Patent Description:
The present disclosure relates generally to closed fluid transfer systems, and more specifically to a vial adaptor assembly enabling transfer of fluids between two containers while maintaining a closed system.

Various types of vial adaptor assemblies for a closed fluid transfer systems are known in the art.

It is known that hazardous medicines are frequently applied in the treatment of certain medical conditions, however the use of such hazardous medicines presents danger to the health care providers. Accordingly, there is a need for a system that allows safe handling of hazardous medicines while reducing the exposure of health care providers and at the same time allows utilization of the entire amount of medicine contained in the system.

A pertinent vial adapter is disclosed in <CIT>.

The present invention seeks to provide an improved vial adaptor assembly for a closed fluid transfer system and a method of use thereof.

There is thus provided in accordance with an embodiment of the present invention a vial adaptor assembly, suitable for use with a vial containing a medicament and a syringe adaptor, which is in turn connectable to a syringe having a piston adapted for selectable displacement in a first direction for drawing fluid into the syringe and in a second direction for expelling fluid from the syringe, the vial adaptor assembly including: a vial connector for non-removable connection with the vial containing a medicament; a syringe adaptor connector for connection with the syringe adaptor; a pressure equalization chamber having a variable volume, which is sealed from the outside environment during use; a liquid pathway communicating between an interior of the vial containing the medicament and an interior of the syringe when the syringe adaptor is connected to the syringe adaptor connector and the syringe is connected to the syringe adaptor and the vial connector is connected to the vial containing the medicament; and a venting pathway communicating between the interior of the vial containing the medicament and an interior of the pressure equalization chamber, when the vial connector is connected to the vial containing the medicament, wherein the pressure equalization chamber and the venting pathway are mutually configured such that, when the syringe adaptor is connected to the syringe adaptor connector and the syringe is connected to the syringe adaptor and the vial connector is connected to the vial containing the medicament, substantially all of any of the medicament that becomes located within the pressure equalization chamber is removed therefrom via the venting pathway and returned to the interior of the vial by displacement of the piston of the syringe in the first direction.

Preferably, the vial adaptor assembly also includes a deformable membrane, which is contained within a volume enclosed between the vial connector and the syringe adaptor connector and fixedly attached therebetween.

Further preferably, the pressure equalization chamber is disposed between the syringe adaptor connector and the deformable membrane. Still further preferably, the vial adaptor assembly also includes a needle element extending longitudinally along a longitudinal axis. Yet further preferably, the vial adaptor assembly also includes a septum element disposed within a portion of the syringe adaptor connector and configured for penetration thereof by a needle of a medical implement, which is adapted to engage the vial adaptor assembly. Still further preferably, the vial adaptor assembly also includes a plurality of circumferentially arranged snaps adapted for fixed engagement with the vial. Further preferably, the vial adaptor assembly also includes a sheath having an upper portion and a spike portion.

In accordance with an embodiment of the present invention, a longitudinal bore is formed through the sheath, and wherein the bore has a "drop" shape, having a wide portion and a narrow portion.

Preferably, a recess extends radially outwardly from the wide portion of the bore and is oppositely directed with respect to the narrow portion of the bore. Further preferably, an opening is formed in the spike portion and is adapted to communicate with the bore, the opening is oriented at the same direction as the recess. Still further preferably, the deformable membrane being a deformable sheet of material having a pre-defined shape, and which is adapted to change its shape in response to pressure that is applied thereon. Yet further preferably, the needle element has a cylindrical portion and a sharp tip and its inner volume defines the liquid pathway. Still further preferably, the needle element has a fin extending radially outwardly from the cylindrical portion and an opening formed in the cylindrical portion and adapted to communicate with the liquid pathway.

In accordance with an embodiment of the present invention, the opening is disposed adjacent the sharp tip of the needle element and is oriented at the same direction as the fin.

Preferably, a liquid medicament collecting and draining well is formed in the syringe adaptor connector, the liquid medicament collecting and draining well has a tapered wall surface and a flat surface. Further preferably, the pressure equalization chamber is formed between the deformable membrane and the syringe adaptor connector. Still further preferably, the deformable membrane is configured to change its shape in response to pressure that is exerted upon, thereby changing the volume of the pressure equalization chamber. Yet further preferably, the needle element is inserted into the wide portion of the bore, thus forming the venting pathway, which extends through the narrow portion of the bore. Still further preferably, the venting pathway at least partially surrounds the liquid pathway.

In accordance with an embodiment of the present invention, the fin is disposed within a portion of the sheath and is adapted to orient the needle element such that the opening of the needle element and the opening of the spike portion are facing the same direction.

Preferably, a tip of the needle element protrudes axially longitudinally from the spike portion and together therewith forms a sharp tip, which is adapted for penetrating a septum of the vial containing the medicament. Further preferably, increasing the pressure within the vial urges transfer of fluid from the vial into the pressure equalization chamber; and decreasing the pressure within the vial urges transfer of fluid from the pressure equalization chamber into the vial.

In accordance with an embodiment of the present invention, a method of communicating a medicament from a vial containing a medicament via a syringe adaptor to a syringe having a piston adapted for selectable displacement in a first direction for drawing fluid into the syringe and in a second direction for expelling fluid from the syringe, including: non-removably connecting a vial adaptor assembly to the vial containing a medicament and via the syringe adaptor to the syringe; displacing the piston in the first direction, thereby drawing a first quantity of the medicament into the syringe; thereafter displacing the piston in the second direction, thereby expelling at least a portion of the first quantity of the medicament into a pressure equalization chamber of the vial adaptor assembly, having a variable volume; and thereafter displacing the piston in the first direction, thereby expelling substantially all of the at least a portion of the first quantity of the medicament from the pressure equalization chamber of the vial adaptor assembly, into the vial.

Preferably, the vial adaptor assembly includes a vial connector for non-removable connection with the vial containing the medicament; a syringe adaptor connector for connection with the syringe adaptor; a pressure equalization chamber having a variable volume, which is sealed from the outside environment during use. Further preferably, a liquid pathway communicating between an interior of the vial containing the medicament and an interior of the syringe when the syringe adaptor is connected to the syringe adaptor connector and the syringe is connected to the syringe adaptor and the vial connector is connected to the vial containing the medicament; and a venting pathway communicating between the interior of the vial containing the medicament and an interior of the pressure equalization chamber, when the vial connector is connected to the vial containing the medicament. Still further preferably, a liquid medicament collecting and draining well is formed in the syringe adaptor connector, the liquid medicament collecting and draining well has a tapered wall surface and a flat surface. Yet further preferably, a deformable membrane is fixedly retained between the vial connector and the syringe adaptor connector and the deformable membrane is configured to change its shape in response to pressure that is exerted upon, thereby changing the volume of the pressure equalization chamber. Further preferably, increasing the pressure within the vial urges transfer of fluid from the vial into the pressure equalization chamber; and decreasing the pressure within the vial urges transfer of fluid from the pressure equalization chamber into the vial.

In accordance with an embodiment of the present invention, a vial adaptor assembly, suitable for use with a vial containing a medicament and a syringe adaptor, which is in turn connectable to a syringe having a piston adapted for selectable displacement in a first direction for drawing fluid into the syringe and in a second direction for expelling fluid from the syringe, the vial adaptor assembly including: a vial connector for non-removable connection with the vial containing a medicament; a syringe adaptor connector for connection with the syringe adaptor; a pressure equalization chamber having a variable volume, which is sealed from the outside environment during use; a liquid pathway communicating between an interior of the vial containing the medicament and an interior of the syringe when the syringe adaptor is connected to the syringe adaptor connector and the syringe is connected to the syringe adaptor and the vial connector is connected to the vial containing the liquid medicament; and a venting pathway communicating between the interior of the vial containing the medicament and an interior of the pressure equalization chamber, when the vial connector is connected to the vial containing the medicament, and wherein the pressure equalization chamber is configured with a liquid medicament collecting and draining well communicating directly with the venting pathway.

Preferably, the vial adaptor assembly is generally axially symmetric about a longitudinal axis; the liquid pathway extends generally along the longitudinal axis; the venting pathway at least partially surrounds the liquid pathway; and the liquid medicament collecting and draining well is generally centered along the longitudinal axis. Further preferably, the pressure equalization chamber and the venting pathway are mutually configured such that, when the syringe adaptor is connected to the syringe adaptor connector and the syringe is connected to the syringe adaptor and the vial connector is connected to the vial containing the medicament, substantially all of any of the medicament that becomes located within the pressure equalization chamber is removed therefrom via the venting pathway and returned to the interior of the vial by displacement of the piston of the syringe in the first direction. Still further preferably, the vial adaptor assembly also includes a deformable membrane, which is contained within a volume enclosed between the vial connector and the syringe adaptor connector and fixedly attached therebetween. Yet further preferably, the pressure equalization chamber is disposed between the syringe adaptor connector and the deformable membrane.

