Surgery – Diagnostic testing – Liquid collection
Reexamination Certificate
1999-08-23
2001-11-20
Lacyk, John P. (Department: 3736)
Surgery
Diagnostic testing
Liquid collection
C606S181000
Reexamination Certificate
active
06319209
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to diagnostic tools and more specifically to a disposable body fluid or tissue collection vial having a sample accessing tool and a sample delivery member for dispensing a sample of body fluid or tissue into a reagent.
BACKGROUND OF THE INVENTION
Several tests are carried out daily on body fluids or tissue taken from patients in hospitals and clinics in order to establish the patient's health or disease state. Blood, semen, saliva, spinal fluid, lymph, perspiration, and urine are body fluids that may be tested to determine a subject's condition. Skin cells, cheek cells, biopsy tissue, and fecal samples are also routinely examined to make medical diagnosis. In addition, several diagnostic procedures are conducted on body fluids and tissues taken for the purpose of forensic analysis.
In the blood sampling field, many diagnostic systems are employed. One of the more commonly used systems involves the collection of blood from a vein through a needle assembly into an evacuated container. The evacuated container provides a pressure differential to facilitate the flow and collection of blood through the needle assembly into the container (Barnwell et al., U.S. Pat. No. 3,648,684). Most procedures of blood sampling and diagnostic testing require that blood be drawn into a vacuum tube that is then removed; subsequently portions of the sample are taken from the tube for diagnostic analysis.
Vessels that contain pre-determined amounts of reagents for use in diagnostic testing are well known. The use of such implements, however, requires one to pipette a sample by way of a measuring device not associated with the vessel. In sensitive assays prone to contamination, such as antibody diagnostic assays or the polymerase chain reaction (PCR), the use of pipettors or other devices that have been used in other laboratory procedures frequently leads to contamination of the assay and false positive results (
PCR Technology, Principles And Applications For DNA Amplification
, Erlich editor, W. H. Freeman Company Publishers, Page 4, 1992). One-step devices that draw blood by venipuncture and allow the blood to mix with chemicals in an attached reservoir have alleviated some of the contamination problems, but these devices draw a significant volume of blood and are not applicable to sensitive diagnostic tests that require a small amount of sample (Ayres, U.S. Pat. No. 3,874,367). Therefore, a disposable single assembly, diagnostic testing device that can be used for sensitive diagnostic testing without having to introduce a pipette or other measuring device is greatly needed.
SUMMARY OF THE INVENTION
The present invention provides a vial for testing a sample, the vial having a base, a sample delivery sleeve, a sample accessing sleeve, and a cap, wherein the sample delivery sleeve detachably attaches to the base, the sample accessing sleeve detachably attaches to the sample delivery sleeve, and the cap detachably attaches to the sample accessing sleeve. The sample accessing sleeve may include a sample accessing tool, such as, for example, a lancet. The sample delivery sleeve may include a sample delivery member, such as, for example, a capillary tube. The base may contain one or more reagents, such as, for example, a solvent, a buffer, an anticoagulant, an antibody, an enzyme, a dye, a growth nutrient, a marker, and a separation particle. The reagent may also be, or may further include, a magnetic, ferromagnetic, or superparamagnetic substance. The base may also contain at least one additive, such as, for example, sepharose, sephadex, cellulose, sephacryl, acrylic beads, plastic, polycarbonate, polytetrafluoroethylene, glass, polystyrene, polyethylene, polyvinyl, protein, starch, glycogen, chitosan, silica, zeolite, magnetic particles, and diatomaceous earth. The vial or parts thereof may be constructed of a material including, for example, one or more of the following: polyethylene, polypropylene, polystyrene, TEFLON®, polycarbonate, polymethylpentene, TEFZEL®, polytetrafluoroethylene, quartz and glass.
The present invention also provides a method for analyzing a sample, including the steps of: providing a vial for testing a sample, the vial including a base, a sample delivery sleeve, a sample delivery member, a sample accessing sleeve, and a cap, wherein the sample delivery sleeve detachably attaches to the base, the sample accessing sleeve detachably attaches to the sample delivery sleeve, and the cap detachably attaches to the sample accessing sleeve; contacting a material comprising the sample with the sample delivery member to retrieve the sample with the sample delivery member; delivering the sample from the sample delivery member to the base; and analyzing the sample contained within the base. In this method, the sample may include, for example, body fluid and/or body tissue, and the base may contain a reagent. The delivering step may include contacting the sample delivery member with the reagent. The reagent may include, for example, one or more of the following: a solvent, a buffer, an anticoagulant, an antibody, an enzyme, a dye, a growth nutrient, a marker, and a separation particle. The reagent may also be or further include a magnetic, ferromagnetic, or superparamagnetic substance. The delivering step may include rotating the sample delivery sleeve from a first position, in which the sample delivery member does not contact the reagent, into a second position, in which the sample delivery member contacts the reagent. In this method, the sample delivery sleeve may attach to the base in both the first position and the second position.
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Erlich, Henry A. (Editor), PCR Technology, Principles and Applications for DNA Amplification, 1989 (p.4).
European Institute of Science
Knobbe Martens Olson & Bear LLP
Lacyk John P.
Wingood Pamela
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