HK1216873B

HK1216873B - Improvements to closed drug transfer system

Info

Publication number: HK1216873B
Application number: HK16104642.6A
Authority: HK
Inventors: 马里诺.克里赫利; 拉阿南．塔沃尔
Original assignee: 伊奎希尔德医疗有限公司
Priority date: 2013-02-07
Filing date: 2014-02-03
Publication date: 2018-02-15

Abstract

The application describes innovative designs for components of a drug transfer apparatus that overcome problems encountered in daily use of prior art apparatuses. Specifically described are components configured to prevent liquid from entering the air chamber of syringes coupled to the apparatus and to prevent tearing of the rubber stopper of drug vials when they are attached to the apparatus.

Description

Improvements in closed drug delivery systems

Technical Field

The present invention relates to the field of fluid transfer devices. More particularly, the present invention relates to a device for contamination-free transfer of a liquid from one container to another.

Background

Medical and pharmacological personnel involved in the preparation and administration of harmful drugs are at risk of exposure to the drug and to vapors of the drug that may escape into the surrounding environment. As referred to herein, a "harmful drug" is any injectable substance that may pose a health hazard upon contact with the harmful drug or vapors of the harmful drug. Illustrative and non-limiting examples of such drugs include, inter alia, cytotoxins, antiviral drugs, chemotherapeutics, antibiotics, and radiopharmaceuticals, such as herceptin, cisplatin, fluorouracil, leucovorin, taxol, metatroxat, gemozar, cyclophosphamide, cytoxan, and cyclophosphamide injections (neosar), as well as combinations of the foregoing (in liquid, solid or gaseous form).

Hazardous drugs in liquid or powder form are contained in vials and are usually prepared in separate rooms by pharmacists equipped with protective clothing, masks and sterile-handling safety cabinets. A syringe (i.e. a hollow needle) provided with a cannula is used to transfer the drug from the vial. After preparation, the hazardous drug is added to a solution contained in a bag for parenteral administration (parentera administration), such as a saline solution for intravenous administration.

Because harmful drugs are toxic, direct physical contact with them or exposure to even minute amounts of the vapors of the drugs significantly increases the risk of developing death from health conditions such as skin cancer, leukemia, liver damage, malformations, miscarriage, and premature labor. Such exposure can occur when containers containing drugs, such as vials (visas), bottles (bottles), syringes, and iv bags, are subjected to excessive pressure resulting in leakage of liquid or air contaminated with the harmful drug to the surrounding environment. Exposure to the harmful drug may also be caused by a medical fluid remaining on the needle tip, on the seal of a vial or iv bag, or by accidental skin puncture by the needle tip. Furthermore, microbial contamination from the environment may be transferred to drugs and liquids through the same exposure route; thereby eliminating infertility with potentially fatal consequences.

US 8,196,614 by the present inventor describes a closed system liquid transfer device designed to provide contamination free transfer of hazardous drugs. According to one embodiment of the invention described in US 8,196,614, fig. 1, 3a to 3d are schematic cross-sectional views of a device 10 for transferring hazardous drugs without contaminating the surrounding environment. The main features of the device that are relevant to the present invention will be described herein. Additional details can be found in the above-mentioned patents.

The proximal portion of the device 10 is a barrel 12, the barrel 12 being adapted to draw a desired volume of a harmful drug from a fluid-moving member, such as a vial 16 or Intravenous (IV) bag, having the harmful drug contained therein, and the barrel 12 being adapted to subsequently move the drug to another fluid-moving member. A connector portion 14 is connected to the distal end of the syringe barrel 12, the connector portion 14 in turn being connected to a drug vial 16 by a drug vial adapter 15.

The syringe barrel 12 of the device 10 includes a cylindrical body 18, the cylindrical body 18 having a tubular throat 20, an annular rubber gasket or stopper assembly 22 fitted over the proximal end of the cylindrical body 18, a hollow plunger rod 24 sealingly passing through the stopper assembly 22, and a proximal plunger rod cap 26, the throat 20 having a much smaller diameter than the body 18, and the plunger rod 24 being pushable and pullable up and down through the stopper 22 by a user through the proximal plunger rod cap 26. A piston 28 made of an elastic material is fixedly attached to the distal end of the piston rod 24. The cylindrical body 18 is made of a rigid material, such as plastic.

A piston 28 sealingly engages the inner wall of the cylindrical body 18 and is movable relative to the cylindrical body 18, said piston 28 defining two variable volume chambers: a distal liquid chamber 30 between the distal face of the piston 28 and the connector portion 14 and a proximal air chamber 32 between the proximal face of the piston 28 and the stopper 22.

The connector portion 14 is connected to the throat 20 of the barrel 12 by a collar that extends proximally from the top of the connector portion 14 and surrounds the throat 20. It should be noted that embodiments of the device need not have a throat 20. In these embodiments, the barrel 12 and the connector portion 14 are formed together as a single element at the time of manufacture, or are permanently attached together, such as by bonding or welding, or are formed with a coupling device, such as a threaded engagement or a Luer connector (Luer connector). The connector portion 14 includes a compressible and reciprocatable double membrane seal actuator that adopts a normal relaxed configuration in which the needle is concealed when the double membrane seal actuator is disposed in the first distal position and the double membrane seal actuator is compressed to expose the needle when moved proximally. The connector portion 14 is adapted to releasably couple to another fluid transfer member, which may be any fluid container having a standard fitting, such as a vial, iv bag or iv cannula, to create a "fluid transfer assembly" through which fluid is transferred from one fluid transfer member to another.

The connector portion 14 comprises a cylindrical hollow outer body; a distal shoulder projecting radially from the body and terminating at a distal end and having an opening through which a proximal end of the fluid transfer member is inserted for coupling; a double membrane seal actuator 34 reciprocally movable inside the main body; and one or more resilient arms 35 serving as locking elements connected at a proximal end to an intermediate portion of a cylindrical actuator housing containing the double membrane seal actuator 34. Two hollow needles, acting as an air conduit 38 and a liquid conduit 40, are fixedly held in a needle holder 36, the needle holder 36 protruding from a central part of the top of the connector part 14 into the interior of the connector part 14.

Tubing 38 and tubing 40 extend distally from needle holder 36, piercing the upper membrane of actuator 34. The distal ends of the tubes 38 and 40 have sharp tips and apertures through which air and liquid, respectively, may pass into or out of the interior of the tubes during fluid transfer operations, as desired. The proximal end of air conduit 38 extends within the interior of proximal air chamber 32 in barrel 12. In the embodiment shown in fig. 1, an air conduit 38 passes through the piston 28 and extends into the interior of the hollow piston rod 24. Air flowing through conduit 38 enters/exits the interior of piston rod 24 and enters/exits air chamber 32 through an opening formed in the distal end of piston rod 24 directly above piston 28. The proximal end of liquid conduit 40 terminates at or slightly proximally from the top of needle holder 36 such that the liquid conduit will be in fluid communication with distal liquid chamber 30 via the interior of throat 20 of syringe barrel 12.

The dual membrane seal actuator 34 includes a housing that holds a proximal disc-shaped membrane 34a having a rectangular cross section and a two-stage distal membrane 34b having a T-shaped cross section, the two-stage distal membrane 34b having a disc-shaped proximal end portion and a disc-shaped distal end portion disposed radially inward with respect to the proximal end portion. The distal end of the distal membrane 34b extends distally from the actuator 34. Two or more resilient elongate arms 35 of equal length are attached to the distal end of the housing of the actuator 34. The arm terminates in a distally enlarged member. When the actuator 34 is in the first position, the tip of the tubing 38 and tubing 40 remains between the proximal and distal membranes, preventing the user from exposing to the tip and being scratched by the tip, and also blocking the ends of the tubing 30 and tubing 40 from the surrounding environment, thereby preventing contamination of the interior of the syringe barrel 12 and leakage of harmful drugs contained therein into the surrounding environment.

The drug vial adapter 15 is an intermediate connector for connecting the connector portion 14 to a drug vial 16 or any other component having a port of suitable shape and size. The vial adapter 15 comprises a disc-shaped central member to which a plurality of circumferential sectors formed on the inner face with a lip to facilitate fixing to the head of the vial 16 are attached on the circumference of the disc and directed distally away from the disc-shaped central member, the vial adapter 15 further comprising a longitudinal extension projecting proximally from the other side of the disc-shaped central member. The longitudinal extension fits into the opening at the distal end of the connector portion 14 to allow for the transfer of medication as described below. The longitudinal extension terminates proximally in a membrane enclosure having a diameter greater than the diameter of the extension. The central opening in the membrane enclosure holds the membrane 15a and makes the membrane 15a accessible.

Two longitudinal channels are formed internally in the longitudinal extension and extend distally from the membrane in the membrane enclosure, the two longitudinal channels being adapted to accommodate the conduits 38 and 40, respectively. Mechanical guiding means are provided to ensure that when the connector part 14 is mated with the drug vial adapter 15, the tubing 38 and tubing 40 will always enter their designated channels in the longitudinal extension. The longitudinal extension terminates distally in a distally projecting spike element 15 b. The spike elements are formed with an opening communicating with the internally formed channel and an opening at the distal tip thereof, respectively.

