JP2775396B2 - Medical bag and manufacturing method thereof - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical bag made of a flexible synthetic resin such as an infusion bag, a medical solution bag, and a blood bag, and a method of manufacturing the same. An object of the present invention is to provide a method for producing a medical bag under sterile and dust-free conditions without any contact with the outside air up to the final product, and a medical bag having an infusion port attached to at least one portion of a main body.

[0002]

2. Description of the Related Art Currently used medical bags are:
There are a bag body formed of two sheets of flexible synthetic resin and a bag body formed of a tube-shaped flexible synthetic resin. In the former case, the periphery of the two sheets is welded to form a bag by interposing an infusion port or the like between the two sheets. On the other hand, in the latter case, the tube is cut into a predetermined size, and an infusion port or the like is interposed at an opening end formed by cutting, and the opening end is welded to form a bag.

[0003]

However, in these methods, when the ends of the sheet or tube are welded to form a bag, the inner surface of the bag body is exposed to outside air in order to interpose an infusion port or the like at the end of the sheet or tube. In the meantime, not only bacteria but also fine particles, fine dust, and cutting waste such as an infusion port may adhere to the inner surface of the bag body, which is not hygienic. In addition, after being formed as a medical bag, it is filled with a chemical solution or the like, so that the number of manufacturing steps increases,
In addition, there is a risk that the chemical solution or the inside of the bag may be contaminated when filling the chemical solution. Further, a large amount of electric power is consumed for welding a large area at the end of the sheet or the tube, which is not always economical. The inventor of the present invention has conducted intensive studies in order to solve the above-described problems, and has reached the following invention.

[0004]

Means for Solving the Problems [1] The present invention provides a method for manufacturing a medical bag comprising the following steps. A step of extruding the constituent materials of the medical bag into a tube in a molten state, a step of welding a mouth having a bottom heated to a side surface of the tube , and pressing the side of the tube with a molding device in a direction perpendicular to the side surface of the tube. , Leaving a passage in the center in the width direction of the tube
The attachment portion is formed so as to be located above and below the mouth portion, and the fusion
When forming a part, a bag for storing the chemical solution in the vertical direction of the tube
Forming a package body , a supply line for a chemical solution extending into the tube into the tube.
Filling a drug solution from the in-nozzle, after welding the passage, the step of cutting the fused portion,
Or a step of cutting and simultaneously welding the passage,

[2] The present invention provides a method for manufacturing a medical bag comprising the following steps. A step of extruding the constituent materials of the medical bag into a tube in a molten state, a step of welding a mouth having a bottom heated to a side surface of the tube , and pressing the side of the tube with a molding device in a direction perpendicular to the side surface of the tube. , Leaving a passage in the center in the width direction of the tube
The attachment portion is formed so as to be located above and below the mouth portion, and the fusion
When forming a part, a bag for storing the chemical solution in the vertical direction of the tube
Forming a package body , a supply line for a chemical solution extending into the tube into the tube.
Filling a drug solution from the in-nozzle, and placing the tube in the cradle, the step of conveying horizontally by the conveying means placed higher than receiving table position, after welding the said passage, the fused portion Cutting,
Or a step of cutting the fused portion at the same time as welding the passage,

[3] The present invention provides a method for manufacturing a medical bag comprising the following steps. A step of extruding the constituent materials of the medical bag into a tube in a molten state, a step of welding a mouth having a bottom heated to a side surface of the tube , and pressing the side of the tube with a molding device in a direction perpendicular to the side surface of the tube. , Leaving a passage in the center in the width direction of the tube
The attachment portion is formed so as to be located above and below the mouth portion, and the fusion
When forming a part, a bag for storing the chemical solution in the vertical direction of the tube
Forming a package body , a supply line for a chemical solution extending into the tube into the tube.
A step of filling a chemical solution from the nozzle of the in, the tube is placed on a receiving table, and the aseptic air supply line extending to the inside of the tube while being horizontally transported by a transport means installed at a position higher than the receiving table. implanting sterile air into the tube from a horizontal position nozzle, after welding the passage, the step of cutting the fused portion,
Or a step of cutting the fused portion at the same time as welding the passage,

[4] The present invention provides a bag containing a chemical solution.
The mouth is attached to the center of the lower end of the body, and both sides of the bag body
A fusion part is formed on the inside of the bag body in the lateral direction.
From near the center to the top and bottom of the bag body and vertically
It is a slope-shaped fusion part that is inclined toward the center of the direction.
Provide medical bags .

