Reagent package

The reagent package includes a container housing section and a container lid that are sealed together to define one or more inside chambers. An opening in the container lid provides access to a corresponding chamber. The chamber opening is controlled by a valve that is pivotable from an open position to a closed position and vice versa. When the valve is in an open position the container chamber can be accessed through the valve with an aspiration probe and a dispensation probe. The reagent package accommodates a filter screen member and a glass ampoule in the container chamber. The glass ampoule contains one reagent ingredient, usually in a dry powder form and the space within the chamber outside the glass ampoule usually contains a reconstituting liquid ingredient. When the reagent package is ready for use a pressure force is imposed on the outside wall of the chamber adjacent the glass ampoule to crush the ampoule and permit the liquid ingredient within the chamber to mix with the powder ingredient released from the glass ampoule. The reagent package can be formed as a dual package with separate non communicable chambers that each contain different reagents. A locking clip member is secured to the reagent package to enhance the seal provided by the valves when the valves are in a valve closed position.

BACKGROUND OF THE INVENTION 
This invention is directed to reagent packaging devices for storing one or 
more ingredients or reagents separate from one another in a single reagent 
package for subsequent mixing in the reagent package, and more 
particularly to a novel reagent package having a valve controlled opening 
with a deflectable valve member at the package opening. 
Automated sample analysis systems as disclosed in U.S. Pat. Nos. 5,268,167 
and 5,399,497 can perform a variety of different tests on a test subject, 
such as a serum sample, in a relatively short period of time. Generally 
the serum sample is separated into a predetermined number of segregated 
portions and a different test is usually performed on each segregated 
portion of the serum sample. It is thus common practice to divide the 
serum sample into a series of separate isolated sample segments that 
correspond to each separate test. The isolated sample segments are enabled 
to co-act with specific reagents to produce an analyzable reaction that 
forms the basis for a test result. 
Different reagents will produce different test results on respective sample 
segments and the compendium of the separate test results provide a body of 
information or data relating to the characteristics of the serum sample. 
As used herein, the term reagent is intended to refer to a single reagent, 
a mixture of two or more reagents and/or a mixture of reagent with a 
reconstituting liquid. 
Reagents for sample analysis systems are preferably used in liquid form to 
permit allotment of a precise predetermined amount of reagent to each 
sample segment and to help ensure that the reaction between the reagent 
and the serum sample is uniform. Generally, the reagent is diluted to a 
desired concentration before it is permitted to co-act with a serum 
sample. 
It is well known that some reagents used in sample analysis systems have a 
limited shelf life especially if produced as a solution of one or more 
reagent components. Therefore, optimum test results between a reagent and 
a serum sample are usually obtained if the reagent is dissolved or diluted 
shortly before being used for test purposes. 
Since the shelf life of a reagent in dry form is usually longer than the 
shelf life of the reagent in a liquid condition it is common practice to 
maintain a reagent in dry condition in a reagent mixing package. In some 
instances, the mixing package is arranged to hold in segregated condition 
a dry reagent component and a liquid reconstituting component. When use of 
the reagent is desired, the components are intermixed within the package. 
One known reagent package such as shown in U.S. Pat. No. 4,515,753 includes 
a reagent in lyophilized powder form in a first breakable capsule and a 
reconstituting liquid for the reagent in a second breakable capsule. The 
capsules are broken by compressing the package to release the contents of 
each capsule for mixing within the package. An outlet port in the package 
permits outside access to the mixed ingredients. Although this reagent 
package provides a freshly mixed reagent for immediate use in a sample 
analysis system, it is difficult to seal the package once the ingredients 
have been mixed. This package also does not permit long term preservation 
of liquid that is openly contained in the package and therefore the 
reconstituting liquid must be maintained in a capsule. 
It is thus desirable to provide a reagent package for one or more reagent 
components wherein the package has a valve controlled opening and wherein 
a reconstituting liquid can be openly stored and preserved in the package 
under a leak-tight seal that is valve controlled and wherein the package 
can optionally accommodate breakable capsules and a filter screen. 
OBJECTS AND SUMMARY OF THE INVENTION 
Among the several objects of the invention may be noted the provision of a 
novel reagent package having a valve controlled opening, a novel reagent 
package having a valve controlled opening wherein the valve can be locked 
in a closed position with a locking clip to provide a substantially 
leak-tight seal, a novel reagent package having a valve controlled opening 
wherein the valve in a movable condition, without the locking clip 
provides an evaporation barrier for liquid contained in the package when 
the valve is in a closed position, a novel reagent package having a valve 
controlled opening wherein the valve can be rendered movable with respect 
to the container opening to optionally select open and closed positions of 
the reagent package, a novel reagent package that can accommodate a 
breakable ampoule with one reagent and an openly stored reconstituting 
liquid, a novel reagent package having a valve controlled opening wherein 
the valve can be locked in a closed position to provide a substantially 
leak tight seal that permits long term storage of a liquid reagent, a 
novel reagent package with a breakable ampoule and a filter screen that is 
structured to resist damage from broken glass, a novel reagent package 
which can be deformed to break a frangible ampoule inside the package 
without damaging the package and without damaging a valve provided on the 
package, a novel reagent package having two separate non-communicable 
chambers to constitute a dual reagent package, a novel reagent package 
that provides valve controlled access to substantially all liquid reagent 
in the package, a novel reagent package that accommodates a breakable 
ampoule and permits aspiration of reagent from the broken ampoule without 
the glass particles, and a novel method of providing controlled access to 
a reagent in a package. Other objects and features of the invention will 
be in part apparent and in part pointed out hereinafter. 
