WO1998033449A1

WO1998033449A1 - Container for intravenous fluid

Info

Publication number: WO1998033449A1
Application number: PCT/US1998/001742
Authority: WO
Inventors: Pieter Wilhelm Stoker
Original assignee: Inmed Investment Holding Company (Proprietary) Limited; Handelman, Joseph, H.
Priority date: 1997-02-03
Filing date: 1998-01-30
Publication date: 1998-08-06
Also published as: AU6137898A; ZA98701B

Abstract

A container (110) for intravenous fluid includes a bag portion (112) of blow moulded construction and ports (114, 116) which are integral with an end portion of the bag portion (112) and which are optionally of injection moulded construction. The port (114) is an administration port and it has an integral sealing diaphragm (132) at its fixed end. Toward its free end, it has, in series, a line of weakness (126), gripping lugs or wings (127) to facilitate twisting off of the end portion, and formations for forming a hermetic seal (12). The port (116) is open at its fixed end to provide a blowing passage for blow moulding of the bag portion (112). It has a seat (144) for a stopper (150), and, similarly to the port (114), a line of weakness (146), gripping lugs (147) and formations for a hermetic seal (148).

Description

CONTAINER FOR INTRAVENOUS FLUID

THIS INVENTION relates to a container for intravenous fluid. It relates also to a method of manufacturing such a container, and to moulding apparatus suitable for use in carrying out the method of the invention.

In accordance with a first aspect of this invention, there is provided a container for intravenous fluid, which is hollow, which is in the form of a moulding of semi-rigid polymeric material, and which has two separate ports, an administration port and an injection port, which are integral with a bag portion of the container .

Each of said two ports may advantageously have sealing formations for hermetically sealing it at two positions spaced along the length of each respective port.

Said bag portion may be of blow-moulded manufacture .

The administration port may comprise an outer tube integral with a wall of the bag portion and a sealing diaphragm hermetically sealing the administration port, the outer tube having a free end portion adapted to be fused into a hermetic seal.

In one embodiment, the administration port may comprise a tubular insert received in leak-tight manner within the outer tube, the insert including said sealing diaphragm. Then, a wall of the insert may be fused to a wall of the outer tube. For this purpose, the wall of the insert may have one or more peripheral sealing ridges .

Instead, the insert may be received tightly within the outer tube in the manner of a crimp fit. Also in this embodiment, sealing formations may be provided at the sealing interface. The sealing formations may be in the form of one or more peripheral ridges .

The insert may be in the form of a moulding. The diaphragm may be integrally moulded with its wall. It may be of rigid construction.

The injection port may comprise an outer tube integral with a wall of the bag portion, a stopper seat defined inside the tube, and a stopper adapted for sealing receipt in the seat, the outer tube having a free end portion adapted to be fused into a hermetic seal.

The seat may be enveloped or surrounded by the outer tube. A wall of said outer tube of the injection port may be stepped forming an inner shoulder to define the stopper seat. Instead, the seat may be provided in an insert which is sealingly received within the outer tube of the injection port.

The respective outer tubes may each have a peripheral line of weakness toward their respective free end portions to facilitate opening the respective tube in use by breaking or severing or tearing off the hermetically sealed end portion.

Conveniently, on each end portion, there may be formed an a-circular gripping portion beyond the line of weakness to facilitate twisting the end portion. In accordance with a second aspect of this invention, there is provided a method of moulding a container for intravenous fluid, the method including moulding one end portion of a bag portion of the container; moulding two tubes to form respectively an administration port and an injection port adjacent each other, each tube being integral with and extending from said one end portion of the bag portion, and having a mouth opening into the bag portion; forming an integral hermetic seal in the mouth of the administration port, the mouth of the injection port being open; moulding the bag portion integrally with said one end portion of the bag portion by blow moulding, blowing taking place via said injection port.

In one method, moulding said end portion of the bag portion and said two tubes may be by injection moulding.

The method may include forming lines of weakness toward end portions of the tubes, the method including pinching or crimping the tubes to render walls of the tubes thin to form the lines of weakness after the tubes have been formed and before the material forming the tubes has completely set. This has the advantage that moulding material for the respective end portion has been injected and passed beyond the location of the lines of weakness before the cross-sectional area is decreased.

