U.S. patent application number 14/068158 was filed with the patent office on 2014-02-27 for method and apparatus for preparing cytological specimens.
This patent application is currently assigned to CYTYC CORPORATION. The applicant listed for this patent is CYTYC CORPORATION. Invention is credited to Theodore S. Geiselman, Roy Ostgaard.
Application Number | 20140057347 14/068158 |
Document ID | / |
Family ID | 46279624 |
Filed Date | 2014-02-27 |
United States Patent
Application |
20140057347 |
Kind Code |
A1 |
Ostgaard; Roy ; et
al. |
February 27, 2014 |
METHOD AND APPARATUS FOR PREPARING CYTOLOGICAL SPECIMENS
Abstract
An automated system for preparing a plurality of cytological
specimens from a plurality of fluid samples in vials includes an
apparatus for collecting a monolayer of cells from each sample and
transferring the cells to a microscope slide for fixing, staining,
and inspection. The system includes a first loading station for
receiving the sample vials, a second loading station for receiving
consumables such as filter membranes, a slide dispenser, and an
unloading area for removing completed specimen slides. To maintain
one-to-one correlation between the samples and specimens produced
therefrom, the system includes a subsystem for identifying each
sample and permanently marking each slide with corresponding
indicia prior to transferring the specimen thereto.
Inventors: |
Ostgaard; Roy; (Marion,
NC) ; Geiselman; Theodore S.; (Kildeer, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CYTYC CORPORATION |
Marlborough |
MA |
US |
|
|
Assignee: |
CYTYC CORPORATION
Marlborough
MA
|
Family ID: |
46279624 |
Appl. No.: |
14/068158 |
Filed: |
October 31, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12465032 |
May 13, 2009 |
8574912 |
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14068158 |
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10421549 |
Apr 22, 2003 |
7579190 |
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12465032 |
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09521531 |
Mar 8, 2000 |
6562299 |
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10421549 |
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09156952 |
Sep 18, 1998 |
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09521531 |
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09520421 |
Mar 8, 2000 |
6572824 |
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10421549 |
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Current U.S.
Class: |
435/309.1 |
Current CPC
Class: |
Y10T 436/114165
20150115; B01L 3/5453 20130101; B01L 2200/025 20130101; C12Q 1/24
20130101; G01N 1/312 20130101; G01N 2035/00752 20130101; B01L
3/50825 20130101; Y10T 436/114998 20150115; B01L 2300/042 20130101;
Y10T 436/11 20150115; G01N 1/2813 20130101; Y10T 436/113332
20150115; G01N 1/30 20130101; Y10T 436/112499 20150115 |
Class at
Publication: |
435/309.1 |
International
Class: |
C12Q 1/24 20060101
C12Q001/24 |
Claims
1. An automated sample processing system for collecting particles
of interest from each of a plurality of sample vials, the system
comprising: a loading station configured for receiving a plurality
of sample vials containing fluid samples having particles of
interest suspended therein; a processor-controlled specimen
collection apparatus configured for collecting particles of
interest from respective sample vials received by the loading
station; and a processor-controlled sample vial transfer assembly
configured for automatically performing the steps of (a) removing a
first individual sample vial from its respective location in the
loading station, (b) transferring the individual first sample vial
to the specimen collection apparatus, wherein the specimen
collection apparatus is configured for automatically collecting
particles of interest from the individual first sample vial, (c)
returning the individual first sample vial to its respective
location in the loading station, and (d) repeating steps (a)
through (c) for each remaining sample vial of the plurality until
all of the sample vials have been processed.
2. The system of claim 1, wherein the particles of interest
comprise cells.
3. The system of claim 1, wherein the sample vial transfer assembly
comprises a sample vial agitator configured for dispersing the
particles of interest within the fluid contained in a respective
sample vial.
4. The system of claim 1, wherein the plurality of sample vials is
stored in a tray received by the loading station.
5. The system of claim 1, further comprising a subsystem configured
for maintaining correlation between each sample vial and the
respective particles of interest collected therefrom.
6. An automated system according to claim 1, wherein the sample
vial transfer assembly is configured for uncapping and recapping
each specimen vial prior to and after, respectively, the specimen
collection apparatus has collected the particles of interest from
the respective sample vial.
7. An automated sample processing system for collecting particles
of interest from each of a plurality of sample vials, the system
comprising: a loading station configured for receiving a sample
vial tray carrying a plurality of closed, capped sample vials, the
sample vials containing fluid samples having particles of interest
suspended therein; a processor-controlled specimen collection
apparatus configured for collecting particles of interest from
respective sample vials carried in a sample vial tray loaded in the
loading station; and a processor-controlled sample vial transfer
assembly configured for automatically performing the steps of (a)
removing a first individual sample vial from its respective
location in the sample tray, (b) agitating the individual first
sample vial using an automated agitator so as to disperse particles
of interest in the respective patient fluid sample contained
therein, (c) uncapping the individual first sample vial, (d)
transferring the individual first sample vial to the specimen
collection apparatus, wherein the specimen collection apparatus is
configured for automatically collecting particles of interest from
the individual first sample vial, (e) recapping the individual
first sample vial, (f) returning the individual first sample vial
to its respective location in the sample tray, and (g) repeating
steps (a) through (f) for each remaining sample vial carried by the
tray until all of the sample vials have been processed.
8. The system of claim 7, wherein the particles of interest
comprise cells.
9. The system of claim 7, further comprising a subsystem configured
for maintaining correlation between each sample vial and the
respective particles of interest collected therefrom.
Description
RELATED APPLICATION DATA
[0001] This application is a continuation of U.S. patent
application Ser. No. 12/465,032, filed May 13, 2009, now U.S. Pat.
No. 8,574,912, which is a continuation of U.S. patent application
Ser. No. 10/421,549, filed Apr. 22, 2003, now U.S. Pat. No.
7,579,190, which is a continuation of U.S. patent application Ser.
No. 09/521,531, filed Mar. 8, 2000, now U.S. Pat. No. 6,562,299,
which is a continuation-in-part of U.S. patent application Ser. No.
09/156,952, filed Sep. 18, 1998, now abandoned, and Ser. No.
10/421,549 is also a continuation-in-part of U.S. patent
application Ser. No. 09/520,421, filed Mar. 8, 2000, now U.S. Pat.
No. 6,572,824, the disclosures of which are incorporated by
reference into the present application in their entirety.
TECHNICAL FIELD
[0002] The present invention relates to preparation of cytological
specimens and, more specifically, to an automated method and
apparatus for preparing a plurality of cytological specimens from a
common number of patient samples and maintaining one-to-one
correlation between the patient samples and the specimens.