In accordance with the present invention, the reagent package includes a 
container having an inside chamber and a restrictable opening to the 
chamber. A valve is positioned on the container to control the opening. 
The valve has a valve closed position to close off and seal the opening 
and a valve open position to permit access to the container chamber 
through the container opening. Preferably the valve is a rocker valve 
which is pivotable about a pivot axis that is spaced above the container 
opening. 
In a preferred embodiment of the invention the reagent package is a dual 
package and includes two separate chambers that are non communicable with 
each other. Each chamber has a separate opening controlled by a separate 
rocker valve. The rocker valves are identical and have pivots that are 
cantilevered at the end of pivot support arms to permit deflection between 
the valve face and the valve pivots. 
When the reagent package is in a valve closed position reagent materials 
inside the container cannot be accessed. Also when the reagent package is 
in a valve closed position a locking clip can be placed on the package to 
further secure the valves against the container opening thereby enhancing 
the valve seal. The locking clip enables the ingredients of the reagent 
package to be stored without degradation for approximately two years under 
refrigeration. 
In one embodiment of the invention the reagent package includes a filter 
screen member in each chamber and a breakable glass ampoule in each 
chamber. The glass ampoule contains one reagent ingredient and is 
preferably in a dry lyophilized condition. The internal chamber space 
outside the glass ampoule can accommodate a reconstituting liquid. When it 
is desired to use the ingredients of the reagent package, a compression 
force is applied to the outside wall of the reagent package proximate the 
glass ampoule to crush the ampoule. The contents of the ampoule are thus 
released and can mix inside the package chamber with the reconstituting 
liquid. If desired, the ampoule can contain a liquid ingredient. 
The reagent package also includes a well portion that defines the lowest 
point in the package. The well portion receives the filter screen member 
and also receives the bottom of the filter screen member through which the 
mixed ingredients of the package are aspirated. The screen member filters 
out any broken glass during aspiration. As the chamber ingredients are 
depleted during aspiration of reagent the unused reagent tends to flow 
into the bottom of the screen member in the well where it can be easily 
aspirated thus minimizing or eliminating any waste of reagent material. 
The invention also includes a method of providing controlled access to a 
reagent. A closed container is provided with a valve controlled opening to 
maintain the container in a sealed condition when the valve is in a closed 
position and to provide access to the container when the valve is in an 
open position. The method further includes arranging the valve as a rocker 
valve at the opening of the container such that the valve is pivotable 
about an axis that is spaced from the container opening. The rocker valve 
can thus be pivoted from the valve open position to the valve closed 
position and vice versa. The rocker valve is provided with a valve face 
having opposite ends. Pivot means for the rocker valve connect to only one 
end of the valve face in cantilever arrangement. The cantilever 
arrangement permits the valve face to be deflectable from the pivot axis 
and permits pressure sealing of the valve face against the opening in the 
container. 
The invention accordingly comprises the constructions and method 
hereinafter described, the scope of the invention being indicated in the 
claims.

Corresponding reference numbers indicate corresponding parts throughout the 
several views of the drawings. 
DETAILED DESCRIPTION OF THE INVENTION 
A reagent package incorporating one embodiment of the invention is 
generally indicated by the reference number 10 in FIGS. 1 and 2A. 
The reagent package 10 includes a container housing section 12 that 
accommodates two glass ampoules 14, 14, two filter screens 16, 16, and a 
container lid 18 that supports two identical rocker valves 20 and 22. A 
locking clip member 24 maintains the rocker valves 20 and 22 of the 
reagent package 10 in a locked and leak-proof condition during shipping 
and storage. 
It should be noted that the reagent package 10 is a dual package with two 
packaging sections 26 and 28 (FIGS. 2A and 5) arranged side-by-side. 
Although the packaging sections 26 and 28 are formed as an integral unit 
of the reagent package 10 the contents of either packaging section 26 and 
28 cannot communicate with the contents of the other packaging section. 
Each packaging section 26 and 28 is similar in structure and function. If 
desired any of the packaging sections 26 and 28 can be formed as a 
separate reagent package. 
