System for closed transfer of fluids having connector

A system includes a syringe adapter having a first end and a second end with the first end of the syringe adapter configured to be connected to a first container and the second end of the syringe adapter including a lock member having an open position and a closed position. The system also includes a vial adapter having a first end and a second end with the second end of the vial adapter configured to be connected to a second container and the first end of the vial adapter having a locking surface. The lock member includes at least one projection that extends radially outward. The syringe adapter has at least one corresponding projection configured to engage the at least one projection of the lock member to retain the lock member to the syringe adapter.

BACKGROUND OF THE INVENTION

1. Field of the Disclosure

The present disclosure relates generally to a system for the closed transfer of fluids. More particularly, the present disclosure relates to a system that provides leak-proof sealing and pressure equalization during engagement of a cannula with a vial, during transfer of a substance from a vial chamber to a barrel chamber via the cannula, and during disengagement of the cannula from the vial.

2. Description of the Related Art

Health care providers reconstituting, transporting, and administering hazardous drugs, such as cancer treatments, can put health care providers at risk of exposure to these medications and present a major hazard in the health care environment. For example, nurses treating cancer patients risk being exposed to chemotherapy drugs and their toxic effects. Unintentional chemotherapy exposure can affect the nervous system, impair the reproductive system, and bring an increased risk of developing blood cancers in the future. In order to reduce the risk of health care providers being exposed to toxic drugs, the closed transfer of these drugs becomes important.

Some drugs must be dissolved or diluted before they are administered, which involves transferring a solvent from one container to a sealed vial containing the drug in powder or liquid form, by means of a needle. Drugs may be inadvertently released into the atmosphere in gas form or by way of aerosolization, during the withdrawal of the needle from the vial and while the needle is inside the vial if any pressure differential between the interior of the vial and the surrounding atmosphere exists.

SUMMARY OF THE INVENTION

In one aspect, a system, such as a system for the closed transfer of fluids, includes a syringe adapter having a first end and a second end with the first end of the syringe adapter configured to be connected to a first container and the second end of the syringe adapter including a lock member having an open position and a closed position. The system also includes a vial adapter having a first end and a second end with the second end of the vial adapter configured to be connected to a second container and the first end of the vial adapter having a locking surface. The syringe adapter is configured to be mated with the vial adapter when the lock member is in the open position and is configured to be locked to the vial adapter when the lock member is in the closed position and positioned adjacent to the locking surface. The lock member includes at least one projection that extends radially outward. The syringe adapter has at least one corresponding projection configured to engage the at least one projection of the lock member to retain the lock member to the syringe adapter.

The system may also include a patient connector having a first end and a second end and defining a passageway with the first end of the patient connector including a locking surface configured to engage the lock member of the syringe adapter and the second end of the patient connector configured to be secured to a patient IV line. The syringe adapter may comprise a body and a seal arrangement positioned within the body with the seal arrangement having at least one membrane and configured to move within the body of the syringe adapter. The vial adapter may comprise a pressure equalization arrangement and a spike. The body of the syringe adapter may define an opening extending transversely relative to a longitudinal axis of the syringe adapter that receives the lock member with the lock member configured to move relative to the body of the syringe adapter between the open position and the closed position. The lock member may include a biasing member that is configured to bias the lock member towards the closed position. The lock member may include a lead-in surface that is configured to contact the second end of the vial adapter and move the lock member from the closed position to the open position when the syringe adapter is mated with the vial adapter.

The biasing member of the lock member may comprise a cantilever spring with the body of the syringe adapter defining a cam surface configured to engage the cantilever spring of the lock member. The cantilever spring may extend in an axial direction with the cam surface extending radially outward from the body of the syringe adapter. The at least one projection of the lock member may comprise a pair of projections positioned on opposite sides of the lock member, and the at least one corresponding projection of the syringe adapter may comprise a pair of corresponding projections configured to engage the pair of projections of the lock member. The lock member may be annular and received within an opening defined by the body of the syringe adapter with the opening of the syringe adapter extending transversely relative to a longitudinal axis of the syringe adapter. The lock member may include a button that is configured to be engaged by a hand of a user of the syringe adapter to move the lock member from the closed position to the open position. The seal arrangement may comprise a membrane carrier having a membrane with the first end of the vial adapter having a membrane configured to engage the membrane of the membrane carrier. The membrane carrier may be biased toward the second end of the syringe adapter via biasing member. The first end of the syringe adapter may include a female luer connector configured to be secured to a syringe.

