GB2121016A - An evacuation device for sterile containers - Google Patents

Abstract

A container for a sterile fluid, such as blood, infusion or nutrient solution or cleaning fluid, normally includes a filler device for the supply of fluid into the container and a tubular evacuation device (3) for enabling discharge of the fluid from the container upon penetration thereof by a connection device shown in part at (45). The evacuation device includes a self- sealing sealing diaphragm (23) of an elastic material. A first cylindrical space (32) is provided and is arranged to accommodate the connection device (45) in sealing surface contact with the evacuation device, and a second space (21), enlarged in relation to the first space, is disposed between the first space (32) and the sealing diaphragm (23). The elastic self-sealing sealing diaphragm (23) is arranged to bend inwardly into the enlarged space (21) when pressure is applied thereto by the connection device. When the connection device is removed, the diaphragm (23) self-seals to preserve the sterility of the contents of the container. Protective diaphragms (14) and (17) are also provided. <IMAGE>

Description

SPECIFICATION An evacuation device for sterile containers The present invention relates to an evacuation devicefor a container arranged to enable discharge of the contents of the container upon penetration thereof bya connection device. Such an evacuation device is intended for use with a containerwhose contents must be kept sterile, for example, for a container for a fluid such as blood, infusion or nutrient solution, or cleaning fluid.

Infusion containers having an evacuation device shaped like an outlet pipe and fitted with a detachable end section are known. When the container is connected to a drip chamber, a connection device is fitted in the outlet pipe after the end section has been broken off. During the time which elapses between the breaking off ofthe end section and the fitting of the connection device the container is open so that its sterility is lost. Moreover, the connection device cannot be removed and replaced for continued treatment, should this be required, since sterility cannot be maintained and after the removal of the connection device the contents ofthe container risk further contamination.

It is an object ofthe present invention to provide an evacuation device in which the drawbacks outlined above are overcome.

According to the present invention there is provided an evacuation device for a container arranged to enable discharge ofthe contents ofthe container upon penetration thereof by a connection device, wherein said evacuation device comprises at least oneself- sealing sealing diaphragm of an elastic material, a first space for the accommodation of a connection device during discharge, and a second space, enlarged in relation to the first space, and disposed between the first space and the sealing diaphragm,the sealing diaphragm being arranged to bend inwardly into said second enlarged space underthe influence of pressure applied by the connection device.

In a preferred embodiment of the invention the evacuation device comprises an insert which encloses said sealing diaphragm and which in addition also comprises an outer protective diaphragm and an inner protective diaphragm each disposed on either side of and at a distance from the sealing diaphragm.

In another preferred embodiment the outer protective diaphragm is produced as a removable attached diaphragm in order to enable, where required, disinfection ofthe outer limiting surface ofthe sealing diaphragm priorto penetration ofthesealing di aphragm bythe connection device.

In some embodiments the sealing diaphragm is produced in a slitted form in orderto facilitate penetration of the diaphragm by the connection device. This also minimisesthe risk of particles being released from the diaphragm when the connection device is moved through it, since the connection device does not need to cut its way through the material of which the diaphragm is made.

Evacuation devices of the invention enable a closed systemforthefluid in the containerto be maintained during the fitting of the connection device and after the connection device has been removed. By this means it is possible to interrupt discharge from the container and to resume it at a later time. Devices of the invention also make it possible to keep the container in a stand-by position without loss of fluid, i.e. with the evacuation device facing downwards to await the resumption of treatment.

Embodiments of the present invention will hereinafter be described, by way of example, with reference to the accompanying drawings, in which Fig. 1 shows one end portion of a container having an evacuation device, Fig. 2 shows a longitudinal section of a first embodiment of an evacuation device; an insert of the evacuation device being illustrated on the left hand side priorto welding, and on the right hand side after it has been welded to an outletsection, Fig. 3 shows a longitudinal section of a second embodiment of an evacuation device, an insert of the evacuation device being illustrated on the left hand side priorto welding, and on the right hand side after it has been welded to an outlet section, Fig. 4a shows a longitudinal section through a fourth embodiment of an evacuation device having an upper surface which is accessible for disinfection, and Fig. 4b shows a longitudinal section through a further embodiment of an evacuation device which similarly has an upper surface which is accessible for disinfection.

