MXPA99006883A - Sliding reconstitution device with seal - Google Patents

Abstract

The present invention provides a connector device (10) for establishing fluid communication between a first container (12) and a second container (14). The device (10) has a first sleeve member (30) having a first end (40) and a second end (42), the first sleeve member (30) having at the first end (40) a first attaching member adapted to attach to the first container (12). The device (10) further has a second sleeve member (32) having a first end (80) and a second end (82), the second sleeve member (32) being associated with the first sleeve member (30) and movable with respect thereto from an inactivated position to an activated position, the second sleeve member (32) having at the second end (82) a second attaching member adapted to attach the second sleeve member (32) to the second container (14). First and second piercing members (34) project from one of the first and second sleeve members (30, 32) for providing a fluid flow path from the first container (12) to the second container (14), and the first and second piercing members (34) are independently hermetically sealed.

Description

SLIDING DEVICE DS RBCO STITÜCION COK SEAL Related Requests The present application is a PCT Application based on U.S. Patent Application No. 08 / 986,580, filed on December 4, 1997 and entitled "Sliding Reconstitution Device With Seal" and U.S. Patent Application No. 09 / 153,116 , filed on September 15, 1998 and titled "Vial Connecting Device for A Sliding Reconstitution Device With Seal".

DESCRIPTION Field of the Technique The present invention relates generally to the release of a beneficial agent for a patient. More specifically, the present invention relates to an improved device for reconstituting a beneficial agent to be delivered to a patient.

Ref .: 30774 Antacadantas gives the Invnción Several drugs are unstable even for a short period of time in a dissolved state and are therefore packaged, stored, and shipped in a powdered or lyophilized state to increase shelf life. In order for the powdered medications to be given intravenously to a patient, the drugs must first be put in liquid form. For this purpose, these medicaments are mixed or reconstituted with a diluent before per-liberated intravenously to a patient. The diluent can be, for example, a dextrose solution, a saline solution, or even water. Normally medications are stored in powdered form in glass jars or ampoules. Other medications, even in the liquid state, must still be diluted before being administered to the patient. For example, some chemotherapy drugs are stored in glass jars or ampoules, in a liquid state, but must be diluted before use. As it is even used, the reconstitution medium put to the medicament sprayed in a medicament already in liquid form, as well as, additionally, dilute a liquid medicament.

Several companies that manufacture the drug do not make the diluent, and vice versa: therefore, the lyophilized drug and the diluent are sold separately. It is necessary for the doctor, pharmacist, nurse, or other medical personnel to mix the medication with the diluent before use. Reconstituting the medication presents a number of problems. The reconstitution procedure is the time consumed and that requires aseptic technique. In addition, the appropriate medication and diluent should be used or the product should be disposed of. The reconstitution procedure should be performed under sterile conditions. It is difficult, in some procedures to reconstitute and maintain sterile conditions. In addition, some medications, such as chemotherapy drugs, are toxic and exposure to medical personnel during the reconstitution procedure can be dangerous. One way to reconstitute a sprayed medication is to inject the diluting fluid directly into the medication vial. This can be done by using a combination of syringe and syringe needle that have the diluent in them. In this regard, the medicine bottles normally include a perforable rubber stopper. The rubber stopper of the medicine bottle is pierced by the needle, and the liquid in the syringe is then injected into the vial. The bottle is shaken to mix the sprayed medication with the liquid. After the medicine and the liquid are mixed, a measured amount of the reconstituted drug is then returned to the syringe. The syringe is then removed from the bottle and the medication can then be injected into the patient. Another method of administering the medicament is to inject the reconstituted drug, contained in the syringe, into a container of parenteral solution. Examples of such containers include the flexible parenteral solution container of MINIBAG ** or the VIAFLEX flexible parenteral solution container sold by Baxter Healthcare Corporation of Deerfield, IL. of Deerfield. IL. These containers of parenteral solution may already have dextrose in themselves or saline solutions. The reconstituted medicament is injected into the container, mixed with the solution in the parenteral solution container and released by administration of intravenous solution placed in a site of a patient access vein. Another method for reconstituting a powdered medicament utilizes a reconstitution device sold by Baxter Healthcare Corporation, product code No. 2B8064. That device includes a double pointy needle and guide tubes mounted around both ends of the needle. This reconstitution device is used to place the vial of the medicament in flow communication with a container of parenteral solution with flexible walls. Once the connection is made by perforate a port of the flexible container with one end of the needle and the vial stopper with the other end of the needle, liquid in the solution container may be forced through the needle into the bottle of the medication by pressing the side walls of the solution container. The bottle is then shaken to mix the liquid and the medicine. The liquid in the bottle is removed by the pressurized air from the solution container in the bottle. When compression of the flexible walled solution container is stopped, the pressurized air in the flask acts as a pump to force the liquid in the flask back into the solution container. An improvement to this product is the subject of the North American Patent No. 4,607,671 normally assigned to Aalto et al. The device of that invention includes a series of protrusions within a shell for grasping a vial of medicament. These protuberances prevent inadvertent disconnection of the device with the bottle. U.S. Patent No. 4,759,756 discloses a reconstitution device which, in one embodiment, includes an improved bottle adapter and bag adapter that allow permanent attachment of a liquid and bottle container. The bag adapter is rotated in relation to the bag adapter to block fluid communication in a first position or the fluid communication effect in a second position. Another form of reconstitution device is seen in U.S. Patent No. 3,976,073 normally assigned to Quic et al. Yet another type of reconstitution device is disclosed in US Patent No. 4,328,802 the Curley et al, entitled "Wet-Dry Syringe Package" which includes a vial adapter having inwardly directed retaining projections to firmly hold the edge of the Cover a vial of medication to secure to the bottle in the vial adapter. The package described by Curley et al. Is directed to reconstitute a medication by using a syringe filled with fluid.

Other methods for reconstituting a medicament are shown, for example, in Patents North American No. 4,410,321 commonly assigned to Pearson, entitled "Cióse Drug Delivery System"; 4,411,662 and 4,432,755 both titled "Sterile Coupling "commonly assigned to Pearson, 4,458,733 a Lyons entitled "Mixing Apparatus"; and the 4,898,209 a Zdeb entitled "Slidig Reconstitution Device Wíth Seal ''. Other related patents including the Patent North American No. 4,872,867 of Kilinger Entitled "Wet-Dry Additivve Assembly"; the North American Patent No. 3,841,329 to Kílinger entitled "Compact Syringe"; U.S. Patent No. 3,826,261 to Kilinger entitled "Vial and Syringe Assembly"; U.S. Patent No. 3,826,260 to Kilinger entitled "Vial and Syringe Combination"; U.S. Patent No. 3,378,369 to Kilinger entitled "Apparatus for Transferring Liquid Between a Container and a Flexible Bag"; and the German specification DE OS 36 27 231.

