JPH10211256A - Coupled body for medical bag - Google Patents

Abstract

PROBLEM TO BE SOLVED: To easily and stably store medical bags for a long time by coupling a medical liquid medicine filling bag made of a synthetics resin which contains hydrogencarbonate ion with a carbon dioxide and/or high-density hydrogencarbonate-containing liquid filling bag together and packing them with a synthetic resin packing material having carbon dioxide permeability not more then those of the both bags. SOLUTION: Dialysis liquid bag 1 is formed of a synthetic resin film such as polyvinyl chloride and filled with hydrogencarbonate ion-containing liquid of 10-80mEq/l density. A drain bag 3 formed of synthetic resin such as polyvinyl chloride is connected thereto by a guide duct. The drain bag 3 is filled with carbon dioxide gas-containing gas, high density hydrogencarbonate-containing liquid, or their mixture. The whole of the coupled bags body is wrapped with a synthetic resin packing material 6 having carbon dioxide permeability smaller than the carbon dioxide permeabilities of the both bags 1, 3. This constitution can effectively set the outside of the bag 1 to a carbon dioxide atmosphere and store it for a long time.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a connected body of medical containers capable of stably storing a bicarbonate-containing liquid, and a method of preserving a bicarbonate-containing liquid in a container using the connected body. More specifically, the present invention relates to a peritoneal dialysis set filled with a bicarbonate ion-containing solution, and a method for storing the same.

[0002]

2. Description of the Related Art Medical solutions containing bicarbonate ions are already widely used in the fields of antidote, hemodialysis solution and the like.
In particular, in the field of peritoneal dialysis, it is regarded as a promising solution as a solution that can be dialyzed in a neutral region that is reasonable for a living body. However, Japanese Unexamined Patent Publication
As disclosed in JP-A-261141 and JP-A-8-164185, in an open system, the volatilization of carbon dioxide gas causes a decrease in bicarbonate ions and an increase in carbonate ions.
There was a problem that H increased. In the case of a container made of a synthetic resin such as that currently used for an infusion bag, the gas permeability is too large, and the usable materials are limited to some. In addition, there is a problem that costs are increased and molding is difficult in order to impart a further low gas permeability to a container having many other restrictions (safety, strength, durability, etc.). Therefore, as described in Japanese Patent Application Laid-Open No. 8-164185, a container containing a solution containing bicarbonate ions is packaged in a packaging material having high gas barrier properties, and a deoxidizer is provided between the liquid container and the packaging material. It has been devised to prevent the use of a liquid having an increased pH by adding an oxygen detector. Furthermore, Japanese Patent Application Laid-Open No. 5-2611
As described in Japanese Patent Publication No. 41, there has been proposed a device in which a space between a container and a packaging material is filled with carbon dioxide gas to prevent an increase in pH of an aqueous solution.

[0003] In the current peritoneal dialysis, a continuous portable peritoneal dialysis method (hereinafter, referred to as CAPD) in which a patient himself / herself can exchange a dialysate bag is common.
APD systems include a one-bag system in which a dialysate bag also serves as a drainage bag and a two-bag system in which both bags are connected by a conduit. The one-bag system has been conventionally used, and a dialysis fluid bag serving as a drainage bag must be always carried during dialysis, which is very troublesome for a patient. on the other hand,
The two bag system allows the dialysate and drain bags to be separated from the extension tube (which is always connected to the patient's peritoneal catheter) during dialysis, so that the patient does not need to carry these bags during dialysis. , The degree of freedom increases.
Further, in the two-bag system, since the number of times of connection between the bag and the extension tube can be reduced, there is an advantage that the chance of contamination is reduced accordingly. For these reasons, the two-bag system has recently been spreading rapidly. However, this two-bag system, when autoclaved,
There is a problem that the inner surface of the empty drainage bag is blocked. When the drainage bag is blocked, the drainage bag does not expand when collecting the dialysate remaining in the abdominal cavity as drainage, so it takes a long time for drainage, and it takes time to peel off the inner surfaces. There was a disadvantage.
In order to solve the above-mentioned disadvantages, it has been proposed to form irregularities on a part of the inner surface of the drainage bag as described in JP-A-6-178804. However, this method has a disadvantage that the manufacturing apparatus must be changed in order to change the surface shape of the sheet, which is costly.