[0008]

From the beginning to the final step, the medical bag can be manufactured in a completely sterile and dust-free state, since the inside of the medical bag and the liquid medicine filled therein do not come into contact with the outside air. In addition, the medical solution can be extruded from each component of the medical bag and filled at the same time as molding. Also, the removal of the drug solution can be easily performed only by penetrating the mouth portion welded to the lowest position of the bag-shaped medical bag body (tube) with a needle.

[0009]

1 shows a medical bag manufacturing apparatus 1A according to the present invention.
2 is a view as viewed from the direction of the arrow A in FIG. 1, and FIG. 3 is a view as viewed from the direction of the arrow B in FIG. The manufacturing apparatus 1A includes an extruder 1, a tube extrusion die 2 (hereinafter, die 2), molding means (molding device 3), and a mouth feeding device 3a. Mold 2
A supply line 5 for aseptic air, a supply line 6 for chemical solution, and an air recovery line 7 are attached to the rear of the nozzle, and each nozzle 5 of the supply line 5 for sterile air and the air recovery line 7
Reference numerals a and 7a are disposed below the mold 2, and the nozzle 6a of the supply line 6 for the chemical solution extends into the molding apparatus 3.
Also, a sterile air supply line 6 is provided in the chemical solution supply line 6.
The nozzle 6c is arranged to extend below the molding device 3. The forming device 3 includes a drive shaft 8a and a conveyor 8b, and rollers 8 are provided on the surface of the conveyor 8b at predetermined intervals. Mouth feeding device 3a
Comprises an arm 3b for conveying the mouth 13 in the direction of the extrusion tube 4, and the bottom of the mouth 13 is heated and maintained at a high temperature.

A molten resin is extruded from an extruder 1 into a mold 2 and extruded from a nozzle of the mold 2 into a tube 4.
The mouth 13 whose bottom is kept at a high temperature is welded to the side surface of the tube 4 in a molten state and is conveyed to the molding apparatus 3. The tube 4 and the bottom of the mouth 13 need only be maintained at such a high temperature that they can be welded to each other. The mounting position of the mouth 13 on the tube 4 can be freely set by appropriately changing the supply position of the supply device 3a. By pressing the tube 4 with a roller 8 by a molding device 3 from a direction perpendicular to the welding direction of the mouth portion 13 as shown in FIG.
As shown in FIG. A passage 10 is formed at the center of the fusion portion 9. The fusion parts 9 are formed in an elongated island shape at equal intervals and in the same shape. This makes it easier to discharge the liquid medicine from the mouth 13 as described later.
The shape and the like of the fused portion 9 can be freely changed by adjusting the shape and arrangement of the roller 8 mounted on the surface of the conveyor 8b. The supply interval of the mouth portion 13 to the tube 4 and the mounting interval can be freely set according to the shape of the fusion portion 9 formed in the tube 4.

The tube 4 is formed while supplying air through a sterile air supply line 5, so that the tube 4 can maintain an expanded shape. Air collection line 7
By communicating with the inside of the tube 4, volatile components of additives such as a plasticizer of the tube 4 that evaporate (evaporate) from the tube 4 in a high temperature state can be collected from the collection line 7, and thus formed as a medical bag. Later, it is sanitary because it does not adhere to the inner surface of the medical bag. The extruded tube 4 is pressed by the roller 8 near the entrance of the molding apparatus 3 and the internal space becomes narrow (narrow path).
The air introduced into the tube 4 from the nozzle 5a is rebounded to the wall of the tube 4 near the narrow path, and the nozzle 7a,
It is discharged outside through the collection line 7. Furthermore, since the drug solution is filled in a closed system while the tube 4 is being extruded, dust and the like do not adhere to the tube 4, which is sanitary.

1 and 4 while injecting a predetermined amount of a chemical solution.
The tube 4 is temporarily placed on the receiving stand 8e as shown in FIG.
And a drive shaft 8c (transporting means: adjusted so that the tube can be transported horizontally). The chemical liquid filling position is always at a position higher than the chemical liquid level in the tube 4 being conveyed while lying down, and the tube 4 is in a state where the chemical liquid is densely filled when the tube 4 is placed on the receiving stand 8e. The tube 4 can be densely filled with a drug solution. Also,
As shown in FIG. 1, the nozzle 6 of the sterile air supply line 6b
c can be extended to the inside of the tube 4 placed horizontally on the transfer table 11, and the required amount of air can be injected from the nozzle 6c at the horizontal position to adjust the amount of air injected into the tube 4 as appropriate. As described above, the tube 4 filled with the drug solution is continuously extruded in the same shape in a horizontal state, so that a medical bag filled with a certain amount of the drug solution or the drug solution and air is uniformly increased in a large number of, for example, 100 units or 200 units. Can be produced. Further, by filling the air at the horizontal position as described above, a constant amount of air can be uniformly injected into the medical bag. A controller (not shown) controls the drive speed of the conveyor 8b of the molding device 3 and the conveyor 8d of the conveyor 11 by taking up the tube 4 from the mold 2.
It can be set freely by interlocking control via.

