Chemistry: molecular biology and microbiology – Apparatus – Inoculator – streaker – or sampler
Reexamination Certificate
1999-08-25
2001-09-18
Beisner, William H. (Department: 1744)
Chemistry: molecular biology and microbiology
Apparatus
Inoculator, streaker, or sampler
C435S030000, C435S040500, C435S307100, C435S288200, C600S570000
Reexamination Certificate
active
06291234
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to apparatus and method for transferring a biological specimen to a cellular suspension, and particularly to a method and apparatus for transferring exfoliated cells from a biological specimen collection exfoliation instrument to a cellular suspension in a specimen vial.
BACKGROUND OF THE INVENTION
In the field of medicine, pathology is the study of the symptoms of disease. One of the most important applications of pathology is the study of individual human cells collected from symptomatic or asymptomatic patients. This subject of pathology is commonly regarded to as cytopathology or simply cytology. Properly applied, cytology can provide valuable and often crucial evidence of the presence and progress of disease. The well-known Papanicolaou test, commonly referred to as the Pap test, is a good example of a cytopathology application. Under the Papanicolaou test, a careful assessment of epithelial cells exfoliated from the uterine cervix can provide advance warning of pre-invasive lesions, and a this early stage of detection anyone of a host of treatments is available to arrest the cancer with a high degree of success.
It is realized that the vehicle for these cytological evaluations plays an important role in the accuracy and precision of disease diagnosis. Until recently, the accepted collection standard for a Pap test was a conventional smear. The smear involved simply wiping exfoliated cells onto a glass microscope slide before fixation. The conventional smear suffered a number of drawbacks, and has now given way to more rigid techniques which are based in the fluid collection, presentation and preparation of epithelial cells.
Although the specific techniques known in the art for process epithelial cells for preparing cytological samples differ in various degrees, they all begin with the collection of epithelial cells in a suitable preservation fluid. It will be appreciated that the immediate transfer of exfoliated cells to the preservation fluid can eliminate preparation artifacts such as air-drying effects which tend to distort and alter the appearance of the cells. Furthermore, the preservation fluid provides a vehicle for carrying the epithelial cells in suspension for subsequent processing steps.
As fluid-based specimen collection and preservation techniques began to supplant the conventional smear for the Pap test, it was learned that the most important advantage in the new techniques lay in the recovery of the epithelial cells. Early published studies using flow cytometry established that transfer efficiency for a conventional smear was typically less than 10%. The new fluid-based specimen collection techniques were able to increase the rate of specimen recovery through the simple step of rinsing the exfoliation instrument, e.g. a plastic spatula or brush, in the preservation fluid. This was the principal reason for the increase in the diagnostic accuracy associated with early mono-layer specimens.
While it has been found that rinsing the exfoliation instrument in the preservation fluid provides an effective method for transferring epithelial cells to the preservation fluid (i.e., collection fluid), the technique is not entirely efficient and there is room for improvement. First, efficiencies may be found in improving the efficiency of the rinsing mode itself. Secondly, the sheer variety of exfoliation instruments commonly in use by today's clinicians has failed to lead to a simple efficient technique for transferring the exfoliated cells. The most common exfoliation instruments in use today include a “broom” instrument, an exfoliation instrument which is a combination of a spatula and a brush, and an instrument known as the Combi™ device which incorporates elements of both previous devices.
Since the conventional simple rinsing action cannot provide an effective transfer technique for all of the known exfoliation instruments, there still remains a need for a method or apparatus for efficiently transferring exfoliated cells from these instruments to the preservation fluid. Accordingly, there is a need for a generalized device for fluid-based sampling systems capable of handling the different types known exfoliation instruments.
BRIEF SUMMARY OF THE INVENTION
The present invention provides method and apparatus for efficiently transferring cells from a variety of common exfoliation instruments to a preservation or collection fluid for preparing a cytological specimen suitable for further processing and analysis.
In one aspect, the present invention provides an apparatus for transferring a biological specimen from a specimen collection device to a specimen vial having a mouth and containing a fluid for carrying the biological specimen, the apparatus comprising: (a) a side wall member being adapted for fitting into the specimen vial; (b) a cross-bar member, the cross-member being fixed to the side member and spanning a portion of the mouth of the specimen vial, the cross-member including an edge for removing the biological specimen from the specimen collection device and the biological specimen being contained by the fluid.
In another aspect, the present invention provides a method for removing a biological cells from a collection device having a broom sampling head comprising bristles attached to a shoulder member, the specimen collection system comprising a specimen vial filled with a preservation fluid, the specimen vial including an interior frame member the interior frame member having a cross-bar member, the cross-bar member spanning a portion of the mouth of the specimen vial and including a lower edge defining a gap between the bottom of the specimen vial, the method comprising the steps of: (a) inserting the broom sampling head of the collection device into the interior frame member in the specimen vial and below the level of preservation fluid; (b) pushing the sampling head of the collection device against the bottom of the specimen vial to splay the bristles and dislodge biological cells from the collection device; (c) rotating the collection device to lodge the shoulder member of the broom under the lower edge of the cross-bar member; (d) pulling upwards on the collection device to disconnect the broom sampling head from the collection device so that the broom sampling head remains submerged in the fluid contained in the specimen vial.
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Raz Ryan S.
Wang Zhaoyu
Beisner William H.
Morphometrix Technologies Inc.
Ridout & Maybee
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