[0004]

SUMMARY OF THE INVENTION The object of the present invention is as follows.
To provide a container (container assembly) that can easily and stably store a medical solution containing bicarbonate ions for a long period of time, or to easily and stably use the container (container assembly) for a long time And a method for preserving a bicarbonate ion-containing solution. Secondly, it is an object of the present invention to provide a container and a method capable of reliably and inexpensively preventing blocking between inner surfaces of an empty container or a container in which almost no object is stored in a plurality of containers connected by conduits.

[0005]

Means for Solving the Problems The present inventors have filled a first synthetic resin container with a medical solution containing bicarbonate ions, and filled the first container with a first synthetic resin container via a conduit. The two containers are in communication with each other, and the second container is filled with carbon dioxide and / or a high-concentration bicarbonate-containing liquid, and the first container and the second container are connected to each other. The above-mentioned problem has been solved by a medical container connected body characterized in that it is packaged with a packaging material made of a synthetic resin having a carbon dioxide gas permeability equal to or lower than that of the above. Furthermore, in the present invention, a medical solution containing bicarbonate ions is filled in a first container, and carbon dioxide and / or high-concentration bicarbonate is placed in a second container made of synthetic resin which is communicably connected to the first container. The first container and the second container are filled with a salt-containing liquid, and the first container and the second container are packaged with a packaging material made of a synthetic resin having a carbon dioxide permeability equal to or lower than the carbon dioxide permeability of these two containers, and subjected to high-pressure steam sterilization. The above object has been achieved by a method for producing a medical drug solution package containing bicarbonate ions, which is characterized by the following.

That is, first, carbon dioxide and / or
Alternatively, by filling a high-concentration bicarbonate-containing liquid, blocking between the inner surfaces of the second container, which had almost nothing therein, was prevented. Next, the same as the second container,
Alternatively, by wrapping the first container and the second container with a packaging material having a lower gas permeability, the carbon dioxide gas permeated from the second container is trapped in the space between the outside of the first container and the package. Be charged. Therefore, the outside of the first container becomes a carbon dioxide gas atmosphere, and the carbon dioxide gas equilibrates inside and outside the first container, thereby increasing the storage stability of the bicarbonate ion-containing liquid in the first container. When the carbon dioxide permeability of the packaging material is smaller than that of the second container, the carbon dioxide gas (bicarbonate gas is generated from the bicarbonate-containing liquid) permeated from the second container having relatively high gas permeability, It is more effectively trapped inside the less permeable packaging material. Thereby, it is possible to more effectively prevent a decrease in bicarbonate ions and an increase in pH of the bicarbonate ion-containing liquid in the first container.

[0007]

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, the linked medical container of the present invention and a method for storing a bicarbonate ion-containing liquid using the linked body will be described in more detail. The first container is a bag formed from a synthetic resin sheet, and the inside thereof is filled with a predetermined amount of a bicarbonate ion-containing liquid at a predetermined concentration.
For example, in the case of CAPD, as shown in FIG. 1, the first container is a dialysate bag 1 for storing a fresh dialysate (before injecting into the patient's peritoneal cavity), in which 10 to 8 bags are stored.
The bicarbonate ion-containing solution having a concentration of 0 mEq / l is 500 to 3
000 ml is filled. The dialysate bag 1 is a bag formed of a single-layer or multilayer film made of a synthetic resin such as polyvinyl chloride, polyolefin such as polyethylene or polypropylene, or polyamide. A conduit 2 is connected to the dialysate bag 1 so as to communicate the liquid with the drainage bag 3 of the second container.
The drainage bag 3 is a bag formed from a synthetic resin such as polyvinyl chloride. The shape of these containers is not particularly limited, but is generally formed by welding a rectangular sheet. The size of the second container depends on its purpose, but in the drainage bag 3 used for CAPD,
Generally, the dialysate bag 1 is slightly larger than the dialysate bag 1 and is formed so as to be able to store a larger amount of liquid. If necessary, the conduit 2 is provided with opening / closing means 4 such as a roller clamp or a ratchet type clamp and a communication pipe 5 so that the inside of the dialysate bag 1 and the drainage bag 3 can be connected or closed. .