DETAILED DESCRIPTION

In the following discussion, “distal” refers to a direction generally toward an end of a system adapted for contact with a container, such as a vial, and “proximal” refers to the opposite direction of distal, i.e., away from the end of a system adapted for contact with the container. For purposes of this disclosure, the above-mentioned references are used in the description of the components of a system in accordance with the present disclosure.

Referring toFIGS. 1 and 2, one aspect of a system10for the closed transfer of fluids includes a syringe adapter12, a vial adapter14, and a patient connector16. The system10provides substantially leak-proof sealing during transfer of a fluid from a first container18, such as a vial, to a second container (not shown), such as a syringe, IV bag, or patient IV line. The leak-proof sealing of the system10substantially prevents leakage of both air and liquid during use of the system10. Although not shown, the system may further include an IV bag adapter as well as other components typically utilized in closed system transfer devices, such as infusion lines and extension sets

Referring toFIGS. 3-14, one aspect of the syringe adapter12includes a body22having a first end24and a second end26and defining interior space28. The first end24of the body22of the syringe adapter12includes a syringe attachment30, such as a female luer connector, that defines a passageway32. Although a female luer connector is shown for connection with a corresponding male luer connector of a syringe (not shown), other suitable connection arrangements may be utilized for connection to a syringe, container, or any other medical device. A cannula34having a distal end36is secured to the syringe attachment30and in fluid communication with the passageway32of the syringe attachment30. The syringe adapter12further includes a seal arrangement38positioned within the body22of the syringe adapter12. The seal arrangement38includes a membrane carrier40that receives a first membrane42and a second membrane44spaced from the first membrane42. The seal arrangement38further includes a biasing member46, such as a compression spring, that engages the membrane carrier40and the syringe attachment30(or the body) and is configured to bias the membrane carrier40toward the second end26of the syringe adapter12. The body22of the syringe adapter12may include structure to enhance gripping of the syringe adapter12by a user. In particular, the body22of the syringe adapter12includes a plurality of annular grooves48that extend around the circumference of the body22of the syringe adapter12, which enhances the ability of a user to grip the syringe adapter12. The body22of the syringe adapter12also includes a plurality of recessed portions adjacent to the first end24of the syringe adapter12that extend in a longitudinal direction and around the circumference of the body22. Additional or alternative grip structures and surfaces may be provided to assist a user in gripping the body22of the syringe adapter12.

Upon engagement of the second membrane44by a corresponding membrane during use, the membrane carrier40is configured to move towards the first end24of the syringe adapter12such that the distal end36of the cannula34pierces the second membrane44to place the syringe adapter12in fluid communication with the corresponding device secured to the syringe adapter12, as discussed below in more detail. After the second membrane44is disengaged from the corresponding membrane, the membrane carrier40is biased back to its original position thereby positioning the distal end36of the cannula34between the first and second membranes42,44. InFIG. 10, the membrane carrier40is shown after being moved toward the first end24of the syringe adapter12with the distal end36of the cannula34piercing the second membrane44. However, the membrane carrier40will only be in the position shown inFIG. 10after engagement with the vial adapter14or the patient connector16.

Such an arrangement shields the distal end36of the cannula34to prevent accidental needle sticks and also prevents the leakage of any fluid during transfer of fluids when using the syringe adapter12. Although the biasing member46is shown as a compression spring, any other suitable biasing arrangement may be utilized to bias the membrane carrier40towards the second end26of the syringe adapter12. Further, although the seal arrangement38includes first and second membranes42,44and the membrane carrier40, any other suitable arrangement for sealing and shielding the cannula34during use may be utilized.

