JPS6219868B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a flexible container for liquid medicine having a filling and dispensing port and a reinforced handle.

Medical solutions for perfusion purposes or intravenous administration are generally stored in glass bottles and then dispensed. The bottles are filled, a special seal is applied, and the filled and sealed bottles are then sterilized. The closure generally consists of a hole for sealing the mouth of the bottle, the hole including a pierceable septum which can later be pierced for entry into the bottle. At the point of use, the protective portion of the closure is removed and the dosing set is applied to the bottle by puncturing the septum in the closure using a sharp cannula. This leads to fluid inside the bottle, which is then administered to the patient through a tube attached to the cannula. In order for the liquid to flow out of the bottle, air must be introduced into the bottle, and this is done through an air filter built into the cannula.
Or it can be done by an air inlet in the enclosure. Potentially, this could result in contamination of the liquid inside the bottle through the air filter or air inlet and is therefore described in patent no. It is desirable to dispense such fluids from plastic containers as illustrated. During administration of the liquid, such flexible containers lose their shape due to atmospheric pressure, so it is not necessary to introduce air into the container. As a result, potential sources of contamination can be eliminated or minimized. However, these flexible containers are difficult to fill and seal, and their flexibility causes them to warp when placed on a hospital hanger, making it difficult to determine the amount of fluid being administered to a patient. It is difficult to read the meniscus (the line that indicates the level of remaining liquid in the container) needed to

In accordance with the present invention, there is provided a lower end sealed wrapper 18 forming the upper part of an enclosure formed by a pair of facing plastic sheets 12, 13 sealed around their peripheries; card 1
7. A flap 19 formed by sealing together two sheets or plastic tubes projecting upwardly from the wrapper 18; a suspension opening 20 in the flap 19; Reinforced rib 2 provided at the lower end sealing part of
2, 21 and has the function of preventing distortion of the bag container portion 11 when it is filled with a medical liquid; A medical solution bag container portion 11 located below the lower end sealing portion of the reinforced handle portion 16; (c) A sheet disposed at the lower end of the bag container portion 11, and (i) a sheet facing the bag container portion 11; 1
2, 13 and sealed to the bag container part 11 so as to communicate with the interior of the bag container part 11 and having open ends 27, 28; (ii) a tubular section 3 in a passageway formed by a tubular portion 26 of the fill port section 25;
1 to provide a passageway 32 with a diameter smaller than the diameter of said passageway in the tubular portion 26 and with an open end 33 at the lower end of the passageway 32 and a hole in the upper end of the passageway 32. an annular flange 3 having a diaphragm 35 formed therein and coextensive with the flange 29 of the filling port portion 25;
(d) a removable stopper 37 for sealing the filling and drug application port 24; A container for liquid is provided. Note that the numbers in the above correspond to the symbols in the accompanying drawings.

The flexible container for medical fluids of the present invention has a filling and dispensing port portion, which comprises a filling port portion and a drug dispensing port portion (consisting of a passageway formed by inserting a sealing tubular section into a tubular portion of the filling port portion). Because it has a drug administration port,
The container can be filled through the first part (i.e. the filling spout part) of this filling and dosing spout, and the second part (i.e. the tubular section for forming the dosing spout part) is then inserted into the filling spout part. inserted into the tubular section.

The containers of the present invention also include reinforced hanger portions so that when suspending the filled container from a hospital pole,
It produces a sharp meniscus and improves reading the level of liquid in the container. The reinforced handle portion comprises a card encased in a sheet forming the handle portion of the container and a reinforcing rib placed across the axis of the container on the handle portion, and further includes a flap and an opening. Be prepared.

The invention is best understood from the following description, taken in conjunction with the accompanying drawings.

FIG. 1 is a front elevational view of a flexible sectional container of the present invention; FIG. 2 is an elevational view of a reinforcing card inserted into the reinforcing handle portion of the container; FIG. 4 is a side elevational view of the container of FIG. 1 filled with liquid; FIG. 4 is a cross-sectional view of an additional inlet/outlet of the container of FIG. Yes; FIG. 5 is a cross-sectional view of the filling and dispensing port of the container of FIG. 1; FIG. 6 is an elevational view of the container as viewed along line 6--6 of FIG. .

