U.S. patent number 3,815,580 [Application Number 05/285,204] was granted by the patent office on 1974-06-11 for apparatus for and method of collecting and preserving cytologic samples.
Invention is credited to Claude Oster.
United States Patent |
3,815,580 |
Oster |
June 11, 1974 |
APPARATUS FOR AND METHOD OF COLLECTING AND PRESERVING CYTOLOGIC
SAMPLES
Abstract
Apparatus is provided in a kit form for use in collecting cell
specimens most generally from the vaginal tract and cervix region
of a female person to preserve the specimens for subsequent
cytologic study. A cell collecting device has a collecting end of a
multi-ridge perimeter formed from sponge-like material with a
handle at an opposite end. The cell sample collecting device has a
notched shaft for separating the device collecting end from the
device handle end in order for the cell collecting end to be
separately sealed in a cell preservative solution included as a
part of the kit. Additionally or alternatively, slides can be
provided for depositing the collected cell sample thereon. A cell
preservative fixative is applied over the specimens on the slides.
The slides and/or the sealed device collecting end are then mailed
or delivered for analysis.
Inventors: |
Oster; Claude (Birmingham,
MI) |
Family
ID: |
23093220 |
Appl.
No.: |
05/285,204 |
Filed: |
August 31, 1972 |
Current U.S.
Class: |
600/572; 604/540;
604/1 |
Current CPC
Class: |
A61B
10/0291 (20130101); A61B 10/02 (20130101); A61B
10/0096 (20130101) |
Current International
Class: |
A61B
10/00 (20060101); A61b 010/00 () |
Field of
Search: |
;128/2B,2W,2R,269,304
;206/63.2R ;195/13.5R |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Cancer, Vol. 7, November, 1954, pp. 1182-1184. .
J.A.M.A., Nov. 19, 1955, Vol. 159, No. 12, pp. 1177-1178..
|
Primary Examiner: Howell; Kyle L.
Attorney, Agent or Firm: Bogdon; Bernard D.
Claims
I claim
1. A cytologic collection and preservation system for preserving
collected cell specimens in a preservative liquid, comprising the
combination of a cytologic collecting device enclosed within an
elongated closed container containing cell preservative liquid
wherein the collecting device has a collector end for collecting
cell specimens with a cylindrical shaft extending from the
collector end to a notched shaft portion disposed at an end of the
collecting device opposite the collector end, said collector end
having a collector body and a collector nose collectively including
sponge-like material disposed substantially symmetrically about the
cylindrical shaft wherein the collector body has a multi-ridge
perimeter with a first set of ridges longitudinally orientated and
parallel to the shaft and wherein the collector nose has a second
set of ridges extending from the multi-ridge perimeter of the
collector body and converging toward a point at the end of the
collecting device opposite the notched shaft portion to dispose
both the collector body and the collector nose for collecting cell
specimens and wherein the elongated container enclosing the
collecting device has a closed bottom for holding the cell
preservative liquid and an open top for initial insertion of the
collecting device into the container with a shaft bearing area
integral with and disposed at the top of the container and further
including a container cap slidably engaged at the top of the
container for closing the container and sealing the liquid within
the container, said cap having an arcuately shaped cut-out at one
edge of the cap for engaging and aligning the notched shaft portion
of the collecting device with the shaft bearing area disposed at
the top of the container wherein when the collecting device is
initially inserted into the container the cap, slidably engaged
with the container, causes the notched shaft portion of the
collecting device to bear against the cap cut-out at one edge of
the cap and the bearing area at the top of the container to break
the shaft of the collecting device at the notched shaft portion and
separate it from a handle of the collecting device to thereby seal
the collecting device within the container in the preservative
liquid for preserving the cell specimens collected by the collector
body and collector nose of the collecting device.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to medical apparatus and method for
collecting and preserving cell specimens for cytologic evaluation
and in particular to medical apparatus in kit form for
self-administering including the collection of and preservation of
cells for subsequent examination.
2. Description of the Prior Art:
In an effort to make medical attention available to a greater
percentage of the world's population many medical kits designed to
be safely administered by individual users are becoming available
in the marketplace. These kits can generally be obtained from local
outlet stores and carry sufficient instructional information so
that they can be safely administered by most people. If individuals
properly follow the instructions with the suggested amount of care,
very reliable results can be obtained through the use of the
medical kits and in specific in the use of those kits where cells
are collected for subsequent examination in the process of
detecting and determining cancer. Since the individuals, which
include primarily females, can collect these cell samples without
difficulty or discomfort but cannot examine the results of their
collection because they lack the proper equipment and expertise, it
is necessary that the efforts of their collection, the cells, be
preserved and forwarded to laboratories or other areas where proper
evaluation can be conducted.
Well-known aspirator type devices have appeared on the market as
collection devices useful in obtaining cells generally from the
area of a woman's vagina for laboratory examination. It should be
understood that any locally available self-administering cell
collecting device cannot substitute for a good thorough examination
by a specially qualified doctor.