The tube 4 filled with the chemical is welded to the passage 10 by a sealing machine (not shown) by welding and / or cutting means (for example, a sealing machine and a cutting machine, and a sealing machine and a cutting machine). And cut by a cutting machine (not shown). Further, welding and cutting can be performed simultaneously and collectively using a sealing machine and a cutting machine (not shown). As a result of the cutting, the elongated island-shaped welded portion 9 is turned into the main body 12 as shown in FIG.
Is formed into an inclined welding portion 9a inclined from the center toward the end (9b is a secondary welding portion formed by welding the passage 10 with a sealing machine). As described above, the medical bag 15 as shown in FIG. 5 can be obtained.

The medical bag 15 has the above-mentioned inclined fusion parts 9a formed on both sides in the longitudinal direction (length direction) of the main body 12, and the mouth part 13 is arranged between the fusion parts 9a. . Body 1
2 is flexible, so that the body 12
The bottom on the side where the mouth 13 is mounted is curved. For this reason, since the position of the mouth 13 is set at a relatively lower end, when the injection needle is punctured into the mouth 13 to discharge the drug solution as shown in FIG. Can be discharged quickly.

Further, in the present invention, after the tube 4 is filled with the chemical solution, the conveying means (tube 4) as shown in FIG.
Of the tube 4 between the shape holding mold 64 and the conveying table 62 composed of the conveyor 28c and the drive shaft 28d adjusted so that the tube 4 can be transported horizontally. It is fixed and conveyed horizontally, finally taken out of the shape-retaining mold 64, and is welded to the passage 10 using a sealing machine / cutting machine 57 (hereinafter referred to as a sealing machine 57), and at the same time, the cutting section 9 is cut. Thereby, it is possible to obtain a medical bag in which a certain amount of the drug solution or the drug solution and air are evenly filled. In addition, welding of the passage 10 by the sealing machine 57,
Instead of cutting the fusion portion 9 at the same time, the fusion portion 9 may be cut by a cutting machine (not shown) after the passage 10 is welded by a sealing machine (not shown). The shape-retaining mold 64 is composed of upper and lower molds having a groove corresponding to the shape of the bag, for example. Since the tube 4 is maintained in a predetermined shape by the shape-retaining mold 64 and filled with the chemical, the filling amount of the chemical or the chemical and the air can be made uniform.

Further, the present invention relates to a manufacturing apparatus 41 shown in FIG.
By providing a means for supplying sterile air, a means for supplying a chemical solution, and a safety means as in A, a system for manufacturing a medical bag under a sterile and dust-free environment can be established (each means shown in FIG. 1 is used). It can also be mounted on the manufacturing apparatus 1A).

The means for supplying aseptic air includes sterilizing filters 45, 4 in the middle of supply lines 25, 26b for aseptic air.
6, valves 54 and 55, heaters 48 and 49 are arranged, and air suction pumps 50 and 51 are attached to the ends. The air supply pressure is the suction pump 50,5
1. It can be adjusted by the valves 54 and 55. The liquid supply means is provided with a valve 5 in the middle of the liquid supply line 26.
3 and a disinfecting filter 63 are arranged, a chemical solution tank 52 is attached to the end, a dissolution tank 65 is connected to the chemical solution tank 52, and a distilled water tank (distillation tower) 61 and a chemical solute tank 60 are connected thereto. It is constituted by doing. After the solute and distilled water are measured in the dissolution tank 65 to adjust the chemical solution, the valve 66 is opened, sterile air is introduced into the dissolution tank 65 from the air supply line 68, and the chemical solution is pressurized. It is opened and temporarily stored in the chemical liquid tank 52 through the chemical liquid supply line 69. In the center of the chemical supply line 26, the supply line 26b for the sterile air is disposed so as to penetrate therethrough. The chemical solution can be adjusted in the dissolution tank 65 and the chemical solution tank 52 without contact with the outside air in a completely closed system, and can be aseptically filled into the extrusion tube 24 through the chemical solution supply line 26. The supply amount of the chemical solution can be adjusted by the valve 53.

