Patent Publication Number: US-9895288-B2

Title: Fluid transfer device

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims priority to U.S. Provisional Application Ser. No. 61/980,196, filed Apr. 16, 2014, which is hereby incorporated by reference in its entirety. 
    
    
     BACKGROUND OF THE INVENTION 
     Field of the Invention 
     The present invention relates to a device for transferring fluid from a container to another container or device. More particularly, the present invention relates to a device that provides a closed environment for transferring fluid from a container to another container. 
     Description of 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. Closed-system transfer devices (CSTDs) are used to prevent such hazardous exposure. However, currently available CSTDs are often complicated and/or costly to manufacture and may be complicated for the healthcare workers to operate. Therefore, there is a need for a CSTD that is easier and more economical to manufacture and easier for healthcare workers to use. 
     SUMMARY OF THE INVENTION 
     In accordance with an aspect of the present invention, a fluid transfer device includes a first portion having a first end and a second end. The first portion includes a first connector configured to be connected to a first container and including a cannula. The fluid transfer device includes a second portion having a first end and a second end. The second end of the first portion extends at least partially into the second end of the second portion. The second portion includes a second connector configured to be connected to a second container and a third connector spaced apart from the second connector. At least a portion of the first portion is axially and rotationally movable with respect to at least a portion of the second portion from a first position in which the first connector is aligned with the second connector to a second position in which the first connector is aligned with the third connector. 
     The first and second portions may be cylindrical. The first end of the first portion may be closed and the second end of the first portion may be open. The first end of the second portion may be closed and the second end of the second portion may be open. 
     The fluid transfer device may further include a sealing member disposed between a portion of the first portion and a portion of the second portion. The sealing member may be positioned within a groove defined by the first portion. 
     The fluid transfer device may include a container sealably engageable with the second connector. The container may be a flexible container. 
     The first connector may be a luer fitting and configured to be connected to a syringe. The second connector may be a snap fit connection configured to secure the second connector to a vial. The third connector may be configured to connect to an IV adapter. 
     When the first portion is in the first position and axially advanced into the second portion, the cannula of the first connector may be in fluid communication with the second connector. When the first portion is in the second position and axially advanced into the second portion, the cannula of the first connector may be in fluid communication with the third connector. 
     The first portion and the second portion may define a chamber, with the first portion axially movable with respect to the second portion from a first position in which the chamber defines a first volume, to a second position in which the chamber defines a second volume, the first volume greater than the second volume. 
     The fluid transfer device may include a handle extending from a portion of the first portion for transitioning the first portion from the first position to the second position. 
     The third connector may define a passageway, with the third connector including a seal configured to seal the passageway of the third connector. 
     In a further aspect, a method of transferring a fluid includes: providing a fluid transfer device having a first portion, a second portion where the first portion extends at least partially into the second portion, a first connector comprising a cannula with the first connector connected to the first portion, a second connector connected to the second portion, and a third connector defined within the second portion and spaced apart from the second connector, where at least a portion of the first portion is movable axially and rotationally with respect to at least a portion of the second portion; engaging a first device with the first connector, engaging a second device with the second connector, and engaging a third device with the third connector; advancing a portion of the first portion into a portion of the second portion until the cannula provides fluid communication between the first device and the second device; withdrawing a portion of the first portion from a portion of the second portion; rotating the first portion with respect to the second portion until the first connector is aligned with the third connector; and advancing a portion of the first portion into a portion of the second portion until the cannula provides fluid communication between the first device and the third device. 
     The first device may be a syringe, the second device may be a vial, and the third device may be an IV adapter. 
     The method may further include: providing a container having an open end and a closed end; placing the container around the second device after connecting the second device to the second connector; and sealably connecting the open end of the container around the second connector. 
     The method may also include piercing a seal positioned adjacent to a passageway of the third connector with the cannula. 
     In a further aspect, a fluid transfer device includes a first portion including a first connector configured to be connected to a first container, and a second portion including a second connector configured to be connected to a second container and a third connector spaced apart from the second connector, with the first connector rotatable relative to the second connector and the third connector. The first and second portions have a first position in which the first connector is aligned with the second connector and a second position in which the first connector is aligned with the third connector, where at least a portion of the first portion is axially movable with respect to at least a portion of the second portion. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a side view of a fluid transfer device according to one aspect of the present invention. 
