Abstract:
A fluid transfer and mixing device for use in the aseptic intermixing of a powder component with a fluid component. The device is of a simple, compact construction that includes a first adapter that can be easily connected to a container containing the powder component and a second adapter that can be removably interconnected with the first adapter and can also be readily connected to a container containing a fluid such as a diluent so as to permit aseptic intermixing of the diluent with the powder. In use a conventional needleless syringe can be easily connected to the first adapter so that the mixture of the powder and diluent can be aseptically aspirated from the first container for subsequent delivery to the patient.

Description:
This is a Continuation-In-Part Application of co-pending U.S. application Ser. No. 09/754,709 filed Jan. 3, 2001. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates generally to transfer devices for use in mixing medicinal substances. More particularly, the invention concerns a novel fluid transfer and mixing device for intermixing a fluid with a powdered medicament and for the aseptic delivery of the mixture to a patient. 
     2. Discussion of the Invention 
     Many medicinal agents intended for parenteral administration are stored in powder form in a bottle or vial under vacuum. The dry medicinal agent in powdered form typically requires reconstitution with a suitable diluent prior to administration. In the past, the diluent has been provided either in a pre-filled syringe or in a glass vial or bottle. The vial or bottle is generally closed by an elastomeric stopper which can be penetrated by a piercing member as, for example, sharp end or blunt end needle. The elastomeric stopper, which may be slit to accept a blunt end cannula, is typically self-closing upon withdrawal of the piercing member. As previously mentioned, when the drug or other beneficial agent is in powdered or lyophilized form, the vial or bottle is under a relatively high vacuum. 
     In the past, the medicament to be delivered to the patient has been prepared by filling a conventional syringe with an appropriate diluent. The seal of the container containing the powder is then pierced by the needle of the filled syringe and the diluent is injected into the container to intermix with the powder. The mixture thus formed is then allowed to aspirate back into the syringe so that it can be delivered to the patient in a conventional manner. 
     Drawbacks of this type of prior art method include the possibility of highly undesirable needlestick. Additionally, the prior art method is troublesome because of the difficulty of locating the center of the stopper or seal of the container that is to be pierced. Further, considerable skill and experience is required to withdraw the entire contents of the medicament from the container containing the mixture of the powder and the diluent so that a proper dose can be delivered to the patient. 
     It is vitally important that the intermixing of the diluent and the powdered agent be done under sterile conditions. Similarly, the transfer of the reconstituted medicinal agent from the vial or bottle into a suitable administration means, such as a syringe, must be done in a careful and sterile manner. The problem of ensuring such fluid transfers under aseptic conditions is especially acute in the case of self-administration of drugs by patients in a home-care environment. 
     A useful apparatus for accomplishing the sterile intermixing and subsequent delivery of the reconstituted beneficial agent to a patient is described in copending U.S. Ser. No. 08/913,432 filed by the present inventor. This application is hereby incorporated by reference as though fully set forth herein. One embodiment of the invention described in the incorporated-by-reference application comprises a fluid control device for the preparation of a medicament by mixing a first substance contained within a first medicinal vessel with a second substance contained in a second medicinal vessel and thereafter the transferring of the drug to a dispensing tool, namely, a syringe. A principal feature of the fluid control device of this earlier-filed application resides in the provision of a base member having a generally tubular intermediate portion defining a lumen in which a flow control member is rotatably inserted. The flow control member has a port fashioned as a female luer connector for receiving a dispensing tool such as a syringe. The flow control member includes integrally formed handles for enabling the manual rotation thereof. 
     As will be better understood from the description that follows, the apparatus of the present invention uniquely eliminates the flow control member found in the apparatus described in the previously filed application thereby simplifying the construction of the device and making it much easier to use and considerably less costly to manufacture. More particularly, the apparatus of the present invention uniquely comprises a greatly simplified, two component mixing device that includes first and second cooperating adapters of novel design. The first adapter, which is used to access a first container, includes a top wall, a cannula depending from the top wall and a resiliently deformable skirt connected to the top wall for telescopically receiving the upper portion of the first container that contains a powdered medicament. The second adapter of the apparatus, which is used for accessing a second container, can be readily connected to and disconnected from the first adapter. In one form of the invention, the second adapter, like the first adapter comprises a top wall, a cannula depending from the top wall and a resiliently deformable skirt connected to said top wall for telescopically receiving the upper portion of the second container that contains a diluent. 