Throughout the description, the same reference numerals have been used to referto identical or equivalentfeatures ofthe device.

Fig. 1 shows one end portion of a flexible container body 1 which is produced of a suitable plastics material such as polyvinyl chloride, polypropylene, polyethylene, polyamide, polyethyleneterephtalate or similarthermoplastics, or laminates formed from combinations of such materials. It is intended thatthe container be filled with a liquid such as blood, a nutrient or infusion solution, or a cleaning fluid. The container and its contents would be sterilised afterthe container had been filled, and it is also intended that the container be disposed of once its contents had been used.

In known mannerthe container is provided with a filler device 2 by means of which the initiallyflattened or compressed container is filled. In addition, the container has an evacuation device 3 by means of which the contents of the container can be discharged in a sterile manner.

The evacuation device 3 comprises a tube-shaped outlet section 4, herein after referred to as an outlet pipe. In all the illustrated embodiments, the outlet pipe 4 has a narrow portion 5 closest to the container body 1 and an enlarged portion 6 furthest from the container body 1. The enlarged portion terminates in a mouthpiece edge 7. The evacuation device is formed in a single piece with the container body and is connected to the interior of the container body.

Fig. 2 illustrates a first embodiment of an evacuation device 3 of the invention. Atubular insert 8 arranged within the outlet pipe 4 has an inner first section 9 and an outer second section 10. The second section 10 suitably possesses a circumferential, axially and outward-facing collar 11. The mouthpiece edge 7 is disposed such that it can be joined to the collar 11 by a welded joint43, and therebyfinally ensure thatthe container is sealed in a sterile manner. The outer second section 10 also possesses a cylindrical wall 12 which is joined to a top wall 13 which in turn encloses an outer protective diaphragm 14. The said innerfirst section 9 comprises a tubular inner portion 15 and an enlarged outer portion 16.The inner portion 15 ofthe section 9 has an external diameter which substantially corresponds to the internal diameter ofthe narrow portion 5 of the outlet pipe 4 such that good frictional adjustment between the portions 15 and 5 is attained.

In addition, thetubularinner portion 15 is sufficiently long that its free end extends into the interior ofthe container body a predetermined amount. This means thatthe residual quantity of air in the container and the volume ofthefluidthat remains in the container after its evacuation can be controlled.

An inner protective diaphragm 17 is disposed in the inner portion 15 at a predetermined distance from the diaphragm 14ofthe outer insert section 10. The enlarged outer portion 16 of the inner insert section 9 has a predominantly cylindrical wall 18, a base wall 19, and a conical, concave intermediate wall 20 which is joined to the inner portion 15. The inner portion 15 therebydefinesafirstspace32 in the insertwhich giveswayto an enlarged second space 21 which, inter alia, is delineated by said intermediate wall 20. The inner insert section 9 is disposed so as to be accommodated with its cylindrical wall 18 in the space which is enclosed by the cylindrical wall 12 ofthe outer insert section 10 so that these cylindrical walls have sealing surface contact with each other.The two inserts are welded together at a circumferential welding point 22 forformation of a hollow unit.

The insert8further comprises a circularself-sealing sealing diaphragm 23 of elastic material, e.g. of a suitable rubber or plastics material. Cooperating engagement devices 25to 27 are disposed on edge portions 24 of the sealing diaphragm andonthetwo insert sections 9 and 10 for stable retention of the sealing diaphragm. The engagement devices 25to 27 are arranged to fix the edge portions 24 of the diaphragm 23 against radial movements and to ensurethatthe diaphragm does not come away, either partially or completely, from the insert sections when pressure is applied to the centre portion ofthe sealing diaphragm 23 by means of a connection device.In the embodiment shown, the engagement devices comprise annular grooves 27 in opposite surfaces ofthe edge portion 24 ofthe sealing diaphragm and corresponding retaining rings 25 and 26 on the facing surfaces ofthe base wall 19 ofthe inner insert section9 and of the top wall 13 ofthe outer insertsection 10. During assemblythesealing diaphragm 23 is placed betweenthetwo insert sections such that the retaining rings 25 and 26 engage in said grooves and retaining rings, whereby the sealing diaphragm 23 is effectively clamped between the insert sections. Thereafter, a welding operation is carried out such that the sealing diaphragm is permanently enclosed in a sterile manner.