         FIG. 2  is an exploded perspective view of the fluid transfer device of  FIG. 1  according to one aspect of the present invention. 
         FIG. 3  is a side view of the fluid transfer device of  FIG. 1  in an initial position according to one aspect of the present invention. 
         FIG. 4  is a side view of the fluid transfer device of  FIG. 3  after the first portion has been pushed into the second portion to establish fluid communication between the syringe and the medicament container according to one aspect of the present invention. 
         FIG. 5  is a side view of the fluid transfer device of  FIG. 4  after the first portion has been withdrawn from the second portion to disengage fluid communication between the syringe and the medicament container according to one aspect of the present invention. 
         FIG. 6  is a side view of the fluid transfer device of  FIG. 5  after the first portion has been rotated with respect to the second portion to align the syringe with the IV adapter according to one aspect of the present invention. 
         FIG. 7  is a side view of the fluid transfer device of  FIG. 6  after the first portion has been pushed into the second portion to establish fluid communication between the syringe and the IV adapter according to one aspect of the present invention. 
     
    
    
     DESCRIPTION OF THE INVENTION 
     For purposes of the description hereinafter, the words “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and like spatial terms, if used, shall relate to the described aspects as oriented in the drawing figures. However, it is to be understood that many alternative variations and aspects may be assumed except where expressly specified to the contrary. It is also to be understood that the specific devices and aspects illustrated in the accompanying drawings and described herein are simply exemplary aspects of the invention. 
     A fluid transfer device of the present invention is used to provide transfer, including reconstitution if necessary, of a fluid medicament from a first container, often a vial, to a patient in a completely closed system such that the medicament is never released into the atmosphere. 
     As shown in  FIGS. 1-7 , the fluid transfer device  10  has a first cylindrical portion  12 , a second cylindrical portion  14 , and at least one sealing member  16  provided between the first cylindrical portion  12  and the second cylindrical portion  14 . 
     The first cylindrical portion  12  has an open end  18  and a closed end  20 . A first connector  22  including a central passageway therethrough extends from the closed end  20  of the first cylindrical portion  12 . A needle cannula  24  is provided in fluid communication with the central passageway of the first connector  22  and may extend into the interior of the first cylindrical portion  12 . The first cylindrical portion  12  may also include a handle  23  extending from the first cylindrical portion  12 , such as from the closed end  20 , which is shown in  FIGS. 2-7 , but not  FIG. 1 . 
     The first connector  22  may be configured to connect to a syringe  26  and may be a standard male luer fitting that can cooperate with a corresponding female luer fitting on the syringe  26  to attach the syringe  26  to the first cylindrical portion  12  as shown in  FIG. 1 , or may be a standard female luer fitting that can cooperate with a corresponding male luer fitting on the syringe  26 , although other suitable connectors may be utilized. The needle cannula  24  is connected to the first connector  22  such that the central passageway of the first connector  22  is sealingly engaged with the needle cannula  24  to provide an air-tight and fluid-tight connection therebetween. 
     The second cylindrical portion  14  has an open end  28  and a closed end  30 . A second connector  32  including a central passageway therethrough extends from the second cylindrical portion  14 , such as the closed end  30  of the second cylindrical portion  14 . A third connector  34  including a central passageway therethrough also extends from the closed end  30  of the second cylindrical portion  14  and is spaced apart from the second connector  32 . 
     The second connector  32  may be adapted for connection to a medicament container  36  that contains a medicament. The container  36  may be a vial having a pierceable septum, as shown in  FIGS. 2-7 . The second connector  32  may be a threaded connector as shown in  FIGS. 3-7  or, as shown in  FIG. 1 , may be a snap-fit connector having vial grip members, hook protrusions, and angled walls, or other suitable connectors. The second connector  32  may include a seal  38 , such as an O-ring, to provide a sealing engagement between the container  36  and the second connector  32 . 