The method may include moulding a step forming an internal annular seat for a bung or stopper in the tube of the injection port.

The method may include forming a pariεon integrally with said end portion of said bag portion, said moulding the bag portion by blow moulding being from said parison.

Injection moulding of said end portion of the bag portion may be effected at an injection moulding station and blow moulding may be effected at a blow moulding station, the method including relocating the moulding from the injection moulding station when it has frozen to an appropriate degree, to the blow moulding station, and commencing injection moulding in respect of a succeeding container while blow moulding is taking place in respect of the preceding container. In this manner, injection moulding apparat s is used and is thus not idle while blow moulding takes place. This enhances production capacity.

The method when it does not include injection moulding steps, may include providing a parison, and moulding said two tubes may be effected by closing a pair of port platens over an end portion of the parison, inserts or cores being provided to form openings of the tubes, and moulding the bag portion may be effected by closing a pair of bag platens over a portion of the parison adjacent said end portion of the parison.

The method may include holding one or more cores or inserts between the port platens prior to forming of the tubes, and moulding said one or more cores or inserts into the respective outer tubes when the outer tubes are moulded. Holding of a core or an insert in respect of the injection port may be by means of a blow nozzle provided to blow air under pressure into the parison to effect blow moulding.

The method may include supplying energy to cause plasticization to cause fusion of the insert (s) into the respective outer tube(s) . The method may include forming lines of weakness toward ends of the tubes during moulding to facilitate breaking end portions of the tubes off in use.

In accordance with a third aspect of this invention, there is provided a moulding apparatus suitable for use in manufacturing a container for intravenous fluid by moulding, the apparatus comprising a pair of port platens having port moulding cavities and holders for holding cores inside the port moulding cavities to mould an administration port and injection port of the container, the holder of the administration port being adapted to hold its core shy of a^' all of the port platens to cause a sealing diaphragm to be formed in the administration port, the holder of the injection port being adapted to hold its core against a wall of the port platen to cause the injection port to be open; a pair of bag platens for enclosing a parison and a blow nozzle arranged to blow through the injection port to form a bag portion of the container by blow moulding.

The pair of port platens may form part of injection moulding apparatus.

In accordance with a fourth aspect of the invention, there is provided a container containing intravenous fluid, the container being a container in accordance with the first aspect of this invention.

The invention is now described by way of examples with reference to the accompanying diagrammatic drawings .

In the drawings Figure 1 shows, in frontal elevation, a first embodiment of a container for intravenous fluid in accordance with the invention; Figure 2 shows, to a larger scale, in section, an administration port and an injection port of the container of Figure 1;

Figure 3 shows, fragmentarily, in section, to yet a larger scale, an insert forming part of an injection port of a variant of the embodiment of Figure 1;

Figure 4 corresponds to Figure 3 but shows yet a further variant of the insert;

Figure 5 shows, in frontal sectional elevation, a first embodiment of moulding apparatus in accordance with the invention;

Figure 6 shows, in end view along lines VI-VI of Figure 5 , one half of the moulding apparatus of Figure 5 ; Figure 7 shows a plan view of the moulding apparatus of Figure 5;

Figures 8 and 9 show, respectively in part sectional, front view and in side view, a second embodiment of a container for intravenous fluid in accordance with the invention; and Figure 10 shows, in front view, fragmentarily, injection moulding apparatus forming part of a second etnbodiment of moulding apparatus in accordance with the invention.

With reference to Figure 1 of the drawings, a first embodiment of a container for intravenous fluid in accordance with the invention is generally indicated by reference numeral 10.

The container 10 comprises a container body or bag portion 12 having, at one end thereof which will be a lower end when in use, but which is shown as an upper end in the drawings, an administration port 14, and an injection port 16. The ports are described in more detail ^■with reference to Figure 2. At an opposed end of the container body 12, it has an apertured suspension lug 18 by means of which the container is suspended in inverted attitude in use.

More or less in the centre of the container body 12, it has a flat demarcated region 20 for applying a label .

