Abstract:
A first container having a first material therein has a piercing tip on a dispensing member which is movable relative to the container to control flow from the container. The first container has a movable portion for facilitating introduction of air into the container. A second container having a second material therein has an inlet and an outlet. The inlet is closed and adapted to be pierced by said tip to facilitate introduction of the first material into the second container.

Description:
BACKGROUND OF THE INVENTION 
     There is a need for apparatus for mixing flowable materials in a manner which is sterile, which overcomes the common problem of &#34;air lock&#34;, while providing containers which are tamper-evident. The present invention is directed to a solution of those problems. 
     SUMMARY OF THE INVENTION 
     The present invention is directed to apparatus for mixing flowable materials in two discrete sealed containers. The first container has a first material therein and a dispensing member terminating in a piercing tip. The dispensing member is movable relative to the first container to selectively control flow from the first container. The first container has a movable portion for facilitating introduction of air into the container to replace material dispensed therefrom. A second container is provided and having a second material therein. The second container has an inlet which is closed and adapted to be opened by the piercing tip on the first container to facilitate introduction of the first material into the second container. 
     It is an object of the present invention to provide apparatus for mixing flowable materials in a manner which is sterile, overcomes the problem of airlock, and provides containers which are tamper-evident. 
     Other objects and advantages will be set forth hereinafter. 
    
    
     For the purpose of illustrating the invention, there is shown in the drawings a form which is presently preferred; it being understood, however, that this invention is not limited to the precise arrangements and instrumentalities shown. 
     FIG. 1 is an exploded view of the first and second containers each containing materials to be mixed. 
     FIG. 2 is a vertical sectional view of the upper end of the first container. 
     FIG. 3 is a sectional view taken along the line 3--3 in FIG. 2. 
     FIG. 4 is a vertical sectional view of the first container with components in a dispensing position and with the second container shown in phantom. 
     FIG. 5 is a sectional view taken along the line 5--5 in FIG. 4. 
    
