WO1994000094A1

WO1994000094A1 - A reconstitution device

Info

Publication number: WO1994000094A1
Application number: PCT/IE1993/000035
Authority: WO
Inventors: Mary Therese Purcell; Oliver St. Clair Hood; Niall Anthony O'sullivan
Original assignee: Mary Therese Purcell; Hood Oliver St Clair; Sullivan Niall Anthony O
Priority date: 1992-06-22
Filing date: 1993-06-22
Publication date: 1994-01-06
Also published as: AU4353093A

Abstract

A reconstitution device (1) for coupling two containers, for example a vial (2) containing a drug and a flexible bag (3) containing a diluent, consisting of an enclosed two part housing (16, 17) within which is mounted a cannula (35) having two tips (37, 38). The device (1) is secured by a vial adaptor (20) to the vial (2) and by a bag adaptor (25) to the bag (3). After securing, the two parts of the housing (16, 17) are telescoped together causing the tips (37, 38) to pierce the vial (2) and bag (3) allowing communication between vial (2) and bag (3). The tips (37, 38) are not exposed at any time before, during or after use.

Description

"A reconstitution device"

Field of the Invention

The present invention relates to a reconstitution device and relates particularly though not exclusively to a device for reconstituting a drug.

More particularly the invention relates to a device of the type comprising first and second securing means for securing the device to first and second containers respectively, first and second piercing and communicating means for piercing and communicating with the first and second containers respectively, and communicating means for allowing communication between the first and second piercing and communicating means, and thereby allowing communication between the first and second containers.

Prior Art

Certain drugs are available in the form of a vial containing the drug in liquid or powder form and a flexible bag containing a diluent, and require to be reconstituted for use. The traditional method of reconstitution is to use a syringe to withdraw drug from the vial and inject the drug into the bag. Persons skilled in the art will be familiar with the many disadvantages of this method. The danger of the 2 health care worker being scratched or pricked, the risk of contamination of the needles, the need to relabel the bag correctly, and the laborious nature of the task.

More recently various mechanisms have been proposed for coupling the vial and bag to reduce the various disadvantages mentioned above.

WO 86/01712 describes various embodiments of a reconstitution device of the type described above, particularly directed to the medical field for the reconstitution of a drug stored in a drug vial with a diluent stored in a flexible bag. The first embodiment described includes two adaptors, a vial adaptor to be fitted over the cap of the vial and secured in this position and including a needle which penetrates the cap of the vial when fitted, and a bag adaptor to be fitted over a bag connector and secured in this position and including a needle which penetrates the bag connector when fitted. The reconstitution device permits permanent coupling of the vial and bag. A communication channel is provided between the two needles and includes a valve which may be closed at the time of fitting and securing, but which may be opened by relative rotation of the vial adaptor and the bag adaptor when it is desired to reconstitute the drug. 3 The above described reconstitution device is intended to reduce wastage of expensive drugs, and in particular, it is intended that the bag and vial may be coupled together in a pharmacy for subsequent use, but the valve may be left in the closed position, and may be opened to allow reconstitution immediately before the drug is to be used, thus avoiding wastage arising from reconstitution and non-use. The reconstitution device is also intended to eliminate the need for relabelling a bag after a drug has been added, because the vial which bears a label is now left permanently connected to the bag. The reconstitution device is also intended to reduce exposure of medical personnel to drugs, in particular by reducing leakage and by reducing the risk of accidental scratching or pricking, and for this purpose the needles are recessed in the adaptors instead of projecting therefrom.

Although the first embodiment described above addresses many of the problems which arise with traditional methods of reconstitution, it reduces but by no means eliminates the risk of scratching or pricking. As mentioned, the needles are recessed in the adaptors, but nevertheless there is a risk of pricking or scratching before and after use.

Object and Summary of the Invention 4 An object of the present invention is to provide an improved reconstitution device which substantially eliminates the problem of pricking and scratching before, during and after use.