The vial 16 has an enlarged circular head with a neck attached to the body of the vial. A proximal seal 16a is in the center of the head, the proximal seal 16a being adapted to prevent the medicament contained therein from leaking outwardly. When the head of the drug vial 16 is inserted into the collar of the drug vial adapter 15 and a distal force is applied to the drug vial adapter 15, the spike elements 15b of the connector portion 14 pierce the seal 16a of the drug vial 16 to allow the internal passage in the connector portion 14 to communicate with the interior of the drug vial 16. As this occurs, a circumferential sector at the distal end of the collar portion of the connector portion is fixedly engaged with the head of the vial 16. After the seal of the vial 16 is pierced, the seal seals around the spike to prevent the drug from leaking out of the vial. At the same time, the top of the internal passageway in the drug vial adapter 15 is sealed by a membrane 15a at the top of the drug vial adapter 15, preventing air or drug from entering or exiting the interior of the drug vial 16.

The process for assembling the drug-transfer device 10 is performed as shown in fig. 3 a-3 d: step 1-as shown in fig. 3a, after bonding the drug vial 16 and the drug vial adapter 15 together, the membrane enclosure 15a of the drug vial adapter 15 is placed adjacent to the distal opening of the connector portion 14 by piercing the proximal seal 16a of the drug vial with spike elements 15 b. Step 2-as shown in fig. 3b, the double membrane engagement process is initiated by the body of the connector portion 14 having an axial movement moving distally until the membrane surround and the longitudinal extension of the drug vial adapter 15 enter the opening at the distal end of the connector portion 14. Step 3-the distal membrane 34b of the actuator 34 is brought into contact with and pressed against the fixed membrane 15a of the drug vial adapter 15 by additional distal movement of the body of the connector portion 14, and after pressing the membranes together, the enlarged elements at the ends of the arms of the connector portion 14 are pressed into the narrower proximal part of the connector portion 14, thereby holding the membranes pressed together and engaged around the longitudinal extension and under the membrane enclosure of the drug vial adapter 15, as shown in fig. 3c, thereby preventing the double membrane sealed actuator 34 from disengaging from the drug vial adapter 15. Step 4-as shown in fig. 3d, additional distal movement of the body of the connector portion 14 moves the actuator 34 proximally relative to the body of the connector portion 15 until the tips of the tubing 38 and tubing 40 pierce the distal membrane of the actuator 34 and the membrane at the top of the drug vial adapter 15 and are in fluid communication with the interior of the drug vial 16. These four steps are performed by one continuous axial movement as the connector part 14 is moved distally relative to the drug vial adapter 15, and will be reversed to separate the connector part 14 from the drug vial adapter 15 by holding the connector part 14 stationary and moving the drug vial adapter 15 distally. It is important to emphasize that the process is described herein as comprising four separate steps, however this is merely for ease of description of the process. It will be appreciated that in practice the engagement (and disengagement) process using the fixed double membrane of the present invention is performed using a single smooth axial movement.

After the drug-moving component 10 shown in fig. 1 is assembled as described above with reference to fig. 3a to 3d, the piston rod 24 may be moved to withdraw liquid from the vial 16 or inject liquid from the syringe into the vial. The transfer of liquid between the distal liquid chamber 30 in the syringe barrel 12 and the liquid 48 in the vial 16 and the transfer of air between the proximal air chamber 32 in the syringe barrel 12 and the air 46 in the vial 16 occurs by an internal pressure equalization process in which the same volume of air and liquid is exchanged by moving through separate channels (represented by paths 42 and 44, respectively, as shown in fig. 1). This is a closed system that eliminates the possibility of air exchange or droplet or vapor exchange between the interior of the assembly 10 and the surrounding environment.

Figure 4a schematically shows the injection of a liquid into a vial. In order to inject the liquid contained in the liquid chamber 30 of the syringe 12 into the vial 16, the drug transfer assembly 10 must be held vertically, i.e. the vial at the bottom is in a vertical position, as shown in fig. 4 a. Pushing the piston 28 pushes the liquid distally out of the liquid chamber through the conduit 40 into the vial 16. At the same time, as the volume of the liquid chamber 30 is reduced by the distally moving piston, the volume of the air chamber 32 increases. This creates a temporary state of negative pressure in the air chamber so air (or inert air) inside the vial 16 will be drawn into the air chamber 32 through the conduit 38. Additionally, simultaneously, as liquid is added to the vial, the volume available for air in the vial is reduced, creating a temporary state of positive pressure, so that air is forced from the vial 16 through the conduit 38 into the air chamber 32, thereby equalizing the pressure in the transfer assembly 10 and reaching equilibrium when the piston 28 stops moving.

Figure 4b schematically shows the withdrawal of liquid from the vial. In order to withdraw liquid from the vial 16 and transfer the liquid into the liquid chamber 30 of the syringe 12, the drug transfer assembly 10 must be turned and held upright, i.e. the vial 16 is in an upside down position, as shown in fig. 4 b. For this operation, when the device 10 is assembled and the plunger 28 in the syringe barrel 12 is pulled in the proximal direction, a state of negative pressure is created in the liquid chamber 30 and liquid is drawn into the liquid chamber 30 through the conduit 40. At the same time the volume of the air chamber 32 is reduced and air is forced out of the air chamber 32 through the conduit 38 into the vial (bubbles created by air entering the vial from the air chamber 40 are shown in figure 4 b). As depicted in fig. 4a and 4b, this simultaneous transfer and simultaneous replacement of equal volumes of air and liquid in the syringe and vial, respectively, constitutes an equalizing system of a closed system.

Although attention is paid to separating the air path 42 from the liquid path 44, there are two positions in the prior art assembly described in US 8,196,614, where the paths cross under certain conditions, allowing for the possibility of: liquid travels from the distal liquid chamber 30 or vial 16 through the air conduit to the proximal air chamber.

In particular, in the prior art device described in US 8,196,614 there is a direct connection between the air channel and the liquid channel:

A. inside the dual membrane seal actuator 34 when the syringe barrel 12 and attached connecting portion 14 are not connected to any other fluid-moving member; and

B. inside the vial 16 at the tip of the spike when the device 10 is assembled as shown in fig. 1.

When part of the liquid does accidentally find its way into the air chamber of the syringe, in addition to obvious aesthetic problems, additional time-consuming working steps become necessary to retrieve the drug and correct the dose.

An example of a protocol when referring to case a is when the syringe contains liquid and is being handled, for example when being transported from a pharmacy to a hospital room. At this point, the piston rod may be accidentally pushed, causing some of the drug to move to the proximal air chamber above the piston where it cannot be expelled from the syringe barrel. In this case, the plunger needs to be pulled back in order to retrieve the drug, which is an extra work step and the moist residue in the air chamber 32 causes aesthetic problems.

Examples of scenarios when referring to case B are when during withdrawal of liquid drug from a vial, which is typically in an upside down position, when it is seen that a bubble of air enters the liquid chamber of the cartridge, or when the cartridge has been filled with more than the required liquid volume. In these cases, pushing the piston rod to return the liquid or air bubble to the vial will also cause some of the liquid to be forced through the air channel into the air chamber of the syringe barrel. The method of removing the air bubbles is a relatively time consuming and complex process that involves disconnecting the syringe from the vial and reconnecting the vial. Special care needs to be taken to avoid pushing the plunger accidentally, which slows down the speed of operation.

Another difficulty with prior art drug transfer assemblies is that the drug vial adapters are often prone to leakage of liquids and vapors to the ambient environment, and vice versa, the drug in the drug vial is susceptible to microbial contamination when air from the ambient environment enters the drug vial because the drug vial adapter is improperly attached to the drug vial. When manually attaching a drug vial adapter, the spike is often improperly centered and/or inserted into the stopper of the drug vial, often at an angle. This inaccuracy tears the rubber stopper of the vial when the vial adapter is fully seated on the vial and the locking tabs force the spike and adapter into place.

It is an object of the present invention to provide an improvement to the drug transfer device described above which will prevent the above mentioned drawbacks.

Other objects and advantages of the invention will appear as the description proceeds.

Disclosure of Invention

In a first aspect, the present invention is a fluid transfer device comprising:

(a) a syringe-like proximal portion comprising:

(i) a cylindrical body;

(ii) a piston movable within the cylindrical body, the piston defining a distal liquid chamber and a proximal air chamber each having a variable volume;

(b) a connector portion fixedly attached to a distal end of the proximal portion, wherein the distal end of the connector portion is adapted to be connectable to a fluid-transfer member, the connector portion comprising:

(i) a needle holder;

(ii) a liquid conduit passing through and rigidly attached to the needle holder, wherein a distal end of the liquid conduit begins at the connector portion and a proximal end of the liquid conduit terminates at the liquid chamber;

(iii) an air conduit passing through and rigidly attached to the needle holder, wherein a distal end of the air conduit begins at the connector portion and a proximal end of the air conduit terminates at the air chamber; and

(iv) a membrane at a distal end of the connector portion, wherein the membrane surrounds the distal ends of the liquid conduit and the air conduit to seal the liquid conduit and the air conduit from the surrounding environment.