The container housing section 12 includes a partition wall 30 that divides 
the container interior into two separate container chambers 32 and 34. 
Each of the container chambers 32 and 34 can accommodate a frangible 
ampoule 14 and a filter screen 16. 
Referring to FIGS. 5 and 8 each container chamber 32 and 34 has an upper 
stepped base portion 36 that supports the ampoule 14 and a lower stepped 
base portion 38 that supports the filter screen member 16. A portion 40 
(FIGS. 1 and 11) of the container housing section 12 which partially and 
closely surrounds each ampoule 14 is of generally cylindrical shape 
whereas a portion 42 of the container housing section 12 that partially 
confines each filter screen member 16 is of generally trapezoidal shape. 
The vertical walls of the housing section 12 are slightly inclined as most 
clearly shown in FIG. 7. 
Opposite sides of the container housing portions 42, 42 (FIGS. 2A and 11) 
include converging inclined portions 44 and 46 that extend upwardly from 
the lower stepped bases 38, 38 (FIG. 1) and merge into a slot 48. As shown 
in FIGS. 2B and 5, an orientation sleeve 54 for the reagent package 10 
depends from one of the upper stepped bases 36. Base pads 56 are provided 
at the lower stepped base sections 38, 38. 
The glass ampoule 14 is a known closed cylindrical structure, fusion sealed 
at one end 57 and contains a reagent 58 (FIGS. 5 and 8) which is 
preferably in a dry lyophilized form to ensure that the reagent 58 remains 
stable for at least a two-year shelf life, for example. The glass ampoule 
14 is designed to be broken under a predetermined pressure applied to each 
cylindrical portion 40 of the housing section 12. 
Each filter screen member 16 is preferably made of a plastic material such 
as polypropylene and is in the form of hollow cylinder having an upper 
open end 60 (FIG. 1) with an upper reinforcing ring 62 of imperforate 
plastic. An opposite lower end 64 of the screen member 16 is of 
imperforate cup-shaped form. Two oppositely disposed fracture resistant 
imperforate vertical sections 66 and 68 extend from the upper open end 60 
to the cup-shaped end 64. The imperforate vertical sections 66 and 68 are 
spaced by two oppositely disposed perforate vertical plastic sections 70 
and 72. The filter screen member 16 can be formed in any suitable known 
manner such as by insert molding wherein a hollow completely perforate 
cylindrical form characteristic of the perforate vertical sections 70 and 
72 is initially molded. The imperforate portions 64, 66 and 68 are then 
molded over predetermined perforate portions of the hollow cylindrical 
form. 
The cup-shaped imperforate base section 64 of each filter screen 16 is 
formed with oppositely disposed V-shaped keying members 76 and 78. A 
detent dimple 80 is located midway between the keying members 76 and 78 on 
one side of the filter screen member 16. 
Referring to FIG. 9, a positioning well 82 is formed at the lower step 38 
of each of the chambers 32 and 34. The positioning well 82 includes 
opposite keyway slots 84 and 86 of complementary size and shape relative 
to the keying members 76 and 78 to locate the lower end 64 of the filter 
screen member 16 in a predetermined axial orientation in the respective 
container chambers 32 and 34. The positioning well 82 also includes 
opposite dimple recesses 88 and 89, one of which receives the detent 
dimple 80 on the filter screen 16. Engagement of the detent dimple 80 with 
one of the dimple recess 88, 89 detents the filter screen member 16 in the 
positioning well 82. Thus when the keying members 76 and 78 engage the 
keying slots 84 and 86 one of the fracture resistant imperforate vertical 
sections 66 and 68 of the filter screen member 16 can always be positioned 
adjacent the frangible ampoule 32 as most clearly shown in FIGS. 1, 5, and 
8. 
Referring to FIGS. 5, 8, 9 and 10 the cup-shaped imperforate lower end 64 
of the screen member 16 occupies substantially the entire volume of the 
well 82. In addition the cup-shaped lower end 64 extends to the upper base 
portion 36 of each of the packaging sections 26 and 28. Under this 
arrangement little or no fluid can seep between the well 82 and the lower 
end 64 of the screen member 16. 
With the filter screen members 16, 16 and the frangible ampoules 14, 14 
located in the chambers 32 and 34, the container lid member 18 can be 
positioned on a top peripheral edge 90 (FIG. 1) of the container housing 
section 12. A peripheral gripper flange 92 is formed around the container 
housing section 12 slightly below the top edge 90 to facilitate sealing of 
the lid member 18 to the housing section 12. If desired the width of the 
flange 92 can be broadened or narrowed at selected locations. 
