A dispenser for powdered medicaments

BACKGROUND OF THE INVENTION

Medicaments are frequently added to bottles of parenteral solution for intravenous administration to a patient. Nu- 25 merous additives are available in powdered form and must be reconstituted by mixing the parenteral solution and the powdered medicament. The powdered medicament may be added directly to the parenteral solution or may be reconstituted and then added back into the parenteral solution bottle for administration to the patient.

Currently two parenteral solution systems are offered: an “open” system and a “closed” system. In either system it is desirable and preferable to invert the medicament package and bring it into sealed engagement with an aperture in the parenteral solution bottle so as to transfer into the additive bottle a quantity of solution for reconstitution of the additive powder. It is undesirable to spill or lose powdered medicament during the act of bringing the medicament package and the parenteral solution bottle into sealed engagement. A problem in the art has been that devices used to prevent inadvertent discharge of the powder have required special provision to assure an adequate flow of solution from the parenteral solution bottle into the medicament package to dissolve the powder. Likewise, a flow path of adequate size is required to transfer the liquid containing the dissolved medicament out of the medicament package back into the parenteral solution bottle.

It is an object of the present invention to provide improved apparatus for the addition of medicaments to both open and closed system parenteral solution bottles.

It is another object of this invention to provide a universal dispensing package for powdered medicaments to be added to intravenous parenteral solution bottles which utilizes a labyrinth to prevent spillage of the medicament.

Other and further objects of the present invention will be apparent to those skilled in the art from reading the following descriptions taken in conjunction with the drawings, in which:

FIG. 1 is a sectional view of a dispensing package embodying the features of the present invention;

FIG. 2 is a partial sectional view showing the embodiment of FIG. 1 in use in conjunction with a closed system intravenous container;

FIG. 3 is a partial sectional view of the package of FIG. 1 particularly showing the details of construction of the powder plug of the present invention; and

FIG. 4 is a sectional view taken generally along lines 4—4 of FIG. 3 showing details of construction of the powder plug of the present invention.

The objects of the present invention may be achieved with a medicament dispensing package which is made up of a reservoir adapted to contain a medicament, a conduit adapted to connect to the reservoir and to convey the medicament from the reservoir to a parenteral solution container, and a powder plug defining a labyrinth which is disposed between the reservoir and the conduit.

A preferred embodiment of the present invention is shown in FIG. 1. A universal dispensing package 10 is made up of a container 12, a conduit 14, and an outer cover 16, and contains a medicament 18. A powder plug 100 characterizes the 5 invention and is connected at the proximal end of the conduit 14 and is interposed between the medicament 18 and the conduit 14.

The container 12 has a shank 20. The outer surface 22 of the shank 20 tapers from a proximal periphery 24 to a distal 10 periphery 26 and generally defines a truncated cone, as shown. The outer surface 22 may have a mechanical thread 28 defined on it to adapt it better to cooperate with the outer cover 16. The container 12 has a large reservoir 30 defined within it.

The conduit 14 is made up of an annular mounting support 32 and a piercing device 34 tapering from the mounting support to the distal, or discharge end 36. The annular mounting support 32 and the piercing device 34 are hollow and together define an internal passage 38. The annular mounting support 32 further comprises a planar portion 40 having a distal surface 42 and a proximal surface 44 which is substantially planar. An annular groove 45 cooperates with the powder plug 100 as further described below to connect the powder plug 100 and the conduit 14 disengageably together. An annular wall 46 is connected to the periphery of the planar portion 40 and tapers toward the axis 41. The wall 46 has an inner surface 48, an outer surface 50 and a second outer surface 52 which tapers toward the inner surface 48. The effect of the

3q tapering of walls 50 and 52 is to provide for fast machine assembly of the conduit 14 to the container 12. Also defined on the outer surface 50 is an annular groove 54 which cooperates with an annular ridge 56 on the shank 20 which serves to hold the conduit 14 to the container 12.

As is shown in FIG. 1, the outer cover 16 surrounds the entire conduit 14 and shank 20. The outer cover 16 is made up of a proximal portion 58, a shoulder portion 60, a conical portion 62 and a plug portion 64. The it portion 58 has internal female threads 66 defined on its which engage the male 40 threads 28 of the container 12 and serve to hold the cover to the container. The plug 64 extends down into the spike 34 filling the distal portion of the passage 38 and preventing discharge of the contents 18 of the container.

In the preferred embodiment, best shown in FIG. 3, the 45 powder plug 100 is composed of a barrier portion 102 and a plurality of arcuate septa connected to the barrier portion 102. The barrier portion 102 is preferably conical having its apex on the side 104 facing the reservoir 30. The pitch of the cone is such as to exceed the angle of repose of the powdered 50 medicament 18. Thus, in the inverted position, the powdered medicament will not build up on the cone but will fall towards the conduit. The arcuate septa define a passageway 106 connecting the interior of the reservoir with an internal passage 108 leading to the internal passage 38.