In accordance with an embodiment of the present invention, the vial adaptor assembly also includes a needle element extending longitudinally along a longitudinal axis.

Preferably, the vial adaptor assembly also includes a septum element disposed within a portion of the syringe adaptor connector and configured for penetration thereof by a needle of a medical implement, which is adapted to engage the vial adaptor assembly. Further preferably, the vial connector also includes a plurality of circumferentially arranged snaps adapted for fixed engagement with the vial. Still further preferably, the vial connector also includes a sheath having an upper portion and a spike portion. Yet further preferably, a longitudinal bore is formed through the sheath, and wherein the bore has a "drop" shape, having a wide portion and a narrow portion.

In accordance with an embodiment of the present invention, a recess extends radially outwardly from the wide portion of the bore and is oppositely directed with respect to the narrow portion of the bore.

Preferably, an opening is formed in the spike portion and is adapted to communicate with the bore, the opening is oriented at the same direction as the recess. Further preferably, the deformable membrane being a deformable sheet of material having a pre-defined shape, and which is adapted to change its shape in response to pressure that is applied thereon. Still further preferably, the needle element has a cylindrical portion and a sharp tip and its inner volume defines the liquid pathway. Yet further preferably, the needle element has a fin extending radially outwardly from the cylindrical portion and an opening formed in the cylindrical portion and adapted to communicate with the liquid pathway.

Preferably, the liquid medicament collecting and draining well has a tapered wall surface and a flat surface. Further preferably, the pressure equalization chamber is formed between the deformable membrane and the syringe adaptor connector. Still further preferably, the deformable membrane is configured to change its shape in response to pressure that is exerted upon, thereby changing the volume of the pressure equalization chamber. Yet further preferably, the needle element is inserted into the wide portion of the bore, thus forming the venting pathway, which extends through the narrow portion of the bore.

In accordance with an embodiment of the present invention, a vial adaptor assembly, suitable for use with a vial containing a medicament and a syringe adaptor, which is in turn connectable to a syringe having a piston adapted for selectable displacement in a first direction for drawing fluid into the syringe and in a second direction for expelling fluid from the syringe, the vial adaptor assembly including: a vial connector for non-removable connection with the vial containing a medicament; a syringe adaptor connector for connection with the syringe adaptor; a pressure equalization chamber having a variable volume, which is sealed from the outside environment during use; a liquid pathway communicating between an interior of the vial containing the medicament and an interior of the syringe when the syringe adaptor is connected to the syringe adaptor connector and the syringe is connected to the syringe adaptor and the vial connector is connected to the vial containing the medicament; and a venting pathway communicating between the interior of the vial containing the medicament and an interior of the pressure equalization chamber, when the vial connector is connected to the vial containing the medicament, and wherein: the vial adaptor assembly is generally axially symmetric about a longitudinal axis; the liquid pathway extends generally along the longitudinal axis; and the venting pathway at least partially surrounds the liquid pathway.

Preferably, the pressure equalization chamber is configured with a liquid medicament collecting and draining well communicating directly with the venting pathway. Further preferably, the liquid medicament collecting and draining well is generally centered along the longitudinal axis. Still further preferably, the pressure equalization chamber and the venting pathway are mutually configured such that, when the syringe adaptor is connected to the syringe adaptor connector and the syringe is connected to the syringe adaptor and the vial connector is connected to the vial containing the medicament, substantially all of any of the medicament that becomes located within the pressure equalization chamber is removed therefrom via the venting pathway and returned to the interior of the vial by displacement of the piston of the syringe in the first direction. Yet further preferably, the vial adaptor assembly also includes a deformable membrane, which is contained within a volume enclosed between the vial connector and the syringe adaptor connector and fixedly attached therebetween.

In accordance with an embodiment of the present invention, the pressure equalization chamber is disposed between the syringe adaptor connector and the deformable membrane.

Preferably, the vial adaptor assembly also includes a needle element extending longitudinally along the longitudinal axis. Further preferably, the vial adaptor assembly also includes a septum element disposed within a portion of the syringe adaptor connector and configured for penetration thereof by a needle of a medical implement, which is adapted to engage the vial adaptor assembly. Yet further preferably, the vial connector also includes a plurality of circumferentially arranged snaps adapted for fixed engagement with the vial.

In accordance with an embodiment of the present invention, the vial connector also includes a sheath having an upper portion and a spike portion.

Preferably, a longitudinal bore is formed through the sheath, and wherein the bore has a "drop" shape, having a wide portion and a narrow portion. Further preferably, a recess extends radially outwardly from the wide portion of the bore and is oppositely directed with respect to the narrow portion of the bore. Still further preferably, an opening is formed in the spike portion and is adapted to communicate with the bore, the opening is oriented at the same direction as the recess. Yet further preferably, the deformable membrane being a deformable sheet of material having a pre-defined shape, and which is adapted to change its shape in response to pressure that is applied thereon.

In accordance with an embodiment of the present invention, the needle element has a cylindrical portion and a sharp tip and its inner volume defines the liquid pathway.

Preferably, the needle element has a fin extending radially outwardly from the cylindrical portion and an opening formed in the cylindrical portion and adapted to communicate with the liquid pathway. Further preferably, the opening is disposed adjacent the sharp tip of the needle element and is oriented at the same direction as the fin. Still further preferably, the liquid medicament collecting and draining well has a tapered wall surface and a flat surface. Yet further preferably, the pressure equalization chamber is formed between the deformable membrane and the syringe adaptor connector.

In accordance with an embodiment of the present invention, the deformable membrane is configured to change its shape in response to pressure that is exerted upon, thereby changing the volume of the pressure equalization chamber.

Preferably, the needle element is inserted into the wide portion of the bore, thus forming the venting pathway, which extends through the narrow portion of the bore. Further preferably, the fin is disposed within a portion of the sheath and is adapted to orient the needle element such that the opening of the needle element and the opening of the spike portion are facing the same direction. Still further preferably, a tip of the needle element protrudes axially longitudinally from the spike portion and together therewith forms a sharp tip, which is adapted for penetrating a septum of the vial containing the medicament. Yet further preferably, increasing the pressure within the vial urges transfer of fluid from the vial into the pressure equalization chamber; and decreasing the pressure within the vial urges transfer of fluid from the pressure equalization chamber into the vial.

Described below in accordance with an embodiment of the present invention is a vial adaptor assembly that is constructed and operative such that when connected to a vial at one side and to a syringe or other medical implement at another side, it enables a closed fluid transfer system. The closed fluid transfer system is configured for maintaining pressure equilibrium in-vial when drawing fluid therefrom or injecting fluid thereto and at the same time enabling safe handling of hazardous medications. It is a particular feature of an embodiment of the present invention that the entire amount of the medication contained within the closed fluid transfer system is utilized, preventing any wastage of medicament during the admixture process of the medication.

It is a further particular feature of an embodiment of the present invention that the vial adaptor assembly provides means for connection to a stopper of a vial. The vial adaptor assembly also provides a sealed access port with a pierceable septum, which is adapted to be connected to a syringe adaptor to allow a bi-directional passage of fluid. The vial adaptor assembly still further provides for means to eliminate pressure differences between the inner fluid pathways of the closed system and the ambient environment.

Reference is now made to <FIG>, which is a simplified pictorial illustration of an assembled vial adaptor for a closed fluid transfer system, constructed and operative in accordance with an embodiment of the present invention. Reference is additionally made to <FIG>, which a simplified sectional illustration of the vial adaptor of <FIG>, <FIG> being taken along lines A - A in <FIG> and to <FIG> & <FIG>, which are simplified respective pictorial and sectional exploded view illustrations of the vial adaptor of <FIG>, <FIG> being taken along lines B - B in <FIG>.

A vial adaptor assembly <NUM> is seen in <FIG>. The vial adaptor assembly <NUM> generally includes a vial connector portion <NUM>, adapted to be securely attached to a syringe adaptor connector portion <NUM> and thus forming an enclosure volume <NUM> therebetween. A deformable membrane <NUM> is disposed within the enclosure volume <NUM> and is preferably fixedly attached in between the vial connector portion <NUM> and the syringe adaptor connector portion <NUM>. A needle element <NUM> extends longitudinally along a longitudinal axis <NUM> from the syringe adaptor connector portion <NUM> to the vial connector portion <NUM>. A septum element <NUM> is disposed within a portion of the syringe adaptor connector portion <NUM> and is configured for penetration thereof by a needle of a medical implement, which is adapted to engage the vial adaptor assembly <NUM>.