With reference to Figure 2, the administration port 14 comprises an outer tube 22 integral with the wall defining the bag portion 12. At a position just external of the top of the bag portion 12, the outer tube 22 has peripheral formations 24, more specifically inner peripheral formations, to effect sealing as will be described hereinafter. Beyond the inner peripheral formations 24, it has a peripheral line of weakness 26 to allow a free end portion of the outer tube 22 to be torn off when the container 10 is to be used.

An end of the outer tube 22 is fused to form an hermetic seal as shown at 28.

Inserted in the outer tube 22 in the region proximate the top of the container body 12, is an internal insert 30 comprising an internal diaphragm 32. The insert 30 is generally in the form of a tube of rigid, pre-moulded material. It has outer peripheral formations 34 complemental to the inner peripheral formations 24 of the outer tube 22.

In one kind of embodiment, the insert 30 is merely tightly gripped within the outer tube 22 and friction between the peripheral formations 24 and 34 effect sealing. In other, preferred, embodiments the peripheral formations are fused together to effect a positive seal. In a variant of simple construction, the injection port 16 similarly comprises an outer tube 42 integral with and in communication with the container body 12 via a wall thereof . The outer tube 42 has a step providing an internal, axially outwardly directed shoulder 44. Spaced beyond the step, there is provided a peripheral line of weakness 46 to allow a free end portion of the outer tube 42 to be torn off.

After filling, a stop per 50, conveniently of a polymeric material, which is advantageously at least slightly resilient, is tightly, frictionally, received within the outer tube 42 and seats on the internal shoulder 44 which provides a seat for the stopper 50. The free end of the outer tube 42 is then fused to form a hermetic seal as shown at 48. If desired, the seal 28 at the end of the outer tube 22 of the administration port 14, can be formed at the time the seal 48 is formed.

With reference to Figure 3, in another variant which is of more complex construction, an insert 52 is receivable within an outer tube corresponding to the outer tube 42 of the injection port but not having the step 44. The insert 52 has a wall 54 having an internal step providing an internal, axially outwardly directed shoulder 58 corresponding to the shoulder 44 and which forms a seat for the stopper 50.

The wall 54 has outer peripheral formations 56 complemental to inner peripheral formations provided in the outer tube corresponding to the inner peripheral formations 24 of the outer tube 22 of the administration port 14.

The insert 52, as was described for the insert

30, can snugly, frictionally be received within its outer tube. However, preferably, the outer peripheral formations 56 are fused with the outer tube 42 to provide a positive seal. In the variant of Figure 3, it is shown that energy, for example in the form of heat, or of ultra-sonic waves, is applied to the peripheral formations 56 to plasticize them to form peripheral areas 56.1 of molten material to effect fusing.

With reference to Figure 4, a similar insert 52 is shown in which a thinner wall area 54.1 is provided intermediate the two outer peripheral formations 56. Under construction, energy is applied to the thinner area 54.1 to plasticize it and to cause fusion to an outer tube.

It is to be appreciated that the insert 30 can be fused in similar manner into the outer tube 22 of the administration port 14.

With reference to Figure 5, 6 and 7, a first embodiment of moulding apparatus for moulding the container 10 by means of blow moulding is generally indicated by reference numeral 60.

The moulding apparatus 60 comprises a first pair of platens 62, respectively having shaped concave formations 64 co-operating, when the platens 62 have been closed onto each other, to form a cavity within which the container body or bag portion 12 is blow-moulded.

Tops of the platens 62 are flat and in line as indicated by reference numeral 66.

A pair of second platens 68 is provided immediately above the pair of first platens 62. The second platens 68 respectively have concave shaped faces 70 defining a concave moulding cavity to form an upper portion of the container body or bag portion 12 as well as the administration port 14 and injection port 16. Extending above the faces 60, as can best be seen in Figures 6 and 7, there are provided secondary moulding cavities generally indicated by reference numeral 72 in Figure 7 and including half-circular cylindrical grooves 74 by means of which the outer tubes 22 and 42 respectively of the administration port 14 and injection port 16 are formed. The first platens 62 and the second platens 68 align very well when closed to ensure smooth blending of the upper portion and the lower portion of the container.

At a so-called parison station, a parison in heated state so as to be plastic, with a lower end thereof sealed, is dropped in position in between the first platens 62. The parison is somewhat inflated to ensure that its^' wall is smooth and so that portions of the wall do not cling to one another. The platens 62 are closed and the parison is severed by means of a "hot knife" to be of appropriate length.

At a so-called blow station, a blow nozzle or blow pin and a dummy pin are positioned inside the open mouth of the parison and the platens 68 are closed while the parison is dilated by means of air under pressure against the mould surfaces to form the container. The outer tubes 22 and 42 are formed around the blow pin and the dummy pin by means of the cylindrical grooves 74.

The insert 30 (which is sealed as shown at 32) is held over the dummy blow nozzle or pin during closing in of the second platens 68 thus to mould the insert 30 into the outer tube 22.

In those variants where the seat for the stopper 50 is provided by the insert 52, also the insert 52 (which is open) can be held^' in like manner on the blow nozzle 82 to be mounted into the outer tube 42. When the material of the container 10 has set, the second platens 68 and the first platens 62 are parted, and the moulded container 10 is removed and de-flashed to provide a neatly finished product.

It is to be appreciated that the blow moulding process is in practice, in general, automatic. Thus, it is expected that the tube of molten plastic material forming the parison will be dropped from a nozzle at a first station, i.e. the parison station. When the parison has reached a pre-specified length, the platens 62 close onto it to pinch the parison as described above, the parison then being cut to length.

The mould then rapidly moves away to a second station or blow station where a blow pin is inserted in the open end of the parison and the parison is then dilated under high pressure to fill the mould cavity as described above. Pressure is maintained until the material has frozen and sufficiently cooled down.

In accordance with the invention, a third station is provided where the insert 30, and if applicable also the insert 52, are ^'automatically picked up and held in position so that closing in of the second platens 68 will form the outer tubes as described above.

An energizing station is provided to apply energy, for example in the form of heat, or in the form of ultra-sonic waves, to heat the portions of the or each insert as described with reference to Figures 3 and 4 to allow fusion. Either energy can be applied from externally of the insert to achieve the situation as sketched in Figure 3, or the energy can be applied from internally of the insert to achieve the situation as described with reference to Figure 4. It is a first advantage of the embodiment of Figures 1 to 4 that a container for intravenous fluid is provided which has both the advantages of a semi-rigid blow moulded construction (which is substantially less expensive than containers which are flexible) and which nevertheless has dual ports providing the same advantages in respect of the dual ports as flexible containers having dual ports.

It is a further advantage that the administration port is sealed positively by means of the insert 30 and its internal membrane 32 during forming of the container body i.e. prior to filling thereof. It is to be appreciated that the integrity of the hermetic sealing of the insert 30 in the outer tube 24 is not of crucial importance because the end of the outer tube is fused as shown at 28.

It is further an advantage in respect of the injection port that provision is made for an internal stopper to be inserted after filling and that further provision is made for fusion of the end of the outer tube of the injection port to ensure integrity of sealing after filling.

It is an advantage, when the end portion of the injection tube has been severed, that the surface of the stopper which is exposed to atmosphere can easily be swabbed to sterilize it, for example, prior to injecting a substance into the container 10 via the stopper.

The Applicant believes that a high quality product with excellent integrity can be provided at a low price in accordance with this invention.

With reference to Figures 8, 9 and 10, another embodiment of a container for containing intravenous fluid is generally indicated by reference numeral 110. The container 110 is similar in many respects to the container 10 described above. Furthermore, generally, like reference numerals are used to refer to like components or features. The embodiment 110 is not again described in detail and emphasis is merely placed on differences to the embodiment 10.

As can best be perceived from Figure 10, an upper portion of a bag portion 112 of the container 110 as well as an administration port 114 and an injection port 116 are formed by injection moulding. Subsequently, the major portion of the bag portion 112 is formed by blow moulding. Injection moulding components for performing the injection moulding are generally indicated by reference numeral 170 in Figure 10. The components 170 comprise a peripheral gate member 170.1 defining a gate 170.2 within which a former member 170.3 is received with clearance to define a peripheral feeding passage 170.4.

