EP0426403A1

EP0426403A1 - Transfer and dispensing device

Info

Publication number: EP0426403A1
Application number: EP19900311814
Authority: EP
Inventors: John Rohrbough
Original assignee: David Bull Laboratories Pty Ltd
Current assignee: David Bull Laboratories Pty Ltd
Priority date: 1989-11-01
Filing date: 1990-10-29
Publication date: 1991-05-08
Also published as: FI905390A0; IE903141A1; NO904733L; NZ234984A; ZA906801B; JPH03186271A; AU637130B2; CA2023887A1; AU6106390A; NO904733D0; KR910009231A

Abstract

A transfer and dispensing device composed of detachable parts, for gravity flow transfer of a medicament from a charging vial to a receiving vial, allowing admixture in the receiving vial without the need, for retransfer to the charging vial. Controlled flow of air facilitates the transfer while preventing leakage of liquid from the device. One of the parts, together with the filled receiving vial, can be detached from the device and connected directly to a device for dispensing the admixture. The transfer and dispensing device includes opposed separable first and second spikes (2,3), each having an outer pointed end (4,5) and an inner attachment end (6,7). A fluid bore (8,9) extends through each spike (2,3) from its inner end (6,7) to its outer end (4,5) and a separate airway (14,15) extends through each spike (2,3) from its outer end (4,5) towards its inner end (6,7). Each airway (14,15) terminates in an air port (18,19) remote from the outer end (4,5) of the spike (2,3) and spaced from the inner end (6,7) of the spike (2,3). Each airway (14,15) contains a flow restriction formation (20,21) to permit, in use, controlled flow of air through the airway (14,15) while preventing flow of liquid through the airway (14,15). The first and second spikes (2,3) have counterpart connection formations (26,27) to enable releasable interconnection of the inner ends (6,7) of the spikes (2,3) so as to flow connect their bores (8,9) in a fluid tight manner and permit a liquid to flow from the outer end (4,5) of one spike (2,3) to the outer end (4,5) of the other spike (2,3) via the flow connected bores (8,9). A limiting means (30,31) on each spike (2,3) limits, in use, the extent of penetration of their outer ends (4,5) through penetrable seals closing vials to be connected to the opposed outer ends (4,5) of the respective spikes (2,3).