U.S. Patent No. 4,898,209 commonly assigned to Zdeb (Patent 209), discloses a sliding reconstitution device which solved some of the problems associated with conventional reconstitution systems. (See Figure 1). As can be seen in Figure 1, Patent ^ 209 discloses a first handle member that is concentrically mounted on a second handle member. The handle members can move axially with respect to each other to cause a needle or cannula to move from a medication container and a diluent container to bring the containers into fluid communication with each other. The process for using the connector of the '209 requires three different steps. The handles have to be rotated with respect to each other to move the device in an unsecured position. The handles are then moved axially with respect to one another to an activated position to pierce the closures of the containers. The handles are rotated again, in an opposite direction from the direction taken in the first stage, to secure the handles in the activated position. The connector described in the patent * 209 allowed to pre-open the device to a franc without interrupting the closing of the bottle. However, no seal was provided on the opposite end of the connector, and the vial and the mounted device had to be used relatively quickly after connection or stored in a sterile environment, such as under a cover. Also, the '209 Patent does not disclose any structure to prevent the device from inadvertently dismounting when it moves to the activated position. The second handle is capable of completely sliding through the first handle member and becoming detached from the first handle member. This would require that the medical staff either reassemble the device, or potentially discard it due to contamination. The device described in the '209 patent also does not provide a visual indication that the device is in the activated position. It is also possible for the device described in the Patent 209 to be inadvertently moved to the non-activated position, by merely rotating the first and second handle members in a direction opposite to that which was taken in the third step described above. Additionally, it was possible for the second container, which is frequently a bottle, to rotate within the device. This could cause perforation of the bottle cap which can lead to filtration of the bottle cap. Additionally it was possible for a bottle to desalinate while it was attached to the device, causing for medical personnel that the joining process is difficult. In addition, the connector could relatively easily be removed from the bottle. Removal of the vial could eliminate all evidence that the reconstitution stage had occurred and possibly lead to the administration of a second unanticipated dose of medication. Finally, the seal had a handle that covered only a portion of the cannula. The handle of the seal was relatively elastic and had the tendency to push the connector away from the medication container when it is coupled and activated thereto. Yet, another connector for attaching a vial of medicament to a container of parenteral solution is described in U.S. Patent No. 4,675,020. Patent 020 discloses a connector having an end that couples to the medication bottle and an opposite end that connects to the solution container. An edge and a surface of the end of the bottle take place between the first and second jaws at the end of the connector. The second jaws 71 terminate at a relatively sharp point that pierces and deforms the surface of the outermost end 94 of the bottle sufficiently to accommodate dimensional variations between the edge and the surface of the outermost end of the bottle. The markings to the left on the surface of the deformable end of the bottle are intended to provide evidence of tamper evidence. However, tamper evidence marks can not be left in jars that have a lid that is too short to rebound on sharp points. The connector described in the Patent 020 has a bolt 25 that penetrates the plugs on the bottle and on the solution container to put these containers in fluid communication. However, because the bolt 25 extends outwardly beyond the flange sections 57, the connector of the x020 can not be pre-attached to the flow container or medication container without piercing the plugs of each. This is undesirable, as long as the period of time in which the drug is to be used begins, and normally this is a shorter period in relation to the normal shelf-life of the drug product. (The '020 patent states that the connector can be preassembled in a medication bottle (column 6, lines 40-49), but there is no detailed description of a structure that would allow such pre-assembly). The device of the '020 does not also provide a structure to prevent a coupled flask that rotates in relation to the bolt 25. A closure of the flask may become damaged or punctured after turning, which in turn may lead to particles of the close to enter the flow that eventually passes to the patient. It can also lead to filtration of the closure of the vial.

Summary Give The Invasion The present invention provides a device for reconstituting fluid. For this purpose, a device having a first handle member and a second handle member which are operatively coupled so that the first handle can slide axially relative to the second handle member has been provided. At one end of the first handle is included a means for connecting the handle to the first diluent container, for example a flexible parenteral bag. The second handle member is adapted to an end opposite the first container for connecting to the second container a beneficial agent, such as a standard medication bottle. The beneficial agent can be a medicament in liquid or lyophilized form. A piercing member is provided within one of the first and second mango members.

Preferably, the piercing member is a double ended cannula for accessing both the first and second containers and establishing a fluid communication between them. The device is movable between an un-activated position and an activated position. When in the second activated position the first and second containers are pierced by the piercing member, putting them in fluid communication so that the medicament and the diluent can be mixed. The second handle member further includes means for sealing the end of the second handle member to the second container. Preferably, the seal is an elastomeric disk-shaped diaphragm having an axially extending elastic handle member that is sized to fit close to the piercing member to protect it from contamination. In a more preferred embodiment, the diaphragm also includes an axially extending, centrally disposed annular rim, which is dimensioned to form a fluid adjustment seal with the opening of the second container. In one embodiment, the coupling device includes means for preventing the device from inadvertently moving from the activated position to the non-activated position. In a more preferred embodiment, the means for securing is a deformable protrusion on one of the handle members which causes an adapted interference between the first and second handle members. In another embodiment of the device a barrier has been included which covers the proximal end of the first handle member. In the present preferred embodiment, the barrier is a thin metal film which covers the opening of the first handle member to protect the cannula from contamination during handling. It is also possible to use a polymer based barrier such as TYVEK®, or paper and the like. In another embodiment, the coupling device includes a plurality of circumferentially spaced, axially extending segmented projections located on the proximal end of the second handle member that is adapted to engage the second container. In a more preferred embodiment, the projections include a planar conducting section in which the projections are oriented on one end of the second container to assist in connecting the device to the second container. The projections further include a narrow section extending from the conductive section in which it terminates to form a reinforcement to firmly attach to the second container. When the second container is a vial of medicament, the connector can be attached to the vial of medicament without piercing the cap of the vial. This is significant because the piercing of the bottle cap initiates the coupling during the period of time. Because simply attaching the connector to the bottle does not result in a piercing through the cap, the connector can be connected to the bottle for a period equivalent to the expiration period of the bottle. In another embodiment, the coupling device includes a means for visually indicating that the coupling device is in the activated position. In the most preferred mode, the medium is a color indication system by means of which the portions of the first handle member, which are not visible when in the activated position, are of a different color than the portions of the first handle member that are visible when they are in the activated position. Thus, in the non-activated position one can see two different colors, but in the activated position only one color is visible. In another embodiment, the coupling device includes a means for preventing the first handle member from the disassociated arrival of the second handle member. In a more preferred embodiment, the second handle member forms a channel for the first handle member and slidably receives the first handle member. A bushing having a larger diameter than the second handle member is connected to the proximal end of the first handle member, preventing it from disengaging arrival when it moves from the unactivated position to the activated position. According to another aspect of the invention, the connector has a diaphragm having a disc having opposite the first and second surfaces. The diaphragm additionally has a cavity or box portion extending axially of the first surface of the disk and a sleeve extending axially of the cavity or box portion. An annular edge extends from the second surface of the disc. The annular rim has a widened distal end which is dimensioned to form a fluid adjustment seal with the closure of the container. According to a further aspect of the invention, the connector has a diaphragm located on the second joining member, and adapted to be located between the piercing member and the second container. The diaphragm has a vertical peripheral edge and an inclined peripheral edge. A reinforcement bracket is located on the second joining member and has a vertical reinforcement bracket and an inclined brace squaring surface. The vertical reinforcement square surface confronts the vertical peripheral edge and the inclined reinforcing square surface confronts the inclined peripheral edge.