Referring again toFIGS. 3-14, the second end26of the syringe adapter12includes a first connection interface50that includes a lock member52that is received within a transverse opening54in the body22of the syringe adapter12. The lock member52is configured to move between a closed position and an open position. The lock member52defines a central opening56and includes a button58that is configured to be engaged by a hand of a user or operator of the syringe adapter12. The lock member52further includes a cantilever spring60that extends in a longitudinal direction of the syringe adapter12. The lock member52is configured to engage a cam surface62that extends radially outward from the body22of the syringe adapter12. In particular, the lock member52is configured to be provided in the closed position, where a portion of the lock member52adjacent to the central opening56of the lock member52is positioned within the interior space28of the syringe adapter12when no external forces are applied to the lock member52. When the lock member52is moved to the open position where the central opening56of the lock member52is aligned with the interior space28of the syringe adapter12or does not create an interference or barrier to objects being inserted into the interior space28, as discussed in more detail below, the cantilever spring60engages the cam surface62to create a biasing force that urges the lock member52back towards the closed position. Accordingly, when the lock member52is moved to the open position, the lock member52will be urged back to the closed position when the external force acting on the lock member52is released. Although the lock member52is shown with the cantilever spring60, any other suitable biasing member may be provided including, but not limited to, compression springs, extension springs, elastomeric material, etc.

Referring toFIG. 11, the lock member52further includes a pair of projections64that extend radially outward from the lock member52. The pair of projections64is configured to engage corresponding projections66provided on the body22of the syringe adapter12to retain the lock member52to the body22of the syringe adapter12. In other words, the projections64of the lock member52are configured to engage the projections66of the body22of the syringe adapter12to prevent the lock member52from being disconnected and removed from the transverse opening54of the body22of the syringe adapter12. Referring toFIG. 13, the lock member52further includes a pair of projections65that extend axially upward from the lock member52. The pair of axially extending projections65may further include a curved portion that engages the external surface of the syringe adapter when the lock member is in the open position, as shown inFIGS. 5 and 8.

Referring toFIG. 14, the lock member52further includes a lead-in surface68that is a concave-shaped depression on the bottom of the lock member52. As discussed below, the lead-in surface68is configured to engage a corresponding connection interface to transition the lock member52from the closed position to the open position.

Referring toFIGS. 15-19, the vial adapter14includes a body80having a first end82and a second end84. The first end82includes a second connection interface90that is configured to mate with and lock with the first connection interface50of the syringe adapter12. The second end84includes a spike member92that is configured to pierce the vial or container18. The spike member92defines a fluid channel94and a vent channel96. The fluid channel94is in fluid communication with a passageway98extending through the second connection interface90. The vent channel96is in fluid communication with a pressure equalization device102, such as a balloon-type or bellows-type pressure equalization arrangement, although any suitable pressure equalization arrangement102may be utilized. The pressure equalization arrangement102is configured to maintain the pressure within the vial18during fluid transfer to prevent the vial18from being pressurized or place in a vacuum. The second end84of the vial adapter14also includes a vial attachment104to secure the vial adapter14to the vial18or other container.

Referring still toFIGS. 15-19, the second connection interface90includes a generally cylinder-shaped body106that defines a locking surface108. The second connection interface90further includes a lead-in surface110. The lead-in surface110of the second connection interface90projects radially outward from the body106of the second connection interface90and defines a rounded transition between the body106and the lead-in surface110. The lead-in surface110is positioned intermediate the ends of the second connection interface90, although any other suitable position may be utilized. The locking surface108is a ring-shaped recess that is recessed relative to the lead-in surface110and configured to receive the lock member52of the first connection interface50. The locking surface108is defined by 90 degree angles, although other suitable shapes and angles may be utilized. The second connection interface90receives a membrane112that closes the passageway98of the second connection interface90. The second connection interface90is configured to be received within the interior space28of the syringe adapter12when the lock member52of the first connection interface50is in the open position and restricted from moving within the interior space28of the syringe adapter12when the lock member52is in the closed position. The lead-in surface110of the second connection interface90is configured to engage the lock member52of the first connection interface50to further move the lock member52and further bias the cantilever spring60. When the second connection interface90is fully mated to the first connection interface50, the lock member52of the first connection interface50is configured to be in the closed position and received within the locking surface108to lock the first connection interface50from longitudinal and transverse movement relative to the second connection interface90, but still allowing rotational movement relative thereto.