The lid member 18 is a stepped structure with generally circular upper 
stepped end sections 94 and 96 joined to a lower stepped section 98 by 
risers 102 and 104. A weight reduction recess 106 is formed in each of the 
upper sections 94 and 96, and a position flag 108 (FIG. 1) projects beyond 
one end of the lid member 18 at the upper section 96. A bar code label 107 
is provided on the container portion 40 below the position flag 106. A 
peripheral gripper flange 109 is formed around the outside border of the 
lid sections 94, 96 and 98, slightly above a lower peripheral edge 111 of 
the lid member 18. If desired the width of the flange 109 can be broadened 
or narrowed at selected locations. The gripper flange 109 on the lid 
member 18 cooperates with the gripper flange 92 on the container housing 
section 12 during securement of the lid member 18 to the housing section 
12. 
A pivot block 110 extends upwardly from the lid section 98 and includes 
side walls 112 and 114 spaced from the respective risers 102 and 104. The 
pivot block 110 also includes horizontal top flanges 118 and 120 for 
engagement with a robot device 121 (FIG. 22) and a weight reduction recess 
116. A first pivot cradle 122 is formed in the riser 102 and a second 
pivot cradle 124 is formed in the side wall 112 of the pivot block 110 
directly opposite the first pivot cradle 122 to accommodate the rocker 
valve 20. The second pivot cradle 124 includes a wide slot portion 126 
(FIG. 5) and a narrow slot portion 128. 
A first pivot cradle 136 similar to the first pivot cradle 122 is formed in 
the side wall 114 of the pivot block 110 and a second pivot cradle 138, 
similar to the second pivot cradle 124, is formed in the riser 104 
directly opposite the first pivot cradle 136 to accommodate rocker valve 
22. Corner strengthening gussets 142 are provided at opposite side ends of 
the risers 102, 104 and the lower section 98 of the lid member 18. 
First and second lid openings 144 and 146 extend through the lower section 
98 of the lid member 18 between the pivot block 110 and the risers 102 and 
104. Each of the lid openings 144 and 146 is surrounded by an O-ring 148. 
The lid openings 144 and 146 extend through identical collars 152 and 154 
(FIGS. 5 and 8) that depend from the lower lid section 98. Each of the 
collars 152 and 154 has a set of four depending fingers 156 that are 
equally spaced around the periphery of the openings 144 and 146. A 
necklace formation of spaced venting recesses 158 (FIG. 5) are formed in 
the outer peripheral surface of the collars 152 and 154 and the fingers 
156. 
The collars 152, 154 and the depending fingers 156 are sized to snugly 
engage the upper open end 60 of each filter screen 16 when the lid member 
18 is positioned on the top portion of the container housing 12. The 
venting recesses 158 ensure that there is a vent between the collars 152, 
154 and the filter screen 16 when the collars 152, 154 and their depending 
fingers 156 engage the open end 60 of the filter screen 16. 
A stub-like projection 162 (FIG. 5) depends from an undersurface 164 of the 
pivot block 110 intermediate the collars 152 and 154. The projection 162 
extends across the under surface 164 in alignment with the partition wall 
30 of the housing section 12. 
The lid member 18 supports the two rocker valves 20 and 22 for pivoted 
movement in side-by-side spaced relationship. Since each rocker valve 20 
and 22 is identical, only the rocker valve 20 will be described in detail. 
Referring to FIGS. 1, 7 and 8 the rocker valve 20 includes a curved valve 
face 166 having stop flanges 168 and 170 provided at respective opposite 
ends 174 and 176 of the valve face 166. A valve opening 172 in the valve 
face 166 is closer to the valve end 176 than it is to the valve end 174. A 
pair of valve pivots 178 and 180 project laterally from respective spaced 
resilient valve support arms 182 and 184. The valve support arms extend 
from the stop flange 170 towards the stop flange 168. The valve pivots 178 
and 180 are thus cantilevered and can deflect with the valve support arms 
182 and 184 toward and away from the valve face 166. 
The valve pivot 178 is of uniform diameter whereas the valve pivot 180 is 
diametrically similar to the pivot 178 but also includes a reduced 
diametrical section 186 to ensure that the rocker valves 20 and 22 are 
positioned on the lid 18 in only one predetermined orientation. 
Once the rocker valves 20 and 22 are mounted with the same orientation on 
the lid member 18, the valve pivot 178 of the rocker valve 20 engages the 
pivot cradle 122 and the valve pivot 180 engages the pivot cradle 124. The 
valve pivots 178 and 180 of the rocker valve 22 similarly engage the pivot 
cradles 136 and 138. A slightly narrowed portion 188 (FIGS. 1 and 2A) of 
the pivot cradles 122, 124, 136 and 138 helps detent the valve pivots 178 
and 180 of each rocker valve 20, 22 in their respective pivot cradles. 
Under this arrangement, the rocker valves 20 and 22 are pivotally supported 
on the lid member 18, and the curved valve face 166 makes surface contact 
with the O-ring 148 that surrounds each of the lid openings 144 and 146. 
