and simultaneously discharging dialysate in the peritoneal cavity.

[0006]

That is, the present invention provides dialysis
A container for storing the fluid, an inflow conduit for injecting the dialysate in the container into the peritoneal cavity, a catheter constantly inserted into the peritoneal cavity, an outflow conduit for removing the intraperitoneal dialysate from the peritoneal cavity, and an inflow conduit or in the peritoneal dialysis apparatus comprising a pipe joint for connecting the outflow conduit and the catheter, the lumen of the mosquito <br/> catheters has a dialysate infusion lumen for coupling the inflow conduit, connecting the outflow conduit Ri Na is separated into the intraperitoneal dialysate discharge cavity, the container for storing the dialysate inlet conduit, Kate
In a closed circuit connecting the tel, peritoneal cavity and outflow conduit
Is a peritoneal dialysis device comprising a mechanism for circulating a dialysate.

[0007]

According to the present invention, the dialysate supplied to the peritoneal cavity contacts the blood through the peritoneum, the peritoneal membrane acts as a permeable membrane, and metabolites in the blood are permeated into the peritoneal cavity. It becomes a liquid. The intraperitoneal dialysate is either discarded as it is, or returned to the dialysate storage container, mixed with the dialysate, and circulated between the peritoneal cavity to perform peritoneal dialysis. The present invention discharges the intraperitoneal dialysate because the catheter that is always inserted into the abdominal cavity consists of a multi-lumen catheter having two ports of a dialysate inlet and an intraperitoneal dialysate outlet, a so-called double lumen catheter. At the same time, the dialysate can be infused into the peritoneal cavity and peritoneal dialysis can be performed continuously. Therefore, the variation of the BUN value is smaller than that of the conventional peritoneal dialysis in which infusion and drainage of the dialysate in the peritoneal cavity are alternately repeated several times,
High dialysis efficiency. The present invention relates to peritoneal dialysis performed continuously at night or at home, and during the daytime activity, the dialysate is retained in the peritoneal cavity to perform peritoneal dialysis.

[0008]

DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of the present invention will be described below with reference to an embodiment.
FIG. 1 is an explanatory view showing a use state of a double lumen catheter showing one example of the present invention, FIG. 2 is an explanatory view of performing peritoneal dialysis while circulating a dialysate, and FIG. FIG. 4 is an explanatory diagram showing an example of performing peritoneal dialysis in which the dialysate is infused into the peritoneal cavity and draining the intraperitoneal dialysate is performed. FIG. 5 is an explanatory diagram showing another example of the case, FIG. 5 is a graph showing the change over time of BUN when intermittent hemodialysis is performed for one week, and FIG. 6 is a patent in Japanese Patent Application No. 2-316652. It is an explanatory diagram of a peritoneal filtration device that performs while applying for daytime,
FIG. 7 is an explanatory view of a peritoneal dialysis apparatus performed during the nighttime dormancy, which was filed in Japanese Patent Application No. 2-316652.

In the figure, 1, 21, 31 and 61 are abdominal cavities, 3 is a dialysate injecting cavity, 4 is an intraperitoneal dialysate outlet, 7 is an inflow conduit,
8 is an outflow conduit, 9 and 10 are fittings, 22, 32 and 62 are dialysate storage containers, 24 is an ultraviolet lamp, 26, 33 and 63 are warmers, 27, 49 and 64 are sterilization filters, 28, 50 and
67 indicates a turbidity sensor, and 30, 52 and 66 indicate double lumen catheters.

FIG. 1 is an explanatory view showing a use state of a double lumen catheter. The double-lumen catheter has an outer tube and an inner tube penetrating the inside of the tube, and has a structure in which liquid is injected and discharged from a plurality of perforations provided in the inner wall of the outer tube and the outer tube wall. are doing. In the double lumen catheter, the distal ends of the outer tube and the inner tube are inserted into the abdominal cavity 1 from the epidermis 2 and are always implanted in the body. At least one dialysate injection hole 5 is formed in the inner wall of the double lumen catheter in the abdominal cavity, and at least one intraperitoneal dialysate drainage hole 6 is formed in the outer tube wall. It is provided. The other end of the double lumen catheter has an inner tube and an outer tube that are exposed to the outside through the outer tube, and an inflow connector 10 and an outflow connector 9 are provided at the ends thereof. The inflow conduit 7 and the outflow conduit 8 are fitted respectively. The inflow connector 10 is provided with a screw thread on the outer wall surface at the open end of the inner tube, and the inner lumen of the inflow conduit 7 is fitted thereto. A joint with a mountain structure is inserted, and the outflow conduit 8 is inserted into the joint protruding from the open end of the inner pipe.
The inner cavity is fitted. Outlet portion connectors 9 and the inflow portion connector 10 is closed is fitted with a cap or the like in the daytime active phase. As such a cap, a cap described in Japanese Utility Model Laid-Open Publication No. 64-19445 is firmly fitted and is preferable.