Referring toFIGS. 20-21, the patient connector16includes a body120having a first end122and a second end124and defining a passageway126that extends therethrough. The first end122of the patient connector16also includes the second connection interface90that is that same as the second connection interface of the vial adapter14. Accordingly, the second connection interface90of the patient connector16includes the same features of the second connection interface90of the vial adapter14described above and cooperates with the first connection interface50in the same manner. The second end124of the patient connector16includes an IV line attachment128, such as a male luer connector, although any other suitable connection arrangements may be utilized.

Referring toFIGS. 22-24, the process of mating the first connection interface50with the second connection interface90is shown. Although the syringe adapter12with the first connection interface50is shown being attached to the vial adapter14with the second connection interface90, the connection of the first connection interface50with the second connection interface90will be similar regardless of the devices incorporating the first and second connection interfaces50,90. As shown inFIG. 22, the interior space28of the syringe adapter12is aligned with the second connection interface90of the vial adapter14. In particular, the longitudinal axis of the syringe adapter12is aligned with the longitudinal axis of the vial adapter14and the lock member52of the first connection interface50is in the closed position. As shown inFIG. 23, the first connection interface50and the second connection interface90are moved towards each other with a portion of the second connection interface90being received within the interior space28of the syringe adapter12. At this position, the lead-in surface68of the lock member52of the first connection interface50engages the second connection interface90, which transitions the lock member52from the closed position (shown inFIG. 22) to the open position (shown inFIG. 23). When the lock member52is moved from the closed position to the open position, the cantilever spring60will engage the cam surface62of the body22of the syringe adapter12, which creates a biasing force that urges the lock member52back to the closed position. Such movement back to the closed position, however, is prevented by engagement of the lock member52with the body106of the second connection interface90. With the lock member52of the first connection interface50in the open position, the second connection interface90is allowed to continue its movement within the interior space28of the syringe adapter12to continue the process of mating the syringe adapter12to the vial adapter14and to move the first connection interface50and the second connection interface90towards a locked engagement.

Referring toFIGS. 23-24, after the lock member52of the first connection interface50is moved to the open position, the membrane112of the second connection interface90engages the second membrane44of the seal arrangement38of the syringe adapter12thereby forming a liquid tight seal during fluid transfer between the syringe adapter12and the vial adapter14. Further insertion of the second connection interface90within the interior space28of the syringe adapter12moves the membrane carrier40toward the first end24of the syringe adapter12against the biasing force of the biasing member46and causes cannula34to pierce the second membrane44of the seal arrangement38of the syringe adapter12and the membrane112of the second connection interface90thereby placing the vial adapter14in fluid communication with the syringe adapter12. When the second connection interface90is inserted a predetermined distance within the interior space28of the syringe adapter12, the lead-in surface110of the second connection interface90engages the lock member52to further compress the cantilever spring60. With further movement, the locking surface108of the second connection interface90will be aligned with the lock member52of the first connection interface50such that the lock member52is received within the locking surface108. In particular, the lock member52is biased towards the closed positioned by the cantilever spring60and when the lock member52reaches the locking surface108, the lock member52is free to move into the closed position where a portion of the lock member52is positioned within the interior space28of the syringe adapter12.

In the position shown inFIG. 24, the first connection interface50is fully mated and locked with respect to the second connection interface90. In such a position, the syringe adapter12is prevented from being disconnected from the vial adapter14due to the engagement between the lock member52of the first connection interface50and the locking surface108of the second connection interface90. Although the locked engagement between the first connection interface50and the second connection interface90prevents axial and transverse movement relative to each other, the first connection interface50and the second connection interface90are free to rotate relative to each when locked to each other, which advantageously prevents IV line tangling and/or other accidental disengagement or device failure associated with lack of rotation between components. In particular, the patient connector16, which is mated with and locked to the syringe adapter12in the same manner as described above in connection with the vial adapter14, is typically attached to a patient IV line and the rotation of the first connection interface50relative to the second connection interface90assists in prevent twisting of a patient IV line connected to the patient connector16. However, the first connection interface50and the second connection interface90may be provided with a keyed surface arrangement to prevent such relative rotation if desired.

