GB2595846A

GB2595846A - An adapter Apparatus

Info

Publication number: GB2595846A
Application number: GB2008013.1A
Authority: GB
Inventors: Robert Bryan Matthew; Richard Ian Wilson Alistair
Original assignee: Overx Medical Ltd
Current assignee: Overx Medical Ltd
Priority date: 2020-05-28
Filing date: 2020-05-28
Publication date: 2021-12-15
Also published as: WO2021239869A1; GB202008013D0

Abstract

A closed system transfer device adaptor assembly (100) such as for selective, isolated transfer of a drug or medicament between a bag or vial container, a syringe and an IV bag receptacle comprises a container connector 8, a first fluid transfer conduit 22 for transferring the container contents via a fluid input port, a second fluid transfer conduit 16 for transferring the container contents to the syringe via a fluid output/input port, a third fluid transfer conduit 14 for transferring the syringe contents to the receptacle via a fluid output port and comprising a three-way valve 30,31 positionable in a first position for opening fluid communication between the container and the syringe and simultaneously closing communication to the receptacle, and a second position closing communication to the container and simultaneously opening communication between the syringe and the receptacle for isolated transfer of the fluid.

Description

An Adapter Apparatus

Field of the Invention

The present invention relates to adaptors for containers (e.g. bags, vials etc.) and particularly, although not exclusively, to CSTD adaptors for containers containing medicines or substances for use in preparing medicines.

Background

Hospital staff and medical professionals routinely prepare and handle hazardous drugs. Many of these drugs are administered intravenously. Preparation of such drugs requires health professionals to prepare a dosage of the drug and to transfer that dose to patients, typically through parenteral administration (i.e. administered or occurring elsewhere in the body than the mouth and alimentary canal) for example via an intra-venous infusion or directly to the patient via syringe injection.

The safe handling of hazardous drugs is important to protect hospital staff and medical professionals who may come into contact with these drugs. This is because although hazardous drugs might effectively treat illnesses, they may also damage the health of hospital staff and medical professionals if they become exposed to the drugs during their handling, preparation, and administration.

In view of this safety requirement, devices have been specifically designed to protect hospital staff and medical professionals from contact with hazardous drugs during their preparation and administration.

These devices are generally referred to in the art as 'closed system drug-transfer devices' (CSTD).

A closed system transfer device (CSTD) is a drug transfer device that physically prohibits the transfer of external contaminants into a drug containment device (e.g. a vial containing a drug fluid), and simultaneously prevents the escape of the drug (or its vapours) from within the drug containment device.

A 'closed system' may be considered to be a device that does not exchange unfiltered air or contaminants with the adjacent environment. A drug containment device may be considered to be one that is both airtight and leak-proof. These definitions of a 'closed system transfer device' are in accordance with the American National Institute for Occupational Safety and Health (NIOSH) definition.

Hospital pharmacies may achieve several hundred chemotherapy or other hazardous drug preparations per day, each of which requires hospital staff and medical professionals to follow medicament mixing procedures that may include (but is not limited to) the following drug preparation activities: (1) Reconstitution of a lyophilized hazardous drug in a drug vial.

(2) Generation of a bolus injection (e.g. a syringe of medication to a defined volume for direct patient injection).

(3) Preparation of an intra-venous (IV) bag containing the correct dose of drug for patient infusion.

To protect patients, hospital staff and medical professionals from potential harm, medical practice standards such as USP800 have been developed to help ensure the safe handling of hazardous drugs throughout the healthcare system.. In order to comply with these standards, a number of CSTDs have been developed and approved for use. The design and number of devices, and their method of use, vary from device to device and some are more effective than others at carrying out certain reconstitution, compounding and drug administration activities.

Typically, three distinct and separate CSTD system components are required to implement and complete drug preparation and administration safely. They are components used separately and in succession, as follows: (a) A Vial Adaptor -this being a component that engages with, and remains attached to, a medicament vial. It often possesses a dual lumen spike to provide direct access to the contents of the vial and to facilitate equalisation of the pressure differential caused when a drug is withdrawn from, or injected into, the vial.

(b) A Syringe Adaptor -this being a separate component that attaches to a standard syringe (e.g. via a Luer type connection) at one end and provides a second specialised connector at the other end to connect to a reciprocal connector on the other CSTD system components such as the Vial Adaptor and: (c) An intra-venous (IV) bag Spike Adaptor -this being a component that is inserted into the base of an IV bag and provides a fluid connection port through which a drug may be introduced into the IV bag.

A common example of the preparation of a small batch of IV bags for infusion in the hospital pharmacy setting could be the preparation of a set of five IV bags containing the same pre-reconstituted drug, but at differing doses, for different patients.

Using one of the widely adopted three-component CSTD systems described above, a medical professional would adopt the following five-step procedure for transferring aliquots of drug from the drug vial to each IV bag: i. Connect a syringe (via the Syringe Adaptor) to the Vial Adaptor engaged with a drug vial; H. Draw into syringe the required dose of drug from the drug vial; Hi. Disconnect the syringe (via Syringe Adaptor) from the Vial Adaptor; iv. Connect the syringe (via Syringe Adaptor) to the IV bag Spike Adaptor and push the aliquot of drug into the IV bag; v. Disconnect the syringe (via Syringe Adaptor) from the IV bag Spike Adaptor.

The medical professional would then repeat steps i to v for a further four cycles to achieve a total of five separately dosed IV bags. Accordingly, the standard use of three distinct and separate component CSTD parts requires at least two connection operations/steps and two disconnection operations/steps per drug preparation cycle. Thus, if a medical professional is required to prepare, for example, a batch of five separate IV bags as might commonly be the case, then he/she must perform 20 connection/disconnection operations or steps.

Each connection/disconnection operation or step not only adds to the total cumulative time of batch production, which over the course of a day requiring many such batches is significant, but also each such operation or step is a point of potential contamination and hazardous drug exposure.

The present invention aims to provide an adaptor assembly which may be used as a closed system drug transfer device (CSTD), or in other devices requiring similar safety features. The present invention has been devised in light of the above considerations to reduce the number of connections/disconnections required for the preparation and administration of hazardous drugs.

Summary of the Invention

At its most general, the invention proposes an adaptor assembly comprising a valve that enables selective, isolated fluid communication between, selectively, a syringe and a container (e.g. a bag, or a vial etc.) or the syringe and a fluid output port independent of the container. Accordingly, drug transfer between a container and a syringe may occur in isolation from drug/medicament transfer (e.g. subsequently) between that syringe and the fluid output port. Any desired receptacle (e.g. an IV bag, or a vial, or other receptacle, or a fluid flow passageway) may be attachable to the fluid output port. The container may be any desired receptacle (e.g. an IV bag, or a vial, a syringe, or other receptacle). Thus, a three-way controlled transfer of a drug or medicament may be performed without requiring any one of the container, the syringe or the receptacle to be disconnected from the adaptor to permit the transfer of the drug/medicament to any other of the container, the syringe or the receptacle. The avoidance of the need to make any such disconnection reduces the likelihood of leakage or spillage of the drug/medicament and also reduces the time taken to complete a transfer of the drug/medicament from the container to the receptacle via the syringe. While the invention is suitable for use as, or as part of, a CSTD system, it is to be understood that the invention is not limited to such use, and has wider uses.

In a first aspect, the invention may provide an adaptor assembly for connection to a container having a container opening, the adaptor assembly comprising: a connector for connection to the container opening so as to place the adaptor in an operable position wherein contents of the container can be transferred from the container through the adaptor; a first fluid transfer conduit for transferring contents of the container from a fluid input port of the adaptor via the container opening; a second fluid transfer conduit for transferring contents of the container to a fluid output/input port of the adaptor for receipt by a syringe; a third fluid transfer conduit for transferring contents of the syringe to a fluid output port of the adaptor for receipt by a receptacle; and, a valve which is positionable in: a first position which opens fluid communication between the fluid input port and the fluid output/input port and which simultaneously closes fluid communication to the fluid output port, and a second position which closes fluid communication to the fluid input port and which simultaneously opens fluid communication between the fluid output/input port and the fluid output port. The fluid output port may be suitable for, or adapted for, connection to an IV bag, or to a vial, or to another receptacle, or to a fluid flow passageway such as a tube, or the like, for onward transfer of the drug/medicament as desired.

