U.S. patent number 3,592,186 [Application Number 04/794,520] was granted by the patent office on 1971-07-13 for cytologic scraper.
Invention is credited to Claude Oster.
United States Patent |
3,592,186 |
Oster |
July 13, 1971 |
CYTOLOGIC SCRAPER
Abstract
An apparatus adapted to be self-administered for obtaining
surface cells from a human being, particularly from the vaginal and
cervical areas of a female, for use in diagnosing cancer, the
apparatus having a spatulalike scraper of heartlike configuration
with two dissimilarly shaped lobes for taking a cellular smear, the
scraper telescoping within a protective cover and being operable to
be extended therefrom and to be rotated for cell collecting when
the apparatus is disposed within the human body.
Inventors: |
Oster; Claude (Southfield,
MI) |
Family
ID: |
25162872 |
Appl.
No.: |
04/794,520 |
Filed: |
January 28, 1969 |
Current U.S.
Class: |
600/570 |
Current CPC
Class: |
A61B
10/0291 (20130101) |
Current International
Class: |
A61B
10/00 (20060101); A61b 010/00 () |
Field of
Search: |
;128/2,2B,304 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
SURGERY, GYNECOLOGY AND OBSTETRICS, Vol. 87, No. 3, Sept. 1948, p.
18 (copy in Gr.335 128/2B).
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Howell; Kyle L.
Claims
I claim:
1. An apparatus for obtaining cells for cytologic examination,
comprising:
an elongated body member having a central axis with a generally
flexible scraper portion at one end of the body member and a handle
at the opposite end, disposed between and integral with the scraper
portion and the handle is an intermediate portion, the scraper end
being formed of substantially nondeformable material defining a
flat section and two lobe sections, the two lobe sections are of
differing shape and each extends outwardly from the elongated body
member defining a plane passing through the axis of the elongated
body member, the lobes being of greater thickness in a direction
extending transversely to the plane than the flat section joining
the lobes and integrally connecting the lobes to the intermediate
portion, the lobes having a rough grained surface texture for
obtaining cells, the intermediate portion having a flexible portion
extending from the scraper end to a cylindrical portion extending
therefrom to the handle, the handle having a circular cross section
and protruding gripping ribs disposed about the circular periphery,
the ribs extending in length in the direction of the axis of the
elongated body member, the handle having an index tab protruding
from the circular periphery of the handle outwardly beyond the
gripping ribs; and
a tubular cover slidably engaging the elongated body member at the
cylindrical portion, the tubular cover having protruding positive
gripping ribs about its periphery, the ribs extending in length in
the direction of the axis of the elongated body member, the
elongated body member being slidable between a retracted position
whereat the scraper portion is disposed substantially interiorally
of the tubular cover and an extended position whereat the scraper
portion is disposed substantially exteriorally of the tubular cover
for rotational manipulation of the handle and the lobes at the
scraper portion when the apparatus is disposed for obtaining cells
for cytologic examination.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a medical instrument for collecting cells
from a female body for cytologic evaluation and, in particular, to
an apparatus having a scraper and a protective cover engaged in a
telescopic relationship for the scraper to extend therefrom and to
collect, upon rotation, cells from surfaces contacted when the
apparatus is disposed substantially within the female body.
2. Description of the Prior Art
In the past, devices used to gather cells from both the vaginal and
cervical areas of the female body for cytologic evaluation had to
be inserted and operated by a person having a special skill, in
order to preclude injury to the individual being examined. The
prior art scraper devices are generally of a configuration and
material which, if not handled by trained personnel, could result
in a puncture or abrasive injury to the areas being examined.
Further, those devices which purport to have elements which act to
stop the scraper from being disposed unduly into the vaginal
opening, either are not designed to gather cells from the
immediately accessible potential growth areas of cancer in the
vaginal and cervical regions or are of such construction as to be
inherently dangerous if not operated by a trained person.
SUMMARY OF THE INVENTION
Accordingly, there is need for an apparatus capable of being
self-administered for collecting cells from both the vaginal and
cervical regions of the female body for cytologic evaluation. The
present invention provides such an apparatus. The medical
instrument of the present invention is particularly useful as a
screening device and greatly facilitates the administration of
medical attention and the conduction of examinations to large
numbers of people, including those in remote areas of the world.