Immediately above the injection moulding components 170, there is provided a pair of injection moulds, of which one only is shown in Figure 10 indicated by reference numeral 168. The mould 168, together with complemental moulding cavities in the complemental mould, defines a moulding cavity 174 for the administration port 114, and a moulding cavity 174.1 for the injection port 116. A core 175 is received within the pair of moulds 168 extending centrally within the opposing mould cavities 174 with clearance to cause an outer tube 122 to be formed. It is significant that the core 175 is checked shy of the former member 170.3 to cause a sealing membrane to be formed integrally with the tube at the point where the tube enters the bag portion.

A core 175.1 has a step as indicated by reference numeral 175.2 which, in conjunction with a step 144.1 in the moulding cavity 174.1, causes an annular shoulder or seat 144 shown in Figure 8 to be formed in the tube 142 forming the injection port 116. The core 175.1 extends into the former member 170.3 to ensure that the tube 142 is open-ended.

As can best be seen from Figures 8 and 10, a pair of lugs or wings 127, 147, is formed toward the free end of each of the tubes 122 and 144 i.e. immediately above lines of weakness 126, 146 to enable the respective tubes 122,

142 easily to be torn off immediately prior to use.

Beyond the wing sections, the respective tubes 122, 142 extend to allow end portions thereof easily to be fused as indicated by reference numerals 128 and 148 during the course of manufacture . In this regard, although the seal 128 can be formed during moulding of the bag, it may conveniently be done in conjunction with forming the seal 148 after the container has been filled with intravenous fluid and before it is sterilized in an autoclave or the like.

The position for a stopper is indicated in chain- dot lines in Figure 8 indicated by reference numeral 150. The stopper 150 will be seated on the seat 144 after filling.

It is to be appreciated that the lines of weakness 126, 146 are formed ideally after the material for the wings 127, 147 and the free end portions of the tubes 122, 142 have passed the positions of the lines of weakness. Thus, advantageously, pinching devices are provided, conveniently mounted in fixed positions relative to the moulds 168, to be operated to perform pinching actions after the material has been injected, and before the material has frozen.

When the upper portion of the bag portion 112 and the ports have been formed by injection moulding, further injection of material forms a parison depending downwardly from the peripheral feed passage 170.4. The mould with the parason depending therefrom is then inserted into moulds similar to the moulds 62 of Figures 5 and 6 forming a blow moulding cavity. Blow moulding is completed by blowing into the parason through the tube 142 to form the bag portion 112 against the mould surfaces.

The embodiment of Figures 8, 9 and 10 and the method described with reference to those drawings are expected to have the same advantages as those described with reference to Figures 1 to 7 above.

Claims

1. A container for intravenous fluid, which is hollow, which is in the form of a moulding of semi-rigid polymeric material, and which has two separate ports, an administration port and an injection port, which are integral with a bag portion of the container.

2. A container as claimed in Claim 1 in which each of said two ports has sealing formations for hermetically sealing it at two positions spaced along the length of each respective port.

3. A container as claimed in Claim 1 or Claim 2 in which said bag portion is of blow-moulded manufacture.

4. A container as claimed in Claim 1, Claim 2 or Claim 3 in which the administration port comprises an outer tube integral with a wall of the bag portion and a sealing diaphragm hermetically sealing the administration port, the outer tube having a free end portion adapted to be fused into a hermetic seal.

5. A container as claimed in Claim 4 in which the administration port comprises a tubular insert received in leak-tight manner within the outer tube, the insert including said sealing diaphragm.

6. A container as claimed in Claim 5 in which a wall of the insert is fused to a wall of the outer tube.

7. A container as claimed in Claim 5 in which the insert is received tightly within the outer tube in the manner of a crimp fit.

8. A container as claimed in any one of Claim 4 to Claim 7 inclusive in which the injection port comprises an outer tube integral with a wall of the bag portion, a stopper seat defined inside the tube, a stopper adapted for sealing receipt in the seat, and in which the outer tube has a free end portion adapted to be fused into a hermetic seal.

