U.S. patent number 3,838,681 [Application Number 05/319,288] was granted by the patent office on 1974-10-01 for device for collection of cells from the vagina.
Invention is credited to John J. Dalton.
United States Patent |
3,838,681 |
Dalton |
October 1, 1974 |
DEVICE FOR COLLECTION OF CELLS FROM THE VAGINA
Abstract
A device of unitary structure for collecting and withdrawing
exfoliated cells from the vagina for the purpose of enabling
Papanicalaou testing, venereal disease testing the like. The device
is formed as a tubular structure having one end rounded for
insertion and including a plurality of axially aligned ridges
disposed alternately with plural rows of diagonal slots, the slots
of each row having a different capillary action capability; the
tubular structure is further characterized to include axially
aligned slots and an axial end hole at the insertion end to provide
optimum functional, yet non-irritating, contact with the cervix and
cervical area of the vagina.
Inventors: |
Dalton; John J. ( Oklahoma
City, OK) |
Family
ID: |
23241627 |
Appl.
No.: |
05/319,288 |
Filed: |
December 29, 1972 |
Current U.S.
Class: |
600/570 |
Current CPC
Class: |
A61B
10/0291 (20130101); A61B 10/04 (20130101); A61B
2010/0074 (20130101); A61B 2017/320008 (20130101) |
Current International
Class: |
A61B
10/00 (20060101); A61B 17/32 (20060101); A61b
010/00 () |
Field of
Search: |
;128/2B,2W,2R,304,239 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Howell; Kyle L.
Claims
What is claimed is:
1. A device for collecting exfoliated cells from the vagina of a
subject user, comprising:
a unitary structure formed as a hollow, cylindrical tubing having a
manipulating end and an insertion end which is closed in rounded
form to define an axial aperture therein, said cylindrical
structure being entirely rigid and including a plurality of
scraping ridges formed axially in circularly spaced relationship on
the external surface thereof, and said tubular structure further
including plural rows of parallel slots aligned transversely
diagonally with each row disposed between adjacent ones of said
scraping ridges, said slots of each of said plural rows being
formed to have a different width within a range of widths assuring
varying degrees of capillary attractive action relative to liquids
encountered.
2. A device as set forth in claim 1 which is further characterized
to include:
a plurality of gripping formations formed on the external surface
of said manipulating end.
3. A device as set forth in claim 1 which is further characterized
to include:
a plurality of axially aligned slots disposed equi-spaced around
the rounded insertion end adjacent said axial aperture.
4. A device as set forth in claim 3 wherein each of said axially
aligned slots has a different width.
5. A device as set forth in claim 1 which is further characterized
in that:
said unitary structure comprises two generally semi-cylindrical
halves joined along one adjacent side by a hinge panel with the
opposite sides including fastener structure such that the
semi-cylindrical halves may be closed and fastened to form said
cylindrical tubing.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates generally to devices for collection of
exfoliated cells from membraneous tissues and, more particularly,
but not by way of limitation, it relates to an improved device for
collection of requisite cell matter from the human female for the
purpose of cancer, gonnococcal and other venereal testing and the
like.
2. Description of the Prior Art
The prior art now includes several similar types of cell collection
device which are primarily directed to usage by the female user
herself in collecting uterine and cervical exfoliated cells from
the membranes of the vaginal walls and vaginal pool. Each of the
known prior devices has been used only in association with a
specified liquid which is expelled or somehow placed within the
vagina prior to extraction of the device with disposition of
collected cells. The use of such liquids have exhibited an inherent
shortcoming due to the fact that each causes some form of
discomfort and/or irritation to the vaginal membranes as well as
the possibility of unknown long term effects which could arise
after prolonged usage.
SUMMARY OF THE INVENTION
The present invention contemplates a cell collection device wherein
a female user, in her own privacy and at her own leisure, can
collect the requisite vaginal cell matter for use in cancer and
venereal disease testing, e.g., the Papanicalaou or well-known Pap
test. In a more limited aspect, the cell collection device consists
of a tubular structure having a rounded end providing smooth, easy
vaginal insertion. The portion of the tubular structure to be
inserted is further characterized by a plurality of axial ridges
and a plurality of diagonal grooves having different capillary
action capability, which in combination provide a high degree of
exfoliated cell collection when the inserted collection device is
rotated. Further ridge and slot structure as well as an axial end
aperture are provided about the rounded insertion end of the
collection device thereby to provide optimum contact with the
cervix and surrounding area.
Therefore, it is an object of the present invention to provide a
self-administered vaginal cell collection device having a high
degree of efficiency for its intended usage.
