Patent Description:
Advances in medical treatment and improved procedures constantly increase the need for improved apparatus for handling medications in liquid form. The demands relating to variety of types, quality, needle safety, microbial ingress prevention and leak prevention are constantly growing. Additionally, advances in sampling or dose dispensing technologies, automated and manual, aseptic or non-aseptic applications, call for new safe concealing solutions for the sampling needle. One extremely demanding application exists in the field where medical and pharmacological personnel that are involved in the preparation and administration of hazardous drugs suffer the risk of being exposed to drugs and to their vapors, which may escape to the surroundings.

Hazardous drugs in liquid or powder form are contained within vials, and are typically prepared in a separate room by pharmacists provided with protective clothing, a mouth mask, and a laminar flow safety cabinet. A syringe provided with a cannula, i.e. a hollow needle, is used for transferring the drug from a vial. After being prepared, the hazardous drug is added to a solution contained in a bag which is intended for parenteral administration, such as a saline solution intended for intravenous administration.

<CIT> to the applicant of the present application describes closed system liquid transfer devices designed to provide contamination-free transfer of hazardous drugs. <FIG> and <FIG> are schematic cross-sectional views of an apparatus <NUM> for transferring hazardous drugs without contaminating the surroundings, according to one embodiment of the invention described in this patent. The main features of this apparatus that are relevant to the present invention will be described herein. Additional details can be found in the aforementioned patent.

The proximal section of apparatus <NUM> is a syringe <NUM>, which is adapted to draw or inject a desired volume of a hazardous drug from a fluid transfer component, e.g. a vial <NUM> or an intravenous (IV) bag in which it is contained and to subsequently transfer the drug to another fluid transfer component. At the distal end of syringe <NUM> is connected a connector section <NUM>, which is in turn connected to vial <NUM> by means of vial adaptor <NUM>.

Syringe <NUM> of apparatus <NUM> is comprised of a cylindrical body <NUM> having a tubular throat <NUM> that has a considerably smaller diameter than body <NUM>, an annular rubber gasket or stopper assembly <NUM> fitted on the proximal end of cylindrical body <NUM>, hollow piston rod <NUM> which sealingly passes through stopper <NUM>, and proximal piston rod cap <NUM> by which a user can push and pull piston rod <NUM> up and down through stopper <NUM>. A piston <NUM> made of an elastomeric material is securely attached to the distal end of piston rod <NUM>. Cylindrical body <NUM> is made of a rigid material, e.g. plastic.

Piston <NUM>, which sealingly engages the inner wall of, and is displaceable with respect to, cylindrical body <NUM> defines two chambers of variable volume: a distal liquid chamber <NUM> between the distal face of piston <NUM> and connector section <NUM> and a proximal air chamber <NUM> between the proximal face of piston <NUM> and stopper <NUM>.

Connector section <NUM> is connected to the throat <NUM> of syringe <NUM> by means of a collar which proximally protrudes from the top of connector section <NUM> and surrounds throat <NUM>. Note that embodiments of the apparatus do not necessarily have a throat <NUM>. In these embodiments syringe <NUM> and connector section <NUM> are formed together as a single element at the time of manufacture, or permanently attached together, e.g. by means of glue or welding, or formed with a coupling means, such as threaded engagement or a Luer connector. Connector section <NUM> comprises a double membrane seal actuator which is moveable in a reciprocating manner from a normal, first configuration in which the needles are concealed when the double membrane seal actuator is disposed in a first, distal position and a second position in which the needles are exposed when the double membrane seal actuator is proximally displaced. Connector section <NUM> is adapted to be releasably coupled to another fluid transfer component, which can be any fluid container with a standard connector such as a drug vial, intravenous bag, or an intravenous line to produce a "fluid transfer assembly", through which a fluid is transferred from one fluid transfer component to another component.

Connector section <NUM> comprises a cylindrical, hollow outer body; a distal shoulder portion, which radially protrudes from the body and terminates at the distal end with an opening through which the proximal end of a fluid transfer component is inserted for coupling; a double membrane seal actuator <NUM>, which is reciprocally displaceable within the interior of the body; and one or more resilient arms <NUM> serving as locking elements, which are connected at a proximal end thereof to an intermediate portion of a cylindrical actuator casing that contains double membrane seal actuator <NUM>. Two hollow needles that function as air conduit <NUM> and liquid conduit <NUM> are fixedly retained in needle holder <NUM>, which protrudes into the interior of connector section <NUM> from a central portion of the top of connector section <NUM>.

Conduits <NUM> and <NUM> distally extend from needle holder <NUM>, piercing the upper membrane of actuator <NUM>. The distal ends of conduits <NUM> and <NUM> have sharp pointed ends and apertures through which air and liquid can pass into and out of the interiors of the conduits respectively as required during a fluid transfer operation. The proximal end of air conduit <NUM> extends within the interior of proximal air chamber <NUM> in syringe <NUM>. In the embodiment shown in <FIG>, air conduit <NUM> passes through piston <NUM> and extends inside of hollow piston rod <NUM>. Air flowing through conduit <NUM> enters/exits the interior of piston rod <NUM> and exits/enters to air chamber <NUM> through an aperture formed at the distal end of piston rod <NUM> just above piston <NUM>. The proximal end of liquid conduit <NUM> terminates at the top of or slightly proximally from the top of needle holder <NUM>, so that the liquid conduit will be in fluid communication with the distal liquid chamber <NUM> via the interior of throat <NUM> of syringe <NUM>.