The connector portion is configured to allow the head of the fluid transfer member to enter the interior of the connector portion and to allow the membrane in the connector portion to be pushed proximally when the membrane located in the head of the fluid transfer member comes into contact with the membrane in the connector portion; the membrane is thus pushed further together causing the distal end of the liquid conduit and the distal end of the air conduit to penetrate the membrane in the connection portion and penetrate the membrane in the head, thereby establishing a liquid channel via the liquid conduit between the interior of the liquid chamber and the interior of the fluid transfer member and establishing a separate air channel via the air conduit between the interior of the air chamber and the interior of the fluid transfer member. The fluid transfer device of the present invention is characterized in that a hydrophobic filter is inserted into at least one location between the air chamber in the air channel and the fluid transfer member.

In an embodiment of the device according to the invention, a section of the air channel is located outside the device.

In an embodiment of the device in the present invention, the connector part comprises a hollow cylindrical outer body having:

(a) a distal shoulder extending radially from the outer body and terminating in an opening into which a proximal end of the fluid transfer member may be inserted for coupling;

(b) a closed proximal cap portion having a central portion including a connector extending proximally from the central portion for connection to a syringe-shaped proximal portion of the device;

(c) a needle holder extending from a central portion of the closed proximal cap into the interior of the outer body for holding two conduits inside the outer body, the two conduits including sharp pointed ends and further being provided with apertures through which liquid and air, respectively, are displaced in a fluid displacement operation; and

(d) a dual membrane seal actuator reciprocally movable within the hollow interior of the outer body;

the dual membrane seal actuator includes:

(i) a cylindrical actuator housing;

(ii) a proximal membrane sealing the proximal end of the housing;

(iii) a distal membrane sealing the distal end of the housing, wherein a portion of the distal membrane extends distally from the housing; and

(iv) at least one resilient arm connected to an intermediate portion of the exterior of the housing at a proximal end of the at least one resilient arm, and the at least one resilient arm including an enlarged locking element at a distal end of the at least one resilient arm; the enlarged locking element has a specifically shaped surface area that interacts with the inner wall of the hollow cylindrical outer body of the connector portion to effect a four step process for connecting or disconnecting the connector portion to or from the fluid-moving member.

These embodiments may include a cannula made of an elastomeric material that surrounds the needle tip and distal opening of the air conduit inside the dual membrane seal actuator.

(b) a closed proximal cap having a central portion comprising a connector extending proximally from the central portion for connection to a throat of a syringe-like proximal portion of the device;

(c) an elongated cylindrical needle holder protruding from a central portion of the closed proximal cap to an interior of the outer body for holding two conduits within the interior of the outer body, the two conduits including sharp pointed ends and further being provided with apertures through which liquid and air, respectively, are displaced in a fluid displacement operation; and

(d) a single-membrane seal actuator reciprocally movable within the hollow interior of the outer body.

The single film seal actuator includes:

(i) a cylindrical actuator housing;

(ii) a proximal O-ring sealing the proximal end of the housing to the outer surface of the elongated cylindrical needle holder;

(iv) at least one resilient arm connected to an intermediate portion of the exterior of the housing at a proximal end of the at least one resilient arm, and the at least one resilient arm including a locking element that expands at a distal end of the at least one resilient arm; the enlarged locking element has a specifically shaped surface area that interacts with the inner wall of the hollow cylindrical outer body of the connector portion to effect a four-step process for connecting or disconnecting the connector portion to or from the fluid-moving member.

These embodiments of the device may include a cannula made of an elastic material that surrounds the tip and distal opening of the needle of the air conduit inside the single membrane seal actuator.

In an embodiment of the device of the invention, the fluid transfer member is a drug vial adapter comprising an air channel and a separate liquid channel, thereby providing a closed transfer system which is not open to or in communication with the environment.

In an embodiment of the device of the present invention, comprising a drug vial adapter, the drug vial adapter comprises:

(a) a distal collar portion comprising a disc-shaped central member having a plurality of fan-shaped portions adapted to facilitate securing of the drug vial adapter to a head of a medical drug vial or to a head of any type of vessel or device having a head similar to a head of a standard medical drug vial, the fan-shaped portions attached to a periphery of the disc-shaped central member and projecting distally away from the disc-shaped central member;

(b) a longitudinal extension projecting proximally from the disc-shaped centerpiece, the longitudinal extension adapted to be coupled to a fluid displacement device;

(c) a membrane sealing the proximal end of the longitudinal extension;

(d) a spike element extending distally from the center of the disc-shaped centerpiece;

(e) an air channel and a liquid channel both formed internally within the longitudinal extension and the spike element, the channels adapted to allow fluid communication from the proximally disposed membrane through the drug vial adapter to an opening on the tip of the spike.

In these embodiments, an annular flat hydrophobic filter is located in the disc-shaped central piece, the drug vial adapter and the filter being adapted to allow fluid flowing in the liquid channel to pass through the drug vial adapter but not through the filter, and to force fluid flowing through the air channel to pass through the filter.

(a) a base adapted to attach to the head of a medical drug vial or to the head of any type of vessel or device having a head similar to the head of a standard medical drug vial;

(b) a top portion, comprising:

(i) a disc-shaped central member and a plurality of wings adapted to facilitate securing the top portion to the bottom portion, the wings attached to a periphery of the disc-shaped central member and projecting distally away from the disc-shaped central member;

(ii) a longitudinal extension projecting proximally from the disc-shaped centerpiece, the longitudinal extension adapted to be coupled to a fluid displacement device;

(iii) a membrane sealing the proximal end of the longitudinal extension;

(iv) a spike element extending distally from the center of the disc-shaped centerpiece;

(v) an air channel and a liquid channel both formed internally within the longitudinal extension and the spike element, the channels adapted to allow fluid communication from a proximally disposed membrane through the drug vial adapter to an opening on the tip of the spike;

(c) a first locking mechanism; and

(d) a second locking mechanism.

A first locking mechanism adapted to lock the top to the bottom such that the tip of the spike cannot come into contact with the plug in the head when the head is attached to the bottom and to release the top from the bottom after the bottom has been attached to the head; and a second locking mechanism adapted to allow the spike to penetrate a plug in the head and immovably lock the top to the bottom after the bottom has been attached to the head.

In these embodiments, an annular flat hydrophobic filter may be located in the disc-shaped element, the drug vial adapter and the filter being adapted to allow fluid flowing in the liquid channel to flow through the drug vial adapter but not through the filter, and to force fluid flowing through the air channel to pass through the filter.

In an embodiment of the device, an annular flat hydrophobic filter is included, one or both of the outer and inner peripheral edges of which are welded, bonded, or mechanically pressed to the drug vial adapter.

In an embodiment of the device, an annular flat hydrophobic filter is included that is supported by and mounted on a plurality of closely spaced support ribs above and/or below.

Embodiments of the device include an annular flat hydrophobic filter comprising a bypass comprising a one-way valve placed in parallel with the filter in the air channel. The one-way valve comprises an elastic cap that fits tightly over the end of the rigid tube.

Embodiments of the device include an annular flat hydrophobic filter that may include a selector valve in an air path between the filter and the fluid transfer member, the liquid being transferred to or from the fluid transfer member. The selector valve is actuated by one of electricity, pressure, or gravity.

In an embodiment where the selection valve is a gravity actuated valve, the valve comprises a housing having a first opening on one side thereof and a second opening on an end thereof, a weight outside the inside of the housing, and an elastic layer connected to the end of the weight facing the second opening. The weight and the elastic layer are dimensioned such that the weight is free to move a short distance inside the housing in a direction parallel to the longitudinal axis of the housing, such that in a first vertical direction gravity pulls the weight downwards, pressing the elastic layer against the second opening, thereby preventing fluid from entering the housing through the second opening; and, in the inverted vertical direction, gravity pulls the weight and attached elastic layer away from the second housing, allowing fluid to enter the housing through the second opening.

In a second aspect, the present invention is a drug vial adapter comprising:

(a) a distal collar comprising a disk-shaped central member and a plurality of fan portions, the disk-shaped central member and fan portions adapted to facilitate securing the drug vial adapter to the head of the drug vial, the fan portions attached to the periphery of the disk-shaped central member and projecting distally away from the disk-shaped central member;

(b) a longitudinal extension projecting proximally from the disc-shaped central member;

(c) a membrane sealing the proximal end of the longitudinal extension;

(e) an air channel and a liquid channel both formed internally within the longitudinal extension and the spike element, the channels adapted to allow fluid communication from the proximally disposed membrane through the drug vial adapter to the opening on the tip of the spike, thereby providing an enclosed transfer device that is not open to or in communication with the environment.

An annular flat hydrophobic filter is located in the disc-shaped central member, the drug vial adapter and filter being adapted to allow fluid flowing in the liquid channel to pass through the drug vial adapter but not through the filter, and to force flow through the filter flowing through the air channel.

In a third aspect, the present invention is a drug vial adapter comprising:

(a) a base adapted to attach to the head of a medical drug vial or any type of vessel or device having a head similar to the head of a standard medical drug vial;

(b) a top portion, comprising:

(i) a disk-shaped centerpiece and a plurality of wings adapted to facilitate securing the top portion to the bottom portion, the wings attached to the periphery of the disk-shaped centerpiece and projecting distally away from the disk-shaped centerpiece;

(iii) a membrane sealing the proximal end of the longitudinal extension;

(v) an air channel and a liquid channel both formed internally within the longitudinal extension and the spike element, the channels adapted to allow fluid communication from the proximally disposed membrane through the drug vial adapter to the opening on the tip of the spike, thereby providing an enclosed transfer device that is not open to or in communication with the environment;

(c) a first locking mechanism; and

(d) a second locking mechanism;

a first locking mechanism adapted to lock the top portion to the bottom portion such that when the head portion is attached to the bottom portion, the tip of the spike cannot come into contact with the plug within the head portion, and to release the top portion from the bottom portion after the bottom portion has been attached to the head portion; and a second locking mechanism adapted to allow the spike to penetrate a plug in the head and immovably lock the top to the bottom after the bottom has been attached to the head.

In an embodiment of the drug vial adapter of the third aspect of the invention, an annular flat hydrophobic filter is located in the disc-shaped central piece, the drug vial adapter and the filter being adapted to allow fluid flowing in the liquid channel to pass through the drug vial adapter but not through the filter and to force fluid flowing through the empty air channel to pass through the filter.

In embodiments of the plurality of drug vial adapters of the first and second aspects of the present invention, one or both of the outer peripheral edge and the inner peripheral edge of the annular flat hydrophobic filter is welded, bonded, or mechanically pressed to the drug vial adapter.

In embodiments of the drug vial adapter of the plurality of drug vial adapters of the first and second aspects of the invention, the annular flat hydrophobic filter is supported by and mounted on a plurality of closely spaced support ribs from above and/or below.

The drug vial adapters of the plurality of drug vial adapters of the first and second aspects of the present invention comprise a bypass comprising a one-way valve positioned in parallel with the filter in the air passageway. The one-way valve comprises an elastic cap that fits tightly over the end of the rigid tube.

The drug vial adapters of the plurality of drug vial adapters of the first and second aspects of the present invention comprise a selector valve in an air path between the filter and the fluid transfer member to or from which liquid is transferred. The selector valve is actuated by one of electricity, pressure, or gravity.

An embodiment of a gravity-actuated valve includes a housing having a first opening on one side thereof and a second opening on an end thereof, a weight inside the housing, and an elastic layer connected to an end of the weight facing the second opening. The weight and the resilient layer are dimensioned such that the weight is free to move a short distance inside the housing in a direction parallel to the longitudinal axis of the housing to allow gravity to pull the weight downwards in a first vertical direction, pressing the resilient layer against the second opening, thereby preventing fluid from entering the housing through the second opening; and allowing gravity to pull the weight and attached resilient layer away from the second housing in an inverted vertical direction, thereby allowing fluid to enter the housing through the second opening.

All the above and other features and advantages of the present invention will be further understood from the following illustrative and non-limiting description of embodiments thereof, with reference to the attached drawings.

Drawings

Figure 1 is a schematic cross-sectional view of a prior art device for the removal of harmful drugs;

figure 2 schematically illustrates the concept of an aspect of the invention;

figures 3a to 3d schematically show a four-step connection sequence between the connector part of the device of figure 1 and the drug vial adapter;

figures 4a and 4b schematically show the concept of operating the device for transferring harmful drugs;

figure 5 shows the actual air passage of the prior art device of figure 1; wherein both ends of the air passage are used as an inlet and an outlet, respectively;

figure 6 schematically shows a possible place where a filter may be placed in the air channel of a drug transfer device according to the present invention;

figure 7 schematically shows an embodiment of the liquid displacement device in which the liquid channel is internal to the device and air exchange takes place between the vial and the proximal air chamber of the syringe via an air channel partly external to the device;

figures 8 to 15 show an embodiment of the invention in which the filter is introduced into the air channel by placing the filter in the vial adapter;

figure 16 is an enlarged view of the prior art double membrane seal actuator shown in figure 1;

figures 17 and 18 show an improvement to the double membrane sealed actuator of figure 16 according to the present invention, which prevents the possibility of liquid entering the air channel if the piston rod of the syringe is accidentally pushed or pulled;

figures 19 and 20 show a modification of the double membrane sealed actuator of figure 16, which simplifies the manufacturing process of the actuator, according to the invention;

figures 21a to 28 show a design designed to overcome the problem of tearing of the rubber stopper in the vial due to the erroneous insertion of the spike;

figure 29 schematically shows a flow diagram of an embodiment of a drug transfer device comprising a one-way valve in parallel with a filter in an air channel;

figure 30 schematically shows the embodiment shown in figure 7 and described in relation to figure 7, but with the addition of a one-way valve in parallel with the filter in the air channel;

figures 31 to 32b are detailed views showing the one-way valve and the implementation thereof when air flows from the vial to the syringe and from the syringe into the vial, respectively;

figures 33 to 41 show an embodiment of a drug vial adapter with a filter and an implemented bypass one-way valve;

fig. 42a and 42b schematically show an embodiment of a gravity-actuated selector valve for preventing clogging of the filter.

Detailed Description

The present invention is an improvement over the drug transfer device described in US 8,196,614. These improvements overcome problems found during commercial development of devices and contribute to the safety of the transfer process performed with these devices. Some of these improvements are directed to embodiments of the apparatus described in US 8,196,614, while other improvements may be used in other prior art or new devices.

Figure 2 shows schematically a first solution to the problem provided by the present invention of liquid being accidentally forced into the air chamber of the syringe. As schematically shown in the figures, this solution is to introduce a hydrophobic filter membrane 50 at a location in the air channel 42 between the vial 16 and the proximal air chamber 32. Such a filter (e.g. a 0.22 micron filter) will not only prevent liquid from flowing into the proximal air chamber, but will also improve protection from microbial contamination by additionally filtering the air.

Fig. 5 schematically illustrates an air transfer path within the device 10 from one end at the tip of the spike of the vial (schematically shown by arrow 52) to the other end thereof at the opening in the distal end of the hollow piston rod (schematically shown by arrow 54).

Figure 6 schematically illustrates some possible locations where a filter may be placed in the air channel of a drug transfer device according to the present invention. The positions shown in fig. 6 are: (a) on the proximal end of the long air duct 38; (b) in the piston rod 24 mounted on the proximal end of the air conduit 38; (c) on an opening in the distal end of the hollow piston rod 24; (d) on throat 20 between barrel 12 and connector portion 14 of the barrel; (e) in the dual membrane seal actuator 34; (f) at the proximal end of the air conduit 38 and the distal end of the flexible membrane 15a of the vial adapter 15; (g) in the medicine bottle adapter right above the sharp nail; and (h) in the air channel inside the spike.

This aspect of the invention may be used in embodiments other than the liquid transfer device described above. For example, fig. 7 schematically shows an embodiment of the liquid transfer device in which the liquid channel is internal to the device (as described above) and air exchange takes place between the vial and the proximal air chamber in the syringe via an air channel partially external to the device. In this embodiment, the proximal end of the exterior of the air channel may be connected to the proximal air channel in the syringe barrel in the following manner, for example: (a) through the hollow piston rod; (b) through a gasket 22 at the top of the barrel; or (c) directly through the wall of the proximal end of the main body 18 of the syringe barrel. The distal end of the exterior of the air channel may be connected to the air channel from the drug vial 16 through the drug vial adapter 15 and connector portion 14, for example: (d) at the junction between the throat 20 of the syringe and the connector portion 14; (e) at the top of the air conduit 38 (in this embodiment, the air conduit 38 is short and does not extend into the interior of the piston rod as in the embodiment of fig. 1); (f) in the dual membrane seal actuator 34; or (g) through the sidewall of the cylindrical hollow outer body of the connector portion 14.

Fig. 8-15 show an embodiment of the present invention in use at present, wherein the filter is introduced into the air channel by placing the filter in the vial adapter 15. This is one location that has been determined to be the most efficient and technically simple to manufacture. A vial adapter of this design may be used not only on the liquid transfer device described in US 8,196,614, made by the applicant of the present application, but also on apparatus for transferring liquid from a vial or (where appropriate modified) from some other type of fluid transfer member.

Fig. 8 shows a syringe 12 with an attached connector portion 14 (at a time before they are connected to a drug vial adapter 15), the drug vial adapter 15 having been modified according to the present invention by the incorporation of a filter 50.

Fig. 9 is an enlarged cross-sectional view of the modified drug vial adapter 15 attached to the drug vial 16. In the figure, it can be seen that the liquid passage 58 and the air passage 60 pass through the drug vial adapter 15 and the filter 50. The filter is made of a very thin disc-shaped sheet material. Holes are cut through the filter to allow liquid to pass freely through the liquid passage 58. The filter 50 is welded or glued or mechanically pressed onto the outer and inner peripheries 57, 57' of the drug vial adapter.

The pressure exerted on the filter 50 by the air or liquid flowing through the air passage 60 may be great enough to tear the filter, or cause the filter to become pleated, or clog the filter 50 by the liquid-even to the extent that the passage 60 is clogged. Thus, to provide mechanical support to withstand the pressure to prevent tearing and keep the filter flat, the flat filter 50 is placed between a plurality of closely spaced upper and lower support ribs 56.

Fig. 10 shows the assembled fluid transfer device comprising a syringe 12, a connector portion 14, a drug vial adapter 15 with a filter 50 and a drug vial 16.