It is also an object of the present invention to provide a cell
collection device which will maintain an optimum efficiency despite
variations as to the physical characteristics and viscosity of
membrane fluids and the like of the individual user.
Finally, it is an object of the present invention to provide an
exfoliated cell collection device for insertion in the vagina which
uses no liquid or other material in association therewith.
Other objects and advantages of the invention will be evident from
the following detailed description when read in conjunction with
the accompanying drawings which illustrate the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of the present invention;
FIGS. 2A, 2B, 2C and 2D are partial elevations of the insertion end
of the invention as progressively rotated by 90.degree.;
FIG. 3 is a plan view of the collection device as it is mold
constructed;
FIG. 4 is a vertical section taken through the collection device as
shown in FIG. 3;
FIG. 5 is a vertical section of the collection device as
illustrated in FIG. 4 when the device is closed and in operative
form;
FIG. 6 is a plan view of an alternative form of cell collection
device as constructed in accordance with the present invention;
FIG. 7 is a plan view of the device of FIG. 6 rotated by
90.degree.; and
FIG. 8 is a section taken along line 8--8 of FIG. 7.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
As shown in FIG. 1, a cell collection device 10 is formed as an
elongated, tubular structure 12 having an insertion portion 14 with
a rounded insertion end 16, and a manipulating end 18. The
manipulating end 18 is formed to include a plurality of axially
aligned ridges 20 peripherally disposed thereabout and providing
more firm finger gripping of device 10 when in use.
The insertion portion 14 of device 10 includes a quadrature array
of alternating ridges and slots; thus, axial ridges 22, 24, 26 and
28 (see also FIGS. 2A-D) are formed along the manipulating section
14 in 90.degree. displaced relationship, and a plurality of
diagonally transverse and parallel slots are formed between each
successive pair of ridges 22, 24, 26 and 28. A parallel group of
slots 30 is formed by a plurality of slots 32 and, in like manner,
a plurality of slots 34 are formed by slots 36, a plurality of
slots 38 formed by slots 40, and a plurality of slots 42 as formed
by slots 44 (see opposite side view, FIG. 2C).
Each of the diagonal slots 32, 36, 40 and 44 are disposed at a
diagonal angle to the transverse which provides an optimum scraping
and collecting efficiency, e.g., on the order of 45.degree. to the
transverse; and, each of slots 32, 36, 38 and 40 are formed to be
of slightly different width thereby to provide most favorable
capillary attraction of membrane liquids and materials in
suspension for all possible users as it is known that the native
fluid materials of the female vagina will vary over specific ranges
as to viscosity, density, electrolytic substance, etc. Thus, for
example, the slots 32 of group 30 may be formed to have a width of
0.030 inches, slots 36 with a width of 0.034 inches, slots 40 with
a width of 0.038 inches and slots 44 with a width of 0.042
inches.
The insertion end 16 of device 10 is formed as a smooth rounded
configuration having an axial aperture 46 formed therein as well as
a quadrature array of axial slots 48, 50, 52 and 54. The axial
slots are each formed on the rounded portion of insertion end 16,
and these, too, may be formed of respective different widths
similar to the diagonal slots 32-44 in the like quadrants of
tubular structure 12.
Considerable problems of manufacture and expense are solved by
forming the device 10 as a one-piece mold structure, as shown in
FIG. 3. The device 10 is singularly molded as two semi-cylindrical
side portions 60 and 62 as joined along one edge by a thin hinge
panel 64. As shown also in FIG. 4, the outer edge of tube portion
60 is formed to include an axially extending groove 66, and the
outer edge of tube portion 62 is formed to include an axially
extending interlocking land 68. Thus, and referring to FIG. 5, it
is only necessary to bend the molded article along the hinge 64 to
close interlocking land 68 within groove 66 along the length of
collecting device 10 such that the tubular structure 12 is
permanently formed, and the collecting device 10 is ready for
usage. It can be noted, too, from FIGS. 4 and 5 that after folding
enclosure to form tubular structure 12, the hinge panel 64 takes a
ridge form to provide the axial ridge 22.
In operation, it is proposed that the cell collecting device 10 be
supplied to the user along with a sealable tube containing a
suitable carrier or vehicle solution, saline solution or the like,
such that the female user can insert and manipulate the collecting
device 10 in prescribed manner and then merely insert the
collecting device 10 within the well-sealed tube with subsequent
shaking of the tube to assure contact of all collected cell matter
in the vehicle solution.