Double membrane seal actuator <NUM> comprises a cylindrical casing that holds a proximal disc shaped membrane 34a having a rectangular cross-section and a two level distal membrane 34b having a T-shaped cross-section with disc shaped proximal portion and a disc shaped distal portion disposed radially inwards with respect to the proximal portion. The distal portion of the distal membrane 34b protrudes distally from actuator <NUM>. Two or more equal length resilient elongated arms <NUM> are attached to the distal end of the casing of actuator <NUM>. The arms terminate with distal enlarged elements. When actuator <NUM> is in a first position, the pointed ends of conduits <NUM> and <NUM> are retained between the proximal and distal membranes, isolating the ends of conduits <NUM> and <NUM> from the surroundings, thereby preventing contamination of the interior of syringe <NUM> and leakage of a harmful drug contained within its interior to the surroundings.

Vial adaptor <NUM> is an intermediate connection that is used to connect connector section <NUM> to a drug vial <NUM> or any other component having a suitably shaped and dimensioned port. Vial adaptor <NUM> comprises a disk shaped central piece to which a plurality of circumferential segments, formed with a convex lip on the inner face thereof for facilitating securement to a head portion of a vial <NUM>, are attached at the circumference of the disk and pointing distally away from it and a longitudinal extension projecting proximally from the other side of the disk shaped central piece. Longitudinal extension fits into the opening at the distal end of connector section <NUM> to allow transfer of the drug as described herein below. The longitudinal extension terminates proximally with a membrane enclosure having a diameter larger than that of the extension. A central opening in the membrane enclosure retains and makes accessible a membrane 15a.

Two longitudinal channels, which are internally formed within the longitudinal extension and that extend distally from the membrane in the membrane enclosure, are adapted to receive conduits <NUM> and <NUM>, respectively. A mechanical guidance mechanism is provided to insure that the conduits <NUM> and <NUM> will always enter their designated channel within the longitudinal extension when connector section <NUM> is mated with vial adaptor <NUM>. The longitudinal extension terminates distally with a spike element 15b which protrudes distally. The spike element is formed with openings in communication with the internally formed channels, respectively and openings at its distal pointed end.

Vial <NUM> has an enlarged circular head portion attached to the main body of the vial with a neck portion. In the center of the head portion is a proximal seal 16a, which is adapted to prevent the outward leakage of a drug contained therein. When the head portion of vial <NUM> is inserted into the collar portion of vial adaptor <NUM> and a distal force is applied to vial adaptor <NUM>, the spike element 15b of the connector section <NUM> pierces the seal 16a of vial <NUM>, to allow the internal channels in the connector section <NUM> to communicate with the interior of drug vial <NUM>. When this occurs, the circumferential segments at the distal end of the collar portion of the connector section are securely engaged with the head portion of vial <NUM>. After the seal of vial <NUM> is pierced it seals around the spike preventing the outward leakage of the drug from the vial. At the same time the tops of the internal channels in vial adaptor <NUM> are sealed by the membrane 15a at the top of vial adaptor <NUM>, preventing air or drug from entering or exiting the interior of vial <NUM>.

The procedure for assembling drug transfer apparatus <NUM> is carried out as shown in <FIG>: Step <NUM> - After the vial <NUM> and vial adaptor <NUM> have been joined together, with spike element 15b penetrating proximal seal 16a of the vial, the membrane enclosure of vial adaptor <NUM> is positioned close to the distal opening of connector section <NUM>, as shown in <FIG>. Step <NUM> - A double membrane engagement procedure is initiated by distally displacing the body of connector section <NUM> with an axial motion until the membrane enclosure and longitudinal extension of vial adaptor <NUM> enters the opening at the distal end of the connector section <NUM>, as shown in <FIG>. Step <NUM> - the distal membrane 34b of actuator <NUM> is caused to contact and be pressed against the stationary membrane 15a of vial adaptor <NUM> by additional distal displacement of the body of the connector section <NUM>. After the membranes are pressed tightly together the enlarged elements at the ends of the arms of the connector section <NUM> are squeezed into the more narrow proximal section of connector section <NUM> thereby holding the membranes pressed together and engaged around the longitudinal extension and under the membrane enclosure of vial adaptor <NUM>, as shown in <FIG>, thereby preventing disengagement of the double membrane seal actuator <NUM> from vial adaptor <NUM>. Step <NUM> - Additional distal displacement of the body of connector section <NUM>, as shown in <FIG>, causes actuator <NUM> to move proximally relative to the body of the connector section <NUM> until the tips of conduits <NUM> and <NUM> pierce the distal membrane of actuator <NUM> and the membrane at the top of vial adaptor <NUM> and are in fluid communication with the interior of vial <NUM>. These four steps are performed by one continuous axial motion as connector section <NUM> is distally displaced relative to the vial adaptor <NUM>, and they will be reversed to separate connector section <NUM> from vial adaptor <NUM> by pulling connector section <NUM> and vial adaptor <NUM> apart. It is important to emphasize that the procedure is described herein as comprising four separate steps, however this is for ease in describing the procedure only. It is to be realized that in actual practice the secured double membrane engagement (and disengagement) procedure using the present invention is carried out using a single smooth axial movement.