Brava Daacripción da loa Drawing » Figure 1 is a selected figure of the U.S. Patent No. 4,889,209, which includes its reference numerals; Figure 2 is an elevated view in a partially transverse section of a reconstitution device of the present invention coupled to a bottle of medicament and parenteral container and in the non-activated position; Figure 3 is a partially sectioned cross-sectional view of the connector device of FIGURE 2 showing the connector in a non-activated position; Figure 4 is a cross sectional view of the connector device of FIGURE 2 not coupled to a parenteral or medicament container; Figure 5 is an end view of the connector of FIGURE 4 taken along the lines I-I; Figure 6 is an end view and a connecting end of the connector bottle of the present invention; Figure 7 is a sectional cross-sectional view of an end connecting the parenteral container of the connector having a direct piercing member; Figure 8 is a cross sectional view of the connector pre-connected to a bottle; Y Figure 9 is a perspective assembled view of the connector of the present invention.

Figure 10 is a partially sectioned cross-sectional view of another embodiment of the connector device of the present invention; and Figure 11 is an elevated view of the connector device adapted to be connected to the liquid container in the form of a syringe.

Description Datalla da laa Modalities Prafaridaa While the invention is susceptible to mode in different forms, it is shown in the drawings and even a preferred embodiment of the invention will be described in detail. It is understood that the present description is considered as an exemplification of the principles of the invention. This description is not intended to limit the broad aspect of the invention to the illustrated embodiments. The present invention provides a connector device that is used to mix two substances within separate containers. More particularly, the invention provides a device for reconstituting a medicament with a diluent. To perform the reconstitution of the medicament, the invention provides an improved apparatus for attaching to the first container, usually a flexible bag, containing a diluent, and to a second container, usually a bottle containing a medicament to be reconstituted. The connector provides fluid communication between the two containers so that the medication can be reconstituted, and the patient released. While the diluent is a liquid, the beneficial agent can be either a powdered or lyophilized drug to be dissolved or a liquid medication to be reduced in concentration. With reference to FIGURE 2, a connector device 10 of the present invention is illustrated. The device 10 is adapted to place a first container 12 containing a liquid to be used as a diluent in the fluid communication with a second container 14 containing a medicament for dilution or reconstitution. Prior to use, the device has means for independently sealing the opposite ends of the device in a sealed manner. The first container 12 is a flexible bag as is normally used to contain solutions received intravenously for a patient. Flexible containers are typically constructed of two sheets of a polymeric material that are bonded at their outer periphery to define a fluid adjustment chamber therebetween. At a point on the periphery of the container 12, a tubular port 20 is inserted between the side walls to provide access to the fluid chamber. Port 20 is normally sealed to a distal end with an elastomeric diaphragm 22 or closure. A second port 21 is shown to allow access by a fluid administration placed to deliver the reconstituted medicament to the patient. Nevertheless, the first container 12 could be any container suitable for containing a liquid used to reconstitute a medicament. The second container 14, is a bottle, which contains the drug to be reconstituted. The bottle 14 is usually a glass container with a rubber stopper 24 inserted in an opening of the bottle 14. The rubber stopper 24 is retained in place by an open hook ring 26 made of a soft metal, such as aluminum, which is hooked around the cap 24 and the neck of the bottle firmly attaching it to the bottle 14. It is a target site 27 centrally located within the aperture by which a needle or cannula passes to access the cap of the bottle. The device 10 can be adapted to accept bottles of any size, particularly bottles of 20 mm and 13 mm. Additionally, the second container 14 could be any container that is adapted to accommodate medications that require reconstitution.