Accordingly, the configuration and action of the valve enables a three-way controlled transfer of a drug or medicament without requiring any one of the container, the syringe or the receptacle (or other destination at the fluid output port) to be disconnected from the adaptor to permit the transfer of the drug/medicament to any other of the container, the syringe or the receptacle (or other destination at the fluid output port). The avoidance of the need to make any such disconnection reduces the likelihood of leakage or spillage of the drug/medicament and also reduces the time taken to complete a transfer of the drug/medicament from the container to the receptacle (or other destination at the fluid output port) via the syringe.

Desirably, the valve is positionable in the second position from the first position by a turning action in which both the second fluid transfer conduit and the third fluid transfer conduit are rotated about the first fluid transfer conduit, or vice versa. Desirably, the valve is positionable in the first position from the second position by a turning action in which both the second fluid transfer conduit and the third fluid transfer conduit are rotated about the first fluid transfer conduit, or vice versa.

In this way, for example, by a simple turning (e.g. revolving) action of both the second fluid transfer conduit and the third fluid transfer conduit, in unison, about the first fluid transfer conduit, or equivalently, a simple turning (e.g. twisting) action of the first fluid transfer conduit relative to both the second fluid transfer conduit and the third fluid transfer conduit, the first, second and third fluid transfer conduits may be appropriately positioned to permit the flow of fluid between the fluid input port and the fluid output/input port (e.g. when the valve is in the first position) and between the fluid output/input port and the fluid output port (e.g. when the valve is in the second position).

Desirably, the valve is reversibly positionable to each of the second position and the first position by the turning action, respectively from each of the first position and the second position. Accordingly, the adaptor may be used multiple times to separately permit the flow of fluid between the fluid input port and the fluid output/input port (e.g. when the valve is in the first position), so as to load a syringe with fluid from the container on multiple separate occasions. This may be followed, on each such occasion, by transferring that fluid between the fluid output/input port and the fluid output port (e.g. when the valve is in the second position), so as to unload the fluid from the syringe into a desired receptacle or destination at the fluid output port (e.g. an IV bag, etc.).

Desirably, the adaptor comprises a hub portion relative to which the second and third fluid transfer conduits extend radially, and into which the first fluid flow conduit extends in a direction transverse to the second and third fluid transfer conduits. Alternatively, the adaptor may comprise a hub portion relative to which the first fluid transfer conduits extends radially, and into which the second and third fluid flow conduits extend in a direction transverse to the first fluid transfer conduit. Accordingly, the valve part may comprise a 'hub-and-spoke(s)' arrangement in which the spoke(s) are revolvable around the hub to open/close fluid communication between the first, second and third fluid transfer conduits by a simple turning action. Desirably, the second and third fluid transfer conduits are arranged to revolve about an axis of the hub, wherein the first fluid flow conduit extends in a direction along the axis of the hub.

Desirably, the second fluid transfer conduit defines an axis for fluid flow which is disposed to be permanently axially aligned in-line with an axis for fluid flow defined by the third fluid transfer conduit.

Alternatively, the first fluid transfer conduit may be arranged to revolve about an axis of the hub, wherein the second and third fluid flow conduits extend in a direction along the axis of the hub.

Desirably, the valve comprises a bridging fluid transfer conduit separate from the first, second and third fluid transfer conduits, wherein the second position of the valve places the second fluid transfer conduit in fluid communication with the third fluid transfer conduit via the bridging fluid transfer conduit so placed therebetween.

Desirably, the first fluid transfer conduit and the bridging fluid transfer conduit are both static with respect to each other. For example, the first fluid transfer conduit and the bridging fluid transfer conduit may be formed within the same piece or component part of the adaptor. The second and third fluid flow conduits may be formed within the same piece or component part of the adaptor. The second and third fluid flow conduits may be revolvable or rotatable in unison relative to the first fluid transfer conduit and the bridging fluid transfer conduit collectively.

Desirably, the valve in the first position blocks an end of the third fluid transfer conduit thereby preventing fluid flow therethrough, and un-blocks both an end of the first fluid transfer conduit and an end of the second fluid transfer conduit thereby permitting fluid flow therethrough. Blockage may be provided by moving a surface part of the valve to obstruct an access opening/end of the third fluid transfer conduit. Un-blockage of both an access opening/end of the first fluid transfer conduit and an access opening/end of the second fluid transfer conduit, may be provided by removing a surface part of the valve from obstruction of an access opening/end of the first fluid transfer conduit and by removing a surface part of the valve from obstruction of an access opening/end of the second fluid transfer conduit.

Desirably, the valve in the second position blocks an end of the first fluid transfer conduit thereby preventing fluid flow therethrough, and un-blocks both an end of the second fluid transfer conduit and an end of the third fluid transfer conduit thereby permitting fluid flow therethrough. Blockage may be provided by moving a surface part of the valve to obstruct an access opening/end of the first fluid transfer conduit.

Un-blockage of both an access opening/end of the second fluid transfer conduit and an access opening/end of the third fluid transfer conduit, may be provided by removing a surface part of the valve from obstruction of an access opening/end of the second fluid transfer conduit and by removing a surface part of the valve from obstruction of an access opening/end of the third fluid transfer conduit.

Desirably, the adaptor comprises a pressure equalization pad which comprises a venting air conduit for transferring air from and/or to the container, via the container opening, thereby to permit equalisation between ambient pressure and air pressure within an interior of the container, when the adaptor is connected to the container.

Desirably, the pressure equalization part comprises a venting air filter part, and the venting air conduit is arranged in fluid communication between the interior of the container and the venting air filter part, when the adaptor is connected to the container. Alternatively, an inflatable bladder may be used in place of (or in addition to/with) the filter part.

Desirably, the third fluid transfer conduit and/or the second fluid transfer conduit comprises a syringe connector adapted for connection with a syringe or syringe adaptor. Desirably, the second fluid transfer conduit and/or the third fluid transfer conduit comprises a hose barb adapted for connection with tubing or with a hose. For example, an end of the third fluid transfer conduit (or an end of the second fluid transfer conduit) is adapted to connect to a standard syringe, desirably using a Luer type connection. An end of the second fluid transfer conduit (or an end of the third fluid transfer conduit) may be adapted to be any connector type that allows a secure attachment to another receptacle. For example, that end could comprise a hose barb, or could comprise another Luer connector or a specialised connector to allow connection to other components such as an IV bag spike or catheter.

Desirably, the container is a vial and the vial adaptor (e.g. at/around the first fluid transfer conduit) comprises a vial connector adapted for connection with the vial.

Desirably, the adaptor is a vial adaptor adapted for connection to a vial which has a mechanically penetrable vial seal which defines a fluid barrier surface, wherein the vial adaptor comprises a penetrating portion supported by a body portion, the penetrating portion projecting from a surface of the body portion and comprising a distal end portion configured to be inserted through the seal past the fluid barrier surface so as to position the distal end portion within the interior of the vial, wherein the penetrating portion contains the first fluid transfer conduit which is open at said distal end portion.

Desirably, the adaptor comprises at least one deflectable tab comprising a proximal end, a distal end, and a protruding portion, the proximal end being supported by the body portion and the distal end being unrestrained so as to allow at least the distal end of the tab to be deflectable away from the penetrating portion, the tab being bendable about an axis that is generally parallel with a longitudinal axis of the penetrating portion.

In a second aspect, the invention may provide a closed system drug transfer device (CSTD) comprising an adaptor as described above, wherein the adaptor is adapted for non-removable connection with the container.

