U.S. patent number 3,633,565 [Application Number 05/024,535] was granted by the patent office on 1972-01-11 for clinical specimen-collecting instrument.
This patent grant is currently assigned to Medical Testing Systems, Inc.. Invention is credited to Bernard McDonald.
United States Patent |
3,633,565 |
McDonald |
January 11, 1972 |
CLINICAL SPECIMEN-COLLECTING INSTRUMENT
Abstract
An elongate clinical instrument comprises a blade and handle for
collecting cells and tissues from body cavities, particularly for
the detection of squamous carcinoma of the cervix. Two slanted
spaced-apart edges on the blade tip describe a conical path during
manual rotation in situ and gather specimens in troughs adjoining
the edges. The blade tip is manually separable from the handle for
forwarding to a pathology laboratory.
Inventors: |
McDonald; Bernard (Malibu,
CA) |
Assignee: |
Medical Testing Systems, Inc.
(Beverly Hills, CA)
|
Family
ID: |
21821096 |
Appl.
No.: |
05/024,535 |
Filed: |
April 1, 1970 |
Current U.S.
Class: |
600/570; D24/147;
408/214 |
Current CPC
Class: |
A61B
10/0291 (20130101); Y10T 408/902 (20150115) |
Current International
Class: |
A61B
10/00 (20060101); A61b 010/00 (); A61b 017/22 ();
B27c 005/00 () |
Field of
Search: |
;128/2,2B,253,302,303,304,305 ;145/117,116,123,126 ;77/67,70 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
820,527 |
|
Aug 1937 |
|
FR |
|
1,451,726 |
|
Jul 1966 |
|
FR |
|
1,173,267 |
|
Dec 1969 |
|
GB |
|
1,084,640 |
|
Sep 1967 |
|
GB |
|
Primary Examiner: Medbery; Aldrich F.
Claims
I claim:
1. An elongate substantially rigid implement for collecting
diagnostic material in situs from body cavities, comprising:
handle means at one end of said implement for manually rotating
said implement about a rotational axis through the longitudinal
center of said elongate implement,
projection means extending radially from said handle means adjacent
to and axially spaced from the distal end of said handle means,
blade means secured to said handle means,
said blade means including at least two spaced-apart slanted
cutting edges, relative to said rotational axis, and which extend
from said distal end of said implement and include the upper
portions of said projection means and which describe a conical path
during rotation of said implement, the lower portions of said
projection means constituting a noncutting portion,
each of said blade means further including a recessed groove
adjoining said cutting edge and extending along the length thereof
for receiving said diagnostic material collected by said edge from
said situs.
2. The structure set forth in claim 1 above, further including:
a structurally weakened neck portion between said handle means and
said blade means for breaking the same apart by application of
manual force thereto.
3. The structure set forth in claim 1 above, wherein:
said elongate implement further includes at said distal end a
domelike protuberance having means to scrape over said situs when
said implement is removed therefrom.
4. The structure set forth in claim 2 above wherein said elongate
implement further includes a domelike protuberance and a reduced
cylindrical portion fixed to said distal end, said protuberance
having a peripheral edge thereon for scraping over said situs when
said implement is removed therefrom.
5. The structure set forth in claim 2 above wherein said blade
means comprises at least two oppositely facing substantially
parallel surfaces.
Description
BACKGROUND OF THE INVENTION
Devices commonly used for collection of samples as required for
detection of interuterine cancer or the like typically include
simple swabs, small wood sticks, brushes, or else relatively
elaborate and costly aspirators. Since the cancer cells are fragile
and break or fall away easily from any surface supporting them, and
since surrounding tissues usually obscure the test area, it is
often difficult to know whether such cells which might have been
initially resting on a swab or stick were jarred or rubbed off and
lost in the attempt to remove the same from the test situs.
The problems associated with specimen collecting in the foregoing
context are notably difficult in the case of squamous carcinoma
which most commonly originates at the squamo columnar junction. An
accurate determination of cancer requires a complete survey of the
entire test area, which would involve multiple biopsies, and even
these would represent localized portions rather than a
comprehensive sampling of the total area. Ideally, fragments of
tissue must be recovered representing the total test situs to
permit preparation of histological slides which retain tissue
architecture as opposed to cytology slides which present a
collection of isolated cells. Surfaces which merely contact a
tissue of a swab or stick collect only loose particles and not
tissue fragments. Moreover, many doctors lack the time and patience
to transfer every collected cell and particle from a stick onto a
microscopic slide, whereby valuable diagnostic material may be
lost, resulting in a risk or erroneous conclusion in respect of the
patient's condition.
Due to the foregoing limitations, many Pap Smears cannot be
accurately diagnosed or else render only an ambiguous result. Where
this is the case, a surgical procedure called "cold conization" is
typically resorted to. However, this is a relatively major
operation requiring hospitalization and general anesthesia. The
invention device disclosed herein is designated to bridge this
diagnostic gap between the office "Pap Smear" and the hospital
"cold cone" thereby preserving many women from the risk of
nondetection on one hand or the discomfort, danger, and expense
inherent in a major operation.