The invention provides a reconstitution device of the type described comprising a housing defining a hollow interior region, the first and second piercing and communicating means being mounted in the hollow interior region of the housing, and being movable together or separately relative to the housing from a non-piercing and non-communicating position within the housing to a piercing and communicating position.

In use, the re-constitution device with the first and second piercing and communicating means contained within the housing is secured to the first and second containers, and after securing has been effected, the first and second piercing and communicating means are moved relative to the housing to pierce and to communicate with the first and second containers. In this way, the first and second piercing and communicating means are never exposed.

In a preferred embodiment of the invention the housing comprises a. first part and a second part, which together define the hollow interior region, the first and second parts being moveable relative to each other from a non-piercing position to a piercing position for providing relative movement between the housing and the first and second piercing and communicating means for moving the first and second piercing and communicating means into the piercing and communication position. Preferably, the first and second parts of the housing are provided by respective tubular members moveable relative to each other with a telescoping action. This preferred embodiment is of simple construction and is easy to operate.

Preferably, a releasable first retaining means is provided for retaining the first and second parts of the housing in the non-piercing position. Advantageously, the first retaining means comprises a retaining lug mounted on one of the first and second parts of the housing engageable with a retaining recess formed in the other of the first and second parts of the housing.

Preferably, the communicating means comprises a cannula extending between the first and second piercing and communicating means. Advantageously, the first and second piercing means are formed by pointed tips on opposite ends of the cannula. An abutment means may be provided on the cannula for engaging at least one of the first and second parts of the housing for moving one of the first and second piercing and communicating means into the piercing and communicating position. Preferably, the abutment means is provided on the cannula intermediate the first and second piercing means. Advantageously, the abutment means comprises an abutment sleeve extending around the cannula.

/ Preferably, guide means are provided in the housing for guiding at least one of the first and second piercing and communicating means into the piercing and communicating position.

Preferably, a pair of first and second apertures are provided in the respective first and second parts of the housing to facilitate movement of the first and second piercing means from the non-piercing and non- communicating to the piercing and communicating positions, and the apertures are covered for sterility purposes by seals pierceable by the first and second piercing means. The advantage of this arrangement is that the piercing points are kept completely sterile by being totally enclosed and sealed up to the moment of use. Preferably, the seals are in the form of sealing membranes integrally formed with the housing.

In accordance with a further feature of the invention second retaining means are provided for retaining one of the first and second piercing means in the piercing position so that when the first and second parts of the housing are moved relative to each other from the piercing position back to the non-piercing position the other of the first and second piercing means is moved to the non-piercing position.

Advantageously, the second retaining means is provided by a pair of inter engageable complementary formations, one of said formations being provided on one of the first and second parts of the housing, and the other being provided on the abutment means.

Preferably, one of the first and second securing means may be releasable securing means for releasably engaging the respective first or second container.

The first securing means may extend from the first part of the housing and the second securing means may extend from the second part of the housing, the first and second securing means and the first and second parts of the housing all being substantially co-axial with one another. Advantageously, the first and second securing means engage the respective containers with a transverse sliding action of the housing relative to the first and second containers. In a preferred embodiment of the invention each securing means defines an engagement cavity which partly defines the portion of the respective container to be engaged therein, an axially extending slot being provided in the securing means for accommodating entry of the container into the engagement cavity.

Advantageously, the respective securing means engage the respective containers with a snap fit action. Preferably, the securing means on the first part of the housing engages a cap of one of the containers, and the securing means on the second part of the housing engages a tubular extension of the other container.

Advantageously, the protective membranes separate the hollow interior region from the respective engagement cavities of the securing means.

Detailed Description of Preferred Embodiment

The invention will be more clearly understood from the following description of an embodiment thereof which is given by way of example only with reference to the accompanying drawings, in which: Fig. 1 is an exploded perspective view of a drug reconstituting device according to the invention,

Fig. 2 is a perspective view of portion of the device of Fig. 1 in the direction of the arrow X of Fig. 1,

Fig. 3 is a cross-sectional elevational view of the device of Fig. 1, shown before use,

Fig. 4 is a cross-sectional elevational view of the device of Fig. 1, shown during use, secured to but not yet communicating with two containers.