It is seen particularly in <FIG> & <FIG> that the syringe adaptor connector portion <NUM> of the vial adaptor assembly <NUM> is generally a dome-shaped element having a connection portion <NUM> extending upwardly therefrom along the longitudinal axis <NUM> and having a socket <NUM> configured for fitting of the septum element <NUM> therewithin, preferably by means of swaging.

It is further particularly seen in <FIG> & <FIG> that the needle element <NUM> is hollow and arranged along the longitudinal axis <NUM>.

The vial connector portion <NUM> of the vial adaptor assembly <NUM> is generally a concave element having an axially extending sheath <NUM> extending from a central location thereof generally along the longitudinal axis <NUM>. The sheath <NUM> is configured for fixed fitting of the needle element <NUM> at least partially therethrough. The vial connector portion <NUM> additionally includes a plurality of circumferentially arranged snaps <NUM>, adapted for fixed engagement with a medical implement, such as a vial.

Reference is now made to <FIG>, which are simplified respective pictorial upward facing and downward facing illustrations of the vial connector portion <NUM> forming part of the vial adaptor assembly100 of <FIG> and to <FIG>, which is a simplified top view illustration of the vial connector portion <NUM> of <FIG>. Reference is additionally made to <FIG>, which are simplified respective sectional illustrations of the vial connector portion <NUM> of <FIG>, taken along mutually perpendicular section lines D - D and E - E in <FIG>.

The vial connector portion <NUM> is an integral part preferably made of plastic and arranged along longitudinal axis <NUM>. It is seen in <FIG> that the vial connector portion <NUM> is generally concave and has a concave wall <NUM>, with an inner surface <NUM> and an outer surface <NUM>. A circumferential rim <NUM> extends radially outwardly from wall <NUM>. A circumferential groove <NUM> is formed in the circumferential rim <NUM> and is disposed in between of two circumferential wall portions <NUM> and <NUM>. It is seen in <FIG> that wall portion <NUM> has an upwardly facing edge <NUM> and a generally curved circumferential protrusion <NUM> is formed on the upwardly facing edge <NUM>.

It is seen in <FIG>, <FIG> that an upwardly extending protrusion <NUM> is formed at a central location of wall <NUM>. The upwardly extending protrusion <NUM> has a plurality of radially spaced generally curved circumferential wall portions <NUM> forming gaps therebetween. An upper circumferential circular edge <NUM> is formed by the plurality of wall portions <NUM>. The generally curved circumferential wall portion <NUM> has an inner wall surface <NUM> and an outer wall surface <NUM>. A generally flat flange <NUM> is integrally formed within the circumference formed by the circumferential edge <NUM>. Flange <NUM> has an upwardly facing surface <NUM> and a downwardly facing surface <NUM> having a generally circular downwardly facing protrusion <NUM> formed thereon. It is seen in <FIG>, <FIG> that a generally curved circumferential protrusion <NUM> is formed on upwardly facing surface <NUM>.

Sheath <NUM> has an upper sheath portion <NUM> extending upwardly from flange <NUM> and a spike portion <NUM> extending downwardly from flange <NUM>. There are several generally curved wall portions <NUM> which surround spike portion <NUM> and are arranged circumferentially and spaced from each other. It is seen that snaps <NUM> are disposed in between of two neighboring curved wall portions <NUM> and extend slightly radially inwardly.

Several generally flat wall portions <NUM> extend radially inwardly from outer wall surface <NUM> and from curved wall portions <NUM> and circumferentially spaced from each other.

It is particularly seen in <FIG>, <FIG> that the upper sheath portion <NUM> has a generally cylindrical portion <NUM> with an outer surface <NUM> and an upwardly facing edge <NUM>. Generally, three re-enforcing ribs <NUM> are arranged circumferentially and extend radially outwardly from the cylindrical portion <NUM>, the ribs are radially spaced from each other. Preferably, each of the ribs <NUM> has an upwardly facing edge <NUM> disposed along a plane that is generally parallel to the plane of upwardly facing edge <NUM> and an upwardly facing tapered edge <NUM> connecting edge <NUM> to edge <NUM>. Ribs <NUM> extend from flange <NUM> to upwardly facing edge <NUM>.

It is particularly seen in <FIG> that the spike portion <NUM> has a generally conical portion <NUM> with an outer surface <NUM> and a downwardly facing edge <NUM>. A tapered circumferential wall surface <NUM> connects the downwardly facing edge <NUM> with the outer surface <NUM>.

It is particularly seen in <FIG> that a longitudinal bore <NUM> is formed through the sheath <NUM> and extends from upwardly facing edge <NUM> to downwardly facing edge <NUM>. It is a particular feature of an embodiment of the present invention, as specifically seen in <FIG>, that bore <NUM> has a "drop" shape, having a wide portion <NUM> and a narrow portion <NUM>. A recess <NUM> extends radially outwardly from the wide portion <NUM> of the bore <NUM> and is oppositely directed with respect to the narrow portion <NUM> of the bore <NUM>. The recess <NUM> extends longitudinally from the upwardly facing edge <NUM> downwardly along a portion of the longitudinal extent of the bore <NUM>.

Bore <NUM> defines an inner surface <NUM> having an upper conical portion <NUM> and a bottom cylindrical portion <NUM>. A generally U-shaped opening <NUM> is formed at the bottom end of the spike portion <NUM>, adjacent downwardly facing edge <NUM> and is adapted to communicate with bore <NUM>. The opening <NUM> is oriented at the same direction as recess <NUM>, therefore opposite to the narrow portion <NUM> of bore <NUM>.

Reference is now made to <FIG>, which are simplified respective pictorial and sectional illustrations of the deformable membrane <NUM> forming part of the vial adaptor assembly <NUM> of <FIG>, <FIG> being taken along lines B - B in <FIG>.

The deformable membrane <NUM> is an integral part, preferably made of plastic high-barrier laminate and arranged along longitudinal axis <NUM>. It is seen in <FIG> that the deformable membrane <NUM> is a deformable sheet of material having a pre-defined shape, and which is adapted to change its shape in response to pressure that is applied thereon. In <FIG> the deformable membrane <NUM> is shown to have a generally concave shape corresponding to the inner surface <NUM> of the vial connector portion <NUM> and similarly corresponding to an inner surface of the syringe adaptor connector portion <NUM>. The deformable membrane <NUM> has an upwardly facing surface <NUM> and a downwardly facing surface <NUM>. The deformable membrane <NUM> further has a circumferential rim <NUM>, having an upwardly facing edge <NUM> and a downwardly facing edge <NUM>. The deformable membrane <NUM> has a centrally located depression <NUM>, having an upwardly facing surface <NUM>, a downwardly facing surface <NUM> and a centrally located aperture <NUM>.

Reference is now made to <FIG>, which are simplified respective pictorial, top view and sectional illustrations of the needle element <NUM> forming part of the vial adaptor assembly <NUM> of <FIG>, Fig. 3C being taken along lines C - C in <FIG>.

The needle element <NUM> is a generally hollow cylindrical integral part, preferably made of metal and arranged along the longitudinal axis <NUM>. The needle element <NUM> has a cylindrical portion <NUM> with an upwardly facing edge <NUM> at one end thereof and a sharp conical tip <NUM> at the other end. The needle element <NUM> has an outer surface <NUM> and an inner surface <NUM>, defining an interior fluid passage, which serves as a liquid pathway <NUM>. It is noted that the liquid pathway <NUM> extends generally along the longitudinal axis <NUM>.

It is seen that a fin <NUM> extends generally radially outwardly from cylindrical portion <NUM>. The fin <NUM> has an upwardly facing edge <NUM>. It is further seen that an opening <NUM> is formed in the cylindrical portion <NUM> and communicates with the liquid pathway <NUM>. The opening <NUM> is disposed adjacent the tip <NUM> of needle element <NUM> and is oriented at the same direction as the fin <NUM>.

Reference is now made to <FIG> & <FIG>, which are simplified respective pictorial and sectional illustrations of the syringe adaptor connector portion <NUM> forming part of the vial adaptor assembly <NUM> of <FIG>, <FIG> being taken along lines B - B in <FIG>.

