US 3570718 A
Description (OCR text may contain errors)
United States Patent Masahito Otsuka Tokyo-to, Japan Dec. 6, 1968 Mar. 16, 1971 Otsuka Pharmaceutical Company Limited Tokyo-to, Japan Apr. 11, 1968 Japan Inventor Appl. No. Filed Patented Assignee Priority CONTAINERS FOR DISPENSING PHYSIOLOGICAL SOLUTIONS 2 Claims, 8 Drawing Figs.
US. Cl. 222/88, 222/88, 215/100  Int. Cl B65d 23/10 Primary Examiner-David M. Bockenek Attorney-Larson, Taylor & Hinds ABSTRACT: A container for dispensing a physiological solution comprising a flexible ampoule member, a hanger provided on the top end wall of said ampoule member, a thin wall portion formed in said top end wall for permitting a syringe needle to pass through, said thin wall portion having a thickness of 0.2 to 0.4 mm., and a tubular projection provided in the bottom end portion of said ampoule member.
CGNTAINERS FOR DISPENSING PHYSIOLOGICAL SOLUTIONS This invention relates to a container for the dispensing of physiological solutions, particularly to an improved flexible container for the storage and dispensing of physiological solutions.
In the prior art a glass container was widely used to dispense physiological solutions, such as isotonic sodium chloride solution, Ringers solution, Lockes solution, glucose solution, blood, etc. For this purpose it has been proposed recently to utilize flexible containers made of polyethylene and the like materials having flexibility and transparency. Such flexible container has an advantage of being free of fragility of glass as compared with the glass container, but in practical use it has such drawbacks as illustrated below. In usual medical practice other medicinal solutions, such as vitamines, medicine for liver, cardiac stimulant, hemostatic, etc. are often added to the physiological solution contained and sealed in the flexible container by injecting the additional medicines through the wall of the container. In such case the needle is occasionally clogged with a scrap of the plastic material of the flexible container, making the accurate addition of the medicines diflicult, and even when the medicines are satisfactorily added into the container it is inevitable that such a scrap contaminates the physiological solution, rendering the solution spoilt.
Further it is a serious problem to provide a suitable fluid outlet from the flexible container, because the fluid in the container must be drawn out without any loss while sterile conditions are maintained. This has never been satisfactorily achieved.
A main object of the invention is accordingly to provide a flexible container which permits later addition of other medicines into the container by injecting them through the wall of the container without contamination by the scrap of the material of the container.
A further object of the invention is to provide a suitable outlet means from the flexible container.
The foregoing and other objects and advantages of the invention will become more apparent from a consideration of the detailed description which follows, taken together with the accompanying drawings. It is to be understood, however, that the drawings are for the purpose of illustration and description only, and are not intended as a definition of the limits of the invention.
FIG. 1 is a side view partly in section of a flexible container of the invention.
FIG. 2 is a bottom view of the container shown in FIG. 1.
FIG. 3 is a top view of the container shown in FIG. 1.
FIG. 43 is a fragmentary view illustrating a sealing portion of the container.
FIG. 5 is a fragmentary view illustrating a means for drawing out the solution from the container.
FIG. s is a longitudinal section of a drawing needle.
FIG. 7 is an enlarged view in section of the drawing needle shown in FIG. 6 along the line H.
FIG. 8 is a fragmentary view illustrating an aspetic air-hole means.
Referring to FIGS. I, 2 and 3 a flexible container embodying the principles of the invention is shown.
An ampoule member of oval section, indicated at 1, comprises a top end wall 2, bottom end wall 3 and graduated sidewall 4. These walls 2, 3 and 4 usually have a thickness ranging from 0.5 to 1.0 mm., preferably 0.7 to 1.0 mm. In the top end wall 2 is provided an aperature' 5, over which is mounted exteriorly of the ampoule member 1 a hollow projection 6 having a thin top wall 7 of a thickness ranging from 0.2 to 0.4 mm., preferably 0.25 to 0.35 mm. Further on the top wall 2 of the ampoule member is provided a hanger member 8 with an opening 9, which extends transversely to reinforce the ampoule member I. An aperture 10 is provided in the bottom end wall 3 over which a tubular extension 11 is mounted exteriorly of the ampoule member 1.
The flexible container of the above construction is made of polyethylene and the like materials having flexibility, transparancy and a property resistant to the heat to be applied externally in sterilizing a physiological solution. Particularly desirable material is high pressure process polyethylene. The container can be easily prepared by the conventional methods, such as blow moulding. According to the blow moulding, the hollow projection 6 can be formed integrally by providing a cavity in the mold to correspond to the projection 6, and the thin top wall '7 of the projection 6 can be easily formed integrally due to greater elongation of the portion than the other portions. The projection 6 can be formed in any desirable shape and size, but a tubular projection having a diameter of 2 to 10 mm. is preferable.
The container illustrated above is charged with a physiological solution through the tubular extension 11, and the end of the extension 11 is thereafter sealed airtight by a suitable means. In the invention it is preferable, as shown in FIG. 41, to close portion by heat sealing with a plastic cover plate 12 having a downward tubular projection 13, so as to keep the solution in the ampoule member I airtight.
- The solution sealed in the container is sterilized by applying a heat externally. Usually a temperature of 101 to 1 12 C. is applied.