Fig. 11 is a cross-sectional view and fig. 12 is a perspective view of a drug vial adapter including a filter that has been developed by the applicant of the present patent application. The vial adapter is manufactured in five separate parts, shown in the following figures, and then assembled as shown in fig. 11. The five parts are: membrane 15a, filter 50, spike assembly, upper section of the drug vial adapter and lower section of the drug vial adapter.

A top view and a bottom view of the upper section of the drug vial adapter are shown in fig. 13a and 13b, respectively. The segment comprises a tubular structure through which the air passageway 60 and the upper portion of the spike assembly (see FIGS. 11 and 15) pass and on the upper surface of which the membrane is mounted; and a plurality of ribs 56 on the oblate lower surface of the tubular structure supporting the filter to prevent damage/breakage of the filter when a force is applied to the filter.

Fig. 14a and 14b show top and bottom views, respectively, of the lower section of the drug vial adapter. The segment includes a plurality of circumferential sectors formed with a flange (ridge) on the inner face of the lower segment for securing a plurality of ribs 56 on a flat circular upper surface to the head of the vial on its lower end to support the filter to prevent damage/breakage of the filter when force is applied to the filter. A platform 57a is made for welding the outer periphery 57 of the filter 50 thereto.

Fig. 15 shows a spike assembly of a drug vial adapter comprising a spike and a tubular structure at its lower end through which a fluid passage 58 passes. The small opening 60a on the side of the disc-shaped platform 65 above the spike is the end of the air passage 60 directly below the distal side of the filter 50, which is located on top of the platform 65. From which the air passage passes through the spike and terminates in an opening 60b at the tip of the spike. The flat upper side (top side) of the disc 65 serves as a platform for welding the inner periphery 57' of the filter 50 to the disc 65. In addition to welding, other methods known in the art for attaching filters, such as by heat sealing, ultrasonic or laser welding, adhesives, mechanical seals and extrusion, and more, may be suitable for use with the present invention. The bottom surface (bottom side) of the tray 65 serves as a welding or gluing platform for attaching the spike assembly to the lower section of the drug vial adapter shown in fig. 14 a.

Fig. 16-18 show another aspect of the invention, namely, an improvement to the double membrane seal actuator 34 of the connector portion 14 that prevents the possibility of liquid entering the air channel if the piston rod of the syringe is accidentally pushed or pulled when the syringe connector is not connected to the drug vial adapter or other component of the drug transfer device.

Fig. 16 is an enlarged view of the connector portion 14 of the prior art drug-transfer device shown in fig. 1. As described above, when the syringe barrel 12 and attached connector portion 16 are not connected to another component, the tip of the needle, which is the air conduit 38 and liquid conduit 40, resides between the proximal and distal membranes of the double membrane seal actuator 34. If the plunger rod of the syringe is pushed in the distal direction, liquid in the liquid chamber below the plunger of the syringe will be forced out of the opening at the distal end of the needle 40 and liquid may be pushed into the opening at the distal end of the needle 38 and into the air chamber above the plunger syringe. If the piston rod is pulled distally, then relative flow of air and liquid occurs and air may be forced from the air chamber of the syringe into the liquid chamber.

The solution provided by the present invention is a cannula 64, the tip of the needle 38 of the air conduit being placed in the cannula 64. The sleeve 64 is made of an elastomeric material and is placed within the dual membrane seal actuator 34.

As shown in FIG. 17, when the liquid chamber 30 contains liquid and the plunger 28 of the syringe barrel is pushed distally, the liquid forced out of the tip of the liquid needle 40 creates pressure within the actuator 34, which causes the sleeve 64 to be squeezed around the tip of the air needle 38, thereby blocking the entry of liquid into the air needle. The harder the push on the piston rod-the more effective the blocking action of the sleeve. In addition, at the same time, the air chamber on the proximal side of the syringe plunger 28 and the suction created in the air needle 38 causes the sleeve 64 to be pressed more tightly against the tip of the air needle, increasing the occlusion effect.

As shown in FIG. 18, when the plunger 28 of the syringe barrel is pulled proximally, the fluid needle 40 is in a suction mode creating a vacuum within the interior of the actuator 34. At the same time, air needle 38 injects air into the interior of actuator 34, so that the air pushes cannula 64 away from the tip of needle 38 and expands the diameter of the tip of the air needle, thereby allowing air to flow out of air needle 38 and into liquid needle 40. As can be seen in fig. 17 and 18, one-way valve operation occurs, i.e. liquid cannot be delivered to the air channel or air chamber in the syringe, but air can pass to the liquid chamber. The ability to draw air into the liquid chamber is deliberately desirable as this is required for certain operations in the preparation of the medicament.

Figures 19 and 20 show a further improvement over the prior art dual membrane seal actuator shown in figure 16. This aspect of the invention simplifies the manufacture of the dual membrane actuator. According to this embodiment, the needle holder 36 fixedly supports the needle formed with the air passage 38 and the liquid passage 40, the needle holder 36 is elongated in length, and is shaped into a cylindrical shape having a circular cross section. In addition, proximal membrane 34a is removed and replaced with an O-ring 66 that fits tightly over the exterior of needle holder 36.

Figure 19 shows the connector portion 14 when not connected to the drug vial adapter 15. In this configuration, the O-ring 66 is at the distal end of the needle holder 36 and the tips of the air and liquid conduits are above the lower membrane 34b of the actuator. When the connector part and the drug vial adapter are pushed together, the actuator is pushed in the proximal part, the O-ring 66 slides the needle holder 36 upwards until it reaches the proximal end of the connector part and the needle has penetrated the lower membrane 34b of the actuator and the membrane at the top of the drug vial adapter, as shown in fig. 20.

Fig. 21a to 28 show a novel type of drug vial adapter designed to overcome the problem of tearing of the rubber stopper in the drug vial due to erroneous insertion of the spike of the drug vial adapter. The vial adapter of the present invention comprises two parts: a base adapted to attach to the head of a medical vial or any type of vessel or device having a head similar to the head of a standard medical vial; and a top portion adapted to be coupled to the bottom portion and also to a medical transfer device, such as a drug transfer device or a connector portion of a syringe as described above, or a syringe.

The method of operation of the drug vial adapter is to keep the spike closed and keep the spike a distance from the rubber stopper of the drug vial until the drug vial adapter is properly placed and locked on the head of the drug vial. At this locking stage, the spike has not yet come into contact with the plug. The proper positioning and locking achieved in this way ensures that the spike is fixed in a centered and vertical position with respect to the rubber plug. Until then the drug vial adapter is ready to be further advanced in an axial movement to guide the tip to pierce the stopper accurately until, in its final position, the drug vial adapter is immovably locked to the drug vial.

It is important to emphasize that the process described herein comprises several steps; however, this is merely for convenience in describing the process. It will be appreciated that in practice the process of using the fixed joint of the present invention is performed using a single smooth axial movement.

Fig. 21a and 21b are perspective views showing different perspectives of the base 102 of the drug vial adapter of the present invention. The base 102 is a generally cylindrical structure having a hollow interior. The lower portion of the structure has an inner diameter that is slightly larger than the inner diameter of the cap portion of the vial to which it is to be attached. On the inside of the lower portion of the base 102 are a plurality of inwardly facing teeth 106. The teeth 106 are on the end of the flexible arms such that the teeth 106 are pushed radially outward and then snap back into their original position when the force on the plurality of teeth is removed. Also seen on the inside of the lower portion of the base 102 are a plurality of inwardly facing teeth 108 associated with the teeth 106. On the outside of the arm where the teeth 106 are attached there are protrusions 110, the protrusions 110 being used to lock the two parts of the vial adapter together.

Fig. 22 shows the top 104 of the vial adapter. The top 104 is a generally cylindrical structure. At the center of the structure is a downwardly projecting spike 118 in fluid communication with an upwardly projecting structure 120, the upwardly projecting structure 120 being designed to be attached to another component of the drug delivery system in a standard manner. At least two wings 116 project downwardly, some of the at least two wings having windows 114 therein, the windows 114 serving to connect the upper portion 104 to the lower portion as will be explained herein below.

Fig. 23a and 23b are perspective views showing different viewing angles of the drug vial adapter 100. The top portion 104 has been slid over the bottom portion 102 and locked to the bottom portion 102 in the first locked configuration. It can be seen in fig. 23a how the protrusions 110 on the base 102 fit into the windows 114 on the wings 116 of the top 104 to complete the locking together of the two parts of the drug vial adapter 100 so that the two parts of the drug vial adapter 100 cannot move relative to each other even when pushed. Fig. 23a also shows that the catch 112 with inwardly facing teeth is on the bottom edge of the bottom part 102 and the outwardly facing flange 122 surrounds the periphery of the top part 104. The catch 112 and the flange 122 interact to lock the top portion 104 to the bottom portion 102 in a second locking configuration described below.

Fig. 24-27 show different stages of attachment of the drug vial adapter 100 into a drug vial.

In the first stage, as shown in fig. 24, the cap of the vial has not yet entered the interior of the base of the vial adapter 100. In enlarged detail a, it can be seen how the protrusion 110 of the bottom part 102 fits into the window 114 of the wing 116 of the upper part 104 to lock the two parts together.