The dialysate is injected into the abdominal cavity 1 from the infusion hole 5 through the infusion solution cavity 3 which is the hollow portion of the inner tube of the double lumen catheter. The intraperitoneal dialysate, which is in contact with the blood through the peritoneum (not shown) and permeates the metabolites in the blood, passes through the drain hole 6 to the drain cavity 4 which is the hollow part of the outer tube.
Through the outlet conduit 8 or returned to the dialysate storage container to be mixed with the dialysate. Injection of the dialysate into the peritoneal cavity and discharge of the dialysate in the peritoneal cavity are performed simultaneously and continuously. Means for preventing inflow into 3 may be provided. In FIG. 1, the double-lumen catheter has a structure consisting of an outer tube and an inner tube inserted through this tube, but the lumen of the catheter is separated by a sheet or the like and is composed of two chambers. A plurality of side holes may be provided, and the other end may have a structure in which a conduit is inserted into each chamber or fitted through a connector.

FIG. 2 is an explanatory diagram of peritoneal dialysis when peritoneal dialysis is performed while circulating a dialysate. The dialysate is stored in the dialysate storage container 22, and is mixed with the intraperitoneal dialysate returned from the abdominal cavity 21 by the circulation pump 23. An ultraviolet lamp 24 is provided in the circulation line of the storage container 22 and the circulation pump 23 so that the dialysate is sterilized by ultraviolet light. The dialysate in the dialysate reservoir 22 is pumped by the infusion pump 25 into a double lumen catheter.
The liquid is supplied to the abdominal cavity 21 from the infused liquid cavity 30. On the way, the dialysate is heated by the heater 26, and then the sterilizing filter
The bacteria are removed by 27 to prevent the bacteria from entering the peritoneal cavity 21 and causing peritonitis. The intraperitoneal dialysate obtained by dialyzing the metabolic product in the blood through the peritoneum in the abdominal cavity 21 is drained from the drainage cavity of the double lumen catheter 30 through the drainage pump 29.
As a result, the liquid returns to the dialysate storage container 22 and is mixed with the dialysate in the container 22. On the way, a turbidity sensor 28 is provided to measure the occurrence of inflammation in the abdominal cavity by measuring the turbidity of the intraperitoneal dialysate. The peritoneal dialysis using the dialysate circulation system as shown in FIG. 2 is preferable when a large amount of dialysate is stored in the dialysate storage container 22 and used. The dialysate volume is 20-200 liters, preferably 40-120 liters. By injecting and draining the dialysate into the peritoneal cavity via a double lumen catheter, peritoneal dialysis can be performed with high dialysis efficiency.

FIG. 3 is an explanatory diagram showing an example of peritoneal dialysis in which fresh dialysate is continuously infused into the peritoneal cavity via a double lumen catheter, and simultaneously the dialysate in the peritoneal cavity is discarded. A fresh dialysate is stored in a dialysate storage container 32 and heated by a heater 33 to be a first bellows part 4 of a bellows pump that is an equal volume pump.
Supplied to 5. The bellows pump has the same capacity as the first bellows part 45
And the second bellows portion 46 have a structure in which the bellows position expands and contracts to the left and right by the crank motor 42, whereby the amount of fresh dialysate injected into the peritoneal cavity 31 and the amount of drainage of intraperitoneal dialysate are made substantially equal. Can be adjusted. In FIG. 3, the first
A first bellows pump in which a bellows portion 45 and a second bellows portion 46 are expanded and contracted to the left and right by a crank motor 42, and a third bellows portion 47 and a fourth bellows portion 48 are crank motors.
Abdominal cavity 3 with the second bellows pump formed by 43
The supply amount of fresh dialysate to 1 and the drainage amount of intraperitoneal dialysate are adjusted to be substantially equal.

