JPH0638829B2 - Medical bag and manufacturing method thereof - Google Patents

Description

The present invention relates to a medical bag and a method for manufacturing the same. More specifically, the invention relates to an economical medical bag having a sealant property and a method for manufacturing the same, which has a port portion made of a polyolefin-based synthetic resin and a drug solution storage portion formed of a film.

<Prior Art> As a method of welding a thermoplastic resin that has a small dielectric loss and cannot be welded using a high-frequency welder, generally, a method of welding using an impulse sealer,
A method of welding using a heated die and a method of welding using an ultrasonic generator are known.

The method of welding using an impulse sealer is to generate heat by applying an electric current to a resistance heating element made of metal whose surface is flat, and using this heat, the films made of thermoplastic resin are strip-shaped or linear. It has a merit that the temperature of the resistance heating element can be easily adjusted. However, in the method of welding using an impulse sealer, for example, when a tube having a low hardness is inserted between two sheet-shaped adherends to be welded, the tube is distorted, or the tube and the two sheets are joined. There is a drawback that a leak may occur because the boundary surface between and cannot be completely sealed.

The method of welding using a heated mold is to heat the mold,
It is a method of welding the adherends made of a thermoplastic resin by using such heat, and adapts the adherends of various shapes by matching the shape of the mold with the shape of the adherend,
It has the advantage that it can be melted by heating. However, the mold temperature is affected by the ambient temperature and changes, and may decrease as the welding is repeated. Therefore, depending on the adherend, it is extremely difficult to control the mold temperature. There is. For example, when the mold temperature is too high, the adherend is melted and deformed during welding, resulting in poor appearance, and when the mold temperature is low, the adherend is adhered during welding. Melts and deforms to cause poor appearance, and when the mold temperature is low, the welding time becomes longer and the productivity decreases, or the adherends do not completely and uniformly weld, that is, poor welding. May occur.

The method of welding using an ultrasonic wave generator propagates the ultrasonic waves generated from the ultrasonic wave generator to the adherend and generates heat by the vibration energy of the ultrasonic waves at the boundary surface of the plurality of adherends that are in contact with each other. This is a method of welding the adherends to each other by such heat, and since the boundary surface of the adherends is welded, there is no appearance defect due to the welding and a heat source is not required, so that the adherends are easily It is possible to weld the bodies together. However, in the method of welding using an ultrasonic generator, adherends made of soft materials such as polybutadiene, low-density polyethylene, thermoplastic elastomers, and ethylene-based copolymers do not melt due to heat generation. You cannot do it. In addition, there are strict regulations regarding the shape, material, performance, etc., including fine particles adhering to the surface, and high safety is required,
For example, when a medical container such as an infusion bag or a blood bag is produced by using an ultrasonic generator, fine particles may be generated on the surface of the container due to the vibration due to the ultrasonic waves. It may require enormous effort. Furthermore, during welding, the melted adherend flows out,
Burrs may occur.

In view of the above circumstances, the present applicant has previously proposed a method capable of easily and uniformly and reliably welding thermoplastic resins which could not be conventionally welded by using a high-frequency welder (Japanese Patent Application No. 2000-242242). 61-286248).

Further, regarding the production of a medical bag using a heating die, in order to solve the above-mentioned problems, the port portion is formed into, for example, a boat shape, and the side wall of the boat portion and the film are evenly welded to form the port. A method of preventing a sealing failure in the vicinity of a portion, a method of using a laminated film having a film having a relatively high melting point on the outside, and the like are adopted.

<Problems to be Solved by the Invention> However, the invention proposed in the above-mentioned Japanese Patent Application No. 61-286248 solves the problems of the prior art, but it has a relatively long welding time and a high frequency welder. It is uneconomical because it is necessary to sandwich a heating element, such as a vinyl chloride resin sheet, between the adherend and it is uneconomical, and as a welding method for products that require low mass production such as medical bag production. Has a problem.

Further, the method using a heating die has a drawback that forming the port portion into a boat shape has a high material cost and a long welding time, and using a laminated film causes a problem because the cost becomes high. .

The present invention has been made in view of the above problems, and a medical bag formed by using a film of a polyolefin-based synthetic resin, having a good sealing property, economical, and improved in welding time, and a method for manufacturing the same. The purpose is to provide.

<Means for Solving the Problems> The present invention is to solve the above problems, and the first invention is to manufacture a bag made of a polyolefin-based synthetic resin including a port portion and a chemical liquid storage portion, A step of heat-sealing the open peripheral edge portion of the film excluding the port portion insertion portion for inserting the port portion to form the chemical liquid storage portion, and the port portion at the port portion insertion portion of the chemical liquid storage portion. A step of inserting and applying a heating die to the peripheral edge portion of the chemical liquid storage portion centering on the port insertion portion, so that a part of the heat-welded portion at the time of forming the chemical liquid storage portion is heated again And a step of heat-sealing the above-mentioned port portion and the drug solution storage portion at a position.