In a third aspect, the invention may provide a method of fluid transfer from a container via an adaptor assembly for connection to a container having a container opening, the method comprising: providing an adaptor assembly; connecting a connector of the adaptor assembly to the container opening so as to place the container adaptor in an operable position wherein contents of the container can be transferred from the container through the container adaptor; by a first fluid transfer conduit of the adaptor, transferring contents of the container from a fluid input port of the adaptor via the container opening; by a second fluid transfer conduit of the adaptor, transferring contents of the container to a fluid output/input port of the adaptor for receipt by a syringe; by a third fluid transfer conduit of the adaptor, transferring contents of the syringe to a fluid output port of the adaptor for receipt by a receptacle; positioning a valve of the adaptor in a first position to open fluid communication between the fluid input port and the fluid output/input port and simultaneously to close fluid communication to the fluid output port, and transferring fluid between the fluid input port and the fluid output/input; positioning a valve of the adaptor in a second position to close fluid communication to the fluid input port and simultaneously open fluid communication between the fluid output/input port and the fluid output port, and transferring fluid between fluid output/input and the fluid output port.

Desirably, the method includes positioning the valve in said second position from the first position by a turning action in which both the second fluid transfer conduit and the third fluid transfer conduit are rotated about the first fluid transfer conduit, or vice versa.

Desirably, the method includes providing a syringe connector at the second fluid transfer conduit, and connecting the syringe connector to a syringe or syringe adaptor.

Desirably, the method includes providing at the second fluid transfer conduit and/or at the third fluid transfer conduit, a hose barb adapted for connection with tubing or with a hose, the method comprising connecting the second fluid transfer conduit and/or at the third fluid transfer conduit to tubing or hosing. For example, an end of the third fluid transfer conduit (or an end of the second fluid transfer conduit) is adapted to connect to a standard syringe, desirably using a Luer type connection. An end of the second fluid transfer conduit (or an end of the third fluid transfer conduit) is adapted to be any connector type that allows a secure attachment to another receptacle. For example, that end could comprise a hose barb, or could comprise another Luer connector or a specialised connector to allow connection to other components such as an IV bag spike or catheter.

Alternatively, or in addition, desirably, the method includes providing at, or around, the first fluid transfer conduit a vial connector adapted for connection with a vial, the method comprising connecting the first fluid transfer conduit to a vial.

Desirably, the method includes providing a vial which has a mechanically penetrable vial seal which defines a fluid barrier surface, wherein the adapter is a vial adaptor comprising a vial connector adapted for connection with a vial, and comprises a penetrating portion supported by a body portion, the penetrating portion projecting from a surface of the body portion and comprising a distal end portion, wherein the method includes inserting said distal end through the seal past the fluid barrier surface so as to position the distal end portion within an interior of the vial, wherein the penetrating portion contains the first fluid transfer conduit which is open at said distal end portion.

Desirably, the adaptor is a vial adaptor which is adapted for non-removable connection with the vial.

In a fourth aspect, the invention may provide a method of closed system drug transfer according to the method described above, wherein the adaptor is adapted for non-removable connection with said container thereby defining a CSTD system The invention includes the combination of the aspects and preferred features described except where such a combination is clearly impermissible or expressly avoided.

Summary of the Figures

Embodiments and experiments illustrating the principles of the invention will now be discussed with reference to the accompanying figures in which: Figure 1 shows a perspective view of the vial adaptor of Figure 1, in which the valve thereof is positioned in a position placing a fluid input port within a cannula, in fluid communication with a fluid output/input port bearing a female Luer-Lock connector; Figure 2 shows a cross-sectional view of the vial adaptor of Figure 1; Figure 3 shows another cross-sectional view of the vial adaptor of Figure 1; Figure 4 shows a perspective view of a vial adaptor according to an embodiment of the invention, in which the valve thereof is positioned in a position placing a fluid output/input port bearing a female Luer-Lock connector, in fluid communication with a fluid output port bearing a male Luer-Lock connector; Figure 5 shows another perspective view (opposite side/direction) of a vial adaptor of Figure 4; Figure 6 shows a cross-sectional view of the vial adaptor of Figure 4; Figure 7 shows a perspective view of the vial adaptor of Figure 4, with the valve of the vial adapter moved to the position shown in Figure 4; Figure 8 shows a perspective view of the vial adaptor of Figure 5, viewed at the same side (direction) of the vial adapter but with the valve of the vial adapter moved to a different position as shown in Figure 1; Figure 9 shows a schematic diagram of the vial adapter of figures 1 to 8, in which the valve thereof is in the position shown in Figures 1 to 3; Figure 10 shows a schematic diagram of the vial adapter of figures 1 to 8, in which the valve thereof is in the position shown in Figure 4 to 6; Figure 11 shows a perspective view of the vial adaptor according to another embodiment, in which the valve thereof is positioned in a position placing a fluid input port within a cannula, in fluid communication with a fluid output/input port bearing a female Luer-Lock connector; Figure 12 shows a cross-sectional view of the vial adaptor of Figure 11; Figure 13 shows a perspective view of a vial adaptor of Figure 11, in which the valve thereof is positioned in a position placing a fluid output/input port bearing a female Luer-Lock connector, in fluid communication with a fluid output port bearing a male Luer-Lock connector; Figures 14A and 14B show a cross-sectional views of the vial adaptor of Figure 13; Figures 15(a) and 15(b) each show a perspective views of a vial adaptor of Figure 1; Figure 16 shows a perspective view of a vial adaptor of Figures 15(a) and 15(b), with a vial connected to a vial connector of the vial adaptor and with a syringe connected to the female Luer-Lock connector of the vial adaptor; Figure 17 shows a schematic cross-sectional view of a vial adaptor according to another embodiment, in which the valve thereof is positioned in a position placing a fluid input port within a cannula, in fluid communication with a fluid output/input port leading to a female Luer-Lock connector; Figure 18 shows a schematic cross-sectional view of a vial adaptor of Figure 17, in which the valve thereof is positioned in a position placing a fluid output/input port in fluid communication with a fluid output port leading to a male Luer-Lock connector.

Detailed Description of the Invention

Aspects and embodiments of the present invention will now be discussed with reference to the accompanying figures. Further aspects and embodiments will be apparent to those skilled in the art. All documents mentioned in this text are incorporated herein by reference. In the drawings, like items are assigned like reference symbols.

Referring to Figure 1, Figure 2 and Figure 3, there is shown a vial adaptor assembly 1 for connection to a vial (not shown) containing (or for receiving) a fluid medicine. The vial may be of the typical type that has a vial opening, typically formed at the top end of the vial, which is covered by a resiliently deformable and mechanically penetrable vial seal defining a fluid barrier (not shown: e.g. an air-tight and fluid-tight rubber diaphragm) via which fluid is extracted/inserted into the vial through a cannula 18 of the vial adaptor when the vial penetrates the fluid barrier and enters the inner volume of the vial.

The vial adaptor includes a vial connector comprising a body portion defining a platform part 2 in the form of a circular disc. The cannula 18 of the vial adaptor defines a penetrating portion supported by the platform part, such that the cannula projects from a lower surface of the platform part 2 in a direction generally perpendicular to the plane of the circular disc. A distal end of the cannula (i.e. the sharp tip) is configured to be inserted through the mechanically penetrable vial seal past the fluid barrier surface so as to position the distal end within the interior of the vial. The cannula contains the first fluid transfer conduit 22 which is open at the distal end/tip of the cannula. A resiliently deformable annular interface sealing ring 23 is attached to the lower surface of the platform part 2. The interface sealing ring possesses a circular through-opening though which the trunk of the cannula passes, such that the interface sealing ring circumscribes the trunk of the cannula where the cannula projects from the lower surface of the platform part. A fluid-fight interface/seal is formed between the convex outer surface of the cannula (i.e. the trunk base) and the interface sealing ring at its through-opening. The resilient deformability of the interface sealing ring is adapted to deform against an abutting surface of a resiliently deformable vial seal when the vial adapter is connected to the vial with the cannula inserted into the vial through the vial seal, so as to form a fluid-tight interface/seal therewith.