Devices for use in making self-examination and collection are not
particularly new to the public, for example, in U.S. Pat. No.
2,905,169 issued to H.E. Neiburgs on Sept. 22, 1959 entitled
"DEVICES FOR CANCER DETECTION" there is included disclosure of a
device designed to be useful in cell collection and capable of
being self-administered. In Neiburgs there is disclosed a tampon
type cell collecting device which after being self-administered,
generally in a female, is placed onto a microscope type slide to
form a smear, with the tampon and slide remaining intact for
subsequent evaluation by qualified examiners. As identified in
Neiburgs, a suitable period of time for contact of the tampon with
the female at the area where the cell collection is taking place,
such as at the cervix, is necessary in order to insure fully
reliable examination results. The time period might extend from 4
to 24 hours.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a preservative view of a kit and its contents,
embodiments according to the principles of the present invention,
for use in self-collection and preservation of sample cells.
FIG. 2 illustrates one embodiment of a sliding cover for the kit
illustrated in FIG. 1.
FIG. 3 illustrates another embodiment of a hinged cover for the kit
illustrated in FIG. 1.
FIG. 4 illustrates a plan view of a cell collecting device
according to the principles of the present invention.
FIG. 5 illustrates an end view of the cell collecting portion of
the embodiment of FIG. 4.
FIG. 6 illustrates an end view of an alternate configuration of the
embodiment illustrated in FIG. 4.
FIG. 7 illustrates a plan view of a cell preservation container as
shown in the kit of FIG. 1.
FIG. 8 illustrates a cross-sectional side view of the cell
preservation container including the cell collecting portion of the
embodiment of FIG. 4.
FIG. 9 illustrates a portion of the kit of FIG. 1 including slides
for smearing with cells collected by the cell collecting portion of
the embodiment of FIG. 4.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
As proponents of ecology and consumers' rights and social welfare
advance their causes, more and more attention is being directed to
measures of aiding a greater percentage of those in need in the
world population. Although many medical advances have been steadily
made over the centuries and recent decades in the practice of
medicine, more and more people have become aware of the fact that
the same rate of improvement is unacceptable if we are to reach
those portions of the general public which are not served.
Accordingly, a low cost convenient kit 10 of FIG. 1 is provided for
self-administering to include cell collecting instructions 12, cell
collecting apparatus 14 and cell collecting preservative measures
including cell preservation container 16 and/or cell slides 18 and
20.
Since the kit 10 is intended for safe and convenient use, it will
be attractively and conveniently packaged in order to insure that
the equipment included with it are kept clean and uncontaminated
during handling. FIGS. 2 and 3 illustrate sliding cover 22 and
hinged cover 24, respectively, for the kit 10 to substantially
protect and seal the kit contents from outside contamination. In
FIG. 4 the cell collecting device 14 of FIG. 1 is more fully
detailed and includes a cell collecting end 26 which generally
comprises an open or closed cell sponge-like material. The cell
collecting end 26 is of a general cylindrical shape. Preferably,
however, as illustrated in FIG. 5, the perimeter of the collecting
end 26 is multiedged and is, for example, octagonal. The octagonal
shape, as shown in FIG. 5, has equal length sides 28 which
intersect to form the ridge edges 30. The extreme end of a nose
portion 31 of the cell collecting end 26 uniformly tapers from each
of the respective sides 28 to a flat end surface 32. In an
alternative configuration, as illustrated in FIG. 6, the nose
portion has uniform taper from each of the sides 28 to an apex
point 33 at an extreme point of the collecting end 26.
The sample collecting device is administered to a human body in an
extremely convenient and comfortable manner and has a handle end 34
joined to the cell collecting end 26 by a notched shaft 36, as best
seen in FIG. 4. The handle end 34 and the notched shaft 36 are
formed of any suitable material such as plastic. The shaft 36,
notwithstanding a notch 38, is of sufficient material strength to
be especially maneuverable during handling and administration of
the cell collecting device 14 to the human body. The notch 38 is
located closer to the cell collecting end 26 than it is to the
handle end 34. The length of the shaft 36 is sufficient for proper
securing in any suitable manner to the cell collecting end 26 and
for proper administering to and within the human body.
In patentee's U.S. Pat. No. 3,592,186 issued July 13, 1971 and
entitled "CYTOLOGIC SCRAPER," there is included sufficient detail
and disclosure, which for the most part can be readily adapted to
the administration of the presently disclosed cell collecting
device, in order to practice and use the herein disclosed
embodiments with relative ease and comfort to gain reliable
results. Appropriate simplified directions can be printed upon cell
collecting instructions 12 to aid any person in administering the
cell collecting device 14 and preserving the collected cells. In
the case of illiterate people, simply picture diagrams can be
readily used to successfully carry the message of operation and
practice to them.