As noted above, the syringe adaptor connector portion <NUM> of the vial adaptor assembly <NUM> is generally a dome-shaped element having connection portion <NUM> extending upwardly therefrom along the longitudinal axis <NUM> and having socket <NUM> configured for fitting of the septum element <NUM> therewithin preferably by means of swaging.

It is seen in <FIG> & <FIG> that the dome-shaped syringe adaptor connector portion <NUM> has a generally curved wall <NUM>, having a flat annular wall portion <NUM> at one end, which connects the curved wall <NUM> with the connection portion <NUM>. The curved wall <NUM> has an outer surface <NUM> and an inner surface <NUM>. A radially outwardly extending circumferential rim <NUM> is formed at another end of the curved wall <NUM>. A downwardly facing tongue <NUM> extends downwardly from circumferential rim <NUM> and generally perpendicularly thereto.

It is seen particularly in <FIG> that a plurality of circumferentially spaced apart grooves <NUM> are formed on a portion of the inner surface <NUM> of the syringe adaptor connector portion <NUM>. The grooves <NUM> generally extend upwardly from a location adjacent the circumferential rim <NUM>. A generally smooth surface <NUM> extends from the upward end of the grooves <NUM> towards a central top location on the inner surface <NUM> of the syringe adaptor connector portion <NUM>, terminating at an upwardly protruding liquid medicament collecting and draining well <NUM>, located at the apex of the dome-shaped syringe adaptor connector portion <NUM>. The liquid medicament collecting and draining well <NUM> has a tapered wall surface <NUM> and a flat downwardly facing surface <NUM> and it is specifically seen in <FIG> that the liquid medicament collecting and draining well <NUM> is generally centered along the longitudinal axis <NUM>.

The connection portion <NUM> has a bottom portion <NUM>, an intermediate portion <NUM> and an upper portion <NUM>. The bottom portion <NUM> includes a series of longitudinally spaced flanges <NUM> having outer circumferential edges <NUM>. A neck portion <NUM> extends upwardly from the uppermost flange <NUM> and connects the bottom portion <NUM> to the intermediate portion <NUM>. The intermediate portion <NUM> is generally cylindrical portion having a first outer diameter, and having a downwardly facing shoulder <NUM> adjacent the neck portion <NUM>. A tapered wall surface <NUM> connects the intermediate portion <NUM> with an upper portion <NUM>.

The upper portion <NUM> is generally cylindrical portion having a second outer diameter, which is generally smaller than the first outer diameter. The upper portion <NUM> has an upwardly facing circumferential edge <NUM>.

A through bore <NUM> is formed through the connecting portion <NUM> and has several different portions, each having a different diameter. The bore <NUM> extends longitudinally along longitudinal axis <NUM>. The upper portion of the through bore <NUM> is socket <NUM>, having a first diameter and extending through the longitudinal extent of the upper portion <NUM>. An intermediate bore <NUM> extends downwardly longitudinally from the socket <NUM> to a location adjacent the neck portion <NUM>. The intermediate bore <NUM> has a second diameter, which is generally smaller than the first diameter of socket <NUM>. A bottom bore <NUM> extends downwardly longitudinally from the intermediate bore <NUM> to downwardly facing surface <NUM> of liquid medicament collecting and draining well <NUM>, forming an aperture <NUM> in the downwardly facing surface <NUM> and thereby communicating with the liquid medicament collecting and draining well <NUM>. The bottom bore <NUM> has a third diameter, which is generally smaller than the second diameter of the intermediate bore <NUM>.

Reference is now made to <FIG>, which are simplified respective pictorial and sectional illustrations of the septum <NUM> forming part of the vial adaptor assembly <NUM> of <FIG>, <FIG> being taken along lines B - B in <FIG>.

The septum <NUM> is a disc shaped integral solid part, preferably made of rubber and arranged along longitudinal axis <NUM>. The septum <NUM> has an upwardly facing surface <NUM>, a downwardly facing surface <NUM> and an outer facing circumferential surface <NUM>. An upwardly facing protrusion <NUM> is formed on the upwardly facing surface <NUM>.

Reference is now made to <FIG> & <FIG>, which are simplified respective pictorial and sectional illustrations of the vial adaptor assembly <NUM> of <FIG>, shown in a first operative orientation, where the vial adaptor assembly <NUM> of <FIG> is about to be connected to a vial, <FIG> being taken along lines B - B in <FIG>.

It is seen in <FIG> & <FIG> that the vial adaptor assembly <NUM> as described with reference to <FIG> is about to be connected to a vial <NUM>. The vial <NUM> has a barrel <NUM> having an inner volume <NUM> and a neck portion <NUM> defining an opening covered by septum <NUM> and fixed in place by an aluminum retaining collar <NUM>. The vial <NUM> is adapted to contain a drug powder <NUM> within its inner volume <NUM> in this operative orientation.

It is seen specifically in <FIG> that the outer portion of the deformable membrane <NUM> is fixedly connected to vial connector portion <NUM> by means of ultrasonic welding of rim <NUM> of the deformable membrane <NUM> with circumferential rim <NUM> of the vial connector portion <NUM>, more specifically the connection is formed between the downwardly facing edge <NUM> of the deformable membrane <NUM> and the circumferential protrusion <NUM> of the vial connector portion <NUM>.

The inner portion of the deformable membrane <NUM> is fixedly connected to the vial connector portion <NUM> by means of ultrasonic welding of centrally located depression <NUM> of the deformable membrane <NUM> with flat flange <NUM> of the vial connector portion <NUM>, more specifically the connection is formed between the downwardly facing surface <NUM> of the deformable membrane <NUM> and the circumferential protrusion <NUM> of the vial connector portion <NUM>.

It is further seen in <FIG> that syringe adaptor connector portion <NUM> is fixedly connected to the vial connector portion <NUM> by means of ultrasonic welding of downwardly facing tongue <NUM> of syringe adaptor connector portion <NUM> which is inserted into the circumferential groove <NUM> of the vial connector portion <NUM>.

It is seen that a portion of axially extending sheath <NUM> is extending through aperture <NUM> of the deformable membrane <NUM>.

It is seen that a pressure equalization chamber <NUM> is formed between the deformable membrane <NUM> and the syringe adaptor connector portion <NUM>, and it is noted that in this operative orientation shown in <FIG> & <FIG>, the volume of the pressure equalization chamber <NUM> is minimal, due to the fact that the upwardly facing surface <NUM> of the deformable membrane <NUM> is mostly positioned adjacent the grooves <NUM> formed on the inner surface <NUM> of the syringe adaptor connector portion <NUM> and the downwardly facing surface <NUM> of the deformable membrane <NUM> is spaced apart from the inner surface <NUM> of the vial connector portion <NUM>. The pressure equalization chamber <NUM> is empty of fluid as shown in this operative orientation.

It is a particular feature of an embodiment of the present invention that the pressure equalization chamber <NUM> contains the liquid medicament collecting and draining well <NUM> therewithin, whereas a direct fluid communication is permitted between the pressure equalization chamber <NUM> and the venting pathway <NUM> via the liquid medicament collecting and draining well <NUM>.

Septum <NUM> is inserted into socket <NUM> of the syringe adaptor connector portion <NUM> and the upper end of the upper portion <NUM> of the connection portion <NUM> of the syringe adaptor connector portion <NUM> is folded during swaging process such as to firmly hold the septum <NUM> within the syringe adaptor connector portion <NUM> by engagement of the upper portion <NUM> with the upwardly facing surface <NUM> of the septum <NUM>. Upwardly facing protrusion <NUM> of the septum <NUM> is exposed for enabling penetration thereof by a needle of a syringe adapter, as described in detail hereinbelow.

The upwardly facing tapered edge <NUM> of the upper sheath portion <NUM> abuts the tapered wall surface <NUM> of the liquid medicament collecting and draining well <NUM> of the syringe adaptor connector portion <NUM>.

It is further seen in <FIG> that cylindrical portion <NUM> of the needle element <NUM> is inserted into the bottom bore <NUM>, which is formed within the connection portion <NUM> of the syringe adaptor connector portion <NUM> and is firmly held therewithin either by adhesive or by heat welding. It is seen that the upwardly facing edge <NUM> of fin <NUM> of the needle element <NUM> preferably abuts the downwardly facing surface <NUM> of the liquid medicament collecting and draining well <NUM> of the syringe adaptor connector portion <NUM>.