The vial connector further includes four deflectable tabs (10, 11) each supported by the platform part so that it projects from the lower surface of the platform part 2, in parallel with, but spaced from, the cannula 18. The deflectable tabs are arranged in two pairs of tabs, with each pair comprising two opposing tabs which face each other from positions equally spaced radially either side of the cannula. A first pair of deflectable tabs face each other across a spacing directed transversely to the direction across which the two tabs of the other pair of tabs oppose each other. This arrangement defines a corral or enclosure at the lower surface of the platform part 2 dimensioned to house and retain a top cap of a vial, and into which the cannula 18 extends.

Each deflectable tab comprises a proximal end, attached to (e.g. formed integrally with) the platform part, a distal end 10, and a protruding portion 11 defining a locking flange. The proximal end is thereby supported by the platform part 2 whereas the distal end 10 is unrestrained. This allows at least the distal end of each tab to be deflectable away from the cannula 18. The platform part 2 and the deflectable tabs are each formed from a plastics material (e.g. by a moulding process) of sufficient resilience to imbue the deflectable tabs with a 'springy' deformability. In particular, each tab is resiliently bendable about its longitudinal axis, this being an axis that is generally parallel with a longitudinal axis of the cannula.

Each tab possesses a locking flange 11 which extends from a side surface of the respective tab so as to be tilted towards the platform part 2 and towards the cannula 18, in a direction generally oblique to the longitudinal axis of the locking flange (and of the cannula). Reference is now made to Figure 16 which shows a vial mechanically connected to the vial connector of the vial adaptor. The vial is of typical design and has a vial chamber part 51, defining a main body portion of the vial for containing fluid medicine and a vial neck terminating at an opening of the vial chamber. A vial top cap 50 is connected to the neck of the vial and sealingly covers the opening of the vial chamber. The vial top cap is of typical design and comprises a rigid plastic or metal annular cap portion the central portion of which comprises an aperture containing the mechanically penetrable vial seal providing the fluid barrier across the full extent of the aperture. The peripheral outer side surface of the annular cap portion presents a cylindrically circumferential bearing/sliding surface against which deflectable tabs 10 of the vial connector may bear as the vial is inserted in to a connection position with the vial connector, as described below.

Each locking flange 11 presents an inclined side surface against which the circumferential edge of the top cap 50 of the vial may slidingly bear/abut in a mechanical interface with the deflectable tab. In particular, by pushing the vial in a direction towards the platform part 2, along the longitudinal axis of the cannula as the cannula is inserted into the vial through the vial seal, the circumferential lip of the top cap 50 of a vial slidingly bears against inclined side surface of the locking flange thereby to exert a deflection force upon deflectable tab directed radially outwardly from the circumferential side of the top cap. This deflects each one of the four tabs, in unison, away from the cannula to accommodate the top cap 50 of the vial into the space between each pair of opposing tabs 10.

The terminal lower edge of the bearing/sliding surface of the vial top cap, being closest to the main body portion of the vial part (i.e. furthest from the top end of the top cap), defines a circumferential lip or 'overhang' surrounding the neck of the vial chamber and, together with the adjacent parts of the neck of the vial, defines a circumferential recess into which the terminal distal ends of each of the four locking flanges 11 may, in unison, snap-fit' to lock the top cap of the vial into a sealing interface with the vial adapter with the cannula positioned within the inner space of the vial chamber 51 in fluid communication with fluid medicine therein. In this locking position, the distal ends of each of the four locking flanges abut against the underside surface of the vial top cap within the recess, to urge the mechanically penetrable vial seal against the opposing resiliently deformable annular interface sealing ring 23, which is attached to the lower surface of the platform part 2, with sufficient force to generate a sealing interface between the two which circumscribes the trunk of the cannula 18 which both surround there.

Collectively, these parts of the adaptor assembly provide a vial connector for connection to the vial around its vial opening, so as to place the vial adaptor in an operable position wherein contents of the vial can be transferred from the vial through the cannula of the vial adaptor. The cannula of the vial adaptor extends not only from the lower surface of the platform part 2, towards its distal (pointed) end, but also through the disc of the support part 2, and thence from an upper surface of the platform part 2 towards a valve assembly of the vial adaptor.

The vial adaptor comprises a revolving valve handle/lever assembly (3, 4) revolvingly mounted upon a spindle 8 formed as the distal end portion of a generally cylindrical mounting column 7. The spindle which defines a rod or pin serving as an axis on which the valve handle assembly revolves (or relative to which the spindle may turn). The proximal end of the mounting column 7 is connected to (e.g. integrally formed or moulded with) the platform part 2, and extends from the upper disc surface/side of the platform part, this being the opposite surface/side of the platform part relative to that from which the cannula 18 extends. The external surface of the mounting column 7 is shaped to define a circumferential ledge portion 21 defined by the upper surface of a step or shoulder formed by a constriction in the outer cylindrical diameter of the mounting column. This construction also defines the outer diameter of the remaining parts of the cylindrical mounting column 7 which define the spindle 8.

The revolving valve handle/lever assembly (3, 4, 100) comprises a first spoke portion 4 and a second spoke portion 3 which each extend radially outwardly, in opposite directions, from a common annular hub portion 100. The annular hub portion possesses a circular through-opening defining a cylindrical collar into which the spindle portion 8 of the mounting column 7 is snugly and slidingly fitted such that the hub portion 100, and the spoke portions (3,4) radiating from it, are revolvable, in unison, about the longitudinal axis of the spindle portion 8. A terminal end of the collar defines an annular bearing surface shaped and configures to slidingly abut against an opposing annular surface presented by the circumferential ledge portion 21 (step or shoulder) formed in the outer cylindrical diameter of the mounting column 7. In this way, the ledge portion defines an abutment 'stop' for the cylindrical collar of the hub portion to slidingly interface as/when the valve handle/lever assembly is revolved about the spindle 8.

Simultaneously, an annular tongue 31 formed on the inner cylindrical collar surface of the annular hub 100, engages within a circumferential groove formed in the outer cylindrical surface of the spindle. The axial separation, along the direction of the longitudinal axis of the mounting column 7, between the circumferential ledge portion 21 and the circumferential groove formed in the outer cylindrical surface of the spindle, substantially matches the axial separation, along the direction of the cylindrical axis of the annular hub portion 100, between the terminal end of the collar (i.e. which defines the annular bearing surface) and the annular tongue 31. Consequently, the revolving valve handle/lever assembly (3, 4, 100) is held in place upon the circumferential ledge portion 21.

The cannula possesses a first fluid transfer conduit 22 possessing a first bore portion extending internally along a direction parallel to the longitudinal axis of the cannula. The first bore portion starts at a conduit opening located immediately adjacent to the pointed tip of the cannula at its distal end, and extends along a linear bore axis within the cannula, extending through the platform part 2 within the mounting column 7 along a direction parallel to the longitudinal axis of the mounting column. The first bore part meets a right-angled bend where an end of the first bore conduit portion joins an end of a second bore portion which continues the first fluid conduit along a second linear bore axis extending in a direction perpendicular to the longitudinal axis of the mounting column and of the first bore portion. The second bore portion extends linearly in a direction from the intemal end of the first bore portion to the external cylindrically curved surface of the spindle 8 to define an access end to the first fluid transfer conduit at the surface of the spindle, and positioned within the hub portion 100.

The function of the first fluid transfer conduit 22 is to provide a conduit along which fluid medicine may be transferred from/to the inner chamber of the vial via the vial opening, depending on the position of the revolving valve handle/lever assembly (3, 4, 100) relative to the internal access end of the first fluid conduit at the spindle surface. When the revolving valve handle/lever assembly (3, 4, 100) is positioned as shown in Figure 1, Figure 2 and Figure 3, and also shown schematically in Figure 9, the inner cylindrical collar surface of the annular hub 100 aligns an internal access end 16A of a second fluid transfer conduit 16 in register with the internal access end of the first fluid conduit 22 at the spindle surface. This particular position of the revolving valve handle/lever assembly (3, 4, 100) permits fluid communication between the first fluid transfer conduit 22 and the second fluid transfer conduit 16.

