JPS6137951B2 - - Google Patents

Description

[Detailed description of the invention]

The present invention relates to a container with a scale, and more particularly to a container with a scale for measuring the amount of liquid discharged and/or the amount of remaining liquid, such as a soft plastic infusion bag containing liquid excluding gas such as air. Conventionally, infusion solutions are commercially available filled in vials, blow-molded bottles made of polypropylene, and bags made of soft polyvinyl chloride. In vials and blow-molded bottles, the internal and external pressures of the bottle reached an equilibrium state due to the outflow of the liquid content, and the outflow of the liquid content stopped, and it was necessary to supply outside air into the bottle with a ventilation needle etc. in order to allow the liquid to flow out again. . In contrast, flexible polyvinyl chloride bags do not require the supply of air into the bag and therefore do not require a ventilation needle.
Therefore, there is no opportunity for outside air from the bedside to flow into the infusion system, and there is an advantage that the liquid content can be used without being contaminated. Furthermore, the flexible bag allows pressurized infusion and rapid axial infusion simply by grasping it from the outside by hand or applying pressure with a clot, which is particularly advantageous in emergency infusions and continuous intra-arterial infusions. However, the bag contains approximately 50ml.
A horizontal interface between the liquid content and the air is created within the bag, and the amount of liquid to be discharged can be confirmed from the scale line attached to the bag and the interface. Therefore, there was a risk that the air present in the bag could be inadvertently injected into the body, causing an air blockage and causing fatal injury. Furthermore, when a connecting tube is connected to the bag, the infusion agent in the bag on the side through which the infusion set is inserted first runs out, and then the infusion agent in the second bag is injected into the body with residual air mixed in. There was an air blockage problem as mentioned above. Furthermore, since air is present in the bag, when the liquid inside the bag is shaken during transport, the plasticizer contained in the polyvinyl chloride,
For example, diethylhexyl phthalate (Di-
Ethyl Hexyl Phthalate (hereinafter abbreviated as DEHP) leaks into the content liquid and forms fine liquid particles (liquid particles).
The problem of floating in the liquid as particles) has been pointed out. It has also been reported that the number tends to increase from tens to hundreds of times when the bag is shaken vigorously compared to when the bag is left standing. The purpose of the present invention is to solve these drawbacks and problems, and to provide a graduated container which solves the difficulty in measuring liquid volume caused by removing gas such as air from a soft plastic container. It is about providing. That is, the present invention includes a liquid storage section made of transparent soft plastic that forms a flat surface when the content liquid is discharged and has a reference line extending vertically on the flat surface, and a hanging section and a hanging section at the upper end of the storage section. When the storage part of the container is provided with a liquid discharge port at the lower end and the liquid is discharged from the state where the liquid is stored, the flat surface part that is formed in close contact from above and the remaining liquid remain below depending on the amount of remaining liquid. This is a container with a scale, characterized in that the container is divided into a curved surface portion, and a scale is provided at a point where the dividing line intersects with the reference line as the amount of discharged liquid and/or the amount of remaining liquid. Hereinafter, the present invention will be explained based on illustrated embodiments. FIG. 1 shows a container according to the present invention with a portion cut away for convenience before being calibrated, and is used to store medicinal solutions such as physiological saline, high-calorie infusions, perfusate, dialysate, or other injection solutions. a liquid storage section 1;
It is provided protrudingly on one periphery and consists of a mouth part 2 for taking in and taking out a medical solution, and a hanging part 19 for suspending the liquid storage part 1. The liquid storage part 1 is made by stacking two sheets 3 made of soft plastic such as vinyl chloride resin, and the peripheral edge 4 is sealed by high frequency welding, heat sealing, etc. to make it liquid-tight except for the introduction part of the mouth part 2. It is made into a shape. Examples of soft plastics used for the liquid storage section 1 include the above-mentioned soft vinyl chloride resin,
Materials that are relatively soft at room temperature, such as polyethylene, polypropylene, ethylene-vinyl acetate copolymer, polyurethane, ionomer (for example, trade name Surlyn), and nylon, can be used as appropriate. These materials are formed into sheets or tubes,