Thus, the curved valve face 166 and the O-ring 148 cooperate to provide a 
first vapor tight seal around the lid openings 144 and 146. When, the 
rocker valve 20 is pivoted in a first direction by pushing downwardly on 
the flange 170 the curved valve face 166 moves relative to the lid opening 
144 from a valve open position (FIGS. 7 and 12), wherein the valve opening 
172 aligns with the lid opening 144, to a valve closed position (FIG. 14) 
wherein an unopen portion 190 of the curved valve face 166 blocks the lid 
opening 144. 
To assemble the reagent package 10, the filter screens 16, 16 and the glass 
ampoules 14, 14 are positioned in the respective chambers 32 and 34 of the 
container housing section 12. The lid member 18 with the rocker valves 20 
and 22 pivotally supported thereon is placed on the top edge 90 of the 
container housing section 12. The gripper flanges 92 and 109 are gripped 
together in any suitable known manner to provide a pressure contact 
between the top edge 90 of the housing section 12 and the lower edge 111 
of the lid member 18 (FIG. 5). A pressure contact is also made between a 
top edge 31 of the partition wall 30 and an aligned lower edge 163 of the 
stub-like projection 162 of the lid member 18 (FIGS. 5 and 8). 
The lid member 18 and the container housing section 12 are sealed together 
using any suitable known sealing means such as hot plate welding. Under 
this arrangement, a leak-tight seal is provided between the container 
housing section 12 and the lid member 18. In addition, a leak-tight seal 
is provided between the top edge 31 of the partition wall 30 and the lower 
edge 163 of the stub-like projection 162 that depends from the 
undersurface 164 of the pivot block 110. The container chambers 32 and 34 
are thus separately sealed and cannot communicate with each other. 
In order to ensure that the weld between the container housing section 12 
and the lid member 18 is leak tight a pressure test can be performed with 
pressure applied through the rocker valves in the valve open position. 
Pressure is transmitted in any suitable known manner to the inside 
chambers 32 and 34 of the reagent package and a leak check is performed 
around the weld portion to determine if there are any leaks. 
Once the lid member 18 and the container housing section 12 are sealed 
together, the lid openings 144 and 146 are the only openings to the 
chambers 32 and 34, and outside access to the lid openings 144 and 146 is 
controlled by the rocker valves 20 and 22. In the valve closed position 
the valve face 166 is resiliently forced against the O-ring 148 by the 
resilient valve support arms 182 and 184 to block the lid openings 144 and 
146 and provide a vapor tight seal of such openings (FIG. 14). Thus when 
the rocker valves 20 and 22 are in the valve closed position the container 
chambers 32 and 34 are closed. 
The rocker valves 20 and 22 can be pivoted from the valve closed position 
of FIG. 14 to the valve open position of FIG. 12 by pushing downwardly on 
the flange 170 to pivot the valve face 166. In this manner, the valve 
opening 172 of each rocker valve 20, 22 aligns with the lid openings 144, 
146 for example, to permit access to the container chambers 32 and 34. 
When the rocker valves 20 and 22 are in the valve open position such as 
shown in FIG. 13 fluid can be dispensed into the container chambers 32 and 
34 with a dispensation probe 192 (FIG. 13). 
When a requisite amount of liquid is dispensed into the respective 
container chambers 32 and 34 through the aligned valve and lid openings 
172, 142, and 172, 144 the rocker valves 20, 22 are pivoted to a valve 
closed position to provide a vapor tight seal. Pivoting of the rocker 
valves 20 and 22 is accomplished by pressing down upon the valve stop 
flanges 168, 168 until they engage the lower section 98 of the lid member 
18. 
The vapor tight seal between the valve faces 166, 166 and the lid openings 
144 and 146 is further enhanced, especially for shipping and storage 
purposes, by applying the locking clip member 24 to the reagent package 
10. 
The locking clip 24 includes a generally rectangular bridge section 194 
(FIG. 1) having opposite end portions 196 and 198 and oppositely disposed 
depending resilient arms 202 and 204. A generally rectangular hollow 
gusset 206 joins the upper middle portion of each arm 202, 204 and also 
joins an undersurface 205 (FIG. 5) of the bridge section 194. An elongated 
vertical opening 208 in each arm 202, 204 aligns with the gusset 206. 
The arms 202 and 204 also include a triangular locking flange 212 that 
projects from an inside surface 214 of the spring arms 202 and 204 at a 
lower end of the vertical opening 208. A detent prong 216 is provided at 
an upper edge 218 of the locking flange 212 to engage a detent projection 
222 (FIG. 6) that projects downwardly from an upper end of the slot 48 of 
the container housing section 12. 
The clip arms 202 and 204 also include diverging gripper end portions 232 
and 234 having knurled formations 236 at the inside surface 214 that 
constitute a grasping surface. 