However, other positions of the revolving valve handle/lever assembly (3,4, 100) place the internal access end 16A of the second fluid transfer conduit 16 out of register (i.e. not aligned) with the internal access end of the first fluid conduit 22 at the spindle surface. Instead, parts of the inner cylindrical surface of the hub part 100 are positioned directly at, and across, the internal access end of the first fluid conduit 22 at the spindle surface thereby blocking access to (i.e. closing) the internal access end of the first fluid transfer conduit 22, and preventing fluid communication between the first 22 and second 16 fluid transfer conduits. Such a 'closed' position is shown in Figure 4, Figure 5 and Figure 6, and also shown schematically in Figure 10.

In particular, the vial adaptor possesses a second fluid transfer conduit 16 comprising a third linear bore portion (16A to 16B) formed within, and along, a first spoke portion 4 of the revolving valve handle/lever assembly (3, 4, 100) and configured for transferring the fluid medicine to/from a fluid output/input port 6 of the adaptor which is formed at the distal end of the first spoke portion 4. This output/input port bears a female Luer-Lock connector adapted for connection to a syringe (not shown), to permit the fluid medicine to be received by/from a syringe (not shown) connected to the output/input port using the female LuerLock connecter.

In addition, the vial adaptor also possesses a third fluid transfer conduit 14 comprising a fourth linear bore portion (14A to 14B) formed within, and along, a second spoke portion 3 of the revolving valve handle/lever assembly (3, 4, 100) and configured for transferring the fluid medicine to a fluid output port 5 of the adaptor which is formed at the distal end of the second spoke portion 3. This output port 5 bears a male Luer-Lock connector 20 adapted for connection to an onward vessel or tubing connected there (e.g. an IV bag, via an intermediate bag adaptor -not shown). The function of the third fluid transfer conduit 14 is to permit fluid medicine to be transferred from the output/input port 6, such as from a syringe (not shown) connected to at the female Luer-Lock connecter, via the valve assembly when appropriately positioned, to the output port Sand therefrom to an onward vessel or tubing connected to the output port 5 (not shown).

Accordingly, in controlling the position of the revolving valve handle/lever assembly (3, 4, 100) relative to the spindle surface, by the revolving valve handle/lever assembly (3, 4, 100) to the position shown in Figure 1, Figure 2 and Figure 3, and also shown schematically in Figure 9, parts of the outer cylindrical surface of the spindle part 8 are positioned directly at, and across, an internal access end 14B of the third fluid conduit 14 located at the hub inner cylindrical surface. This has the effect of blocking access to (i.e. closing) the internal access end 14B of the third fluid transfer conduit 14, and preventing fluid communication to the third fluid transfer conduit.

However, the spindle part 8 possesses a linear bridging fluid transfer conduit 30 defining a bore (30A to 30B) which passes through the spindle in a direction generally perpendicular to the longitudinal axis of the cannula, and generally parallel to the bore axes of both the bore of the second fluid transfer conduit 16 and the bore of the third fluid transfer conduit 14. The bore of the bridging fluid transfer conduit 30 is also positioned adjacent to, and generally parallel with, the second bore portion of the first fluid flow conduit 22 within the spindle part 8. The bridging fluid transfer conduit defines/joins two access ends bore (30A and 30B) positioned at opposite sides (not diametrically opposite) of the outer cylindrical surface of the spindle part 8, one of which access ends 30B is positioned adjacent to the inner access end of the first fluid transfer conduit 22.

Neither the bridging fluid transfer 30 conduit nor the second bore part of the first fluid transfer conduit 22 passes along a diameter of the spindle part 8, or in other words, none intersects the central longitudinal, cylindrical axis (i.e. centre-line) of the spindle part 8. Instead, both are positioned eccentrically relative to the central longitudinal, cylindrical axis of the spindle part 8. In particular, the bore axis of the second bore part of the first fluid transfer conduit is offset from the central longitudinal axis of the spindle part by the same distance (say, distance X) that the bore axis of the bridging fluid transfer conduit is also offset, but at the opposite side of that central longitudinal axis. Similarly, the bore axes of the second and third fluid transfer conduits (16, 14) are also each offset from the central longitudinal axis of the spindle part 8 by the same distance (distance X). The bore axes of the second and third fluid transfer conduits (16, 14) are also substantially mutually parallel and mutually aligned (in register) with each other, at least where those bore axes approach the spindle part 8. The bore axes of: the bridging fluid transfer conduit; the second bore part of the first fluid transfer conduit; the second fluid transfer conduit at least where that bore axis approaches the spindle part 8; and, the third fluid transfer conduit at least where that bore axis approaches the spindle part 8, are substantially coplanar. This means that, in a first position of the revolving valve handle/lever assembly (3,4, 100), such as is shown in Figure 1, Figure 2 and Figure 3, and also shown schematically in Figure 9, the second bore part of the first fluid transfer 22 conduit aligns in register with the second fluid transfer conduit 16 and, simultaneously, the internal access end of the third fluid transfer conduit 14 and both access ends of the bridging fluid transfer conduit, are closed/blocked-off by covering portions of the inner cylindrical surface of the hub portion 100. Conversely, in a second position of the revolving valve handle/lever assembly (3,4, 100), such as is shown in Figure 4, Figure Sand Figure 6, and also shown schematically in Figure 10, the second and third fluid transfer conduits (16, 14) mutually align in register with opposite ends, respectively, of the bridging fluid transfer conduit 30, while simultaneously the second bore part of the first fluid transfer 22 conduit is closed/blocked-off at its internal access end by obstructing portions of the inner cylindrical surface of the hub portion 100.

In this way, the first position of the valve assembly, such as is shown in Figure 1, Figure 2 and Figure 3, and also shown schematically in Figure 9, of the revolving valve handle/lever assembly (3, 4, 100) aligns an internal access end of a second fluid transfer conduit 16 in register with the internal access end of the first fluid conduit 22 at the spindle surface. This particular position of the revolving valve handle/lever assembly (3, 4, 100) permits fluid communication between the first fluid transfer conduit 22 and the second fluid transfer conduit 16. However, other positions of the revolving valve handle/lever assembly (3, 4, 100) place the internal access end of a second fluid transfer conduit 16 out of register (i.e. not aligned) with the internal access end of the first fluid conduit 22 at the spindle surface. Instead, parts of the inner cylindrical surface of the hub part 100 are positioned directly at, and across, the internal access end of the first fluid conduit 22 at the spindle surface thereby blocking access to (i.e. closing) the internal access end of the first fluid transfer conduit, and preventing fluid communication between the first and second fluid transfer conduits. Such a position is shown in Figure 4, Figure 5 and Figure 6, and also shown schematically in Figure 10.

The vial adaptor also includes a venting conduit 19 which is illustrated in cross-section in Figure 3 and Figure 6, and schematically in figures 9 and 10. The venting conduit comprises a first venting bore portion extending internally along a direction parallel to the longitudinal axis of the cannula, adjacent to, but isolated from, the first fluid transfer conduit. The first venting bore portion starts at a vent opening located immediately adjacent to the pointed tip of the cannula at its distal end, and extends along a linear bore axis within the cannula, extending through the platform pail 2 within the mounting column 7 along a direction parallel to the longitudinal axis of the mounting column. The first venting bore portion meets a right-angled bend where an end of the first venting bore portion joins an end of a second venting bore portion, of greater bore diameter, which continues the venting conduit along a second linear bore axis extending in a direction perpendicular to the longitudinal axis of the mounting column 7 and of the first venting bore portion. The second venting bore portion extends linearly in a direction from the internal end of the first venting bore portion towards a cylindrical filter bore portion 26 of yet greater bore diameter than that of the second venting bore portion. The second venting bore portion opens into an internal end of the filter bore portion so as to be in fluid communication with it, and the filter bore portion continues the venting conduit onwards until it terminates at an external access end accessible at the upper surface of the platform part 2, adjacent to the mounting column 7. The filter bore portion defines the inner space of a filter holder 9 of the vial adaptor, which is connected to (e.g. formed/moulded integrally with) the external surface of the mounting column 7, and the external surface of the platform part 2. The filter holder is adapted to snugly house a cylindrical air filter 25 piece such that the outer, convexly curved cylindrical surface of the filter piece forms an air-fight interference fit against the opposing inner, concavely curved cylindrical surface of the filter bore portion 26 of the venting bore 19. The filter piece presents a flat, circular, terminal inner end surface directly to the second venting bore portion where the second venting bore portion opens into the filter bore portion. The filter piece also presents another flat, circular, terminal inner end surface, at its opposite end, directly to the open air where the venting conduit ends.

