JPH01185264A - Medical treatment bag and its manufacture - Google Patents

Abstract

PURPOSE:To improve a seal quality further enabling the melt mounting time to be shortened by mounting a film in its opening peripheral edge pat, excepting a port part insertion mounting part, to be melted by heat and forming a chemicals storage part thereafter inserting a port part into the port part insertion mounting part of the chemicals storage part, mounting the port part to be thermally melted to the chemicals storage part, and so on. CONSTITUTION:A port part 1 and a chemicals storage part 2 are formed by the same material, but the forming material uses olefin type synthetic resin of good chemical resistance. In case of a film being an inflation film, a bag mounts its shoulder part and bottom part to be thermally fusion bonded, forming the chemicals storage part 2. Next inserting the port part 1 into a port part insertion mounting part 4, which is only one opening part, finally applying a heating metal mold to a peripheral edge part of the chemicals storage part 2 containing the port part insertion mounting part 4, the port part and the chemicals storage part are mounted to be thermally fusion bonded. In this way, the heating metal mold eliminates its pressing force unbalance for the film, while preventing the film from floating from the port part 1, leakage and/or a break in the vicinity of the port part can be completely prevented.

Description

DETAILED DESCRIPTION OF THE INVENTION <Industrial Application Field> The present invention relates to a medical bag and a method for manufacturing the same. More specifically, the present invention relates to improvements in an economical medical bag with good sealing properties and a method for manufacturing the same, which has a port portion made of polyolefin synthetic resin and a drug storage portion formed from a film.

<Prior art> As methods for welding thermoplastic resins that have low dielectric loss and cannot be welded using a high-frequency welder, there are generally two methods: welding using an impulse sealer;
A method of welding using a heated mold and a method of welding using an ultrasonic generator are known.

The method of welding using an impulse sealer involves passing an electric current through a metal resistance heating element with a flat surface to generate heat, and using the generated heat to weld films mainly made of thermoplastic resin together in a band-like or This is a method of welding in a straight line, and has the advantage that the temperature of the resistance heating element can be easily controlled. However, with the method of welding using an impulse sealer, for example, if a tube with low hardness is inserted between two sheet-shaped adherends and welded, the tube may become distorted or the tube and the two sheets may The disadvantage is that leakage may occur due to the inability to completely seal the interface with the

The method of welding using a heated mold involves heating the mold,
This is a method of welding adherends made of thermoplastic resin using such heat, and by matching the shape of the mold to the shape of the adherend, it can be adapted to adherends of various shapes,
It has the advantage of being able to be heated and melted. However, the mold temperature varies depending on the surrounding atmospheric temperature and may drop as welding is repeated, so depending on the adherend, it may be extremely difficult to control the mold temperature. There is. For example, if the mold temperature becomes too high, the adherend will melt and deform during welding, resulting in poor appearance; if the mold temperature is low, welding will take a long time. Productivity may decrease, and adherends may not be completely uniformly welded, that is, poor welding may occur.

The method of welding using an ultrasonic generator involves propagating the ultrasonic waves generated by the ultrasonic generator to the adherends, and generating heat by the vibrational energy of the ultrasonic waves at the interface between the adherends that are in contact with each other. This is a method of welding the adherends together using such heat.Since the interface of the adherends is welded, there is no appearance defect due to welding, and no heat source is required. It is possible to weld objects together. However, when welding using an ultrasonic generator, adherends made of soft materials such as polybutadiene, low-density polyethylene, thermoplastic elastomers, and ethylene copolymers do not heat up and melt, so these soft materials cannot be used. I can't. In addition, there are strict regulations regarding fine particles attached to the surface, shape, material, performance, etc., and a high level of safety is required.
For example, when manufacturing medical containers such as infusion bags and blood bags using an ultrasonic generator, fine particles may be generated on the surface of the container due to ultrasonic vibrations, and it is difficult to remove the fine particles. It can require a huge amount of effort. Furthermore, during welding, the molten adherend flows out,
Paris may occur.

In view of the above circumstances, the present applicant has previously proposed a method for easily, uniformly and reliably welding thermoplastic resins that could not be welded together using a high-frequency welder (patent application). (Sho 61-286248).

In addition, in order to solve the above-mentioned problems regarding the manufacture of medical bags using heating molds, the port portion is formed into a boat shape, for example, and the side wall of the boat shape portion and the film are evenly welded. Methods of preventing seal failure near the port portion, and methods of using a laminate film with a film having a relatively high melting point on the outside have been adopted.

<Problems to be Solved by the Invention> However, although the invention proposed in Japanese Patent Application No. 61-286248 solves the problems of the prior art, it requires a relatively long welding time and does not require high-frequency welding. This welding method is uneconomical because it requires sandwiching a heating element, such as a sheet of vinyl chloride resin, between the adherend and the adherend, and it is a welding method for products that require low cost and mass production, such as the production of medical bags. There is a problem with that.

Furthermore, the method of using a heated mold has the drawbacks that molding the port part into a boat shape requires high material costs and a long welding time, while using a laminate film is problematic because it increases the cost. .

The present invention was made in view of the above problems, and provides a medical bag formed using a polyolefin synthetic resin film, which has good sealing properties, is economical, and has an improved welding time, and a method for manufacturing the same. The purpose is to provide.

<Means for Solving the Problems> The present invention solves the above-mentioned problems, and the first invention is directed to the production of a polyolefin synthetic resin bag including a port portion and a drug storage portion. a step of thermally welding the open peripheral portion of the film excluding the port insertion portion for inserting the port portion to form a drug storage portion; and inserting the port into the port insertion portion of the drug solution storage portion. and a heating mold is applied to the peripheral portion of the chemical liquid storage part centered on the port insertion part, so that a part of the part to be heated and welded at the time of forming the chemical liquid storage part is heated again. and a step of thermally welding the port portion and the drug storage portion.

A second invention is a bag made of polyolefin synthetic resin that includes a port portion and a drug solution storage portion, wherein the drug solution storage portion has a port insertion portion for inserting the port portion. The open peripheral portion of the film is formed by heat welding, and the port portion inserted into the port insertion portion and the drug solution storage portion form a drug solution storage centering on the port insertion portion. The present invention relates to a medical bag characterized in that the heated portion is heat-welded at the peripheral edge portion of the medical bag so as to cover a part of the heated welded portion when the drug solution storage portion is formed.

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

According to the invention in Box 1, after the open peripheral portion of the film excluding the port insertion portion is thermally welded to form the drug solution storage portion, the port portion is inserted into the port insertion portion of the drug solution storage portion. Since the port part and the chemical storage part are thermally welded, there is no possibility that an imbalance will occur in the force with which the heating mold presses the film, such as when welding while deforming the film with a heating mold. Therefore, the film is not torn at the transition from welding the film and the port section to welding the films together, and leakage can be prevented at the welded section between the port section and the chemical liquid storage section.

In addition, since the port is inserted so that it is almost in close contact with the port insertion part, when the film is heated and melted,
This prevents the film from lifting up from the port portion, and therefore prevents tearing and leakage of the film near the welded portion between the port portion and the chemical liquid storage portion.

Furthermore, since the periphery of the drug solution storage part including the port insertion part is heat-welded, there is no chance of welding failure at the transition area between the port insertion part and the adjacent periphery. Therefore, reliable sealing can be achieved.

<Example> Next, the medical bag of the present invention will be described based on the drawings.

FIG. 1 is a schematic diagram of a medical bag according to an embodiment of the present invention, and shows a case where a blown film is used as the film.

As shown in FIG. 1, the medical bag of the present invention has a port section (
1) and a chemical liquid storage part (2), the only opening part of the chemical liquid storage part (2) is formed into a bag shape by thermally welding a film at the first seal part (3). Insert the port part (1) into the port part insertion part (4), which is the port part (
1) and the chemical solution storage section (2) are thermally welded together at the second seal section (5).

The port portion (1) is provided as an inlet/outlet for a medical solution, etc., and is a tubular body having an open end and a closed end. After the medical solution is stored in the medical bag, the port part (1) is closed with a rubber plug (
(not shown), etc., but the port part (1
) is formed into a thin film to cover the outside of the rubber stopper and protect it in a sterile condition.

Medicine i storage 1 (2) is a bag-shaped part that stores medicine, etc. formed by thermally welding a blown film or a pair of sheet-like films, and the port insertion part (4)
The first seal part (3
) is formed by hot melt compression bonding. That is, when a blown film is used as the film, the shoulders and the bottom of the bag are heat-welded, and when a pair of sheet-like films are used as the film, the shoulders, the bottom, and both sides of the bag are heat-welded.

In addition, since bags are generally provided with a shoulder hanging hole (6) and a bottom hanging hole (7) as shown in Figure 1, the first seals on the shoulder and bottom are only at the peripheral edge of the film. For example, as shown in Figure 1, there is a hanging hole (6
) and (7). In addition, the shoulder part including the port insertion part (4) is designed to be convenient for insertion and welding of the port part, regardless of the presence or absence of the shoulder hanging hole (6).
Preferably, it is sealed in the shape shown.

The port part (1) and the chemical storage part (2) are made of the same material, and the material used for forming them is an olefin-based synthetic resin with good chemical resistance, such as polyethylene, polypropylene, or a copolymer thereof. and elastomers.