Further, by heat sealing and high frequency welding these, the flat liquid storage section 1 is obtained. In order to improve the reproducibility of the flat shape after the liquid content is discharged, the liquid storage portion 1 is preferably made of two sheets stacked one on top of the other and their peripheral edges 4 bonded together as shown in FIG. A laminate film of nylon and polyethylene can also be used for this purpose. In addition, examples of transparent soft plastics when it is necessary to heat sterilize the contents together with the liquid storage part 1 such as high-pressure steam sterilization include the above-mentioned soft vinyl chloride resin, polyurethane, polypropylene, and molded into the liquid storage part 1. There is an ethylene-vinyl acetate copolymer that is crosslinked with radiation such as electron beams to impart heat resistance. The liquid storage portion 1 is preferably made of a transparent material when it is necessary to visually inspect the liquid contained therein. A part of the peripheral part (high frequency welding part, heat seal part) 4 of the liquid storage part 1 has one end of a cylinder 5 made of hard vinyl chloride resin with openings at both ends between the pair of transparent soft plastic sheets 3. They are held together and heat-sealed using high frequency welding. A large diameter portion 6 with an enlarged inner diameter is provided at the other end of the cylinder 5.
A collar 7 extending outward is formed at the tip. As clearly shown in FIG. 2, a dish-shaped sealing member 8 is fitted onto the upper surface of the cylindrical body 5 and is shaped to fit into the large diameter portion 6 and the collar 7, respectively. This dish-shaped sealing member 8 is made of a soft plastic material such as soft vinyl chloride resin, and a central portion 10 that matches the liquid flow portion 9 of the cylinder 5 can be easily penetrated with a pin needle (not shown). It is thin because of its thickness. As clearly shown in FIG.
A rubber stopper 12 having a hole therein is inserted therein.
The upper surface 13 of the inner part of the annular groove 11 of this plug 12
protrudes from the outer portion 14 of the annular groove 11,
A plurality of recesses 15 are provided to indicate the portions to be penetrated by the bottle needle during injection solution supply or mixed injection. A ring-shaped plug holding member 16 is further provided on the lower surface of the peripheral edge of the plug 12, and the plug 12 is crimped and fixed in the direction of the sealing member 8 so as to be fluid-tight to the collar 7 of the cylinder 5. It is welded. That is, the plug holding member 16 is made of hard plastic such as hard vinyl chloride, and has a collar portion 1 on its outer periphery.
7, and an annular protrusion 18 having a wedge-shaped cross section that fits into the annular groove 11 of the rubber plug body 12 is provided on the inner peripheral edge to protrude upward. By fitting into the annular groove 11, the annular protrusion 16 connects the outer portion 14 of the plug 12 to the sealing member 8.
In this state, the flange 15 and the flange 7 of the cylindrical body 5 are welded together via the peripheral edge of the sealing member 8 in a liquid-tight manner. There are no particular restrictions on the welding method in this case, but heat sealing using high frequency ultrasonic waves or the like is usually used. According to the mouth part having the above-described structure, since the sealing member 8 is present on the lower surface of the rubber stopper body 12, there is no risk of contact with the medicinal liquid in the container body 1, and therefore the rubber There is no risk of elution of quality components. Furthermore, even if the pin needle is pierced and removed,
There is no risk that the peripheral edge of the rubber plug body 12 will be distorted and the chemical solution will leak around the rubber plug body.
However, this is because this peripheral portion is firmly held by the annular projection 18 of the stopper holding member 14 and the hard plastic material of the large diameter portion 6 of the cylinder 5. In addition, since the cylindrical body 5 at the mouth is made of hard plastic, it can be used in addition to plastic bottle needles.
Even when a metal bottle needle is used, there is no risk of accidentally penetrating it to the outside of the mouth, and the tip of the mouth has an overall large shape due to the large diameter part 6 or the brim of the cylinder. This makes it extremely easy to handle when piercing the bottle with a needle. The mouth part 2 is integrally molded to prevent contact between the rubber stopper 12 and the drug solution in the container body 1, and to serve as a welding medium between the stopper holding member 16 and the collar 7 of the cylinder body 5. Although an example has been described in which a dish-shaped sealing member is used, this is not necessarily the case. Alternatively, sealing may be performed without intervening. Further, the sealing between the plug holding member 16 and the large diameter portion 6 of the cylinder 5 is performed using a flange 7 provided on the large diameter portion 6.