The function of the venting conduit is to provide a conduit along which air may be transferred, i.e. 'vented', to (or from) from the inner chamber of the vial, via the vial opening, as medicine is drawn from (or inserted into) the inner chamber of the vial through the first fluid transfer conduit 22. This allows the air pressure within the vial to equalise with the ambient air pressure outside the vial. The presence of the air filter 25 allows particulates and contaminants to be removed from air that is being vented to (or from) the vial and thereby to prevent contamination of the medicine by ambient particulates and contaminants when air is vented into the vial during withdrawal of medicines form the vial (i.e. both via the cannula), and to prevent contamination of the ambient environment by medicine particulates and vapours when air is vented from the vial during insertion of medicines into the vial (i.e. both via the cannula).

Referring to Figure 7 and Figure 8, here is shown perspective views of the vial adaptor. Figure 7 shows the vial adaptor when in the second position of the revolving valve handle/lever assembly (3, 4, 100), such as is shown in Figure 4, Figure Sand Figure 6, and also shown schematically in Figure 10. Figure 8 shows the vial adaptor when in the first position of the revolving valve handle/lever assembly (3, 4, 100), such as is shown in Figure 1, Figure 2 and Figure 3, and also shown schematically in Figure 9.

Referring to Figure 7, two discontinuous sections of a linear visual indicator strip 13 each extent, in parallel and collinearly, along the uppermost outer surface of the valve handle/lever assembly (3, 4, 100). An intermediate, bridging section of the linear visual indicator strip 13 also extends along the uppermost spindle end surface 8. When the vial adaptor is in the second position of the revolving valve handle/lever assembly, two discontinuous sections of a linear visual indicator strip 13 and the bridging section of the linear visual indicator strip, are brought in to collinear alignment. This is visibly clear and is a visual indicator, to the user, that the fluid output/input port 6 is in fluid communication with the fluid output port 5. Conversely, when the vial adaptor is in the first position of the revolving valve handle/lever assembly, as shown in Figure 8, the bridging section of the linear visual indicator strip is moved out of collinear alignment with the two discontinuous sections of a linear visual indicator strip 13. This is visibly clear and is a visual indicator, to the user, that the fluid output/input pod 6 is not in fluid communication with the fluid output ports.

Referring to Figure 8, two discontinuous sections of a second visual indicator strip (12, 12B) each extent along respective adjacent outer side surfaces of the first spoke portion 4 and of the hub portion 100 of the valve handle/lever assembly (12B upon 4, 100), and of the mounting column 7 upon which the hub portion rests (part 12 upon part 7). When the vial adaptor is in the first position of the revolving valve handle/lever assembly, the two discontinuous sections of the second visual indicator strip are brought in to alignment, as shown in Figure 8, so as to present the appearance of a continuous indicator strip. This is visibly clear and is a visual indicator, to the user, that the fluid input pod 22 is in fluid communication with the fluid output/input port 6. Conversely, when the vial adaptor is in the second position of the revolving valve handle/lever assembly, as shown in Figure 7, the two discontinuous sections of the linear visual indicator strip are moved out of alignment and appear to be discontinuous. This is visibly clear, and is a visual indicator, to the user, that the fluid output/input port 6 is not in fluid communication with the fluid input port 22.

A stop flange 28 extends radially outwardly from the convex outer cylindrical surface of the hub portion 100 of the valve assembly, at a position immediately adjacent to the circumferential ledge portion 21 of the of the mounting column 7 upon which the hub portion rests. The stop flange possesses a lug portion which depends from the stop flange 28 so as to extend past the circumferential ledge portion 21 in a direction towards the platform part 2. A semi-circular collar portion 29 extends radially outwardly from the convex outer cylindrical surface of the mounting column 7, being located immediately adjacent to the circumferential ledge portion 21 so as to be positioned at the same axial distance, in a direction parallel to the longitudinal axis of the mounting column, from the platform part 2 as is the lug portion. This means that when the valve handle/lever assembly (4, 5, 100) is in the second position, as shown in Figure 7, the lug is brought into abutment with a first terminal end of the semi-circular collar portion 29, by action of anti-clockwise rotating the hub portion 100 relative to the mounting column 7. This abutment prevents further such rotation in the same direction. Conversely, when the valve handle/lever assembly (4, 5, 100) is in the first position, as shown in Figure 8, the lug is brought into abutment with a second terminal end (not shown -it is simply the diametrically opposite end to the first terminal end) of the semi-circular collar portion 29, by action of clockwise rotating the hub portion 100 relative to the mounting column 7. This abutment prevents further such rotation in the same direction.

Figures 9 and 10 schematically illustrate the effect of rotation of the valve assembly, within the bore 31 of the hub portion 100, from the first position (Figure 9) to the second position (Figure 10) by such anti-clockwise rotation. As can be seen, the effect is to move the access ends (16A, 16B) of the second fluid transfer conduit 16, out of their position of alignment with the first fluid transfer conduit 22, and into a new position of alignment with the bridging fluid transfer conduit 30. Simultaneously, the bridging fluid transfer conduit 30 is brought into alignment with the third fluid transfer conduit 14, thereby placing the second 16 and third 14 fluid transfer conduits in fluid communication, via the bridging fluid transfer conduit 30, whereas the internal access end of the first fluid transfer port 22 is closed-off by the hub portion. In particular, this anti-clockwise rotation (indicated in Figure 10) rotates the inner access port 16A of the second fluid transfer conduit 16, into register with a first access end 30A of the bridging fluid transfer conduit 30, and also rotates the inner access port 14B of the third fluid transfer conduit 14, into register with a second access end 30B of the bridging fluid transfer conduit 30. The result is that the outer ends (16B, 14A) of the second 16 and third 14 fluid transfer conduits, corresponding to the output/input port 6 and the output port 5, respectively, are placed in fluid communication.

Figures 11 to 14B show perspective and cross-sectional views of a vial adaptor according to a second embodiment of the invention which shares all of the features of the first embodiment of the invention as described above with reference to figures 1 to 10, with the exception that the structure of the filter holder 9 and filter bore portion 26 of the first embodiment is replaced with an alternative structure for housing an air filter 25. In particular, the second venting bore portion of the venting conduit 19, extends linearly in a direction from the internal end of the first venting bore portion into to a cylindrical filter chamber 41 defined by a covering portion which extends radially outwardly from, and is integrally formed with, the outer circumferential surface of the mounting column 7, in the manner of an umbrella, to define a covered volume surrounding a base end of the mounting column 7 where the mounting column meets the upper surface of the platform part 2B. The surface of the covering portion of the filter chamber extends over, but is spaced from, an opposing surface of the platform part 2B surrounding the mounting column 7. The annular filter 43 (extents?) resides in the space between the opposing surfaces of the covering portion and the platform part such that opposite annular end surfaces of the filter 43 form an airtight seal against both surfaces concurrently. This provides an air-permeable annular barrier between the second venting bore portion of the venting conduit 19 and the exterior of the device. The covering portion defining the filter chamber, is housed within an outer housing cover defined by an internal space of a filter housing cap 42 integrally formed with the hub portion 100 and arranged to cover the upper surface of the platform part 2B to contain the mounting column 7 and to contain an annular air filter piece 43 and filter chamber 41.

Figures 14A and 14B show the venting conduit 19 starting from the pointed tip of the cannula with the first venting bore portion heading parallel to the longitudinal axis of the cannula towards the filter chamber 41.

The first venting bore portion of the venting conduit extends to a position that is laterally adjacent to the filter chamber, at which point it meets the second venting bore portion which extends in a direction perpendicular to the longitudinal axis of the cannula. The second venting bore portion of venting conduit 19 exits to an open space 44 defined by the filter chamber 41 surrounding the base of the mounting column 7. Air that exits the venting conduit 19 into this space passes through to the annular air filter 43.