The locking clip member 24 further includes a pair of spaced cylindrical 
pins 242 and 244 (FIGS. 1, 5 and 6) that depend from the bridge section 
194 for engagement against the upper surfaces 246, 246 of the valve faces 
166, 166 as shown in FIGS. 5 and 6. Although not shown a flat portion can 
be provided on the upper surface 246 of the curved valve face 166 to 
engage the free end of the cylindrical pins 242 and 244. The cylindrical 
pins 242 and 244 thus constitute valve face engagement members. 
When the locking clip 24 is installed onto the reagent package 10 the 
locking flanges 212 on each of the clip arms 202 and 204 engage the detent 
projections 222 at opposite sides of the container housing section 28 as 
shown in FIG. 15. The cylindrical pins 242 and 244 thus exert a downward 
force on the upper surface 246 of the valve face 166 to compress the 
O-ring 148 and provide an enhanced pressure seal between the valve face 
166 and the O-ring 148. The enhanced pressure seal between the valve face 
166 and the O-ring 148 is attributable to downward deflection of the valve 
face 166 by the cylindrical pins 242 and 244, due to the cantilever 
arrangement of the valve pivots 178 and 180. The amount of deflection of 
the curved valve face 166 is a function of the length of the cylindrical 
pins 242 and 244. Preferably the pins 242 and 244 are at least a height 
that is sufficient to maintain the under surface 205 of the bridge section 
194 elevated from the top surface end sections 94 and 96 of the container 
lid 18. The locking clip member 24 also serves as a shipping cover for the 
reagent package 10 and if desired the bridge section 194 of the locking 
clip 24 can be used to accommodate a label or any other package indicia. 
An assembled reagent package 10 with the glass ampoules 14, 14 and the 
filter screen members 16, 16 can receive a reconstituting liquid in each 
of the chambers 32 and 34. Since the liquid installation operation for 
each packaging section 26 and 28 is similar, the description of this 
operation will focus on the packaging section 26. 
Referring to FIGS. 11 and 12 the rocker valve 20 is pivoted into an open 
position. A predetermined amount of reconstituting liquid 193 is dispensed 
by the dispensation probe 192 through the open rocker valve 20 into the 
chamber 32. When liquid dispensation is completed the rocker valve 20 is 
pivoted to the valve closed position of FIG. 14 to provide a vapor tight 
seal of the chambers. Suitable labels (not shown) can be applied to the 
surface of the reagent package at the cylindrical portion 40 or the 
trapezoidal portion 42. 
The locking clip 24 is then installed onto the reagent package 10 with the 
rocker valve in the valve closed position as shown in FIG. 15. The 
pressure enhanced valve seal provided by the locking clip 24 can enable 
the contents of the reagent package 10 to be adequately stored under 
refrigeration for up to two years without degradation. 
It should be noted that when the locking clip 24 is positioned on the 
reagent package 10 the pressure of the cylindrical pins 242 and 244 on the 
curved valve surface 166 of the rocker valves 20 and 22 will restrict 
rotation of the curve valve face from the valve closed position to the 
valve open position. The bridge section 194 of the locking clip 24 also 
shields the rocker valves 20 and 22 from outside access and therefore 
prevents inadvertent movement of the rocker valves 20 and 22 from the 
valve closed position. Thus the reagent package 10 can be freely handled 
when the locking clip 24 is installed as shown in FIG. 20. 
When the reagent package is ready to be used in a sample analysis system 
(not shown), the locking clip 24 is removed and the reagent package 10 is 
positioned at a known activation device of the sampling system (not 
shown). The activation device prepares the reagent package 10 for further 
processing in the sample analysis system. For example the activation 
device can "exercise" the locked valves 20 and 22 by opening and closing 
the valves a few times since they have been in a compressed state for the 
duration of their storage. The rocker valves 20 and 22 can then be easily 
pivoted due to the cantilevered arrangement of the valve pivots 178 and 
180 which exert a slight downward resilient force of the face 166 against 
the O-rings 148. 
A known bar code reader device 300 (FIGS. 1 & 21) can read the bar code 
label 107 on the reagent package 10 and determine from information in the 
bar code whether the package has ampoules or has only liquid. The type of 
reagents contained in the package 10 can also be determined by the bar 
code reader device 300. The flag portion 108 provides a physical 
distinguishing feature that facilitates proper orientation of the reagent 
package 10 in the sample handling and reagent trays (not shown) and 
locating a "home" position of the reagent package 10. 
For example referring to FIG. 21, the bar code reader device 300 can select 
a particular reagent from an array of reagent packages such as 10A, 10B, 
and 10C. Based on a reading by the bar code reader device 300 of the bar 
code labels 107 on the reagent packages 10A, 10B and 10C the bar code 
reader device 300 will read one of the reagent packages such as 10C. The 
package 10C is brought, in a known manner to an ampoule activation-breaker 
device (not shown) that squeezes the cylindrical portions 40 of the 
packaging sections 26 and 28 until the glass ampoules 14 are broken inside 
the chambers 32 and 34. 