BACKGROUND
[0003] Cytology is a branch of biology dealing with the study of
the formation, structure, and function of cells. As applied in a
laboratory setting, cytologists, cytotechnologists, and other
medical professionals make medical diagnoses of a patient's
condition based on visual examination of a specimen of the
patient's cells. A typical cytological technique is a "pap smear"
test, in which cells are scraped from a woman's cervix and analyzed
in order to detect the presence of abnormal cells, a precursor to
the onset of cervical cancer. Cytological techniques are also used
to detect abnormal cells and disease in other parts of the human
body.
[0004] Cytological techniques are widely employed because
collection of cell samples for analysis is generally less invasive
than traditional surgical pathological procedures such as biopsies,
whereby a tissue specimen is excised from the patient using
specialized biopsy needles having spring loaded translatable
stylets, fixed cannulae, and the like. Cell samples may be obtained
from the patient by a variety of techniques including, for example,
by scraping or swabbing an area, or by using a needle to aspirate
body fluids from the chest cavity, bladder, spinal canal, or other
appropriate area. The cell samples are placed in solution and
subsequently collected and transferred to a glass slide for viewing
under magnification. Fixative and staining solutions may be applied
to the cells on the glass slide for preserving the specimen for
archival purposes and for facilitating examination.
[0005] It is generally desirable that the cells on the slide have a
proper spatial distribution, so that individual cells can be
examined. A single layer of cells is typically preferred.
Accordingly, preparing a specimen from a fluid sample containing
many cells typically requires that the cells first be separated
from each other by mechanical dispersion, fluidic shear, or other
techniques so that a thin, monolayer of cells can be collected and
deposited on the slide. In this manner, the cytotechnologist can
more readily discern abnormal cells. The cells are also able to be
counted to ensure that an adequate number of cells have been
evaluated.
[0006] Certain methods and apparatus for generating a thin
monolayer of cells on a slide advantageous for visual examination
are disclosed in U.S. Pat. Nos. 5,143,627, 5,240,606, 5,269,918 and
5,282,978, all of which are assigned to the assignee of the present
invention and all of the disclosures of which are incorporated
herein by reference in their entirety.
[0007] According to one method disclosed in these patents, a
patient's cells in a preservative fluid in a sample container are
dispersed using a spinning sample collector disposed therein. A
controlled vacuum is applied to the sample collector to draw the
fluid through a screen filter thereof until a desired quantity and
spatial distribution of cells is collected against the filter.
Thereafter, the sample collector is removed from the sample
container and the filter portion impressed against a glass slide to
transfer the collected cells to the slide in substantially the same
spatial distribution as collected.
[0008] While apparatus manufactured according to the teachings of
one or more of these patents have been commercially successful,
such as the ThinPrep..RTM.. 2000 System manufactured and sold by
Cytyc Corporation located in Marlborough, Mass., such apparatus
requires substantially constant attendance by a trained operator.
For example, for each specimen to be prepared, the operator must
load the system with an open sample vial containing the patient's
cells in preservative fluid, a sample collector with filter, a
glass slide, and an open fixative bath vial containing a fixative
solution. The system then cycles automatically, the cells being
dispersed by the sample collector, collected against the filter,
and transferred to the slide. The slide is then automatically
deposited in the fixative bath vial where it must be retrieved by
the operator for manual loading in a staining rack for further
processing. Thereafter, the sample vial and sample collector must
be removed from the system, to avoid inter-sample contamination,
before replacements and a new slide are installed to produce
another specimen from a different patient's sample.
[0009] Once a specimen is prepared, fixed, and stained, the
specimen may be manually visually inspected by a cytotechnologist,
typically under magnification, and with or without various sources
of illumination. Alternatively or additionally, automated machine
vision systems have been adapted to aid cytological inspection. For
example, an automated vision system may perform a preliminary
assessment of the entire slide on which the specimen is disposed to
alert the cytotechnologist to potentially the most relevant areas
of the slide for close inspection, or may be used to rescreen
specimens already analyzed by the cytotechnologist.
SUMMARY OF THE INVENTION
[0010] While automated specimen preparation systems such as those
described hereinabove perform as designed, it is desirable to
further reduce manual intervention required of a system operator so
as to increase system throughput and operating efficiency.
Accordingly, it is desirable to provide the capability wherein a
plurality of sample vials, sample collectors with filters, and
inspection media such as, for example, glass slides may be loaded
in the system. The system then cycles automatically until all of
the sample vials are processed and respective specimen slides
produced. As a result, after initial loading, the system can
operate unattended.
[0011] In one embodiment of the invention, a system includes a
sample vial tray for loading of a plurality of closed, capped
sample vials. The vials include particles of interest, such as
cells, tissue samples, assay product, or other material, typically
dispersed in a fluid medium. A sample vial transfer assembly
serially retrieves each sample vial, unscrewing a cap thereof, and
positioning the now open vial in a position for cooperation with a
sample collector and filter, which may be drawn automatically from
another tray having a plurality of sample collectors. A sample
collector or other mechanism prepares the sample for collection
such as, for example, by agitating the sample in a manner so as to
create a generally uniform dispersion of particles of interest
throughout the sample. Once the particles cells are dispersed,
collected against the filter, and transferred to a slide drawn
automatically from a slide dispenser having a plurality of clean
slides stored therein, the slide is then automatically deposited in
a fixative bath vial for a period sufficient to fix the specimen on
the slide. Alternatively, the fixative solution may be applied
directly to the specimen on the slide by spraying with an air brush
or similar technique. In either case, the slide may then be
transferred to one of a number of multi-position staining racks
previously loaded in the system, so that the fixative solution may
dry. Once a first patient's specimen is prepared, the open sample
vial is recapped and replaced in the sample vial tray. The filter
of the sample collector may be breached to prevent reuse and
resultant inter-sample contamination. The next sample vial can then
be retrieved and the specimen preparation method repeated until all
of the sample vials are processed. Accordingly, once the system
operator loads the sample vial tray, sample collector tray, slide
dispenser, and staining racks, and initiates the automatic
sequence, the system can operate unattended.
[0012] In order to maintain the integrity of the specimens so
produced, it is desirable to maintain one-to-one correlation
between the contents of the sample vials and the respective
specimens produced therefrom. When a cell sample is collected from
a patient and deposited in the preservative fluid in the sample
vial, creating cellular particles in a liquid suspension, the vial
may be marked with unique identifying indicia corresponding to the
type of sample, patient, date obtained, etc. In one embodiment, the
identifying indicia may be a bar code label. When the sample vial
is loaded into the system and retrieved from the sample vial tray
by the sample vial transfer assembly, the indicia corresponding to
the sample is identified. In the case of a bar code, a laser bar
code scanner can be used.