Description

The present invention relates to a transfer and dispensing device, and more particularly to such a device which may include ends to penetrate seals of opposed medicament containing vials, for medicament transfer therethrough from one vial to the other.
U.S. Pat. 2,724,383 to Lockhart, U.S. Pat. 3,392,726 to Pochyla, and U.S. Pat. 2,362,025 to Price, variously disclose devices formed of a single hollow needle having opposed pointed ends and an intermediate portion fixing the needle in the first of two telescoping necks of two opposed flexible bags or other medicament containers, the first charged with a powder and the second with a liquid, and each having a seal facing its needle end, such that on moving the necks toward each other, the needle ends penetrate the seals to flow connect the containers.
When so connected, the second bag is squeezed or other extraneous mechanical means are used to force the liquid from this container into the first container to admix with the powder, whereupon the latter in whose neck the needle intermediate portion is affixed, may be separated from the empty container and used as a hypodermic syringe, or be provided with a separate dispensing needle.
U.S. Pat. 3,306,563 to Soto shows a similar single hollow needle having opposed pointed ends and an intermediate flange coated with adhesive to form seals at the needle ends as they puncture opposed flexible bags forced against the flange to flow connect the bags, one charged with a liquid medicament and the other with a powder medicament to be admixed, the resulting filled bag apparently being separated from the empty bag and squeezed to dispense the admixture via the exposed needle end.
U.S. Pat. 4,405,047 to Barba discloses a similar single needle having opposed pointed ends and an intermediate flange, but in this case with two parallel bores communicating the needle ends at slightly axially offset points, the needle being used vertically so that its ends penetrate stoppers on opposed upper and lower medicament containing vials forced thereagainst to flow connect the vials, the upper vial being charged with a liquid and the lower one with a powder, whereupon the lower vial is filled with the liquid by gravity flow from the upper vial, and the filled lower vial then separated from the needle.
This patent further discloses a second needle, also used vertically and having two parallel bores, but having only one pointed end forming an upper inlet end containing both bores, the opposite end being fixed as a lower outlet end within a dispensing device drip chamber therebelow and containing only one of the bores, the other bore leading to an outwardly directed ball valve containing branch portion remote from the needle ends and serving as an air relief line. The stopper of the above noted filled lower vial is then repenetrated by the second needle pointed end to flow connect it with the drip chamber to dispense its contents.
It would be a significant advance in the art to provide a transfer and dispensing device of detachable parts for gravity flow transfer of a medicament to a receiving vial for admixture therein without retransfer to a charging vial, under controlled flow of air facilitating the transfer while preventing leakage of liquid from the device, yet permitting one of the parts and the filled receiving vial to be detached and connected directly and without modification to a device for dispensing the admixture.
It is accordingly an object of the present invention to overcome, or at least alleviate one or more of the difficulties and/or deficiencies related to the prior art.
Accordingly in a first aspect of the present invention, there is provided a transfer and dispensing device comprising opposed separable first and second spikes, each having an outer pointed end and an inner attachment end,
a fluid flow bore extending through each spike from its inner end to its outer end, and a separate airway extending through each spike from its outer end toward its inner end and terminating in an air port remote from its outer end and spaced from its inner end, each airway containing a flow restriction formation permitting, in use, controlled flow of air therethrough while preventing flow of liquid therethrough,
the first spike inner end having a connection formation communicating with its bore and the second spike inner end having a counterpart connection formation communicating with its bore, the two connection formations enabling the releasable interconnection of the inner ends of the spikes to flow connect their bores in fluid tight condition to permit a liquid to flow from the outer end of one spike to the outer end of the other spike via the flow connected bores; and
a limiting means on each spike to limit, in use, the extent of penetration of their outer ends through penetrable seals closing respective vials to be connected to the opposed outer ends of the respective spikes.
The transfer and dispensing device according to this aspect of the present invention may provide gravity flow transfer of a liquid medicament from a charging vial thereabove penetrated by the upper spike, to a solid or liquid medicament in a receiving vial therebelow penetrated by the lower spike, for admixture in the receiving vial without retransfer to the charging vial, under controlled flow of air facilitating the transfer while preventing liquid leakage from the device, yet permitting the lower spike and receiving vial to be detached from the upper spike and connected directly and without modification to a device for dispensing the admixture.
It will be understood that the device may be used to administer quickly and safely a preset dosage of two medicaments separated from each other until used, and readily combined at the time of use, under improved conditions of sterility, the device may be provided in compact storable sterile form. The device may be fabricated from conventional materials and components in simple and inexpensive manner.