     In using the apparatus of one form of the present invention, the first and second adapters are first interconnected and the assemblage thus formed is then connected to the first container containing the lyophilized or powdered medicament. Next the second, or diluent container is connected to the adapter assemblage so that the diluent can flow through the assemblage and directly into the first container where it will intermix with the powder contained therewithin. This done, the second adapter along with the diluent container is disconnected from the first adapter. With the first adapter still connected to the first container, which now contains the reconstituted medicament that is to be administered to the patient, the second container is accessed by a needleless syringe so that the mixture can be aspirated from the second container and delivered to the patient in a conventional manner using the thusly filled syringe. 
     Other prior art fluid control and coupler devices known to applicant include U.S. Pat. No. 4,638,975 issued to Iuchi et al; U.S. Pat. No. 4,997,420 issued to Van Der Heiden et al; U.S. Pat. No. 5,104,387 issued to Pokorney et al; and U.S. Pat. No. 5,334,163 issued to Sinnett. 
     SUMMARY OF THE INVENTION 
     It is an object of the present invention to provide a novel, easy-to-use fluid transfer and mixing device for use in the aseptic intermixing of a powder component with a fluid component. 
     Another object of the invention is to provide a device of the aforementioned character that is of a simple, compact construction that includes a first adapter that can be easily connected to a container containing the powder component and a second adapter that can be removably interconnected with the first adapter and can also be readily connected to a container containing a fluid such as a diluent so as to permit aseptic intermixing of the diluent with the powder. 
     Another object of the invention is to provide a device as described in the preceding paragraph in which the second adapter includes a connector component includes filter means for filtering particulate matter from fluid flowing through the connector component. 
     Another object of the invention is to provide a device as described in the preceding paragraph in which a conventional needleless syringe can be easily connected to the first adapter so that the mixture of powder and diluent can be aseptically aspirated from the first container for subsequent delivery to the patient. 
     Another object of the invention is to provide a transfer and mixing device that includes filter means for filtering particulate matter from the mixture to be delivered to the patient. 
     Another object of the invention is to provide a device of the character described which both avoids needlestick and at the same time is very easy to use because the first and second adapters are designed to effortlessly and precisely snap onto and securely grip the first and second containers. 
     Another object of the invention is to provide a device that is uniquely designed so that, after the mixing step and upon separation of the first and second adapters by relative rotation thereof, the user is left with an adapter that is already connected to the container containing the medicament mixture to be delivered and has ready access to a luer connector provided on the adapter to which a needleless syringe can be easily connected. 
     Another object of the invention is to provide a device as described in the preceding paragraph that includes valving means for controlling fluid flow through the first adapter. 
     Another object of the invention is to provide a third transfer apparatus of the class described which is of a simple construction, can readily be used in the home care environment and one that can be inexpensively manufactured in quantity. 
     These and other objects of the invention are satisfied by the apparatus of the invention that will be described in the paragraphs that follow. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a generally perspective view of the first and second adapters of the invention shown in an interconnected configuration. 
     FIG. 2 is a view partly in cross section of the assemblage shown in FIG.  1 . 
     FIG. 3 is an exploded view of the assemblage shown in FIG.  2 . 
     FIG. 4 is a side-elevational view showing the assemblage illustrated in FIG. 1 interconnected with a container containing a fluid. 
     FIG. 5 is a side-elevational view showing the assemblage of FIG. 4 interconnected with a container containing a powdered medicament. 
     FIG. 6 is a side-elevational view similar to FIG. 5, but showing the assemblage made up of the second adapter and the container that contained the fluid disconnected from the first adapter and a container that originally contained the powered medicine. 
     FIG. 7 is a side-elevational view showing the assemblage of FIG. 6 interconnected with a conventional needleless syringe assembly. 
     FIG. 8 is an enlarged fragmentary side-elevational view similar to FIG. 7, but showing the syringe assembly separated from the first adapter. 
     FIG. 9 is a side-elevational view, partly in cross section showing another form of the first and second adapters of the invention shown in an interconnected configuration. 