[0013] Next, an analytical element, such as a microscope slide, is
marked with indicia corresponding to the sample indicia. In one
embodiment, the analytical element is marked with ink transferred
thereto by a printer. The ink may be transferred to multiple
overlapping locations, spatially offset from each other on the
analytical element, to improve the readability of the element
indicia.
[0014] The element indicia are then read automatically by the
system. In the case where the element indicia are man-readable
alphanumeric characters, an optical character recognition system
can be employed in the reading step. Once the system verifies that
the element indicia corresponds to the sample indicia, the cells in
the sample vial are dispersed, collected, and transferred to the
analytical element to produce the specimen. In one embodiment, the
system collects a spatial distribution of the cellular particles
from the liquid suspension and disposes the collected particles on
a stratum of the analytical element or slide. The spatial
distribution may be substantially a monolayer of cells collected on
a filter or porous membrane of a sample collector. The filter or
membrane of the sample collector may be breached mechanically,
pneumatically, hydraulically, or otherwise in order to prevent
reuse of the sample collector and resultant inter-sample
contamination
[0015] An apparatus according to the invention for processing a
specimen from a fluid sample may include a processor, an identifier
in communication with the processor for identifying indicia
corresponding to the sample, a marker in communication with the
processor for marking an analytical element with indicia
corresponding to the sample indicia, and a reader in communication
with the processor for reading the element indicia. Once the
processor verifies that the element indicia correspond to the
sample indicia, a specimen transferrer in communication with the
processor transfers a specimen from the sample to the analytical
element.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The invention, in accordance with preferred and exemplary
embodiments, together with further advantages thereof, is more
particularly described in the following detailed description taken
in conjunction with the accompanying drawings in which:
[0017] FIG. 1 is schematic front view of an automated specimen
processing apparatus in accordance with one embodiment of the
present invention;
[0018] FIG. 2 is a schematic top plan view of the specimen
processing apparatus depicted in FIG. 1;
[0019] FIG. 3 is a schematic front view of an identification
correlation subsystem of a specimen processing apparatus in
accordance with one embodiment of the present invention;
[0020] FIG. 4 is a schematic top plan view of the identification
correlation subsystem of a specimen processing apparatus depicted
in FIG. 3;
[0021] FIG. 5 is a schematic perspective view of a capped sample
vial in accordance with one embodiment of the present
invention;
[0022] FIG. 6 is a schematic perspective view of a sample collector
during cell collection in accordance with one embodiment of the
present invention;
[0023] FIG. 7A is a schematic side view of a pre-contact condition
of a sample collector approaching a specimen slide;
[0024] FIG. 7B is a partial schematic cross-sectional view of the
apparatus depicted in FIG. 7A taken along line 7B-7B.
[0025] FIG. 7C is a schematic side view of an initial contact
condition for a sample collector contacting a specimen slide;
[0026] FIG. 7D is a schematic side view of a full contact condition
of a sample collector contacting a specimen slide;
[0027] FIG. 8 is a schematic perspective view of a rotatable
interface for mating with a torque pattern of a sample vial
cap;
[0028] FIG. 9A is a schematic perspective view of a unidirectional
interface in a sample vial tray for mating with anti-rotation
features of a sample vial body; and
[0029] FIG. 9B is a schematic perspective view of a bidirectional
interface for mating with anti-rotation features of a sample vial
body.
DESCRIPTION
[0030] FIGS. 1 and 2 are schematic front and top plan views of an
automated specimen preparing system 10 for preparing a plurality of
specimens from a plurality of fluid samples. The system 10 may be
mounted on a wheeled instrument cart 12 for portability. Depicted
with an upper cover 14 and front door 16 in open positions, the
system 10 includes a specimen preparing apparatus 18 or
transferrer, functionally of the type disclosed in the
aforementioned patents subject to improvements discussed further
herein below. Namely, the specimen preparing apparatus 18 includes
subassemblies for automatically dispersing, collecting, and
transferring a monolayer of cells to an analytical element, such as
a microscope slide. The particular structural details of the
specimen preparing apparatus 18, however, may vary from those
disclosed in the aforementioned patents.
[0031] The system 10 includes a first loading station 20 for
receiving a plurality of patient samples, each disposed in a sample
vial 22, as best seen in FIG. 5. As depicted, the sample vial
loading station 20 may have more than one tier to accommodate
multiple sample vial trays 24, two trays 24 being shown. Each tray
24 is removable to facilitate handling and preloading of the vials
22. In one embodiment, each tray 24 may include locations for forty
samples vials 22, providing a system 10 that can automatically
process up to eighty samples without operator intervention. For a
system 10 with a process cycle time of about ninety seconds per
sample, eighty samples can be processed in about two hours of
continuous, unattended operation.
[0032] The system 10 also includes a second loading station 26 for
receiving a plurality of sample collectors 28 disposed in a sample
collector tray 30. As best seen in FIG. 6, each sample collector 28
has a porous membrane or filter 29 at one end thereof against which
cells are collected. The sample collector loading station 26 may
have more than one tier to accommodate multiple sample collector
trays 30, two trays 30 being shown. Each tray 30 is removable to
facilitate handling and preloading of the sample collectors 28. In
one embodiment, each tray 20 may include locations for one hundred
sample collectors 28, providing a system 10 which can automatically
process the eighty samples without operator intervention. The
collectors 28 may also be provided to the operator preloaded in the
collector tray 30, which may be reusable or discardable, as
desired. Both loading stations 20, 26 include elevators for raising
and lowering the trays 24, 20, as required, so that sample vial and
collector transfer assemblies can access, respectively, each of the
sample vials 22 and collectors 28.
[0033] Blank glass microscope slides are preloaded in two removable
cartridges 32, each with the capacity to hold one hundred slides.
Two cartridges 32 are provided to ensure that there are a
sufficient number of slides available in the system 10 to process
the maximum number of sample vials 22. While glass microscope
slides are typically used for preparing cytological specimens,
other analytical elements, such as natural or synthetic material
assay strips and the like, are suitable for other analyses and
testing, as known by those skilled in the art, and could be
employed in the system 10 with suitable handling equipment.