When the ampoule 14 is broken by compressing the outside of the reagent 
package 10 at the portion 40 the breaking glass is unlikely to puncture 
the adjacent imperforate portion 68 of the filter screen 16. Other 
breaking portions of the ampoule 14 are not adjacent the filter screen 16 
and therefore do not constitute a danger to the filter screen 16. 
During the mixing process, the reagent package is spun and anything that is 
relatively heavy such as pieces of broken glass 14a, 14b, 14c and 14d tend 
to move away from the filter screen 16 toward the cylindrical portion 40 
of the container housing section 12. Thus since the glass shards from the 
broken ampoule 14 will tend to move away from the imperforate portions 70 
and 72 of the filter 16 there is minimal risk of damage to the filter 
member 16 by the spinning process. Further, the engagement of the 
depending fingers 156 of the lid 18 in the upper end 60 of the filter 
screen 16 holds the top of the filter screen 16 in engagement with the 
collars 152 and 154. Such engagement prevents any glass shards from 
entering the filter screen 16 through the upper end 60. Thus there is no 
opening in the filter screen member 16 for broken glass to enter. 
Breakage of the ampoules 14 will enable the lyophilized ampoule ingredients 
58 to mix with the reconstituting liquid 193 inside the chamber. The 
reagent package 10 is spun back and forth automatically by the same 
ampoule-activator device (not shown) to mix the ingredients inside the 
chamber until a desired amount of mixing is obtained resulting, in a 
reagent solution 248. 
The reagent package 10 is preferably spun several times in one direction, 
stopped and then spun in a reverse direction. This spinning procedure can 
be repeated several times in order to obtain complete mixing of the 
released material from the ampoule with the reconstituting liquid inside 
the chamber. The spinning process causes the liquid to climb up the sides 
of the package and dissolve any powder that may adhere to the upper wall 
portions of the chambers 32 and 34 when the ampoule 14 is broken. 
The mixing cycle for each reagent package can be different depending upon 
the type of reagent and the type of liquid in the chambers 32 and 34. 
Therefore the spinning cycles in opposite directions and the amount of 
repetition of the spinning cycles can be separately determined for 
packages with different reagents. 
When mixing of the package ingredients is completed a robot will pick up 
the reagent package 10 and move it to an appropriate reagent tray (not 
shown). Based on information in the bar code label 107 the ampoule 
activator device can be directed to transport the reagent package to a 
predetermined reagent tray (not shown). 
When the reagent package 10 is located in a selected reagent tray it is 
oriented such that the flag 108 faces a predetermined direction for use as 
an optical triggering device to help facilitate precise orientation of the 
reagent package 10 to an aspiration position. A predetermined amount of 
the reagent solution 248 is aspirated for test purposes by an aspiration 
probe 192a that is protracted, in any suitable known manner, into the 
chamber 32 for example through the rocker valve 20 when the rocker valve 
20 is in the valve open position. It should be noted that the probe 192a 
is preferably a liquid level sensing probe such that the amount of probe 
projection in the chamber 32 is just enough to go below the surface of the 
reagent solution 248 in the chamber 32. 
The probe 192a upon entering the chamber 32 through the open valve 20 
projects into the hollow space or chimney of the filter screen 16. The 
liquid drawn into the probe 192a is thus protected by the filter screen 16 
from any glass shards 14a, 14b, 14c. The filter screen 16 thus filters out 
and prevents any glass from the broken ampoule 14 from passing to the 
inside or chimney section of the filter 16. The liquid mixture in the 
chamber 32 thus, enters the chimney section of the filter screen 16 
without glass shards 14a, 14b, 14c from the ampoule 14. 
The bar code label 107 on the reagent package can also indicate the number 
of aspirations intended for the reagent package 10. The number of 
aspirations corresponds to the number of tests that the reagent package 
will support. A bar code reading can thus be obtained at the fill stage of 
the reagent package indicating the intended test capacity of the reagent 
package 10. Based on such reading the amount of materials 58 and 193 
initially placed in the package can be predetermined to ensure that there 
is little or no wasted reagent solution 248. 
As previously noted the lower end 64 of the screen member 16 occupies the 
lowest portion of the package 10 at the positioning well 82. Thus the 
aspiration probe 192a can reach down to the lower end 64 of the filter 
screen 16 to extract substantially all of the liquid reagent solution 248 
that is in the reagent package 10 thereby preventing any waste of reagent 
solution 248. 
Based on information in the bar code label 107 as to the number of tests 
encoded in the package 10 the sample analysis system monitor (not shown) 
can count the number of test doses of fluid aspirated from the reagent 
package 10. Thus the sample analysis system can keep an ongoing record of 
how many test doses have been obtained from the reagent package 10 and 
cease aspirations when a predetermined number of test doses are obtained. 