Fig. 5 is a cross-sectional elevational view of the device of Fig. 1, shown during use, secured to and communicating with two containers, and

Fig. 6 is a cross-sectional elevational view of the device of Fig. 1, shown after use, still secured to two containers but communicating with one only of the containers.

Referring to the drawings there is illustrated a drug reconstituting device according to the invention indicated generally by the reference numeral 1 for connecting two containers, namely, a first container and a second container together for delivering a drug in the first container into a diluent in the second container. In this embodiment of the invention the device 1 is for connecting a first container provided by a vial 2 which contains the drug in powder, liquid or syrup form with the second container provided by a bag 3 of flexible plastics material which contains the diluent. Such vials and bags will be well known to those skilled in the art, and only those parts of the vial 2 and bag 3 relevant to the invention are illustrated in the drawings and will be described briefly before the reconstituting device 1 is described in detail.

The vial 2 comprises an outlet means formed by an open mouth 4 which is closed by a cap 6, a central portion of which is formed by a pierceable closure membrane 7. The bag 3 comprises an outlet means formed by a tubular outlet member 9 defining an outlet bore 10 which is closed by a pierceable closure membrane 11. A securing neck or groove 12 extends circumferentially around the tubular outlet member 9 to facilitate securing a reconstituting device to the outlet member 9. Such construction of tubular outlet members 9 on diluent bags 3, and caps 6 on drug vials 2 is well known to those skilled in the art. The reconstituting device 1 comprises a housing 15 which is formed in two parts, namely, a first part 16 and a second part 17. The first part 16 is formed by an outer cylindrical tubular member 18, and the second part 17 is formed by an inner cylindrical tubular member 19 which is slidable within the outer member 18 with a telescoping type action.

A first securing means comprising a vial connector 20 for connecting and securing the housing 15 to the vial 2 extends substantially axially from the outer member 18 and engages the cap 6 of the vial 2 with a snap fit action as will be described below.

A second securing means comprising a bag connector 25 for connecting the housing 15 to the bag 3 extends axially from the inner tubular member 19 for engaging the outlet member 9 of the bag 3 with a snap fit action as will also be described below.

First and second disc members 27 and 28 are provided in the outer and inner members 18 and 19, respectively, and define with the outer and inner members 18 and 19 a hollow interior region 29. The first and second disc members 27 and 28 also isolate the hollow interior region 29 from the respective vial connector 20 and bag connector 25. In this embodiment of the invention the outer member 18, the vial connector 20 and first disc member 27 are of plastics material and are integrally injection moulded together. The inner member 19, bag connector 25 and second disc member 28 are also of plastics material integrally injection moulded together.

A first guide means, namely, a guide post 30 having a guide bore 31 extending therethrough extends upwardly from the first disc member 27 into the hollow interior region 29 and carries and slidably engages a cannula 35 of stainless steel material. The cannula 35 terminates at opposite ends in respective first and second piercing means, namely, a vial piercing point 37 and a bag piercing point 38 for piercing the closure membrane 7 in the vial cap 6 and the closure membrane 11 in the outlet 9 of the bag 3, respectively. The cannula 35 extending between the piercing points 37 and 38 acts as a communicating means communicating the piercing points 37 and 38 for communicating the vial 2 and bag 3 on piercing of the closure membranes 7 and 11. A first protective membrane 40 integral with the first disc member 27 closes the guide bore 31 of the guide post 30 for protecting the vial piercing point 37 of the cannula 35. A second protective membrane 41 formed in the second disc member 28 protects the bag piercing point 38 of the cannula 35. The inner and outer members 19 and 18 are slidably moveable relative to each other from a non-piercing position illustrated in Figs. 3 and 4 to a piercing position illustrated in Fig. 5 whereby the vial and bag piercing points 37 and 38 pierce the protective membranes 40 and 41 followed by the closure membranes 7 and 11 of the vial 2 and bag 3 when the vial 2 and bag 3 are secured to the device 1. A first releasable retaining means comprises a retaining lug 43 extending outwardly from the inner member 19 engageable in a retaining recess 44 in the outer member 18 for retaining the inner and outer members 18 and 19 in the non-piercing position and releasable to permit relative movement of the inner and outer members 18 and 19 to the piercing position. The retaining lug 43 is carried on a resilient member 46 integrally injection moulded with the inner member 19. Provision of the retaining means allows the device 1 to be secured to the vial 2 and bag 3 without danger of the vial and bag piercing points 37 and 38 of the cannula 35 piercing the closure membranes 7 and 11 of the vial 2 and bag 3, respectively.