Although an example has been described in which bonding is performed via the flange 7, it may also be possible to bond directly to the large diameter portion 6 without specifically providing such a flange 7. As examples of hard plastics used for the cylinder body 5 and the plug holding member 16, in addition to the above-mentioned hard vinyl chloride resin, relatively hard materials that can withstand heat sterilization such as polyethylene, polycarbonate, and polypropylene can be used as appropriate. In addition to the above-mentioned soft vinyl chloride resin, polyethylene, polyester resin, urethane resin, discontinuous pore elastic plastic foam, etc. are appropriately used as the soft plastic used as the sealing member provided on the bottom surface of the plug body 12. It is possible. As the rubber material used for the stopper 12, any known rubber stopper used as a conventional rubber stopper for penetrating a bottle needle may be used as appropriate. Furthermore, there is naturally no limit to the number of openings that can be attached to the liquid storage section 1. On the opposite side of the mouth portion 2, that is, at the upper end of the liquid storage portion 1, a substantially triangular hole is provided as a hanging portion 19 of the liquid storage portion 1, and is made of the same material as the liquid storage portion 1. This hanging portion 19 can be provided at the same time when the peripheral edge 4 of the soft plastic sheet 3 is high-frequency welded and heat-sealed. This hanging part 19
is not particularly limited, whether it is a hole or a protrusion as described above, as long as it has a shape that allows the liquid storage section 1 to be suspended. Further, although the material thereof does not necessarily have to be the same as that of the liquid storage section 1, it is preferable to use the same material in terms of the number of workpieces since it can be integrally molded. Alternatively, the mouth portion 2 may be a tube with a closure means such as a protected syringe needle at one end. Next, a method of marking the scale on the liquid storage section 1 will be explained. As shown in FIG. 3, from the hanging part 19 to the opening part 2
4, draw the center lines 21 so that they overlap, and pour purified water 22 into the liquid storage part 1 as shown in FIG.
Inject 100ml (or 100g) each time, suspend the container from the hanging part 19, and connect the contact point 23 at the lower end of the overlapping and vertically extending center line 21 of the front and back surfaces of the flat surface 20. A line was drawn at right angles to the center line 21 to form a scale 24. That is, it is divided into a flat surface portion 25 that is formed in close contact with each other from above and a curved surface portion 26 that is formed downward depending on the amount of liquid inside, and the point where the dividing line 27 intersects with the surface center line 21 is the contact point 23. That is. Injection of this purified water 22 is 500ml per container.
(or 500g). Then, calculate the distance from the top of the liquid storage section 1 to each scale 24.
Measurements were made for 10 containers, and the average value was used as a scale indicating 100 to 500 ml for the graduated container of the present invention. Regarding this method of marking the scale, it is possible to first inject 500 ml of purified water and measure the contact points every time 100 ml is discharged as described above. In fact, as shown in FIG. 5, two perpendicular lines are drawn in parallel on the surface of the flat surface 20 of the liquid storage section 1 at 5 mm left and right from the center of the flat surface to serve as reference lines 28, 28. A 1 to 4 scale 29 was drawn perpendicularly to the reference lines 28, 28 using the average value.
Further, on the back side of the flat surface 20 of the liquid storage section 1, two perpendicular lines corresponding to the front side are similarly drawn, and the space between them is filled in black to form a belt-shaped reference line 30, thereby obtaining a graduated container. These reference lines and scales may be made of colors other than black, or may be made using color shading, tone, or complementary colors to directly measure the liquid volume from the overlap or deviation of curves, broken lines, and patterns. good. Therefore, one of the matching lines may be transparent, and the other portions may be colored. In the above description, the flat surface 2 of the liquid storage section 1 is described as a preferable example.