[0034] One or more staining racks 34 may be provided in an
unloading area 36 of the system 10 to receive the slides once the
cytological specimens have been transferred thereto. In the
depicted embodiment, four staining racks 34 are provided, each with
a capacity of twenty slides. Accordingly, eighty sample vials 22
can be processed without having to remove the staining racks 34.
Staining rack adaptors may be provided so that the staining racks
34 can be loaded into automated, commercially available cytological
specimen stainers after removal from the system 10. Accordingly,
prepared specimens can be efficiently and rapidly unloaded from the
system 10 and the specimens stained with minimal manual
intervention.
[0035] Once a specimen has been transferred to a slide and before
the slide is disposed in the staining rack 34, a fixative solution
may be applied to the specimen at a coating station 38. The coating
station 38 includes a fixative reservoir 40 which holds the
solution used to fix or preserve the specimen on the slide after
preparation by the system 10. In one embodiment, the reservoir has
sufficient capacity to allow at least a day and preferably a week
of average usage without the need for refilling or replacement. The
fixative may be applied to the specimen by an air brush technique
in which the fixative solution is gently sprayed on the specimen so
as not to disturb the spatial distribution of the cells on the
slide.
[0036] More specifically, in one embodiment, an airbrush having a
generally conical spray distribution pattern may be used to apply a
substantially uniformly dense layer of fixative solution to a
generally circular cell transfer area on the slide. A fine mist may
be applied in one or more short duration bursts to prevent
displacing a monolayer of cells on the slide, typically using a
very small volume of fluid dispensed from the airbrush using very
low differential air pressure. For example, each burst may apply
about 20.+-.2.mu.l of fixative solution over a period of about 0.6
seconds. A slight positive pressure may be maintained in the
reservoir 40 to compensate for any pressure head, thereby
maintaining control of the dispensed volume per burst. The airbrush
may be of any conventional design capable of handling the small
volumes applied and capable of providing the desired uniform
conical spray distribution pattern. In general, primarily an
airbrush nozzle, needle valve, and body are employed, with flow
being controlled by an external valve, rather than a trigger valve
typically supplied with the airbrush. The pressure source applied
to the airbrush may be calibrated and maintained at a fixed
pressure in order to ensure a predetermined fixative flow rate for
a particular airbrush, thereby achieving the desired dispensed
volume per burst.
[0037] During preparation of each specimen, a small volume of
preservative fluid from the sample vial 22 is drawn through the
collector membrane 29. A waste bottle 42 is provided in fluidic
communication with the specimen preparing apparatus 18 so that
waste fluid can be drained during specimen preparation. The waste
bottle 42 may be mounted to an interior of the front door 16 to
facilitate removal and replacement of the bottle 42 for
emptying.
[0038] A waste bin 44 may also be provided to catch used sample
collectors 28. Prior to being discarded, the porous membrane or
filter 29 of each collector 28 may be breached so that the
collector 28 cannot be reused and possibly contaminate another
specimen. The membrane 29 may be breached by any of a variety of
methods. For example, the collector 28 may be overpressurized,
pneumatically with air or hydraulically with fluid, so as to burst
the membrane. Alternatively, the membrane 29 can be mechanically
ruptured, for example, by impressing the membrane 29 on a sharp
object, such as a pointed protrusion or knife edge mounted in the
system 10. For preparing cytological specimens, the membrane may
have a pore size on the order of about ten microns or less.
[0039] A computer controller or processor 46 is provided to
communicate with and coordinate operation of the various sensors
and components of the system 10 to permit automatic, unattended
operation during specimen preparation. The processor 46 includes an
appropriate operator interface 47 with associated input keypad or
buttons and an output display, such as a liquid crystal diode
display. Instructions, prompts, and error messages may be in text,
error code, or symbol formats. Text displays may be in a variety of
operator selectable languages, such as English, French, German,
Italian, Japanese, and Spanish. Audible outputs corresponding to
operator prompts, error conditions, keypad inputs, and completion
of automatic processing may be provided. A thermal paper printer 48
or other type of printer may be provided, as well, to generate a
permanent paper record of system operation and sample processing.
For example, for each batch of eighty or fewer sample vials 22
processed, the printer 48 may generate a report containing the date
and time processing began, a listing of the sample vials 22 not
successfully processed (including error type and tray location),
and a listing of the sample vials 22 successfully processed
(including sample identification information and tray
location).
[0040] In order that the system 10 maintains correlation between
each sample vial 22 and a respective specimen prepared therefrom,
an identification correlation subsystem 50 is provided, as depicted
schematically in front and top plan views in FIGS. 3 and 4,
respectively. In accordance with one embodiment of the present
invention, in order to prepare a specimen from a sample vial 22, a
selected capped vial 22a is removed from one of the sample vial
trays 24 by a sample vial transfer assembly 52. The vial transfer
assembly 52 includes a four-fingered gripper 54 configured to
reliably and repeatable grasp a cap 56 of the vial 22a. The vial
transfer assembly 52 is movable about a plane above the vial tray
24, left to right and into and out of the drawing as depicted in
FIG. 3, so that the gripper 54 can be aligned above any of the
forty vials 22 loaded in the tray 24. Once aligned with a desired
vial 22a, the tray 24 is raised by the tray elevator, the vial cap
56 grasped by the gripper 54 and tightened as will be discussed in
greater detail herein below, and the tray 24 lowered. In order to
access vials 22 on the other tray 24, the vial transfer assembly 52
can be retracted to one side, outside a footprint of the trays 24
and the tray elevator operated to raise or lower the tray 24, as
necessary. Similar handling is provided for the sample collectors
28 and collector trays 30.
[0041] Each vial 22 includes identifying indicia, such as a bar
code label 58 mounted thereon, which corresponds to and uniquely
identifies the vial 22 and the sample contained therein. The
selected vial 22a is then presented by the vial transfer assembly
52 to an identifier, such as a laser scanner bar code reader 60, so
that the particular vial 22a can be identified. Because the
circumferential orientation of the vials 22 in each tray 24 and
that of the respective bar code labels 58 can vary, upon
presentation to the bar code reader 60, the vial transfer assembly
52 rotates the sample vial 22a about a vertical axis passing
generally through an axial centerline thereof, as best seen in FIG.
4, to present the label 58 to the reader 60.
[0042] Once the bar code label 58 or other identifying indicia has
been identified and communicated to the processor 46, the processor
46 directs the preparation of an analytical element, such as a
microscope slide 62, for receipt of a specimen from the selected
vial 22a.