SUMMARY OF THE INVENTION
The invention in this case consists of an elongate tool or
implement 10 for clinical or office use by physicians, and
comprising a handle portion 12 and a blade portion 14. Blade
portion 14 is essentially flat or planar and has a pair of
oppositely facing and spaced-apart edges 16 and 18 adapted to
scrape the entire circumference of the squamo columnar junction
area with a deep-ploughing action. A storing groove or trough 20
and 22 adjoins each of the edges 16 and 18, respectively, and
receives the samplings progressively obtained by the stated edges
during rotation of the instrument. Rotation is accomplished by
force manually applied to handle portion 12. Following removal of
implement 10 from the cervical canal, force is manually applied to
portions 12 and 14 as required to break the implement at the
location of thinned neck portion 17 therebetween, after which blade
14 with the collected matter in grooves 20 and 22 may be dropped
into a biopsy bottle and sent to a laboratory for pathological
analysis.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 shows a partly fragmented elevational view of the structure
disclosed herein,
FIG. 2 shows a view corresponding with FIG. 1 but with the
structure rotated 90.degree. relative thereto,
FIG. 3 shows a tip view looking downward onto the structure shown
in FIGS. 1 and 2,
FIG. 4 shows a cross-sectional view taken along line 4--4 of FIG.
1,
FIG. 5 shows a cross-sectional view taken along line 5--5 of FIG.
1, and
FIG. 6 shows a cross-sectional view taken along line 6--6 of FIG.
1.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to FIG. 1, implement 10 may be seen to comprise handle
portion 12 and flat blade portion 14 integrally formed therewith of
substantially rigid material such as plastic. Blade portion 14 has
oppositely facing substantially parallel surfaces 13 and 15 seen
particularly from FIG. 2, and a structurally weakened neck portion
17 defined by a transverse groove across both surfaces 13 and 15
resulting in a reduced cross-sectional thickness as shown more
clearly in FIG. 5.
Blade portion 14 is an elongate cutter shaped along the sides
thereof to correspond generally with the natural contours of the
cervix of a human uterus as required for maximum effectiveness in
performing its intended function. Thus, the opposite side contours
defined by thin lips or cutting edges 16 and 18 may be seen to
diverge from relatively close proximity therebetween near distal
end 19 to a maximum width at oppositely directed projections 21 and
23. The edges 16 and 18 thus describe a conical path when implement
10 is rotated by manual force applied to handle 12. If only one
edge were made to function as a specimen collector, the lateral
forces on such blade would be unbalanced during rotation of
implement 10 and its longitudinal axis in the manner described
below, whereby two oppositely directed edges are preferred in the
symmetrical relationship suggested by edges 16 and 18. A separate
recessed groove adjoins each of the edges 16 and 18 as suggested by
grooves 20 22, respectively, and extends coterminally therewith so
as to describe the same conical path as edges 16 and 18 during
rotation of implement 10 as discussed above. The number of edges
16, 18 of adjoining grooves 20, 22 could be more than two in
number, but as a practical matter only two of each, as suggested by
the structure shown in the accompanying drawing, have been found to
provide all the advantages sought in this case. Also, while the
angularity of the edges 16, 18 and adjoining grooves 20, 22 could
be varied slightly, the preferred arrangement is for the included
angle to be from about 10.degree. to 30.degree. between the edges
in that portion between distal end 19 and line 4--4 in FIG. 1, for
example, increasing to about 45.degree. to 60.degree. included
angle in the flared portion from line 4--4 to oppositely extending
projections 21 and 23. Of particular importance is the fact that
edges 16, 18 are directed in opposite directions as seen in FIGS. 3
and 4.
Distal end 19 of implement 10 has a bulbous or mushroom-shaped
protuberance extending therefrom and comprising button or dome 25
connected to end 19 by recessed shaft 26 of lesser diameter than
portion 25. Dome 25 has a peripheral scraping edge 30 thereon.
Handle portion 12 may be cylindrical, but in the preferred
embodiment has a plurality of longitudinal strengthening ribs 27
symmetrically arranged about the center axis 28 of the handle as
seen particularly from FIG. 6.
In operation, implement 10 is initially introduced onto the
cervical canal with distal end 19 projecting therewithin and with
oppositely directed projections 21 and 23 bearing against the outer
surfaces of the squamo columnar junction. While thus positioned,
implement 10 is rotated 360.degree. about axis 28, although such
rotation could obviously be more than one complete turn. During the
foregoing movement, edges 16 and 18 bear uniformly throughout their
length with the surfaces which they contact and which have
substantially the same contours as the path defined by the edges
during the stated rotation. The relationship between edges 16, 18
and grooves 20, 22 as discussed above results in a plowing and
scraping action whereby edges 16, 18 detach cells, surface tissue
and other diagnostic material from the test situs, such material
being channeled into the mentioned grooves as it is progressively
accumulated. During withdrawal of implement 10, additional cells or
the like are captured by the mild scraping action of the peripheral
edge 30 of protuberance 25 and retained about recessed shaft
portion 26 on distal end 19 of the implement. Thereafter, force is
applied through portions 12 and 14 as required to fracture
completely through groove 17 and separate the two stated portions.
Blade portion 14, with the collected matter in grooves 20, 22 is
then dropped into a biopsy bottle which is sealed and sent to a
laboratory for pathological analysis.
From the foregoing, it may be seen that the structure and method in
this case provide a rapid and effective means for collecting
diagnostic matter and with a minimum of specialized skill. The
plowing and scraping action of blade edges 16, 18 assures complete
collection of matter throughout the entire test area whereby a
comprehensive sampling is achieved, and further assures that such
matter will include surface tissue structure rather than loose
cells only. The area thus sampled is wider and of greater yield
potential than could be accomplished by multiple biopsies. The
tissue sheared from the test surface is shallow, so that pain or
postoperative bleeding are not encountered in using implement 10.
Moreover, the procedure can be carried out simply during the course
of a pelvic examination in a medical office and requires no
elaborate medical or hospital surgery equipment.
* * * * *