Although an example has been described in which a verification line is also provided on the back side of 0, the verification line on the back side does not necessarily need to be provided. Furthermore, when the reference line is a large number of vertical lines, the liquid amount can be measured with high accuracy by utilizing the refraction of the liquid. When filling this container with a scale with a chemical solution, etc., the container with a scale shown in FIG. This can be easily achieved by filling the liquid storage portion 1 with the liquid, inserting the liquid so as not to form a space above the mouth portion, and adhering the liquid by the above-described means. In addition, when using a graduated container filled with a medicinal solution, the hanging part 19 of the container is hung on a girdle stand as shown in FIG. is filled with a drug solution, an intravenous needle (not shown) is inserted into the patient's vein, and infusion is started. As the medicinal solution is gradually discharged from the container and injected, the liquid storage portion 1 forms a flat surface portion 25 from above, and a curved surface portion 26 below becomes smaller. The amount of liquid can be determined by reading the position of a dividing line 27 formed by the black belt-like reference line on the back side touching the area between the two reference lines on the front surface of the liquid storage part 1 using the scale 29. I can do it. This scale is 100ml from the top to the first scale, 2 scales from 1 to 2, 3 scales from 2 to 3, 4 scales from 3 to 4, and 4 scales below the 4th scale. By setting the scale to 5, the amount of liquid discharged can be known, and by adding a reverse scale, the amount of remaining liquid can be read.
Each of these scales has an expected value of 100ml. In addition, since the liquid storage portion 1 of this graduated container is made of soft plastic, the contents can be discharged by gravity, no ventilation needle is required, and there is no bacterial contamination caused by outside air. In addition, pressurized infusion and rapid infusion can be performed simply by grasping the liquid storage part from the outside or pressurizing it with a cuff, which is convenient for emergency infusion or continuous intra-arterial infusion. There is no fear of In addition, even if a plurality of graduated containers are connected by a connecting tube, no air is contained, so the container containing the infusion set is emptied of its contents one by one, and there is no risk of air being introduced into the body. Furthermore, since air is removed from the graduated container of the present invention, the liquid contained therein is less likely to vibrate, and there is no fear that fine particles contained in the material of the liquid storage section will elute. In addition, when the reference line is misaligned between the front and back sides, the error can be reduced by aligning the reference line in advance and measuring, and since the reading position is on the reference line, Individual errors due to reading are small. Therefore, since this verification line indicates the reading position as described above, it may be a broken line instead of a solid line as described above. Further, depending on the shape of the dividing line, even if the collation line is a curved line extending from the top to the bottom in the shape of a square, for example, this will not impede the effects of the present invention in any way. Furthermore, the hanging part 19 is made hard and the liquid storage part 1
The distortion may be eliminated. Next, we compared the scaled container of the present invention with a soft polyvinyl chloride resin bag (hereinafter referred to as PVC bag) containing an infusion solution made by Terumo Corporation, which has the same shape and the same material as a comparative example, and examined the accuracy and precision of the scale. A comparative study was conducted. [Measurement method] Measurements were performed in pairs, with one person standing 1.5m above the floor.
The liquid flowing out from the container hung on the garter stand was read every 100 ml using the scale on the container, and while one other person was out of sight, the liquid flowed into the measuring cylinder through the infusion set connected to the container. The amount of liquid contained in the container was measured. A total of 10 containers, including 5 PVC bags and 5 graduated containers of the present invention, were measured once by 5 groups of people, and the accuracy and precision of the 2nd, 3rd, and 4th scale amounts of both containers were determined. Comparisons were tested using analysis of variance. The 1st and 5th scale amounts were excluded from the measurement because of PVC.
Regarding BATSUGU, according to the Japanese Pharmacy's General Regulations for Preparations "Injections"
contains about 2 v/vo/o excess of liquid per 500 ml, while for the graduated containers of the present invention it is
This is because the amounts of liquid contained in each scale are different, so it is not possible to simply compare the amounts of each scale. Table 1 shows the results of a variance analysis conducted to compare the accuracy of each scale amount between this PVC bag and the graduated container of the present invention.