9. A container as claimed in Claim 8 in which a wall of said outer tube of the injection port is stepped forming an inner shoulder to define the stopper seat.

10. A container as claimed in Claim 8 in which the seat is provided in an insert which is sealingly received within the outer tube of the injection port.

11. A container as claimed in Claim 8, Claim 9 or Claim 10 in which the respective outer tubes each has a peripheral line of weakness toward their respective free end portions to facilitate opening the respective tube in use by breaking or severing or tearing off the hermetically sealed end portion.

12. A container as claimed in Claim 11 in which, on each end portion, there is formed an a-circular gripping portion beyond the line of weakness to facilitate twisting the end portion.

13. A method of moulding a container for intravenous fluid, the method including moulding one end portion of a bag portion of the container; moulding two tubes to form respectively an administration port and an injection port adjacent each other, each tube being integral with and extending from said one end portion of the bag portion, and having a mouth opening into the bag portion; forming an integral hermetic seal in the mouth of the administration port, the mouth of the injection port being open,- moulding the bag portion integrally with said one end portion of the bag portion by blow moulding, blowing taking place via said injection port.

14. A method as claimed in Claim 13 in which moulding said end portion of the bag portion and said two tubes is by injection moulding.

15. A method as claimed in Claim 14 which includes forming lines of weakness toward end portions of the tubes, the method including pinching or crimping the tubes to render walls of the tubes thin to form the lines of weakness after the tubes have been formed and before the material forming the tubes has completely set.

16. A method as claimed in Claim 14 or Claim 15 which includes moulding a step forming an internal annular seat for a bung or stopper in the tube of the injection port.

17. A method as claimed in Claim 14, Claim 15 or Claim 16 which includes forming a parison integrally with said end portion of said bag portion, said moulding the bag portion by blow moulding being from said parison.

18. A method as claimed in any one of Claim 14 to Claim 17 inclusive in which injection moulding of said end portion of the bag portion is effected at an injection moulding station and blow moulding is effected at a blow moulding station, the method including relocating the moulding from the injection moulding station when it has frozen to an appropriate degree, to the blow moulding station, and commencing injection moulding in respect of a succeeding container while blow moulding is taking place in respect of the preceding container.

19. A method as claimed in Claim 13 which includes providing a parison, and in which moulding said two tubes is effected by closing a pair of port platens over an end portion, of the parison, inserts or cores being provided to form openings of the tubes , and in which moulding the bag portion is effected by closing a pair of bag platens over a portion of the parison adjacent said end portion of the parison.

20. A method as claimed in Claim 19 which includes holding one or more cores or inserts between the port platens prior to forming of the tubes, and moulding said one or more cores or inserts into the respective outer tubes when the outer tubes are moulded.

21. A method as claimed in Claim 20 in which holding of a core or an insert in respect of the injection port is by means of a blow nozzle provided to blow air under pressure into the parison to effect blow moulding.

22. A method as claimed in Claim 20 or Claim 21 which includes supplying energy to cause plasticization to cause fusion of the insert (s) into the respective outer tube(s).

23. A method as claimed in any one of Claim 19 to Claim 22 inclusive which includes forming lines of weakness toward ends of the tubes during moulding to facilitate breaking end portions of the tubes off in use.

24. A moulding apparatus suitable for use in manufacturing a container for intravenous fluid by moulding, the apparatus comprising a pair of port platens having port moulding cavities and holders for holding cores inside the port moulding cavities to mould an administration port and injection port of the container, the holder of the administration port being adapted to hold its core shy of a wall of the port platens to cause a sealing diaphragm to be formed in the administration port, the holder of the injection port being adapted to hold its core against a wall of the port platen to cause the injection port to be open; a pair of bag platens for enclosing a parison and a blow nozzle arranged to blow through the injection port to form a bag portion of the container by blow moulding.

25. A moulding apparatus as claimed in Claim 24 in which the pair of port platens form part of injection moulding apparatus.

26. A container containing intravenous fluid, the container being a container as claimed in any one of Claim 1 to Claim 12 inclusive.