The housing cap 42 is rotafingly moveable relative to both the cylindrical filter chamber 41 and the mounting column 7 by turning the hub portion relative to the platform part. However, because one annular end surface of the filter chamber 43 is statically sealed to the surface of the covering portion of the filter chamber and the other annular end is also statically sealed to the opposing surface of the platform part 2B surrounding the mounting column 7, all air leaving the venting conduit must pass through the filter 43 to reach the external environment. Similarly, in reverse flow, all air entering the venting conduit 19 first must pass through the filter 43.

Figures 15(a) and 15(b) each show perspective views of a vial adaptor of Figure 1, when in the second position shown in Figure 7. Figure 16 shows a perspective view of a vial adaptor of Figures 15(a) and 15(b), with a vial 51 connected to a vial connector (2, 10, 11) of the vial adaptor and with a syringe 60 connected to the female Luer-Lock connector at the output/input port 6 of the vial adaptor, placing the syringe in fluid communication with the vial. An anti-clockwise revolving of the syringe, and vial adapter valve assembly, relative to the vial 51, moves the vial adapter into the first position shown in Figure 8.

Figure 17 shows a schematic cross-sectional view of a vial adaptor according to another embodiment, in which the valve 64 thereof is positioned in a position placing a first fluid transfer conduit 22 within a cannula 18, in fluid communication with a second fluid transfer conduit 16 leading to a female Luer-Lock connector (not shown in detail) at the output/input port 6. Figure 18 shows a schematic cross-sectional view of a vial adaptor of Figure 17, in which the valve thereof is positioned, by a twisting action of the second and third fluid transfer conduits in unison, in a position placing second fluid transfer conduit 16 in fluid communication with a third fluid transfer conduit 14 leading to a male Luer-Lock connector (at output/input port 5, not shown in detail). This is an alternative implementation of the same general inventive concept of revolving part of the device in order to achieve two possible fluid pathway alignments. In particular, the valve assembly comprises an axle part (4, 5) containing the second fluid transfer conduit 16 and the third fluid transfer conduit 14. Each of the second fluid transfer conduit 16 and the third fluid transfer conduit 14 extends linearly in a direction along the longitudinal axis of the axle part from a respective inner access opening adjacent to a spindle portion 60 of the axle part, to a respective outer access opening adjacent to (or in fluid communication with) the fluid output/input port 6 or the fluid output port 5, as the case may be. The longitudinal axes of the bores of the second fluid transfer conduit 16 and the third fluid transfer conduit 14 are aligned to be mutually parallel and collinear, defining a mutual axis. This mutual axis is offset eccentrically from the centre-line longitudinal axis of the axle part and of the spindle portion 60 of the axle part.

An annular circumferential groove circumscribes the outer cylindrical surface of the axle part so as to define a uniformly deep groove of rectangular cross-section, circling around the centre-line longitudinal axis of the axle part. The groove defines a pair of flat, parallel and annular side walls (62, 63) which oppose each other across the convex, cylindrically curved groove floor. This cylindrically curved groove floor also defines the outer cylindrical surface of the spindle portion 60. A respective inner access opening or each of the second and third fluid transfer conduits, is presented at a respective one of the two annular side walls, at locations adjacent to a spindle portion 60 of the axle part.

The terminal end of the mounting column 7B defines a hub 100B defining a through-opening through which the spindle portion passes. The spindle portion is rotatable, by a twisting action as indicated in Fig.18, to turn the axle part (4, 5) about its longitudinal centre-line axis thereby to revolve the second fluid transfer conduit 16 and the third fluid transfer conduit 14 around that axis. This revolution occurs because the second fluid transfer conduit 16 and the third fluid transfer conduit 14 are both mutually eccentrically offset from the centre-line axis of the axle part. The hub comprises a bridging fluid transfer conduit 15 which extends linearly along a direction parallel to the longitudinal centre-line axis of the axle part, but is eccentrically offset from the centre-line axis of the axle part at a position diametrically opposite of the centre-line axis of the axle part relative to the position of the internal access opening of the first fluid transfer conduit 22. This places the internal access opening of the first fluid transfer conduit and an internal access opening of the bridging fluid transfer conduit at opposite sides of the centre-line axis each equidistant from their respectively nearest adjacent surface of the spindle part 60. The distance of eccentric offset of the bridging fluid transfer conduit equals that of the second fluid transfer conduit 16 and the third fluid transfer conduit 14 relative to the centre-line longitudinal axis of the axle part. The aforementioned twisting action, indicated in Fig.18, which turns the axle part (4,5) about its longitudinal centre-line axis, thereby also revolves bridging fluid transfer conduit 15 around that axis to place the bridging fluid transfer conduit 15 aligned in register with, and in fluid communication with, both the second fluid transfer conduit 16 and the third fluid transfer conduit 14.

In a first position, shown in Fig.17, an inner access opening of the second fluid transfer conduit 16 aligns in register with an inner access opening of the first fluid transfer conduit 22 so as to place the fluid input port in fluid communication with the fluid output/input port. This first position causes the hub 100B to obstruct and close an inner access opening of the third fluid transfer conduit 14, thereby closing communication between the fluid output port and the fluid output/input port. In a second position, shown in Fig.18, the inner access opening of the second fluid transfer conduit 16 aligns in register with an inner access opening of the bridging fluid transfer conduit 15 so as to place the fluid output/input port in fluid communication with the fluid output port. This second position causes the hub 100B to obstruct and close an inner access opening of the first fluid transfer conduit 22, thereby closing communication between the fluid output/input port and the fluid input port.

In the embodiments described herein, and in any other embodiment of the invention, the valve portion of the adaptor device may be coated with, of formed from, PTFE (Polytetrafluoroethylene), which has numerous advantageous properties making it most suitable for use in the present invention. The tensile and compressive properties of PTFE are particularly suited to forming fluid-tight seals at the rotating/moving interfaces of the spindle and hub of the valve assembly. PTFE is quite flexible and does not break when subjected to stresses of 0.7 Nfriirri2 according to ASTIVID 790, Flexural modulus is about 350 to 650 Ncernm2 at room temperature, about 2000 Nlinm'' at -80"C; about 200 Nirnm2 at 1000 and about 45 Nimm2 at 230°C. The hardness Shore D, measured according to the method ASTM D 2240; has values comprised between 050 and 060. According to DIN 53456 (load 13.5 Kg for 30 sec) the hardness sways between 27 and 32 Nirnin2. PTFE possesses the lowest friction coefficients of ail solid materials; between 0.05 and 0.09. The static and dynamic friction coefficients are almost equal, so that there is no seizure or stick-slip action. Furthermore, when increasing the load, the friction coefficient decreases until reaching a stable value. In addition, the friction coefficient increases with the speed, and remains constant when subject to temperature variations. PTFE is one of the most thermally stable plastic materials. There are no appreciable decompositions at 260°C, so that PTFE, at this temperature, still possesses most part of its properties. PTFE is practically inert against known elements and compounds.

PTFE is insoluble in almost all solvents at temperatures up to about 300°C.

The features disclosed in the foregoing description, or in the following claims, or in the accompanying drawings, expressed in their specific forms or in terms of a means for performing the disclosed function, or a method or process for obtaining the disclosed results, as appropriate, may, separately, or in any combination of such features, be utilised for realising the invention in diverse forms thereof.

While the invention has been described in conjunction with the exemplary embodiments described above, many equivalent modifications and variations will be apparent to those skilled in the art when given this disclosure. Accordingly, the exemplary embodiments of the invention set forth above are considered to be illustrative and not limiting. Various changes to the described embodiments may be made without departing from the spirit and scope of the invention.

For the avoidance of any doubt, any theoretical explanations provided herein are provided for the purposes of improving the understanding of a reader. The inventors do not wish to be bound by any of these theoretical explanations.

Any section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described.