     FIG. 10 is a side-elevational view, partly in cross section that is similar to FIG. 9, but showing the valve of the apparatus in an open configuration. 
     FIG. 11 is a side-elevational view illustrating another form of the first connector of the invention. 
     FIG. 12 is a cross-sectional view taken along lines  12 — 12  of FIG.  11 . 
     FIG. 13 is an enlarged, cross-sectional view of the area designated in FIG. 12 by the numeral  13 . 
    
    
     DESCRIPTION OF THE INVENTION 
     Referring to the drawings and particularly to FIGS. 1,  2  and  3 , one form of the apparatus of the invention for transferring and mixing first and second substances contained within first and second containers to form a mixture that can be delivered to a patient is there illustrated. As shown in FIG. 5, the first container  14  includes a container portion  14   a  that contains a powered or lypholized substance  16 . Container  14  also includes an upper, generally cylindrically shaped portion  14   b  over which the first adapter  18  of the apparatus is closely received (see also FIG.  2 ). 
     Adapter  18  is uniquely designed to gain access to container portion  14   a  of container  14  via a piercing cannula and here includes a top wall  20 . Extending from top wall  20  is the hollow, piercing cannula  22  that protrudes into a resiliently deformable, umbrella-like skirt, the construction of which will presently be described. Also extending from top wall  20  in an opposite direction is first connector  24  (see also FIG.  3 ). Container  14  is of conventional construction and includes an elastomeric seal or stopper (not shown) that seals the open upper end of the generally cylindrically shaped portion  14   b . Accordingly, when first adapter  18  is mated with container  14 , in the manner shown in FIG. 4, hollow cannula  22  will pierce the elastomeric stopper opening communication between container portion  14   a  and connector  24 . 
     As best seen in FIGS. 2 and 3, adapter  18  also includes the previously mentioned, resiliently deformable skirt  26  that is connected to top wall  20 . Skirt  26  here comprises the first connector means of the invention for interconnecting the first adapter with the first container. Skirt portion  26  is provided with a plurality of circumferentially spaced slits  26   a  that permit the skirt to securely snap over upper portion  14   b  of container  14  and into the configuration shown in FIG. 5 of the drawings. 
     Threadably connected to the first adapter  18  is a second adapter  30  which is of the configuration best seen in FIGS. 2 and 3. Second container  30  also includes a top wall  32  and a resiliently deformable skirt portion  34  that is connected to top wall  32 . Skirt portion  34 , which comprises the second connector means of the invention for interconnecting the second adapter with the second container, also includes a plurality of circumferentially spaced slits  34   a . Also connected to top wall  32  and extending therefrom is a second piercing cannula  36 , which is of the construction shown in FIGS. 2 and 3. Also connected to and extending from top wall  32  is a second connector  38 . While connectors  24  and  38  may take various forms, connector  24  is preferably provided in the form of a male luer connector, while connector  38  is preferably provided in the form of a female luer connector that will mate with connector  24  when the parts are threadably interconnected by relative rotation of the first and second adapters to form the construction shown in FIG.  2 . As will be described in greater detail in the paragraphs that follow, connector  24  is also configured to threadably mate with aspirator means having a connector  40  of the type found on conventional, readily commercially available needleless syringes  42  (see FIGS.  7  and  8 ). 
     As shown in FIG. 4, second adapter  30  is adapted to mate with a second container  44 . Second container  44  includes a container portion  44   a  which is here filled with a diluent  46 , and an upper, generally cylindrically shaped portion  48  that is also sealably closed by an elastomeric member such as an elastomeric stopper (not shown). Container  44 , like container  14 , is of conventional construction and is readily commercially available. 
     With the construction shown in the drawings, second adapter  30  can be mated with container  44  in the manner shown in FIG. 4 with the piercing cannula  36  piercing the elastomeric seal so as to open communication between container portion  44   a  and the outlet  38   a  of connector  38 . 