[0043] Referring to FIG. 4, a slide carriage 64, translatable along
a carriage rail 66, first extracts a slide 62 from one of the slide
cartridges 32. Each slide 62 has tightly toleranced dimensions and
chamfered edges to facilitate handling and transfer of the slide 62
by the components of the system 10 and minimize the likelihood of
mishandling or jamming. In one embodiment, the slide 62 is
manufactured from glass and has a width of about one inch, a length
of about three inches, and a thickness of about 0.04 inches. One
end 68 of the slide 62 is frosted or coated to facilitate marking,
as will be discussed in greater detail herein below. The frosted
end 68 may have an area of about one square inch. A frosted annulus
70, defining an area to where the cells are transferred, may also
be provided to facilitate manual or automatic scanning of sparse
specimens. The bounded specimen area may have an area of about one
square inch, substantially equivalent to the surface area of the
membrane 29. Additionally, one corner 72 of the frosted end 68 of
each slide 62 may be chamfered to a greater degree than the other
corners to ensure proper orientation of the slide 62 in the slide
cartridge 32 and proper presentation of the slide 62 to downstream
components.
[0044] Once the bar code label 58 on the sample vial 22a has been
identified and before the sample vial 22a is uncapped and a
specimen produced therefrom, the slide carriage 64 conveys the
slide 62 to a marker in communication with the processor 46 for
marking the slide 62 with indicia corresponding to the sample
indicia on the bar code label 58. In one embodiment, the marker may
be a printer 74, such as an ink jet printer, thermal printer, laser
printer, or other suitable marker capable of producing
substantially permanent indicia on the slide 62. In the depicted
embodiment, the printer 74 is a dot matrix impact printer utilizing
a multi-pin impact head 76 and replaceable ribbon cartridge 78,
which feeds an ink ribbon 80 to a zone between the impact head 76
and the slide 62.
[0045] The processor 46 next directs the printer 74 to mark the
slide 62. The slide indicia may have any of a variety of forms
including one or more alphanumeric characters, as shown generally
at 82. It is generally desirable to mark the slides 62 with
man-readable indicia so that the cytologist examining a fixed,
stained specimen can readily identify the specimen and associated
sample from which the specimen was prepared. Further, specimens are
often archived and retained for extended periods. Accordingly, it
is generally desirable to avoid using an indicia standard that may
fall into disuse or become obsolete. While the slide indicia may be
marked on an adhesive label bonded to the slide 62, subsequent
processing such as fixing and staining may degrade the indicia or
bond. Because specimen slides 62 are often archived in slide file
drawers, it is generally desirable that the slide indicia 82 be
oriented along the width or narrow dimension of the frosted end 68
so as to be readable without requiring removal of the slide 62 from
the file drawer.
[0046] The slide indicia printing method and printing media should
be resistant to the solvents used in the specimen preparing,
fixing, and staining processes. Typical solvents include ethanol,
methanol, xylene, water, and a clarifier solution consisting of
0.025% glacial acetic acid in distilled water. In general,
commercially available carbon black based printing ink ribbons 80
have been found to perform well when printing on frosted ends 68
produced by coating the ends of the slides 62 with a white epoxy
paint material.
[0047] In order to generate readily discernible characters 82 using
a low cost printer 74, the processor 46 may control operation of
the printer 74 and the slide carriage 64 so as to first transfer a
spot of ink to a first location on the slide 62 and then transfer
another spot of ink to a second location offset spatially and
slightly overlapping the first location. By double-striking, or
alternatively striking a third or more times in different offset
directions to blend the ink spots in a particular region of the
character, a relatively low cost nine pin dot matrix printer can
produce alphanumeric characters substantially visually consistent
with those produced by a much more expensive dot matrix printer
having many more pins in the impact head.
[0048] Once the slide 62 is marked, the processor 46 directs the
slide carriage 64 to advance the slide 62 along the carriage rail
66 to a reader in communication with the processor 46 for reading
the slide indicia 82. In the case where the specimen indicia is
composed of alphanumeric characters, the reader may be an optical
character recognition (OCR) scanner 84 or system. In one
embodiment, a total of four strikes are employed per pin using a
nine pin printer in order to meet OCR font specifications typical
for higher resolution dot matrix printers.
[0049] The processor 46 verifies both that the slide indicia 82 is
readable by the OCR scanner 84 and that the slide indicia 82
corresponds to the sample indicia identified from the bar code
label 58 on the selected vial 22a. In the event the slide indicia
82 cannot be read or the slide indicia 82 does not correspond to
the sample indicia, the slide 62 may be removed automatically from
the slide carriage 64 using an ejector or other apparatus, as
discussed in greater detail hereinbelow, and discarded in the waste
bin 44 or other waste receiving area. If multiple slides 62 fail in
succession or if more than a predetermined number of slides fail
during processing of a batch of sample vials 22, the system 10 may
be programmed optionally to halt automatic operation and alert the
operator with a suitable error message.
[0050] Upon verification of both criteria, the sample vial transfer
assembly 52 removes the cap 56 from the sample vial 22a so that the
specimen preparing apparatus 18 can cycle. A sample collector 28 is
taken automatically from the collector tray 30 at the second
loading station 26 and inserted into the specimen preparing
apparatus 18. Thereafter, the membrane 29 of the collector 28 is
inserted into the specimen vial 22a to a predetermined depth as
shown in FIG. 6 and, in one embodiment, the collector 28 is rotated
to disperse the cells in the preservative fluid. A vacuum system 88
applies a controlled pressure and vacuum cycle to the collector 28
so that cells are collected in a monolayer against the membrane 29.
The cells are subsequently transferred to the zone within the
frosted annulus 70 on the slide 62 as shown schematically in FIGS.
7A-C. According to another embodiment, the sample vial 22 may be
rotated prior to uncapping to disperse the cells in the
preservative solution, as will be discussed in greater detail
hereinbelow.
[0051] In order to provide for transfer of the collected cells to
the slide 62 without disturbing the spatial distribution thereof,
it is desirable that the membrane 29 of the collector 28 first
contact the slide 62 generally at a single location, forming a
predetermined small pre-contact angle between the substantially
planar membrane 29 and a deposition surface of the slide 62, and
then gently and gradually enter into complete contact with the
slide 62.
[0052] As depicted in FIG. 7A, after collecting the cells on the
membrane 29, the specimen preparing apparatus 18 inverts the
collector 28 to drain any excess fluid therein into the waste
bottle 42 mounted on the cart door 16. The apparatus 18 slowly
elevates the membrane 29 to a position proximate the slide 62,
which is retained in an inverted orientation in a slide holder 90
hanging from two studs 92 captured by the slide carriage 64.
