Ampule shield

An ampule shield has a center tube with an upper end, and an outer tube extending coaxially with the center tube and attached to the center tube below the upper end of the center tube. The outer tube extends some distance beyond a lower end of the center tube. The outer tube is spaced from the center tube to provide a cylindrical space within the shield for receiving an ampule. A removable cap for attachment to a bottom of the outer tube is provided.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
The present invention relates generally to the field of medical devices, 
and in particular to an ampule shield. 
2. Background Information 
Homan U.S. Pat. No. 4,645,073 discloses a package for enabling a user to 
mix a diluent with a hazardous material and then fill a syringe with the 
resultant solution without endangering the immediate environment which 
comprises an elastomerically stoppered glass vial containing the material 
and a sealed transparent plastic bag enclosing the vial and having a 
septum means therein to sealingly receive the needle of a diluent 
containing syringe therethrough as the needle moves through the stopper of 
the vial to provide a seal when the needle is withdrawn. 
Fournier et al. U.S. Pat. No. 4,982,769 also discloses a package for 
enabling a user to mix a diluent with a hazardous material and then fill a 
syringe with the solution without endangering the immediate environment, 
but this package requires that the package container after opening 
interengage with the packaged device (having means for cooperating with a 
medicament vial for use therewith) to provide a sealed interior space in 
which means for cooperating with a vial is operable to cooperate with a 
vial contained in the space. 
Kolber et al. U.S. Pat. No. 5,171,214 discloses a system for separately 
storing and subsequently mixing the contents of at least two containers in 
one of the containers which comprises two containers, a syringe assembly 
attached to the second container and extending between the two containers, 
and an adapter connecting the first container or vial to the syringe 
assembly wherein a skirt member circumscribes the outside of the vial and 
has rachet means that cooperates with complementary rachet means on the 
adapter to prevent disengagement of the vial from the adapter. 
SUMMARY OF THE INVENTION 
The present invention was therefore developed to provide an efficient 
ampule shield. The present invention provides the following novel features 
and advantages. 
It should be remembered that the present invention was developed to help 
facilitate the reconstitution of a freeze dried medicinal preparation 
packaged within a glass ampule. The device, therefore, provides a "closed" 
system which minimizes or eliminates any exposure of the contained product 
to the clinician during mixing and draw-up into a syringe. However, the 
invention as defined in the claims may be readily adaptable to other 
applications, as would be apparent to one skilled in the art. 
According to an embodiment of the invention, the ampule shield comprises a 
center tube having an upper end portion, an outer tube extending coaxially 
with and attached to the center tube some distance from the upper end 
portion of the center tube, and extending some distance beyond a lower end 
of the center tube, the outer tube being spaced from the center tube to 
provide a cylindrical space within the shield for receiving an ampule, and 
a removable cap for attachment to a bottom of the outer tube. 
According to another embodiment, an interior wall of the outer tube is 
inwardly tapered at an upper end to fit an ampule when disposed in the 
shield. In another embodiment of the ampule shield, the cap includes a 
raised central portion for resting against an ampule bottom when disposed 
in the shield. In one embodiment, the raised portion is in the shape of a 
cross. 
In another advantageous embodiment, a standard male luer fitting is 
provided at the upper end portion thereof. 
In another embodiment, the outer tube is provided with an outwardly 
extending lip and the cap is provided with a corresponding recess for 
engaging the lip when the cap is assembled to the outer tube. 
According to another embodiment, the ampule shield is used with an opened 
ampule containing a freeze-dried substance, the center tube extending into 
the ampule and into the freeze-dried substance, the outer tube 
encompassing an outer surface of the ampule, and the cap closing the 
ampule within the shield. A syringe containing a diluent attaches to the 
standard male lure fitting. An embodiment of a method of reconstituting a 
freeze-dried substance in an opened ampule comprises utilizing this 
embodiment of the ampule shield. 
In another embodiment, an ampule shield for use with an opened ampule 
includes first tube means having an end for extending into an inside of an 
opened ampule, second tube means, concentric with and attached to the 
first tube means, for surrounding outside walls of an opened ampule, and 
cap means, attachable to the second tube means, for enclosing an opened 
ampule within the ampule shield. 
According to another embodiment, the first tube means further includes 
engagement means, disposed at an end thereof opposite the end which 
extends into an opened ampule, for engaging an external device which can 
provide a diluent through the first tube means into an opened ampule.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
The invention will now be described in more detail by example with 
reference to the embodiments shown in the Figures. It should be kept in 
mind that the following described embodiments are only presented by way of 
example and should not be construed as limiting the inventive concept to 
any particular physical configuration. 
With reference to the longitudinal cross-sectional view of FIG. 1, the 
ampule shield 100 comprises a center or inner tube 102 having a standard 
male luer fitting 104 at an upper end portion, a coaxial outer tube 106 
attached to the center tube 102 near the upper end and extending a short 
distance beyond a lower end thereof. 
The outer tube 106 is set off from the center tube 102 to provide a 
cylindrical space 108 within the shield 100. The interior wall 110 of the 
outer tube 106 has an inward taper 114 at the upper end. A removable cap 
112 fits onto the bottom of the outer tube 106. In use, an ampule is 
secured in the shield 100 with the cap 112. The inward taper 114 on the 
outer tube 106 is intended to conform with an open end of an ampule in a 
friction fit. However, since not all ampules break cleanly, the taper 114 
alone cannot be relied on to achieve a good seal. 
