Source: http://www.google.com/patents/US7300633?dq=6,587,403
Timestamp: 2014-08-01 02:16:45
Document Index: 765594457

Matched Legal Cases: ['art 302', 'art 304', 'art 304', 'art 302', 'art 302', 'art 304', 'art 302', 'art 302', 'art 304', 'art 302', 'art 304', 'art 302', 'art 304']

Patent US7300633 - Specimen collection container - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsThe present invention recognizes that sample handling devices, particularly those used for testing for substances of abuse, do not allow for a separation of the bulk sample from a sample thereof to be tested. The present invention provides such a device and methods of use. The present invention includes...http://www.google.com/patents/US7300633?utm_source=gb-gplus-sharePatent US7300633 - Specimen collection containerAdvanced Patent SearchPublication numberUS7300633 B2Publication typeGrantApplication numberUS 10/211,199Publication dateNov 27, 2007Filing dateAug 2, 2002Priority dateJul 25, 2001Fee statusPaidAlso published asUS20030027359Publication number10211199, 211199, US 7300633 B2, US 7300633B2, US-B2-7300633, US7300633 B2, US7300633B2InventorsRobert Thomas Hudak, Zhumin Guan, Yuchang Wu, Ying YangOriginal AssigneeOakville Hong Kong Company LimitedExport CitationBiBTeX, EndNote, RefManPatent Citations (109), Non-Patent Citations (8), Referenced by (6), Classifications (19), Legal Events (7) External Links: USPTO, USPTO Assignment, EspacenetSpecimen collection containerUS 7300633 B2Abstract The present invention recognizes that sample handling devices, particularly those used for testing for substances of abuse, do not allow for a separation of the bulk sample from a sample thereof to be tested. The present invention provides such a device and methods of use. The present invention includes but is not limited to a specimen collection device that includes a chamber such that the chamber is capable of collecting a specimen. The device also includes a reservoir such that the reservoir is capable of receiving a portion of the specimen from the chamber and optionally so that the reservoir is capable of receiving a test device. The device includes a valve including a valve body and a valve plunger functionally interposed between the chamber and the reservoir that is capable of transferring at least a portion of the specimen from the chamber to the reservoir such that the chamber and the reservoir are not in direct fluid communication. The device includes a detachable handle able to engage the valve plunger. The device optionally includes a means for fluidic communication between the chamber, the valve and the reservoir.
CROSS REFERENCE TO PREVIOUS APPLICATIONS This application claims benefit of priority to and is a continuation-in-part of currently pending U.S. Utility application Ser. No. 09/915,494 filed Jul. 25, 2001 entitled �SPECIMEN COLLECTION CONTAINER�, and is incorporated by reference in its entirety herein.
TECHNICAL FIELD The present invention relates generally to the field of sample collection and handling devices. The integrated sample collection and handling devices of the present invention can be used to manipulate samples, including samples used to test for analytes, in particularly drugs of abuse, antibodies, antigens and biological moieties such as glucose.
BRIEF DESCRIPTION OF THE FIGURES FIG. 1A depicts the relative spatial arrangement of the parts of an illustrative integrated sample collection and handling device and also the relative spatial alignment of a test device used with the device.
SUMMARY The present invention recognizes that sample collection and handling devices, particularly those used for testing for substances of abuse, do not allow for a separation of the bulk sample from a sample thereof to be tested. The present invention provides such a device and methods of use.
An element of the present invention is �integral to� another element of the present invention when the two elements are manufactured or assembled as a single piece.
�Directly�, means that one structure is in physical contact with another structure, or, when used in reference to a procedure, means that one process effects another process or structure without the involvement of an intermediate step or component.
�Indirectly� means that one structure is not in immediate physical contact with another structure, but rather contacts an intermediary structure that contacts the other structure. When used in reference to a procedure, �indirectly� means that one process effects another process or structure by way of an intermediate step or component.
A �barrier� is a thin piece of material that is optionally not rigid. By �thin� it is meant that the thickness of the material is lesser that either its length or width. A �puncturable barrier� of the present invention can be punctured by a puncturing structure when brought into contact with a puncturable barrier with sufficient force, can protrude through a puncturable barrier. Suitable materials for such barriers include foils, plastics, and foil-plastic laminates.