After drug transfer assembly <NUM> shown in <FIG> is assembled as described hereinabove with reference to <FIG>, the piston rod <NUM> can be moved to withdraw liquid from vial <NUM> or to inject liquid from the syringe into the vial. The transfer of liquid between the distal liquid chamber <NUM> in the syringe <NUM> and liquid <NUM> in the vial <NUM> and transfer of air between the proximal air chamber <NUM> in the syringe <NUM> and air <NUM> in the vial <NUM> takes place by an internal pressure equalization process in which the same volumes of air and liquid are exchanged by moving through separate channels symbolically shown in <FIG> by paths <NUM> and <NUM> respectively. This is a closed system which eliminates the possibility of exchange of air or liquid drops or vapor between the interior of assembly <NUM> and the surroundings.

In the years since the apparatus <NUM> described above was invented applicant has made numerous improvements to the components of the apparatus while retaining the basic features and mode of assembly and disassembly as described above.

With respect to connector section <NUM>, several improvements have been made leading up to the present invention. In co-pending Israeli patent application no. <CIT>, is described a solution to a problem that sometimes occurred when using the apparatus.

<FIG> is an enlarged view of the prior art connector section <NUM> of the drug transfer apparatus shown in <FIG>. As described herein above, when syringe <NUM> and attached connector section <NUM> are not connected to another component, the tips of the hollow needles that form the air conduit <NUM> and liquid conduit <NUM> reside between the proximal and distal membranes of double membrane seal actuator <NUM>. If the piston rod of the syringe is pushed in a distal direction, then liquid that is in the liquid chamber below the piston of the syringe will be forced out of the opening at the distal end of liquid conduit <NUM> and can be pushed into the opening at the distal end of air conduit <NUM> and forced into the air chamber above the piston syringe. If the piston rod is pulled distally, then the opposite flow of air and liquid takes place and air can be forced from the air chamber into the liquid chamber of the syringe.

A solution provided in <CIT> to the applicant of the present application is shown in <FIG>. That solution is a sleeve <NUM> into which the tip of the needle comprising the air conduit <NUM> is placed. Sleeve <NUM> is made of an elastomeric material and is placed inside the double membrane seal actuator <NUM>.

As shown in <FIG>, when liquid chamber <NUM> contains liquid and the piston <NUM> of the syringe is pushed distally the fluid that is forced out of the tip of the liquid conduit <NUM> creates pressure inside actuator <NUM> that causes sleeve <NUM> to be pressed around the tip of the air conduit <NUM>, thus blocking the passage of liquid into the air needle. The harder one pushes on the piston rod - the more effective is the blocking action of the sleeve. Additionally at same time, suction is created in the air chamber of the syringe on the proximal side of piston <NUM> and in the air conduit <NUM> causing the sleeve <NUM> to be pressed even more tightly against the tip of the air conduit, thereby increasing the blocking action.

As shown in <FIG>, when the piston <NUM> of the syringe is pulled proximally the liquid conduit <NUM> is in suction mode, creating vacuum in the interior of actuator <NUM>. At same time the air conduit <NUM> injects air into the interior of actuator <NUM> thus air pushing sleeve <NUM> away from the tip of conduit <NUM> and expanding its diameter thereby allowing air to flow out of the air conduit <NUM> into the liquid conduit <NUM>. From <FIG> it can be seen that a one-way valve operation is taking place, i.e. liquid can't pass to the air channel or air chamber in the syringe, but air can pass to liquid chamber. The ability to draw air into the liquid chamber is purposely desired since it is required for certain manipulations during drug preparation.

<FIG> show another improvement first described in <CIT> to the prior art double membrane seal actuator shown in <FIG>. This aspect of the present invention simplifies manufacturing of the double membrane actuator. According to this embodiment, the length of needle holder <NUM> that fixedly supports the needles that form air conduit <NUM> and liquid conduit <NUM> is lengthened and its shape is made cylindrical with a circular cross section. Additionally the proximal membrane 34a is removed and is replaced with an O-ring <NUM> that fits tightly over the exterior of needle holder <NUM>.

<FIG> shows the connector section <NUM> when it is not connected to a vial adaptor <NUM>. In this configuration the O-ring <NUM> is at the distal end of the needle holder <NUM> and the tips of the air and liquid conduits are above the lower membrane 34b of the actuator. As the connector section and vial adaptor are pushed together, the actuator is pushed in the proximal section with the O-ring <NUM> sliding up the needle holder <NUM> until it reaches the proximal end of the connector section and the needles have penetrated the lower membrane 34b of the actuator and the membrane at the top of the vial adaptor as shown in <FIG>.