In a preferred embodiment, the passageway 106 is defined by the septa 110,112,114,116,118 and 120. As may be seen in FIG. 4, septa 110 and 112 are arcuate and concentric about the axis and are mirror images of each other. Septum 100 is made up of surfaces 122 and 124 which are vertical during 60 discharge, have end portions 126 and 128, and a distal surface 130 which contacts the proximal surface 44 of the conduit support 32. Similarly, septum 112 has surfaces 132 and 134, end portions 136,138 and a distal surface 140.

Septa 114 and 116 are concentric about the axis 41 and are 65 also mirror images of each other. Septum 114 has surfaces 142 and 144, end portions 146 and 148, and a distal surface 150. Similarly, septum 116 has surfaces 152 and 154, end portions 156 and 158, and distal surface 160.

The innermost septa 118 and 120 are mirror images of each 70 other, are arcuate, concentric about the axis 41, define interior passage 108 and extend into conduit 14. Septum 118 has an inner surface 162, an outer surface 164, a distal surface 166 and end surfaces 168 and 170. Similarly, septum 120 is made up of an inner surface 172, an outer surface 174, a distal sur75 face 176 and end surfaces 178 and 180. An arcuate ridge 182

3,662 is defined on the outer surface 164 and an arcuate ridge 184 is defined on outer surface 174. As shown in FIG. 3, ridges 182 and 184 cooperate with the groove 45 in the conduit 14 to connect the powder plug 100 and the conduit 14 together and to hold the distal surfaces of the septa in contact with the proximal surface 44 of the conduit support 32. Thus, the distal surfaces 130, 140, 150,160, 166 and 176 contact the surface 44 when the powder plug is in place in order to define the passageway 106.

The medicament may take a number of paths through the powder plug when passing from the reservoir into the conduit as will be apparent from inspection of the drawings. A typical path is shown by the arrow 186 in FIG. 4. The passageway or channel is defined between septa 110,114, between septa 114 and 116, between septa 114 and 120 and between septa 118 and 120 into passage 108 leading to passage 38.

A typical entry path for fluid is shown by arrow 188.

The powder plug 100 which characterizes the invention is substantially comprised of a solid material, such as polyethylene, polypropylene, or the like. As described above, the powder plug 100 is substantially coextensive with the interior surface of that portion of the reservoir which is immediately adjacent to the conduit, has a connector portion attached to it and is adapted to cooperate with the interior surface of the conduit to hold the plug in a predetermined fixed position with relation to the conduit and the reservoir.

The preferred embodiment as shown in the figures utilizes a connector portion which is substantially concentric with a circular solid portion. It is to be understood that the plug portion may be other than circular in shape, if desired, or if dictated ³⁰by the internal surface of the container. It is to be further understood that the connector portion may be eccentrically placed on the plug where preferred or where dictated by the arrangement of the conduit with regard to the reservoir.

The plug may be formed from one solid piece by diecasting ³⁵or by machining from a solid stock.

The container 12 is preferably made of polyethylene, but may be made of a similar elastically recoverable material, if desired. The conduit 14 is preferably made of a rigid ₄₀polyethylene but may be made of any other suitable plastic or metal. The piercing device 34 is typically made of the same material as the remainder of the conduit 14, but if desired may be made of a different material such as metal or alloy. The outer cover 16 is typically made of a water impermeable 45 plastic, such as heavy gauge polyethylene, but may be made of rubber or other suitable water impermeable material, such as drawn aluminum.

The minimum height h of the passageway 106 is shown in FIG. 3. To prevent the powdered medicament 18 from falling out of the package 10 when inverted, the ratio of the height h to the length of the passageway may be less than the tangent of the angle of repose of the powdered medicament. Preferably the minimum length of the passageway 106 is at least five times the minimum height h of the passageway 106.

In use, the outer cover 16 is removed. This may be accomplished by pulling on a pull-tab, not shown, where provided, which propagates a tear along the base of the proximal portion 58 in well known fashion. When used with a closed system intravenous container 70, as is shown in FIG. 2, the piercing device 34 is inserted through a sealing member 72 and a rubber stopper 74 of the closed system intravenous container 70. The passage 38 provides communication between the in,930 terior 69 of the container 70 and the contents 18 of the dispensing package 10. Where the medicament 18 is dry, the walls of the container 12 may be compressed and the tip or discharge end 36 submerged in the intravenous solution 76 by inverting the assembled system. The powder plug 100 prevents the discharge of the powder during this operation. A suitable portion of the intravenous solution 76 may be drawn into the container 12 in order to dissolve the dry medicament. The reconstituted medicament solution may be discharged 10 from the package 10 by compressing the sides of the container

12. The reconstituted medicament passes through the passages 106 and 108 into the parenteral solution container 70. The steps may be repeated to flush the container, if desired.

Similarly, the package of FIG. 1 may be used with an open system parenteral solution container, not shown, by inserting the shank 22 of the container into the mouth of the parenteral solution container.

The terms and expressions which have been employed are 20 used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed