Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Calorimeter
Reexamination Certificate
2000-11-11
2003-09-09
Warden, Jill (Department: 1743)
Chemical apparatus and process disinfecting, deodorizing, preser
Analyzer, structured indicator, or manipulative laboratory...
Calorimeter
C422S050000, C422S051000, C422S067000, C422S067000, C436S164000, C436S169000, C436S170000, C436S180000
Reexamination Certificate
active
06616893
ABSTRACT:
BACKGROUND OF INVENTION
1. Field of Invention
The present invention relates to testing of body fluids of humans and animals. More particularly it relates to test kits for diagnosis of pregnancy, drug use, or for illness of person or animal contributing the sample being tested.
2. Prior Art
Testing for pregnancy in the home and through commercial labs has long used test strips activated by certain properties of bodily fluids. Most such tests require the user to be very accurate with a fluid stream to hit a target on a small test strip. Testing using diagnostic strips that are reactive to certain chemicals, enzymes, body by products, or other fluid characteristics have also been used in recent years to diagnose illness in both humans and animals as well as to ascertain if the fluid contributor is or has recently used drugs.
In the case of pregnancy testing must such devices feature a strip held in the hand of the user who is required to urinate upon the strip and thereafter wait for some type of result yielded by the strip. Other such pregnancy testing devices require the user to place fluid into a receptacle which is then exposed to a test strip for a time period generally which the user must determine.
Drug testing in the workplace, in athletics, and by potential employers is also a common occurrence. Such testing generally requires the user to contribute a sample which is then sealed in a container and shipped to a commercial lab for the individual tests requested by the party seeking the testing of the sample. The lab then exposes the samples to the various test strips or other reactants that will provide the requested information.
As is obvious, pregnancy tests requiring a user to hit a small target with a urine stream, and then to time the reaction of the fluid with a test strip, have inherent problems. First, the fluid stream is not always accurately directed to the target thus causing problems with unintentional wetting of the user's person or other areas of the room in which the test is taking place. Second, many such tests require the user to time the contact of the test strip with the fluid collected. Should the time be miscalculated, the result can be in doubt.
Finally, the entire process is somewhat unsanitary since the user may be required to move about with urine soaked test strips or to place test strips in containers of urine or other bodily fluids and thereafter remove them after the defined time period of exposure. All of this transport and moving about risks contamination of the test being conducted as well as contact with sometimes infectious bodily fluids by the user or testing personnel performing the test.
Additional problems result in the arena of drug testing during athletic events or by employers seeking to make for a drug free workplace. In such cases the sample is generally collected, sealed, and then transported to a lab. Thereafter, the lab technicians expose the fluid sample to the appropriate reactant to determine if the contributed sample contains the marker for the drug or disease or condition for which it is being tested.
In such cases the risk of damage or contamination to the sample during transport is always a concern as is the risk of adulteration by the person being tested. Also, since currently used test strip style testing is generally not configurable on site, valuable time is lost in the transport from the site of the fluid contribution to the lab so that the test can be configured to determine if the marker in the fluid is present.
U.S. Pat. No. 5,976,895 (Cipkowski) teaches a device for collecting fluid samples and shipping them to a lab wherein a test card is inserted through a slot in the cap and read through the sidewall of the container. While Cipkowski provides for improved sanitation by the provision of a slot that cooperates with a card, the technician still must remove the cap to insert the card risking spillage and damage during transport. Also, there is no provision to time the test being conducted built into the kit thus requiring the user to time the exposure of the card and strips to the fluid.
Commercially available devices such as the TESTCUP® by Rocher Diagnostics feature easily viewed results however the device must be overturned for a defined period and then turned upright for the test to proceed. The risk of leakage of contaminated body fluids if the cap is ill fitted is ever present since the device must be overturned. Nether is the device easily configurable on site should the user wish to configure their own screening tests for certain diseases, condition, or drugs.
As such there exists a need for a device that will allow for easy placement of fluid in a container for testing. Such a device should feature viewable results without the need for insertion or removal of test strips into the container. The device should further require little or no agitation or overturning that might encourage leaking of fluids from the container. Such a device should feature a self timing mechanism to stop the reaction of fluid with the provided test strip as well an optional ability to be configurable on site by the party using the device. Still further, a timer to inform the tester of the proper time frame for the test being conducted would be desirable.
SUMMARY OF THE INVENTION
Applicant's device provides an easily manufactured and operated test kit for medical conditions of humans and animals as well as for testing of pregnancy and when properly configured for the presence of drugs. The device is a kit that allows for the placement of the body fluid to be tested inside a sealable outer container which need not be agitated or overturned to work.
The kit features an inner test cup or reservoir cup dimensioned for a cooperative engagement with a substantially transparent test container vessel. When inserted into an interior cavity formed in the container vessel the test cup which is of an outside dimension slightly smaller than the inside dimension of the interior cavity of the container vessel forms a seal with the container vessel at the open ends of both the container vessel and the reservoir test cup.
The seal formed by a sealing means such as cooperatively engageable open ends on both the container vessel and the reservoir cup prevents fluid from entering separation cavity formed between the outside of the reservoir cup wall and the inside of the container vessel wall. The cavity thus remains separated from the fluid in the reservoir cup by the sealing means and the wall of the reservoir cup.
One or a plurality of test strips are mounted to the exterior surface of the sidewall of the test cup using a means for attachment of the test strips to the wall surface such as adhesive or slots or capillaries formed into the wall surface to cooperatively engage the test strips. The strips could also be mounted on the inside wall of the container vessel but the current best mode mounts them to the reservoir cup. The test strips are thus in the separation cavity and isolated from any fluid in the reservoir cup.
Communication between the test strips and the fluid in the reservoir cup is provided by one or a plurality of apertures communicating through the sidewall of the reservoir cup. The sizing and position of the apertures thereby provide the desired communication between any fluid placed in the reservoir cup interior fluid cavity and the test strips attached to the outer wall of the reservoir cup.
By using the apertures communicating with the fluid supply and the test strips the kit is self timing in that the test strips can be configured to absorb fluid from the aperture at a desired rate by the material in the test strip as well as adjustment of the area of the apertures. Since the test strips communicate over the entire area of the apertures fluid only communicates into the test strip by absorption and is thereafter transmitted upward toward the top of the test strip by capillary action.
Once the test strip has absorbed a sufficient amount of fluid to have reached the reactant positioned at the uppermost area of the test
Harms Donn K.
Siefke Sam P.
Warden Jill
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