Insofar as the studs 92 are of different lengths, the holder 90 and
the slide 62 are positioned in an orientation which is slightly
offset from horizontal.
[0053] FIG. 7B is a partial schematic cross-sectional view of the
specimen preparing apparatus 18 and slide holder 90 depicted in
FIG. 7A, taken along line 7B-7B. Viewed in conjunction with FIG.
7A, as the apparatus 18 continues to elevate the collector 28, two
pre-adjusted jack screws 94 first contact the slide holder 90 at
one end thereof. As the apparatus 18 elevates the collector 28
further, the holder 90 achieves a more horizontal orientation due
to contact with the jack screws 94 until an edge of the membrane
29, shown generally at 29a in FIG. 7C, contacts the slide 62. At
this point in the cycle, the angle formed between the membrane 29
and the slide 62 may be on the order of several degrees or less,
typically 0.75.+-.0.25 degrees.
[0054] As the apparatus 18 is raised further to an end-of-travel
position, as depicted in FIG. 7D, substantially full planar contact
results between the membrane 29 and the slide 62, as the slide
holder 90 is effectively fully supported by the membrane end of the
collector 28. Note the clearance between the jack screws 94 and the
holder 90 at the end-of-travel position. Accordingly, by initially
providing a two point contact between the jack screws 94 and slide
holder 90, the holder 90 and, as a result, the slide 62 mounted
thereon, can be oriented in such a manner as to be nearly parallel
to the collector membrane 29 when the membrane edge 29a first
touches the slide. 62. As the apparatus 18 moves to the
end-of-travel position, the slight rotation of the holder 90
through about one degree or so conforms the membrane 29 to the
surface of the slide 62, gently displacing any excess liquid from
the surface of the membrane and substantially preventing the
capture of air bubbles between the membrane 29 and the slide 62
without disturbing the spatial distribution of the cells. With
intimate contact now achieved between the membrane 29 and the slide
62, the cells captured therebetween can be readily transferred, for
example with minimal positive pressurization of the collector 28
which slightly bows the membrane into a convex configuration.
[0055] As the membrane 29 is thereafter withdrawn from the surface
of the slide 62, the reverse procedure takes place, leaving the
transferred cells on the slide 62 in a undisturbed monolayer,
substantially similar to the spatial distribution created when
initially collected against the membrane 29. By providing clearance
between the studs 92 and the slide holder 92 which affords a
limited vertical range of motion of the slide holder 90, monolayers
of cells can be reliable and repeatably transferred to slides 62
from a plurality of patient samples. Additionally, because the
slide holder 90 is effectively floating at the time of cell
transfer on a fluid bearing created at the interface of the
membrane 29 and the slide 62, variability in slide thickness,
membrane location, and slide/membrane parallelism are readily
accommodated. Accordingly, there is no requirement for time
consuming, precision setup of the apparatus 18 and slide holder 90
to ensure proper cell transfer.
[0056] After transferring the cells to the slide 62, a fixative
solution may then be applied to the transferred specimen and the
slide 62 transferred from the slide carriage 64 to one of the
staining racks 34 at the unloading area 36 using a slide transfer
assembly such as a translating slide ejector 86. The slide ejector
86 and/or the unloading area 36 may include automatic height and
side-to-side translation capability, so as to be able to accept the
prepared specimen slide 62 in a next open slot in any one of the
plurality of staining racks 34.
[0057] After preparation of the specimen, the membrane 29 of the
used collector 28 is breached and the collector 28 discarded in the
waste bin 44. The cap 56 is replaced on the sample vial 22a and the
vial 22a returned to its location in the vial tray 24. If there
exist additional sample vials 22 which have not yet been processed,
a next vial 22 is removed automatically, the sample indicia
identified, and a next specimen prepared therefrom according to the
steps described hereinabove.
[0058] In order that the system can process automatically the
specimens from fluid samples in the sample vials 22, each vial 22
and cap 56 includes one or more structural features which
facilitate grasping of the closed, capped vial 22 by the sample
vial transfer assembly 52, as well as removal and reinstallation of
the cap 56. In one embodiment depicted in FIG. 5, the sample vial
22 includes a body 23 having a generally cylindrical outer surface,
an open end, a closed end, and at least one lug 25 disposed about
the outer surface. The lug 25 performs an anti-rotation function,
preventing the body 23 from rotating when disposed against adjacent
structure. The sample vial cap 56 is releasably engagable with the
body 23, the cap 56 including an outer surface with a torque
pattern 27 thereon for mating with a rotatable interface of the
sample vial transfer assembly 52 as discussed more fully
hereinbelow. A seal is disposed between the body 23 and the cap 56
so as to be capable of forming a substantially fluid-tight seal
therebetween.
[0059] Instead of a single anti-rotation lug 25, the body 23 may
include a plurality of lugs 25 disposed about a perimeter of the
body 23, such as the six equi-spaced lugs 25 of the embodiment of
FIG. 5. While the lugs 25 may be disposed anywhere on the body 23
accessible to the sample vial transfer assembly 52 or related
structure of the system 10, the lugs 25 may be disposed
advantageously proximate the open end of the body 23 and the cap
56. In this manner, torque may be applied to both the body 23 and
the cap 56 at approximately the same axial plane to minimize any
induced moment in the vial 22 during removal and installation of
the cap 56.
[0060] The sample vial body 23 may be manufactured from a
substantially transparent or translucent material so that a level
of the fluid sample therein can be readily discerned by the system
operator to ensure the presence of a sufficient amount of fluid for
subsequent processing. The body 23 may also include fluid level
indicia 31 disposed on the outer surface thereof, such as a
circumferentially-disposed frosted annular band. Accordingly, the
vials 22 can be rapidly visually screened by the operator prior to
loading in the vial tray 24 to prevent loading a vial 22 with too
much or too little fluid which might not be processed successfully
by the specimen preparing apparatus 18. The fluid level indicia 31
may be provided in addition to the sample bar code label 58
discussed hereinabove.
[0061] The cap may be manufactured from polypropylene or other
suitable material and may include knurling 33 or other anti-slip
feature along an outer perimeter thereof to facilitate manual
handling by a nurse or doctor during sample procurement, as well as
the system operator during manual loading and loading of the sample
vial trays 24. The cap torque pattern 27 may be at least one
generally radially disposed rib 35. In the embodiment depicted in
FIG. 5, the torque pattern 27 includes six generally radially
disposed, equi-spaced ribs 35.