When the contents of the reagent package are depleted, the package is 
transported to an exit position of the reagent tray (not shown). A robot 
290 (FIG. 22) can then grasp the flanges 118 and 120 on the container lid 
18 to lift the reagent package 10 and transport it to a waste receptacle 
(not shown). 
In some instances because of test requirements the reagent package 10 need 
only contain a premixed liquid reagent solution. Therefore there is no 
need to include the glass ampoules 14 and the filter screens 16 in the 
reagent package 10. The reagent package 10 is thus arranged in the manner 
shown in FIGS. 16-20 without the glass ampoules 14, and without the filter 
screens 16. 
A reagent liquid solution 254 is dispensed into the reagent package 10 
through the valve opening 172 when the rocker valve 20 is in a valve open 
position (FIG. 18). When a predetermined amount of liquid has been 
dispensed into the reagent package 10 the rocker valve 20 is pivoted to a 
valve closed position as shown in FIG. 19 and the package 10 is provided 
with the locking clip 24 to provide an enhanced seal that prevents any 
outside gases from entering the chambers 32 and 34. Appropriate labels and 
bar coding are applied to the reagent package 10 in a manner similar to 
that previously described. 
The reagent package 10 of FIG. 20 with liquid reagent only can be stored 
under refrigeration for approximately two years. When use of the reagent 
package 10 is desired the user removes the locking clip 24 to reduce the 
pressure on the rocker valves 20 and 22. 
With the locking clip 24 removed from the reagent package 10 the rocker 
valves 20 and 22, after initial exercise movement, can be easily pivoted 
from the valve open position to the valve closed position and vice versa. 
The reagent package 10 without the filter screen and glass ampoule also 
permits utilization of all liquid in the chambers 32 and 34 since the 
positioning well 82 in each chamber represents the lowest point of the 
reagent package 10. This lowest point of the reagent package 10 aligns 
with the valve controlled opening 142 of the reagent package 10. Thus the 
aspiration probe is directed toward the lowest point of the package when 
the aspiration process is being performed. 
The two different chambers 32 and 34 of the reagent package permit 
containment of different reagents to carry out two different assays. 
However the reagent package can be provided as a single chamber structure 
wherein the partition wall 30 would become an outside wall. The lid member 
of the single chamber reagent package would have an end at the pivot block 
110. 
It should be noted that the robot always picks up the reagent package for 
transport when the rocker valves are in a valve closed position, which 
minimizes the possibility of interference between the robot fingers and 
the flanges 118 and 120 on the pivot block that are provided for 
engagement with the robot fingers. 
Since the flag 108 and the location sleeve 54 at the base 36 are on the 
same end of the reagent package, the package can be oriented in a 
predetermined direction to ensure that the correct reagents are placed in 
each chamber during filling and that a record can be made in the bar code 
information 107 as to which chamber contains which reagents. 
Robot handling of the reagent package can also be accomplished with robot 
finger engagement at the slot 48. The inclined surface portions 44 and 46 
at the base of the container 12 facilitate positioning of the robot 
fingers in the slot 48. 
Some advantages of the present invention evident from the foregoing 
description include a reagent package that permits self contained storage 
of one or more reagent components maintained separately from each other 
until use of a reagent mixture is desired. A further advantage is that the 
opening to the container is valve controlled permitting easy opening and 
closure of the container. The valve has the capability of providing a 
container seal of variable tightness such as a vapor tight seal in one 
instance and an enhanced pressure seal in a second instance when a 
pressure force is imposed on the rocker valve by the locking clip for the 
reagent package. Other advantages of the invention include a reagent 
package that can be easily opened and closed by shifting the rocker valve 
from a valve open position to a valve closed position. The reagent package 
includes structural features that permit predetermined orientation of the 
package to accurately identify the ingredients contained in each chamber 
of the package. A further advantage is that a filter screen provided in 
the package includes a fracture resistant section and a perforate section, 
the fracture resistant section being positionable adjacent a breakable 
ampoule to minimize the possibility of damage to the filter screen when 
the ampoule is broken within the container. A keying arrangement on the 
filter screen ensures that the filter screen is placed in a predetermined 
orientation within the container. A further advantage is that the 
container has a well portion that defines the lowest portion of the 
container. The well portion aligns with an aspiration probe thereby 
ensuring that all ingredients of the container can be drawn from the 
lowest portion of the container to eliminate any wasted reagent. The 
reagent package is structured to be easily handled manually or by a robot. 
A locking clip for the container locks the valves into a sufficiently leak 
tight condition that enables the ingredients in the container to be stored 
for approximately two years under refrigeration without degradation. 
In view of the above, it will be seen that the several objects of the 
invention are achieved and other advantageous results attained. 
A various changes can be made in the above constructions and method without 
departing from the scope of the invention, it is intended that all matter 
contained in the above description or shown in the accompanying drawings 
shall be interpreted as illustrative and not in a limiting sense.