The connector 10, as mentioned above, is adapted to connect to both the flexible bag 12 and the bottle 14 and to put the contents of the flexible bag 12 and the bottle 14 in fluid communication with each other. The connector device 10 has first and second handle members 30 and 32. The first handle member 30 is associated with the second handle member 32 for relative axial movement from a non-activated position (Figure 2) to an activated position (FIG. Figure 3). What does it mean by the activated position is that a piercing member 34 of the connector 10 penetrates the cap of the bottle in a manner which places the flow channel of the piercing member in communication with the enclosed volume of the bottle. That means that by the non-activated position is that the piercing member 34 of the connector 10 does not penetrate the stopper of the bottle in a manner which places the flow channel of the piercing member in communication with the enclosed volume of the bottle. While Figure 3 shows the connector 10 attached to the flexible bag 12, it should be understood that it is not necessary for the connector 10 to be connected to the flexible bag 12 either in the non-activated or activated position. Preferably, the first and second handle members were made using the techniques that mold the standard injection, although it will be understood that other manufacturing techniques can be employed. In a preferred embodiment, the first and second handles 30 and 32 were made of a still rigid deformable polymeric material such as polycarbonate, polyester, polyolefin, or combinations thereof or the like. The first non-activated position, as shown in FIGURE 2, is allowed to couple the connector 10 to both the flexible container 12 and the bottle 14 without piercing the sealing member 24 of the bottle 14. In the activated position, as shown in FIG. FIGURE 4, a piercing member 34, such as a cannula or needle, has pierced the closures 22 and 24 of both containers 12, and 14 that establish fluid communication therebetween to reconstitute a medicament contained in the vial 14. With Referring to FIGURES 2-4 and 9, the means are provided for slidably mounting the first handle member 30 and the second handle member and more preferably the first handle member 30 is slidably mounted within the second handle member 32 for the axial movement and relative rotating in them. The first handle member 30 has a generally cylindrical wall 33 which defines a central channel 35 for receiving a portion of the piercing member 34. The piercing member has a central fluid passage 37 for establishing a fluid flow path between the first and second containers 19 and 14. The first handle 30 has a first end 40 for connecting to the container 12 and a second end 42 for retaining the piercing member 3. The second end 42 terminates in a first flange 44 having a larger diameter than that of the cylindrical wall 33. Two circumferentially spaced activation slots 46 are provided on the outer surface 33 of the first handle 30 and extend through the first flange. 44 and terminate at an intermediate portion of the cylindrical wall 33. Preferably the activation slots 46 are spaced apart at about 180 degrees independently and generally have a square-shaped cross section. As will be described later, the activation slots 46 accommodate the ridges located on an inner surface of the second handle 32 to allow relative axial movement of the first and second handles 30 and 39 when the ridges and grooves are conducted in alignment. The first handle 30 further includes two circumferentially spaced axial locking flanges 50 extending axially from a surface of the first flange 44 and a termination near the first end 40 of the first handle 30. The axial flanges 50 are each preferably located at 90 Degrees of the activation slots 46. The device also includes means for securing the device in the activated position. For this end, the axial flanges 50 have an elongated end portion 51 which, as will be described later, help to secure the connector 10 in an activated position. A bushing 52 is provided to the first end 40 of the first handle 30. The bushing 52 has a bushing handle 54, an opening 55, a flange 56 adjacent to the opening 55, and a thin sheet metal closure 58. (FIG. ). The bushing handle 54 slides on the cylindrical wall 33 and forms an interference adapted therewith. A stop 57 is provided on the first handle 30 for splicing one end of the sleeve 54. The stop 57 includes several circumferentially spaced protuberances. Preferably, the bushing handle 54 has an inner surface having two axially spaced annular flanges or edges 60 (Figure 4), which provide a seal with the cylindrical wall 33. The flange 56, as will be explained below, acts as a means for stopping the first and second handle members 30 and 32 of the disengaged arrival from one another when the connector is in the activated position and also provides a manual retention for moving the first and second handles 30 and 32 axially with respect to one of the other. The means for stopping could be another structure such as a ring or washer associated with the first or second handle members 30 and 32 to prevent them from sliding independently. The thin sheet metal seal 58 is preferably heat sealed to the bushing 52 and freely attached thereto so that it can be pulled away by pulling the pull tab 59. It is contemplated by the present invention that the seal could be made of a thin sheet of aluminum or of a polymer-based material such as TYVEK®, or spun paper or other material that is capable of being detachably attached to the cap and capable of providing a barrier to the ingress of contaminants. It is also contemplated that sealing can be accomplished by induction welding or other sealing techniques. In preferred embodiments, the edges that couple to the tubular port are relatively sharp for greater security of grip of the tubular port. As will be described later, the second handle member 32 has a separate seal such that the device is hermetically sealed independently to the opposite ends. Preferably the bushing was made of a low melting temperature material such as polyethylene or the like. The first end 40 of the first handle member 30 has means for joining the first container or a first joint member. In a preferred form, the means include eight elastic tabs 70 that extend downwardly and inwardly. The tabs 70 are folded inwardly and downwardly when the connector 10 is coupled to the tubular port 20. The collective force of the tabs attempting to bend from returned to their original position extending outwardly secure the connector 10 to the tubular port 20. The force The collective of the tabs attempting to bend from returned to their original, outwardly extending position secures the connector 10 to the tubular port 20 such that it can not be separated without using a considerably excessive force that is normally used to operate the device. Such force would likely break, separate or notably deform one or more of the tabs 70 or other portions of the connector in the process. Thus, the medium firmly connects the connector to the first container. Although the present device utilizes eight tabs 70, it can be appreciated by a reasonable skill in the art that more or fewer tabs could be used without departing from the scope of the present invention. At the second end 42 of the first handle 30 there is provided an axis or hub 71 generally mounted concentrically. The shaft 71 extends from a bottom wall 72 of the first handle member 30. A portion of the piercing member 34a is for piercing the cap 24 of the bottle and a portion 34b, is arranged in the central chamber 35, is for piercing the diaphragm 22 of the container 12. The shaft 71 is hermetically sealed to the piercing member 34 and has a conductive section for orienting an elongated end of the diaphragm on the shaft during assembly. In the present preferred embodiment, the piercing member 34 is a metal cannula having oblique bevels or angles 73 on each end. It is also possible to manufacture the cannula 34 of a plastic material. For a plastic cannula, it is possible to fabricate the cannula 34 integrally with the first handle member 30 such as molding. It is also possible for the members of I ± D ± a? Ia? ¿5 a | 'S S4 to be 2asc5sa2 ?? a ± Brias that they meet together. It is also contemplated that one horadar member could be made of a polymeric material and the other horadar member made of metal. The second handle member 32 has first and second end portions 80 and 82 respectively. The first end portion 80 has a first diameter and the second portion 82, or proximal end, has a second diameter which is larger than the first diameter. In a preferred form, the first and second portions 80 and 82 are generally cylindrical in shape and arranged concentrically to define a channel 83 in which the first handle 30 is received. With reference to FIGURE 6, the second portion 82 of the second handle 32 preferably has means for joining, and preferably means for firmly joining, the device to the bottle 14 or a second joining member. The means shown in six segmented projections 84 extending axially and arranged circumferentially to connect to the bottle 14. The segmented projections 84 are generally trapezoidal in shape and are separated by openings 85 to define a bottle received in the chamber 86 to receive a surface of the flask 14. Although the present device utilizes six segmented projections 84 it can be seen that by reasonable skill in the art, that fewer or more projections could be used without departing from the scope of the present invention. What it means that by "firmly joining" is that in order to remove the jar from the connector, one would have to exert a considerably excessive force, which is normally used to operate the device. Such force would likely break, separate or notably deform one or more of the segmented ledges 84 or other portions of the connector in the process. As shown in FIGURE 6, all of the projections 84 include a flat conductor section 87, which helps to properly align the bottle 14 to be properly aligned with the second handle member 32 while attaching to the second handle member 32. Three of the projections 84a also include, adjacent to a flat conductive section 87, the elastic tabs 88 taper radially and internally, from a distal end to a proximal end, whereupon the medical professional should urge a neck 90 of the bottle 14 to end of connecting it to the second handle member 32. It can be seen that the tabs are capable of flexing and the projections are capable of flexing independently to accommodate the closures of the variant diameter bottle. Preferably, the distal end of the projections has a curved end that is smooth to avoid cutting the medical personnel handling the connector. The tabs 88 shown have a space 89 between the distal end of the tab and the projection. However, the tongues 88 could also be formed as solid protuberances without departing from the invention. As best seen in Figure 6, the three projections 84b that remain have axial extensions, fixed flanges 92 extending from a generally wedge-shaped reinforcing bracket 96. The reinforcement bracket 96 spans the fixed flanges 92 from the annular reservoir 97. In front, the axially internal end of the reinforcement bracket 98 is essentially flush with the annular reservoir 97. The reinforcement bracket has a sloping cover 100 ascending from which the flanges 92 extend generally from a central portion thereof. In a preferred way, the fixed flanges 92 extend externally axially beyond a distal end of the tabs 88 to assist in aligning the bottle with the chamber 86 that receives the bottle during insertion. The fixed flanges 92 are capable of nicking one or more sidewall portions 102 of the engaging metal 26 of the bottle 14 in order to inhibit the bottle 14 to the elastomeric closures 22 and 24 of the bottle 14 and the flexible container 12 through the sealing member. piercing 34. The rotation of the bottle may also cause the hourglass member of a sleeve 106 which covers the piercing member 3. While prefering three projections with the elastic tabs 84a and three projections with axial tabs 84b, providing more or less the projections with the elastic tabs 88 or the flanges 92 will not depart from the scope of the present invention. It is also preferable that the projections of the tongues and the projections with the fixed flanges are arranged for alternating purposes. It may also be desirable to put a flexible holding member, such as a collapsible wrapper or the like, around the projections 84 to aid in holding the bottle. A sealing member 103 located within the chamber 86 that receives the flask and splices to the annular reservoir 97 has a disc 104 with a bevel 105 on its peripheral edge. The disc 104 has a centrally disposed axially extending sheath 106 that is dimensioned to fit over the piercing member 34. The sheath 106 has an elongate distal end 107 that is dimensioned to fit over the shaft 71. The elongate end 107 has an increased cross sectional thickness that increases the grip that the sheath has on the shaft 71. The sealing member 106 is made of an elastomeric material that is sufficiently deformable so that pressure is not exerted on the end of the bottle to cause the member of drilling 34 moves away from the bottle cap 24 when the connector is in the activated position. The sheath 106 has a low module so that it easily be folded on itself when the device is in the activated position. The sealing member 103 hermetically seals the piercing member 34 from contamination during handling and storage. The sealing member 103 also forms a fluid adjustment seal with a surface of the bottle 14. In a more preferred embodiment, the disc 104 further includes a centrally disposed, annular edge 109 extending axially in a direction opposite to the sleeve 106. The annular rim 109 is dimensioned so that it closely and sealably fits over an opening of the bottle 14 to prevent leakage of the bottle 14. The annular rim 109 has an externally enlarged side wall 109a forming a cam sealed with the closure of the vial . Further, centrally disposed within the annular rim, where the sheath 106 joins the disc 104, the disc 104 has a portion 108 having a reduced transverse sectional thickness to facilitate the piercing of the disc 104 by the piercing member 34. A difference of the second jaw identified by reference numeral 74 in Patent No. 4,675,020, discussed above, which was designed to contact a deformable end surface identified by reference numeral 94 of a medicament bottle to accommodate dimensional differences in height of the hook of a franc of medicament, the fixed flanges 99 of the present invention do not contact a deformable end surface of the metal ring 26. Thus, the fixed flanges are not related by the dimensional differences in the distance between one edge of the vial and a deformable end surface. In fact, when the bottle 14 is coupled to the connector 10, the fixed flange 92 can not contact the deformable end surface of the bottle while the deformable end surface is completely covered by the sealing member 103. In turn, the present device is related to the dimensional differences in the heights of the bottle surface using the sealing member 103. The disc 104 and the sheath 106 of the flexible sealing member 103 deforms the ratio by dimensional differences in the height of the surface of a jar. Because of the expanded area, as well as the deformable natural facility of the disc 104, the sealing member 103 can be related by a wider range of dimensional tolerances on the surface of the bottle and therefore is an improvement over the sharp projections of the second. gag of the '020 Patent. Figures 4 and 9 show a means 111 for hermetically sealing the second end of the second handle 32. The means for sealing 111 operates independently of the means for sealing the first end of the first handle. That is, the sealing means 111 can be removed while the first end 40 of the first handle 32 sealed by the closure 58. The means 111 preferably is freely attached to the second handle member 32 and is capable of providing an obvious indication of tampering that the Half sealer has removed. The sealing means 111 and can be a cap that fits over the second end of the second handle 32, a barrier material such as a sheet of thin metal or polymeric material, a breakable closure is fragilely connected to the second handle member 32, a separable seal or similar. Figures 2-4, and 9 also show that the second handle 32 has a side wall 110 with an exterior 112 and an interior surface 114. A set of opposing gripping edges 116, spaced circumferentially 180 degrees from each other, extends to along the outer wall, from a flange 118 defined in the splice of the first and second portions 80 and 82, to a portion of the surface of the first portion 80. The tapers 120 of the grip flange 116 internally in the direction of side wall 110 at an outermost end 122. As will be explained below, grip flanges 116 provide a manual hold to assist in turning the first and second handle members 30 and 32 relative to one another. The device further includes a means for visually indicating that the device is in the uninsured position. In a preferred form, the gripping lips provide a visual indication that when aligned with the fastening flanges 50 of the first handle 30, the first and second handles 30 and 32 were located by axial movement.