The inside of the second container is filled with a required amount of carbon dioxide gas, carbon dioxide-containing gas, or high-concentration bicarbonate-containing liquid, or a mixture thereof. For example, a bicarbonate-containing solution such as a sodium bicarbonate solution may be injected into the second container so that the carbon dioxide partial pressure in the second container is 2 to 760 mmHg, or the second container is filled with a bicarbonate-containing solution. Carbon dioxide concentration is 0.
Carbon dioxide gas may be injected so as to be 26 to 100%. Here, if the concentration of the carbon dioxide gas or the bicarbonate-containing liquid to be injected into the second container is low, the outside of the first container cannot be effectively brought into a carbon dioxide gas atmosphere, so that the pH of the bicarbonate ion-containing liquid increases. Resulting in. Conversely, if the concentration of the carbon dioxide gas or the bicarbonate-containing liquid is too high, the carbon dioxide gas outside the first container permeates into the first container, and lowers the pH of the bicarbonate ion-containing liquid. Thus, even if the concentration of the carbon dioxide or bicarbonate-containing liquid injected into the second container is too low or too high,
The bicarbonate ion-containing liquid in the container cannot be stably stored for a long time. Therefore, it is preferable to adjust the concentrations of the bicarbonate-containing liquid and the carbon dioxide gas so that the partial pressure of the carbon dioxide gas and the concentration of the carbon dioxide gas in the second container fall within the above ranges. In order to increase the concentration of carbon dioxide in the second container, it is also effective to remove air from the second container in advance by using a deaeration pump or the like, and then to add high-concentration carbon dioxide. Next, the amount of bicarbonate-containing liquid or carbon dioxide gas to be injected into the second container is 2.0 to 25.0, which is the maximum filling amount of the second container.
% Has the effect of preventing blocking of the inner surface of the second container. That is, if the injection amount is smaller than the above, the second
Container blocking cannot be effectively prevented.
Conversely, if the injection amount is too large, the proportion of these in the second container will increase, and the usable amount of the second container, for example, the amount of drainage that can be stored in the drainage bag will decrease.

Further, the whole container connected body is encased by a synthetic resin wrapping material 6, and the carbon dioxide gas permeability of this packaging material is made smaller than the carbon dioxide gas permeability of the first container and the second container. The outside of the first container can be more effectively brought into a carbon dioxide gas atmosphere. More specifically, the carbon dioxide gas permeability of the second container is set to be 10 to 1 more than the gas permeability of the packaging material.
^{0 6 cm 3 · cm / cm} 2 · sec · cmHg that large as preferred. For example, if the gas permeability of the second container is 1
0 ^-8 to 10 ^-10 cm ³ · cm / cm ² · sec · cmHg
And the gas permeability of the packaging material 6 is 10 ^-12 to 10 ^-14 cm ³
By reducing the size to cm / cm ² · sec · cmHg, carbon dioxide gas can be effectively trapped between the first container and the packaging material.

The carbon dioxide permeability of the first container is desirably equal to or less than the carbon dioxide permeability of the second container. Originally, the first container preferably has a small gas permeability in order to make the inside of the first container a closed system. However, as described above, it is very difficult to realize low gas permeability as a container for filling a medical solution. Therefore, the packaging material is provided with low carbon dioxide gas permeability, so that the entire interior of the packaging material is made to be a closed system. Giving the packaging material low carbon dioxide permeability is simpler and cheaper than implementing the first container itself in contact with the chemical solution with low gas permeability. However, if the carbon dioxide permeability of the first container is too large, as described above, if the bicarbonate-containing liquid having a considerably high concentration is filled in the second container, the carbon dioxide gas is contained in the first container. Penetrates to lower the pH of the medical solution. Therefore, the carbon dioxide permeability of the first container is desirably equal to or less than the carbon dioxide permeability of the second container so as to enhance the preservability of the bicarbonate ion-containing liquid filled therein. Furthermore, if the carbon dioxide permeability of both containers is the same, there is an advantage that the carbon dioxide gas permeated by the first container and the second container becomes the same, and the gas balance can be easily calculated. Although the shape and dimensions of the packaging material are not particularly limited, it is preferable that the packaging material is formed into a bag shape by welding a rectangular or square sheet having a size that can easily accommodate the above-described plurality of containers. It is also advantageous if the end is open and the part can be welded.