The safety means includes a liquid leak detection sensor 58 (hereinafter, sensor 58) provided in front of the carrier 62, a sealing machine 57 provided behind the carrier, and a valve 56 arranged in the middle of the air recovery line 27. And each line 2
Valves 5 provided in the middle of 5, 26b, 26, 69
3, 54, 55, 66, 67 and the liquid leakage signal of the sensor 58 are received and the valves 53, 54, 55, 56,
66, 67, the lines 25, 26b, 26, 27,
A controller 59 is provided for instructing the closing of the fluid passages 68 and 69 and the closing of the passage of the tube 24 in which the sealing machine 57 is filled with the chemical solution. When the sensor 58 detects the leakage of the chemical solution, the valves 53, 54, 55, 56, 6
6, 67 are closed, and the passage of the tube 24 is blocked by the sealing machine 57, so that bacteria in the atmosphere can be prevented from entering the mold 22 and the pushing tube 24. In addition, the controller 59 can adjust the opening and closing of the fluid channels of the valves 53, 54, 55, 66, and 67 to adjust the supply amounts of the air and the chemical solution. The sensor 58 can be arranged not only in front of the transfer table 62 but at any position where liquid leakage can be detected.

As described above, the present invention provides the following (1) to (4)
Can be fully addressed. (1) Sterility of Raw Material Since the mold 22 is always maintained at 200 ° C. during operation, all bacteria are killed near the mold 22 even if the raw material inlet (hopper) is opened and the raw material is charged. At the start of the operation after the installation of the mold 22, the extruder 21 is connected to the mold 22.
The test operation is performed for a predetermined time until the temperature in the inside becomes 200 ° C. to kill the bacteria. (2) Sterility of chemical solution Distilled water heated to 80 ° C. and a solute are mixed in a distilled water tank 61 (distillation tower 61) in a chemical solution tank 52, and the mixture is extruded through a sterilization filter 63 and filled in a tube 24. As such, sterility can be maintained. (3) Sterility of injected air The air is pushed out from the air suction pumps 50 and 51 through the supply lines 25 and 26 b of the sterilized air, and the tube 24 is pushed out.
Continue to supply within. Air is sterilized filter 45, 46
Alternatively, sterility is maintained because the liquid is supplied through the heaters 48 and 49 (temperature about 200 ° C.). (4) Maintenance of sterility at the time of occurrence of an accident A liquid leak detection sensor 58 is arranged at a predetermined position, and when an abnormality of these sensors 58 is detected by the controller 59, all the valves 53, 54, 55, 56, sealing machine 57 can be closed to make all systems closed.

[0020]

Since the components of the medical bag are extruded and the process of manufacturing the medical bag having the final shape is performed, the inside of the medical bag and the liquid medicine filled therein do not come into contact with the outside air. Medical bags can be manufactured in a completely sterile and dust-free state. Since the liquid medicine is extruded from each component of the medical bag and filled in a sterilized state at the same time as molding, it is sanitary, the manufacturing process can be greatly simplified, and it is advantageous for mass production. The tube can be fused only by pressing the tube in a high temperature state, and can be sealed only by welding a passage having a much smaller area than the width of the tube, so that the power consumption is small and the economic effect is high. It is sanitary because the additives in the tube material do not remain on the inner surface of the tube. Since the mouth is welded to the extruded tube in a high temperature state at the high temperature, it can be easily attached to the bag body and can be firmly fixed. Further, the chemical solution can be discharged only by penetrating the bag (tube) with a needle, and there is no waste as in a conventional rubber stopper, so there is no risk of contaminating the inside of the main body and the chemical solution. In addition, since it can be manufactured separately from the main body, it is possible to adopt a mouth that matches the size of the medical needle according to the purpose of the infusion. Since the mouth is provided at a low position at the end of the bag (tube), the chemical solution therein can be discharged smoothly. The medical bag can be filled with a certain amount of a drug solution or a drug solution and air, and the injection amount of air can be adjusted as needed.

[Brief description of the drawings]

FIG. 1 is a schematic view of an apparatus for manufacturing a medical bag of the present invention.

FIG. 2 is a schematic view of a tube formed by the apparatus of FIG. 1 (an enlarged view of an arrow A in FIG. 1).

