GB2214486A

GB2214486A - Container

Info

Publication number: GB2214486A
Application number: GB8801242A
Authority: GB
Inventors: John David Yair
Original assignee: Individual
Current assignee: Individual
Priority date: 1988-01-20
Filing date: 1988-01-20
Publication date: 1989-09-06
Also published as: ZA89393B; IE890155L; GB8801242D0

Abstract

Container for liquid drugs or other substances to be adminstered by hypodermic injection includes a sealed flexible bag (12) e.g. of sheet plastics material forming a reservoir enabling any quantity or quantities of the substance to be withdrawn by suction without admitting air. The container includes a rigid mouth portion (10) bonded to the bag and defining an opening sealed by a rubber or elastomeric diaphragm (14) which can be pierced by the needle for withdrawal of the substance, and a protective cage (18) may be provided within the reservoir to prevent accidental piercing of the bag by the needle. The bag may be located in an outer box (20). <IMAGE>

Description

CONTINEF? This invention relates to vials or other containers for liquid drugs or other substances to be administered by hypodermic injection.

Present practice is to supply such substances in rigid containers, commonly glass vials, having a closure or cap which includes a diaphragm of rubber or other elastomeric material to be pierced by the needle of a hypodermic syringe when a dose is to be drawn off. The required quantity is drawn from the container by suction created by extending the piston or plunger of the syringe.

This will speedily create a vacuum within the container preventing further withdrawal of liquid as the container is otherwise airtight. The accepted technique for avoiding this is to use the syringe to inject a quantity of air into the container through the cap at least sufficient to enable the required dose to be withdrawn without difficulty. If a succession of doses are needed the container may be pre-pressurised by use of the syringe to inject a substantial volume of air.

In these manners of use it is necessary first to extend the syringe plunger, then to insert the needle through the cap, then to depress the plunger to inject the air, and then to withdraw the plunger once more to extract the required dose.

Because of the risk of cross-infection syringes and needles are desirably used for one injection only and to prevent any possibility of further usage designs of syringe are being developed which are impossible or extremely difficult to operate more than once. Thus they may incorporate some means of preventing a second withdrawal or operation of the plunger or piston after a single first operation, i.e. a working or injecting stroke. It will not be possible to use syringes of this type for pre-pressurising or othe,rwise injecting air into the container as above as this involves two working strokes of the piston or plunger.

Furthermore the air which is first drawn into the syringe through the needle and then injected into the container may not be sterile and may give rise to risk of infection bearing in mind that the drugs are normally supplied in quantities sufficient for a number of successive doses and that injections are often made in non-sterile surroundings, even out of doors in the tropics under primitive conditions as with mass immunisation programmes. Also some drugs or substances may be subject to deterioration in the presence of air which may mean that the remaining contents of the container has to be used quickly or will be wasted, or, if kept for too long with extra air (non-sterile) admitted, may be used in an ineffective or possibly even harmful form.

A further disadvantage of the known types of rigid container is that it is extremely difficult to extract all the contents through diaphragm by way of a needle.

As the container becomes empty a quantity of the liquid cannot be reached by the needle, again resulting in unnecessary wastage of possibly expensive drugs.

The object of the invention is to provide a container which is cheap and economical to manufacture and fill, which can be used effectively and simply with hypodermic needles and syringes of all kinds including non-re-usable syringes limited to single stroke operation, which improves standards of sterility even under adverse conditions, and which reduces wastage of the drugs or other substances.

According to the invention there is provided a container for liquid drugs or other substances to be administrated by hypodermic injection including a reservoir defined at least in part buy a sealed bag formed of a flexible impervious material to provide a variable volume chamber in which the substance is contained so enabling any required quantity of quantities of the substance to be withdrawn by suction without admitting any air to the reservoir.

Preferably the container includes a rigid neck or mouth portion to which the bag is attached provided with a rubber or elastomeric diaphragm which can be pierced by the hypodermic needle and preferably said cap or closure mounts a protective cage extending within the reservoir to prevent the needle piercing the wall of the bag from within the container.

The bag may be located within a rigid protective outer sleeve or box though this is not essential.

Some examples of the invention are now described with reference to the accompanying drawings wherein Figure 1 is an exploded perspective view of one form of drug container Figure 2 is a side view of the assembled container of Figure 1; Figure 3 is a vertical cross-section of another form of container; and Figure 4 is a side view of a yet further form of container.

Referring to Figure 1 a filled and sealed container comprises a rigid top or neck portion 10, e.g. a plastics moulding, a bag 12 formed from flexible impervious material e.g. transparent flexible polyethylene or other sheet plastics conveniently in tubular form, the neck of the bag being sonically welded or otherwise bonded to neck portion 10; a rubber or elastomeric diaphragm 14, and a top closure 16 secured to portion 10 to seal diaphragm 14 in place across a central mouth opening of the top. A protective cage 18 depends from neck portion 10 into bag 12 co-axial to the mouth and is slotted or otherwise pierced so that fluid can flow freely into the cage from the remaining part of bag 12 at all positions, particularly when the container is inverted.The reservoir defined by the assembled bag and top will normally be completely filled witch the liquid drug or other substance i.e. no air space need be left.