A combined abutment means and second guide means, namely, an abutment and guide sleeve 50 extends around the cannula 35 for abutting engagement with the guide post 30 and/or the second disc member 28 for causing the cannula 35 to move with one of or both of the outer and inner members 18 and 19 to facilitate piercing of one or both of the closure members 7 and 11 by the vial and bag piercing points 37 and 38 of the cannula 35. The abutment and guide sleeve 50 is of plastics material and is fixed in position on the cannula 35 slightly below the mid-position of the cannula 35. Second retaining means for retaining the vial piercing point 37 in the piercing position comprises a retaining spigot 51 extending axially from the abutment sleeve 50 and integrally formed therewith which engages a complementary retaining bore 52 formed in the guide post 30 and co-axial with the guide bore 31. This facilitates disposing of the device 1 when attached to the vial 2 without any danger to the user of being scratched or pricked by the bag piercing point 38 of the cannula 35 as will be described below.

Returning now to the vial connector 20, the vial connector 20 comprises a base 54 extending outwardly of the outer member 18 and around the first disc member. 27, and a side wall 55 extending from the base 54 and defining with the base 54 a vial engagement cavity 56 for engaging the cap 6. A lip 57 extending inwardly from the side wall 55 engages against the cap 6. An entry slot .58 defined by the base 54, side walls 55 and the lip 57 slidably engages the cap 6 for transversely entering the cap 6 into the engagement cavity 56, and a pair of rails 61 are provided on the base 54 to facilitate this transverse movement. The rails 61 are in the form of parallel ribs on the surface of the base 54, and integrally formed with the base. Portions 59 of the lip 57 extend at opposite sides into the slot 56 for engaging a neck portion 60 of the vial 2 beneath the cap 6 with a snap fit action for releasably securing the vial 2 in the vial engagement cavity 56.

The bag connector 25 comprises a side wall 65 extending axially of the inner member 19. The side wall 65 defines with the second disc member 28 a bag engagement cavity 66 for engaging the outlet member 9 of the bag 3. An entry slot 68 defined by the side walls 65 facilitates transverse entry of the outlet member 9 into the bag engagement cavity 66.

To use the device 1, the first step is to secure the device 1 in position. With the inner member 19 and outer member 18 in the non-piercing position and the retaining lug 43 engaged in the retaining recess 44, the device 1 is secured to the vial 2 by entering the cap 6 of the vial 2 into the vial engagement cavity 56 through the entry slot 58 in the direction of the arrow A, see Fig. 1, until the vial 2 is securely engaged in the vial engaging cavity 56 by the snap fit action of the projecting portions 59 of the lip 57 of the neck 60 of the vial 2. The device 1 is then secured to the bag 3 by engaging the outlet member 9 in the bag engagement cavity 66 through the entry slot 68 in the direction of the arrow B until the snap fit action of the side walls secures the outlet member 9 in the bag engagement cavity 66 and the lug 67 in the inside face of the resilient member 46 mates with neck 12 of the outlet member.