<CIT> and <CIT>, both to the applicant of the present application, describe needle valves that can be incorporated into the membrane actuator of the connector section <NUM>. The needle valves prevent the possibility of liquid travel through the air conduit from the distal liquid chamber <NUM> or vial <NUM> to the proximal air chamber when the connector section <NUM> is not connected to a vial or other fluid transfer component. The needle valves also simplify the construction of the membrane actuator making it possible to use a single membrane actuator instead of a double membrane actuator as in the connector section shown in <FIG>.

<FIG> is a schematic cross-sectional view of a connector section <NUM>. In this embodiment the prior art double membrane seal actuator <NUM> in the connector section <NUM> that comprises two membranes 34a and 34b and arms <NUM> (see <FIG>) is replaced with an actuator <NUM> comprising an embodiment of a needle valve <NUM>, only one membrane 34b, and arms <NUM>. It is important to note that in this embodiment it is not necessary to seal the proximal end of actuator <NUM> in any fashion because the task of enclosing the ports <NUM> at the distal ends of the air and liquid conduits when the connector is not connected to another fluid transfer component, which in the prior art was accomplished by membranes 34a and 34b, is accomplished in the single membrane actuator <NUM> by the needle valve arrangement and membrane 34b alone and in some embodiments by the needle valve itself.

Referring to <FIG>, actuator <NUM> comprises a valve seat <NUM> comprising two bores through which the needles of air conduit <NUM> and liquid conduit <NUM> pass. It is noted that embodiments of actuator <NUM> are also described that contain one bore for use in liquid transfer apparatus that comprises only one needle <NUM>.

When the syringe and attached connector are not connected to any other component of the apparatus, as shown in <FIG>, the actuator <NUM> is at the distal end of connector section <NUM> and the tips of needles <NUM> and <NUM> are located in the bores in the seat <NUM> of the needle valve. In this configuration the ports <NUM> in the sides of the needles are blocked by the interior walls of the bores completely isolating the needles from each other, thereby preventing air from entering the liquid chamber of the syringe or liquid from entering the air chamber.

When the syringe and attached connector are connected to another component of the apparatus, such as a vial adaptor, the actuator <NUM> is pushed towards the proximal end of connector section <NUM>. Since needles <NUM> and <NUM> are fixed to the connector <NUM> by the needle holder <NUM>, as actuator <NUM> moves proximally, the tips of needles <NUM> and <NUM> and ports <NUM> are pushed out through the distal end of the bores in the seat <NUM> of the needle valve, through membrane 34b, and through the membrane at the top of the vial adaptor, thereby establishing open fluid paths in the respective channels.

The first goal for the connector is to completely eliminate the possibility of migration of liquid to the air chamber. This can happen, for example, if pressure differentials between the air and liquid chambers exist after disconnection from a vial adaptor and if the pressure in the air chamber is lower than that in the liquid chamber, resulting in undesired migration of liquid to the air chamber. The second goal is to prevent leaks or damage to the connector during accidental pushing of the syringe plunger. One of the frequently performed drug transfer operations in hospital settings is known as IV push or bolus injection. Typically the required amount of drug is prepared in a syringe in the hospital pharmacy and delivered to the ward where a qualified nurse administers the drug to the patient through a previously established IV line. A common problem associated with the procedure is that during the trip from pharmacy to ward or at bedside the piston of the syringe is sometimes unintentionally pushed expelling some of the drug from the barrel of the syringe or the piston is unintentionally pulled. High pressures of up to <NUM> atmospheres can be easily generated by manually pushing the plunger of small volume syringes (<NUM>-<NUM>). Such pressure may cause the connector to disintegrate or the membranes to be detached. The connector shown in <FIG> is proposed as a solution to the problems associated with such unintended transfer of fluids between the air and liquid chambers and to resist high pressures created during accidental pushing the of plunger. As can be seen in the figure, when the connector <NUM> is not connected to an adapter <NUM>, the ports <NUM> at the distal end of needles <NUM> and <NUM> that allow exchange of fluid between the surroundings and the hollow interiors of the needles are blocked by the interior of the bore in seat <NUM> of the needle valve. If the syringe is filled or partially filled with liquid, then if a force is exerted to try to push the plunger forward and to force liquid to flow through the needle, no liquid can exit the needle through port <NUM>. Conversely, if a force is exerted to pull the plunger backwards no air can enter through port <NUM> and flow through the interior of the needle into the barrel of the syringe.

<CIT> to the applicant of the present application describes embodiments of septum holders for use in connector sections that are used to connect syringes to other elements of liquid transfer apparatuses. All of the embodiments of the septum holders described in that patent application comprise a septum holder body, at least one resilient elongated arm that terminates with a distal enlarged element attached to the sides of the body, and a septum. The septum holders of <CIT> are characterized in that they comprise at least one bore that functions as the seat of a needle valve. The bore is created in the septum or in an insert fixed in either the body of the septum holder or in the septum. The septum holders described in <CIT> are also characterized in that the septum is attached to the bottom of the body of the septum holder projecting downwards parallel to the at least one elongated arm.