Two axially activating flanges 130 are located on the inner surface 114 of the first portion 80 of the second handle 32. The activation ridges 130 extend from the proximal annular reservoir and end near the uppermost end 122. The activation ridges 130 are spaced apart. circumferentially at 180 degrees to each other and each is located between the grip flanges 116 on opposite sides of the second handle 32. The activation ridges 130 are sized to fit within the activation grooves 46 to allow relative axial movement of the first and second handle members 30 and 32. As can be seen in Figures 2-5 and 9, a second flange 140 is provided on the inner surface 114 at the uppermost end 122 of the second handle 32. The second flange 140 extends. axially descending and terminating near a surface of the activation ridges 130 to define an opening 142 therebetween. As shown in Figure 2, when the connector 10 is in the non-activated position, the first flange 44 on the first handle 30 is located within the opening 142 and can rotate therein. The connector 10 further includes means for blocking axial movement of the first and second handle members. To this end and in a preferred form, the second flange 140 additionally includes a first and second opposed sets of fixing slots 144 and 146 that are separated by a deformable protrusion 148. (Figure 5). When the connector 10 is in the not activated position. The fixing edges 50 of the first handle are located within either the first or second fixing slots 144 and 146. When the fixing edges 50 engage the first set of locking slots 44, the activation tabs 130 will be out of alignment with the activation grooves 46 and will be blocked from an axial movement by splicing the first flange 44 and the activation flanges 130. After no axial movement is possible in this position, the device 10 is in a fixed position. Figure 5 shows the activation ridges 130 in alignment with the activation slots 46, so the connector is in the unsecured position and ready for axial movement to the activated position. It can be appreciated that the other means may be provided to block axial movement of the connector such as a key wrench securing the first handle member 30 and splicing a surface of the second handle member 32 to prevent axial movement until the key wrench be removed by the medical staff. It is also possible to apply tape or a foldable wrap material through the splice of the first and second handle members that must be removed before the handle members can move axially with respect to one another. Numerous other structures may be contemplated without departing from the present invention. To move from the fixed position of a non-fixed position, the first member 30 is rotated with respect to the second member 32, in such a way that it urges the fastening edges 50 to pass the protrusion 148, to bring the activation flanges 130 into alignment with the activation grooves 46. In pressing the fixing edges 50 pass the protuberance 148, the second handle 32 can temporarily take an oval shape, as the fixing edges 50 contacting the protuberances 148, are allowed for the rotation of the first and second handle members 30 and 32. When in the non-fixed position, the fastening edges 50 will align with the fastening flanges 116 to provide a visual indication in which the connector 10 is in the non-fixed position. In this position, the first and second handle members 30 and 32 can move axially in the activated position shown in Figure 3.