Thermal welding of the port part (1) and the chemical liquid storage part (2) is performed in the second seal part (5), and the second seal part (5) is connected to the chemical liquid storage part including the port part insertion part (4). (2), which overlaps with the first seal part (3) of the shoulder part so as to cross the port part (1) inserted into the port part insertion part (4) as shown in the figure. It is provided in a band-like shape that extends up to. Therefore, the first seal part (3) and the second seal part (
5) Seal failure does not occur at the boundary.

Next, a method for manufacturing a medical bag, which is the invention of Box 1 of the present application, will be explained.

First, the port insertion part (4
), i.e., the shoulders and bottom of the bag if the film is a blown film, or the shoulders, bottom, and both sides of the bag if the film is a pair of sheet-like films. to form a chemical liquid storage section (2) (first step). Next, the port part (1) is inserted into the port part insertion part (4), which is the only opening of the drug solution storage part (2) formed in the first step (second step), and finally, the port part insertion part (2) is inserted. A heating mold is applied to the peripheral part of the chemical liquid storage part (2) including the attached part (4), and the chemical liquid storage part (2)
) Heat the port part (1) and chemical solution storage part (2) inserted into the port part insertion part (4) in the second step at a position where a part of the heated part during formation can be heated again. All you have to do is weld it (3rd step).

Here, the reason why the open peripheral part of the film and the film and the port part (1) are not thermally welded together is that the process is divided into three steps. This is to eliminate the unbalance of the pressing force of the heating mold against the film and to prevent the film from lifting up from the port part (1), and by adopting this method, leakage and tearing near the port part can be completely prevented. be able to.

<Example 1> A blown film (Jl size 0.25 mm, fold II diameter 140 mm) of propylene-ethylene random copolymer (FL6711N, manufactured by Sumitomo Chemical Co., Ltd.) was used as the film, and this and polypropylene (Wlol
, Manufactured by Sumiya Kagaku Kogyo ■).
After filling the bag with 550 d of water and sterilizing it in an autoclave at 121°C for 20 minutes, we conducted a pressure test of 0.7 kg/cm and a drop test from a height of 1 m, and found no abnormalities such as leaks or bag breakage. I was not able to admit.

The sealing machine used was a thermocompression press (MKP-753, manufactured by Mikado Metal Industries, Ltd.), and the sealing conditions were 300° C. and 3 seconds in both the first and third steps.

<Example 2> A sheet-like film of polyethylene (F208-1, manufactured by Sumitomo Chemical Industries, Ltd.) was used as the film, and a bag was manufactured from this and a port portion of polyethylene (G801, manufactured by Sumitomo Chemical Industries, Ltd.). 550m, add 1 liter of water
After autoclave sterilization at 10° C. for 30 minutes, the same test as in Example 1 was conducted, and no abnormalities such as leakage or bag breakage were observed.

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

<Effects of the Invention> As is clear from the above explanation, the following advantages can be obtained by adopting the present invention.

(1) Conventionally, when attaching the port part using the heat welding method,
Previously, special members were used to prevent leaks, but since this is no longer necessary, it is economical and the welding time can be shortened.

(2) Compared to bags manufactured by conventional heat welding,
Leakage can be significantly reduced.

(3) The port part is easy to process, which saves time and effort in manufacturing.

(4) Since the medical bag is manufactured by thermal welding using a polyolefin synthetic resin film with good chemical resistance, it is possible to provide a hygienic and safe medical bag.

[Brief explanation of the drawing]

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 (1)

[Scope of Claims] 1) In the production of a polyolefin synthetic resin bag comprising a port portion and a drug storage portion, the open periphery of the film excluding the port insertion portion for inserting the port portion; a step of thermally welding the parts to form a drug solution storage section, a step of inserting the port section into a port insertion section of the drug solution storage section, and a periphery of the drug solution storage section centered on the port insertion section. applying a heating mold to the part and thermally welding the port part and the chemical liquid storage part at a position such that a part of the heated welded part during the formation of the chemical liquid storage part is heated again. Method of manufacturing medical bags. 2) The method for manufacturing a medical bag according to claim 1, wherein the drug solution storage section is formed from a pair of sheet-like films. 3) The method for manufacturing a medical bag according to claim 1, wherein the drug solution storage section is formed of a blown film. 4) A bag body made of polyolefin synthetic resin that includes a port portion and a chemical liquid storage portion, wherein the chemical liquid storage portion is located at the open periphery of the film excluding the port insertion portion for inserting the port portion. The port part inserted into the port part insertion part and the drug solution storage part are formed by heat welding the part, and the peripheral part of the drug solution storage part centered on the port part insertion part. A medical bag, characterized in that the heated part is heat-welded so as to cover a part of the heated welded part when forming the drug solution storage part.