Referring to the drawings, FIG. 1 illustrates a flexible configurable container 10 of the present invention suitable for pharmaceutical liquids. container 1
0 includes a sealed flexible bag container portion 11 made of a chemically inert plastic material such as polyvinyl chloride. The bag container portion 11 is the container 10
1 sealed along the perimeter 14 to form a
Plastic sheets 12 and 13 facing each other
It consists of A reinforced handle portion 16 is formed upwardly from one end 15 of the bag container portion 11. The reinforced handle portion 16 includes a hard reinforced card 17 encased in a envelope 18 formed by two plastic sheets 12, 13 when sealed together. Extending from the envelope 18 is a flap 19 formed by sealing two sheets or protruding plastic tubes together and having an opening 20 therein for hanging the container 10 in use. During the sealing process reinforcing ribs 21, 22 are formed to provide additional stiffness to the handle portion 16. Reinforcement card 17 placed in the handle portion 16 of the container 10
strengthens the handle portion 16. Flexible containers tend to stretch and buckle when suspended for use, making it difficult to measure the level of liquid in the container. When suspending the container 10 from a hospital post, the reinforced hanging portion 16 acts to prevent distortion of the bag container portion 11, thus creating a sharp meniscus and improving calibration and fluid level reading. be done. Of course, the opening 20 in the flap 19 can be of various shapes.

Depending on the intended end use for the container 10, whether for perfusion of fluids or intravenous fluids, one or more additional ports may be incorporated into the bag container portion 11. I can do it. As illustrated, a filling and dispensing port 24 is provided at the end 23 of the bag container portion 11 opposite the handle portion 16. Additional entrances and exits 45 may also be provided. The filling and dispensing port 24 has open ends 27 and 2
8, the filling port portion 25 is formed by a semi-rigid tubular portion 26 having a
It extends into the bag container part 11 so as to communicate with the interior of the bag container part 11 . End 2 of filling port portion 26
An annular flange 29 extends from 8. The fill opening portion 25 is sealed in place during assembly of the bag container portion 11. The tubular portion 26 of the filling port portion 25 is
It is placed in place between the two plastic sheets 12, 13 forming the side walls of the bag container part 11. As the peripheries of the facing sheets 12, 13 are sealed together, the fill opening portion 25 is sealed in place, which provides passage into the interior of the bag container portion 11 for filling purposes. give.

After filling the bag container part 11 with liquid through the fill opening part 25, a sealing tubular section 31 forming a dosing opening part 30 is inserted into the filling opening part 25 and sealed thereto. The application port portion 30 includes a tubular section 31 through which a passageway 32 having an open end 33 communicates.
The other end 34 of the passageway 32 is sealed by a diaphragm 35 that can be perforated. Extending from the open end 33 of the dispensing port portion 30 is an annular flange 36 adapted to mate with the flange 29 of the fill port portion 25 . The application port portion 30 is sealed by a stopper 37 . The plug body 37 has an annular cover flange 3 extending therefrom together with the flange 29 of the filling port portion and the flange 36 of the application port portion.
9 and includes a knob 40 extending therefrom. A ring-shaped weakened portion 41 is formed in the pivot 37 to facilitate removal. Filling port portion 25, dispensing port portion 30 and plug 37 are sealed together along their flanges after assembly. When the container 10 is used for a liquid to which no drug is to be added, the filling/medication port 24 is sufficient and there is no need to add any other ports.

The additional inlet/outlet 45 is placed in one of the plastic sheets 12, 13 forming the side walls and is sealed thereto, consisting of a tubular section 46 having an open end 47 and a closed end 48 and into which a passageway 49 opens. Closed end 48 is spaced apart from open end 47;
A septum 50 is formed which can be pierced to facilitate insertion of a needle or cannula into the bag container portion 11. A plastic stopper 51 is placed over the tubular section 46 and comprises a tubular section 52 formed by a side wall 53 and a distal wall 54 from which an annular flange 55 extends. End wall 54 includes a thinned portion 56 to facilitate opening of plug 51. Knob base 57
extends from the end wall 54 and a knob 5 extends therefrom.
Contains 8. Sheets 12 and 13 block the flow,
The flange 55 of the closure 51 is sealed directly to one of the sheets 12, 13 of the bag container part 11 so as to form a further pierceable septum. As can be seen, because the septum 50 that allows the drilling of the additional port 45 is spaced from the open end 47, the additional port 45 requires drilling with a long hypodermic needle; The possibility of puncturing the opposite wall of the container 10 is minimized. Additionally, once sterilized, the plug 51 remains sterile so that there is no need to clean the pierceable septum 50 with a disinfectant during use.

Container 10 can be assembled to form bag container portion 11 from two sheets of plastic that are sealed together (preferably by heat sealing). Before sealing the peripheries of the facing sheets 12, 13 to form the bag container portion 11, the tubular portion 26 of the fill opening portion 25 is placed between the two plastic sheets in place and sealed as described above. do. Remove the excess plastic sheet from the sides of the bag container part 11, if the bag container part 11 is intended for use in the case of intravenous fluids or other fluids that may require the addition of drugs. Then, the application opening portion 30 is sealed to the plastic sheets 12 and 13 forming the side walls of the container 10.
A suitable liquid is then added to the bag container section 11 through the filling port section 25, after which the tubular section 31 to form the dosing port section 30 is inserted and sealed in place.