In the second stage, as shown in fig. 25, the cap portion of the drug vial begins to enter the interior of the bottom portion of the drug vial adapter 100. In enlarged detail a, it can be seen how the cap portion of the vial pushes teeth 106 and teeth 108 radially outward as the back side of teeth 108 pushes wings 116 radially outward. The protrusions 110 of the base 102 are pushed into the windows 114 on the wings 116 of the upper portion 104 to hold the two portions locked together and yet not allow the upper and lower portions 104, 102 to slide into each other.

In the third stage, as shown in fig. 26, the cap of the vial has entered the interior of the base of the vial adapter 100 to the end. In enlarged detail a, it can be seen how the teeth 108 continue to push the wings 116 radially outward. At the same time, the cap portion of the vial no longer pushes the teeth 106 outward to allow the teeth 106 and the arm to which the projection 110 is attached to spring radially inward. Thus, the teeth 106 move under the edge of the cap to securely attach the vial to the vial adapter 100, and the protrusions 110 of the base 102 are pulled out of the windows 114 on the wings 116 of the upper portion 104, thereby unlocking the lock between the two portions.

It should be noted that at this stage, the spike has not yet contacted the stopper within the top of the vial; for this to occur, all locks must be unlocked, indicating that the adapter is fully attached and that the spike is in a centered and perpendicular position relative to the rubber stopper of the vial and ready for precise piercing. Even if one lock is not opened, the portions 102 and 104 do not move until all locks are in place and unlocked. Thus, when in the fourth stage, as shown in fig. 27, the top 104 of the drug vial adapter is pushed down towards the drug vial, the spike is pushed through the drug vial stopper right centrally and perpendicular to the drug vial stopper. As the top 104 slides over the bottom 102, the wings 116 slide over and grip the sides of the vial to add greater stability to the connection. Eventually, the teeth on the top of the snap (snap)112 slide over the top of the flange 122 to lock the two parts of the drug vial adapter 100 together, thereby inhibiting reverse movement that might pull the spike out of the drug vial. In the embodiment of the drug vial adapter, the catch 112 is configured such that both an audible sound as well as a visual observation will confirm to the user that the attachment process has been completed.

Fig. 28 shows the drug vial adapter 100 of the present invention immovably attached to a medical drug vial in its final position. Embodiments of the vial adapter 100 designed to be coupled to a transfer device (e.g., as described above) may be provided with a filter in the top 104, e.g., above the spike as described above.

As described above, when the hydrophobic filter is provided as a barrier preventing water from intruding into the air passage of the fluid transfer device, the filter may be clogged when liquid is pressed into the pores of the filter by pressure. In addition, some liquids (such as alcohol) may be more likely to clog filter clogging, as hydrophobicity depends on the surface tension properties of the liquid. Longer exposure to liquids is another factor that affects and reduces the hydrophobic properties.

Under normal use conditions of the fluid displacement device, only slight clogging of the filter may occur, which may allow pressure reversal and easy opening. In some instances of operator misuse or error, however, the filter may remain permanently clogged, thereby rendering the critical pressure equalization system inoperative.

The present invention seeks to provide a complete solution to the problem of clogging of filters. The solution of the invention includes one or both of the following: 1) protecting the filter from high pressure, thereby preventing permanent clogging of the filter; and 2) providing a bypass blockage if the filter is permanently clogged.

Bypass solution

The following modifications were made to overcome the clogging of the filter by a one-way bypass which, in the event of filter clogging, would bypass the filter and would allow unimpeded withdrawal of medicament from the vial and air flow from the air chamber of the syringe into the vial for pressure equalization purposes. The bypass is in fact a one-way valve placed in parallel with the filter on the air passage.

Fig. 29 schematically shows a flow diagram of a drug transfer device substantially identical to fig. 2 but with the addition of a one-way valve 51 parallel to the filter 50 on the air channel 42. During withdrawal, air may flow from the air chamber 32 at the back of the syringe to the vial 16 for pressure equalization. During this flow, air may pass through the filter 50 or the one-way valve 51 or both. In the case of reverse flow, such as during an injection, air may flow from the vial 16 through the filter 50 to the air chamber, but air may not flow through the one-way valve 51. If liquid (rather than air) flows from the vial, the filter blocks the liquid and the one-way valve also blocks any flow therethrough.

Fig. 30 schematically shows the embodiment shown in fig. 7 and described in connection with fig. 7, but with the addition of a one-way valve in parallel with the filter in the air channel. Fig. 30 (similar to fig. 7) shows an embodiment of the device in which the air channel and the respective connection regions for the two ends of the air channel run outside the syringe.

Fig. 31 schematically illustrates the embodiment of the vial adapter 15 shown in fig. 9 and described in relation to fig. 9, but with the addition of a one-way valve placed parallel to the filter 50 in the air passage.

Fig. 32a and 32b are detailed views of the one-way valve 51 and the operation of the one-way valve when fluid flows from the vial to the syringe and from the syringe to the vial, respectively. The one-way valve 51 is an elastic cap 55 that fits tightly over the end of a rigid tube 53, the rigid tube 53 bypassing the filter 50 in the air conduit through which air flows between the syringe and vial. The check valve 51 is a normally closed valve.

When air or liquid flows from the vial to the filter, as shown in fig. 32a, the air or liquid can only flow through the filter 50 and is blocked from flowing through the tube 53 by the cap 55. The greater the pressure exerted on the valve closure, the tighter the cap is pushed against the outer wall of the tube. Thus air can flow through the filter into the cartridge when liquid is blocked by both the filter and the one-way valve.

As air flows from the syringe to the vial, such as during withdrawal of liquid from the vial as shown in fig. 32b, the air may flow through the filter 50 and/or through the one-way valve 51. If the filter 50 becomes clogged, air will naturally enter the tube 53 and will create an inside-to-outside pressure on the cover 55 and will force the cover to expand and allow air to flow between the outside of the tube 53 and the inner wall of the cover 55. When the operator stops the extraction process, the pressure inside the cap 55 drops and the cap 55 reseals against the tube/seat.

Fig. 33-41 show an embodiment of a drug vial adapter with a filter and an operating bypass check valve. To facilitate understanding of the structure of the vial adapter, it can be seen in these figures that the vial adapter is assembled step by component. Most of the features of the vial adapter have been described previously in the related embodiments shown in fig. 11-15 and 21 a-28, and thus only the most relevant parts to understand the features of this embodiment will be identified in the figures.

The spike 118 member (see similar fig. 15) can be seen in fig. 33 before being welded into place. The resilient cap 55 will be placed over the laterally extending tube 53 from the spike member, thus creating a one-way valve as seen in the figure. In this embodiment, the drug vial adapter is of the same novel type as the drug vial adapter attachment mechanism described in fig. 21a to 28, which is designed to overcome the problem of tearing of the rubber stopper in the drug vial due to erroneous insertion of the spike of the drug vial adapter. For clarity and brevity, the base 102 of the vial adapter will not be shown in the following figures. The means at the top of the figure to which the spike member is welded is the top 104 of the vial adapter shown in figure 22.

FIG. 34 shows the flow path through the spike member. The flow channel labeled a-a is a fluid channel 58 that reaches straight up from the spike tip at the bottom to the top of the tube into which the fluid needle 40 of the syringe enters when the syringe is engaged with the adapter.

The flow channel labeled B-B is one end of the air channel. One end of the air channel starts at one of the two openings 60b on the spike tip (see fig. 15-not visible in this figure) and exits at the side opening 60a on the spike member. Once the spike member is welded to the top 104 of the adapter, the opening 60b will be directly below the filter (as will be seen in the figures below).

The flow channels C-C are one-way valves. The resilient cap 55 will be pushed onto the laterally extending tube 53 of the channel C-C, thus forming a one-way valve. The other end of channel C-C is not covered by a filter and can enter a portion of the air channel up to the air chamber of the syringe barrel.

Fig. 35 shows the spike member in place and welded to the top 104 of the drug vial adapter. The resilient cover 55 is shown with an arrow pointing to its designated position. The upper opening 60C of the flow channel C-C is visible in this figure.

In FIG. 36, the upper opening 60a of air passage B-B is seen on the left side.

In fig. 37, the assembly of the resilient cover 55 in its final position can be seen.

Fig. 38 shows a first step in introducing the filter tray 50 into the assembly.

In fig. 39, the filter is placed in place and welded to the top 104 of the drug vial adapter. The flow passage B-B and the resilient cap 55 are now covered and blocked from the cartridge by the filter 50, which acts as a barrier against liquid ingress into the air passage C-C, it being seen that the top opening 60C of the air passage C-C is not covered by the filter.

Fig. 40 shows the upper section ready for final assembly (see similar fig. 13a and 13 b). Which covers, seals and surrounds the top 104 of the vial adapter. The majority of the interior of the member serves as an air channel into which the syringe barrel's air needle 38 is inserted. The flexible membrane 15a seals the top of the member and acts as an access port for the syringe of the transfer device of this embodiment.

Fig. 41 shows the full top of the drug vial adapter sealed and ready for attachment to the base and then to the drug vial.