When it is desired to deliver the drug in the vial 2 into the diluent in the bag 3, the resilient member 46 is depressed radially inwardly relative to the outer member 18 in the direction of the arrow C of Fig. 3 thereby disengaging the retaining lug 43 from the retaining recess 44. The inner member 19 is then moved axially into the outer member 18 in the direction of the arrow D of Fig. 3 to the piercing position, thereby causing the vial and bag piercing points 37 and 38 to pierce the protective membranes 40 and 41, respectively, and in turn the closure membranes 7 and 11, respectively. The cannula 35 is guided by the guide bore 31 in the guide post 30 as the piercing points 37 and 38 are being moved into the piercing position. The cannula 35 is also guided by the sliding axial movement of the sleeve 50 which is a flush fit in the outer member 18 and which is constrained to linear axial movement by a key 80 on the inner surface of the outer member 18 and a complementary keyway 81 in the side wall of the sleeve 50. Key 80 also mates with keyway 82 in the inner member 19 so that lug 43 in the inner member 19 is aligned with recess 44 in the outer member 18. Should one of the closure membranes 7 or 11 be resistant to piercing of the respective piercing points 37 and 38 as the inner member 19 is moved inwardly into the outer member 18 either the guide post 30 or the second disc member 28 engages the abutment sleeve 50 so that further movement of the inner member 19 into the outer member 18 causes the vial or bag piercing point 37 or 38 to pierce the closure membrane 7 or 11 which is resisting piercing. On the inner member 19 being moved relatively into the outer member 18 to the piercing position, the first and second piercing points 37 and 38 pierce the closure membranes 7 and 8 thereby communicating the vial 2 and bag 3 through the cannula 35. Thus it will be appreciated that the piercing points 37 and 38 do not contact the drug or diluent until the moment of use, unlike the situation described in WO 86/01712. As a result the time for any contamination to take place or for any chemical reaction between piercing points 37 and 38 and drug and diluent^'is greatly reduced.

By squeezing the bag 3 diluent is delivered through the 18 cannula 35 into the vial 2 which mixes with and dilutes the drug in the vial 2. The mixture in the vial 2 is then withdrawn back into the diluent in the bag 3. This operation is' continued a number of times until all 5 • traces of the drug in the vial 2 have been drawn into the bag 3. This procedure will be well known to those skilled in the art. To facilitate thorough draining of the drug from the vial 2 into the bag 3 the device 1, vial 2 and bag 3 should be oriented so that the vial 2

10 \ is above the bag 3 as the remaining portion of the mixture is being drawn from the vial 2 into the bag 3. Also the sleeve 50 is located on the cannula 35 in a position so that the piercing point 37 only just penetrates the vial 2, and as a result when the vial 2

15 is upside down above the bag 3, the piercing point 37 is at the very bottom i.e. just proud of the cap 6 of the vial 2, and all the drug drains from the vial 2.

The bag 3 is now ready for use. If desired the device 1 may be removed from the bag 3 and the device 1 and

20 vial 2 may be discarded. Removal of the device 1 and vial 2 facilitates use of the bag 3. Removal is achieved by moving the inner member 19 axially into the outer member 18 into the non-piercing position shown in Fig. 6. As the inner member 19 is being moved relative

25 to the outer member 18 the retaining action of the retaining spigot 51 in the retaining bore 52 retains the cannula 35 with the vial piercing point 37 engaged in the closure membrane 7 or the cap 6 of the vial 2. The bag piercing point 38 of the cannula 35 disengages from the closure membrane 11 of the outlet member 9 of the bag 3 and also disengages from the protective membrane 41 and the bag piercing point 38 is returned to the hollow interior region 29 thereby avoiding any danger of a user being pricked or scratched with the bag piercing point 38. The device 1 and vial 2 remain assembled together and may be disposed. Since the vial piercing point 37 is engaged in the vial 2 there is no danger of a user being scratched or pricked by the vial piercing point 37. Another reason for removal of the vial and device is to allow the contents of a second vial to be added to the contents of the bag, where a double dose is required to be administered or where two compatible drugs are to be administered at the same time.

