Surgery – Diagnostic testing – Sensitivity of skin to allergens or radiation
Reexamination Certificate
2001-08-31
2003-04-29
Winakur, Eric F. (Department: 3736)
Surgery
Diagnostic testing
Sensitivity of skin to allergens or radiation
Reexamination Certificate
active
06554777
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to: an improved system for making multi-site skin tests; new and improved components used in the system; and a method of using the system.
BACKGROUND OF THE INVENTION
U.S. Pat. Nos. 5,738,108 and 5,792,071, which issued to Applicant and which are incorporated herein by reference, are directed to various components of a system including a multi-site skin-test device, a tray of reservoirs for holding allergenic extract, and a tray lid.
A test device, also referred to herein as an applicator, of such a system is depicted in FIG.
1
. The test device
5
, includes an elongated handle
6
. Multiple inverted U-shaped limbs
7
extend outwardly and downwardly from the handle
6
. Each limb
7
includes a horizontal bight section
8
attached approximately at its mid-point to the underside of the handle
6
and a pair of downwardly extending legs
10
. The distal ends of legs
10
lie in approximately the same plane, and each end has skin puncturing points indicated generally at
12
. For example, the points
12
may take the form of nine pressure-type sharp points clustered closely together to create a capillary effect between the points for holding liquid in the interstices or spaces between the points as disclosed in Kravitz U.S. Pat. No. 3,136,314. The disclosure of U.S. Pat. No. 3,136,314 is incorporated herein by reference. The cross-sectional size of the legs
10
does not appreciably exceed the cross-sectional size of the points
12
.
The handle
6
includes a guide formation
13
that extends generally transversely to the handle
6
. The guide formation
13
includes a vertically extending concave groove or recess
14
. Preferably, the applicator
5
will be integrally molded, such as by injection molding, from a suitable plastic. It could be formed, however, from other materials by other methods. By injection molding the applicator
5
from a plastic, the cost of these units can be reduced to a point at which the applicators are disposable after a single use. The applicators
5
, therefore, can be sterilized before shipment. A healthcare worker can then open the packages, use the sterilized applicators, and discard the applicators immediately after using them.
The system also includes a tray
30
, depicted in
FIG. 2
, for use in accordance with such an applicator or test device
5
. The tray
30
has an upper surface
35
. Twenty-four reservoirs
33
, which extend downwardly from surface
35
, are arranged in a repeating pattern that corresponds to the patterns of the distal points
12
of the test device
5
. The reservoirs are used for storing allergenic skin test solutions to be loaded onto the pointed ends
12
of the test device
5
. The reservoirs
33
are grouped into three batteries, labeled A, B, and C, each including eight reservoirs.
Referring to
FIG. 3
, the eight reservoirs of a particular battery are labeled one through eight starting with the reservoir in the upper-right-hand corner and proceeding clockwise. As discussed in more detail in Applicant's U.S. Pat. No. 5,792,071, the reservoirs
33
each have a semi-cylindrical upwardly extending interior half
23
and an opposite inclined side
24
that is generally semi-conical.
Referring again to
FIG. 2
, to help a system user quickly and accurately guide the pointed ends
12
properly into each of the reservoirs
33
, each of the three batteries or sets of reservoirs
22
in the tray
30
is provided with an upright orienting pin
32
. The orienting or guide formation
13
on the handle
6
of the test device
5
is co-operable with the guide or orienting pin
32
. When the handle
6
of the test device
5
is inserted between the pair of upright parallel tabs
31
and the guide formation
13
of the handle is placed against the guide pin
32
, the test device can then be lowered properly aligned with the battery of reservoirs. When the test device
5
is lowered in proper alignment, each vertical leg
10
will be oriented so that its pointed ends
12
will be directly over the bottom of a reservoir
33
. Each pair of tabs
31
is located such that when the guide formation
13
on of the test device
5
engages an orienting pin
32
the vertical edges of the tabs
31
nearer to the pin
32
will be engaged by the horizontal portions of the limbs
7
nearest the pin
32
. Thus, each pin
32
, each guide formation
13
, each pair of limbs
7
juxtaposed to the formation
13
, and each pair of tabs
31
jointly cooperate to readily guide and orient each test device
5
with respect to a set of reservoirs
33
.
Applicant's U.S. Pat. No. 5,738,108 discloses including formations
34
on opposite sides along the bottom edge of the test device's handle
6
to prevent the test device
5
from being inserted into the tray rotated 180 degrees from its proper orientation, which would undesirably result in the points
12
picking up test solutions from the wrong reservoirs
33
. The formations
34
protrude from opposite sides of the handle
6
and are positioned such that they will engage the upper ends of the guide tabs
31
if a user attempts to insert the test device
5
wrong-end-to.
Referring to
FIG. 4
, the system may further comprise an adhesive-backed label
400
placed onto a lid or cover
21
that preferably forms an airtight seal when placed over the tray
30
. Trays covered with lids
21
can be stacked to save space in refrigerators used to store the trays when they have been filled with skin test solutions and are not in use.
A shortcoming of the system described above is that test solution can be spilled from the reservoirs when the tray is bumped, otherwise moved abruptly, tilted onto its side, and the like.
Other conventional systems include capped reservoirs. For instance,
FIG. 5
depicts a system available from Panatrex, Inc. of Placentia, Calif. Referring to
FIG. 6
, the Panatrex system includes multiple wells
600
and well lids
602
. The manufacturer typically places well lids
602
onto wells
600
individually. This is an undesirably time-consuming process, which, of course, produces a corresponding undesirable manufacturing-cost component. Referring again to
FIG. 5
, the consumer, a healthcare professional, must insert each of the assembled well-and-lid combinations individually into a corresponding hole
502
in the reservoir-holding tray
500
. Closure caps
504
, which are located on the test device limbs, rest on a circular ridge
604
(
FIG. 6
) of each lid
602
. In use, however, test solutions tend to undesirably accumulate around the well openings and ultimately adhere to the test device's closure caps
504
in systems of the type shown in FIG.
5
.
Cost and ease and speed of use are important factors considered by healthcare professionals when they are deciding which allergy skin test system to use. A need, therefore, exists in the prior art for a cost-effective pre-assembled skin-test system having capped reservoirs that overcomes the foregoing shortcomings of prior art multi-site skin-test systems.
BRIEF SUMMARY OF THE INVENTION
In accordance with an illustrative embodiment of the invention, a multi-site allergy-skin-testing system includes a tray with reservoirs having an upwardly facing ledge surface. The ledge extends outwardly from an inner surface of an upper portion of the reservoirs. A bottom downwardly facing surface of each reservoir cap is adapted to rest on the upwardly facing ledge surface of the reservoirs. The upper portion of each reservoir is preferably adapted to receive a reservoir cap so that a relatively tight fit is achieved between the inserted reservoir caps and the upper portion of the reservoirs. The tight fit between the upper portion of the reservoirs and the reservoir caps advantageously eliminates the need for time-consuming and expensive manufacturing processes, such as ultrasonically welding the caps to the reservoirs.
The system also comprises a strip of interconnected reservoir caps. The caps of a strip are interconnected with one another via connection members. Each rese
Banner & Witcoff , Ltd.
Veniaminov N.
Winakur Eric F.
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