In prescribed usage, the female user need only grasp the
manipulating end 18 of collection device 10 for manual insertion
upward into the vagina. It is assumed that the user will assume a
most comfortable position suitable for her particular insertion as
this will vary greatly with different female users. The collecting
device 10 is then inserted as far as possible, i.e., until firm
resistance is met, to assure that the insertion end 16, axial
aperture 46 and end slots 48, 50, 52 and 54 will come into contact
with the cervix and cervical area. Upon positioning, it is
recommended that the user merely rotate collecting device 10 by
three or four revolutions, withdraw the collecting device 10, and
thereafter place collecting device 10 in the provided sealable tube
of vehicle liquid. It is then merely necessary to deliver the tube
and material to a qualified laboratory, gynecologist or other
qualified cytotechnologist.
The above-described insertion and rotation procedure has several
favorable effects. Since the vaginal tract in most female users is
a curved or up-tilted passageway, the insertion of a rigid
collecting device 10 causes a straightening out of the tract to
provide firm pressures more deeply up within the vaginal tract in
the area of the cervix. Thereafter, with rotation of collecting
device 10, the coactive effects of capillary attractive scraping
slots 32-44 and the scraping ridges 22-28 effect optimal collection
of exfoliated cell matter present in the vaginal upper tract. In
addition, rotation of the axial aperture 46 and end slots 48-54
provide effective yet non-irritating contact with the cervix and
its surrounding area thereby to effect collection of a greater
amount of more freshly deposited exfoliated cell matter. It should
also be noted that use of cell collection device 10 relies in no
way upon collection of matter from the vaginal pool as is requisite
in other prior art self-administered devices.
FIGS. 6, 7 and 8 illustrate an alternative form of cell collecting
device 70 which is also of rigid nature and may be molded from
selected plastic materials. The collecting device 70 is formed to
include a suitable handle 72 with a gripping end portion 74, handle
72 being formed integral with and extending into a hollow,
cylindrical collecting portion 76. The collection portion 76
includes a single axially aligned scraping ridge 78 integrally
formed along the side thereof (see also the end view of FIG. 8),
and there is formed therein a plurality of axially linearly arrayed
indentations 80. Still further, one side of collection portion 76
is extended as an arcuate projection 82 to provide more efficient
scraping of the cervix and cervical area.
The indentations 80 as arrayed along the outer surface of scraping
portion 76 and arcuate projection 82 may be varied as to outside
diameter to aid in capillary attraction of collected matter. The
arcuate projection 82 also includes a plurality of end indentations
84, and a plurality of axially aligned scraping ridges 86 and
indentations 88 as formed on the inner surface of arcuate
projection 82. A pair of transverse grooves 90 and 92 are formed
about approximately one-quarter of a conical joinder formation 94
between handle 72 and collecting portion 76.
In operation, the collecting device 70 is used in the same manner
as is the collecting device 10 of FIG. 1. That is, the device is
manually inserted by means of handle 72 to extend collecting
portion 76 inward and upward within the vagina until arcuate
projection 82 comes in contact with the cervical area. Whereupon,
rotation of device 70 by means of gripping end 74 serves to move
the arcuate projection 82 about the cervix in pressing but
non-irritating contact, and exfoliated cells are collected by the
combination of indentations 80 and scraping ridges 78 and 86.
Further, upon removal of the collecting device 70, the transverse
grooves 90 and 92 serve to collect still further cell matter from
yet another area of the vaginal tract. The removed collecting
device 70 is then placed in a selected form of sealable tube
containing the vehicle liquid, shaken, and then delivered or
dispatched to a doctor or processing facility.
It is presently contemplated that the self-administered cell
collection devices can be made readily available through available
merchandising outlets such as supermarkets, drug stores, federal
facilities and the like, thus enabling a far greater percentage of
females to have the advantage of the Papanicalaou test, venereal
disease test, etc. In particular, this would be a great stride
forward in detection and prevention of uterine and cervical cancer,
as a very large percentage of females do not yet avail themselves
of the test possibilities due to the fact that they do not bother,
are embarrassed by gynecological proceedings, or are uninformed
through not having adequate medical advice and contact with
knowledgeable physicians. The present invention enables a
fool-proof device which anyone can use and thereby obtain good
results. It has already been proven in clinical testing that the
collecting devices described herein will provide a greater
cross-section of cell types and much greater volume of total cell
collection than any of the prior art devices including the
traditional scraping and sampling tools of the gynecologist.
Changes may be made in the combination and arrangement of elements
as heretofore set forth in the specification and shown in the
drawings; it being understood that changes may be made in the
embodiments disclosed without departing from the spirit and scope
of the invention as defined in the following claims.
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