The advantages of the invention are many. The principal advantage of the invention is that the piercing points 37 and 38 remain enclosed before, during and after use, so that there is no risk of pricking or scratching. A further advantage is that the piercing points 37 and 38 are completely sterile. A still further advantage is that by virtue of the fact that the housing comprises an outer and inner member 18 and 19 slidable relative to each other from a non- piercing to a piercing position, the device 1 may be assembled to a vial 2 and bag 3 without piercing of the closure membranes 7 and 11 in the vial and bag until it is desired to administer the drug so that the time for contamination is reduced. This is a particularly important advantage in that it facilitates assembly of a device 1 to a vial and bag in a pharmacy for despatch to a ward of a hospital or the like. The mixing of the drug and diluent can then be deferred until the drug is to be administered, and this operation can readily easily be carried out on the ward of a hospital.

It will be appreciated that while the device has been described as being arranged to retain the vial piercing point 37 in the piercing position and accordingly, the bag piercing point 38 within the hollow interior region 15 when the device 1 is detached from a bag 3, it is envisaged in certain cases that movement of the inner and outer members relative to each other from the piercing to the non-piercing position may cause the cannula to move relative to the inner and outer members so that both piercing points are protected within the hollow interior region.

While the housing has been described as comprising first 16 and second 17 parts movable relative to each other, while this is preferable, it is not essential. Further, it will be appreciated that while the first 16 and second 17 parts of the housing have been described as being of cylindrical tubular construction, the first and second parts of the housing may be of any other suitable or desired construction.

It is further envisaged that while it is preferable, it is not essential that the first 37 and second 38 piercing means be provided on the same cannula 35. In certain cases, it is envisaged that separate cannulae may be provided and these would be communicated by a suitable communicating means. Needless to say, it is envisaged that any other suitable communicating means besides a cannula may be provided. It will of course be appreciated that other suitable piercing means besides a pointed cannula may be used.

While a particular shape and construction of first 20 and second 25 securing means for securing the housing to the vial 2 and bag 3 have been described, any other suitable securing means may be used. In all cases, it is not essential that the securing means should be releasable securing means. Needless to say, any other suitable first retaining means may be provided for retaining the housing in the non-piercing position. Any other suitable second retaining means may be provided for retaining the cannula with the vial piercing point engaged in the vial. Indeed, in certain cases, the second retaining means may be dispensed with.

It is also envisaged that the securing means may be provided by connectors which would be engageable with the vial and bag respectively by axially inserting the cap of the vial and outlet member of the bag into the respective securing means.

Claims

1. A reconstitution device comprising first (56,58,59) and second (65,66,68) securing means for securing the device to first (2) and second (3) containers respectively, first (37) and second (38) piercing and communicating means for piercing and for communicating with the first (2) and second (3) containers respectively, and communicating means (35) for allowing communication between the first (37) and second (38) piercing and communicating means, and thereby allowing communication between the first (2) and second (3) containers characterized in that the device (1) comprises a housing (15) defining a hollow interior region (29), the first (37) and second (38) piercing and communicating means being mounted in the hollow interior region (29) of the housing (15), and being movable together or separately relative to the housing (15) from a non-piercing and non-communicating position within the housing (15) to a piercing and communicating position.

2. A reconstitution device as claimed in Claim 1, characterized in that the housing (15) comprises a first part (16) and a second part (17), which together define the hollow interior region (29), the first and second parts (16,17) being moveable relative to each other from a non-piercing position to a piercing position for providing relative movement between the housing (15) and the first (37) and second (38) piercing and communicating means for moving the first (37) and second (38) piercing and communicating means into the piercing and communication position.

3. A reconstitution device according to Claim 2, characterized in that the first (16) and second (17) parts of the housing (15) are provided by respective tubular members (18,19) moveable relative to each other with a telescoping action.

4. A reconstitution device according to Claim 2, characterized in that a releasable first retaining means (43,44,46) is provided for retaining the first (16) and second (17) parts of the housing (15) in the non-piercing position.