<FIG>, and <FIG> are respectively front, cross-sectional, and exploded views of an embodiment of a septum holder <NUM> described in <CIT>. Septum holder <NUM> is comprised of a disk shaped annular body <NUM>. Two equal length resilient elongated arms <NUM> are attached to the sides of body <NUM>. The arms terminate with distal enlarged elements <NUM>. The bottom part of body <NUM> is comprised of a cylindrical section that projects downward between arms <NUM>. A cavity <NUM> is created in the bottom part of body <NUM> into which is fitted an insert <NUM> comprising two bores <NUM> that form the seat of a needle valve. In alternative embodiments insert <NUM> can have different shapes than that shown and in one embodiment can be comprised of two separate pieces of tubing that are inserted into parallel bores of appropriate diameters created in the bottom part of body <NUM>.

Septum <NUM> is made of a single piece of cylindrically shaped resilient material. The upper part of septum <NUM> has a hollow interior forming a cylindrical recess <NUM> having an inner diameter no larger than that of the outer diameter of the cylindrical section at the bottom of body <NUM>. After insert <NUM> is fitted into cavity <NUM>, septum <NUM> is pushed over the bottom part of body <NUM> until the solid part of septum <NUM> below recess <NUM> butts against the bottom of bores <NUM> in insert <NUM> thereby isolating the bottoms of the interior of the bores from the external environment. Septum <NUM> is fixedly held on the body <NUM> of septum holder <NUM> by any means known in the art. For example, the resilient material of the septum may be strong enough to grip the sides of the cylindrical section at the bottom of body <NUM> to hold the septum in place; or, as shown in <FIG>, in embodiments of the septum holder the cylindrical section at the bottom of body <NUM> may have threads or teeth <NUM>, or an equivalent structure created on its outer surface and septum <NUM> may have similar structure on the inner diameter of its hollow interior (not shown in <FIG>) so that the two structures interlock when septum <NUM> is pushed over the bottom part of body <NUM>. In other embodiments other methods, such as gluing, ultrasonic forming, or laser or ultrasound welding are used.

<FIG> schematically shows the septum holder of <FIG>, and <FIG> in a connector section <NUM> of a closed system liquid transfer apparatus. The connector section <NUM> is essentially the same as that in the prior art apparatus described herein above. Cylindrical outer housing <NUM> of the connector section is attached to syringe <NUM>. Two hollow needles, which function respectively as an air conduit <NUM> and as a liquid conduit <NUM>, are fixedly attached to the upper end of outer housing <NUM> of the connector section. At the lower end of the needles, adjacent to the pointed distal tips, are ports <NUM> that allow fluid communication between the exterior and the hollow interiors of the needles. External ridges <NUM> near the bottom of cylindrical outer housing <NUM> serve as finger grips for use when attaching the connector section and syringe to other elements of the drug transfer system. Ridges <NUM> are not essential and can be eliminated or replaced with other means, for example a roughened surface area, to accomplish the same purpose.

A septum holder <NUM> is located inside of cylindrical outer housing <NUM> of the connector section. As shown, the distal ends of needles <NUM>,<NUM> are inserted into bores <NUM> in insert <NUM> (see <FIG>). If the insert <NUM> is made of a flexible material, e.g. silicon, the diameters of bores <NUM> are smaller than the outer diameter of the shafts of the needles and therefore the resilient material of which the insert is manufactured pushes radially against the shaft of the needle sealing the ports <NUM>. When not connected to another element of a liquid transfer system the distal enlarged elements <NUM> of arms <NUM> are engaged in the shoulder portion <NUM> at the distal end of outer housing <NUM>. As shown in <FIG>, in this position the tips of the needles are isolated from the outside by septum <NUM> at the bottom and the walls of the bores <NUM> pressing radially on the shafts of the needles prevent fluids from entering or exiting the interior of the needles. Connection of the connector section to a fluid transfer component, e.g. a vial adaptor, a spike adaptor for connection to an IV bag, or a connector for connection to an IV line, is accomplished in the same manner as in the prior art described herein above. When the septum of the fluid transfer component is pushed against septum <NUM>, septum holder <NUM> begins to move upwards inside outer housing <NUM> and the tips of the needles begin to exit bores <NUM> and penetrate the solid material of septum <NUM>. The tips of the needles pass through septum <NUM> and the septum of the fluid transfer component as septum holder <NUM> continues to be pushed upwards, thereby establishing air and liquid channels between the element of the liquid transfer system attached to the fluid transfer component and the proximal air chamber and distal liquid chamber in the syringe.

<FIG> schematically show embodiments of a septum holder <NUM> described in<CIT>. The septum holders shown in these figures are identical with the exception of the number of resilient arms <NUM> - two arms in <FIG> and four arms in <FIG>.