A �lateral flow detection device� is a device that determines the presence and/or amount of an analyte in a liquid sample or specimen as the liquid sample or specimen moves through a matrix or material by lateral flow, such as an immunochromatographic device. Lateral does not imply a horizontal configuration of such test device.
Chamber With reference to FIG. 1A, the chamber 100 of the specimen collection device can take the form of any number of different symmetrical configurations such as cylindrical, convex, conical, elliptical, square, triangular, generally triangular rectangular; unsymmetrical configurations such as peanut shaped, kidney shaped or hybrid combinations thereof all with an inner surface and an outer surface. For example, a generally triangular or a half elliptical shaped chamber 100 is demonstrated in FIG. 1B. Furthermore, the absolute size of the chamber 100 can be varied to meet the expected volumetric size of the specimen to be contained within the chamber 100.
Reservoir The specimen collection device can include at least one reservoir. The reservoir is configured to accept a measured portion of the specimen dispensed and delivered from the chamber 100 and to allow the testing of such measured portions of the specimen. In one aspect of the reservoir, the reservoir includes a bottom part 302 and a top part 304. The top part 304 of the reservoir can be engaged to the lower portion of the chamber 100 while the bottom part 302 of the reservoir is separately arrayed. In another alternative aspect of the present invention, the bottom part 302 of the reservoir can be engaged in a base unit 306 which engages the bottom portion of the chamber. In either alternative aspects, the top part 304 of the reservoir is arrayed directly above the bottom part 302 of the reservoir in a functionally mated manner. The bottom part 302 of the reservoir can contain, but is not limited to containing, a sloping channel 310 which directs a measured portion of the specimen into a narrow trough 312 formed at the bottom of the sloping channel 310 which trough 312 is roughly equal in volume to the volume of measured portion of the specimen which is dispensed and delivered from the chamber 100 into the reservoir. It is in this trough 312 the measured portion of the specimen resides to be tested with a test device or element such as a test strip. As mentioned above, the top part 304 of the reservoir mates functionally with the bottom part 302 of the reservoir. In another alternative aspect, the top part 304 of the reservoir can contain an opening 314 such as a slot to permit the functional engagement of a test strip or test device 500. In another alternative aspect of the present invention, the top and bottom part 302 of the previously described reservoir are hermetically sealed together. In another embodiment of the reservoir, the opening 314 arrayed in the top part 304 of the reservoir is provided with a removable physical barrier. Suitable physical barriers can include, but are not limited to, plugs, films and self-adhesive seals made of paper, wax paper, plastic materials, thin metal films, metallicized plastic or paper, or a select scored cover made integral with the adjacent reservoir material at the top of the reservoir which scoring allows the selectively scored cover area to be removed through breakage of the scored areas.
Specimen The specimen collection device of the present invention is capable of collecting specimens including liquid specimens of the nature and character as described above in the definition portion of this disclosure. Alternatively, the specimen collection device can collect other types of specimens. For example, the specimen may be composed of fine powdery materials such as talc, carbon black, pharmaceutical preparations, or gases such as argon or methane. Additional specimens can include atmospheric specimens that can be tested for particulates or radioactive isotopes such as radon. The specimen collection device described herein would be useful for all such specimen types which require sample testing while all the while preserving an uncompromised portion of the original specimen for archiving and later analysis.
Valve Another aspect of the specimen collection device can include at least one valve 200. While in the first functional mode a valve 200 functions so as acquire a measured portion of a specimen from the specimen collected in the chamber 100 of the specimen collection device while at the same time sealing off and protecting the chamber 100 interior, specimen, valve interior and measured portion of the specimen from contaminating agents in the surrounding environment. During the second functional mode a valve 200 physically separates the measured portion of the specimen from the specimen remaining in the chamber 100 while continuing to seal off and protect the chamber 100 interior, specimen, valve interior and measured portion of the specimen from contaminating agents in the surrounding environment. While in these first two functional modes a valve 200 also acts to prevent the leakage of the specimen from the chamber 100 and the measured portion of the specimen from a valve 200. The third function of the valve 200 is to deliver and dispense the measured portion of the specimen into the reservoir while continuing to seal off and protect the chamber 100 interior and specimen from contaminating agents in the surrounding environment. Throughout this last functional mode, the valve 200 acts to prevent the leakage of the specimen from chamber 100.