【table】

[Table] As a result, individual differences A and
No difference C was observed between the PVC bag and the graduated container of the present invention. In addition, the average value of the 2nd, 3rd, and 4th scale volume of the PVC bag is 102.65ml, and the scaled container of the present invention is 101.04ml.
The latter value was close to the expected value of 100ml. On the other hand, a significant difference was observed in the 2nd, 3rd, and 4th scale amounts. The confidence limits for the population mean of these scale quantities are
105.36±2.02ml, 102.04±2.02ml, 98.14±2.02ml
However, there is no problem in using it for infusion. Next, in order to examine the precision of the scale amount, Table 2 shows the results of a variance analysis performed using the standard deviation of the measured values as the value of the precision of the scale amount.

[Table] As a result, no significant difference was observed between the two containers regarding the precision of the scale amount. For these reasons, the graduated container of the present invention has almost the same accuracy as a conventional pneumatic container, and can be used clinically.

[Brief explanation of the drawing]

FIG. 1 is a partially cutaway front view of a container before a scale according to the present invention is attached, and FIG. 2 is an exploded perspective view of the opening of the container shown in FIG. 1. FIG. 3 is a partially cutaway front view showing how the scale is applied to the container according to the present invention, and FIG. 4 is a perspective view thereof. FIG. 5 is a partially cutaway front view showing an embodiment of the graduated container according to the present invention. FIG. 6 is a perspective view showing an example of use of the graduated container according to the present invention. DESCRIPTION OF SYMBOLS 1...liquid storage part, 2...mouth part, 3...soft plastic sheet, 4...peripheral part, 5...cylindrical body, 6...large diameter part, 7...brim, 8...sealing member, 9...liquid distribution part,
10... Central portion, 11... Annular groove, 12... Plug body, 1
3... lower surface, 14... outer part, 15... recess, 16...
Plug body holding member, 17... collar portion, 18... annular projection,
19... Hanging part, 20... Flat surface, 21... Center line, 2
2...Purified water, 23...Contact, 24...Scale, 25...Flat surface portion, 26...Curved surface portion, 27...Parting line, 28
...Verification line, 29...Scale, 30...Verification line, 31...Infusion set.

Claims (1)

[Scope of Claims] 1. A transparent soft plastic liquid storage part that forms a flat surface when the content liquid is discharged and has a reference line extending vertically on the flat surface, and a liquid storage part that is suspended from the upper end of the storage part. When the storage part of the container is provided with a liquid discharge port at the lower part and the lower end of the container, when the liquid is discharged from the state where the liquid is stored, a flat surface part that is formed in close contact from above and a lower part according to the amount of remaining liquid are formed. 1. A container with scales, characterized in that the container is divided into a curved surface portion remaining on the surface, and a scale is provided at a point where the dividing line intersects with the reference line as the amount of discharged liquid and/or the amount of remaining liquid. 2. The scaled container according to claim 1, wherein the reference lines are provided on both sides of the flat surface so as to overlap with each other. 3. The graduated container according to claim 1, wherein the reference line is a straight line extending in the vertical direction. 4. The graduated container according to claim 2, wherein one of the reference lines is two parallel lines and the other has a thickness equal to the distance between the parallel lines. 5 Claim 1 in which the matching line is a pattern
Container with scale as described in section. 6. The graduated container according to claim 2, wherein the colors of the reference lines are complementary to each other.