Preferably the top is in the form of an elongated oval or diamond in plan view so that it fits the neck of the bag 12 in the easiest way and facilitates the flattening of the bag around cage 18 as the contents are withdrawn.

The bag may locate within a rigid outer box or cover 20, possibly snap-engaged with the neck portion 10 or top closure 16 to prevent external pressure or possible puncturing of the bag during handling, transport or storage though this may not always be necessary. The outer box 20 need not be sterile or airtight, indeed it may include an aperture e.g. in its bottom to ensure that there is no vacuum resisting flattening of bag 12.

It will be seen that in order to withdraw any required quantity of liquid from the variable volume chamber defined by bag 12 it is only necessary to insert the hypodermic needle through diaphragm 14 without first withdrawing or operating the plunger or piston1 then the latter will be operated to suck out the required dose, the needle is then simply withdrawn from the diaphragm and the injection is ready to be made. It is not necessary to pre-pressurise or otherwise inject air into the reservoir to obtain the required quantity.

Successive doses will be withdrawn in the same way until the bag is completely flattened by external air pressure forcing the last remaining drops of liquid into the cage.

A small residue of liquid may remain trapped in the cage or against the neck portion 10 which will prevent the neck of the bag flattening but it is anticipated that this kind of wastage will be far less than in the case of a conventional rigid container e.g. a glass vial of conventional bottle shape.

The assembled and filled container is neat and compact in shape as seen in Figure 2, as it is formed from plastics it can be designed for the most economical use of materials, for low cost mass production manufacture -techniques, and for the most effective use of storage and transport space. The shape of container shown in Figure 2 can be packed much more densely and will weigh less than the equivalent capacity of round glass bottle or vial. Any size or capacity of container can readily be provided.

A container of more conventional shape but utilizing the principles of the invention is shown diagrammatically in Figure 3. Here a flexible bag 312 has a cylindrical body and a reduced diameter neck to fit within an outer rigid casing 320 of conventional bottle shape, the diaphragm 314 being sealed against a neck ring 315, which carries the cage 318 as previously described, by a screwon top closure in the form of a nut or cap 316.

Alternatively this cap could be a metal closure crimped or swaged onto the neck of body 320 or a plastics cap could be bonded or welded thereto.

Figure 4 illustrates another possible form of container in which the rigid neck portion 410 is reduced to a minimum and is circular in cross-section to define a mouth carrying the diaphragm 414, portion 410 being formed with an integral cage 418. A bag 412 formed from tubular plastics material has a welded seam at top and bottom, the central portion of the top of the bag being welded or otherwise bonded to the outer periphery of the neck portion 410. This design is economical of materials though care will be needed to ensure that there is adequate sealing at the junction between the top seams of the bag and the neck portion.

Claims

CL A IFl,S

1. A container for liquid drugs or other substances to be administrated by hypodermic injection including a reservoir defined at least in part by a seal bag formed of a flexible impervious material to provide a variable volume chamber in which the substance is contained so enabling any required quantity or quantities of the substance to be withdrawn by suction without admitting any air to the reservoir.

2. A container as in Claim 1 including a rigid mouth portion to which the bag is attached provided with a diaphragm which can be pierced by a hypodermic needle to effect said withdrawal.

3. A container as in Claim 1 or 2 wherein said mouth portion includes a cap or closure sealing the diaphragm across an opening of the mouth portion.

4. A container as in Claim 2 or 3 including a protective cage extending from the mouth portion within the reservoir to prevent piercing of the wall of the bag by a hypodermic needle inserted through the mouth portion.

5. A container as in Claim 2 wherein said flexible impervious material is flexible sheet plastics and the mouth portion is also formed from plastics with the bac welded or otherwise bonded thereto.

6. A container as in any preceding claim including a rigid protective outer box or cover within which the bag is located.

7. A container as in Claim 6 so far as dependent on Claim 2 wherein said outer box or cover engages with said mouth portion.

8. A container as in Claim 2 or 7 wherein the mouth portion is in the form of an elongated oval or diamond in plan view so that it fits into a neck of the bag and facilitates the flattening of the bag as the contents are withdrawn.

9. A container as in Claim 2 wherein the mouth portion is in the form of a neck portion of circular crosssection and the bag is formed from tubular plastics material having a welded seam at top and bottom, the cental portion of the top of the bag being welded or otherwise bonded to the outer periphery of the neck portion.

10. A container as in Claim 6 or 7 wherein the bag has a cylindrical body and reduced diameter neck and the rigid outer cover is bottle shaped so that the bao fits therein, the mouth portion comprising a closure secured to a neck of the casing.

11. A container for liquid drugs or other substances to be adminstered by hypodermic injection substantially as hereinbefore described with reference to and as shown in rigures 1 and 2r Figure 3; or Figure 4 of the accompanying drawings.