The medical instrument comprises a substantially resilient scraper
having a generally irregular heart-shape which is telescopically
engaged with a protective cover. When the apparatus is disposed
substantially within the female body at the vaginal opening, the
scraper is extensible and rotatable by the individual from whom the
cells are to be obtained. The scraper is shaped to collect cells
from the walls of the vagina and the fornix and os portions of the
cervix, regardless of the orientation of the cervix. An indexer is
provided to give external indication to the operator of the
relative position of the scraper when in operation.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of an example of an embodiment
according to the principles of the present invention showing a
scraper in an extended position;
FIG. 2 is a plan view of the exemplary embodiment illustrated in
FIG. 1, showing a scraper, a scraper handle and a cross section of
a protective cover, with the scraper in a retracted position;
FIG. 3 is a cross-sectional view through FIG. 2 on the plane of the
line 3-3, looking in the direction of the arrows;
FIG. 4 is a cross-sectional view through FIG. 2 on the plane of the
line 4-4, looking in the direction of the arrows;
FIG. 5 is a cross-sectional view through FIG. 2 on the plane of
line 5-5, looking in the direction of the arrows; and
FIG. 6 is an illustration of the application of the apparatus
illustrated in FIG. 1 showing a suggested method of holding during
operation thereof and a fragmentary cross-sectional view of the
vaginal and cervical areas of the female human body.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENT
Since the apparatus is capable of being self-administered, it lends
itself to widespread geographical use. It is now possible to
effectively service remotely located areas which are still without
medical facilities. Because of its intended universal use and
because many of the areas have no sterilization equipment, it is
practical that the apparatus be disposed of after a single use.
Accordingly, its manufacturing design and the material used
throughout, although in keeping with the purpose of the apparatus,
are selected to minimize its cost. Additionally, it will be
appreciated that the physical dimensions of a single unit apparatus
are selected to accommodate the vast majority of the people.
Referring now to the drawings, FIG. 1 illustrates in perspective a
cytologic scraping apparatus, generally shown at 10, having a
scraper, generally shown at 12, extending from a cover 14. The
extended position is the operative position and operation is
accomplished by manipulation of a knob 16, which is connected to
the scraper 12 through a handle 20 and on an intermediate shaft 18.
The disposed relationship of the scraper 12, the intermediate shaft
18, the handle 20 and the knob 16 is best seen in FIG. 2.
Further to FIG. 2, wherein the apparatus is shown in plan view and
in partial section, the cover 14 is of cylindrical configuration,
preferably having thin substantially rigid wall construction. It is
desirable that the cover 14 be relatively nonabsorbent and/or have
a low rate of absorption, and to have a low coefficient of friction
on its exterior surface when in contact with the human skin, in
order to retain its configuration and to be applied without
difficulty or discomfort. Optionally, the entrant end 24 of the
cover 14 may be ferruled inwardly (not shown) as an added measure
to facilitate its administration to the female body at the vaginal
opening. The sectional view of FIG. 3, best illustrates
longitudinally extending protruding ribs 25, which are optionally
included to provide a gripping surface for use when the cytologic
scraping apparatus 10 is being applied.
The inner surface of the cover 14 is slidably engaged with the
handle 20 and in combination, they are of such material and size so
as to maintain engagement under static conditions, but to be free
to be rotated and slid one within the other when external force is
applied. The handle 20, accordingly, is also cylindrical and is
able to register its entire length within the cover 14, as
illustrated in FIG. 1.
Also shown in FIG. 1, the knob 16 is in contact with the cover 14.
As best seen in FIG. 2, the surfaces which meet to form that
contact are surfaces 26 and 28 of the cover 14 and the knob 16,
respectively. When the surfaces 26 and 28 are in contact, the
scraper 12 cannot be extended farther into the body when in an
operative position. This stop acts to preclude injury caused by
undue penetration of the scraper 12. As will be appreciated,
penetration of the scraper 12 is relative to the location of the
cover 14. As is described hereinafter, the penetration depth of the
cover 14 is readily controllable.
FIG. 4 is a section along the plane of the line 4-4 viewed in the
direction of the arrows and best illustrates longitudinally
extending ribs 30, similar in nature to the ribs 25, but of shorter
length. The ribs 30 are provided to enable the knob 16 to be
rotated without undue difficulty. Since after the cytologic
scraping apparatus 10 is inserted into the vaginal opening of the
female, the relative rotated position of the scraper 12 is no
longer particularly evident, an indexer 32 is provided on the knob
16. Various views of the indexer 32 are shown in FIGS. 1, 2 and 4.
In the absence of the ribs 30, the indexer 32 can also be used to
aid in the rotation of the knob 16.