A second aspect of the present invention is a bag made of a polyolefin-based synthetic resin including a port portion and a chemical liquid storage portion, wherein the chemical liquid storage portion includes a port portion insertion portion for inserting the port portion. The open peripheral portion of the film to be removed is formed by heat-sealing, and the port portion inserted into the port portion insertion portion and the chemical liquid storage portion have a chemical liquid storage centered around the port bag insertion portion. The present invention relates to a medical bag, wherein a heated portion is heat-welded so as to cover a part of the heat-welded portion at the time of forming the chemical liquid storage portion at a peripheral portion of the portion.

<Operation> Next, the operation of the present invention will be described using the first invention.

According to the first invention of the present application, after the open peripheral edge portion of the film excluding the port portion insertion portion is heat-welded to form the chemical liquid storage portion, the port portion is inserted into the port portion insertion portion of the chemical liquid storage portion. Since the port part and the chemical solution storage part are heat-welded, an imbalance may occur in the force with which the heating mold presses the film, such as when the film is deformed by the heating mold during welding. Therefore, since the film is not broken at the portion where the welding of the film and the port portion is changed to the welding of the films, it is possible to prevent the leakage at the welding portion of the port portion and the chemical liquid storage portion.

In addition, since the port is inserted so that the port fits closely to the port insertion part, when the film is heated and melted,
The film does not lift from the port portion, and therefore, the tearing or leak of the film in the vicinity of the welded portion between the port portion and the chemical liquid storage portion can be prevented.

Furthermore, since the peripheral edge portion of the chemical liquid storage portion including the port portion insertion portion is heat-welded, a welding failure may occur at the transition portion between the port portion insertion portion and the peripheral portion adjacent thereto. And therefore a reliable seal can be achieved.

<Example> Next, the medical bag of the present invention will be described with reference to the drawings.

FIG. 1 is a schematic view of a medical bag according to an embodiment of the present invention, showing a case where an inflation film is used as a film.

As shown in FIG. 1, the medical bag of the present invention has a port portion.
A bag body comprising (1) and a drug solution storage part (2), wherein the film is heat-welded at the first seal part (3) to form a bag-like drug solution storage part (2) at the only opening. Insert the port part (1) into a certain port part insertion part (4) to insert the port part (1) and the chemical solution storage part (2).
And are heat-welded at the second seal portion (5).

The port (1) is provided as an entrance and exit for chemicals,
A tubular body having an open end and a closed end. After the drug solution is stored in the medical bag, the port (1) is sealed with a rubber stopper (not shown), etc., but the closed end of the port (1) covers the outside of the rubber stopper. It is formed into a thin film to protect it in a sterile condition.

The drug solution storage part (2) is a bag-shaped part that stores a drug solution or the like formed by heat welding an inflation film or a pair of sheet-shaped films, and the open peripheral part of the film except the port part insertion part (4). The first seal part (3) is formed by hot melt pressing. That is, when an inflation film is used as the film, the shoulder portion and the bottom portion of the bag are heat-sealed, and when a pair of sheet-like films are used as the film, the shoulder portion, the bottom portion and both side portions of the bag are heat-welded.

Since the bag is generally provided with a shoulder hanging hole (6) and a bottom hanging hole (7) as shown in FIG. 1, the first sealing parts at the shoulder and the bottom are the peripheral portions of the film. As well as, for example, as shown in Fig. 1, hanging holes (6) and (7)
It is provided to surround. Also, the shoulder part including the port insertion part (4) is sealed in the shape shown in the drawing for convenience of inserting and welding the port part regardless of the presence of the shoulder hanging hole (6). Is preferred.

The port portion (1) and the chemical liquid storage portion (2) are formed of the same material, but the forming material is an olefinic synthetic resin having good chemical resistance, such as polyethylene and polypropylene, and their copolymers. And elastomers.

The heat seal between the port part (1) and the chemical storage part (2) is the second seal part.
(5), the second seal part (5) is the peripheral part of the drug solution storage part (2) including the port part insertion part (4), and as shown in the figure, the port part insertion part (4) ) Is provided in the shape of a strip extending across the port portion (1) inserted in (1) to the position overlapping the first seal portion (3) of the shoulder portion. Therefore, no sealing failure occurs at the boundary between the first seal portion (3) and the second seal portion (5).

Next, a method for manufacturing the medical bag according to the first invention of the present application will be described.