Septum holder <NUM> is structurally the same as that shown in <FIG> with the exception that the arms <NUM> are attached to the sides of the body in a way that allows them to move in a different manner. Septum holder <NUM> is comprised of a cylindrically shaped annular body <NUM>. Two (or four) parallel equal length, downward extending, resilient, elongated arms <NUM> are attached to the sides of body <NUM>. The arms terminate with distal enlarged elements <NUM>. The distal enlarged elements are shaped roughly like a human foot with a rounded outwardly facing rear side and a pointed inwardly facing front side. The bottom section of body <NUM> is comprised of a cylindrical section that projects downward parallel to arms <NUM>. A cavity is created in the bottom part of body <NUM> into which is fitted an insert comprising one or two bores that form the seats of needle valves. Ribs <NUM> or equivalent structure may be present in the interior of body <NUM> to provide mechanical strength and support to the insert.

Septum <NUM> is made of a single piece of cylindrically shaped resilient material. The upper part of septum <NUM> has a hollow interior forming a cylindrical recess having an inner diameter no larger than that of the outer diameter of the cylindrical section at the bottom of body <NUM>. After the insert is fitted into the cavity in body <NUM>, septum <NUM> is fitted over the cylindrical bottom section of body <NUM> (much as a knitted cap is pulled over a head) until the solid part of septum <NUM> butts against the bottom of the bores in the insert; thereby isolating the bottoms of the interior of the bores from the external environment. Septum <NUM> is fixedly held facing downward on the body <NUM> of septum holder <NUM> by any means known in the art, such as described herein above.

<FIG> schematically show the difference between the attachment of the arms to the septum holder of <FIG> and the septum holder of <FIG>. In <FIG> a pair of arms is located facing each other on opposite sides of the septum holder. The enlarged elements at the distal end of the arms move back and forth along an extension of a diameter of the circular cross-section of the body of the septum holder in the direction shown by the double headed arrows in <FIG>. In the septum holder of <FIG>, a pair of arms is located one alongside the other on the same side of the septum holder. The enlarged elements at the distal end of the arms move back and forth along extensions of parallel chords of the circular cross-section of the body of the septum holder in the directions shown by the double headed arrows in <FIG>.

It is noted that other septum holders, for example the other embodiments of septum holders described in the above referenced <CIT>, can be adapted mutatis mutandis, by locating the arms as described with reference to <FIG> as can other septum housings such as those shown in <FIG>, <FIG> and <FIG>. It is also noted that septum holders similar to those shown in <FIG> can be manufactured having only one arm or more than four arms. A very stable configuration can be obtained by the use of three arms, although this would be a more complex embodiment to manufacture.

The changes made to the attachment of the arms to the sides of the septum holder that have been described above with respect to <FIG> have necessitated a redesign of connector sections that comprise these septum holders.

<FIG> schematically shows the exterior of connector section <NUM>, which is described in detail in co-pending application <CIT>. The internal elements of connector section <NUM>, i.e. the septum holder and either one or two needles, are surrounded by an outer housing <NUM>. Outer housing <NUM> has the shape of a right prism with a generally square cross-section and an open distal (bottom) end into which the proximal end of an adapter component, e.g. a vial adapter, can be inserted. The proximal (upper) part <NUM> of outer housing <NUM> can be constructed in many ways in order to connect to a component, e.g. a syringe or an IV line, of a fluid transfer apparatus.

It is a purpose of the present invention to provide an improved septum holder that will overcome a problem in manufacture and sterilization of a product that comprises the septum holders of the prior art.

Further purposes and advantages of this invention will appear as the description proceeds.

The invention relates to a connector section for a liquid transfer apparatus, according to claim <NUM>.

The connector section comprises: a cylindrical outer body having a proximal end adapted to be attached to syringe and an open distal end comprising a shoulder portion; at least one hollow needle fixedly attached to the proximal end of the body of the connector section, the needle having at least one port at its lower end adjacent to its pointed distal tip that allows fluid communication between the exterior and the hollow interior of the needle; and a septum holder located inside of the cylindrical body of the connector section.

The septum holder comprises: (a) a body having an upper body part and a lower body part, the lower body part comprising a bored out interior; (b) an insert comprising at least one bore that forms the seat of a needle valve, the insert fitted loosely into the interior of the lower body part; and (c) a septum comprising an upper part attached to an exterior surface of the lower body part of the septum holder and a lower part of the septum that extends downward beyond the lower edge of the lower body part of the septum holder.

In the septum holder of the connector section the insert can freely move up and down in the interior of the lower body part and the septum can freely move up and down on the exterior surface of the lower body part.

In embodiments of the connector section of the invention the body of the septum holder comprises a disk shaped annular upper body part with at least one resilient elongated arm terminating with a distal enlarged element attached to the side of the upper body part.

In embodiments of the connector section of the invention the body of the septum holder comprises a lower body part comprised of a cylindrically shaped annular section that projects downward from the upper part parallel to the at least one arm. In some of these embodiments the lower body part of the septum holder comprises an outwardly projecting edge at its lower end.

