JP2000350780A - Medical heat exchanger bag and method for manufacturing the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To inhibit crimped parts from sticking on other sterilized articles such as tubes, without any additional process, during steam sterilization. SOLUTION: In this heat exchanger bag, a supply port 1 for taking liquid in, a discharge port 2 for discharging the liquid taken in from the supply port 1 and a fluid path 3 for communicating the discharge port 2 and the supply port 1 are formed by crimping predetermined parts of 2 PVC sheets 4, 4'. In this case, the outer surfaces of the crimped parts 4a are embossed.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical heat exchange bag used for heating a replacement fluid for supplementing water removed from blood in hemodiafiltration or the like.

[0002]

2. Description of the Related Art A general medical heat exchange bag is a bag in which two PVC (polyvinyl chloride) sheets are stacked, partially heated and pressure-bonded to form a bag-like liquid flow path. Then, by being mounted on a heat exchange device having an external heat source such as a heater, heat exchange of a replacement fluid (replenisher) in the liquid flow path is performed via a PVC sheet. Then, the medical heat exchange bag is sterilized by EOG (Ethylene Oxide Gas) in a state of being put in the sterilization bag, whereby the medical sterilization bag is manufactured.

In such a medical heat exchange bag, E
In order to prevent the residual of the sterilant during OG sterilization from affecting the human body, store for a long time until the sterilant is removed,
Before use, it was necessary to sufficiently wash with physiological saline or the like.
In order to prevent this problem, steam sterilization has been used instead of EOG sterilization to eliminate the use of a sterilant during sterilization.

[0004]

However, in sterilization by steam sterilization, the heat exchange bag for medical use and a tube or a sterilization bag connected to the medical heat exchange bag are stuck due to high temperature, and it is troublesome to remove the bag during use. There was such a problem.

That is, since the medical heat exchange bag is put in the sterilization bag and sterilized while the tube and the fluid replacement circuit are connected, for example, when the medical heat exchange bag and the sterilization bag adhere to each other, the medical heat exchange bag is used. It takes time and effort to remove the tube from the sterilization bag, and if the medical heat exchange bag and the tube connected to the heat exchange bag adhere to each other, it takes time to release the tube during use.

In order to prevent the above problem, it is conceivable to interpose paper between the medical heat exchange bag, the tube and the sterilization bag. However, this paper becomes garbage when used, and the paper is interposed. There is a problem that a new process is required. It is also conceivable to form a medical heat exchange bag with a PVC sheet having a roughened outer surface to suppress sticking during steam sterilization. However, there was also a problem that the surface was smoothed and sticking was easily generated in this portion.

SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances, and has been made in view of the medical use, which can suppress sticking to a tube or other article to be sterilized even in a crimped portion without increasing the number of steps in steam sterilization. An object of the present invention is to provide a heat exchange bag and a method for manufacturing the same.

[0008]

According to the first aspect of the present invention,
A supply port for taking in the liquid by pressing a predetermined portion of the plurality of sheets facing each other, a discharge port for discharging the liquid taken in from the supply port, and a liquid flow path communicating the discharge port with the supply port In the medical heat exchange bag formed with the and, the outer surface of the crimped portion is embossed. According to such a configuration, for example, the contact area between the medical heat exchange bag and other articles to be sterilized during steam sterilization can be reduced.

According to a second aspect of the present invention, there is provided a supply port for taking in a liquid by pressing a predetermined portion of a plurality of sheets facing each other, a discharge port for discharging the liquid taken from the supply port, and the discharge port. And a liquid flow path communicating with the supply port, in the method for manufacturing a medical heat exchange bag, wherein the plurality of sheets are crimped, wherein the outer surface of the crimping portion is embossed. . According to this configuration, the embossing process is performed while forming the supply port, the discharge port, and the liquid channel when the predetermined portion is pressed. Due to this embossing, the outer surface of the crimped portion is provided with an uneven shape.

According to a third aspect of the present invention, the average roughness of the surface of the pressure-bonded portion by the embossing is 0.5 μm or more,
m or less. The invention according to claim 4 is characterized in that the average roughness of the surface of the press-bonded portion by the embossing is set to 1.0 μm or more and 30 μm or less.

[0011]

Embodiments of the present invention will be specifically described below with reference to the drawings. The medical heat exchange bag according to the present embodiment performs heat exchange of a replacement fluid (replenisher) in a liquid flow path via a PVC sheet by being mounted on a heat exchange device having an external heat source such as a heater. As shown in FIGS. 1 and 2, predetermined portions of two facing PVC sheets 4 and 4 ′ are pressure-bonded to form a supply port 1, a discharge port 2, and a liquid channel 3. .
That is, the non-compression-bonded portions 4b of the sheets 4, 4 'are formed so as to communicate with the supply port 1 and the discharge port 2 as shown in the figure, and the inside thereof is used as a liquid flow path 3 for flowing a replacement fluid.