First, the open peripheral portion of the film excluding the port insertion portion (4) for inserting the port (1), that is, the shoulder and bottom of the bag when the film is an inflation film, the film is a pair of sheets. In the case of film-shaped film, the shoulder, bottom and both sides of the bag are heat-welded to hold the drug solution storage unit.
Form (2) (first step). Next, the port portion (1) is inserted into the port insertion portion (4) which is the only opening of the chemical liquid storage portion (2) formed in the first step (second step), and finally, the port portion. Applying a heating mold to the peripheral portion of the chemical liquid storage portion (2) including the insertion portion (4), at a position where a part of the heated portion at the time of forming the chemical liquid storage portion (2) is heated again, Port part (1) inserted into port part insertion part (4) in the second step and chemical solution storage part
It suffices to heat weld (2) (third step).

Here, as described above in the section of action, it is necessary to divide the open peripheral edge portion of the film and the film portion and the port portion (1) into three steps without heat welding. This is for eliminating the imbalance of the pressing force of the mold and for preventing the port portion (1) or the film from floating. By adopting this method, it is possible to completely prevent leakage and breakage near the port portion.

<Example 1> An inflation film (thickness 0.25 mm, folding diameter 140 mm) of propylene-ethylene random copolymer (FL6711N, manufactured by Sumitomo Chemical Co., Ltd.) was used as a film, and this was used together with polypropylene (W101, Sumitomo Chemical Co., Ltd.). A bag is manufactured from the port of Kogyo Co., Ltd., 550 ml of water is put into the bag, and autoclave sterilization is performed at 121 ° C for 20 minutes, and then 0.7
When a withstand pressure test of kg / cm and a drop test from a height of 1 m were conducted, no abnormalities such as leaks and bag breakages were observed.

A thermocompression-bonding press (MKP-75S, manufactured by Mikado Metal Industry Co., Ltd.) was used as the sealing machine, and the sealing conditions were 300 ° C. and 3 seconds in both the first step and the third step.

<Example 2> A sheet-shaped film of polyethylene (F208-1, manufactured by Sumitomo Chemical Co., Ltd.) was used as a film, and a bag was manufactured from this and a port portion of polyethylene (G801, manufactured by Sumitomo Chemical Co., Ltd.). Then, put 550 ml of water in the bag, 110 ℃, 30
After carrying out autoclave sterilization for a minute, the same test as in Example 1 was carried out and no abnormality such as leak or bag breakage was observed.

The dimensions of the film, the sealing machine, and the sealing conditions are the same as in Example 1.

<Effects of the Invention> As is apparent from what has been described above, the following advantages can be obtained by adopting the present invention.

(1) In the past, when the port portion was attached by the heat welding method, a special member was used to prevent the leak, but it is economical because it is not necessary and the welding time can be shortened.

(2) Leakage can be significantly reduced as compared with a conventional bag manufactured by heat welding.

(3) Since the port part can be easily processed, the labor for manufacturing can be saved.

(4) Since a medical bag is manufactured by heat welding using a polyolefin synthetic resin film with good chemical resistance,
A hygienic and safe medical bag can be provided.

[Brief description of drawings]

 FIG. 1 is a schematic diagram showing an embodiment of the present invention. <Explanation of main symbols> 1: Port part, 2: Chemical solution storage part 3: First seal part, 4: Port part insertion part 5: Second seal part

Claims (4)

[Claims] 1. When manufacturing a bag made of a polyolefin synthetic resin including a port portion and a chemical solution storage portion, heat is applied to an open peripheral edge portion of the film excluding a port portion insertion portion for inserting the port portion. The step of welding to form the drug solution storage part, the step of inserting the port part into the port part insertion part of the drug solution storage part, and the heating of the peripheral part of the drug solution storage part centering on the port part insertion part A medical bag comprising a step of applying a mold to heat-weld the port portion and the chemical liquid storage portion at a position such that a part of the heat-welded portion when the chemical liquid storage portion is formed is heated again. Manufacturing method. 2. The method for producing a medical bag according to claim 1, wherein the drug solution storage portion is formed of a pair of sheet-shaped films. 3. The method for producing a medical bag according to claim 1, wherein the drug solution storage portion is formed of an inflation film. 4. A bag made of a polyolefin-based synthetic resin, comprising a port portion and a chemical liquid storage portion, wherein the chemical liquid storage portion is a film excluding a port portion insertion portion for inserting the port portion. The open peripheral portion is formed by heat welding, and the port portion inserted into the port insertion portion and the chemical liquid storage portion have a chemical liquid storage portion centered around the port portion insertion portion. A medical bag, wherein the heated portion is heat-welded so that the heated portion extends to a part of the heated-welded portion at the time of forming the chemical liquid storage portion.