     The third connector  34  may be adapted for connection to an IV adapter  40  through which the medicament will be administered to the patient. Such a connector may be any standard connector known in the art including, but not limited to, a connector having a groove including a locking portion wherein the IV adapter  40  has protrusions for engagement with the groove or a connector having protrusions wherein the IV adapter  40  has a groove including a locking portion for engagement with the protrusions. The third connector  34  may further include a seal  42 , such as an elastomeric seal or the like. The seal  42  may be air-tight and fluid-tight and adapted to seal the central passageway of the third connector  34 . Such a seal may also be adapted to allow the passage of the needle cannula  24  through the seal  42  in a manner in which the seal  42  provides an air-tight and fluid-tight seal around the needle cannula  24  and, on removal of the needle cannula  24  from the seal  42 , reseals to provide an air-tight and fluid-tight seal for the central passageway of the third connector  34 . 
     The first cylindrical portion  12  and/or the second cylindrical portion  14  may each be formed of a single piece or may comprise a sidewall portion  44  and a closure portion  46  as shown in  FIGS. 1-7 . The sidewall portion  44  and closure portion  46  may be connected using a suitable means that provides an air-tight and fluid-tight seal including, but not limited to, welding or adhesive. 
     The outer diameter of the first cylindrical portion  12  is slightly less than the inner diameter of the second cylindrical portion  14  such that a portion of the open end  18  of the first cylindrical portion  12  extends into a portion of the open end  28  of the second cylindrical portion  14 . In this manner, the first cylindrical portion  12  and the second cylindrical portion  14  define an internal chamber. The needle cannula  24  is contained within this chamber. 
     The first connector  22 , the second connector  32 , and the third connector  34  are positioned such that the first connector  22  can be axially aligned with either the second connector  32 , or the third connector  34  when the first cylindrical portion  12  is mated with the second cylindrical portion  14  and rotated with respect to the second cylindrical portion  14 . 
     The first cylindrical portion  12  is movable axially and rotationally with respect to the second cylindrical portion  14 . The first cylindrical portion  12  is axially movable with respect to the second cylindrical portion  14  from a first position (shown in  FIGS. 3, 5, and 6 ) to a second position (shown in  FIGS. 1, 4, and 7 ) where the volume of the chamber in the first position is greater than the volume of the chamber in the second position. In addition, the first cylindrical portion  12  is rotatable with respect to the second cylindrical portion  14  from a first position (shown in  FIGS. 1 and 3-5 ) where the first connector  22  is aligned with the second connector  32  to a second position (shown in  FIGS. 6 and 7 ) where the first connector  22  is aligned with the third connector  34 . 
     The sealing member  16  is provided between an outer sidewall surface  48  of the first cylindrical portion  12  and an inner sidewall surface of the second cylindrical portion  14 . As shown in  FIG. 2 , the sealing member  16  may be an O-ring and may sit in a groove  52  in the outer sidewall surface  48  of the first cylindrical portion  12  or the inner sidewall surface of the second cylindrical portion  14 . A second sealing member  16  may also be provided. The sealing member  16  is adapted to provide an air-tight and fluid-tight seal between the first cylindrical portion  12  and the second cylindrical portion  14  yet still allow for the axial and rotational movement of the first cylindrical portion  12  with respect to the second cylindrical portion  14 . 
     A container  54  having an open end  56  and a closed end  58  may also be provided. The open end  56  of the container  54  is sealably connected around the second connector  32 . The connection between the second connector  32  and the open end  56  of the container  54  may be a threaded connection or may utilize an elastic band that stretches over the container  54  and fits into a groove in the second connector  32 , although any suitable connection that provides an air-tight and fluid-tight seal may be used. 
     The container  54  may be flexible and may be made of plastic or any suitable material that allows it to be fit over the medicament container  36  that contains the medicament and sealed to the second connector  32 . The container  54  may be a plastic bag. 