In a preferred aspect of the present invention the transfer and dispensing device may further include associated first and second vials, each forming a medicament containing chamber having an opening closed by a penetrable seal, the medicament of the second vial being a liquid and that of the first vial being a liquid or a solid, the vials being arranged such that upon penetrating the first vial seal by the first spike outer end and penetrating the second vial seal by the second spike outer end, gravity flow transfer of the liquid from the second vial through the bores of the opposed interconnected spikes to the first vial will take place when the second spike is disposed generally above the first spike.
Preferably, the connection formations include a luer lock formation on the first spike and a counterpart luer lock formation on the second spike mating with the first spike luer lock formation. When detached from the second spike, the first spike may be directly connected without modification to a dispensing device having a corresponding counterpart luer lock formation mating with the first spike luer lock formation.
In particular, each flow restriction formation may comprise a check valve and/or a hydrophobic air filter.
In a preferred embodiment of the present invention the first and/or second spike is tubular and defines a generally axial bore therethrough, the or each airway includes an outer end portion located laterally of the axial bore and extending from the spike outer end and a branch portion extending outwardly from the spike at a point remote from the spike outer end and toward the spike inner end at an inclined angle to the axis of the bore, and the or each flow restriction formation comprises a check valve in the form of a ball valve in the corresponding branch portion.
More preferably the spikes are tubular and define generally axial bores therethrough, each airway includes an outer end portion located laterally of the axial bore and extending from the spike outer end and a branch portion extending outwardly from the spike at a point remote from the spike outer end and toward the spike inner end at an inclined angle to the axis of the bore, and each flow restriction formation comprises a check valve in the form of a ball valve in the corresponding branch portion.
Thus, when the opposed spikes are interconnected and arranged generally one above the other with their bore axes extending generally vertically, the lower spike ball valve will permit air outflow through its port while preventing liquid outflow therethrough, and the upper spike ball valve will permit air inflow through its port while preventing liquid outflow therethrough.
In an alternative embodiment of the present invention, the fluid bore is located laterally of the spike axis and includes a scoop-type outer end opening, and the airway includes an outer end portion located laterally of the spike axis and extending centrally from the spike at a point remote from the spike outer end; the diameter of the airway being such that fluid flow through the airway is prevented.
It has been found that the device according to this aspect of the present invention may have a reduced tendency for liquid or vacuum blockage of the airway in use. Preferably the diameter of the airway is in the range of approximately 0.5mm to approximately 1.5mm.
More preferably in this embodiment the flow restriction formation in the airway comprises a hydrophobic air filter and optionally a cap therefor. A hinged cap air filter is preferred. In use in this embodiment when the opposed spikes are interconnected and arranged generally one above the other, the first and second vial seals may be penetrated. The hinged caps may then be opened to permit air to vent the respective vials and permit fluid flow with gravity.
Limiting means may be provided on the spikes to limit the extent of penetration of their outer ends through corresponding penetrable seals closing respective vials to be connected to the opposed spike outer ends. Also, a removable closure may be provided for the inner end of one spike to seal its bore thereat upon detachment from the inner end of the other spike.
In a further aspect of the present invention there is provided a kit of parts including first and second vials, each forming a medicament containing chamber having an opening closed by a penetrable seal; and a transfer and dispensing device comprising each having an outer pointed end and an inner attachment end,
a fluid flow bore extending through each spike from its inner end to its outer end, and a separate airway extending through each spike from its outer end toward its inner end and terminating in an air port remote from its outer end and spaced from its inner end, each airway containing a flow restriction formation permitting, in use, controlled flow of air therethrough while preventing flow of liquid therethrough,
the first spike inner end having a connection formation communicating with its bore and the second spike inner end having a counterpart connection formation communicating with its bore, the two connection formations enabling the releasable interconnection of the inner ends of the spikes to flow connect their bores in fluid tight condition to permit a liquid to flow from the outer end of one spike to the outer end of the other spike via the flow connected bores; and
a limiting means on each spike to limit, in use, the extent of penetration of their outer ends through penetrable seals closing respective vials to be connected to the opposed outer ends of the respective spikes.
Preferably the kit further includes a dispensing device including a bore and a connection formation communicating with its bore and adapted to mate with the counterpart connection formation of the second spike.
The present invention will be now more fully described with reference to the accompanying drawings. It should be understood, however, that the description following is illustrative only and should not be taken in any way as a restriction on the generality of the invention described above.
In the drawings,