When it is required in a hospital to add additional medicines such as vitamins, liver medicines, heart stimulant, hemostatic, etc. to the solution sealed in the ampoule member 1, such medicines are injected into the ampoule member I through the thin top wall 7 of the projection 6. As the thickness of the wall 7 is in the range of 0.2 to 0.4 mm., no scrap is made by the insertion of the needle irrespective of the type of the needle used, thus assuring easy and accurate addition of the additional medicines to the solution without blockade of the needle and contamination of the solution by the scrap. Further, such a thickness as 0.2 to 0.4 mm. is sufficient to give the mechanical strength required for this kind of the container. These facts were first confirmed as the results of numerous experiments by the present inventors.
In pratical use the container having been filled with a physiological solution is hung on a suitable hook inserted to the opening 9 of the hanger 8 provided at the top of the ampoule member 1. The solution is drawn out from the container by means of the drawing needle shown in FIGS. 5, 6 and 7. The drawing needle, indicated at 14, has a conic top portion 15 with a sharply pointed end 16, and an inner passageway 17 extends from the rear end of the needle 14 to the conic top portion 15, where it is branched to three openings 18. Each opening 18 is perforated in respective grooves 19 which are carved on the conic top portion 15 of the needle 14 and extend longitudinally from the vicinity of the pointed end 16 to the openings 18. Most preferably three openings may be formed in the needle 14 as illustrated in FIG. 8, but the number of the openings may vary, one, two or more than three. The conic top portion 15 is integrally joined with a middle portion 20 which is adapted to snugly fit the inside diameter of the downward tubular projection 13 of the cover plate 12 sealing the bottom end of the tubular extension 11 of the ampoule member I. The middle portion 20 is integrally joined with a rear portion 21 of a larger diameter which will be connected to a conventional drawing tube 31 with a flow meter, flow regulater and injection syringe (not shown). A flange 22 is provided on the rear portion 21 so as to facilitate the insertion of the drawing needle M.
To draw out the solution from the container, the drawing needle 14 previously sterilized is inserted through the tubular projection 13 and the cover plate 12 previously sterilized into the ampoule member 1 till the middle portion 20 becomes firmly engaged with the inner wall of the tubular projection 13 as shown in FIG. 5. The needle M has the sharply pointed end 16 and openings 18 perforated in respective grooves 19 ata short distance from the pointed end, so that no plastic scrap is produced and the solution in the container is drawn out without the blockade of the openings and the contamination of the solution by the scrap. Further as the middle portion 20 of theneedle I4 is firmly kept in engagement with the inner" wall of the tubular projection 13, the solution can be drawn out from the container without leakage and with a continuance of the sterile conditions.
In a preferred embodiment, to assure perfect engagement of the needle 14 with the tubular projection 13 and prevention of the leakage of the solution, annular projections 23 may be provided on the inside surface of said projection. Further, by inserting elastrneric plug such as rubber plug in the tubular projection 13 more secure result will be obtained, and when the needle is drawn out after use, the plug will block the hole made in it due to elasticity thereof and automatically stop further dripping of the solution from the container.
To prevent the entry of germs in the air through the hole which is made in the later addition of medicines on the thin top wall 7 of the hollow projection 6, a needle 24 with a holder 25 having a sterilized filter 26 can be inserted as shown in FIG. 8, to let the air in through the filter, which greatly satisfies aseptic requirements in drip injection.
The above method can be applied also when no later addition of medicines is done and the hole is not made in the thin top wall 7. In this way, the deformation of the container can be prevented when drawing out the solution in the container. That is, when there is no air hole the pressure in the container will decrease by drawing the contents out, thereby giving deformation of the container as the liquid is drawn out. This is an advantage of the flexible container, but by the deformation no longer permits accurate reading of the contents. On the other hand, by providing the above air-hole means the contents can be drawn out aseptically without deformation of the container.
A hollow 27 provided in hanger 8 is intended for receiving the injection needle (not shown) to make the container handy to carry with the injection needle.
Instead of forming the container in an oval section, it may also be round in section.
1. A container for dispensing a physiological solution comprising a flexible ampoule member, a hanger provided on the top end wall of said ampoule member, a thin wall portion formed in said top end wall for permitting a syringe needle to pass through, said thin wall portion having a thickness of 0.2 to 0.4 mm., and a tubular projection provided in the bottom end portion of said ampoule member, said ampoule member being sealed airgight by means of a cover plate having a downward tubular projection.
2. In combination, a container for dispensing a physiological solution comprising a flexible ampoule member, a hanger provided on the top end wall of said ampoule member, a thin wall portion formed in said top end wall for permitting a syringe needle to pass through, said thin wall portion having a thickness of 0.2 to 0.4 mm., a tubular projection provided in the bottom end portion of said ampoule member, and a cover plate having a downward tubular projection for sealing said ampoule member airtight, and a drawing needle comprising a conic top portion having a sharply pointed end, a middle portion to be snugly fitted into said tubular projection of the cover plate to seal the bottom end of the tubular projection of the ampoule member, a rear portion to be connected to a drawing tube, and an inner passageway penetrated from said rear end portion to said conic top portion proximate to said pointed end and communicated with at least one opening formed in the sidewall of said conic top portion.