Moving from the non-activated position (Figure 2) to the activated position (Figure 3), the first and second handles 30 and 32 move axially until the bushing 52 of the first handle 30 contacts the upper end 122 of the second handle to stop the axial movement. In this position, the elongated portion 51 of the fixing lips 50 will be secured in the fixing groove 144 and forms an adapted interference thereof. It can also be appreciated that the difference of the device of the '209 Patent sectioned in Figure 1 which requires a third step to move to a secured position, the present connector automatically closes after moving in the activated position. Thus, once placed in the activated position, the connector can not move back to a non-activated position. Additionally, while in the activated position, the first and second handle members will be locked from the relative rotational movement. Thus, it can be said that the means are provided to automatically secure the connector in the activated position. The means to ensure can be said that. is responsible for the movement of the connector in the activated position. The means for securing in the activated position also includes means for locking the first and second handle members from the relative rotational movement. It can be appreciated that the other structures could satisfy the means for closing the connector in the activated position such as providing an adapted interference between the first and second handle members by shaking one of the handle members or by providing when in the activated position the tabs on the first and second handle members that secure each other. Also, in the activated position the piercing member 34 pierces the closures 22 and 24 of the first and second containers 12 and 14 by placing the containers in fluid communication to allow reconstitution of the lyophilized medicament in the vial 14. The device 10 additionally includes means for determine that the connector is in the activated position. In a preferred form, the means for determining a color coding the system where the first handle member 30 is a color, such as blue, and the second handle member 32 is of another color, such as white. The bushing 52 is of a different color than the first handle member 30. When the first handle member 30 and the second handle member 32 are fully in the activated position, no color of the first handle member 30, in this case blue , it will be visible. If any color, in this case blue, shown, the medical personnel will immediately know that the device 10 is not fully activated. In order to operate the present connector in a method for reconstituting a medicament, the connector is removed from a package in which it is shipped, the foil barrier 58 is detached from the cap 52, and the port 20 of the flexible bag 12 is inserted into the central channel 35 of the first handle member 30. When the port 20 is inserted into the first handle 30, the cannula 34 will pierce the diaphragm 22 of the flexible bag 12. When the diaphragm 22 is pierced and the diluent of the flexible bag 12 filled the cannula 34. However, at this point the flexible bag 12 and the bottle 14 are not in fluid communication due to the disc 104 which blocks the fluid flowing through the cannula 34. The medical professional will also remove the sealing means 111 of the second handle member 111 and firmly attaches to the bottle 14 in the receiving chamber 86. With both ends the connector can be attached to the container 12 and the bottle 14. Having both bottle 14 and the flexible container 12 engage Two and perforated diaphragm 22, the medical professional will then rotate the first handle 30 in relation to the second handle 32, as described above, to place the device 10 in the non-fixed position. Once the device 10 is in the unsecured position, the medical professional will move the first handle 30 axially relative to the second handle 32 until the bushing 52 splices the uppermost end 122 of the second handle member 32 causing the end of the cannula pierce the rubber stopper 24 of the bottle 4. Once the rubber stopper 3 is punctured, the first and second containers 12 and 14 will be in fluid communication. The medical professional will then press the flexible bag 12 to force the fluid into the bottle 14 to reconstitute the medicament, shaking the bottle 14 as necessary to facilitate reconstitution, and inverting the bottle 14 in relation to the bag 12 to allow the reconstituted medicament. , return the flow in the container. It can be seen that the safe steps of this method of reconstituting a medicament can be unnecessary if the device is received pre-attached to the bottle, pre-attached to the fluid container or pre-packed both to the bottle and to the flexible container.

In another embodiment of the present container, the beveled end 73 of the cannula 34 could be replaced by a direct end 150 as shown in Figure 7. As shown in Figure 8, it is possible to pre-pack the bottle 14 to the connector 10 for delivery . The pre-attachment of the bottle 14 to the connector 10 can be carried out using aseptic joining techniques. The preferred method of pre-attaching the device 10 to the bottle 14 includes the steps of: 1) locating the bottle 14 and the second end 82 of the second handle 32 in opposite relation, 2) simultaneously driving the segmented projections 84 in the coupling operation with the vial 14 while the connection is sterilized by exposing the connecting portions of the device 10 and the bottle 4 with, preferably, gamma sterilization or other sterilization energies or techniques, 3) securing the vial 14 to the connector. These steps can be carried out manually by the medical staff or automatically by a machine. By mounting the pre-assembly of the bottle 14 and the connector 10 can be wrapped in an outer pocket for shipping and storage. Figure 10 shows another embodiment of the connector device of the present invention, generally referred to with reference numeral 200.

The connector device 200 of Figure 10 is similar to the connector device 10 described in Figures 2-9 and the identical elements will be referred to with identical reference numerals. As shown in Figure 10, the connector device 200 has a sealing member 202 in the form of a diaphragm similar to the sealing member 103 in Figures 2-9. The diaphragm 202 generally comprises a disc 204 and a sheath 206. The disc 204 has a first surface 208 opposite the second surface 210. The disc has a peripheral edge 212 comprising a beveled peripheral surface 214 attached to a vertical peripheral surface 216. The disc 204 also has a central opening 222 extending in the disc 204 from the second surface 210. An annular edge 218 extending outwardly from the second surface 210 to the central opening 222. The annular rim 218 has a widened side wall externally 220. Disk 204 additionally has a cavity portion 224 extending outwardly from, or below, the first surface 208. The cavity portion 224 has a base 226 and an annular side wall 228 extending from the base 226 and is connected to the first surface 208 in the central aperture 222. The base 226 has a central portion 230 that confronts the distal end of the Hollowing member 34. The cavity portion 224 is defined by the annular side wall 228 and the base 226 extending further from the first surface 208 of the disc 204. The piercing member 34 is spaced from the central portion 230 to a distance "d". As shown in Figure 10, the central opening 222 is driven in and is in communication with the cavity portion 224. As also shown in Figure 10, the sheath 206 extends from the first surface 208. The sheath 206 has a side wall 231. The side wall has a first section 232, • a second section 234 and a third section 235. The second section 234 has a side wall thinner than the first section 232. Thus, the second section 234 represents a portion of the side wall 231 having an outer diameter smaller than an outer diameter of the remnant of the sheath 206 (first section 232 and third section 235). This smaller outer diameter portion, or the second section 234 define a collapsed area. The sheath 206 also has an elongated distal end 236 in the third section 235 sized to fit over the axis 71 of the piercing member 34.

Figure 10 also shows the annular reservoir 97, the projections 84 and the fixed flanges 92. The connector device 200 has modified the reinforcing brackets 240 located between the annular reservoir 97 and the fixed flanges 92. The modified reinforcement bracket 240 is of rounded ends and have an inclined reinforcing bracket surface 242 extending from annular reservoir 97. To the front, the axial inner end of the reinforcement bracket 240 is essentially flush with the annular reservoir 97. The modified reinforcement brackets 240 also have a vertical reinforcement bracket surface 244 extending along the projection 84 and joining the bracket surface of reinforcement 242. The inclined reinforcing bracket surface 242 and the vertical reinforcing bracket surface 240 are dimensioned to closely match the beveled peripheral surface 216 and the vertical peripheral surface 214 respectively. In a preferred embodiment, there are a total of nine modified reinforcing brackets 240 spaced around the circumference in the annular reservoir 97. The reinforcing brackets 240 cooperate to maintain proper alignment of the sealing member 202 adjacent the annular reservoir 97 where the central portion 230 is maintained adjacent to the hole member 34. Since the reinforcement brackets 240 are rounded ends and the sealing member 202 is located on the surfaces of inclined reinforcing brackets 242, the reinforcement brackets 240 do not contact a surface of end of the closure of the bottle 14. The reinforcing brackets 240 function to center the sealing member 202 and reduce the tendency for the sealing member, becoming misaligned when a bottle is connected to the connector. The misalignment may possibly cause the member to pierce the first hole through a wall of the sleeve and then through the disc and into the closure 22 of the bottle 14. While the bottle 14 is finally pierced, the member of the hole passes to through a potentially non-sterile environment. This problem of potential misalignment is prevented with the connector 200. First, the reinforcing corners 240 cooperatively maintain the diaphragm 202 properly aligned with the bottle 14. The inclined reinforcing bracket surface 242 confronts the beveled peripheral surface 216. The corner surface vertical reinforcement 240 confronts the vertical peripheral surface 214. These surfaces cooperate adequately by locating the disk 204 of the diaphragm 202 within the chamber 86 that receives the vial, and preventing the disc 204 from being pushed aside. The cavity portion 224 also aids in reducing the tendency for the piercing member to pierce through the first section 232 of the sheath 206 and then through the central portion 230. Because the cavity portion 224 is further removed in front of the first surface 208 of the disc 204, the distance between the central portion 230 (the present surface pierced by the piercing member 34) and the distal end of the piercing member 34 is reduced to a distance "d". Because the distance "d" is minimized, the distal end of the piercing member 34 only travels a short distance before piercing the central portion 230. In addition, the thicknesses of the second section 234 and the annular wall 228 are dimensioned as that these are the first surfaces to collapse as the piercing member 34 advances toward the bottle 14 during activation. The second section 234, or collapse zone, collapses prior to any remaining portion of the sheath 206. These structures of the reinforcing brackets 244 and the diaphragm 202 prevent the piercing member 34 from improperly piercing a side wall of the sheath 206 in, for example, the first section 232. The structures ensure that the first pierce member 34 of the central portion 230 and then the closure 22 of the bottle 14. Also, the cavity portion 224 and the annular edge 218 cooperatively provide the opening 222 which is deeper than, for example, the depth provided by the annular edge 109 of the diaphragm 103 of Figures 2-10. This deepest opening 222 provides an improved cam seal for the externally enlarged side wall 220 on the bottle 14. Figure 11 shows a modified connector device 300. At one end of the connector device 300, the device is fitted with a conventional luer lock 302. The luer lock can cooperate with a coupled luer lock 302 connected to a syringe 304. It is understood that the male and female components of the luer lock 302 can be connected between the connector 10 and the syringe 304. Thus, the first container 12, previously described as a liquid container which normally comprises a flexible bag, can also comprise the syringe 304. The syringe 304 contains a liquid which can be used to reconstitute the medicament in the bottle 14 by means of the horadar member 34 piercing a closure of syringe 304.