In FIG. 3, the bulbs 34 to 41 are shown in white.
4, 37, 38 and 40 are open, shown in black 35, 36, 39
And 41 indicate a closed state. The state of FIG. 3 is warmed by the dialysate reservoir 32 fresh dialysate is warmer 33 from the first
The intraperitoneal dialysate that has flowed into the bellows portion 45 and previously filled in the second bellows portion 46 is discarded from the valve 40 to the drainage container 51. On the other hand, in the second bellows pump, the fresh dialysate previously filled in the third bellows portion 47 is sterilized by the sterilization filter 49 through the valve 37 and injected into the abdominal cavity 31. The dialysate in the abdominal cavity 31 is measured for turbidity by the turbidity sensor 50 and the valve 38
And flows into the fourth bellows section 48. Each bellows part has the same capacity, and when a series of operations is completed, the open valve changes to the closed state, the closed valve changes to the open state,
The same operation is performed by reversing the operations of the first bellows pump and the second bellows pump.

FIG. 4 shows a case in which a double roller pump is used as an equal volume pump in peritoneal dialysis in which fresh dialysate is continuously infused into the peritoneal cavity via a double lumen catheter and at the same time the intraperitoneal dialysate is discarded. FIG. Fresh dialysate is stored in the dialysate storage container 62, and after being heated by the heater 63, the bacteria are removed by the sterilization filter 64, and the double-lumen roller pump 65 passes through the double lumen catheter 66 to the abdominal cavity 61. Injected. The double roller pump is a pump in which two inflow conduits (tubes) and two outflow conduits (tubes) having the same inner diameter are hung on one roller pump. Since the inner diameters of the tubes are the same, the dialysis is injected into the abdominal cavity 61. The volume of the fluid and the volume of the intraperitoneal dialysate discharged from the abdominal cavity 61 are adjusted to be substantially the same. The intraperitoneal dialysate discharged from the abdominal cavity 61 is measured in the turbidity sensor 67 and then discarded in the drainage container 68.

[0016]

Example 1 In FIG. 2, 50 liters of fresh dialysate was stored in a dialysate storage container 22, and the dialysate was heated to body temperature by a heater 26, and injected into the abdominal cavity 21 at a rate of 100 ml per minute. The intraperitoneal dialysate was discharged from the peritoneal cavity 21 at the same speed, returned to the dialysate storage container 22, and peritoneal dialysis was performed for 8 hours while mixing with the dialysate in the container using the circulation pump 23. Next, after the dialysate in the peritoneal cavity was drained into a drain bag, 2 liters of fresh dialysate was separately injected into the peritoneal cavity, and peritoneal dialysis was performed in the peritoneal cavity for 16 hours. Total 24
Table 1 shows the clearance of urea and β ₂ -microglobulin obtained by peritoneal dialysis over time.

[0017]

Example 2 In FIG. 4, a fresh dialysate was injected into the abdominal cavity 61 at a rate of 100 ml / min, and an intraperitoneal dialysate was injected into the abdominal cavity 61 at the same speed.
Peritoneal dialysis of draining from the drainage container 68 for 8 hours. Next, peritoneal dialysis was performed in the abdominal cavity for 16 hours while 2 liters of the fresh dialysate was injected into the abdominal cavity 61 . Table 1 shows the clearance of urea and β ₂ -microglobulin obtained by peritoneal dialysis for a total of 24 hours.

[0018]

Comparative Example 1 In the peritoneal filtration apparatus shown in FIG. 6, 2 liters of fresh dialysate was injected into the peritoneal cavity 71. The pore size of the first filtration membrane 74 of the first filter 72 is 14 mμ, and the membrane area is 0.2 m ² . 1st filter 7
The intraperitoneal dialysate that has passed through 2 flows into the second filtrate chamber 7 of the second filter 73.
9 and filtered by the first filtration membrane 74 of the first filter 72 .
Thereafter, the mixture is mixed with the filtrate filtered by the second filtration membrane 75 of the second filter 73 and returns to the peritoneal cavity 71. At this time, the second supply liquid chamber of the second filter 73
From 78, a part of the filtrate filtered by the first filtration membrane 74 of the first filter 72 is discharged through the discharge conduit 76. The pore size of the second filtration membrane 75 is 3.5 mμ, and the membrane area is 0.2 m ² . The circulating dialysate flow rate is 80 ml / min, the filtrate flow rate of the first filter 72 is 40 ml / min,
The filtrate in the second filter 73 was at a flow rate of 38 ml / min, and the dewatering flow rate was 2 ml / min. Then, at night, the peritoneal dialysis apparatus of FIG. 7 was used. The first dialyzer 81 and the second dialyzer 82 use the first filter 72 and the second filter 73 of FIG. 6 used during the day.
This is a peritoneal dialysis device that has been changed to dialysis using a cycler. A closed circuit in which the treated dialysate circulates is formed between the first dialysate chamber 86 on the filtrate side of the first dialyzer 81 and the first dialysate storage container 83. Also, a closed circuit is formed between the second dialysate chamber 88 on the filtrate side of the second dialyzer 82 and the second dialysate storage container 84 in which the processed dialysate that has passed through the second dialysate membrane 87 circulates. . After the intraperitoneal dialysate supplied from the abdominal cavity 80 passes through the first dialyzer 81, the peritoneal dialysis is performed while circulating through a closed circuit returning to the abdominal cavity 80 through the second dialyzer 82. The circulating dialysate flow at that time is 100 ml / min, and the fresh dialysate flow of the cycler is 100 ml.
Per minute for 8 hours. Table 1 shows the clearance of urea and β ₂ -microglobulin obtained by peritoneal dialysis for a total of 24 hours.