Figure 1 is a schematic exploded view of a transfer and dispensing device according to an embodiment of the present invention, formed of an opposed pair of unilateral spikes;
Figure 2 is a schematic view of the device of Figure 1 in generally vertical position, having opposed medicament containing vials attached via their penetrated seals to the spike outer ends for gravity flow transfer of a liquid from the upper vial through the device to the lower vial, and
Figure 3 is a schematic exploded view of a transfer and dispensing device according to an alternative embodiment of the present invention.
Figure 3a is a partial side view of the transfer and dispensing device of Figure 3 along the line A-A.

Referring to the drawings, and initially to Figure 1, a vial transfer and dispensing device 1 is shown, including a pair of opposed separate unilateral spikes 2,3, respectively having an outer pointed end 4,5 and an inner attachment end 6,7, and a fluid flow bore 8,9 extending through the spike from an outer end opening 10,11 to an inner end opening 12,13 thereof.
Spikes 2,3 also respectively have a separate airway 14,15 extending through the spike from an outer end opening 16,17 toward inner end 6,7 and terminating in an air port 18,19 remote from outer end 4,5 and spaced from inner end 6,7. Each airway 14,15 contains a flow restriction formation permitting controlled flow of air therethrough while preventing flow of liquid therethrough, such as a check valve in the form of a ball valve 20,21 having a ball 22,23, e.g. of stainless steel, and/or a hydrophobic air filter 24,25 (shown in phantom in Figure 1), each of which operates in known manner to permit air to bypass ball 22,23 or flow through filter 24,25, i.e. in either direction, while preventing liquid outflow through port 18,19.
Optionally, each hydrophobic air filter 24,25 may be provided with a hinged cap 24a, 25a. The hinged caps further assist in preventing flow of liquid through the airways 14,15.
In particular, spikes 2,3 are tubular and define generally axial bores 8,9 therethrough, while airways 14,15 respectively include an outer end portion 14a, 15a located laterally of axial bore 8,9 and extending from spike outer end 4,5, and a branch portion 14b,15b extending outwardly from spike 2,3 at a point remote from spike outer end 4,5 and toward spike inner end 6,7 at an inclined, e.g. 45 degree, angle to the axis of bore 8,9.
Thus, when opposed spikes 2,3 are interconnected and arranged generally with spike 3 inverted above spike 2 and their bore axis extending generally vertically, upright ball valve 20 of lower spike 2 will permit air outflow through port 18 while preventing liquid outflow therethrough, and inverted ball valve 21 of upper spike 3 will permit air inflow through port 19 while preventing liquid outflow therethrough.
Inner end 6 of spike 2 has a connection formation such as an external luer lock tab 26 and tapered female inlet 28 communicating with bore 8, and inner end 7 of spike 3 has a counterpart connection formation such as an internal luer lock tab 27 and tapered male outlet 29 communicating with bore 9 and mating with external luer lock tab 26 and tapered female inlet 28 to interconnect releasably inner ends 6,7 of spikes 2,3 and flow connect their bores 8,9 in fluid tight condition, to permit a liquid to flow from outer end opening 11 of spike 3 to outer end opening 10 of spike 2 via the flow connected bores 8,9. These luer lock formations permit easy and rapid connection and relase of spikes 2,3, and may be of standard size.
Lateral flanges 30,31 are provided on the intermediate shank portions of spikes 2,3 adjacent branch portions 14b,15b, to define pointed outer ends 4,5 outwardly thereof as relatively short ends, and to form finger grips to aid in manipulating spikes 2,3 to connect and disconnect inner ends 6,7, e.g. by twisting clockwise to connect their luer lock formations and counterclockwise to disconnect such formations, as well as limiting means to limit the extent of penetration of such short outer ends 4,5 through the penetrable seals closing the vials to be connected to spikes 2,3 (Figure 2). Outer ends 4,5 need only be sufficiently long to penetrate the vial seals to communicate openings 10,11 and 16,17 with the vial chambers.
A removable closure cap 32 is attached by cord or strap 33 to branch portion 14b of lower spike 2 for mounting on inner end 6, e.g. to enclose external luer lock tab 26, for sealing bore 8 thereat upon detaching spike 2 from inner end 7 of spike 3. To further aid in detaching spike 3 from spike 2, a vertical twist tab 34 may be provided on the side of spike 3 extending in a radial plane passing through the axis of bore 9.