Applicant's cell collecting apparatus 14 is significantly different
from the cell collecting devices known to exist. The human
engineering aspects, including the total length and width of cell
collecting end 26, are such that the vast majority of females can,
without the aid of another person, conveniently, easily and
comfortably administer and operate the cell collecting apparatus 14
within their respective bodies to collect cell specimens
particularly from the vaginal and the cervix regions. It will be
appreciated that the cell collecting device 14 as illustrated in
FIG. 4 of the present disclosure, can readily be used with the
cover 14, as best illustrated in FIG. 2 of applicant's issued U.S.
Pat. No. 3,592,186. In actual application, the present device could
then be easily administered as illustrated and described for FIG. 6
of the previously mentioned applicant's patent.
Once collection of the cells has been accomplished it is necesary
to preserve the collected samples for subsequent examination by
qualified analysts serving at properly equipped analysis stations.
According to the principles of applicant's invention, preservation
can be accomplished in at least one of two or more different ways.
FIGS. 7 and 8 illustrate, in more detail, the cell preservation
container 16 of FIG. 1. The cell preservation container 16
comprises a preservative fluid holding body 40 and an interlocking
sliding cover 42. The sliding cover 42 is interlocked to the fluid
holding body 40 by any suitable means such as by integrally formed
sliding rails 44 and 46 disposed at the top and at opposite sides
of the fluid holding body 40. Cooperatively engaged with the
sliding rails 44 and 46 and formed as an integral part of cover 42,
are interlocking guides 48 and 50 disposed at opposite sides of the
cover 42. The cover 42 and the fluid holding body 40 when fully
engaged, lock in any suitable manner such as a snap lock to make a
fluid tight seal to preclude preservative from leaking from the
container 16 and to preclude contaminates from entering into the
container 16. Immediately after a person collects cells the cell
collecting portion 26 of the cell collecting device 14 is inserted
into the preservative solution or fluid 51 and the sliding cover 42
is caused to slide in the direction of arrow 52 to engage the notch
38 of the shaft 36 at a shaft breaking assembly 54.
The shaft breaking assembly 54 comprises for example an irregular
saw tooth arrangement 56, most probably integrally formed with the
fluid holding body 40 at its uppermost edge and an arcuate shaped
cutout 58 formed at the edge of the sliding cover 42. The notch 38,
the shaft 36, the saw tooth arrangement 56 and arcuate cutout 58
are designed in such a manner that only a slight amount of force is
necessary to break the shaft 36 at the notch 38. This can be
accomplished either by persuading the cover 42 in the direction of
arrow 52 with the notch 38 at the breaking assembly 54 until the
shaft 36 is severed at the notch 38, or by holding the notch 38 at
the breaking assembly 54 and bending the shaft 36 at that part of
the shaft designated 36', in the direction of arrow 60 until the
shaft 36 is severed at the notch 38.
The cell preservation container 16 including the body 40 and the
cover 42 are formed of suitable material to hold and seal the
preservative solution 51 and to account for the severing of the
shaft 36 at the notch 38. The suitabe material may be one or a
combination from the plastic family. The cell preservative solution
51 may be, for example, an alcohol and water mixture or simply a
suitable solution similar or identical to commercially available
unscented hairspray.
In the alternative, or as a duplicate step to insure and confirm
reliable analysis results, slides 18 and 20 may be smeared with
cells collected by the cell collecting device 14 and processed for
further examination. As hereinbefore mentioned, slides 18 and 20
are part of kit 10 and more specifically are included in
self-contained slide holder box 62. As will be appreciated from the
disclosure in patentee's hereinbefore mentioned U.S. Pat. No.
3,592,186, a suitable cell collecting device such as device 14 must
collect cells from all portions to be investigated. In the case of
a woman self-administering the cell collecting device 14 in the
area of her vagina and cervix, it is necessary to insure that cells
be collected from all portions of the area under investigation, in
order to provide reliable analysis results. From FIGS. 4, 5 and 6,
it will be appreciated that, for example, the cell collecting end
26 might best, at its sides 28 and ridge edges 30, collect cells
from the vaginal region and might best, at its nose portion 31 at
either the flat end surface 32 or the apex point 33, collect cells
from the cervix region. Accordingly, as best shown in FIG. 9, the
cell collecting device 14 is in one instance rolled along slide 20,
in a motion in the direction of arrow 64, to deposit upon the
slide, cells which have adhered to sides 28 and the ridge edges 30
of the cell collecting end 26. In another instance, the cell
collecting end 26 is dragged along slide 18, in the direction of
arrow 66, to deposit upon the slide, cells which have adhered
either to the flat end surface 32 or the apex 33 of the cells
collecting end 26. Fixatives are then applied over each of the
slides 18 and 20 to properly preserve and adhere the cells to the
slides for subsequent examination. The slide holder box 62 may then
be either covered, for example, in either manner as hereinbefore
described for FIGS. 2 and 3 with regard to the kit 10 and delivered
or mailed to the respective appropriate station for cytologic
examination and analysis.
* * * * *