Apparatus and method for self-obtaining PAP smears

An apparatus and method of obtaining self-administered PAP smears is disclosed which includes a hollow, cylindrical speculum of suitable minimum inside diameter to permit mirror vision therethrough. The speculum is formed with an angled front orifice wherein the front angle between the orifice and the axis of the speculum is particularly designed to easily fit about the cervix. The entire squamocolumnar junction of the uterine cervix is exposed within the front orifice to permit complete wiping, preferably under visual observation through a hand mirror. A hinged, elongated spatula and an angled endocervical sampler are included as part of the test equipment to faciliate the taking of uncontaminated, accurate specimens.

BACKGROUND OF THE INVENTION 
1. Field of the Invention 
This invention relates generally to methods and apparatus for self 
obtaining cervical cytologic samples for subsequent testing using the 
Papanicalou test (Pap test) for the early detection of cervical cancer. 
2. Discussion of the Prior Art 
The PAP test is a method of screening for uterine, cervical, and vaginal 
cancer. The American Cancer society recommends that for normal women under 
forty a PAP smear be taken every three years after three consecutive 
yearly normal PAP smears. Some gynecologists do not feel this is often 
enough. This invention is designed as an additional PAP test which can be 
taken in ones home and which can be used yearly in addition to but not in 
substitution for the regular three year gynecological examination. 
The PAP test is traditionally taken by a gynecologist by inserting a 
speculum into the vagina in a manner to expose the cervix. To accomplish 
this, the woman must remain in a reclining position. Various types of 
speculums and numerous cervical scrapers or probes have been developed for 
this purpose. The cytologic specimens collected are then placed upon 
microscope slides, or more recently, in liquid fixative for automated 
reading. They are evaluated for hormonal levels and to determine the 
presence of cancers, precancers and vaginal infections. 
Most of the prior art equipment has been designed for use by gynecologists 
and is not suitable for self-administration. There have been previous 
attempts to develop PAP test apparatus that could be self administered. 
However, those devices have not included endocervical sampling and have 
not specifically wiped the squamocolumnar junction, the two places where 
cancers start. Because of these they are regarded as not safe. The need 
remains to provide an accurate, non-traumatic self-administered apparatus 
and method for the collection of cervical tissue for cytologic evaluation. 
SUMMARY OF THE INVENTION 
The present invention relates to the field of PAP tests, and is directed to 
an improved apparatus and method for obtaining PAP smears. 
In accordance with the teachings of the present invention, a hollow, 
cylindrical speculum of suitable inside diameter to permit sampling is 
provided. The speculum is formed with an angular front orifice wherein the 
front angle between the orifice and the axis of the speculum is designed 
to comfortably accept the cervix from the angle the cervix meets the 
vagina when the woman is upright. The orifice edge has a rounded bead to 
avoid cutting the fragile vaginal tissue. Because of the angularity, the 
orifice can surround the cervix to facilitate its isolation from the 
impinging vaginal tissue. The cylindrical body holds back the vaginal 
tissue which presses inward from all directions. The prior art speculums 
used by gynecologists only isolate the cervix from vaginal tissue above 
and below it, and remain in place only when the woman is fully reclining, 
so they cannot be self-administered. By isolating the cervix in the 
angular orifice of the speculum, the endocervix and the squamocolumnar 
junction can be wiped with ease by the user without the danger of loosing 
wiped cells by brushing them against unrestricted vaginal walls, providing 
a complete specimen. The inside diameter of the speculum is designed to be 
large enough to enable the user to observe the positioning of the speculum 
and use of the probes by employing a hand mirror. In this manner, 
positioning of the speculum orifice about the cervix, and the sampling, 
can be checking by visual observation. This provides test results that are 
far superior to any that have heretofore been achieved with prior art 
self-administered PAP test equipment. 
An angled endocervical sampler and an elongated angled spatula are provided 
as part of the test equipment to facilitate the taking of specimens from 
the endocervical canal and the cervix respectively. 
The angled front orifice of the speculum, together with the ability to 
permit visual observation through the hollow speculum interior by 
utilizing a mirror, assures that uncontaminated specimens can thus be 
taken, even by unskilled persons. 
It is an object of the present invention to provide a novel apparatus and 
method for self-obtaining PAP smears which includes a hollow speculum with 
a front orifice that is angled to fit about the cervix, the speculum 
having sufficient internal diameter to facilitate visual observation by 
mirror to assure correct placement. 
It is another object of the present invention to provide a novel apparatus 
and method for self obtaining PAP smears which comprises a hollow, plastic 
speculum, the speculum terminating forwardly in a front orifice that is 
angled at approximately twenty-six degrees from the longitudinal axis of 
the speculum, and an endocervical sampling tool having a fibrous sampling 
end, offset from the handle body by a total angle of approximately one 
hundred twenty degrees, and a handle which when braced against the inside 
wall of the speculum gives control to the endocervical sampling, the 
device being suitable to extract a sample from the endocervical canal, and 
a spatula having a hinged scraper to conform to the various contours of 
the cervix during scraping, and an angled handle, which when braced 
against the inside wall of the speculum, gives even pressure and control 
to the wipe, and. 
Other objects and a fuller understanding of the invention will be had by 
referring to the following description and claims of a preferred 
embodiment thereof, taken in conjunction with the accompanying drawings, 
wherein like reference characters refer to similar parts throughout the 
several views and in which:

