Surgery – Diagnostic testing – Liquid collection
Reexamination Certificate
1998-08-24
2001-03-06
Hindenburg, Max (Department: 3736)
Surgery
Diagnostic testing
Liquid collection
Reexamination Certificate
active
06196979
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a liquid biological sample collection unit that is suitable for using with a centrifugal analyzer disk. More particularly, the sample collection unit consists of a relatively flat cassette and optionally an applicator that holds and controls the cassette during sample collection and is used to place the casette into the analyzer.
BACKGROUND
Biological samples are primarily taken into evacuated glass or plastic tubes, such as Vacutainer™tubes (Becton Dickinson) from a subject. Normally, a double ended needle is first inserted into a subject's vein, and the other end of the needle is used to puncture a septum in an adjoining evacuated tube. Alternatively, two needles may be connected by a tube. In such an arrangement, a first needle may be inserted into a vein, while a second needle goes through a septum of a sample collection tube. The blood sample so obtained must be transferred to various analyzers from this tube. This represents additional work, may lead to contamination or mixup of the samples, and may present health hazards for laboratory staff. It is preferable to take biological samples from a subject directly into vessels that may be incorporated directly into analyzers.
There is a trend in the art to use analyzers that can perform multiple assays from a very small biological sample. An analyzer disk such as a Bio-Compact Disk™ (Burstein Laboratories, Inc.) provides the capacity for hundreds or even thousands of DNA tests, immunoassays and other clinical tests to be conducted simultaneously using a small sample volume. Such devices make it feasible to simultaneously perform multiple analyses of biological samples from a single small sample. Thus, it is important to improve the collection of biological samples and the transfer of the same into suitable containers for rapid and efficient sample analysis.
Some have recognized such a need especially in view of the significant health hazards involved with obtaining biological samples. Automatic skin pricking lancet devices have been developed to replace traditional needles. Usually these lancet devices have an extractable spring loaded blade or dart for pricking the patient's skin upon pressing a button, lever mechanism or switch. The blade then automatically retracts back into the device housing thereby preventing the individual obtaining the biological sample from the subject from being pricked by the blade. A sample of blood is normally then extracted from the subject using a pipette to extract the blood sample by capillary action. Alternatively, the subject may drop a sample into a collection container after being pricked. Examples of such pricking devices may be found in Biro et al., U.S. Pat. No. 5,133,730.
Moisson, U.S. Pat. No. 4,959,196 discloses an auto-pricking device integral with an assembly for testing blood samples to evaluate the presence and concentrations of particular substances. After the patient's finger is pricked with this device, the patient deposits a drop of blood onto a strip with a reactive agent. The blood is then automatically tested by means of a reflectometer integral with the assembly. This device lacks a means to transfer blood to a more sophisticated analyzer for additional testing.
Mawhirt et al., U.S. Pat. No. 5,518,006 disclose a blood sampling apparatus for collecting and storing a blood sample from a patient for subsequent transfer to an external blood receiving means. Such a blood sampling apparatus for collecting and transferring blood is not specifically adapted for using with a disk suitable for engagement with a centrifugal analyzer such as a CD or DVD player. Moreover, it is not adapted to be used in conjunction with an applicator for easy blood collection.
SUMMARY OF THE INVENTION
In one aspect the present invention provides an apparatus for collecting biological samples so that the samples can be transferred directly from a patient into an analyzer without intermediate processing. The apparatus is suitable for use with centrifugal player disks such as CD and DVD disks and is specifically designed to facilitate transfer of a biological sample from a subject into a CD or DVD disk for analysis by an analyzer adapted to obtain information from the same. In some embodiments, the apparatus is a cassette that is flat so that it fits into a compact-disk shaped analyzer disk. In some embodiments, the apparatus is evacuated. The apparatus may optionally contain one or more reagents and active components such as batteries, pumps, light sources, assay elements and microprocessors that may be used to deliver a sample into an analyzer or to assist in performing assays.
In another aspect, the invention provides an applicator for handling the cassette in order to facilitate taking a sample and inserting the cassette into an analyzer. The applicator is adapted to accommodate the cassette and to disengage the cassette after the biological sample is obtained. Preferably, the applicator is substantially pen-shaped and is preferably partially transparent so that the cassette may be viewed from outside the applicator. Also, preferably the applicator contains one or more compression rods that may be operably linked to a means for controlling the same such as a button. The compression rods may be used to evacuate or create a vacuum within the cassette, and they may be used to guide the cassette out of the applicator.
REFERENCES:
patent: 4142517 (1979-03-01), Stavropoulos et al.
patent: 4959196 (1990-09-01), Moisson
patent: 5133930 (1992-07-01), Biro et al.
patent: 5518006 (1996-05-01), Mawhirt et al.
patent: 5638828 (1997-06-01), Lauks et al.
patent: 5800781 (1998-09-01), Gavin et al.
patent: 5892577 (1999-04-01), Gordon
patent: 5922617 (1999-07-01), Wang et al.
patent: 5971941 (1999-10-01), Simons et al.
patent: 6030581 (2000-02-01), Virtanen
patent: 0 417 305 A1 (1991-03-01), None
patent: WO 97/21090 (1997-06-01), None
Burstein Technologies, Inc.
Hindenburg Max
Oppenheimer Wolff & Donnelly LLP
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