As shown in Figure 2, associated, e.g. lower and upper, vials 40,41, which may be of the standard known type, respectively forming a medicament containing chamber having an opening 42,43 closed by a penetrable seal 44,45, such as a rubber plug or stopper, may be used with device 1. Upper vial 41 is charged with a preset dosage of a liquid, e.g. sterile water, as medicament 47, and lower vial 40 is charged with a preset dosage of either another liquid or a solid, such as a particulate powder or tablet, etc., as medicament 46 compatible with, e.g. dissolvable in, medicament 47 of upper vial 41.
Thus, upon penetrating seal 44 of upright lower vial 40, positioned on a, e.g. horizontal, support surface, by forcing thereagainst downwardly directed pointed outer end 4 of upright spike 2 as lower spike up to flange 30, and penetrating seal 45 of inverted upper vial 41, held above device 1, by forcing vial 41 downwardly against upwardly directed pointed outer end 5 of inverted spike 3 up to flange 31, i.e. when upper spike 3 is connected to lower spike 2, gravity flow transfer of liquid 47 from upper vial 41 through bores 8,9 of the opposed interconnected spikes 2,3 to lower vial 40 will take place.
This transfer will clearly occur when spike 3 and its penetrated liquid containing vial 41 are disposed generally above spike 2 and its liquid or solid containing vial 40, sufficiently to achieve gravity flow. At this time, any air in lower vial 40 will be vented through upright lower spike valve 20 and/or hydrophobic air filter 24, while vacuum lock in upper vial 41 will be prevented by inflow of compensating bleed line or relief line air through inverted upper spike valve 21 and/or hydrophobic air filter 25, into upper vial 41 as its liquid 47 flows into lower vial 40 to admix with its liquid or solid 46.
On the other hand, valves 20,21 and/or filters 24,25, by their very nature, will prevent outflow of liquid from device 1, otherwise sealed by the connection of inner ends 6,7 and the respective interconnections of spike outer ends 4,5 in penetrating engagement with seals 44,45 of vials 40,41.
This prevention of liquid outflow will be achieved in any upright or inverted position of spikes 2,3 due to the inherent operation of valves 20,21 and/or hydrophobic air filters 24,25, and thus the flow control system in airways 14,15 will function generally in any spatial orientation, i.e. horizontal, vertical, angular, upright or inverted positioning, of the opposed spikes. However, for proper and efficient operation spike 3 must be positioned above spike 2 to assure gravity flow of liquid 47 from its connected vial 41 to vial 40 therebelow.
Once transfer of liquid 47 to lower vial 40 has been completed, spike 3 may be easily and rapidly detached from spike 2 by mere twisting action, e.g. aided by flanges 30,31 and tab 34, to disconnect their luer lock connections 26,28 and 27,29 at inner ends 6,7, for removing spike 3 and its vial 41 and exposing inner end 6 of spike 2 still connected to vial 40. Inner end 6 of spike 2 can then be sealed by closure cap 32, and spike 2 and its connected vial 40 manually shaken to assure complete admixing of medicaments 46 and 47.
Spike 2 and vial 40 may then be used directly and without modification with a standard dispensing device, such as a conventional empty disposable syringe, having a bore and a counterpart, e.g. standard, connection formation, like luer lock tab 27 and tapered male outlet 29, communicating with its bore and mating with luer lock tab 26 and tapered female outlet 28 of spike 2, to interconnect releasably the syringe and spike 2 and flow connect their bores in fluid tight condition. The admixed medicaments 46,47 in vial 40 can be dispensed via bore 4 of spike 2 into the syringel e.g. by simply inverting vial 40 and aspirating any desired volume thereof into the syringe.
As shown in Figure 3 an alternative embodiment of a vial transfer and dispensing device 1 is shown where like parts are identified with like numerals. Opposed spikes 2′ and 3′ have a separate relatively narrow airway 14′,15′ extending through each spike from an outer end opening 16′,17′ adjacent the pointed end toward inner end 6′,7′ and terminating in an air port 18′,19′ remote from outer end 4′,5′ and spaced from an inner end 6′,7′. Each airway 14′,15′ contains a flow restriction formation permitting controlled flow of air therethrough, such as a hydrophobic air filter 24′,25′ which permits air to flow through filter 24′,25′, while preventing liquid outflow through port 18′,19′. Each hydrophobic air filter 24′.25′ is provided with a hinged cap 48,49 which may be opened to permit air to vent the respective vials and permit fluid flow with gravity.