    
     DETAILED DESCRIPTION 
     Referring to the drawings in detail, wherein like numerals indicate like elements, there is shown in FIG. 1 a first container 10 and a second container 12. As shown more clearly in FIG. 2, the first container 10 has a neck 14 at its outlet. Neck 14 has integral beads on its outer periphery snapped over beads on the inner periphery of a closure 16. A major portion of the neck 14 beginning at the outlet end thereof is free of beads so as to be smooth. 
     The closure 16 has an inner annulus 18 integral in one piece therewith and connected to the outer portion by a bight 19. The lower end of the annulus 18 is provided with a seal 20 integral in one piece therewith and connected thereto by a weakened or thinned peripheral portion. Annulus 18 and closure 20 form a well radially inwardly of and in frictional contact with the inner surface of the neck 14. 
     Beneath the elevation of the seal 20, and above the elevation of the threads thereon, the neck 14 has one or more radially disposed openings 22. Within the opening 22, there is provided on a shoulder thereof a sterilized air filter 24. The inner periphery of the outer portion of closure 16 in the area of the threads thereon is provided with an axially extending groove 26 for each opening 22. As shown in FIG. 3, there is illustrated two grooves 26 diametrically opposite one another with the number of grooves corresponding to the number of openings 22. The outer peripheral surface of closure 16 is preferably roughened so as to provide for a good gripping surface. At the appropriate time as will be explained hereinafter, closure 16 is rotated relative to the container 10 so that each groove 26 may be aligned with an associated opening 22. Rotation of closure 16 does not result in axial movement thereof. Each groove 26 is open at its lower end so that environmental air may flow upwardly therethrough and into the container 10. 
     The container 10 is provided with a dispensing member designated generally as 28. Member 28 has an axially extending flow passage 32 and a cylindrical barrel 34 at its lower end. At its upper end, the member 28 is provided with a piercing tip 30. Between tip 30 and barrel 34, the member 28 is provided with a shoulder 36. The shoulder 36 is spaced from the bight 19 as shown in FIG. 2. At its lower end, as shown more clearly in FIG. 4, the barrel 34 has a piercing wedge 38 integral in one piece therewith. Wedge 38 is provided on a small segment of the lower periphery of the barrel 34 and is aligned with a peripheral portion of the seal 20. 
     The dispensing member 28 is provided with a tamper-evident shield 40. Shield 40 is telescoped over the dispenser member 28 and the closure 16. At its lower end, the shield 40 has a bead 42 which is snapped under a radially outwardly extending flange 44 on the neck 14. Outwardly from the bead 42, the shield 40 has a pull tab 46. In the area of the pull tab 46, the shield 40 is provided with one or more weakened zones 48. See FIG. 3. The weakened zones 48 readily tear or break when pull tab 46 is manipulated to facilitate removal of the shield 40. Whenever shield 40 is removed from the container 10, and then replaced, there is visible evidence of tampering with the contents of container 10. Shield 40 has a shoulder 50 which engages bight 19 so that pressure on shield 40 cannot move member 28 in an axial direction. 
     Referring to FIGS. 1 and 4, the second container 12 has an inlet tube 54 open at its free end and closed at its other end which is integral in one piece with the container 12. At the location where inlet tube 54 joins the container 12, the flow passage through tube 54 is closed by a disc 56. Disc 56 has at least a major portion of its periphery weakened or thinned where it joins the container 12. Container 12 is preferably also provided with an outlet 58 which may be separate and discrete from the inlet tube 54. 
     There are a wide variety of circumstances wherein it is desirable to mix the materials of containers 10 and 12 just prior to usage. One such circumstance is when the materials have a substantially longer shelf life so long as they are not mixed. By way of example, the material within container 12 may be water and the material within container 10 may be a salt solution and when mixed, provides a saline solution, emulsion, mixture, etc. Alternatively, the solution may be an intravenous nutrition solution containing nutrients such as glucose, amino acids, vitamins containing one or more of potassium, calcium, magnesium, and phosphates; and or medication. 
     The method of using the containers 10 and 12 is as follows. At the time when it is desired to mix the material in container 10 with the material in container 12, an upward pulling force is exerted on the pull tab 46 whereby the shield 40 tears or breaks along the zone 48. Thereafter, shield 40 is readily removable. Dispensing member 28 is inserted through the tube 54 until the piercing tip 30 pierces the disc 56. A small portion of disc 56 remains integral with the container 12 whereby the disc cannot mix with the materials within container 12. See FIG. 4. 
     Thereafter, the dispensing member 28 is moved in an axial direction until the wedge 38 pierces the seal 20 as shown in FIG. 4 and shoulder 36 engages bight 19. The material in container 10 is introduced into container 12 in any convenient manner such as by elevating container 10 so that the material flows due to gravity, or by squeezing the container 10 which is sufficiently flexible so as to cause the material therein to enter container 12. Thereafter, the closure 16 is rotated from the position shown in FIG. 3 to the position shown in FIG. 5. Environmental air enters the container 10 via groove 26 and opening 22 to replace the material which has been dispensed. Any such air entering the container 10 is cleansed of dust or other particles by the filter 24. The air entering container 10 expands the same to its original condition and enters the second container 12. Thereafter, the solution, emulsion, or mixture of the first and second materials may be discharged through outlet 58 or discharged through tube 54 after removal of member 28 from tube 54. If desired, container 12 may be subjected to a shaking step to provide intimate mixing before dispensing from container 12. 
     If desired, the inner periphery of the lower cylindrical portion of the shield 40 may have axially extending V-shaped beads whose apex is in frictional contact with the annulus 18 on the closure 16. To facilitate alignment of groove 26 with the hole 22, an indicator mark is preferably provided on the outer peripheral surface of flange 44 and a similar indicating mark is provided on the outer periphery of closure 16 adjacent the location of groove 26. Groove 26 will be aligned with opening 22 when the indicator marks are aligned with each other. In most situations, container 10 will be substantially smaller than container 12 as illustrated in the drawings. However, it is within the scope of the present invention to utilize containers of different sizes than that illustrated. In order that the lower end of groove 26 may communicate with the atmosphere, the bead 42 is interrupted at the location of the groove 26. 
     In view of the above description, it will be noted that the first and second materials are capable of being mixed in a sterile manner with the first container having means for indicating tampering and means for preventing an airlock. 
     The present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof and, accordingly, reference should be made to the appended claims, rather than to the foregoing specification, as indicating the scope of the invention.