An outward taper 116 at the upper end of the inner tube 102 may also be 
provided to better fit an ampule. In this embodiment, the inner tube 102 
outward taper 116 frictionally engages with the inside of an ampule 
opening, while the outer tube 106 inward taper 114 simultaneously 
frictionally engages with the outside of the ampule opening. 
As can be seen in the enlarged portion of FIG. 1a, the outer tube 106 is 
provided with a circumferential, outwardly extending lip 119 which engages 
a corresponding recess 118 in cap 112 to provide a secure seal 
therebetween. The illustrated cap 112 also has an upwardly projecting 
portion 120 on which the bottom of an ampule would rest when the cap 112 
is assembled to the tube 106. 
FIG. 1b shows an end view from the top of the shield 100. Male luer fitting 
104 and circumferential lip 119 can be readily seen in this figure. 
The ampule shield 100 could be used for any freeze-dried product dispensed 
in ampules, thus facilitating reconstitution of freeze-dried medicinal 
preparations normally packaged in glass ampules. In such a use, the tube 
portions 106 and 102 of the shield 100 would be slipped onto an open 
ampule containing a freeze-dried material (not shown) so that the lower 
end of the center tube 102 extends inside the ampule and penetrates the 
freeze-dried material and the interior inward taper 114 of outer tube 106 
seals off the opening around the upper portion of the ampule. The cap 112 
is then affixed to the bottom of the outer tune 106 of shield 100 
effectively sealing the system. 
The center tube 102 is designed to have a length which extends into the 
material in the bottom of the ampule but stops just short of bottoming out 
on the ampule. Sufficient space will thus exist to permit the flow of 
diluent from a syringe through the tube 102 to reconstitute a freeze-dried 
substance in the ampule and withdraw the reconstituted substance back up 
tube 102 into the syringe. 
The diluent or a solvent would then be dispensed into the ampule through 
tube 102 by means of, for example, a syringe (not shown) attached to the 
LUER fitting 104 of the ampule shield 100 center tube 102 to reconstitute 
the freeze-dried material in the ampule. The reconstituted or mixed 
product would then be withdrawn completely into the syringe. Any leakage 
around the open end of the ampule which might occur is trapped inside the 
shield 100. 
A standard female LUER cap (not shown) can thereafter be placed on the 
fitting 104 of tube 102 so that the complete unit, i.e., the shield 100 
with ampule therein, can be sealed and discarded. This helps to prevent 
accidental exposure to any unused product remaining in the ampule. 
In a preferred embodiment, the ampule shield 100 is injection molded of a 
clear, medicinal grade of thermoplastic. Its parts are preferably composed 
of a clear, good clarity thermoplastic such as medical grade 
polypropylene, polystyrene or "K-Resin" (butadiene-styrene copolymer). 
The illustrated shield 100 was designed for a specific application, i.e., 
for use with Tice.RTM.-BCG product which is contained in a 2 mL. ampule. 
However, the invention is not limited to such use and could be produced to 
accommodate other ampule sizes, e.g., 1 mL., 5 mL., 10 mL., etc., and 
designs. 
In this regard it is noted that there are several glass manufacturers 
supplying the market with ampules, such as Wheaton Glass, O-I Kimble, 
Comar Glass and others. Each company offers various "standard" sizes but 
from company to company the standards frequently differ in diameter or 
height dimensions. There is thus no apparent "industry" standard for 
ampules. Thus, the particular dimensions of an embodiment of the present 
invention would depend on the ampuie it is to be used with. 
There is no pressure relief system featured in the illustrated design, 
however, such a modification would be well within the ability of one 
skilled in the art, and would be considered within the scope of the 
claims. A venting system is not necessary in applications where only a 
small amount of diluent, e.g., 1 to 2 mL., is required. Such a low volume 
of fluid does not introduce any significant pressure into the ampule 
shield 100, even when closed by cap 112. The seal between the cap 112 and 
the outer tube 106 and the seal between the ampule opening and the tapered 
upper portion is sufficient to prevent the ampule from being ejected from 
the shield under these conditions. 
FIG. 2 shows a side view of the shield 100, which may be manufactured with 
a single mold, with breakable nib 201 connecting outer tube 106 and cap 
112. Cap 112 can be seen to have a flat base portion and an extending 
portion 202 which fits around the outside of outer tube 106 when assembled 
thereto. As can be seen in FIG. 2a, a bottom end view of the shield 100, 
the raised portion 120 of the base 112, on which the bottom of an ampule 
will rest in use, is made in the form of a cross. 
It is understood that various other modifications will be apparent to and 
can be readily made by those skilled in the art without departing from the 
scope and spirit of the present invention. Accordingly, it is not intended 
that the scope of the claims appended hereto be limited to the description 
set forth above but rather that the claims be construed as encompassing 
all of the features of patentable novelty which reside in the present 
invention, including all features which would be treated as equivalents 
thereof by those skilled in the art to which the invention pertains. 
For example, pressure relief means could be provided for applications where 
a large amount of diluent will be added to an ampule within the shield. 
Such pressure relief means could take any number of forms, as would be 
readily apparent to one skilled in the art. 
The interior contours of the shield may be varied in design to fit a 
particular type of ampule. The illustrated embodiment is of a generally 
circular-type cross-section, however, other cross-sections could be used 
within the scope of the invention to accommodate corresponding ampules so 
configured. 
The preferred embodiment is formed of medical grade polypropylene, 
polystyrene or "K-Resin" (butadiene-styrene copolymer), however, other 
suitable materials well known to those skilled in the technology may be 
substituted therefore.