GB2339773A

GB2339773A - Vial connector system

Info

Publication number: GB2339773A
Application number: GB9916900A
Authority: GB
Inventors: Robert Mcconnell
Original assignee: GALEN Ltd
Current assignee: GALEN Ltd
Priority date: 1998-07-17
Filing date: 1999-07-19
Publication date: 2000-02-09
Also published as: GB9916900D0; AU2000230610A1; WO2001051002A1

Description

2339773 VIAL CONNECTOR SYSTEM The present invention relates to a vial

connector system, namely to a system for use in bringing the interior of a vial into fluid flow communication with a conduit.

Particularly in the medical field, many substances are packaged in vials, to maintain their integrity and cleanliness. This is particularly important for medicaments for administration and substances for addition to blood or plasma for eventual administration.

It is frequently desirable to have a system that ensures that once a vial is connected to a conduit (generally leading to a bag of fluid), disconnection is impossible or very difficult. Thus a medical worker can be confident that once the correct vial has been connected, in clean and sterile conditions, it cannot then be removed, giving a risk of contamination and possible replacement by an incorrect vial.

A standard vial has a body, a narrow neck, and an enlarged head closed by a pierceable closure. The enlarged head generally includes a collar for retaining the closure. The head has a rearwardly pointing shoulder.

Examples of vial connectors are disclosed in US-A 4,675,020, EP-A-285,424 and W093/24095. A simple connector may have a circular base, a tubular spike passing through the centre of the base, and an annular 2 array of detent members surrounding the spike. Each detent member has a column portion and a radially inner projection or tooth. The dimensions are such that a vial can be pushed onto the spike and, as the spike penetrates the vial's closure, the head of the vial pushes past the teeth. The column portions flex outwards slightly to allow this, and then snap-engage behind the shoulder to lock the vial in place. To prevent the direct application of force to the detent members to facilitate removal of the vial, there may be a further annular wall surrounding them.

Nevertheless, such a connector tends not to be fully reliable. As a practical matter, the array of detent members and the base will be formed by a moulding technique. Since it must be possible to withdraw the mould components from the formed article, the teeth are not formed so as to grip the vial head (and thus the mould core) irreversibly. Thus for example EP-A-285,424 discloses a device having detent elements which each have a tooth which, in profile, has a tapering upper surface and a relatively abrupt lower surface. This is so that a vial can be pushed in relatively easily, but resists withdrawal. Nevertheless, for reasons explained above, the lower surfaces cannot be formed without some taper, which inevitably assists in the withdrawal of a vial.

Therefore EP-A-285,424 teaches the provision of further means for locking a vial in place, namely a retainer that 3 engages over the vial, e.g. engaging in ratchet teeth provided in an outer wall.

This system is effective but is rather cumbersome.

W093/24095 discloses a different approach to mitigating the effects of moulded detent teeth. There are additional, separately formed detent elements having supplementary detent teeth that project inwardly between the teeth of the first array, and resilient means for urging the supplementary teeth inwardly. The result can be less bulky than the system of EP-A-285,424 but is still rather elaborate to produce and assemble.

The present inventionladopts a rather different approach: it employs a circular array of detent elements having radially inwardly projecting detent teeth, said is teeth being undercut so as to be capable of engaging a suitably dimensioned vial's head virtually irreversibly.

Suitably the array is provided by a main member having a base from which projects a tubular spike surrounded by said array of detent elements. The elements are suitably provided by columns whose outer ends bear the teeth. The base suitably has openings at the angular locations of the columns. Thus the member can be produced by moulding in a mould whereof one mould part has an array of mould pins which project through said openings in the moulded member; end portions of said pins being shaped to define the undercut surfaces of said detent elements.

A separate moulded item may be a rear member providing an annular disc portion for overlying the rear of said base and closing off said openings. It may be secured to said main member, suitably by ultrasonic welding.

Usually there will be a third component which is a protective cap covering the tubular spike and enclosing it in a sealed volume. The cap is suitably cup-shaped, with a cylindrical wall whose outer portions embrace and are sealed to the periphery of the base of the main member and/or the disc portion of the rear member. The cylindrical wall is suitably provided with a circular line of weakness or tear strip so that an outer portion can be removed to expose the tubular spike and allow engagement of a vial.

An embodiment of the invention will now be described in more detail with reference to the accompanying drawings in which:

Fig. 1 is a sectional view showing a device embodying the present invention in use, engaging a vial; Figs. 2 and 3 are views in plan and elevation of the main member of the device; Fig. 4 is a sectional view through a mould during moulding of the main member; Fig. 5 is a side elevation of the rear member; Fig. 6 is a sectional view of the protective cap; and Fig. 7 is a sectional view of the device in its completed state.