In embodiments of the connector section of the invention the septum of the septum holder comprises an upper part having a hollow interior in the form of a cylindrical recess having an inner diameter larger than that of the outer diameter of the cylindrically shaped annular section. In some of these embodiments the upper rim of the septum of the septum holder is structured as an inwardly projecting edge configured such that, when pushed over the outwardly projecting edge at the lower end of the cylindrically shaped annular section of the lower body part, the upper rim of the septum interacts with the outwardly projecting edge to hold the septum on exterior surface of the septum holder.

In embodiments of the connector section of the invention, when the connector section is not connected to another element of the liquid transfer system, the distal enlarged element of the at least one arm of the septum holder is engaged in the shoulder portion at the distal end of body of the syringe connector and the distal end of the at least one needle is inserted into the at least one bore in the insert of the septum holder.

All the above and other characteristics and advantages of the invention will be further understood through the following illustrative and non-limitative description of embodiments thereof, with reference to the appended drawings.

One of the products manufactured by the applicant of this patent application is a unit for closed transfer of liquids comprised of a syringe connected to a connector section. These units, after manufacture and assembly, are packed in blister packs and sent to be sterilized before shipment to customers. Sterilization is carried out by placing the blister packs in a closed container or room that is then filled with ethylene chloride. The blister pack is comprised of a thermoplastic front, which is impervious to gas and bacteria, sealed to a paper back, which is impervious to bacteria but allows gas molecules to pass through it. The ethylene oxide gas enters the blister pack through the paper back and enters the inside of the syringe and connector section through the needle openings and sterilizes the syringe and connector section. After a period of time a vacuum is created in the container to draw the sterilizing gas out of the blister packs and then air is introduced into the blister packs, which are then a sterile product ready for use.

If the connector section comprises a septum holder such as shown in <FIG>, the ports <NUM> at the tips of the air and liquid channels are blocked by the sides of the bores in the insert <NUM> when the connector section is not connected at its distal end to another element such as a vial adapter. This is the situation when the product described above is placed in the blister pack. Because ports <NUM> are blocked the sterilizing gas cannot enter the body of the syringe which can't be sterilized, which of course is unacceptable. The current solution to this problem is to seal the syringe and attached connector in the blister pack with the septum holder <NUM> pulled downwards from the location shown in <FIG> until the distal enlarged elements <NUM> of arms <NUM> are outside of the outer housing <NUM> of the connector section. In this configuration the ports <NUM> have been removed from the bores in the insert <NUM> allowing the sterilizing gas to enter the interior of the syringe and to be replaced with sterile air. After the sterilization process is completed the septum holder is pushed back to its correct location with the distal enlarged elements <NUM> engaged in the shoulder portion <NUM> at the distal end of outer housing <NUM>, the tips of the needles in the bores <NUM> in insert <NUM>, and the top of septum <NUM> sealing the bottom of the bores <NUM> as shown in <FIG> and <FIG>.

After sterilization the boxed product is delivered from the sterilization site to the manufacturing site and the blister packs need to be taken out from the boxes in order to move the septum holder to its correct position and then pack the blisters back into the boxes. Moving the septum holder to its correct position inside the connector section while both are sealed inside the blister pack is a difficult and very time-consuming task that can only be done manually. All of this extra handling adds a great deal of expense to the manufacturing process.

The same problem exists for all embodiments of the prior art connectors shown in the background section of this application.

The present invention is a septum holder that was invented to overcome this problem. It can be used, for example in connector section <NUM> shown in <FIG> or connector section <NUM> shown in <FIG>. The septum holder of this invention comprises a septum that can be moved up and down on the septum holder to alternately block or unblock the ports at the tips of the needles.

<FIG> and <FIG> are cross-sectional views that show the moveable septum at two different locations on the septum holder.

<FIG> schematically shows the septum holder <NUM> of the invention in a connector section of a closed system liquid transfer apparatus. The connector section is, with the exception of the septum holder, the same as that in the prior art connector section <NUM> shown in <FIG> or connector section <NUM> shown in <FIG> described herein above. Outer housing <NUM> or <NUM> of the connector section is configured at its upper end to be connected to another component of the liquid transfer system such as a syringe or an IV line. Two hollow needles, which function as an air conduit <NUM> and as a liquid conduit <NUM> respectively, are fixedly attached to the upper end of outer housing <NUM> or <NUM> of the connector section. At the lower end of the needles, adjacent to the pointed distal tips, are ports <NUM> that allow fluid communication between the exterior and the hollow interiors of the needles. External ridges <NUM> near the bottom of outer housing <NUM>/<NUM> serve as finger grips for use when attaching the connector section and syringe to other elements of the drug transfer system. Ridges <NUM> are not essential and can be eliminated or replaced with other means, for example a roughened surface area, to accomplish the same purpose.

Septum holder <NUM> is comprised of a body <NUM> comprising a disk shaped annular upper part. Two equal length resilient elongated arms <NUM> are attached at the sides of the upper part of body <NUM>. The arms terminate with distal enlarged elements <NUM>. The bottom part of body <NUM> is comprised of a cylindrically shaped annular section <NUM> that projects downward from the upper part between arms <NUM>. At the lower end of annular section <NUM> is an outwardly projecting edge <NUM>. An insert <NUM> comprising two bores <NUM> that form the seat of a needle valve is fitted loosely into the center of annular section <NUM> so that the insert is free to move up and down in annular section <NUM>.