DESCRIPTION OF THE PREFERRED EMBODIMENT OF THE INVENTION 
Although specific terms are used in the following description for the sake 
of clarity, these terms are intended to refer only to the particular 
structure of the invention selected for illustration in the drawings, and 
are not intended to define or limit the scope of the invention. 
Referring now to the drawings, there is illustrated in FIG. 1 and 2 a novel 
speculum 10 which is a hollow cylindrical configuration. Preferably the 
speculum is fabricated with thick side walls of polypropylene, 
polyethylene, or other suitable material. The speculum includes a body 12 
that is approximately seven inches in length with an enlarged rounded bead 
22 about the periphery of the forward orifice. The orifice is designed to 
minimize injury to the soft vaginal tissue when in use. 
The body 12 terminates rearwardly in an unobstructed rearward opening 14 
(FIG. 3) and forwardly in an angled orifice 16. As best seen in FIG. 2. 
The orifice is formed at an angle of between twenty degrees and thirty 
degrees from a plane drawn parallel to the longitudinal axis of the 
speculum to facilitate easy application about the cervix 18. An angle of 
approximately twenty-six degrees has been found to be optimum in most 
instances for this purpose as indicated by the double headed arrow 20. 
Preferably, the edge of bead 22 which defines the orifice 16 is rounded as 
indicated to provide a thickness or diameter of approximately one eighth 
inch to three sixteenth inches. 
In order to use the apparatus of the present invention for self-obtaining 
PAP smears, the speculum 10 should be well lubricated with mineral oil or 
petroleum jelly (not shown), and then with the users hand 48 positioned as 
illustrated in FIG. 3, the speculum 10 should be inserted into the vagina 
50. The users thumb 52 should be placed interiorly of the rearward 
speculum opening 14 to permit the speculum to be pressed downwardly during 
insertion. This downward pressure allows the forward end or or tip 54 of 
the speculum 10 to pass over the cervix 18 without scraping or other 
trauma. The speculum should then be manipulated as necessary to position 
the cervix 18 to reset in the angled orifice 16 comfortably and 
completely. See FIGS. 3, 5, 7, and 8. When properly positioned, the 
speculum 10 will have no tendency to back out or to move on its own until 
the operator consciously moves the speculum. As above set forth, a mirror 
(not shown) can be employed by the user to visually observe that the bead 
22 of the orifice completely surrounds the cervix. 
Referring now to FIGS. 4 and 5, with the speculum 10 properly positioned, 
the endocervical sampler 30 can be inserted through the hollow interior 56 
of the speculum 10, it's angle 24, approximately 25 degrees, braced 
against the inside wall of the speculum, and the fibrous tip 32, angled at 
the angle 31, approximately 117 degrees, inserted into the endocervical 
canal 26, to remove a portion of the mucoid fluid 58 from the entrance to 
the endocervical canal. Preferably, a hand mirror (not shown) can be 
employed to assure the proper positioning of the bent tip 32 directly 
within the endocervical canal 26. It will only be necessary to enter the 
opening into the endocervical canal 26 approximately one quarter to one 
half of an inch to obtain a suitable specimen. The material 58 thus 
removed when the endocervical sampler is withdrawn through the speculum 10 
should then be placed on a conventional slide and covered with a carbowax 
fixative in well known manner, or placed in a liquid fixative for 
automated reading. 
Referring now to FIGS. 7 and 8, an elongated spatula 34 is then inserted 
forwardly through the interior 56 of the speculum 10 until the wiping 
surface 46 of the hinged scraper head 38 touches the surface of the cervix 
18. The operating end 42 of the handle body 36 is offset from the rest of 
the handle body by an angle of approximately thirteen degrees. By 
manipulating the handle body 36, and by levering it's angle against the 
speculum interior for even pressure and control, the scraper head 38 
should then gently but firmly be moved up one side of the cervix, across 
the top and then down the other side in a circular motion. All of the 
material on the scraper wiping surface 46 (squanmous cell sample) should 
be deposited on the slide marked "vaginal", or placed in a fluid fixative 
for automated reading. The spatula should then be re-introduced through 
the speculum and the procedure should be repeated in the opposite 
direction to be sure that the entire squamocolumnar junction is wiped. The 
circular wiping may be repeated if it is felt that any portion of the 
cervix is missed. Because of the advantages provided by the angular offset 
of the operating end 42 from the axis of the spatula handle 36, a hand 
mirror (not shown) may be employed to observe the movement of the scraper 
head over the cervix to thereby assure complete wiping. The squamous cell 
sample 66 can be applied upon a glass slide, and covered in known manner 
with the carbowax fixature or placed in a liquid fixative for automated 
reading. With the samples properly fixed they can be shipped to an 
approved testing laboratory for reading. 
Although the invention has been described with a certain degree of 
particularity, it is understood that the present disclosure has been made 
only by way of example and that numerous changes in the details of 
construction and the combination and arrangement of parts may be resorted 
to without departing from the spirit and scope of the invention. Thus the 
scope of the invention should not be limited by the foregoing 
specifications, but rather, only by the scope of the claims appended 
hereto.