[0011]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS As described in the "Embodiment of the invention", FIG. 1 shows a peritoneal dialysis set of a two-bag system in which a dialysate bag 1 and a drainage bag 3 are connected as an example of the present invention. The dialysate bag 1 is made of a soft polyvinyl chloride resin or polyethylene, and the drainage bag 3 and the conduit 2 are made of a soft polyvinyl chloride resin. In addition, dialysate bag 1
And the packaging material 6 for packaging the drainage bag 3 are made by depositing aluminum on a multilayer film made of a synthetic resin such as polyolefin polyamide such as polyethylene or polypropylene, so that the gas permeability is considerably smaller than that of the two bags. It has become something. Respectively Both bags are carbon dioxide permeable gas permeable packaging material, dialysate bag 1 is ^{2 × 10 -9 cm 3 · cm} / cm 2 · sec · cmHg, drain bag 3 is 2 × 10 ^-9 cm ³・ Cm / cm ²・ sec ・
cmHg, packaging material 6 is 3.5 × 10 ^-13 cm ³ · cm / c
m ² · sec · cmHg. The conduit 2 is closed by the clamp 4 and the communication pipe 5 so that the two bags cannot communicate with each other before use. When using this peritoneal dialysis set, the dialysate can be injected into the patient's body by breaking the communication tube 5. The amount of dialysate to be filled in the dialysate bag 1 is 500 to 3000 ml depending on necessity, and the drainage bag can store the amount of drainage obtained by adding the ultrafiltration amount from the body to the dialysate amount. Thus, it is designed slightly larger than the dialysate bag 1. The dialysate to be filled in the dialysate bag 1 contains glucose and N
a ⁺ , Ca ²⁺ , Mg ²⁺ , Cl ⁻ , bicarbonate ion (HC
O ₃ ⁻ ) and lactate ions (C ₂ H ₅ COO ⁻ ). However, in this solution, bicarbonate ions are easily bound to calcium and magnesium due to a change in pH, and are easily precipitated. Therefore, it is preferable to store these separately. The drain bag is filled with 100 to 300 ml of carbon dioxide gas.

In this embodiment, as shown in FIG. 1, various amounts of carbonic acid are contained in the drainage bag 3 by using a peritoneal dialysis set of a two-bag system in which the dialysate bag 1 is filled with a bicarbonate ion-containing solution. The gas was injected, and the effect on the storage stability of bicarbonate ion-containing peritoneal dialysate and the prevention of blocking of the drainage bag was examined.

Example 1 First, a peritoneal dialysis set of a two-bag system was prepared by dispensing about 2000 ml of a dialysate having the composition shown in Table 1 into a dialysate bag having a display volume of 2000 ml. Next, a carbon dioxide gas is prepared so as to have a concentration of 70%, and 100, 200, and
Each 300 ml was dispensed. After that, the above peritoneal dialysis set is packaged under reduced pressure (not vacuum) in the packaging material 6 and then 115
Autoclave sterilization was performed at 30 ° C for 30 minutes. After sterilization,
Table 2 shows the effect of the injected carbon dioxide on the blocking of the drainage bag.

[0014]

[Table 1]

[0015]

[Table 2]

Example 2 The following experiment was conducted to examine the effect of carbon dioxide gas injected into the drainage bag on the storage stability of the bicarbonate ion-containing dialysate in the dialysate bag. About 1000 ml (displayed amount: 1000 ml) of the dialysate having the same composition as in Example 1 was dispensed into the dialysate bag, and 0, 100, 200, and 300 ml of 70% concentration carbon dioxide gas were injected into the drainage bag, respectively. The two-bag system peritoneal dialysis set was packaged under reduced pressure with a packaging material (the amount of air in the packaging material was about 300 ml). Further, the peritoneal dialysis set was subjected to autoclave sterilization at 115 ° C. for 30 minutes, and then stored at room temperature for 18 hours. Then, the blocking of the drainage bag and the pH of the solution in the dialysate bag were measured. Table 3 shows the results. As the amount of carbon dioxide injected into the drainage bag increases, the anti-blocking effect increases,
It can also be seen that the increase in the pH of the bicarbonate ion-containing dialysate is suppressed.

[0017]

[Table 3]

[0018]

According to the present invention, namely, the linked medical container or the storage method using the same, the bicarbonate ion-containing liquid can be easily and stably stored for a long period of time. it can. Secondly, in a plurality of containers connected by conduits, it is possible to reliably and inexpensively prevent blocking between inner surfaces of empty or containers in which almost no objects are stored.