The front and back surfaces of the PVC sheets 4 and 4 'are roughened in advance, and the two PVC sheets 4 and 4' are stuck together to form a supply port 1, a discharge port 2, and a liquid flow path 3. Are not closed. This also prevents the non-pressed portion 4b of the medical heat exchange bag 5 from sticking to the tube 6 and the sterilization bag 12 described later. Other resin sheets may be used in place of the PVC sheets 4 and 4 ', and in this case also, it is preferable that the front and back surfaces have rough surfaces in advance.

With this configuration, the replacement fluid supplied from the tube 6 fixed to the supply port 1 is supplied to the bent liquid flow path 3.
Is heated by a heat exchange device (not shown) during the flow, and is discharged from a tube 6 fixed to the discharge port 2. And
The discharged replacement fluid is taken in as a replenisher in the patient's body for HDF (hemodiafiltration) or HF (hemofiltration) treatment or the like.

As shown in FIG. 2, when the two PVC sheets 4 and 4 'are crimped, when the upper die 8 and the lower die 9 abut against each other, a high frequency is generated therebetween. That is, predetermined portions of the PVC sheets 4 and 4 'are pressure-bonded by so-called high-frequency welding to form a pressure-bonded portion 4a. Here, high-frequency welding refers to a method of applying a high-frequency electromagnetic field to an insulator such as a PVC material, causing a dielectric loss therein to generate heat, and bonding the melted insulators together. A high-frequency electromagnetic field of about 10 to 40 MHz is used.

Further, as shown in FIGS. 3 (a) and 3 (b), an abutting portion 8a of the upper mold 8 with respect to the PVC sheet 4 and an upper surface 7a of the lower mold 7 in the figure have irregularities. ,
When the upper die 8 and the lower die 7 are in contact with each other, the outer surfaces of the press-bonded portions 4a of the PVC sheets 4, 4 'are embossed. It should be noted that the uneven shape in FIG.
However, a similar concavo-convex shape is also formed on the upper surface 7 a of the lower mold 7. The concave-convex shape is constituted by a plurality of minute rectangular concave portions 9 arranged in a plurality of rows and columns at predetermined intervals, and relative convex portions 10 formed between the concave portions 9.

The shape of the concavo-convex shape is not limited to that described above. For example, as shown in FIGS. 4A and 4B, a plurality of square pyramids 11 are arranged, and
0 'and the other portions may be concave portions 9', or other concave and convex shapes.

Here, if the irregular shape is too rough, the contact area with the upper mold 8 and the lower mold 7 becomes small, and there is a possibility that excessive melting due to concentration of energy at one point or poor sealing due to insufficient melting may occur. Is calculated by calculating the arithmetic mean roughness (JIS
B0601) The thickness is preferably in the range of 0.5 μm to 50 μm, more preferably 1.0 μm to 30 μm.

Next, a method of sterilizing the medical heat exchange bag having the above configuration will be described. As shown in FIG. 5, the medical heat exchange bag according to the present embodiment has a sterilization bag 12 with the tube 6 and the subsequent fluid replacement circuit 13 connected thereto.
And sterilized by autoclaving.

This high-pressure steam sterilization method is to forcibly discharge air in an autoclave containing articles to be sterilized,
This is a method in which high-temperature steam is injected to sterilize the steam at a high temperature. This is because the introduction of steam is more advantageous in obtaining sterilization efficiency and a predetermined temperature than in the case of using dry heat.

In the present embodiment, a cut is made in the longitudinal direction of the sterilization bag 12 so that sterilization can be performed effectively.
A paper with good air permeability (for example, Japanese paper) is attached to the cut (not shown). Thereby, at the time of steam sterilization,
High-temperature steam enters the sterilization bag 12 from the paper portion, and can sterilize the medical heat exchange bag 5 and every corner of the rehydration circuit 13.

In such a steam sterilization method, despite the presence of steam at a high temperature, the medical heat exchange bag 5, the rehydration circuit 13 including the tube 6, and the sterilization bag 12 are hardly stuck. ing. This is because P
Using VC sheets 4, 4 'and crimping portion 4a
This is because the surfaces of the non-pressed portion 4b and the press-bonded portion 4a of the medical heat exchange bag 5 are both rough, and the contact area with the rehydration circuit 13 and the sterilization bag 12 is reduced. .

Therefore, according to the present embodiment, since the embossing process is performed when the PVC sheets 4 and 4 'are crimped, the medical heat exchange bag 5 which does not easily adhere during steam sterilization without increasing the number of manufacturing steps is obtained. be able to. Although the present embodiment has been described above, the overall shape of the medical heat exchange bag 5, the shape of the liquid flow path 3, the positions where the supply port 1 and the discharge port 2 are formed, and the like are merely examples, and the gist of the present invention is described. It goes without saying that various changes can be made without departing from the scope.