5. A reconstitution device according to Claim 4, characterized in that the first retaining means comprises a retaining lug (44) mounted on one of the first (16) and second (17) parts of the housing (15) engageable with a retaining recess (44) formed in the other of the first (16) and second (17) parts of the housing.

6. A reconstitution device according to any one of the preceding claims, characterized in that the communicating means (35) comprises a cannula (35) extending between the first (37) and second (38) piercing and communicating means.

7. A reconstitution device according to Claim 6, characterized in that the first (37) and second (38) piercing and communicating means are formed by pointed tips (37,38) on opposite ends of the cannula (35).

8. A reconstitution device according to Claim 6, characterized in that an abutment means (50) is provided on the cannula (35) for engaging at least one of the first (16) and second (17) parts of the housing for moving one of the first (37) and second (38) piercing and communicating means into the piercing and communicating position.

9. A reconstitution device according to Claim 8, characterized in that the abutment means (50) is provided on the cannula (35) intermediate the first (37) and second (38) piercing and communicating means.

10. A reconstitution device according to Claim 9, characterized in that the abutment means (50) comprises an abutment sleeve (50) extending around the cannula (35).

11. A reconstitution device according to Claim 1, characterized in that guide means (30) are provided in the housing for guiding at least one of the first (37) and second (38) piercing and communicating means into the piercing and communicating position.

12. A reconstitution device according to Claim 1, characterized in that a pair of first (40) and second (41) pierceable seals are provided in the respective first (16) and second (17) parts of the housing (15) to facilitate movement of the first (37) and second (38) piercing and communicating means from the non-piercing and non-communicating to the piercing and communicating positions.

13. A reconstitution device according to Claim 12, characterized in that the pierceable seals (40,41) are in the form of membranes (40,41) integrally formed with the housing (15,16,17,18,19).

14. A reconstitution device according to Claim 1, characterized in that second retaining means (51,52) are provided for retaining one of the first (37) and second (38) piercing means in the piercing and communicating position so that when the first (16) and second (17) parts of the housing (15) are moved relative to each other from the piercing and communicating position back to the non-piercing and non-communicating position the other of the first (37) and second (38) piercing means is moved to the non- piercing position.

15. A reconstitution device according to Claim 14, characterized in that the second retaining means (51,52) is provided by a pair of inter engageable complementary formations, one of said formations (52) being provided on one of the first (16) and second (17) parts of the housing, and the other of said formations (51) being provided on the abutment means (50).

16. A reconstitution device according to Claim 1, characterized in that one or both of the first (20) and second (25) securing means may be releasable securing means for releasably engaging the respective first (2) and/or second (3) containers.

17. A reconstitution device according to Claim 1 characterized in that the first securing means (20) extends from the first part (16) of the housing (15) and the second securing means (25) extends from the second part (17) of the housing (15), the first (20) and second (25) securing means being substantially co¬ axial with the first (16) and second (17)^{^}parts of the housing (15).

18. A reconstitution device according to Claim 1 characterized in that the first (20) and second (25) securing means engage the respective containers (2,3) with a transverse sliding action of the housing (15) relative to the first (2) and second (3) containers.

19. A reconstitution device according to Claim 1 characterized in that each securing means defines an engagement cavity (56,66) which partly defines the portion of the respective container (2,3) to be engaged therein, an axially extending slot (58,68) being provided in the securing means for accommodating entry of the container (2,3) into the engagement cavity (56,66) .

20. A reconstitution device according to Claim 1 characterized in that the respective securing means

(20,25) engage the respective containers (2,3) with a snap fit action.

21. A reconstitution device according to Claim 2, characterized in that the securing means (20) on the first part (16) of the housing (15) engages a cap (6) of one of the containers (2), and the securing means (25) on the second part (17) of the housing (15) engages a tubular extension (9) of the other container (3).

22. A reconstitution device according to Claim 12 characterized in that the protective membranes (40,41) separate the hollow interior region (29) from the respective engagement cavities (56,66) of the securing means (20,25).