U.S. patent number 3,662,930 [Application Number 05/051,088] was granted by the patent office on 1972-05-16 for a dispenser for powdered medicaments.
This patent grant is currently assigned to American Home Products Corporation. Invention is credited to Eugene J. Meierhoefer.
United States Patent |
3,662,930 |
Meierhoefer |
May 16, 1972 |
A DISPENSER FOR POWDERED MEDICAMENTS
Abstract
The disclosure is directed to an improvement in a dispensing
package for adding a supplemental medicine to a parenteral solution
container which is characterized by a plug disposed between the
medicament reservoir and the discharge conduit. The plug has a
labyrinth through which solid medicament must pass on discharge.
The function of the labyrinth is to prevent the additive powder
from being spilled or misdistributed out of the package as the
package is being brought into functional engagement with an
intravenous solution bottle.
Inventors: |
Meierhoefer; Eugene J. (West
Chester, PA) |
Assignee: |
American Home Products
Corporation (New York, NY)
|
Family
ID: |
21969263 |
Appl.
No.: |
05/051,088 |
Filed: |
June 30, 1970 |
Current U.S.
Class: |
222/564;
604/414 |
Current CPC
Class: |
A61J
1/2089 (20130101); A61J 1/201 (20150501) |
Current International
Class: |
A61J
1/00 (20060101); B67d 003/00 () |
Field of
Search: |
;222/563,564,569,80
;128/272 ;138/42 ;141/330 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Coleman; Samuel F.
Assistant Examiner: Stack, Jr.; Norman L.
Claims
I claim:
1. A dispensing package for powdered medicaments to be added to a
parenteral solution prior to parenteral administration
comprising:
A. a reservoir adapted to contain a medicament;
B. a conduit connected to said reservoir, and adapted to convey
said medicament from said reservoir to a parenteral solution
container;
C. a fluid guide structure disposed in said conduit, said fluid
guide structure having
1. A conical surface with its apex directed toward said medicament,
the slope of said conical surface being greater than the angle of
repose of said medicament; and
2. First and second septa connected to said fluid guide structure
and engaging interior surfaces of said conduit.
2. A dispensing package as defined in claim 1 wherein each of said
first and second septa have a ridge defined on their outer surfaces
and said conduit has a groove defined on its inner surfaces adapted
to be engaged by said ridges on said first and second septa.
3. A dispensing package as defined in claim 1 wherein said fluid
guide structure further comprises a plurality of septa and said
conduit further comprises a substantially planar surface adapted to
be sealably engaged by said plurality of septa and said planar
surface together with said plurality of septa define an elongated
passageway.
4. A dispensing package as defined in claim 3 wherein the length of
said passageway is at least five times the height of said
passageway.
5. A dispensing package as defined in claim 3 wherein said septa
are of substantially semicircular configuration centered about a
common axis.
6. A dispensing package as defined in claim 3 wherein the ratio of
the height of said passageway to the length of said passageway is
less than the tangent of the angle of repose of said powdered
medicament.
Description
This invention is directed to an improvement in dispensing packages
for parenteral medicaments which are to be added to an intravenous
solution bottle prior to administration to a patient. The
improvement is characterized by the interposition of a labyrinth
between a powdered medicament contained in a reservoir portion of
the medicament package and a conduit used to introduce the
medicament into a parenteral solution bottle. Typically the conduit
is a hollow "spike." The labyrinth is a series of intricate
passageways defined in a "powder plug." The powder plug and its
inherent labyrinth prevent the powdered medicament from being
spilled or misdistributed out of the conduit as the package is
being brought into functional engagement with the parenteral
solution bottle.
The package is an improvement on the package described in United
States patent application Ser. No. 742,872, filed July 5, 1968, by
Howard J. Levin. The improvement comprises, in part, the
substitution in the Levin package of a powder plug for the membrane
filter described by Levin.
BACKGROUND OF THE INVENTION
Medicaments are frequently added to bottles of parenteral solution
for intravenous administration to a patient. Numerous 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 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 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 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 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 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 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 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 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 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 surface 176 and end surfaces
178 and 180. An arcuate ridge 182 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 by 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 or 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 polyethylene 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 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 interior 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 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 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.
* * * * *