The inner elastic protective diaphragm 17 is relativelythin and protects the contents ofthe container against particle contamination, whilst the outer elastic protective diaphragm 14, which is also relativelythin, protects the inner sealing diaphragm 23 against bacterial contagion. The outer protective diaphragm 14 and the enclosed sealing diaphragm 23 together define a third space 33 in the insert, the diameter of the third space 33 being substantiallythe same as that of the second enlarged space 21.

Fig. 2 also shows a section of a connection device 45 which may,forexample, be connected to a drip chamber(notshown).ln Fig. 2 the connection device 45 has been inserted into the evacuation device.

Reference number 44 indicates a preferably slightly conical section ofthe connection device. The section 44 has an external diameterthatis as large as or larger than the internal diameter ofthetubular portion 15.

This means thatthe conical section 44 sealingly abuts the inner limiting surface ofthe inner portion 15. The section ofthe connection device shown constitutes solely an illustration ofthe aforementioned sealing abutment. Of course, with a connection device in the inserted position both the protective diaphragms 14 and 17 and the sealing diaphragm 23 would be pierced and moved aside bythe connection device.

Fig. 3 shows an alternative embodiment of the invention in which the inner insert section 9 is made up of first and second cooperating elements 9a and 9b.

The first elements 9 has a substantially cylindrical end area 39 closestto the sealing diaphragm 23, and this encloses a substantially cylindrical area 15a of the second element 9b which is located furthest away from the sealing diaphragm 23. The diameters of the cylindrical areas 39 and 1 5a are arranged to give a friction fit between the two elements 9a and 9b.

The first element9a also has a tubular inner portion 15which cooperates by means of good frictional adjustment with the narrow portion 5 ofthe outlet pipe 4and extends into the interior ofthe container body 1.

The narrow portion 5 ofthe outlet pipe 4 is provided with a flared projection 35which is arranged to cooperate with a corresponding projection 36 in the end area 39 ofthefirst element9a to secure the position of the first element 9a in the outlet pipe. The second element 9b has a substantially cylindrical wall 37 which is connected both to the base wall 19 thereof and to a second base wall 38 which forms the transition for the cylindrical area t5a. The cylindrical area 1 5a is connected to the inner protective diaphragm 17 which defines a space 30 within thefirst element 9a and open to the interior ofthe container.

The flared projection 35 in the outlet pipe 4 expandsto an inner diameter exceeding the outer diameter of the end area 39 of the element 9a. Thus, the projection also forms a contact surface forthe second base wail 38 ofthe second element and thereby contributes towards securing the position of the second element 9b in the outlet pipe 4. The wall portions 37 and 38 thus correspond to the intermediate wall 20 ofthe embodiment shown in Fig. 2. The disposition of the innerfirst section 9 as two separate linked elementsfacilitates the manufacture ofthe insert when the inner protective diaphragm 17 is to be located within the tubular inner portion 15 as is shown in Fig. 3.

The outer second section 1 0a ofthe insert8 is in the embodiment shown in Fig. 3 disposed with its top wall 13 enclosed by an inner, generally cylindrical wall 41 and byan outer cylindrical wall 42. The inner cylindrical wall 41 connects the top wall 13 with the outer protective diaphragm 14, and the outer cylindrical wall 42forms a contact and connection device forthe mouthpieceedge7 oftheoutlet pipe4.

The construction ofthe outer second section 1 Oa which is illustrated in Fig. 3 acts to stiffen the second section 1 Oa such thatthe fixing ofthe sealing diaphragm 23 is reinforced. Anotherfactorwhich contributes towards this is, as shown in the figure, the location ofthe retaining rings 25,26 and the annular grooves 27 primarily in the area between the cylindrical wall 37 of the second element 9b and the inner wall 41 ofthe second section 1 0a.

In the embodiment of Fig. 3,the cylindrical surfaces ofthe cylindrical wall 18 ofthe enlarged outer portion 16 do not contact the adjacent surface of the sealing diaphragm 23 and the cylindrical wall 12 ofthe outer second section 1 Oa. This embodiment can be selected in orderto facilitate production sincethe sterility of the evacuation device is guaranteed by the welded joints 22 and 43, between the cylindrical wall 18 and the second section 1 0a and between the enlarged portion 6 of the outlet pipe and the second section 1 Oa respectively.

Fig.4a shows an embodiment of an evacuation device which is similar to that of Fig. 3 inthatthe inner insert section 9 is composed ofafirstelement9c cooperating with a second element9d.Thefirst element9cofthe inner insert section terminates at its upper end in a thicker edge portion 34which is arranged to cooperate with respective grooves 46 and 47 formed in the narrow portion 5 ofthe outlet pipe 4 and in the second element9d. Thefirstelement9c is arranged to be fixed relative to the second element and relative to the outlet pipe 4 respectively by means ofthe snap-action cooperation ofthe edge portion 34 and the grooves 46 and 47.

Inthe embodiment shown in Fig.4a,the outer second section 1 Ob of the tubular insert 8 is shaped as an annular attachment section 48 which abuts against the sealing diaphragm 23. In its central section the annular section 48 has an aperture exposing the upper surface ofthe sealing diaphragm 23. This aperture is defined by a conical surface 50 which provides a relatively gentle transition to the upper surface ofthe sealing diaphragm in ordertofacilitatethedisinfec- tion thereof and ofthe region thereabouts. The annular section 48 is further provided with a downwardlyfacing attachment ring 26 for cooperation with an upper annular groove 27 formed in the sealing diaphrag m;23.The sealing diaphragm 23 is also fixed to the second element sod ofthe inner insert section 9 by means of a lwergrnove 27 in the diaphragm and an upwardly facing attachment ring 25 in the upper surface of the second element 9d. The annularsection 48 is joined-tothe mouthpieceedge7 ofthe enlarged portion 6 of the outlet pipe 4 by means of a weld 51. An upper diaphragm 49 covers the aperture of the annular section 48 and is detachably mounted (e.g.

glued orwelded) on the annular section. The upper diaphragm 49 may have projecting portions suitable for use as gripping devices when the diaphragm is to be removed.

Fig.4b shows an embodiment in which the design and shape ofthe inner insert section 9 is substantially the same as that ofthe second element ofthe embodiment shown in Fig. 4a. Between the cylindrical region 15a ofthe inner insert section 9 and the narrow portion 5 of the outlet pipe 4 a free space is defined which makes it possible to match the internal diameter ofthe cylindrical region 1 5a with the external diameter of the connection device 45to be inserted whilst retaining the shape and diameter ofthe narrow portion 5 of the outlet pipe.Itwill be realised that this enables a considerable rationalisation and reduction ofthe costs of production and stocking since the outlet pipe 4 can be made to a uniform design and size which into a large extent independent of the internal diameter ofthe cylindrical region 1 5a. In some ofthe embodiments shown, the cylindrical region 15a extends into the container. In the embodiment shown in Fig. the cylindrical region 1 5a is arranged to terminate next to the wall ofthe container 1. In fact, the length of the cylindrical region 1 5a is chosen in dependence upon the residual quantity of air and the volume of fluid that it is required to retain in the container after use.

The sealing diaphragm 23 is arranged to have sufficient elasticity such that it returns immediately to its flat initial position after it has been penetrated by a pointed connection device, and the connection device has subsequently been withdrawn from the insert.

The elasticity ofthe sealing diaphragm is also sufficiently high and the plasticity ofthe material thereof is sufficiently greatforthe sealing diaphragm to conform itself in shape to and enclose the inserted connection device. This ensures thatthe diaphragm forms a seal aroundtheconnection device during the evacuation operation, such a seal being required primarilyfromthe point of view of hygiene. In orderto ensure the necessary resilience ofthe central portions ofthediaphragmsothatsaidflatinitial position can be rapidly assumed after the connection device has been withdrawn from the insert. It is also important, that the sealing diaphragm has a minimum thickness of approximately 1.0 mm.Preferably, the sealing diaphragm has a thickness in the range 1.5 mm to 2.5 mm. These material thicknesses are related to presently proposed materials. If other materials are used they may, of course, make it possible or necessary for the sealing diaphragm to have different dimensions.

In orderto prevent fluid leakage, a sealing connection is made between the connection device and the evacuation device 3. This sealing connection can be ensured as shown in Fig. 2 by providing the connection device 45 with the slightly conical section 44 which makes sealing contactwith the innersurface of the tubular inner portion 15 or 15a. Alternatively, the inner surface ofthe inner portion 15 or 1 5a may be slightly conical, or both the surfaces may be suitably inclined.

To facilitate the penetration of the sealing diaphragm by the pointed connection device, the area of penetration ofthe diaphragm may be provided with one or several weakened zones, for example, by cuts or scores that penetratethe material wholly or partially. Thus, the weakened zones may comprise a single cut, or a series of intersecting cuts.

The enlarged space21 of the inner insert section 9 is of a sufficient size to enable the sealing diaphragm to bend freely into the spaceunderthe effect ofthe pressure from the pointed connection device asthe latter penetrates the sealing diaphragm. After penetration the resilient energythat is accumulated through the inward bending is released so that when the connection device is removed, an instantaneous return ofthe deflected central portion ofthe sealing diaphragm to a flat initial position is achieved so that perfectsealing is attained and guaranteed.

The embodiments shown in Figs. 4a and 4b are particularly designed for applications wherefluid is removed from the container more than once. To prepare the containerfor use, the upper diaphragm 49 is torn off. In certain applications an additive is supplied to the fluid, e.g. by means of a hypodermic syringe which is inserted down through the sealing diaphragm and the inner protective diaphragm 17.

Once the supply of additive is concluded, it is possible to re-disinfectthe sealing diaphragm in conjunction with subsequent insertion of the connection device 45.

Itwill be readily appreciated that repeated removal and insertion ofthe connection device and intervening supply of additive to the fluid can be easily performed, especiallywhen using the embodiments shown in Fig.

4whilst retaining the required sterility and cleanliness ofthe fluid. Previous techniques for providing containers of the kind treated here with special supply devices (additive gates) are simplified bytheinventionsince the evacuation device can also be used forthis purpose. In many applications this means both simplified handling and a cheaper container.

In orderto increase the engagement between the insert8 and the outlet pipe,the insert may befitted with annular projections 31 which penetratethewall ofthe outlet pipe as is shown in Fig. 2.

The insert is pre-sterilised and introduced intothe outlet pipe 4 under hygienic conditions, after which the insert is welded to the outlet pipe at its mouthpiece edge. In some embodiments, the upper edges ofthe outlet pipe 4 and of the insert 8 have to be trimmed before the welding operation is performed. The welding ofthetwo insert sections 9and loins preferably undertaken by means of ultrasonics, whilst the welding ofthe insert and the outlet pipe maybe performed by any suitable method, for example, by thermal welding. The insert sections are preferably manufactured ofthe same plastics material as are the container and its outlet pipe.

The container may be provided with a separate diaphragm-sealedaperature forthe introduction of various additives, for example forthe addition of drugs and/or nutrients into an infusion solution. As a rule,the containeris fitted with suspension devices (not shown) which are disposed in the end ofthe containerfacing away from the evacuation device 3 so thatthe container can be suspended during use. The filler device as well as the evacuation device can be protected by protective sleeves or similar devices in orderto ensure complete hygiene, which protective sleeves are removed when the container is used.

During use the compressed container is filled with a required fluid via thefiller device, after which it is sealed, preferably by welding and the filled container is sterilised. During evacuation a connection device is made to penetrate by means of its pointed end the three diaphragms ofthe evacuation device insert, after which fluid drainage is commenced. This drainage can be interrupted when required andthe connection devicewithdrawnfrom the insert. Itis possibleto withdrawthe connection device without fluid leaving the container, and, if the interruption is of short duration, without any loss of sterility. Subsequently, the connection device may be reinserted through the previously penetrated sealing device.

The invention is not limited to the embodiments described above, and variations thereof are possible.