The cylindrical portion <NUM> of the needle element <NUM> is further inserted through bore <NUM> formed within sheath <NUM>. It is a particular feature of an embodiment of the present invention that the needle element <NUM> is inserted into the wide portion <NUM> of bore <NUM>, thus forming a venting pathway <NUM> extending through the narrow portion <NUM> of the bore <NUM>. The venting pathway <NUM> is located between the outer surface <NUM> of the needle element <NUM> and the inner surface <NUM> defined by bore <NUM> and thus at least partially surrounds the liquid pathway <NUM>, which extends within the needle element <NUM>. The outer surface <NUM> of the needle element <NUM> is circumferentially enclosed by the wide portion <NUM> of bore <NUM>.

It is seen in <FIG> that the fin <NUM> of the needle element <NUM> is disposed within recess <NUM> formed within bore <NUM> of the sheath <NUM>. The fin <NUM> is adapted to orient the needle element <NUM> such that opening <NUM> of the needle element <NUM> and U-shaped opening <NUM> of the spike portion <NUM> are facing the same direction.

It is further seen in <FIG> that sharp conical tip <NUM> of the needle element <NUM> slightly protrudes downwardly from the tapered circumferential wall surface <NUM> of the spike portion <NUM> and together therewith forms a sharp tip, which is adapted for penetrating septum <NUM> of vial <NUM>.

Spike portion <NUM> of the sheath <NUM> and the sharp conical tip <NUM> of the needle element <NUM> are circumferentially surrounded by snaps <NUM> of the vial connector portion <NUM>.

It is noted that the vial adaptor assembly <NUM> is generally axially symmetric about longitudinal axis <NUM>.

Reference is now made to <FIG> & <FIG>, which are simplified respective pictorial and sectional illustrations of the vial adaptor assembly <NUM> of <FIG>, shown in a second operative orientation, where the vial adaptor assembly <NUM> of <FIG> is connected to the vial <NUM>, <FIG> being taken along lines B - B in <FIG>.

It is appreciated that all spatial relationships between the various components of the vial adaptor assembly <NUM>, as described with reference to <FIG> & <FIG> remain unchanged and additional relationships between the vial adaptor assembly <NUM> and the vial <NUM> now exist in this second operative orientation shown in <FIG> & <FIG>, as described in detail hereinbelow.

It is seen in <FIG> that upon attachment of the vial adaptor assembly <NUM> to the vial <NUM>, sheath <NUM> penetrates the septum <NUM> of the vial <NUM>, such that the spike portion <NUM> of the sheath <NUM> and the sharp conical tip <NUM> of the needle element <NUM> are now disposed within the inner volume <NUM> of the vial <NUM>. It is noted that both opening <NUM> of the needle element <NUM> and the U-shaped opening <NUM> of the spike portion <NUM> are now disposed within the inner volume <NUM> of the vial <NUM>.

It is further seen in <FIG> that flat wall portions <NUM> of the vial connector portion <NUM> radially engage the retaining collar <NUM> of the vial <NUM> to provide for stable connection between the vial adaptor assembly <NUM> and the vial <NUM>. Downwardly facing protrusion <NUM> of the vial connector portion <NUM> engages the septum <NUM> of the vial <NUM> for the same purpose.

The vial adaptor assembly <NUM> is fixedly and irremovably attached to the vial <NUM> by means of locking engagement of snaps <NUM> of the vial connector portion <NUM> with the neck portion <NUM> and with the retaining collar <NUM> of the vial <NUM>.

Reference is now made to <FIG> & <FIG>, which are simplified respective pictorial and sectional illustrations of the vial adaptor assembly <NUM> of <FIG>, shown in a third operative orientation, where the vial adaptor assembly <NUM> of <FIG> and the vial <NUM> are about to be connected to a syringe, having a syringe connector attached thereto, <FIG> being taken along lines B - B in <FIG>.

It is appreciated that all spatial relationships between the various components of the vial adaptor assembly <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below and additional relationships between the vial adaptor assembly <NUM> and the vial <NUM> and between a syringe <NUM> and a syringe adaptor <NUM> now exist in this third operative orientation shown in <FIG> & <FIG>, as described in detail hereinbelow.

It is seen in <FIG> & <FIG> that the syringe <NUM> is attached to the syringe adaptor <NUM>, the syringe adaptor <NUM> that is used in accordance with an embodiment of the present invention is such as the Onguard® syringe adaptor, commercially available from B. Braun of Bethlehem, Pennsylvania, USA.

The syringe <NUM> has a barrel <NUM> having an inner volume <NUM>, which is confined at one end by a piston <NUM>, which is fixedly connected or integrally made with a plunger rod <NUM> that is slidable relative to the barrel <NUM>. The syringe <NUM> has a luer <NUM> at another end thereof, which is adapted to be threadably attached to the syringe adaptor <NUM>. It is noted that the syringe <NUM> contains a diluent <NUM> within the inner volume <NUM> of the barrel <NUM>.

It is seen in <FIG> & <FIG> that the syringe <NUM>, which is connected to the syringe adaptor <NUM> is about to be connected to the vial adaptor assembly <NUM>, which was previously connected to vial <NUM>, as described with reference to <FIG> & <FIG>.

Reference is now made to <FIG> & <FIG>, which are simplified respective pictorial and sectional illustrations of the vial adaptor assembly <NUM> of <FIG>, shown in a fourth operative orientation, where the vial adaptor assembly <NUM> of <FIG> and the vial <NUM> are connected to the syringe <NUM> through the syringe connector <NUM> attached thereto, thus forming a closed fluid transfer system, <FIG> being taken along lines B - B in <FIG>.

It is appreciated that all spatial relationships between the various components of the vial adaptor assembly <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below. Additional relationships between the vial adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM> now exist in this fourth operative orientation shown in <FIG> & <FIG>, as described in detail hereinbelow.

It is seen in <FIG> & <FIG> that the syringe adaptor <NUM>, which is connected to the syringe <NUM>, as shown in <FIG> & <FIG>, is now connected to the vial adaptor assembly <NUM>. It is seen that the syringe adaptor <NUM> includes an outer surface <NUM>, and inner surface <NUM> and a downwardly facing edge <NUM>. A syringe adaptor needle <NUM> is contained within the syringe adaptor <NUM>.

The syringe adaptor <NUM> is attached to the connection portion <NUM> of the syringe adaptor connector portion <NUM>, such that connection portion <NUM> of the syringe adaptor connector portion <NUM> is contained within the inner volume of the syringe adaptor <NUM> and a snap <NUM> which is radially inwardly extending from the inner surface <NUM> of the syringe adaptor <NUM> is adapted to be locked against the downwardly facing shoulder <NUM> of the syringe adaptor connector portion <NUM>. The inner surface <NUM> of the syringe adaptor <NUM> engages flanges <NUM> of the syringe adaptor connector portion <NUM> to provide stable connection between the syringe adaptor connector portion <NUM> and the syringe adaptor <NUM>. The downwardly facing edge <NUM> of the syringe adaptor <NUM> is disposed in vicinity of annular wall portion <NUM> of the syringe adaptor connector portion <NUM>.

It is seen particularly in <FIG> that the syringe adaptor needle <NUM> penetrates the septum <NUM> and extends into the intermediate bore <NUM> of through bore <NUM> of the syringe adaptor connector portion <NUM>, thereby creating a fluid passage from the inner volume <NUM> of the syringe <NUM>, through the syringe adaptor needle <NUM>, via the liquid pathway <NUM> of the needle element <NUM> and into the inner volume <NUM> of the vial <NUM> via opening <NUM> at the tip <NUM> of the needle element <NUM>, which is located within this inner volume <NUM>.

Reference is now made to <FIG> & <FIG>, which are simplified respective pictorial and sectional illustrations of the vial adaptor assembly <NUM> of <FIG>, shown in a fifth operative orientation, where fluid is delivered from the syringe <NUM> into the vial <NUM> using the closed fluid transfer system, <FIG> being taken along lines B - B in <FIG>.

It is appreciated that all spatial relationships between the various components of the vial adaptor assembly <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below, relationships between the adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below. Additional relationships between the vial adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM> now exist in this fifth operative orientation shown in <FIG> & <FIG>, as described in detail hereinbelow.

It is seen in <FIG> & <FIG> that the plunger rod <NUM> of the syringe <NUM> is pushed inwardly into barrel <NUM> of the syringe <NUM> by the user, such that the plunger rod <NUM> slides relative to barrel <NUM> of the syringe <NUM> and thus expels the diluent <NUM> contained within the inner volume <NUM> of the syringe <NUM> through the needle <NUM> of the syringe adaptor <NUM> into the needle element <NUM> of the vial adaptor assembly <NUM> and further into the inner volume <NUM> of the vial <NUM>, whereas the diluent <NUM> is mixed with the drug powder <NUM> and forms a fluid drug mixture <NUM>. The plunger rod <NUM> is shown in <FIG> & <FIG> in the process of expelling diluent <NUM> out of the barrel <NUM> of the syringe <NUM>.