     The fluid transfer device  10  may also include a third cylindrical portion  60  having a first open end  62  and a second open end  64 . The third cylindrical portion  60  has an outer diameter that is smaller than the inner diameter of the first cylindrical portion  12  and the second cylindrical portion  14 . The first open end  62  of the third cylindrical portion  60  abuts the closed end  20  of the first cylindrical member  12  and the second open end  64  of the third cylindrical portion  60  abuts the closed end  30  of the second cylindrical member  14  when the first cylindrical portion  12  is advanced into the second cylindrical portion  14  as shown in  FIGS. 1, 4, and 7 . This results in a more equal distribution of force during this operation. In addition, the third cylindrical portion  60  stabilizes the device during rotation of the first cylindrical portion  12  with respect to the second cylindrical portion  14  as shown in  FIG. 6 . All of the components including the first cylindrical portion  12 , the second cylindrical portion  14 , the first connector  22 , the second connector  32 , the third connector  34 , and the container  54  may be made from any suitable material having the necessary chemical resistance and strength including, but not limited to, polypropylene (PP) and polyvinyl chloride (PVC). 
     In use, as shown in  FIG. 3 , the fluid transfer device  10  is placed in a first position where the first connector  22  is axially aligned with the second connector  32  and the first cylindrical portion  12  extends from the second cylindrical portion  14 . A first device, such as a syringe  26  having a diluent, is connected to the first connector  22 . A second device, such as a medicament container  36 , is connected to the second connector  32 . A third device, such as IV adapter  40  or other device for delivery of the medicament to the patient, is connected to the third connector  34 . The container  54  may then be placed over the medicament container  36  and sealingly secured to the second connector  32 . 
     As shown in  FIG. 4 , by actuating the handle  23 , the first cylindrical portion  12  is at least partially advanced into the second cylindrical portion  14  reducing the volume of the chamber and causing the needle cannula  24  to enter the medicament container  36  creating a fluid passageway between the syringe  26 , connected to the first connector  22 , and the medicament container  36 , connected to the second connector  32 . The needle cannula  24  may enter the medicament container  36  by piercing a septum on the top of the medicament container  36  or any other arrangement as long as a fluid passageway is provided between the syringe  26  and the medicament container  36 . At this point, if the medicament is ready for administration to the patient, it can be drawn into the syringe  26 . If the medicament is a powder or liquid that needs to be reconstituted, the necessary fluid/solvent can be injected into the medicament container  36  from the syringe  26  and, upon completion of the reconstitution, the medicament can be drawn into the syringe  26 . 
     As shown in  FIG. 5 , after the medicament has been drawn into the syringe  26 , the first cylindrical portion  12  is at least partially withdrawn from the second cylindrical portion  14 , such as by actuating the handle  23 , thus increasing the volume of the chamber defined between the first cylindrical portion  12  and the second cylindrical portion  14 . As the first cylindrical portion  12  is partially displaced from the second cylindrical portion  14 , the needle cannula  24  is removed from the medicament container  36 . Then, as shown in  FIG. 6 , the first cylindrical portion  12  is rotated with respect to the second cylindrical portion  14  until the first connector  22  is axially aligned with the third connector  34 . After rotation of the first cylindrical portion  12 , as shown in  FIG. 7 , a portion of the first cylindrical portion  12  is again pushed into the second cylindrical portion  14  reducing the volume of the chamber defined between the first cylindrical portion  12  and the second cylindrical portion  14 , thereby causing the needle cannula  24  to enter the IV adapter  40  creating a fluid passageway between the syringe  26  connected to the first connector  22  and the IV adapter  40  connected to the third connector  34 . At this point, the medicament can be injected from the syringe  26  into the IV tube for delivery to the patient. This procedure may be repeated until all the medicament has been delivered to the patient. 
     The fluid transfer device  10  has at least two advantages over prior closed system transfer devices. First, the number of components is reduced resulting in a corresponding reduction in manufacturing costs. Second, the entire drug reconstitution process and transfer of the drug to the IV bag is contained within one component, so the number of different devices that the user must use to complete this process and the number of actions the user must perform is reduced as compared to prior art transfer devices. 
     While the present invention is described with reference to several distinct aspects of a fluid transfer device and method of use, those skilled in the art may make modifications and alterations without departing from the scope and spirit. Accordingly, the above detailed description is intended to be illustrative rather than restrictive.