Fig. 1 shows a conventional vial 10 in outline. A neck 12 leads to an enlarged head 14 with a pierceable septum 16. The illustrated device includes a main member 20 providing a circular array of detent elements 22, each having at its outer end region an inwardly projecting tooth 24. Each tooth has an axially outer surface 26 sloping radially and axially inwardly, to assist the relative inward passage of the head 14 of a vial. This surface is at an acute angle to an undercut axially inner surface 28. Thus there are axially inwardly directed edges or spikes 30 which engage behind the head 14 of the vial, and tend to engage ever tighter if an attempt is made to pull the vial free. The main member 20 also has a generally conventional central tubular spike 32, arranged to pierce the septum 16 as the head 14 engages behind the teeth 24, and a rearwardly projecting tubular boss 34 communicating with the spike.

The detent elements 22 project from a circular base 35 which has openings in register with the teeth 24. A rear member 40 has an annular base 42 and a rearwardly projecting conduit portion 44 (which may be in communication with a port 46 of a medical fluid bag 48 and may include an extension 45 as shown in fig. 5.) It is sealed, e.g. by ultrasonic welding, to the rear of the main member so that the openings in the base 35 thereof are closed off, and the tubular spike 32 is in flow 6 communication with the conduit portion 44.

Fig. 1 also shows a base part 50 of a protective cap 52, most of which was torn away to permit engagement of the vial, as will be explained below. The base part 50 is a tubular member that embraces the peripheral edges of the base 35 of the main member and the base 42 of the rear member 40, and is sealed thereto.

The main member is shown on its own in Figs. 2 and 3 and its production is shown in Fig. 4. This employs a mould 60 including a mould base 62 which defines the rear of the component base 35, a main outer mould part 64 which defines the outer and end surfaces of the detent elements 22, and a main mould core 66 which broadly defines the cup-like inner profile of the device, and the outer surface of the tubular spike 32. A rear mould member 68 carries an annular array of withdrawable core pins 70 for defining the radially inner surfaces of the detent elements 22 and (most importantly) the undercut surfaces 28 of the teeth. A central core pin 72 defines the interior of the tubular spike 32. The use of withdrawable mould pins for creating such complex moulded shapes is in itself well known. The preferred material for the main member is polycarbonate.

Fig. 6 shows the protective cap 52. The base part 50 visible in Fig. 1 is joined by a pair of lines of weakness 54 (defining a tear strip 56 with a pull tab 57) to a cup portion 58. This provides tamper-evidence.

Polypropylene is a suitable material.

Fig. 7 shows the device in assembled form.

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Claims

1. A vial connector system comprising a moulded vial retainer comprising a base and a circular array of detent elements projecting forwardly from the base, each detent element having the form of a resilient column projecting away from the base and bearing a radially inwardly projecting detent tooth, the surface of the tooth facing the base having the form of an undercut, the arrangement being such that a vial with an enlarged head can be engaged by pushing the head rearwardly into the circular array, towards the base, the columns flexing resiliently radially outwardly to allow the head to pass the teeth, whereafter the teeth engage behind the head, the undercut form of the teeth causing them to resist any attempted withdrawal of the vial.

2. A vial connector system according to claim 1 wherein the base of the vial retainer has openings at the angular locations of the detent elements for the passage of mould pins from the rear side of the base, for use in moulding the undercut surfaces of the teeth.

3. A vial connector system according to claim 2 including a rear member which overlies the rear surface of the base and closes off said openings.

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4. A vial connector system according to any preceding claim including a tubular spike projecting forwardly from the base within the array of detent elements.

5. A vial connector system according to any preceding claim including a protective cup member which embraces and/or is connected to the base and which encloses the detent elements; the cup member being wholly or partly removable to permit engagement of a vial. 10

6. A mould for producing a moulded vial retainer of a vial connector system according to any preceding claim, said mould having means defining a main mould cavity; a main mould core extending in a first direction into the 15 main mould cavity; and a rear mould member bearing a circular array of mould pins which, in use, extend into the main mould cavity in a direction opposite to said first direction, said pins terminating with angled surfaces for producing said undercut tooth surfaces.

7. A mould according to claim 6 wherein the means defining a main mould cavity comprise means defining a generally cup-shaped cavity having a base from which said main mould core projects, and a mould base which substantially closes off the mouth and is spaced from the main mould core so that the base of the vial retainer is defined between them; said mould base having an array of through-openings through which the mould pins extend in use.

S. A method of producing a vial connector system according to any of claims 1 to 5 wherein a vial retainer is moulded by means of a mould according to claim 6 or claim 7.

9. A method according to claim 8 including a further step of producing a rear member and connecting it to the rear surface of the base to close off the openings.

10. A vial connector system substantially as herein described with reference to and as illustrated in the accompanying drawings.

11. A mould for providing a vial retainer substantially as herein described with reference to and as illustrated in the accompanying drawings.

12. A method of producing a vial connector system substantially as herein described with reference to and as illustrated in the accompanying drawings.

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