It is specifically seen in <FIG> that the diluent <NUM> is forced from the barrel <NUM> of the syringe <NUM> into the inner volume of the needle <NUM> of the syringe adaptor <NUM>, and further flows through intermediate bore <NUM> of the syringe adaptor connector portion <NUM> into the liquid pathway <NUM> of the needle element <NUM> and enters the inner volume <NUM> of the vial <NUM> through opening <NUM> of the needle element <NUM> and further through U-shaped opening <NUM> of the spike portion <NUM>.

It is a particular feature of an embodiment of the present invention that due to the passage of diluent into the inner volume <NUM> of the vial <NUM>, the pressure within the vial <NUM> is increased and thus urges passage of air, indicated by arrow <NUM> in <FIG>, from the inner volume <NUM> of the vial <NUM> into pressure equalization chamber <NUM> formed between the deformable membrane <NUM> and the syringe adaptor connector portion <NUM>, thus causing deformation of the shape of the membrane <NUM>, such that it is now inverted.

It is seen that the volume of the pressure equalization chamber <NUM> is now increased in comparison to the volume of pressure equalization chamber <NUM> as shown in <FIG>, due to the fact that air passed from the inner volume <NUM> of the vial <NUM> into the pressure equalization chamber <NUM>, as indicated by arrow <NUM>, causing deformation of the membrane <NUM>, such that the upwardly facing surface <NUM> of the deformable membrane <NUM> is spaced apart from the grooves <NUM> formed on the inner surface <NUM> of the syringe adaptor connector portion <NUM> and the downwardly facing surface <NUM> of the deformable membrane <NUM> is mostly disposed adjacent the inner surface <NUM> of the vial connector portion <NUM>.

It is specifically seen in <FIG> that air passes from the inner volume <NUM> of the vial <NUM> and flows into venting pathway <NUM> , formed between the outer surface <NUM> of the needle element <NUM> and the narrow portion <NUM> of bore <NUM> of the sheath <NUM> and enters the pressure equalization chamber <NUM> through the gap formed between upwardly facing edge <NUM> of sheath <NUM> of the vial connector portion <NUM> and between liquid medicament collecting and draining well <NUM> of the syringe adaptor connector portion <NUM>.

It is a particular feature of an embodiment of the present invention that increasing the pressure within the vial <NUM> urges transfer of fluid from the vial <NUM> into the pressure equalization chamber <NUM> and decreasing pressure within the vial <NUM> urges transfer of fluid from the pressure equalization chamber <NUM> into the vial <NUM>.

Reference is now made to <FIG> & <FIG>, which are simplified respective pictorial and sectional illustrations of the vial adaptor assembly <NUM> of <FIG>, shown in a sixth operative orientation, where the closed fluid transfer system composed of the vial adaptor assembly <NUM> attached to both the vial <NUM> and the syringe <NUM> is inverted, such that the vial <NUM> faces upwards, <FIG> being taken along lines B - B in <FIG>.

It is appreciated that all spatial relationships between the various components of the vial adaptor assembly <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below, relationships between the adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below. Additional relationships between the vial adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM> now exist in this sixth operative orientation shown in <FIG> & <FIG>, as described in detail hereinbelow.

It is seen in <FIG> & <FIG> that the closed fluid transfer system, including the vial <NUM>, vial adaptor assembly <NUM>, syringe adaptor <NUM> and syringe <NUM> all connected to each other, is flipped in order to aspirate fluid drug mixture <NUM> from the inner volume <NUM> of the vial <NUM> into the syringe <NUM>.

It is seen that in this operative orientation the syringe <NUM> is empty and the sharp conical tip <NUM> of needle element <NUM> is submerged within fluid drug mixture <NUM>, such that both opening <NUM> of the needle element <NUM> and U-shaped opening <NUM> of the spike portion <NUM> are submerged within the fluid drug mixture <NUM>.

Reference is now made to <FIG> & <FIG>, which are simplified respective pictorial and sectional illustrations of the vial adaptor assembly <NUM> of <FIG>, shown in a seventh operative orientation, where fluid is drawn from the vial <NUM> into the syringe <NUM> using the closed fluid transfer system, <FIG> being taken along lines B - B in <FIG>.

It is appreciated that all spatial relationships between the various components of the vial adaptor assembly <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below, relationships between the adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below. Additional relationships between the vial adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM> now exist in this seventh operative orientation shown in <FIG> & <FIG>, as described in detail hereinbelow.

It is seen in <FIG> & <FIG> that the plunger rod <NUM> of the syringe <NUM> is pulled outwardly relative to barrel <NUM> by the user, such that the plunger rod <NUM> slides relative to barrel <NUM> of the syringe <NUM> and thus the fluid drug mixture <NUM> contained within the inner volume <NUM> of the vial <NUM> is aspirated through the needle element <NUM> of the vial adaptor assembly <NUM> into the needle <NUM> of the syringe adaptor <NUM> and further into the inner volume <NUM> of the syringe <NUM>. The plunger rod <NUM> is shown in <FIG> & <FIG> in the process of aspirating fluid drug mixture <NUM> into the barrel <NUM> of the syringe <NUM>.

It is specifically seen in <FIG> that the fluid drug mixture <NUM> is aspirated from the inner volume <NUM> of the vial <NUM> through opening <NUM> of the needle element <NUM> and further through U-shaped opening <NUM> of the spike portion <NUM> and into the liquid pathway <NUM> of the needle element <NUM> and further flows through intermediate bore <NUM> of the syringe adaptor connector portion <NUM> into the inner volume of the needle <NUM> of the syringe adaptor <NUM> and further into barrel <NUM> of the syringe <NUM>.

It is a particular feature of an embodiment of the present invention that due to the aspiration of fluid drug mixture <NUM> out of the inner volume <NUM> of the vial <NUM>, the pressure within the vial <NUM> is decreased and thus urges passage of air, indicated by arrow <NUM> in <FIG>, from the pressure equalization chamber <NUM> formed between the deformable membrane <NUM> and the syringe adaptor connector portion <NUM> into the inner volume <NUM> of the vial <NUM>, thus causing deformation of the shape of the membrane <NUM>, such that it is now inverted.

It is seen that the volume of the pressure equalization chamber <NUM> is now decreased in comparison to the volume of pressure equalization chamber <NUM> as shown in <FIG>, due to the fact that air passed from the pressure equalization chamber <NUM> into the inner volume <NUM> of the vial <NUM>, as indicated by arrow <NUM>, causing deformation of the membrane <NUM>, such that the upwardly facing surface <NUM> of the deformable membrane <NUM> is mostly disposed adjacent the grooves <NUM> formed on the inner surface <NUM> of the syringe adaptor connector portion <NUM> and the downwardly facing surface <NUM> of the deformable membrane <NUM> is spaced apart from the inner surface <NUM> of the vial connector portion <NUM>.

It is specifically seen in <FIG> that air passes, as indicated by arrow <NUM>, from the pressure equalization chamber <NUM> through the gap formed between upwardly facing edge <NUM> of sheath <NUM> of the vial connector portion <NUM> and between liquid medicament collecting and draining well <NUM> of the syringe adaptor connector portion <NUM> and flows into venting pathway <NUM> , formed between the outer surface <NUM> of the needle element <NUM> and the narrow portion <NUM> of bore <NUM> of the sheath <NUM> and into the inner volume <NUM> of the vial <NUM>.

Reference is now made to <FIG> & <FIG>, which are simplified respective pictorial and sectional illustrations of the vial adaptor assembly <NUM> of <FIG>, shown in an eighth operative orientation, where a relatively small amount of fluid is retrieved from the syringe <NUM> into the vial <NUM> using the closed fluid transfer system, <FIG> being taken along lines B - B in <FIG>.

It is appreciated that all spatial relationships between the various components of the vial adaptor assembly <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below, relationships between the adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below. Additional relationships between the vial adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM> now exist in this eighth operative orientation shown in <FIG> & <FIG>, as described in detail hereinbelow.