Throughout this specification, including the claims which follow, unless the context requires otherwise, the word "comprise" and "include", and variations such as "comprises", "comprising", and "including" will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

It must be noted that, as used in the specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from "about" one particular value, and/or to "about" another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by the use of the antecedent "about," it will be understood that the particular value forms another embodiment. The term "about" in relation to a numerical value is optional and means for example +/-10%.

Claims

Claims: 1. An adaptor assembly for connection to a container having a container opening, the adaptor assembly comprising: a connector for connection to the connector opening so as to place the adaptor in an operable position wherein contents of the container can be transferred from the vial through the adaptor; a first fluid transfer conduit for transferring contents of the container from a fluid input port of the adaptor via the container opening; a second fluid transfer conduit for transferring contents of the container to a fluid output/input port of the adaptor for receipt by a syringe; a third fluid transfer conduit for transferring contents of the syringe to a fluid output port of the adaptor for receipt by a receptacle; a valve which is positionable in: a first position which opens fluid communication between the fluid input port and the fluid output/input port and which simultaneously closes fluid communication to the fluid output port, and a second position which closes fluid communication to the fluid input port and which simultaneously opens fluid communication between the fluid output/input port and the fluid output port.
2. An adaptor according to any preceding claim wherein the valve is positionable in said second position from said first position by a turning action in which both the second fluid transfer conduit and the third fluid transfer conduit are rotated about the first fluid transfer conduit, or vice versa.
3. An adaptor according to any preceding claim wherein the valve is positionable in said first position from said second position by a turning action in which both the second fluid transfer conduit and the third fluid transfer conduit are rotated about the first fluid transfer conduit, or vice versa.
4. An adaptor according to claim 2 and claim 3 in which the valve is reversibly positionable to each of said second position and said first position by said turning action, respectively from each of said first position and said second position.
5. An adaptor according to any preceding claim wherein said valve in said first position blocks an end of said third fluid transfer conduit thereby preventing fluid flow therethrough, and un-blocks both an end of said first fluid transfer conduit and an end of said second fluid transfer conduit thereby permitting fluid flow therethrough.
6. An adaptor according to any preceding claim wherein said valve in said second position blocks an end of said first fluid transfer conduit thereby preventing fluid flow therethrough, and un-blocks both an end of said second fluid transfer conduit and an end of said third fluid transfer conduit thereby permitting fluid flow therethrough.
7 An adaptor according to any preceding claim wherein said second fluid transfer conduit defines an axis for fluid flow which is disposed to be permanently axially aligned in-line with an axis for fluid flow defined by said third fluid transfer conduit.
8 An adaptor according to any preceding claim wherein said valve comprises a bridging fluid transfer conduit separate from the first, second and third fluid transfer conduits, wherein said second position of the valve places the second fluid transfer conduit in fluid communication with the third fluid transfer conduit via the bridging fluid transfer conduit so placed therebetween.
9. An adaptor according to any preceding claim wherein the first fluid transfer conduit and the bridging fluid transfer conduit are both static with respect to each other.
10. An adaptor according to any preceding claim comprising a hub portion relative to which the second and third fluid transfer conduits extend radially, and into which said first fluid flow conduit extends in a direction transverse to the second and third fluid transfer conduits.
11. An adaptor according to claim 10 wherein the second and third fluid transfer conduits are arranged to revolve about an axis of the hub, wherein the first fluid flow conduit extends in a direction along said axis of the hub.
12 An adaptor according to any preceding claim comprising pressure equalization part which comprises an venting air conduit for transferring air from and/or to the container, via the container opening, thereby to permit equalisation between ambient pressure and air pressure within an interior of said container, when said adaptor is connected to said container.
13. An adaptor according to claim 12 wherein said pressure equalization part comprises a venting air filter part, and said venting air conduit is arranged in fluid communication between said interior of said container and said venting air filter part, when said adaptor is connected to said container.
14. An adaptor according to any preceding claim wherein the third fluid transfer conduit and/or the second fluid transfer conduit comprises a syringe connector adapted for connection with a syringe.
15. An adaptor according to any preceding claim wherein the second fluid transfer conduit and/or the third fluid transfer conduit comprises a hose barb adapted for connection with tubing, or with a hose, or comprises a connector adapted for connection with a syringe, or with an IV bag, or with spike, or with a catheter.
16. An adaptor according to any preceding claim wherein the container is a vial and the first fluid transfer conduit comprises a vial connector adapted for connection with the vial.
17 An adaptor according to claim 16 adapted for connection to a vial which has a mechanically penetrable vial seal which defines a fluid barrier surface, wherein the vial adaptor comprises a penetrating portion supported by a body portion, the penetrating portion projecting from a surface of the body portion and comprising a distal end portion configured to be inserted through the seal past the fluid barrier surface so as to position the distal end portion within the interior of the vial, wherein the penetrating portion contains the first fluid transfer conduit which is open at said distal end portion.
18. An adaptor according to claim 17 comprising at least one deflectable tab comprising a proximal end, a distal end, and a protruding portion, the proximal end being supported by the body portion and the distal end being unrestrained so as to allow at least the distal end of the tab to be deflectable away from the penetrating portion, the tab being bendable about an axis that is generally parallel with a longitudinal axis of the penetrating portion.
19. A closed system drug transfer device (CSTD) comprising an adaptor according to any preceding claim wherein said adaptor is adapted for non-removable connection with said container.
20. A method of fluid transfer from a container via an adaptor assembly for connection to a container having a container opening, the method comprising: providing an adaptor assembly; connecting a connector of the adaptor assembly to the container opening so as to place the container adaptor in an operable position wherein contents of the container can be transferred from the container through the container adaptor, by a first fluid transfer conduit of the adaptor, transferring contents of the container from a fluid input port of the adaptor via the container opening; by a second fluid transfer conduit of the adaptor, transferring contents of the container to a fluid output/input port of the adaptor for receipt by a syringe; by a third fluid transfer conduit of the adaptor, transferring contents of the syringe to a fluid output port of the adaptor for receipt by a receptacle; positioning a valve of the adaptor in a first position to open fluid communication between the fluid input port and the fluid output/input port and simultaneously to close fluid communication to the fluid output port, and transferring fluid between the fluid input port and the fluid output/input; positioning a valve of the adaptor in a second position to close fluid communication to the fluid input port and simultaneously open fluid communication between the fluid output/input port and the fluid output port, and transferring fluid between fluid output/input and the fluid output port.
21. A method according to claim 20 including positioning the valve in said second position from said first position by a turning action in which both the second fluid transfer conduit and the third fluid transfer conduit are rotated about the first fluid transfer conduit, or vice versa.
22. A method according to claim 20 or claim 21 including providing a syringe connector at the second fluid transfer conduit, and connecting the syringe connector to a syringe.
23. A method according to any of claims 20 to 22: the method including providing at the second fluid transfer conduit and/or at the third fluid transfer conduit: a hose barb adapted for connection with tubing or with a hose or a syringe connector for connection with a syringe, or a connector adapted for connection with an IV bag, or a connector adapted for connection with spike, or a connector adapted for connection catheter, the method comprising connecting the second fluid transfer conduit and/or at the third fluid transfer conduit to tubing or hosing, or to a syringe, or to an IV bag, or to a spike, or to a catheter; and/or, method including providing at the first fluid transfer conduit a vial connector adapted for connection with a vial, the method comprising connecting the first fluid transfer conduit to a vial.
24 A method according to any of claims 20 to 23 including providing a vial which has a mechanically penetrable vial seal which defines a fluid barrier surface, wherein the adapter is a vial adaptor comprising a vial connector adapted for connection with a vial, and comprises a penetrating portion supported by a body portion, the penetrating portion projecting from a surface of the body portion and comprising a distal end portion, wherein the method includes inserting said distal end through the seal past the fluid barrier surface so as to position the distal end portion within an interior of the vial, wherein the penetrating portion contains the first fluid transfer conduit which is open at said distal end portion.
25. A method of closed system drug transfer according to any of claims 20 to 24 wherein said adaptor is adapted for non-removable connection with said container thereby defining a CSTD system.