In use, the stopper 37 of the dispensing port portion 30 is removed and the sharp cannula of the dispensing set is inserted into it, puncturing the septum 35, thereby allowing liquid to pass through the tubing of the dispensing set (not shown). Bag container portion 1 to allow flow from container 10 to the patient.
Provide a passage to the inside of 1. As the liquid is administered, the bag container portion 11 of the container 10 due to atmospheric pressure
loses its shape. Therefore, no ventilation is required, thereby minimizing the possibility of contamination. Similarly,
The reinforced handle portion 16, and in particular the card placed therein, prevents the container 10 from distorting so that the meniscus formed by the liquid can be easily read and the amount of liquid being administered to the patient easily determined. and can be determined accurately.

As previously mentioned, if container 10 is to be used for the storage and administration of intravenous fluids that may require the addition of additional drugs,
Sheet 1 constituting the flexible bag container portion 11
2, 13 can be provided with an additional entrance/exit 45. If it is necessary to add drug to the liquid in container 10, additional access port 45 can be opened by grasping tab 58 and applying pressure, thereby breaking the thin section of cover 51 and exposing septum 50.
cover 51 can be opened. A diaphragm 50 that can be pierced as illustrated in FIG.
Insert the needle of a syringe or additional vial through and transfer the drug in the syringe or vial into bag container portion 11 .

[Brief explanation of the drawing]

FIG. 1 is a front elevational view of a flexible sectional container of the present invention; FIG. 2 is an elevational view of a reinforcing card inserted into the handle portion of the container; FIG.
4 is a side elevational view of the container of FIG. 1 filled with a liquid; FIG. 4 is a side elevational view of the container of FIG.
FIG. 5 is a cross-sectional view of an additional port for the container of FIG. 1; FIG. 5 is a cross-sectional view of the fill and dispense port for the container of FIG. 1; FIG. FIG. 3 is an elevational view of the container as seen along; 10...Flexible assembly type container, 11...Bag container part, 12, 13...Plastic sheet, 14
...Periphery, 16...Reinforcement hand part, 17...Reinforcement card, 18...Wrap, 19...Flap, 20
... Opening, 21, 22 ... Reinforcement rib, 24 ... Filling and drug application port, 25 ... Filling port part, 26 ... Tubular part, 27, 28 ... Open end, 29 ... Flange, 30 ... Medication opening portion, 31...Tubular section, 3
2... Passageway, 33... Open end, 35... Diaphragm,
36...Flange, 37...Plug body, 39...Flange, 40...Knob, 45...Additional entrance/exit,
46... tubular section, 47... open end, 48...
Sealed end, 50... diaphragm, 51... plug body, 52...
... Tubular section, 55 ... Flange, 57 ... Knob base, 58 ... Knob.

Claims (1)

[Scope of Claims] 1 (a) A lower-end sealed package 1 constituting the upper part of an enclosure formed by sealing a pair of plastic sheets 12 and 13 facing each other along their peripheries.
8. A reinforcing card 17 placed in this package, a flap 19 formed by sealing together two sheets or plastic tubes protruding upward from the package 18, and a suspension provided within the flap 19. opening 20 and flap 19
A reinforced handle portion 16 is comprised of reinforcing ribs 22 and 21 provided at the inner and lower end sealing portions of the package 18, and has the function of preventing distortion of the bag container portion 11 described below when the bag container portion 11 is filled with medical fluid. (b) a bag container portion 11 for medical liquid that constitutes the lower part of the enclosure and is located below the lower end sealing portion of the reinforced handle portion 16; (c) a bag container portion 11 that is disposed at the lower end of the bag container portion 11; , (i) Sheet 1 facing the bag container part 11
2, 13 and sealed to the bag container part 11 so as to communicate with the interior of the bag container part 11 and having open ends 27, 28; (ii) a tubular section 3 in a passageway formed by a tubular portion 26 of the fill port section 25;
1 to provide a passageway 32 with a diameter smaller than the diameter of said passageway in the tubular portion 26 and with an open end 33 at the lower end of the passageway 32 and a hole in the upper end of the passageway 32. an annular flange 3 having a diaphragm 35 formed therein and coextensive with the flange 29 of the filling port portion 25;
(d) a removable stopper 37 for sealing the filling and drug application port 24; Container for liquid.