Chamber, Reservoir and Valve Configurations As should be apparent from the above disclosure and the drawings, the chamber 100 and reservoir 300 can be constructed in a number of different arrangement. In one aspect of the present invention, however, the chamber 100 and reservoir 300 form a single unit. In another aspect of the present invention, the chamber 100 and reservoir form separate units.
Test Device The test device 500 of the present invention can be of any test element known in the art and preferably comprises at least one lateral flow detection device such as a test strip. (For examples of test devices and test strips see U.S. patent application Ser. Nos. 09/579,672; 09/579,673; 09/653,032; 60/233,739 and 09/860,408). The one or more test strips can be of any shape and dimensions, but preferably is a substantially rectangular or rectangular test strip. The one or more test strips can be used separately or can be arrayed on or in a common support such as a test card. Preferably, multiple test strips of a test device 500 can be arranged such that the sample application regions of the test strips can be contacted with the specimen in the reservoir 300 of the present invention.
The material or materials of the test strip can be bound to a support or solid surface such as found, for example, in thin-layer chromatography and may have an absorbent pad either as an integral part or in liquid contact. For example, a test strip may comprise nitrocellulose sheet �backed�, for example with a supporting sheet, such as a plastic sheet, to increase its handling strength. This can be manufactured by forming a thin layer of nitrocellulose on a sheet of backing material. The actual pore size of the nitrocellulose when backed in this manner will tend to be lower than that of the corresponding unbacked material. Alternatively, a pre-formed sheet of nitrocellulose and/or one or more other bibulous or non-bibulous materials can be attached to at least one supporting sheet, such as a sheet made of polymers (see, U.S. Pat. No. 5,656,503 to May et al., issued Aug. 12, 1997). The supporting sheet can be transparent, translucent or opaque. In the aspect of the-present invention where the support sheet is transparent, the supporting sheet is preferably moisture impervious but can be moisture resistant or moisture pervious. The test strip can be assembled in a test device 500 such that the support sheet is optionally on the side of the test strip that can be viewed from the upper face of the test device 500. In this way the one or more test strips can be viewed along the surface of a test device 500 or through openings in a test device 500 housing the one or more test strips. In another embodiment of the present invention the one or more test strips can be viewed through a window comprised of a transparent material such as glass, plastic, or mylar, but preferably break resistant.
EXAMPLES Example 1 Manufacture and Construction of the Device The chamber 100, valve 200, top part of the reservoir 304, top portion of the base unit 306 may be molded and formed as a single unit from a polypropylene composition. The valve handle 212 with its guiding pin 222 and detachable head 224, the valve plunger 214, the bottom portion of the base unit 306 and the lid 400 maybe molded and formed separately from a similar polypropylene composition. The O-rings 220 which are seated around the circumference of the body of the valve plunger 213 are molded and formed of silicone.
Example 2 Use of the Device for Testing One or More Drug Analytes The following describes the preferred method of utilizing the integrated sample collection and handling device of the present invention for the detection of drugs of abuse. Preferably a biological specimen such as a urine specimen can be provided directly from a test subject into the chamber 100 through the chamber upper opening 102. Alternatively, the biological specimen can be provided indirectly from a test subject into said chamber 100 such as through the use of a syringe used to withdraw a blood sample from a test subject which sample can then be deposited into the chamber. After deposit of the biological sample into the chamber 100, said chamber upper opening 102 can be rotatably mated and closed by the use of a threaded lid 400 with an O-ring 600 arrayed in a sealably between the upper opening 102 and the threaded lid 400. The threaded lid 400 irreversibly and unidirectionally engages with the sloped projections 112 present on the outer upper surface of the chamber 100 to create a tamper resistant seal. The chamber 100 may additionally be sealed with a tamper evident seal by disposing a plastic heat shrink band around the sealed lid 400 and the upper exposed portion of the chamber 100 and subsequently gently heating the band with a gently heating device such as a hair dryer which shrinks the band.
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