Referring again toFIGS. 22-24, in order to disconnect the first connection interface50from the second connection interface90, the button58of the lock member52of the first connection interface50is engaged by a user and pushed radially inward to transition the lock member52from the closed position to the open position. The second connection interface90can then be removed from the interior space28of the syringe adapter12in the reverse order of the steps to connect the first connection interface50to the second connection interface90. When the second connection interface90is finally separated from the first connection interface50, the lock member52is moved to the closed position and the biasing member46of the seal arrangement38of the syringe adapter12moves the membrane carrier40to its original position with the distal end36of the cannula34positioned between the first and second membranes42,44. Although the first and second connection interfaces50,90are each provided with the lead-in surfaces68,110, only one of the first and second connection interfaces50,90may be provided with a lead-in surface68,110. Furthermore, neither of the first and second connection interfaces50,90may be provided with the lead-in surfaces68,110, which will require the lock member52of the first connection interface50to be manually moved from the closed position to the open position to allow mating of the first and second connection interfaces50,90. More specifically, the lock member52of the first connection interface50may be moved from the closed position to the open position by engaging the button58of the lock member52and moving the lock member52radially inward such that the lock member52is moved to the open position thereby allowing the mating of the first and second connection interfaces50,90.

Referring toFIGS. 25-27, a second aspect of a system140for the closed transfer of fluids is provided. The system140is similar to the system10shown inFIGS. 1 and 2with like reference numbers used for like elements. Rather than providing a lead-in surface that extends radially outward and positioned intermediate the ends of the body of the second connection interface90, the second connection interface90of the system140shown inFIGS. 25-27includes a lead-in surface at the first end of the second connection interface90adjacent the membrane. The lead-in surface of the aspect shown inFIGS. 25-27is embodied as a slight blend at the top of the connection interface90and assists in moving the lock member52from the closed to the open position. Further, the body22of the syringe adapter12does not include any grip structures.

Although not shown, the systems shown inFIGS. 1-27, may include one or more indication arrangements to provide a user with feedback when the connection interfaces are fully locked or separated. In particular, the body22of the syringe adapter12may be provided with openings with inner and outer tubes that cover one another when the part is in the locked position and not cover one another when the part is in the initial or unlocked position. Alternatively, only one color change component may be provided that is visible within the opening in the body of the syringe adapter12when the device is in the locked or unlocked position. The first and second connection interfaces50,90may also be provided with one or more tactile or auditory indicators to provide an indication of the state of the connection between the first and second connection interfaces50,90. The indication arrangement may also be embodied as alignment lines, dots, symbols, words, or other suitable indicia to assist a user in operating the system. Furthermore, although the seal arrangement38of the syringe adapter12includes a membrane carrier40and first and second membranes42,44, any other suitable arrangement for sealing and delivering a fluid may be provided.

Referring toFIG. 28, the position of the cantilever spring60of the lock member52and the cam surface62of the body22of the syringe adapter12may be reversed. For example, as shown inFIG. 28, the body22of the syringe adapter12is formed with a biasing member144, such as a cantilever spring, that is configured to contact a cam surface146provided on the lock member52of the first connection interface50. The lock member52operates in the same manner as described above in connection with system10.

Referring toFIG. 29, a further aspect of the second connection interface90is shown. The second connection interface90shown inFIG. 29is similar to aspects of the second connection interface shown inFIGS. 1-28and described above. The second connection interface90ofFIG. 29, however, includes a lead-in surface156positioned adjacent to the membrane112or first end of the second connection interface90. The lead-in surface156assists in moving the lock member52from the closed to the open position. The second connection interface90shown inFIG. 29is provided in connection with a vial adapter, although this aspect may be utilized in connection with any medical device and any component of a system for the closed transfer of fluids.