     In using the apparatus of the invention, connector  18  is first threadably interconnected with adapter  30  in the manner shown in FIGS. 1 and 2. The assemblage thus formed is interconnected with container  44  in the manner shown in FIG.  4 . This assemblage, which now comprises adapters  18  and  30  and container  44 , is next mated with container  14  in the manner shown in FIG.  5 . As previously mentioned, container portion  14   a  is under vacuum so that when hollow cannula  22  pierces the elastomeric seal that seals the upper portion of container  14 , the fluid will be automatically and rapidly drawn into container portion  14   a  in the manner indicated by the droplets “D” in FIG.  5 . In a short period of time, the diluent  46  contained within container  44  will flow into container portion  14   a  of container  14  and will rapidly intermix with the powered or lypholized medicament  16  contained within container  14 . 
     Once the diluent and the powered medicament is thoroughly mixed, container  44  along with second adapter  30  is threadably disconnected from adapter  18  to form the configuration shown in FIG. 6 that comprises container  14  and adapter  18 . As depicted in FIG. 6, the diluent has now intermixed with the powdered medicament to form the mixture generally designated in FIG. 6 by the numeral  50 . 
     The next step in the method of the invention is to access the assemblage shown in FIG. 6 using the aspirator means which functions to aspirate from container  14  the mixture contained therein. The aspirator means is here provided in the form of a conventional syringe assembly such as syringe assembly  42 . This can readily be accomplished by threadably interconnecting connector  40  of the aspirator or syringe assembly with connector  24  of the first adapter  18  so as to form the assemblage illustrated in FIG.  7 . The aspirator or syringe  42  can then be used in a conventional manner to withdraw the mixture  50  from vial  14  in order to appropriately fill the aspirator or syringe  42 . The aspirator can then be disconnected from the assemblage in the manner shown in FIG. 8 so that the mixture  50  that is now contained within the aspirator can be delivered to the patient via an appropriate administration line having a male luer connector affixed thereto. 
     Turning next to FIGS. 9 and 10, an alternate form of the apparatus of the invention is there shown. This apparatus is similar in many respects to that shown in FIGS. 1 through 3 and like numerals are used to identify like components. The primary difference between this latest form of the invention and the earlier described embodiments resides in the fact that valving means is provided within the first adapter to control fluid flow through the connector portion thereof. The character of this novel valving means will presently be described. 
     First adapter  54  of this latest form of the invention is of similar construction to adapter  18  and includes a top wall  56  from which both a piercing cannula  58  and a connector  60  extend in the manner shown in FIG.  9 . 
     Also connected to top wall  56  is a resiliently deformable slitted skirt-like portion  62 , which is of similar character to skirt-like portion  26  as previously described. 
     As before, connector  54  is provided with circumferentially spaced slits  54   a  and is adapted to be threadably mated with second connector  64  and also with a container, such as container  14 , that contains a powered medicament. 
     Second adapter  64  is of a similar construction to second adapter  30  and includes a top wall  66  from which a piercing cannula  68  and a connector  70  extend in the manner shown in FIG.  9 . Also connected to and extending from top wall  66  is a resiliently deformable, slitted skirt-like portion  72  which is of similar construction to skirt-like portion  34  of second adapter  30 . As before, second adapter  64  is adapted to be interconnected with a container such as container  44  containing a diluent or other suitable medicinal fluid. 
     The novel valving means of this latest form of the invention comprises a slitted elastomeric member  76  which is sealably received within the outlet port  60   a  of connector  60  in the manner illustrated in FIG.  9 . Member  76 , when in its normal expanded configuration shown in FIG. 9, functions to sealably close outlet  60   a . However, when adapter  64  is mated with adapter  62  in the manner shown in FIG. 10, the stem component  70   a  of connector portion  70  of adapter  64  will function to compress valve member  76  in the manner shown in FIG. 10 thereby opening a fluid flow passageway  76   a  formed within member  76  so as to permit passage of fluid between the respective connector portions of adapters  62  and  64 . With this construction, when adapter  62  is connected to vial  14  (see FIG.  6 ), the mixture of the diluent and the powdered medicament will be sealably contained within container  14  until the aspirator means, or syringe,  42  is mated with the assemblage in the manner previously discussed. Upon mating the syringe assembly with adapter  54 , the valve member  76  will once again be compressed by the stem of the syringe permitting the medicament mixture to be aspirated from the container. 