[Brief description of the drawings]

FIG. 1 is a schematic view showing an example of a connected container containing a solution containing bicarbonate ions of the present invention.

[Explanation of symbols]

 1. Dialysate bag 2. Conduit 3. Drainage bag 4. Opening / closing means 5. Communication pipe 6. Packaging material

Claims (17)

[Claims] 1. A first synthetic resin container is filled with a medical solution containing bicarbonate ions, and a second synthetic resin container is communicatively connected to the first container by a conduit. The second container is filled with a carbon dioxide gas and / or a bicarbonate-containing liquid having a high concentration, and the first container and the second container are provided with a carbon dioxide gas permeable lower than or equal to the carbon dioxide permeability of these two containers. A linked medical container packaged with a synthetic resin packaging material having a property. 2. The medical container assembly according to claim 1, wherein the carbon dioxide permeability of the first container is equal to or less than the carbon dioxide permeability of the second container. 3. The carbon dioxide gas permeability of the second container is 10 to 10 ⁶ cm ³ · cm / cm ² ··· more than the gas permeability of the packaging material.
3. The linked medical container according to claim 1 or 2, which is larger by sec · cmHg. 4. The packaging material has a carbon dioxide permeability of 10 ^-12 to 1.
^{0 -14 cm 3 · cm / cm} 2 · medical container connection body according to any one of claims 1, 2 or 3 is sec · cmHg. 5. The second container has a carbon dioxide permeability of 10 ^-8 to 1.
^{0 -10 cm 3 · cm / cm} 2 · sec · medical container connection body according to any one of claims 1, 2, 3 or 4 is cmHg. 6. The bicarbonate-containing liquid filled in the second container has a carbon dioxide partial pressure of 2 to 760 mmHg.
The linked medical container according to any one of 2, 3, 4 and 5. 7. The method according to claim 1, wherein the concentration of carbon dioxide gas filled in the second container is 0.26 to 100%.
Or the linked medical container according to any one of the above items 6. 8. The method according to claim 1, wherein the amount of carbon dioxide gas injected into the second container is 2.0 to 25.0% of the maximum filling amount of the second container. 7. The linked medical container according to any one of items 7 to 7. 9. The medical container connected body is a set for peritoneal dialysis, wherein the first container is a dialysate container, and the second container is a drainage container. , 5,
9. The linked medical container according to any one of items 6, 7, and 8. 10. The medical solution according to claim 1, wherein the medical solution is a peritoneal dialysis solution having a bicarbonate ion concentration of 10 to 80 mEq / l.
The medical container assembly according to any one of 2, 3, 4, 5, 6, 7, 8 and 9. 11. A medical solution containing bicarbonate ions,
A second container made of synthetic resin, which is filled in a container and communicably connected to the first container, is filled with a carbon dioxide gas and / or a high-concentration bicarbonate-containing liquid, and further, the first container and the second container Are packaged in a packaging material made of a synthetic resin having a carbon dioxide permeability equal to or lower than the carbon dioxide permeability of these two containers, and sterilized by high-pressure steam. Manufacturing method. 12. The carbon dioxide gas permeability of the second container is 10 to 10 ⁶ cm ³ · cm / cm ² · s more than the gas permeability of the packaging material.
12. The value of ec · cmHg is larger.
The method for producing a medical drug solution package according to the above. 13. The bicarbonate-containing liquid filled in the second container has a carbon dioxide partial pressure of 2 to 760 mmHg.
13. The method for producing a medical drug solution package according to any one of items 1 and 12. 14. The method according to claim 11, wherein the concentration of carbon dioxide gas filled in the second container is 0.26 to 100%. . 15. The injection amount of carbon dioxide into the second container is as follows:
The method according to any one of claims 11, 12, 13, and 14, wherein the maximum filling amount of the second container is 2.0 to 25.0%. 16. The medical container connector according to claim 11, wherein the first container is a dialysate container, and the second container is a drainage container.
4. The method for producing a medical drug solution package according to any one of items 4 and 15. 17. The medical drug solution is a peritoneal dialysis solution having a bicarbonate ion concentration of 10 to 80 mEq / l.
12. The method for producing a medical drug solution package according to any one of items 12, 13, 14, 15, and 16.