Protecting filters against clogging

As can be seen from fig. 4b and 4a, respectively, the usual method of aspirating liquid from a vial using the fluid transfer device described herein is to invert the syringe with the vial attached thereto, thereby inverting the vial; also, a common method of injecting liquid into a vial is to hold the vial in a vertical position with the syringe above it. If the device includes a filter in the air transfer path, the filter needs to be protected from excessive pressure when the vial is in the inverted position. Typically in this position, there should be no pressure on the filter, as when the plunger of the syringe is pulled down, air flows from the air chamber in the syringe through the filter into the vial, while liquid does not enter the air channel. If too much liquid has been previously removed, a problem may arise when the device is in this position and the operator pushes the syringe plunger in order to push the air bubble back into the vial or the liquid back into the vial to correct the dose. In this case, pressure is created within the drug vial and the liquid is forced into the drug vial adapter and into the filter. If the operator pushes too hard, the liquid may permanently clog the filter. Thus, as shown in fig. 4b, when liquid is removed from the vial, it is necessary to protect the filter by closing the air passage to the filter. When the vial is in the upright position and liquid is injected into the vial, as shown in fig. 4a, there is no contact between the liquid and the filter; the problem of liquid clogging the filter should therefore not occur and it is not necessary to protect the filter.

To prevent the above-described problem of filter clogging, embodiments of the fluid transfer device include a selector valve in the air transfer path between the vial and the filter. When the device is in the upside down position with the vial on top, the valve must close the air path before the filter to prevent liquid flowing in the direction of the filter from reaching the air path, and must open the air path for normal air flow from the syringe into the vial. When the device is in the upright position with the vial at the bottom, then the valve must not interfere with the flow of air in either direction.

Some different type of selection valve may be used, such as an electrically actuated solenoid valve or other valve actuated by pressure exerted by liquid flowing through a passage of the device. The two positions of the vial (i.e., upright and inverted) suggest that a good solution could be a gravity-actuated valve. There are many embodiments of gravity-actuated selector valves that incorporate liquid displacement devices.

One embodiment of a gravity-actuated selector valve is schematically illustrated in fig. 42a and 42 b. For clarity and convenience of presentation, the two figures are schematic and show the flow channels outside the device. In actual use, the channels and components (i.e., filters and valves) are designed into or within the device. This embodiment has been constructed and found by the present inventors to provide a solution for protecting the filter from overpressure when placed in the air channel between the interior of the vial and the filter.

Gravity-actuated valves are characterized by a heavy sealing member that is typically movable between two positions. In fig. 42a, the vial is in an upside down position with the gravity-actuated selector valve 70 placed in the air transfer path 42 between the vial and the filter 50. The gravity-actuated valve includes a housing 72 having an opening 74 on one side of the housing 72 and another opening 76 on a proximal end thereof. Inside the housing 72 there is a weight 78, the weight 78 carrying an elastic layer 80 attached to the end of the weight facing the opening 76, the elastic layer 80 being made of, for example, silicone rubber. The weight 78 and the resilient layer 80 are dimensioned such that the weight can move freely a short distance inside the housing 72 in a direction parallel to the longitudinal axis of the housing. In the position of fig. 42a, gravity pulls the weight 78 downward, pressing the resilient layer 80 against the narrow opening 76. In this position, if liquid is pushed into the air transfer path 42, the liquid may enter the housing 72 from the side through the inlet 74, but cannot exit because the resilient layer 80 blocks the opening 76. The greater the pressure generated in the vial, the better the valve opening 76 is sealed because any liquid or air forced into the housing of the valve will assist the force of gravity to push the weight 78 downward.

In the position shown in fig. 42 a. If air flows in the opposite direction in the air transfer path 42, i.e., from the syringe to the vial, the pressure exerted by the air lifts the weight 78 and resilient layer 80, thereby unblocking the outlet 76, allowing air to flow unimpeded through the housing 72 and continue to advance through the opening 74 to the vial. When the air flow stops, the weight 78 drops down and the resilient layer 80 again seals the opening 76.

In fig. 42b, the position of the vial is now vertical and the one-way valve 70 is fully open for any flow direction, i.e.: the weight 78 with the resilient layer 80 is moved by gravity so that both the opening 76, 78 in the housing 72 are open.

As shown in fig. 42a and 42b, to avoid the elastic layer 80 and attached weight 78 from sticking to the opening 76 by vacuum when the device is inverted, the opening 76 is not formed directly on the wall of the housing 72, but on the end of a tube having a very small diameter and protruding a short distance into the interior of the housing 72.

The reason for the placement of the opening 74 on the side of the housing 72 is to avoid rapid air flow from moving the weight 78 toward the tube opening 76 and blocking the flow. If the opening 74 is formed in the housing 72 on the opposite side of the opening 76, blocking flow may occur, although this is a simpler and intuitive construction, but in some cases as previously described, this is not effective, and the weight 78 may be pushed by the flowing fluid onto the opening 76 and may block flow and prevent the desired function, thus being the preferred method at the side inlet where the flow of fluid has a neutral effect on the movement of the weight. While fig. 42a and 42b schematically depict the passage to a gravity-actuated valve, the drawings of the valve housing and valve are exact and can be made as shown.

Although embodiments of the present invention have been described by way of example, it is to be understood that the invention is capable of numerous variations, modifications and adaptations, without departing from the scope of the claims.

Claims

1. A fluid transfer device, comprising:

(a) a syringe-like proximal portion comprising:

(i) a cylindrical body;

(i) a needle holder;

(ii) a liquid conduit passing through and rigidly attached to the needle holder, wherein a distal end of the liquid conduit begins at the connector portion and a proximal end of the liquid conduit terminates at the distal liquid chamber;

(iii) an air conduit passing through and rigidly attached to the needle holder, wherein a distal end of the air conduit begins at the connector portion and a proximal end of the air conduit terminates at the proximal air chamber; and

(iv) a membrane at a distal end of the connector portion, wherein the membrane surrounds the distal ends of the liquid conduit and the air conduit to block the liquid conduit and the air conduit from an ambient environment;

wherein the connector portion is configured to allow a head of the fluid transfer member to enter the interior of the connector portion and to allow a membrane located in the head of the fluid transfer member to push the membrane in the connector portion proximally when the membrane is in contact with the membrane in the connector portion; thereby pushing the membranes further together such that the distal ends of the liquid conduit and the air conduit penetrate the membranes in the connector portion and penetrate the membranes in the head, thereby establishing a liquid channel via the liquid conduit between the interior of the distal liquid chamber and the interior of the fluid transfer member and a separate air channel via the air conduit between the interior of the proximal air chamber and the interior of the fluid transfer member;

the fluid transfer device is characterized by inserting a hydrophobic filter into the air channel in at least one location between the proximal air chamber in the syringe-like proximal end of the fluid transfer device and the fluid transfer member.

2. The device of claim 1, wherein a portion of the air channel is located outside of the device.

3. The apparatus of claim 1, wherein the connector portion comprises a hollow cylindrical outer body having:

(a) a distal shoulder projecting radially from the outer body and terminating in an opening into which a proximal end of the fluid transfer member is inserted for coupling;

(b) a closed proximal cap portion having a central portion including a connector projecting proximally from the central portion for connection to the syringe-shaped proximal portion of the device;

wherein the dual membrane seal actuator comprises:

(i) a cylindrical actuator housing;

(ii) a proximal membrane sealing the proximal end of the housing;

(iii) a distal membrane sealing the distal end of the housing, wherein a portion of the distal membrane projects distally from the housing; and

(iv) at least one resilient arm connected to an intermediate portion of the exterior of the housing at a proximal end of the at least one resilient arm, and the at least one resilient arm including an enlarged locking element at a distal end of the at least one resilient arm; the enlarged locking element has a specifically shaped surface area that interacts with an inner wall of the hollow cylindrical outer body of the connector portion to effect a connection or disconnection for the connector portion to or from a fluid transfer member.

4. The apparatus of claim 1, wherein the connector portion comprises a hollow cylindrical outer body having:

(a) a distal shoulder projecting radially from the outer body and terminating in an opening for insertion of a proximal end of a fluid transfer member for coupling;

(b) a closed proximal cap having a central portion including a connector projecting proximally from the central portion to connect to a throat of the syringe-like proximal portion of the device;

(c) an elongated cylindrical needle holder projecting from the central portion of the closed proximal cap to the interior of the outer body for holding two conduits within the interior of the outer body, the two conduits including sharp pointed ends and further being provided with apertures through which liquid and air, respectively, are displaced in a fluid displacement operation; and

(d) a single-membrane seal actuator reciprocally movable within the hollow interior of the outer body;

wherein the single membrane seal actuator comprises:

(i) a cylindrical actuator housing;

(ii) a proximal O-ring sealing a proximal end of the housing to an outer surface of the elongated cylindrical needle holder;

5. The device of claim 3, comprising a sleeve made of an elastic material surrounding the tip and distal opening of the needle of the air conduit inside the dual membrane seal actuator.

6. The device of claim 4, comprising a sleeve made of an elastic material surrounding the tip and distal opening of the needle of the air conduit inside the single membrane seal actuator.

7. The device of claim 1, wherein the fluid transfer member is a drug vial adapter, wherein the drug vial adapter comprises an air channel and a separate liquid channel, thereby providing a closed transfer system that is not open to or in communication with the environment.