[0023]

EXAMPLES Hereinafter, the present invention will be described more specifically with reference to examples. The examples illustrate the invention by way of example and do not limit the invention.

[0024]Example 1  Arithmetic mean roughness of the outer surface of the crimped part by embossing
(JIS B0601) 0.4μm and steam sterilization
When sterilized, 24 of the 48 samples were stuck
No set, perforated or bad seal set
Was.

[0025]Example 2  Arithmetic mean roughness of the outer surface of the crimped part by embossing
(JIS B0601) 0.6μm and steam sterilization
In the case of sterilization, 3 of the 48 samples
Set with no holes, holes or bad seals
Was.

[0026]Example 3  Arithmetic mean roughness of the outer surface of the crimped part by embossing
(JIS B0601) 1.1, 10, 25 μm
When sterilized by steam sterilization,
The sample with a hole or poor sealing was 0.

[0027]Example 4  Arithmetic mean roughness of the outer surface of the crimped part by embossing
(JIS B0601) Decomposed by steam sterilization as 35 μm
In the case of bacteria, 3 sets of sticking out of 48 sets of samples
3 sets of items with holes, holes or bad seals
Was.

[0028]Example 5  Arithmetic mean roughness of the outer surface of the crimped part by embossing
(JIS B0601) Sterilized by steam sterilization as 45 μm
In the case of bacteria, of the 48 sets of samples, 0
And 7 sets with holes, holes or bad seals
Was.

[0029]Example 6  Arithmetic mean roughness of the outer surface of the crimped part by embossing
(JIS B0601) Destroyed by steam sterilization as 55μm
In the case of bacteria, of the 48 sets of samples, 0
And 26 sets with holes, holes or bad seals.
Was.

[0030]

According to the first aspect of the present invention, the outer surface of the crimped portion is embossed, so that during steam sterilization, sticking with other articles to be sterilized or a sterilization bag can be suppressed. When using the medical heat exchange bag, the labor for peeling off the agglutinated portion can be saved.

According to the second aspect of the present invention, since the embossing process is performed at the time of press-fitting the predetermined portion, it is possible to manufacture the medical heat exchange bag having the effect of the first aspect without increasing the number of steps. According to the third and fourth aspects of the present invention, the adhesion between the crimped portion and other articles to be sterilized, the sterilization bag, or the like is suppressed, and the sealing is poor due to excessive melting or insufficient melting due to concentration of one point of energy during manufacturing. Can be prevented.

[Brief description of the drawings]

FIG. 1 is a top view showing a medical heat exchange bag according to the present invention.

FIG. 2 is a sectional view showing a medical heat exchange bag according to the present invention and an upper mold and a lower mold for embossing.

FIG. 3 (a) is an enlarged bottom view showing the uneven shape of the surface in contact with the medical heat exchange bag in the upper mold of FIG. 2;
(A) AA line sectional view

FIG. 4 (a) is an enlarged bottom view showing another uneven shape of a surface in contact with the medical heat exchange bag in the upper mold of FIG. 2;
(A) BB line sectional view

FIG. 5 is a front view showing a state in which the medical heat exchange bag according to the present invention and the fluid replacement circuit connected thereto are put in a sterilization bag.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 ... Supply port 2 ... Discharge port 3 ... Liquid flow path 4, 4 '... PVC sheet 5 ... Medical heat exchange bag 6 ... Tube 7 ... Lower mold 8 ... Upper mold 9 ... Concave part (concave part by embossing) 10 ... Convex Part (convex part by embossing) 11 ... square pyramid 12 ... sterilization bag 13 ... rehydration circuit

Claims (4)

[Claims] 1. A supply port for taking in a liquid by pressing a predetermined portion of a plurality of sheets facing each other, a discharge port for discharging a liquid taken from the supply port, and the discharge port and the supply port. A medical heat exchange bag in which a liquid flow path communicating with the medical heat exchange bag is formed, wherein an outer surface of a crimped portion is embossed. A supply port for taking in the liquid, a discharge port for discharging the liquid taken in from the supply port, and the discharge port and the supply port. The method for manufacturing a medical heat exchange bag in which a liquid flow path communicating with the medical heat exchange bag is formed, wherein when the plurality of sheets are crimped, the outer surface of the crimped portion is embossed. Production method. 3. The method for manufacturing a medical heat exchange bag according to claim 1, wherein an average roughness of a surface of the crimped portion by the embossing is set to 0.5 μm or more and 50 μm or less. 4. The method for manufacturing a medical heat exchange bag according to claim 1, wherein the average roughness of the surface of the press-bonded portion by the embossing is set to 1.0 μm or more and 30 μm or less.