Chemistry: analytical and immunological testing – Including sample preparation
Reexamination Certificate
2000-02-15
2001-11-27
Beisner, William H. (Department: 1744)
Chemistry: analytical and immunological testing
Including sample preparation
C436S177000, C436S046000, C436S063000, C435S040510, C435S287300, C435S288500, C435S307100
Reexamination Certificate
active
06323040
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a system for preparing a specimen from a cellular suspension of biological cells. In particular, the invention relates to apparatus and method for preparing a specimen comprising a uniform distribution of biological cells on a substrate surface.
BACKGROUND OF THE INVENTION
The collection or preservation of biological cells in fluid suspension is common in medicine and biology for the purpose of detecting disease. For example, naturally voided urine contains urothelial cells from the lining of the bladder. If the urothelial cells are separated from the urine and then placed on a substrate surface, such as a microscope slide, examination of the cells can determine the presence or absence of certain diseases. Another example is the PAP Smear Test which involves the artificial exfoliation of epithelial cells from the cervix of the uterus and the subsequent suspension of the exfoliated epithelial cells in a water/alcohol solution to preserve and protect the cells. If the epithelial cells are separated from the solution and then deposited on a microscope slide, examination of the cells can determine the presence or absence of pre-cancerous lesions on the cervix.
However, current techniques for the preparation of specimens from cellular suspensions are deficient since the cellular suspensions may contain debris and contaminants which can interfere with the examination of the desired (“target”) cells. For instance, in the case of cervical epithelial specimen samples, the contaminants may include leukocytes, erythrocytes, bacteria and mucus. In addition, the typical specimen sample may contain several layers of cells and/or the cells may overlap one another, thereby rendering the detection of cell abnormalities difficult. Another reason is that, for the Pap test or indeed any other type of test requiring an exfoliation instrument, the technique of transferring the collected cells from the exfoliation instrument to the glass slide can be very inefficient. In some studies it has been shown that less than 20% of the collected sample is effectively transferred. By contrast, a liquid-based specimen allows, as a preliminary step, all of the collected cells to be rinsed or washed off of the exfoliation instrument into the collection fluid thereby improving specimen recovery and aiding in subsequent diagnostic accuracy.
With the exception of a membrane filter tube, all components used in the preparation of a biological specimen are reusable. This gives rise to the possibility of sample-to-sample contamination which in the context of medical applications cannot be ignored.
Accordingly, there remains a need for an apparatus and method for preparing specimens from cellular suspensions which enhances the ease and accuracy of evaluation of biological cells for abnormalities, and which eliminates the potential for sample-to-sample contamination.
SUMMARY OF THE INVENTION
According to the present invention, there is provided an apparatus and a method for preparing biological specimens from cellular suspensions which enhances the specimen recovery as well as the ease and accuracy of evaluation of biological target cells for abnormalities. In another aspect, the apparatus is designed to be disposable so as to eliminate the possibility of sample-to-sample contamination.
The biological specimen preparation system features an integrated processing unit or IPU. Advantageously, the integrated processing unit according to the present invention is inexpensive and easy to manufacture, using known injection-molded techniques. The design of the IPU also features the elimination of moving parts. The IPU is externally actuated wherein the motive force for the movement and distribution of fluids during the processing of the specimen is supplied externally.
In a first aspect, the present invention provides a biological specimen preparation system for depositing a portion of a biological specimen on a slide wherein the biological specimen is held in a vial, the biological specimen preparation system comprises: (a) a specimen processing unit having an input port for coupling to the vial containing the biological specimen and including a specimen conditioning chamber, and a specimen output port for depositing the conditioned specimen on the slide, an input channel connecting the input port to the specimen conditioning chamber and the specimen conditioning chamber having an output coupled to the specimen output port through an output channel, a first flow regulator for regulating the flow of the biological specimen through said input channel, and a second flow regulator for regulating the flow of the biological specimen through the output channel; (b) an actuation module for controlling the movement of the biological specimen in the specimen processing unit, the actuation module including an injector for injecting a portion of the biological specimen from said vial into the specimen conditioning chamber, a first actuator for actuating the first flow regulator and a second actuator for actuating the second flow regulator.
In another aspect, the present invention provides a method for preparing a biological specimen in a disposable specimen processing unit, the disposable specimen processing unit including an input port for coupling to a vial containing the biological specimen, and output port for coupling to a slide, the method comprising the steps of: (a) injecting a portion of the biological specimen from the vial to a first specimen conditioning chamber in the disposable specimen processing unit; (b) moving the biological specimen from the first specimen conditioning chamber to at least another specimen conditioning chamber in the disposable specimen processing unit for further conditioning; (c) moving the biological specimen form the last specimen conditioning chamber to a specimen enrichment chamber in the disposable specimen processing unit; (d) enriching the biological specimen in the specimen enrichment chamber by passing the biological specimen over a filter to remove contaminants from the biological specimen; (e) moving the enriched biological specimen from the specimen enrichment chamber to the output port for deposition on the slide.
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Raz Ryan S.
Robertson Gordon
Beisner William H.
Ridout & Maybee
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