8. The apparatus of claim 7, wherein the drug vial adapter comprises:

(a) a distal collar portion comprising a disk-shaped central member having a plurality of fan portions adapted to facilitate securing the drug vial adapter to the head of a medical drug vial, or to the head of any type of vessel or device having a head similar to the head of a standard medical drug vial, the plurality of fan portions attached to the periphery of the disk-shaped central member and projecting distally away from the disk-shaped central member;

(c) a membrane sealing a proximal end of the longitudinal extension;

(e) an air channel and a liquid channel both formed internally within the longitudinal extension and the spike element, the channels adapted to allow fluid communication from the proximally disposed membrane through the drug vial adapter to an opening on the tip of the spike element;

wherein an annular flat hydrophobic filter is located in the disc-shaped central member, the drug vial adapter and the filter being adapted to allow fluid flowing in the liquid channel to pass through the drug vial adapter but not through the filter and to force fluid flowing through the air channel to pass through the filter.

9. The apparatus of claim 7, wherein the drug vial adapter comprises:

(b) a top portion, comprising:

(i) a disc-shaped centerpiece and a plurality of wings adapted to facilitate securing the top portion to the bottom portion, the wings attached to a periphery of the disc-shaped centerpiece and projecting distally away from the disc-shaped centerpiece;

(iii) a membrane sealing a proximal end of the longitudinal extension;

(v) an air channel and a liquid channel both formed internally within the longitudinal extension and the spike element, the channels adapted to allow fluid communication from the proximally disposed membrane through the drug vial adapter to an opening on the tip of the spike element;

(c) a first locking mechanism; and

(d) a second locking mechanism;

wherein the first locking mechanism is adapted to lock the top portion to the bottom portion such that the tip of the spike element cannot come into contact with the plug in the head portion when the head portion is attached to the bottom portion, and to release the top portion from the bottom portion after the bottom portion has been attached to the head portion; and

the second locking mechanism is adapted to allow the spike element to penetrate the stopper in the head and immovably lock the top to the bottom after the bottom has been attached to the head.

10. The device of claim 9, wherein an annular flat hydrophobic filter is located in the disc-shaped central member, the drug vial adapter and the filter being adapted to allow fluid flowing in the liquid channel to flow through the drug vial adapter but not through the filter and to force fluid flowing through the air channel to pass through the filter.

11. The device of claim 8 or claim 10, wherein one or both of the outer and inner peripheral edges of the annular flat hydrophobic filter are welded, bonded, or mechanically pressed to the drug vial adapter.

12. The device of claim 8 or claim 10, wherein the annular flat hydrophobic filter is supported by and mounted on a plurality of closely spaced support ribs above and/or below.

13. The device of claim 1 or claim 8 or claim 10, comprising a bypass comprising a one-way valve, the one-way valve being positioned in parallel with a filter in the air passage.

14. The device of claim 13, wherein the one-way valve comprises a resilient cap that fits tightly over an end of the rigid tube.

15. A device as claimed in any one of claim 1 or claim 8 or claim 10, comprising a selector valve in the air path between the filter and the fluid transfer member to or from which liquid is transferred.

16. The apparatus of claim 13, comprising a selector valve in the air path between the filter and the fluid transfer member, liquid being transferred to or from the fluid transfer member.

17. The apparatus of claim 15, wherein the selector valve is actuated by one of electricity, pressure, or gravity.

18. The apparatus of claim 16, wherein the selector valve is actuated by one of electricity, pressure, or gravity.

19. The apparatus of claim 17, wherein the selection valve is a gravity-actuated valve comprising a housing having a first opening on one side thereof and a second opening on an end thereof, a weight inside the housing, and an elastic layer connected to an end of the weight facing the second opening; wherein the weight and the elastic layer are dimensioned such that the weight is freely movable a short distance inside the housing in a direction parallel to the longitudinal axis of the housing; wherein, in a first vertical direction, gravity pulls the weight downward, pressing the elastic layer against the second opening, thereby preventing fluid from entering the housing through the second opening; and, in an inverted vertical direction, gravity pulls the weight and attached elastic layer away from the second opening, thereby allowing fluid to enter the housing through the second opening.

20. The apparatus of claim 18, wherein the selection valve is a gravity-actuated valve comprising a housing having a first opening on one side thereof and a second opening on an end thereof, a weight inside the housing, and an elastic layer connected to an end of the weight facing the second opening; wherein the weight and the elastic layer are dimensioned such that the weight is freely movable a short distance inside the housing in a direction parallel to the longitudinal axis of the housing; wherein, in a first vertical direction, gravity pulls the weight downward, pressing the elastic layer against the second opening, thereby preventing fluid from entering the housing through the second opening; and, in an inverted vertical direction, gravity pulls the weight and attached elastic layer away from the second opening, thereby allowing fluid to enter the housing through the second opening.

21. A drug vial adapter comprising:

(a) a distal collar portion including a disk-shaped central member and a plurality of fan portions adapted to facilitate securing the drug vial adapter to the head of the drug vial, the fan portions attached to a periphery of the disk-shaped central member and projecting distally away from the disk-shaped central member;

(b) a longitudinal extension projecting proximally from the disc-shaped centerpiece;

(c) a membrane sealing a proximal end of the longitudinal extension;

(e) an air channel and a liquid channel both formed internally within the longitudinal extension and the spike element, the channels adapted to allow fluid communication from the proximally disposed membrane through the drug vial adapter to an opening on the tip of the spike element, thereby providing a closed transfer system that is not open to or in communication with the environment;

wherein an annular flat hydrophobic filter is located in the disc-shaped central member, the drug vial adapter and the filter being adapted to allow fluid flowing in the liquid channel to pass through the drug vial adapter but not through the filter, and to force fluid flowing through the air channel to flow through the filter.

22. A drug vial adapter comprising:

(b) a top portion, comprising:

(ii) a longitudinal extension projecting proximally from the disc-shaped centerpiece, the longitudinal extension adapted to be coupled to a fluid transfer system;

(iii) a membrane sealing a proximal end of the longitudinal extension;

(v) an air channel and a liquid channel both formed internally within the longitudinal extension and the spike element, the channels adapted to allow fluid communication from the proximally disposed membrane through the drug vial adapter to an opening on the tip of the spike element, thereby providing a closed transfer system that is not open to or in communication with the environment;

(c) a first locking mechanism; and

(d) a second locking mechanism;

wherein the first locking mechanism is adapted to lock the top portion to the bottom portion such that the tip of the spike element cannot come into contact with a plug within the head portion when the head portion is attached to the bottom portion, and to release the top portion from the bottom portion after the bottom portion has been attached to the head portion; and

23. The drug vial adapter of claim 22, wherein an annular flat hydrophobic filter is located in the disc-shaped central member, the drug vial adapter and the filter being adapted to allow fluid flowing in the liquid channel to pass through the drug vial adapter but not the filter and to force fluid flowing through the air channel to pass through the filter.

24. The drug vial adapter of claim 21 or claim 23, wherein one or both of the outer peripheral edge and the inner peripheral edge of the annular flat hydrophobic filter is welded, bonded, or mechanically pressed to the drug vial adapter.

25. The drug vial adapter of claim 21 or claim 23, wherein the annular flat hydrophobic filter is supported by and mounted on a plurality of closely spaced support ribs above and/or below.

26. The drug vial adapter of claim 21 or claim 23, comprising a bypass comprising a one-way valve positioned in parallel with a filter in the air channel.

27. The vial adapter of claim 26, wherein the one-way valve comprises a resilient cap that fits snugly over an end of the rigid tube.

28. The vial adapter of claim 21 or claim 23, comprising a selector valve in an air path between the filter and the fluid transfer member to or from which liquid is transferred.

29. The vial adapter of claim 26, comprising a selector valve in an air path between the filter and the fluid transfer member, liquid being transferred to or from the fluid transfer member.

30. The vial adapter of claim 28, wherein the selector valve is actuated by one of electricity, pressure, or gravity.

31. The vial adapter of claim 29, wherein the selector valve is actuated by one of electricity, pressure, or gravity.

32. The vial adapter of claim 30, wherein the selector valve is a gravity-actuated valve comprising a housing having a first opening on one side thereof and a second opening on an end thereof, a weight inside the housing, and an elastomeric layer attached to an end of the weight facing the second opening; wherein the weight and the elastic layer are dimensioned such that the weight is freely movable a short distance inside the housing in a direction parallel to the longitudinal axis of the housing; wherein, in a first vertical direction, gravity pulls the weight downward, pressing the elastic layer against the second opening, thereby preventing fluid from entering the housing through the second opening; and, in an inverted vertical direction, gravity pulls the weight and attached elastic layer away from the second opening, thereby allowing fluid to enter the housing through the second opening.

33. The vial adapter of claim 31, wherein the selector valve is a gravity-actuated valve comprising a housing having a first opening on one side thereof and a second opening on an end thereof, a weight inside the housing, and an elastomeric layer attached to an end of the weight facing the second opening; wherein the weight and the elastic layer are dimensioned such that the weight is freely movable a short distance inside the housing in a direction parallel to the longitudinal axis of the housing; wherein, in a first vertical direction, gravity pulls the weight downward, pressing the elastic layer against the second opening, thereby preventing fluid from entering the housing through the second opening; and, in an inverted vertical direction, gravity pulls the weight and attached elastic layer away from the second opening, thereby allowing fluid to enter the housing through the second opening.