Each spike 2′,3′ is tubular and defines a fluid bore 8′,9′ therethrough located laterally of the spike axis and includes a scoop-type outer end opening 10′,11′ which is rearwardly spaced from the spike pointed end on a concave face 26′,27′. Airway 14′,15′ includes an outer end portion 14a′,15a′ located laterally of the spike axis and a radial portion 14b′,15b′ extending outwardly from spike 2′,3′ at a 90^o angle.
Lateral flanges 30′,31′ are provided on the intermediate shank portions of spikes 2′,3′ to define pointed outer ends 4′,5′ outwardly thereof as relatively short ends, and to form finger grips to aid in manipulating spikes 2′,3′ to connect and disconnect inner ends 6′,7′, e.g. by twisting clockwise to connect their luer lock formations and counterclockwise to disconnect such formations, as well as limiting means to limit the extent of penetration of such short outer ends 4′,5′ through the penetrable seals closing the vials to be connected to spikes 2′,3′ (Figure 2). Outer ends 4′,5′ need only be sufficiently long to penetrate the vial seals to communicate openings 10′,11′ and 16′,17′ with the vial chambers.
Thus when opposed spikes 2′ and 3′ are interconnected and arranged generally with spike 3′ inverted above spike 2′, the hydrophobic air filter 24′ will permit air outflow through port 18′ while preventing liquid outflow therethrough and hydrophobic air filter 25′ will permit air inflow through port 19′ which preventing liquid outflow therethrough.
All portions of the spikes, including the short pointed outer ends, may be made from any suitable rigid plastic such as polycarbonate, e.g. by injection molding technique, especially with all portions of each spike being integrally interconnected, e.g. by sonic welding technique, to form a one-piece member. Thus, no portion of the spikes need be made from metal, which is significant in the case of plastic short pointed outer ends 4,5 in that while they will be sufficiently pointed to achieve rapid penetration of standard rubber or like material stoppers on the vials, they will not be so sharp as to present a danger of puncturing the skin of the user.
Moreover, in fabricating the plastic spikes, there is no need to undergo the trouble and expense of providing separate metal needles for incorporation into the spikes and connecting the other spike portions thereto, e.g. by staking technique, nor of cutting or grinding the metal needle outer ends to form them into sharp pointed ends to penetrate the vial stoppers, and in turn cleansing the needles to remove undesired metal particulates generated during the cutting or grinding.
On the other hand, valves 20,21 may contain balls 22,23 of stainless steel or other suitable commercially available material. Hydrophobic air filters are conventional elements which may be made of appropriate hydrophobic plastic and simply mounted, e.g. as discs, against recessed shoulders inwardly of the ports in accordance with known techniques.
Hence, the device according to the present invention may be used as a manually operated liquid-liquid (wet-wet) or liquid-solid (wet-dry powder) mixing and transfer system. It is especially useful for combining the medicaments by one-way transfer from the upper vial to the lower vial without retransfer to the upper vial, instead attaining mixing only in the lower vial, after detaching the upper spike and its vial and closing the lower vial and lower spike.
The spikes and vials may be compactly prepackaged as disposable, one-time use, sterile items, e.g. as an emergency kit, with the spikes connected as a preassembled unit having removable protective caps (not shown) on their outer ends, with similar caps being provided on the vial stoppers.
This permits the steps of opening the package, removing the caps, pushing the vials onto the spike ends for transfer and mixing, separating the filled lower vial and lower spike from the upper spike and upper vial, closing the lower spike inner end with its cap, agitating the medicaments in the lower vial, replacing the cap by the standard syringe, and dispensing the medicament mixture, e.g. by aspirating it into the syringe, all to be effected easily and rapidly, without danger to the user from contact with toxic or hazardous medicaments or substances or sharp metal needle points, or the need to modify the lower spike to accommodate such standard syringe, and at minimum risk of contaminating the sterile medicaments or the environment.