While the specific embodiments have been illustrated and described, the numerous modifications are to be considered without departing significantly from the spirit of the invention, and the scope of protection is only limited by the scope of the accompanying claims.

It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects or products to which it refers. Having described the invention as above, property is claimed as contained in the following:

Claims (69)

1. A connector device for establishing fluid communication between a first container and a second container characterized in tit comprises: a first handle member having a first and a second end, the first handle member has at the first end a first joint member adapted to join the first container; a second handle member having a first end and a second end, the second handle member tis associated with the first handle member and movable relative thereto from an unactivated position to an activated position, the second handle member it has at the second end a second joint member adapted to join the second handle member to the second container; a first and second piercing members projecting from one of the first and second handle members to provide a fluid flow path from the first vessel to the second vessel; and means for independently sealing the first and second piercing members.

2. The device according to claim 1, characterized in tthe means for sealing independently comprises: a release union of sealing material to the first end of the first handle member; and the means for hermetically sealing the second piercing member.

3. The device according to claim 2, characterized in tthe sealing material is selected from the group consisting of a thin sheet of metal, a polymeric material and paper.

4. The device according to claim 2, characterized in tthe means for sealing the second piercing member is a diaphragm.

5. The device according to claim 4, characterized in tthe diaphragm has a disc and a sheath extending axially and away from the disc.

6. The device according to claim 5, characterized in tthe disc further comprises an annular edge disposed centrally extending axially in a direction away from the sheath, the annular rim is sized to fit over a closure of the second container.

7. The device according to claim 6, characterized in tthe disc further comprises a centrally located piercing section having a cross sectional thickness less than a portion of the diaphragm exterior to the piercing section.

8. The device according to claim 5, characterized in tthe diaphragm is capable of being deformed to accommodate dimensional variations in a height of a closure of the second container.

9. The device according to claim 6, characterized in tthe annular rim is capable of folding radially outwards to be related by dimensional differences in a height of a closure in the second container.

10. The device according to claim 5, characterized in tthe cover completely covers the second piercing member.

11. The device according to claim 10, characterized in tthe sheath has an elongated distal end.

12. The device according to claim 5, characterized in tthe disk has a beveled peripheral surface.

13. The device according to claim 5, characterized in tthe sheath is sized to fit over the total of the piercing member.

14. The device according to claim 12, characterized in tthe piercing member takes place by means of an axis or hub and wherein the sheath has an elongate distal end sized to fit over the axis or hub.

15. The device according to claim 6, characterized in tthe annular edge has an axially tapering side wall from an end proximal to a distal end,

16. The device according to claim 1, characterized in tthe first and second members of handle each has a cylindrically shaped wall generally having interior and exterior surfaces.

17. The device according to claim 16, characterized in that it further comprises a means for securing the connector in the activated position.

18. The device according to claim 17, characterized in that the means for securing comprises: a first flange on the first end of the second handle; a pair of opposed locking grooves located on the flange of the first end of the second handle; and a pair of fastening flanges on the outer surface of the wall of the first handle, the fastening flanges extend axially along a portion of the wall to slide in the fixing slots, the fastening flanges each having a elongate portion proximate the first end of the first handle and forms an interference adapted in the fixing slots to secure the connector in the activated position.

19. The device according to claim 16, characterized in that the first handle member is slidably mounted within the second handle member to relatively axially and rotatably move therethrough.

20. The device according to claim 19, characterized in that the connector is movable between the secured and unsecured positions, wherein in the secured position the first and second handle members are locked from relative axial movement, and where in the position unsecured, the first and second connectors are capable of a relative axial movement.

21. The device according to claim 20, characterized in that the connector further comprises: a pair of opposed activation grooves extending axially along a portion of the outer wall of the first handle member, and ending near the first end of the first mango member; a first flange on the first end of the second handle member; a pair of opposing activation flanges located on the inner surface of the second handle member and extending axially from the vicinity of the second end and short termination of the first flange to define an opening therebetween, the activation flanges are sized to adapt within the activation grooves to allow relative axial movement of the first handle member with respect to the second handle member; and wherein in the fixing position the activation flanges are out of alignment with the activation grooves and the first and second handle members can not move axially with respect to one another and in the unsecured position the activation flanges are in alignment with the activation grooves and the first and second connector members can move axially with respect to one another.

22. The device according to claim 20, characterized in that the connector moves between the secured and unsecured position by rotating the first handle member with respect to the second handle member.

23. The device according to claim 19, characterized in that it additionally comprises a means associated with the connector for preventing the first handle member from disengaging arrival of the second member when moving from the non-activated position to the activated position.

24. The device according to claim 23, characterized in that the means for preventing the first and second handle members of the disassociated arrival comprising a bushing connector to the first end of the first handle member.

25. The device according to claim 1, characterized in that the second joining member comprises a receiving chamber.

26. The device according to claim 25, characterized in that the second joining member comprises a plurality of segmented projections extending axially and circumferentially spaced, the projections having a proximal end and a distal end, the projections are adapted to be coupled to the second container. .

27. The device according to claim 26, characterized in that the projections have a conductive section to the distal end of the projections.

28. The device according to claim 26, characterized in that at least one of the projections has a radially tapering tab internally extending from the conductive section.