[0062] The seal may be manufactured from any suitable material
which can be sterilized and which is capable of withstanding attack
by the preservative fluid, which may typically contain a solution
of methanol in a buffer. For example, the seal may be manufactured
from a multicomposite material such as a resilient rubber layer
laminated with a suitable vapor barrier and may be disposed within
the cap 56. The cap 56 and the body 23 may have mating screw
threads, a bayonet fitting, or other retention feature so as to be
releasably engageable. In one embodiment, a substantially
fluid-tight seal between the body 23 and the cap 56 may be formed
when at least between about 5 and 50 inch-pounds of torque is
applied to the cap 56 relative to the body 23. A more typical
torque range may be on the order of about 20 to 30 inch-pounds,
with about 25 inch-pounds being preferred. To ensure that the
fluid-tight seal is produced when the patient's cells are first
disposed in the preservative fluid and to prevent leakage or
evaporation of the preservative fluid during transport and storage,
each of the cap 56 and the body 23 may include alignment markers
37, 39, such that the alignment markers 37, 39 indicate a
fluid-tight seal when at least aligned.
[0063] FIG. 8 is a schematic perspective view of one design of a
rotatable interface 142 disposed radially inwardly of the grippers
54 of the vial transfer assembly 52. The interface 142 includes a
torque pattern 144 for mating with the torque pattern 127 of the
sample vial cap 56. The rotatable interface 142 is shown inverted,
to better depict the interface torque pattern 144 formed therein.
In this embodiment, the interface torque pattern 144 includes six
raised wedge-shaped sectors 146. The sectors 146 are substantially
equi-spaced about the interface 142, which is rotatable about a
longitudinal axis 148 thereof, and sized to mate with the torque
pattern 127 of the cap 56. Accordingly, the ribs 35 of the cap 56
fit in grooves 150 formed between the sectors 146 of the interface
142 and react against substantially vertical faces of the sectors
146 to permit both loosening and tightening of the cap 56.
[0064] To prevent rotation of the sample vial body 23 during these
operations, the body 23 may be disposed in a bore 152 formed in the
sample vial tray 24 having a unidirectional interface 154 along an
edge 160 thereof for mating with the lugs 18 of the body 23, as
depicted in FIG. 9A. The interface 154 includes six ramps 156, each
including a substantially vertical face 158 which abuts one of the
body lugs 25. Accordingly, the capped vial 22 may be disposed in
the bore 152 with a flange 140 of the body 23 supported along the
edge 160. The rotatable interface 142 may then be engaged with and
tighten the cap 56, to ensure a fluid-tight seal prior to removing
the vial 22 from the sample tray 24. Due to the orientation of the
ramps 156, the lugs 25 react against the ramp faces 158 during
tightening to positively secure and prevent rotation of the vial
body 23.
[0065] Once the cap 56 has been tightened, the vial transfer
assembly 52 may grasp the capped vial 22 about the circumference of
the cap 56 with the grippers 54, remove the vial 22 from the bore
152 in the tray 24, rotate the vial 22 in front of the bar code
reader 60, and deposit the capped vial 22 in a bore 162 formed in a
vial sleeve 164, such as that depicted in FIG. 9B in wire form
representation. The six lugs 25 of the capped vial 22 are received
in every other one of twelve axially extending slots 166 formed
along an upper edge 168 of the sleeve 164, the flange 140 of the
vial 22 being supported by the edge 168. Once in the bore 162 with
the lugs 25 disposed in the slots 166, further processing may
proceed.
[0066] As discussed hereinabove, a slide 62 is printed and the
slide indicia 82 verified as being readable and corresponding to
the vial bar code label 58. The vial 22 may then be uncapped and
the sample collector 28 can be disposed in the vial 22 and rotated
to disperse the cells in the sample. According to an alternative
embodiment, once the capped vial 22 is disposed in the sleeve 164
and before the vial 22 is uncapped, the sleeve 164 may be rotated
in one or both directions to disperse the cells in the preservative
solution. Thereafter, a pin, clamp, or other structural feature of
the system 10 may engage one of a series of notches 170 formed in a
flange 172 of the sleeve 164 to prevent rotation of the sleeve 164
and the vial 22 disposed therein while the rotatable interface 142
engages and unscrews the cap 56. The cap 56 is then retracted by
the gripper 54 of the vial transfer assembly 52 and the sample
collector 28 disposed in the preservative solution in the vial 22
to collect the cells against the filter 29 thereof and thereafter
transfer the cells to the slide 62. Once the cytological specimen
has been prepared, the cap 56 is reoriented over the open vial 22
and screwed onto the body 23 until a substantially fluid-tight seal
has been formed. The axially extending slots 166 which engage the
lugs 25 form a bi-directional interface, to react against the body
lugs 25 during both removal and installation of the cap 56 on the
body 23. Each of the axial slots 166 may be formed to include,
optionally, a generally circumferentially disposed portion, shown
generally at 174, to lock a suitably sized lug against axial
translation, if desired.
[0067] Of course, other suitable materials, dimensions, and
configurations for the body 23, the cap 56, the ribs 35, the lugs
25, the fluid level indicia 31, and other features of the sample
vial 22 will be apparent to those skilled in the art, those
disclosed being provided as examples only. For example, while the
mating ribs 35 and sectors 146 provide a positive, self-centering
drive, other mating structure such as pins and annular tracks may
be used. Further, the sample vial 22 may be used in other
applications and contain other than cytological samples in
preservative solution.
[0068] The automated specimen preparing system 10 described herein
employs certain specimen preparing innovations disclosed in the
aforementioned patents in combination with batch processing
capability to prepare gynecological and other cytological specimens
in a highly efficient, reliable manner. The system 10 may also be
used to batch process other specimens such as those including
tissue samples, assay products, and other materials. Industry and
regulatory acceptance of a system 10 and method in accordance with
the teachings set forth herein are based, in part, on the
capability to maintain one-to-one correlation between a patient
sample and a specimen produced therefrom. Accordingly, a specimen
is not produced on an unmarked slide 62, or on a slide 62 on which
the specimen indicia are not readable or do not correlate with the
sample indicia bar code label 58 identified from the selected vial
22a. By aborting the specimen preparing cycle prior to collection
of the cells against the membrane 29, unidentifiable or
misidentified specimen slides are not produced, saving cycle time,
consumables, and the patient's sample.
[0069] When a patient's cells are first collected and deposited in
a sample vial 22 prefilled with preservative solution, a preprinted
bar code label 58 with a unique accession number is applied to the
sample vial 22. A second matching bar code label 58 is applied to a
patient information sheet, listing relevant patient identifying
information, as well as information regarding the tests or analyses
to be performed on the specimen prepared from the sample.
Accordingly, when data from the patient information sheet is
entered into a database at a sample receiving area in a cytological
laboratory, data from the bar code label 58 on the patient
information sheet can also be input, either manually or preferably
automatically using a laser scanner. The specimen produced from the
sample with the matching bar code will therefore readily be
identifiable as being from a particular patient.
[0070] Once the system 10 is loaded with the samples and
consumables by the operator, the system 10 runs in an automated
manner under control of the processor 46 until all sample vials 22
are processed, or until such time as a system malfunction occurs or
a consumable, such as a sample collector 28 or slide 62, is
depleted. To minimize the likelihood of the latter situation,
sensors are provided throughout the system 10 to verify the
presence of sufficient consumables to process all loaded samples
prior to the initiation of automatic operation. Sensors may also be
provided to monitor levels in the waste bottle 42 and waste bin 44,
so that the operator can be alerted to elevated levels of waste,
which could interrupt processing during automatic cycling.
[0071] Accordingly, when the operator initiates automatic
processing, for example, by selecting "Start Batch" from a menu on
the display or using a dedicated keypad input, the system 10 checks
that sample vials 22 are loaded and a minimum number of necessary
consumables and staining racks are available to complete processing
of all the samples. If sufficient consumables and waste capacities
exist, the system 10 starts the automatic sample processing cycle.
The cycle continues until all of the loaded sample vials 22 have
been processed, the operator manually interrupts the cycle, or a
system error occurs which cannot be automatically rectified. If
insufficient consumables or waste capacities exist, the operator
may correct the condition or, alternatively, override the system 10
and initiate automatic processing anyway. In the event a prior
automatic cycle had been interrupted, "Start Batch" may be used to
resume automatic cycling at the point of interruption, after
checking system consumables and capacities. In order to protect the
operator from injury by moving components during automatic cycling,
access points such as the upper cover 14 may be interlocked.
[0072] If the operator chooses to interrupt the automatic cycle
prior to completion, the operator may select "Interrupt Batch."
Upon receipt of the interrupt signal, the processor 46 interrupts
the automatic cycle in an orderly manner, for example, by
completing preparation of a specimen in process, transferring the
completed specimen slide 62 to a staining rack 34 in the unloading
area 36, and capping and returning the selected sample vial 22a to
the vial tray 24. After that sample processing cycle has been
completed and moving components are at rest at respective home
positions, the operator access interlocks are unlatched and the
operator is notified. The operator may then open the upper cover 14
or access other internal areas of the system 10, as desired.
[0073] A "Maintenance" function can also be provided in which the
system 10 supports operator level maintenance activities such as
jogging of the moving components to or from respective home
positions to provide the operator access to various interior
volumes of the system 10, for example, to clear a jam or to
retrieve a mishandled slide 62. Other maintenance functions may
include emptying of the waste bottle 42 and bin 44, priming of the
fixative coating station 38 with the fixative solution, and
advancing of paper in the system printer 48. The system 10 may also
provide operator selectable diagnostic tests to facilitate system
troubleshooting or verify proper system operation. For example, a
pneumatic test may be initiated of the vacuum system 88 of the
specimen preparing apparatus 18 to ensure sufficient volumetric
flow rate and negative pressure level. A display test could be used
to verify display operation.
[0074] A usage log may be provided to track total number of samples
processed, total number of specimens produced, total system run
time, and other relevant usage parameters. The processor 46 may
also maintain an error log which lists, for example, the last fifty
errors detected by the system 10 and which may be displayed or
printed at the discretion of the operator. A typical log entry may
include date and time of the error, sample indicia and tray
location, and disposition or corrective action. In one embodiment,
the system 10 identifies any sample vial 22 from which a specimen
was not successfully prepared, along with the reason for the
failure, such as "sample too dense" or "cap too tight."
[0075] Detectable conditions that could cause specimen quality
problems are flagged by the system 10 and noted to the operator on
the display and paper printout. If possible, a partially collected
specimen is returned to the vial 22 and preparation of the slide 62
is aborted. If the problem is associated with a particular selected
sample vial 22a, the system 10 recovers after returning the
selected vial 22a to the vial tray 24 and recording the error,
processing the remaining sample vials 22 in the batch. However, if
the error is a system level problem, such as a motor or sensor
failure, jammed mechanism, or other malfunction that is not
automatically recoverable and requires operator or qualified
service personnel intervention, the automatic cycle is halted and
the error recorded and reported to the operator.
[0076] Upon installation or commissioning of the system 10, or
thereafter as required, the processor 46 may be initialized and
setup functions enabled or disabled. For example, the date and time
may be input, as well as the respective formats thereof. The system
printer 48 may be directed to automatically print diagnostic test
results or sample processing data at the end of every automatic
batch cycle. A date/time stamp may be enabled to print the date and
time a specimen was prepared on the frosted end 68 of each slide
62, in addition to the slide indicia 82. Optionally, the name or
other identifier of the cytological laboratory preparing the
specimen with the system 10 may be printed on the slide 62 as
well.
[0077] While there have been described herein what are to be
considered exemplary and preferred embodiments of the present
invention, other modifications of the invention will become
apparent to those skilled in the art from the teachings herein. For
example, while the system 10 and method have been described for
preparing a single specimen from each sample vial 22, the system 10
could be programmed to permit two or more specimens to be prepared
from a single sample vial 22. In such instances, the slide indicia
82 could include an additional character or identifier to indicate
the first specimen, second specimen, third specimen, etc.
Alternatively, the sample vial 22 could be reprocessed by inserting
the vial 22 in a tray 24 in a next batch for a subsequent automatic
cycle.
[0078] The disclosed components of the system 10 may be
manufactured in various sizes, configurations, and materials.
Additionally, the system 10 may be used to prepare specimens from
non-gynecologic cytological samples, such as cells sourced from
fine needle aspirates, from mucoid specimens taken from respiratory
and gastrointestinal tracts, from body fluids such as serous
effusions and urinary and cerebrospinal fluids, from superficial
brushings and scrapings from oral cavities, nipple secretions, skin
lesions, and eye brushings, and from other sources.
[0079] The particular methods of manufacture and particular
arrangements of discrete components, geometries, and
interconnections therebetween disclosed herein are exemplary in
nature and are not to be considered limiting. It is therefore
desired to be secured in the appended claims all such modifications
as fall within the spirit and scope of the invention. Accordingly,
what is desired to be secured by Letters Patent is the invention as
defined and differentiated in the following claims.
* * * * *