<FIG> & <FIG> illustrate a situation where an excessive amount of fluid drug mixture <NUM> was aspirated from the vial <NUM> into the syringe <NUM> and in this operative orientation shown in <FIG> & <FIG>, the user retrieves a small amount of fluid drug mixture <NUM> back from the syringe <NUM> into the inner volume <NUM> of the vial <NUM>. Alternatively, it may be required to retrieve a small amount of fluid, such as air, back from the syringe <NUM> into the inner volume <NUM> of the vial <NUM> in case air was inadvertently aspirated from the vial <NUM> into the syringe <NUM>.

It is seen in <FIG> & <FIG> that the plunger rod <NUM> of the syringe <NUM> is pushed inwardly by the user, such that the plunger rod <NUM> slides relative to barrel <NUM> of the syringe <NUM> and thus expels a small amount of fluid drug mixture <NUM> from the syringe <NUM> through the needle <NUM> of the syringe adaptor <NUM> into the needle element <NUM> of the vial adaptor assembly <NUM> and further into the inner volume <NUM> of the vial <NUM>. The plunger rod <NUM> is shown in <FIG> & <FIG> in the process of expelling a portion of the fluid drug mixture <NUM> out of the barrel <NUM> of the syringe <NUM>.

It is specifically seen in <FIG> that a first portion of the fluid drug mixture <NUM> is forced from the barrel <NUM> of the syringe <NUM> into the inner volume of the needle <NUM> of the syringe adaptor <NUM>, and further flows through intermediate bore <NUM> of the syringe adaptor connector portion <NUM> into the liquid pathway <NUM> of the needle element <NUM> and enters the inner volume <NUM> of the vial <NUM> through opening <NUM> of the needle element <NUM> and further through U-shaped opening <NUM> of the spike portion <NUM>.

It is seen particularly in <FIG> that upon returning of the fluid drug mixture <NUM> into the inner volume <NUM> of the vial, and due to the fact that the spike portion <NUM> is submerged within fluid drug mixture <NUM>, a second portion of the fluid drug mixture <NUM> contained in the inner volume <NUM> of the vial <NUM> is pushed into pressure equalization chamber <NUM> formed between the deformable membrane <NUM> and the syringe adaptor connector portion <NUM> due to increase of pressure within the vial <NUM>. It is particularly seen that this second portion of fluid drug mixture <NUM> that is pushed into pressure equalization chamber <NUM> flows from the inner volume <NUM> of the vial <NUM> and flows into venting pathway <NUM> , formed between the outer surface <NUM> of the needle element <NUM> and the narrow portion <NUM> of bore <NUM> of the sheath <NUM> and enters the pressure equalization chamber <NUM> via the gap formed between upwardly facing edge <NUM> of sheath <NUM> of the vial connector portion <NUM> and between liquid medicament collecting and draining well <NUM> of the syringe adaptor connector portion <NUM>. It is seen that the second portion of the fluid drug mixture <NUM> is accumulated within the pressure equalization chamber <NUM>, and specifically within liquid medicament collecting and draining well <NUM> of the syringe adaptor connector portion <NUM> in this operative orientation. It is noted that air remains within the vial <NUM> in this operative orientation.

It is seen that the volume of the pressure equalization chamber <NUM> is now increased in comparison to the volume of pressure equalization chamber <NUM> as shown in <FIG>, due to the fact that fluid drug mixture <NUM> passed from the inner volume <NUM> of the vial <NUM> into the pressure equalization chamber <NUM>, as indicated by arrow <NUM>, causing deformation of the membrane <NUM>, such that the upwardly facing surface <NUM> of the deformable membrane <NUM> is spaced apart from the grooves <NUM> formed on the inner surface <NUM> of the syringe adaptor connector portion <NUM> and the downwardly facing surface <NUM> of the deformable membrane <NUM> is mostly disposed adjacent the inner surface <NUM> of the vial connector portion <NUM>.

Reference is now made to <FIG> & <FIG>, which are simplified respective pictorial and sectional illustrations of the vial adaptor assembly <NUM> of <FIG>, shown in a ninth operative orientation, where fluid is partially retrieved from the vial <NUM> into the syringe <NUM> using the closed fluid transfer system, <FIG> being taken along lines B - B in <FIG>.

It is appreciated that all spatial relationships between the various components of the vial adaptor assembly <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below, relationships between the adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below. Additional relationships between the vial adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM> now exist in this ninth operative orientation shown in <FIG> & <FIG>, as described in detail hereinbelow.

It is seen in <FIG> & <FIG> that the plunger rod <NUM> of the syringe <NUM> is pulled outwardly by the user, such that the plunger rod <NUM> slides relative to barrel <NUM> of the syringe <NUM> and thus a portion of the fluid drug mixture <NUM> contained within the inner volume <NUM> of the vial <NUM> is aspirated through the needle element <NUM> of the vial adaptor assembly <NUM> into the needle <NUM> of the syringe adaptor <NUM> and further into the inner volume <NUM> of the syringe <NUM>. The plunger rod <NUM> is shown in <FIG> & <FIG> in the process of aspirating fluid drug mixture <NUM> into the barrel <NUM> of the syringe <NUM>.

It is specifically seen in <FIG> that the fluid drug mixture <NUM> is aspirated from the inner volume <NUM> of the vial <NUM> through opening <NUM> of the needle element <NUM> and further through U-shaped opening <NUM> of the spike portion <NUM> and into the liquid pathway <NUM> of the needle element <NUM> and further flows through intermediate bore <NUM> of the syringe adaptor connector portion <NUM> into the inner volume of the needle <NUM> of the syringe adaptor <NUM> and further into barrel <NUM> of the syringe <NUM>. Aspiration of fluid drug mixture <NUM> puts the entire inner volume of the system under vacuum.

It is a particular feature of an embodiment of the present invention that in this operative orientation, the spike portion <NUM> of the vial connector portion <NUM> is submerged within the fluid drug mixture <NUM>. Due to the aspiration of fluid drug mixture <NUM> out of the inner volume <NUM> of the vial <NUM>, the pressure within the vial <NUM> is decreased and vacuum is created, thus urges passage of the second portion of fluid drug mixture <NUM>, which accumulated within pressure equalization chamber <NUM> as shown and described with reference to <FIG>, from the pressure equalization chamber <NUM> formed between the deformable membrane <NUM> and the syringe adaptor connector portion <NUM> into the inner volume <NUM> of the vial <NUM>, thus causing deformation of the shape of the membrane <NUM>, such that it is now inverted and the pressure equalization chamber <NUM> is disposed in its minimal volume.

It is noted that when the pressure equalization chamber <NUM> is in its minimal volume, the deformable membrane <NUM> is pushed against the inner surface <NUM> of the syringe adaptor connector portion <NUM>. Grooves <NUM> are used to prevent fluid entrapment between the deformable membrane <NUM> and the inner surface <NUM> of syringe adaptor connector portion <NUM>. When the system is orientated such as shown in <FIG> & <FIG>, gravity causes the fluid to be collected within the pressure equalization chamber <NUM> and vacuum from the syringe <NUM> urges the fluid drug mixture <NUM> upwardly back into the vial <NUM> and then in turn into the syringe <NUM> via liquid pathway <NUM> of the vial adaptor assembly <NUM>.

It is seen that the volume of the pressure equalization chamber <NUM> is now decreased in comparison to the volume of pressure equalization chamber <NUM> as shown in <FIG>, due to the fact that a portion of the fluid drug mixture <NUM> passed from the pressure equalization chamber <NUM> into the inner volume <NUM> of the vial <NUM>, causing deformation of the membrane <NUM>, which compensates for the vacuum that is created in the pressure equalization chamber <NUM>, such that the upwardly facing surface <NUM> of the deformable membrane <NUM> is mostly disposed adjacent the grooves <NUM> formed on the inner surface <NUM> of the syringe adaptor connector portion <NUM> and the downwardly facing surface <NUM> of the deformable membrane <NUM> is spaced apart from the inner surface <NUM> of the vial connector portion <NUM>.

It is specifically seen in <FIG> that the fluid drug mixture <NUM> flows upwardly from the pressure equalization chamber <NUM> through the gap formed between upwardly facing edge <NUM> of sheath <NUM> of the vial connector portion <NUM> and between liquid medicament collecting and draining well <NUM> of the syringe adaptor connector portion <NUM> and flows into venting pathway <NUM> , formed between the outer surface <NUM> of the needle element <NUM> and the narrow portion <NUM> of bore <NUM> of the sheath <NUM> and into the inner volume <NUM> of the vial <NUM>. The amount of air within the vial <NUM> remains unchanged in this operative orientation.