29. The device according to claim 26, characterized in that a plurality of projections have tabs that internally narrow radially extending from the conductive section.

30. The device according to claim 26, characterized in that at least one of the projections has a fixed flange.

31. The device according to claim 29, characterized in that a plurality of the projections have fixed flanges.

32. The device according to claim 31, characterized in that the projections extend from an annular reservoir and wherein the fixed flanges extend axially from a reinforcing bracket on the annular reservoir outwardly to a position proximate the distal end of the projections for act as an adapted guide to help connect to the second container.

33. The device according to claim 30, characterized in that the tapers of the fixed flange internally radially approach the distal end of the projections.

34. The device according to claim 31, characterized in that the projections have tongues and the projections have fixing flanges arranged in alternating order on the annular reservoir.

35. The device according to claim 25, characterized in that a portion of the second piercing member is located in the receiving chamber when the connector is in the activated position and the second the piercing member is outside the receiving chamber when the device is in the receiving position. the position not activated.

36. The device according to claim 31, characterized in that the tabs and projections are independently flexible to facilitate attachment to the second container.

37. The device according to claim 19, characterized in that the first end of the first handle member has an opening with a plurality of tongues extending internally and downwardly therein, the tabs were adapted to attach to the first container.

38. The device according to claim 1, characterized in that it comprises a bushing connected to the first end of the first handle, the device additionally comprises a stop on the first handle member for splicing one end of the bushing.

39. The device according to claim 38, characterized in that the stop comprises a plurality of circumferentially spaced protuberances located next to the first end of the first handle member.

40. The device according to claim 1, characterized in that the connector additionally comprises a means for visually indicating that the connector is in the activated position.

41. The device according to claim 40, characterized in that the means for visually indicating that the coupling device is in the activated position comprises a color indication.

42. The device according to claim 41, characterized in that the first handle member has a first color, and the second handle member has a second color noticeably different than the first color, wherein the first color when in the activated position is not . visible.

43. The device according to claim 1, characterized in that it additionally comprises means for securing the device in the activated position.

44. The device according to claim 43, characterized in that the means for securing the device comprises means for preventing relative axial movement of the first and second handle members.

45. The device according to claim 44, characterized in that the means for preventing relative axial movement is responsible for moving the device in the activated position.

46. The device according to claim 45, characterized in that the means for preventing relative axial movement of the first and second handle members comprises adapted interference between the first and second handle members.

47. The device according to claim 46, characterized in that the interference fit comprises: a first flange on the first end of the second handle, the first flange extending axially downward and briefly terminating a surface of the fastening flanges to define an opening between them; a pair of the first and second opposing fixing slots in the first flange, each of the first and second fixing slots are spaced apart from one another; a set of fastening flanges on the first handle member extending axially from the second end of the first handle member and briefly terminating the first end of the first handle member, each of the fastening flanges having an elongated end adjacent to the first end of the first handle member, the holding flanges are dimensioned to slide within the first and second fixing slots; when in the activated position a second tab on the second end of the first handle member that is located within the opening; and wherein the elongated ends of the clamping lips provide an interference fit with the second slots when in the activated position to prevent the device from moving back to the non-activated position.

48. The device according to claim 1, characterized in that it additionally comprises: means for visually indicating that the connector is in the unsecured position.

49. The device according to claim 48, characterized in that the means for indicating that the device is in the unsecured position comprises: a gripping flange extending axially on a portion of the first handle member, the gripping flange is in alignment with one of the clamping lips when the connector is in the unsecured position.

50. The device according to claim 49, characterized in that there are two gripping edges on the opposite sides of the first handle member.

51. A connector device for establishing fluid communication between a first container and a second container, the device is characterized in that it comprises: a first handle member having a first end and a second end, the first handle member having at the first end a means for joining the first container; a second handle member having a first end and a second end, the second handle member is associated with the first handle member and movable in an axial direction relative thereto from an unactivated position to an activated position, the second a handle member having at the second end a means for joining the second container; a first and second piercing member projecting from one of the first and second handle members to provide a fluid flowing from the first container to the second container; and means for independently hermetically sealing the first and second members of boring.

The device according to claim 51, characterized in that the means for connecting to the second container comprises: a receiving chamber.

53. The device according to claim 52, characterized in that it additionally comprises: a plurality of segmented projections extending axially and circumferentially on the second end of the second handle member adjacent to the receiving chamber, the projections are adapted to couple to the second container.

54. The device according to claim 52, characterized in that a portion of the second piercing member is located within the receiving chamber when the device is in the activated position and where the second the piercing member when in the activated position is outside the the receiving chamber

55. The device according to claim 51, characterized in that the first and second hourdar members are integral with each other.

56. The device according to claim 51, characterized in that the first and second hourdar members were made of different materials.

57. The device according to claim 56, characterized in that the first and second hourdar members were made of a material selected from the group consisting of plastic, and metal.

58. The device according to claim 1, characterized in that the second joining member comprises: a receiving chamber sized to accommodate the closure of the second container and having an annular reservoir; a plurality of segmented projections extending axially and circumferentially spaced circumferentially to the receiving chamber, wherein the projections have a proximal end and a distal end; and a plurality of circumferentially spaced reinforcing brackets on the annular reservoir, the reinforcement brackets have an inclined surface extending between the annular reservoir and the segmented projections and have a vertical reinforcement bracket surface extending from the inclined surface to along a portion of the projection.

59. The device according to claim 58, characterized in that at least one of the projections has a fixed flange.

60. The device according to claim 58, characterized in that a plurality of the projections have fixed flanges.

61. The device according to claim 59, characterized in that the fixed flange extended from the reinforcement brackets out axially to a position proximate the distal end of the projections to act as a guide adapted to assist in connecting to the second container.

62. The device according to claim 58, characterized in that a plurality of projections having fixed flanges and a plurality of projections have internally tapering tabs radially extending from a conductive section where the projections with the tabs and the projections with the flanges are arranged in alternating order on the receiving chamber.

The device according to claim 58, characterized in that it additionally comprises a diaphragm having a disc, the diaphragm located inside the chamber that receives the bottle, the disc has a peripheral bevel surface and a vertical peripheral surface.

64. The device according to claim 63, characterized in that the vertical peripheral surface confronts the vertical reinforcement square surfaces and the bevel peripheral surface confronts the inclined peripheral surfaces.

65. The device according to claim 4, characterized in that the diaphragm comprises: a disk having first and second opposed surfaces: a cavity portion extending axially from the first surface of the disk and a sleeve extending axially from the portion cavity; and an annular edge extending from the second surface of the disc, the annular rim has a distal end engaged, the distal end is dimensioned to form a fluid adjustment seal with the closure of the container.

66. The device according to claim 65, characterized in that the cavity portion comprises a base and an annular wall portion, the annular wall portion connected to the disk in the first surface.

67. The device according to claim 65, characterized in that the sheath has side walls and a portion of the side walls has an outer diameter smaller than an outer diameter of the remanent of the sheath to define a collapsed area.

68. The device according to claim 67, characterized in that the collapsed area is located in a central portion generally along the length of the sheath.

69. The device according to claim 65, characterized in that the diaphragm has a peripheral bevel surface joining a vertical peripheral surface.