The intermediate shaft 18, as hereinabove mentioned, is connected
and preferably integral with the handle 20 and the scraper 12. The
shaft 18 and the scraper 12 are of suitable resilient material in
order to flex a slight amount under normal operating forces and yet
be rigid enough to scrape the areas of contact upon rotation. The
intermediate shaft 18 is substantially cylindrical, as best seen in
the sectional view of FIG. 5, and is free to flex equally in all
directions upon exertion of a given force. At the junction of the
intermediate shaft 18 and the scraper 12, the cylindrical shape of
the intermediate shaft 18 is reduced into the area of the scraper
12. The scraper 12 is substantially flat and is in the shape of a
heart having dissimilarly shaped lobes 34 and 36. The lobe 34 also
takes on the appearance of a fin diagonally disposed to the
longitudinal axis established by the shaft 18. The fin has an apex
or outwardmost point of generally convex shape, and when viewed
from the side has a slightly bulging appearance, as best seen in
FIG. 5, which is a sectional view in the direction of the arrows at
the plane of the line 5-5. The lobe 36 is of oblong shape with
convex end and is similarly diagonally disposed to the axis
established by the shaft 18. The lobe 36 extends a greater diagonal
distance from the axis of the shaft 18 than does lobe 34. FIG. 5
also best shows the rounded and slightly bulging side view of the
lobe 36.
It is well accepted that a roughened surface texture is more
desirable to collect cells from the vaginal and cervical regions of
a female. Not all scraper instruments necessarily need have a
roughened texture created thereon, since certain materials
inherently have suitable surfaces. Certain grades of wood and gauze
have been successfully used to collect cells from the areas under
examination. The scraper 12, as illustrated in FIG. 2, has a rather
extensive textured surface, which extends substantially up to the
junction with the intermediate shaft 18. It will be appreciated
that the texture plays a most important part along the outer
perimeter of the lobes 34 and 36 and immediately to each side of
the perimeter edge.
As mentioned hereinabove, the cytologic scraping apparatus 10 is
particularly capable of being self-administered for vaginal and
cervical examinations, and further it can be operated effectively
regardless of the position assumed by the examined person as she
operates the apparatus. Reliable results are obtainable whether the
examined person is standing, squatting, sitting or lying.
In operation, the woman assumes a comfortable position and after
having removed the cytologic scraping apparatus from its protective
and sterile packaging, grasps the cover 14 at the end closest to
the knob 16 with one hand and knob 16 with the other hand. FIG. 6
illustrates the general area involved in the examination. She then,
without undue force, inserts the apparatus into her body, entrant
end 24 preceding, past the vulva 38 substantially into the vagina
40, practically until the hand grasping the cover 14 would need to
release its grip if penetrated farther. Once the cover 14 is
comfortably inside, the woman exerts slight force against the knob
16 thereby extending the scraper 12 farther into the vagina 40
until she senses that the scraper 12 cannot be extended farther or
until the cover surface 26 and the knob surface 28 are in contact
(FIG. 1). When the cover 14 has been properly positioned, the
surface 26 and 28 will be able to be contacted and the apparatus is
ready to be operated. This arrangement is best illustrated in FIG.
6 where the lobe 34 is in contact with the os 42 of the cervix 44
and the lobe 36 is in contact with the vaginal wall 46. The
above-described arrangement will accommodate the majority of
women.
The knob 16 is now ready to be rotated and should be for a minimum
of one full turn, taking note of the initial location of the
indexer 32 so it can be returned to at least that position to
accomplish one full turn. Because of the resilience of the scraper
12 and the intermediate shaft 18 and the freedom of the cover 14 to
pivot slightly in its location, relatively little discomfort will
be felt as the scraper 12 is rotated. The dissimilarly shaped lobes
34 and 36 are configured to contact the vaginal walls 46, the
ectocervix 48 and the os 42 of the cervix 44 to allow the scraper
12 to collect cells on its roughened surface for cytologic
evaluation. The scraper 12 is successful in collecting cells from
the cervix 44 regardless of the orientation it may assume.
After a scraping has been accomplished, the knob 16 is urged
outwardly thereby retracting the scraper 12 to assume a retracted
position with respect to the cover 14, as best shown in FIG. 2. The
woman then extracts the cytologic scraping apparatus 10 from her
body and then presents it to a clinic aid for deposition of the
cellular scraping upon a slide for cytologic examination.
Alternatively, the woman could once again extend the scraper 12 and
smear the scrapings from the lobes 34 and 36 upon a slide and apply
a usual fixative thereto and send the slide, properly identified,
to a laboratory for examination.
The ease of operation of the apparatus, the reliable results
achieved through its use, the fact that it is capable of
self-administration and can be made inexpensively, renders this
inventive apparatus a ideal instrument for screening great
multitudes of women to determine the existence or nonexistence of
cancerous growth in the cervical and vaginal areas. This apparatus
will enable medical personnel presently involved in conducting such
examinations to devote their time to other critical matters.
Because instruction in the use of the cytologic scraping apparatus
10 is possible through printed picture form on instructional
sheets, the apparatus can be used by the literate and nonliterate
alike, making it ideally suited to be used in remote underdeveloped
areas of the world.
This invention is described by way of illustration rather than
limitation, and accordingly it is understood that this invention is
to be limited only by the appended claim taken in view of the prior
art.
* * * * *