[0019]

[Comparative Example 2] Current hemodialysis was performed at a blood flow rate of 150 ml / min.
The clearance of urea and β ₂ -microglobulin per day was calculated from the cumulative clearance for one week after four hours, once each, and the results are shown in Table 1.

[0020]

Comparative Example 3 Two liters of a fresh dialysate was injected into the peritoneal cavity, and peritoneal dialysis was performed for 6 hours. Thereafter, the intraperitoneal dialysate was drained, and 2 liters of fresh dialysate was injected into the peritoneal cavity. Table 1 shows the clearance of urea and β ₂ -microglobulin obtained by peritoneal dialysis for a total of 24 hours after repeating this operation four times a day. The unit of clearance is liter / day.

[0021]

[Table 1]

As apparent from Table 1, Examples 1 and 2, which are the peritoneal dialysis devices of the present invention, are the same as those of the current hemodialysis (Comparative Example).
It has much better dialysis performance than 2) or peritoneal perfusion device (Comparative Example 3). In addition, the dialysis efficiency was higher than that of Comparative Example 1, which was a peritoneal dialysis device combined with a separation membrane.

[0023]

According to the present invention, since the catheter which is always inserted into the peritoneal cavity is a multi-lumen catheter having two inlets, that is, a dialysate inlet and an intraperitoneal dialysate outlet, a so-called double lumen catheter, the intraperitoneal dialysis is performed. The dialysate can be simultaneously injected into the peritoneal cavity while draining the fluid, and continuous peritoneal dialysis can be performed. Therefore, compared with the conventional peritoneal dialysis in which the infusion of the dialysate in the peritoneal cavity and the drainage are alternately repeated several times, the fluctuation of the BUN value is small and the dialysis efficiency is high.

[Brief description of the drawings]

FIG. 1 is an explanatory view showing a state of use of a double lumen catheter showing an example of the present invention.

FIG. 2 is an explanatory view showing an example of the present invention when performing peritoneal dialysis while circulating a dialysate.

FIG. 3 is an explanatory view showing an example of performing peritoneal dialysis in which fresh dialysate is injected into the peritoneal cavity and dialysate in the peritoneal cavity is drained.

FIG. 4 is an explanatory diagram showing another example of performing peritoneal dialysis in which fresh dialysate is injected into the peritoneal cavity and the intraperitoneal dialysate is drained.

FIG. 5 is a graph showing the time course of BUN when intermittent hemodialysis is performed for one week.

FIG. 6 is an explanatory view of a peritoneal filtration apparatus performed during daytime activities, which was filed in Japanese Patent Application No. 2-316652.

FIG. 7 is an explanatory view of a peritoneal dialysis apparatus performed during nighttime dormancy for which a patent application has been filed in Japanese Patent Application No. 2-316652.

[Explanation of symbols]

 1, 21, 31, 61 Abdominal cavity 3 Dialysate infusion cavity 4 Intraperitoneal dialysate discharge cavity 7 Inflow conduit 8 Outflow conduit 9, 10 Fitting 22, 32, 62 Dialysate storage container 26, 33, 63 Heater 27, 49, 64 Bactericidal filter 28, 50, 67 Turbidity sensor 30, 52, 66 Double lumen catheter

Claims (1)

(57) [Claims] A container for storing a dialysate, an inflow conduit for injecting a permeate into the peritoneal cavity, a catheter constantly inserted into the peritoneal cavity, In a peritoneal dialysis device comprising an outflow conduit for removing from the abdominal cavity and a fitting for connecting the inflow conduit or the outflow conduit to the catheter, the lumen of the catheter has a dialysate infusion portion connected to the inflow conduit. , Ri Na are separated into the intraperitoneal dialysate discharge lumen for connecting the outflow conduit, volume for storing dialysate
Devices, inflow conduits, catheters, peritoneal and outflow conduits
Include a mechanism for circulating dialysate in the closed closed circuit.
A peritoneal dialysis device characterized by the following .