Claims

1. A transfer and dispensing device comprising opposed separable first and second spikes, each having an outer pointed end and an inner attachment end,
a fluid flow bore extending through each spike from its inner end to its outer end, and a separate airway extending through each spike from its outer end toward its inner end and terminating in an air port remote from its outer end and spaced from its inner end, each airway containing a flow restriction formation permitting, in use, controlled flow of air therethrough while preventing flow of liquid therethrough,
the first spike inner end having a luer lock connection formation communicating with its bore and the second spike inner end having a counterpart luer lock connection formation communicating with its bore,the two connection formations enabling the releasable interconnection of the inner ends of the spikes to flow connect their bores in fluid tight condition to permit a liquid to flow from the outer end of one spike to the outer end of the other spike via the flow connected bores; and
a limiting means on each spike to limit, in use, the extent of penetration of their outer ends through penetrable seals closing respective vials to be connected to the opposed outer ends of the respective spikes.

2. A device according to claim 1 including associated first and second vials, each forming a medicament containing chamber having an opening closed by a penetrable seal, the medicament of the second vial being a liquid and the medicament of the first vial being a liquid or a solid, the vials being arranged such that, in use, upon penetrating the first vial seal by the first spike outer end and penetrating the second vial seal by the second spike outer end, gravity flow transfer of the liquid from the second vial through the bores of the opposed interconnected spikes to the first vial will take place when the second spike is disposed generally above the first spike.

3. A device according to claim 1 wherein the connection formations include a luer lock formation on the first spike and a counterpart luer lock formation on the second spike mating with the first spike luer lock formation.

4. A device according to claim 1 wherein the first and/or second flow restriction formation comprises a check valve.

5. A device according to claim 1 wherein the first and/or second flow restriction formation comprises a hydrophobic air filter and cap therefor.

6. A device according to claim 1 wherein the first and/or second flow restriction formation comprises a check valve and a hydrophobic air filter.

7. A device according to claim 1 wherein the first and/or second spike is tubular and defines a generally axial bore therethrough, the or each airway includes an outer end portion located laterally of the axial bore and extending from the spike outer end and a branch portion extending outwardly from the spike at a point remote from the spike outer end and toward the spike inner end at an inclined angle to the axis of the bore, and the or each flow restriction formation comprises a check valve in the form of a ball valve in the corresponding branch portion.

8. A device according to claim 1 wherein the first and/or second spike is tubular and defines a generally axial bore therethrough, the or each airway includes an outer end portion located laterally of the axial bore and extending from the spike outer end and a branch portion extending outwardly from the spike at a point remote from the spike outer end and toward the spike inner end at an inclined angle to the axis of the bore, and the or each flow restriction formation comprises a check valve in the form of a ball valve in the corresponding branch portion, such that when the opposed spikes are interconnected and arranged generally one above the other with their bore axes extending generally vertically, the lower spike ball valve will permit air outflow through its port while preventing liquid outflow therethrough, and the upper spike ball valve will permit air inflow through its port while preventing liquid outflow therethrough.

9. A device according to claim 1 wherein she outer end of at least said first spike has a concave face and the fluid flow bore opens into that concave face, the airway having a diameter over at least part of its length of sufficient restriction to at least substantially prevent liquid flow therethrough.

10. A device according to claim 9 wherein the diameter of the airway is in the range of approximately 0.5mm to 1.5mm.

11. A device according to claim 9 wherein the first and/or second flow restriction formation comprises a hydrophobic air filter and cap therefor.

12. A device according to any one of the preceding claims wherein a removable closure is provided for the inner end of one spike to seal its bore thereat upon detachment from the inner end of the other spike.

13. A kit of parts including first and second vials, each forming a medicament containing chamber having an opening closed by a penetrable seal; and a transfer and dispensing device comprising opposed separable first and second spikes, each having an outer pointed end and an inner attachment end, each having an outer pointed end and an inner attachment end,
a fluid flow bore extending through each spike from its inner end to its outer end, and a separate airway extending through each spike from its outer end toward its inner end and terminating in an air port remote from its outer end and spaced from its inner end, each airway containing a flow restriction formation permitting, in use, controlled flow of air therethrough while preventing flow of liquid therethrough,
the first spike inner end having a connection formation communicating with its bore and the second spike inner end having a counterpart connection formation communicating with its bore, the two connection formations enabling the releasable interconnection of the spikes to flow connect their bores in fluid tight condition, to permit a liquid to flow from the outer end of one spike to the outer end of the other spike via the flow connected bores; and
a limiting means on each spike to limit, in use, the extent of penetration of their outer ends through penetrable seals closing respective vials to be connected to the opposed outer ends of the respective spikes.

14. A kit of parts according to claim 13 further including a dispensing device including a bore and a connection formation communicating with its bore and adapted to mate with the counterpart connection formation of the second spike.

15. A device according to claim 1, substantially as hereinbefore described with reference to Figures 1 and 2 or Figures 3 and 3a of the accompanying drawings.