     Turning next to FIGS. 11 through 13, another form of the second adapter of the apparatus of the invention is there shown and generally designated by the numeral  80 . This adapter is similar in many respects to the previously described adapter  30  and like numerals are used in FIGS. 11 through 13 to identify like components. Adapter  80  can be mated with all of the various previously described components in the same manner and for the same purposes as previously described adapter  30 . The primary difference between this latest form of the second adapter and the earlier described form thereof, namely adapter  30 , resides in the fact that filter means is provided within second adapter  80  to filter particulate matter from the fluid flowing through the connector portion thereof. 
     As best seen in FIG. 12 adapter  80  includes a top wall  82  and a resiliently deformable skirt portion  34  that is connected to top wall  82 . Skirt portion  34 , is of the construction previously described and includes a plurality of circumferentially spaced slits  34   a . Also connected to top wall  82  and extending there from is a second piercing cannula  84 , which is of the construction best seen in FIG.  12 . Also connected to and extending from top wall  82  in the opposite direction is a second connector  86 . Connector  86 , like connector  38  of adapter  30  is provided in the form of a female luer connector that will mate with first connector  24  of the previously described embodiment of the invention when the parts are threadably interconnected by relative rotation of the first and second adapters (see for example FIG.  2 ). 
     As illustrated in FIGS. 12 and 13, the stem portion  86   a  of connector  86  is provided near its upper extremity with a circumferentially extending groove  88  within which the filter means of the invention is retained in the manner indicated in FIG.  13 . This filter means is here provided in the form of a generally disk shaped member  90  that can be constructed of any suitable material that will filter particulate matter from fluid flowing through the stem portion of the connector. For example, materials such as a porous plastic material can be used to construct filter member  90 . 
     As was earlier described in connection with the embodiment shown in FIGS. 1 through 8, connector  24  is of a configuration that will mate with adapter  80  as well as being of a configuration will threadably mate with aspirator means having a connector  40  of the type found on conventional, readily commercially available needleless syringes  42  (see for example FIGS.  7  and  8 ). 
     Skirt portion  34  of adapter  80 , which comprises the second connector means of the invention, functions to permit the interconnection of adapter  80  with the previously identified second container  44  (see for example FIG.  4 ). In this regard, as previously discussed, second container  44  includes a container portion  44   a  which is filled with a diluent  46 , and an upper, generally cylindrically shaped portion  48  that is also sealably closed by an elastomeric member such as an elastomeric stopper (not shown). When the second adapter  80  is mated with container  44  the piercing cannula  84  pierces the elastomeric seal of the container so as to open communication between container portion  44   a  and the stem portion  86   a  of connector  86 . 
     In using the apparatus of this latest form of the invention, connector  18  is first threadably interconnected with adapter  80 . The assemblage thus formed is next interconnected with container  44  (see for example FIG.  4 ). This assemblage, which now comprises adapters  18  and  80  and container  44 , is next mated with container  14  (see for example FIG.  5 ). As previously mentioned, container portion  14   a  is under vacuum so that when hollow cannula  22  of the first adapter pierces the elastomeric seal that seals the upper portion of container  14 , the fluid will be automatically and rapidly drawn into container portion  14   a  in the manner indicated by the droplets “D” in FIG.  5 . In a short period of time, the diluent  46  contained within container  44  will flow into container portion  14   a  of container  14  and will rapidly intermix with the powered or lypholized medicament  16  contained within container  14 . 
     Unlike the embodiment of the invention described in connection with FIGS. 1 through 8, use of the alternative form of second adapter  80  will ensure that particulate matter that might be contained within vial  44  will be effectively filtered out by the filter means or filter  90  of the alternative form of the second adapter  80  is shown in FIGS. 11 through 13 prior to the fluid flowing into container  14 . Without filter  90 , particles contained within vial  44  will flow into container  14  unabated and will later aspirated into a syringe such as the syringe  42  shown in FIG. 7 for later delivery to a patient via an appropriate administration line having a male luer connector affixed thereto. 
     Having now described the invention in detail in accordance with the requirements of the patent statutes, those skilled in this art will have no difficulty in making changes and modifications in the individual parts or their relative assembly in order to meet specific requirements or conditions. Such changes and modifications may be made without departing from the scope and spirit of the invention, as set forth in the following claims.