Septum <NUM> is made of a single piece of cylindrically shaped resilient material. The upper part of septum <NUM> has a hollow interior forming a cylindrical recess <NUM> having an inner diameter larger than that of the outer diameter of annular section <NUM> at the bottom of body <NUM>. The upper rim of the septum <NUM> is structured as an inwardly projecting edge <NUM> that, when pushed over outwardly projecting edge <NUM> at the bottom of annular section <NUM>, interacts with edge <NUM> to hold septum <NUM> on septum holder <NUM>. Because of the length of the wall of annular section <NUM>, septum <NUM> can move up or down on the septum holder between the two limiting positions shown in <FIG> and <FIG>.

After the prior art connector sections described herein as well as those shown in <FIG> and <FIG> is manufactured a quality control check is carried out by inserting the proximal end of a simulated adapter, such as that used to connect the connector section to a drug vial, intravenous bag, or an intravenous line, into the opening at the distal end of the cylindrical, hollow outer body of the connector section. As in the procedure for assembling the drug transfer apparatus described herein above the simulated adapter is pushed against the septum <NUM> in the septum holder until the simulated adapter and the septum holder become attached to each other. Continue pushing the simulated adapter and the attached septum holder <NUM> upwards in the connector section until the tips of the needles <NUM>,<NUM> exit bores <NUM> and pass through septum <NUM>. The simulated adapter and attached septum holder are then pulled downwards until the tips of the needles are pulled back through septum <NUM> and reenter bores <NUM> blocking ports <NUM>. The elastomeric material of which the septum is made seals the hole as the needle is pulled back through it. Further pulling of the simulated adapter downwards separates it from the septum holder. This process is repeated at least one more time before the quality of the connector section is verified.

The quality control check described above provides an additional benefit. The act of puncturing the septum greatly reduces the amount of force that the end user is required to exert to assemble the drug transfer apparatus in the pharmacy, clinic, or hospital ward. It has been found that a considerable amount of force is needed to puncture the septum the first time. The second time that the needle passes through the septum requires significantly less force than the first time and the third and subsequent times that the needle passes through the septum requires significantly less force than the second time.

The syringe-connector section unit is sealed in the blister pack with septum <NUM> pulled down as shown in <FIG>. With the septum in this configuration the insert <NUM> is also lowered removing ports <NUM> at the distal end of the needles from bores <NUM> in insert <NUM> and the sterilization procedure can be carried out as required.

After the sterilization procedure is completed the product can be delivered to a customer as is and without the need to be sent to the manufacturing site for moving the septum holder to reseal the ports <NUM>. Re-sealing of the ports <NUM> is accomplished automatically when septum <NUM> and insert <NUM> are pushed upward from the location shown in <FIG> to the location shown in <FIG> during first connection of the connector section to a fluid transfer component, e.g. a vial adaptor, a spike adaptor for connection to an IV bag, or a connector for connection to an IV line. After the first connection the ports <NUM> remain in sealed position in all following connection procedures.

Claim 1:
A connector section for a liquid transfer apparatus, the connector section comprising: a septum holder (<NUM>) located inside of a cylindrical outer body (<NUM>/<NUM>) of the connector section, the cylindrical outer body (<NUM>/<NUM>) having a proximal end adapted to be attached to syringe and an open distal end comprising a shoulder portion (<NUM>); at least one hollow needle (<NUM>,<NUM>) fixedly attached to the proximal end of the cylindrical outer body (<NUM>/<NUM>) of the connector section, the at least one hollow needle (<NUM>,<NUM>) having at least one port (<NUM>) at its lower end adjacent to its pointed distal tip that allows fluid communication between the exterior and the hollow interior of the needle (<NUM>,<NUM>), the septum holder (<NUM>) comprising:
a body (<NUM>) having an upper body part and a lower body part, the lower body part comprising a bored out interior,
an insert (<NUM>) comprising at least one bore (<NUM>), and
a septum (<NUM>) wherein:
(a) the insert (<NUM>) fits loosely into the bored out interior of the lower body part of the body (<NUM>) of the septum holder (<NUM>); and
(b) the septum (<NUM>) comprises an upper part and a lower part; wherein the upper part of septum (<NUM>) is attached to an exterior surface of the lower body part of the body (<NUM>) of the septum holder (<NUM>) and the lower part of the septum (<NUM>) extends downward beyond the lower edge of the lower body part of the body (<NUM>) of the septum holder (<NUM>);
wherein
(i) the bore (<NUM>) forms a seat of a needle valve, and the insert (<NUM>) can freely move up and down between an upper position at which the insert is configured to block the at least one port and a lower position at which the insert is configured to unblock the at least one port; and
(ii) the septum (<NUM>) can freely move up and down on the exterior surface of the lower body part of the body (<NUM>) of the septum holder (<NUM>).