It is a particular feature of an embodiment of the present invention that the fluid drug mixture <NUM> that becomes located within the pressure equalization chamber <NUM> during injection of the fluid drug mixture <NUM> back into the vial <NUM> is collected within the collecting and draining well <NUM> due to the geometry of the syringe adaptor connector portion <NUM> forming the liquid medicament collecting and draining well <NUM> at the bottom of the pressure equalization chamber <NUM> and due to the pressure differential between the pressure equalization chamber <NUM> and the inner volume <NUM> of the vial <NUM>. It is specifically noted that the liquid medicament collecting and draining well <NUM> is formed by the tapered wall surface <NUM> and the flat downwardly facing surface <NUM>.

The plunger rod <NUM> is shown in the process of aspirating the required amount of fluid drug mixture <NUM> into the syringe <NUM>, thus a portion of the fluid drug mixture <NUM> still remains within pressure equalization chamber <NUM>, as shown in this operative orientation.

Reference is now made to <FIG> & <FIG> are simplified respective pictorial and sectional illustrations of the vial adaptor assembly <NUM> of <FIG>, shown in a tenth operative orientation, where the required amount of fluid <NUM> is retrieved from the vial <NUM> into the syringe <NUM> using the closed fluid transfer system, <FIG> being taken along lines B - B in <FIG>.

It is appreciated that all spatial relationships between the various components of the vial adaptor assembly <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below, relationships between the adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below. Additional relationships between the vial adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM> now exist in this tenth operative orientation shown in <FIG> & <FIG>, as described in detail hereinbelow.

It is seen in <FIG> & <FIG> that the plunger rod <NUM> of the syringe <NUM> is further pulled outwardly by the user, such that the plunger rod <NUM> slides relative to barrel <NUM> of the syringe <NUM> and thus a portion of the fluid drug mixture <NUM> contained within the inner volume <NUM> of the vial <NUM> is aspirated through the needle element <NUM> of the vial adaptor assembly <NUM> into the needle <NUM> of the syringe adaptor <NUM> and further into the inner volume <NUM> of the syringe <NUM>. The plunger rod <NUM> is shown in <FIG> & <FIG> at the end of the aspiration process of the fluid drug mixture <NUM> into the barrel <NUM> of the syringe <NUM>.

It is specifically seen in <FIG> that the fluid drug mixture <NUM> is aspirated from the inner volume <NUM> of the vial <NUM> through U-shaped opening <NUM> of the spike portion <NUM> and further through opening <NUM> of the needle element <NUM>, which are submerged within the fluid drug mixture <NUM>, and into the liquid pathway <NUM> of the needle element <NUM> and further flows through intermediate bore <NUM> of the syringe adaptor connector portion <NUM> into the inner volume of the needle <NUM> of the syringe adaptor <NUM> and further into barrel <NUM> of the syringe <NUM>.

It is a particular feature of an embodiment of the present invention that due to the aspiration of fluid drug mixture <NUM> out of the inner volume <NUM> of the vial <NUM>, the pressure within the vial <NUM> is decreased and thus urges passage of the second portion of fluid drug mixture <NUM>, which accumulated within pressure equalization chamber <NUM> as shown and described with reference to <FIG>, from the pressure equalization chamber <NUM> formed between the deformable membrane <NUM> and the syringe adaptor connector portion <NUM> into the inner volume <NUM> of the vial <NUM>. The deformable membrane <NUM> remains in the same orientation as shown in <FIG>.

It is a particular feature of an embodiment of the present invention that the volume of the pressure equalization chamber <NUM> is now empty of fluid drug mixture <NUM>, due to the fact that the second portion of fluid drug mixture <NUM> that was previously accumulated in the pressure equalization chamber <NUM> is now transferred back into the inner volume <NUM> of the vial <NUM>. It is specifically seen in <FIG> that the entire amount of fluid drug mixture <NUM> is forced out from the pressure equalization chamber <NUM> during aspiration of fluid by the syringe <NUM> due to the geometry of the syringe adaptor connector portion <NUM> forming the liquid medicament collecting and draining well <NUM> at the bottom of the pressure equalization chamber <NUM> and due to the pressure differential between the pressure equalization chamber <NUM> and the inner volume <NUM> of the vial <NUM>.

It is specifically seen in <FIG> that the entire amount of fluid drug mixture <NUM> is drained from the pressure equalization chamber <NUM> and only air remains within the pressure equalization chamber <NUM>. It is noted that after all of the fluid drug mixture <NUM> is drained from the pressure equalization chamber <NUM>, the air contained within the pressure equalization chamber <NUM> is drawn into the inner volume <NUM> of the vial <NUM> as indicated by arrow <NUM>, in order to continue the pressurizing process, optionally until the entire amount of fluid drug mixture <NUM> remaining in the vial <NUM> is drawn into the syringe <NUM>.

The plunger rod <NUM> is shown at the process of the aspiration process in <FIG>, when the required amount of fluid drug mixture <NUM> was aspirated into the syringe <NUM>, thus there is no fluid remaining within pressure equalization chamber <NUM>, as shown in this operative orientation.

Reference is now made to <FIG> & <FIG>, which are simplified respective pictorial and sectional illustrations of the vial adaptor assembly <NUM> of <FIG>, shown in an eleventh operative orientation, where the syringe <NUM> along with the syringe connector <NUM> are disconnected from the vial adaptor assembly <NUM> and the vial <NUM>, <FIG> being taken along lines B - B in <FIG>.

It is appreciated that all spatial relationships between the various components of the vial adaptor assembly <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below, relationships between the adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM>, as described with reference to <FIG> & <FIG> remain unchanged other than mentioned below. Additional relationships between the vial adaptor assembly <NUM> and the vial <NUM> and between the syringe <NUM> and the syringe adaptor <NUM> now exist in this eleventh operative orientation shown in <FIG> & <FIG>, as described in detail hereinbelow.

It is seen in <FIG> & <FIG> that the syringe <NUM> remains attached to the syringe adaptor <NUM>. The syringe <NUM> and the syringe adaptor <NUM> are now disconnected from the vial adaptor assembly <NUM>, similar to the operative orientation shown in <FIG> & <FIG>.

It is appreciated that any fluid drug mixture <NUM> remaining within the inner volume <NUM> of the vial <NUM> is sealed therewithin by means of septum <NUM>. Any fluid drug mixture <NUM> within the syringe <NUM> is sealed therewithin by means of a septum contained within the syringe adaptor <NUM>, thus providing for a closed system for fluid transfer sealed from the outside environment.

Claim 1:
A vial adaptor assembly (<NUM>), suitable for use with a vial (<NUM>) containing a medicament and a syringe adaptor (<NUM>), which is in turn connectable to a syringe (<NUM>) having a piston (<NUM>) adapted for selectable displacement in a first direction for drawing fluid into said syringe (<NUM>) and in a second direction for expelling fluid from said syringe (<NUM>), said vial adaptor assembly (<NUM>) comprising:
a vial connector (<NUM>) for non-removable connection with said vial (<NUM>) containing a medicament;
a syringe adaptor connector (<NUM>) for connection with said syringe adaptor (<NUM>);
a pressure equalization chamber (<NUM>) having a variable volume, which is sealed from the outside environment during use;
a liquid pathway (<NUM>) communicating between an interior (<NUM>) of said vial (<NUM>) containing said medicament and an interior of said syringe (<NUM>) when said syringe adaptor (<NUM>) is connected to said syringe adaptor connector (<NUM>) and said syringe (<NUM>) is connected to said syringe adaptor (<NUM>) and said vial connector (<NUM>) is connected to said vial (<NUM>) containing said medicament; and
a venting pathway (<NUM>) communicating between said interior (<NUM>) of said vial (<NUM>) containing said medicament and an interior of said pressure equalization chamber (<NUM>), when said vial connector (<NUM>) is connected to said vial (<NUM>) containing said medicament,
characterized in that said pressure equalization chamber (<NUM>) and said venting pathway (<NUM>) are mutually configured such that, when said syringe adaptor (<NUM>) is connected to said syringe adaptor connector (<NUM>) and said syringe (<NUM>) is connected to said syringe adaptor (<NUM>) and said vial connector (<NUM>) is connected to said vial (<NUM>) containing said medicament, substantially all of any of said medicament that becomes located within said pressure equalization chamber (<NUM>) is removed therefrom via said venting pathway (<NUM>) and returned to said interior (<NUM>) of said vial (<NUM>) by displacement of said piston (<NUM>) of said syringe (<NUM>) in said first direction.