Sample collection device with extraction sleeve

Surgery – Diagnostic testing – Liquid collection

Reexamination Certificate

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Details

C600S572000

Reexamination Certificate

active

06200275

ABSTRACT:

FIELD OF THE INVENTION
The present invention is related to devices for collection of specimen and delivery of specimen for diagnostic testing, particularly collecting and delivering, e.g., saliva or urine, or the like, for diagnostic tests. The device of the present invention provides an absorbent foam member and a sleeve for extracting the fluid specimen from the member, and is particularly useful for the collection and simple-delivery of a specimen from a mammal while maintaining aseptic conditions.
BACKGROUND OF THE INVENTION
Various methods and devices have been used to collect and deliver specimen for diagnostic testing. One conventional method for collecting a saliva specimen is to use a cotton swab. The saliva sample can then be applied to a test device by contact with the swab or the sample can be rinsed from the swab.
Various devices comprising test tube like structures with sample absorbing means have been described for collecting biological samples for diagnostic testing. Examples of such devices are described in U.S. Pat. No. 4,123,224, U.S. Pat. No. 5,000,193, U.S. Pat. No. 5,022,409, U.S. Pat. No. 5,260,031, U.S. Pat. No. 5,268,148, U.S. Pat. No. 5,283,038, U.S. Pat. No. 5,339,829, U.S. Pat. No. 5,376,337, U.S. Pat. No. 5,380,492, U.S. Pat. No. 5,393,496, U.S. Pat. No. 5,479,937 and U.S. Pat. No. 5,494,646.
In a copending application, U.S. application Ser. No. 08,712,682, a simple device for collecting and delivering a specimen for diagnostic testing is described. In accord with the disclosure, a specimen collecting device comprises an elongated foam member having a longitudinal axis and an uncompressed cross sectional area, the elongated foam member being circumscribed by a hollow tubular member along a portion of the longitudinal axis, the hollow tubular member has a cross sectional area less than the uncompressed cross sectional area of the foam member so that the foam member is compressed along the circumscribed portion.
SUMMARY OF THE INVENTION
The present invention provides an improved device for collecting and delivering a specimen for diagnostic testing, wherein the device provides a simple and convenient method for extracting the sample from a foam member. In accord with the present invention, a specimen collecting device comprises an elongated foam member having a longitudinal axis and an uncompressed cross sectional area, the elongated foam member being circumscribed by a hollow tubular member along a portion of the longitudinal axis, the hollow tubular member has a cross sectional area less than the uncompressed cross sectional area of the foam member so that the foam member is compressed along the circumscribed portion. Around the hollow tubular member is a flexible sleeve member having a first end that fits snugly around the hollow tubular member and a second end with an enlarged diameter that can surround the uncompressed foam member. Conveniently, the sleeve member can be moved along the hollow tubular member to cover and uncover the portion of the foam member that is not circumscribed by the hollow tubular member.
The sample collection device of the present invention is particularly useful for collecting saliva specimen and delivering the sample to a DNA collection matrix from which DNA for PCR testing can be isolated. The collection device of the present invention provides a simple and inexpensive method for collecting and delivering the saliva sample. Further, in preferred embodiments, the foam member of the collection device provides more consistent and accurate samples.
The sample collection device of the present invention is also particularly useful for collecting saliva or urine specimen and delivering the sample for a rapid drug abuse test.
The collection and delivery device of the present invention provides a simple and inexpensive device for asepticly collecting and delivering a specimen sample. In preferred embodiments of the present invention, the foam member with the flexible sleeve of the collection and delivery device provide more consistent and accurate aseptic samples.
The sample collection devices of the present invention can be used to provide fluid samples, particularly saliva or urine samples, for DNA testing for forensic and paternal identification, RNA testing, antibody testing, testing for particular drugs, and other similar diagnostic procedures.


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