FIG. 3 is a view taken in the direction of arrow B in FIG. 2;

FIG. 4 is a schematic view of a step of filling the tube in FIG. 3 with a chemical solution.

FIG. 5 is a schematic view of a medical bag of the present invention.

FIG. 6 is a view showing a use state of the medical bag.

FIG. 7 is a schematic view of the vicinity of a tube carriage.

FIG. 8 is a schematic view of an apparatus for manufacturing a medical bag according to the present invention.

[Description of sign]

 1A, 41A Medical bag manufacturing equipment 1, 21 Extrusion molding machine 2, 22 Mold 3, 23 Molding equipment 3a Mouth supply device 3b Arm 4, 24 Tube 5, 6b, 25, 26b Aseptic air Supply line 5a, 6c, 26c Nozzle 6, 26 Chemical supply line 6a Nozzle 7, 27 Air recovery line 7a Nozzle 8 Roller 8a, 8c, 28d Drive shaft 8b, 8d, 28c Conveyor 8e, 62e Receiving stand Reference Signs List 9 fusion part 9a fusion part 9b secondary fusion part 10 passage 11 tube carrier 12 body 13 mouth 14 chemical solution 15 medical bag 41 pressing roller 44 transport member 45 sterilizing filter 46 sterilizing filter 47 removing Bacterial filter 48 Heater 49 Heater 50 Air suction pump 51 Air suction pump 52 Chemical tank 53 Valve 54 Lube 55 Valve 56 Valve 57 Sealing machine 58 Sensor 59 Controller 60 Chemical solution solute tank 61 Distilled water tank (distillation tower) 62 Conveyor 63 Disinfection filter 64 Mold holding mold 65 Dissolution tank 66 Valve 67 Valve 68 Air supply line 69 Chemical supply line

Claims (4)

(57) [Claims] 1. A method for manufacturing a medical bag, comprising the following steps: A step of extruding the constituent materials of the medical bag into a tube in a molten state, a step of welding a mouth having a bottom heated to a side surface of the tube , and pressing the side of the tube with a molding device in a direction perpendicular to the side surface of the tube. , Leaving a passage in the center in the width direction of the tube
The attachment portion is formed so as to be located above and below the mouth portion, and the fusion
When forming a part, a bag for storing the chemical solution in the vertical direction of the tube
Forming a package body , a supply line for a chemical solution extending into the tube into the tube.
Filling a drug solution from the in-nozzle, after welding the passage, the step of cutting the fused portion,
Or a step of cutting and simultaneously welding the passage, 2. A method for manufacturing a medical bag, comprising the following steps. A step of extruding the constituent materials of the medical bag into a tube in a molten state, a step of welding a mouth having a bottom heated to a side surface of the tube , and pressing the side of the tube with a molding device in a direction perpendicular to the side surface of the tube. , Leaving a passage in the center in the width direction of the tube
The attachment portion is formed so as to be located above and below the mouth portion, and the fusion
When forming a part, a bag for storing the chemical solution in the vertical direction of the tube
Forming a package body , a supply line for a chemical solution extending into the tube into the tube.
Filling a drug solution from the in-nozzle, and placing the tube in the cradle, the step of conveying horizontally by the conveying means placed higher than receiving table position, after welding the said passage, the fused portion Cutting,
Or a step of cutting the fused portion at the same time as welding the passage, 3. A method for manufacturing a medical bag, comprising the following steps: A step of extruding the constituent materials of the medical bag into a tube in a molten state, a step of welding a mouth having a bottom heated to a side surface of the tube , and pressing the side of the tube with a molding device in a direction perpendicular to the side surface of the tube. , Leaving a passage in the center in the width direction of the tube
The attachment portion is formed so as to be located above and below the mouth portion, and the fusion
When forming a part, a bag for storing the chemical solution in the vertical direction of the tube
Forming a package body , a supply line for a chemical solution extending into the tube into the tube.
A step of filling a chemical solution from the nozzle of the in, the tube is placed on a receiving table, and the aseptic air supply line extending to the inside of the tube while being horizontally transported by a transport means installed at a position higher than the receiving table. implanting sterile air into the tube from a horizontal position nozzle, after welding the passage, the step of cutting the fused portion,
Or a step of cutting the fused portion at the same time as welding the passage, 4. Inside the lower end of a bag body containing a chemical solution
The mouth is attached to the center and the fusion parts are formed on both sides of the bag body.
Towards the top and bottom of the and from the center in the vertical direction
Characterized in that it is a fusion part in the form of an inclined slope.
Medical treatment bag.