Forexample,the invention can be applied to noncompressible containers of plastics material orto containers of a different material, for example, of glass. In an alternative embodiment, the outlet pipe could have a substantially uniform inner diameter (without any expanded section) forthe accommodation and welding into position therein of an insert consisting of several sections, the insert having an outer uniform diameter matched to the inner diameter ofthe outlet pipe. The inner insert section is provided with a through channel closestto the container for accommodating the pointed connection device, and an enlarged space for receiving the outwardly bent sealing diaphragm as in the previously described embodiments.Even ifa self-sealing sealing diaphragm is normally sufficient to ensurethe necessary hygiene between two evacuations, several, e.g.

two, such sealing diaphragms can, if so required, be disposed after each otherwith intervening spaces and enlarged spaces which enable a required favourable outwards bending of each sealing diaphragm. The two sealing diaphragms are thus enclosed by inner and outer protective diaphragms as previously described.

The invention has been described above in conjunction with embodiments where the outlet pipe 4 and the inserts cooperating therewith possesses a circular cross-section. Of course, the invention is applicable to embodiments having othercross-sections,forexam- ple, where the evacuation device has an oval or polygon or other cross-section.

In the preceding description it has been statedthat the insert sections 9 and 10 are joined to each other and to the outlet pipe 4 by means of welded joints. It will be appreciatedthatthe connections must ensure thatthe insert sections are joined with each other and to the outlet section complelelytightly. Of course, any tightjoint may be used, and the elements may be joined for example, using an adhesive joint or a snap-action joint combined with a sealing agent, or the like.

Claims (15)

1. An evacuation deviceforacontainerarranged to enable discharge ofthe contents ofthe container upon penetration thereof buy a connection device, wherein said evacuation device comprises at least one self-sealing sealing diaphragm of an elasticinaterial, a firstspacefortheaccommodation of a connection device during discharge, and a second space, en larged in relation to the first space, and disposed between thefirstspace and the sealing diaphragm, the sealing diaphragm being arranged to bend inwardly into said second enlarged space underthe influence of pressure applied by the connection device.

2. An evacuation device as claimed in Claim 1, wherein the sealing diaphragm is enclosed between an inner protective diaphragm and an outer protective diaphragm, the inner protecting diaphragm defining said first space from the interior ofthe container, and the outer protective diaphragm being spaced from the sealing diaphragm and defining therewith a third space having a diameter at least equivalent to the diameter ofthe first space.

3. An evacuation device as claimed in Claim 1 or 2, further comprising a hollow outlet section in which an insert of a thermoplastics material is disposed, said insert comprising said sealing diaphragm and forming said spaces.

4. An evacuation device as claimed in Claim 3, wherein a region ofthe limiting walls of the first space is arranged for sealing surface contact with the connection device and has an inner dimension and shape which is matched to the outer dimension and shape ofthe connection device in the area of sealing surface contact, and wherein said region of the limiting walls of the first space is spaced from outer limitingwallsoftheoutletsection.

5. An evacuation device as claimed in Claim 3 or 4, wherein the insert comprises an innersection and an outer section, and cooperating engagement means are provided on said insert sections and on the sealing diaphragm for retaining the sealing diaphragm.

6. An evacuation device as claimed in Claim 5, wherein the inner insert section forms said first space and said enlarged second space.

7. An evacuation device as claimed in Claim 6, wherein the inner section is formed of first and second cooperating elements the second element being disposed closer to the sealing diaphragm than the first element and forming said first space and said enlarged second space.

8. An evacuation device as claimed in any of Claims Sto 7, wherein the engagement means are circumferential retaining rings and grooves formed in opposing surfaces ofthe sealing diaphragm and ofthe insert sections.

9. An evacuation device as claimed in any of Claims 5to 8, wherein the outer insert section is formed with said outer protective diaphragm, and the inner insert section is formed with the inner protective diaphragm.

10. An evacuation device as claimed in any of Claims 5to 9, wherein an inner portion ofthe inner insert section extends a predetermined amount into the interior of the container.

11. An evacuation device as claimed in any of Claims 3to 10, wherein the insert is welded into position in the outlet section.

12. An evacuation device as claimed in any of Claims 3to 11, wherein the outlet section is produced in a single piece with the container.

13. An evacuation device as claimed in any preceding claim, wherein the area of the sealing diaphragm arranged to be penetrated by the connection device is provided with weakened zones wholly or partially extending through the sealing diaphragm.

14. An evacuation device as claimed in Claim 13, wherein said weakened zones comprise a number of intersecting cuts.

15. An evacuation deviceforacontainersubstan- tially as hereinbefore described with reference to and as illustrated in the accompanying drawings.