U.S. patent number 3,636,940 [Application Number 05/018,184] was granted by the patent office on 1972-01-25 for method for collecting cellular material by circulating a fluid within a body cavity.
Invention is credited to Leland C. Gravlee.
United States Patent |
3,636,940 |
Gravlee |
January 25, 1972 |
**Please see images for:
( Certificate of Correction ) ** |
METHOD FOR COLLECTING CELLULAR MATERIAL BY CIRCULATING A FLUID
WITHIN A BODY CAVITY
Abstract
A washing method for irrigating a body cavity using an apparatus
having an inlet tube which is open at both ends, and is adapted to
have its forward end extend into a body cavity and its rear end
connected to a source of washing fluid. Additionally, an outlet
tube, which is open at both ends forms part of the apparatus. The
inlet tube has its forward end adapted to extend into the body
cavity with its rear end connected to a source of suction. A
sealing member is positioned on the outlet and inlet tubes
intermediate their ends and is adapted to seal the entrance to the
body cavity. In operation, the source of suction provides a
negative pressure to the body cavity and washing solution will pass
through the inlet tube into the body cavity, accumulate cells and
matter therefrom and pass through the outlet tube to a collection
point.
Inventors: |
Gravlee; Leland C. (Mountain
Brook, AL) |
Family
ID: |
26690825 |
Appl.
No.: |
05/018,184 |
Filed: |
March 10, 1970 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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688723 |
Dec 7, 1967 |
3527203 |
Sep 8, 1970 |
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421013 |
Dec 24, 1964 |
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Current U.S.
Class: |
600/563; 604/38;
604/41; 604/215 |
Current CPC
Class: |
A61M
1/0058 (20130101); A61B 10/0291 (20130101); A61B
2010/0216 (20130101) |
Current International
Class: |
A61M
1/00 (20060101); A61B 10/00 (20060101); A61b
010/00 () |
Field of
Search: |
;128/2,2B,240,241,227,228,276,278,350,2F,2W |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Howell; Kyle L.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a division of my previous application, Ser. No.
688,723 which was filed on Dec. 7, 1967, now Pat. No. 3,527,203,
and which is a continuation-in-part of my previous application,
Ser. No. 421,013 filed Dec. 24, 1964, now abandoned.
Claims
What is claimed is:
1. A method for collecting cellular material from the inner walls
of the uterus in a manner which will facilitate obtaining a sample
from a substantial portion of the inner walls of the uterus without
subjecting the patient to undue pain or discomfort comprising:
sealing the uterus;
subjecting the interior of the uterus to a negative pressure and
simultaneously therewith drawing into the uterus a washing fluid in
the form of a spray whereby the fluid will contact the inner walls
of the uterus and will accumulate cellular and other material
therefrom; and
extracting the washing fluid together with the cellular material
from the uterus while retaining the uterus in a negative pressure
condition while continuously drawing washing fluid into the uterus
so that only a minimum amount of washing fluid is retained in said
uterus at any given time to thereby alleviate the danger of passage
of the fluid containing collected matter to other portions of the
body prior to extraction thereof from the uterus for collection and
ultimate testing purposes.
2. The invention in accordance with claim 1 wherein the fluid is
passed through a pair of adjacent tubes having openings in both
ends thereof with the forward end of each tube adapted to be
positioned within the uterus and the rear end of each tube adapted
to be connected respectively to a source of washing fluid and a
source of suction so that when said tubes are properly positioned
and connected washing fluid will be drawn through one of said tubes
into said uterus and thereafter from said uterus through the other
of said tubes into a collection container associated with said
source of suction carrying therewith collected cellular and other
matter from the uterus.
3. The invention in accordance with claim 2 wherein sealing of the
uterus is accomplished by an adjustable sealing member slidably
mounted on said tubes in sealing engagement therewith and being
adapted to be positioned in sealing engagement with the entrance to
the uterus.
4. The invention in accordance with claim 2 wherein the fluid
passing through one of said tubes into the uterus is drawn through
a row of aligned holes in the exterior surface of the one tube so
as to contact the inner walls of the uterus in the form of a spray,
the other of said tubes containing a plurality of openings through
which the washing fluid and collected matter will pass when being
drawn from the uterus into said other tube for collection, the area
of the openings in said other tube being greater than the area of
the openings in said one tube to facilitate removal of the washing
fluid from the uterus without undue accumulation of fluid within
the uterus.
5. The invention in accordance with claim 4 wherein the row of
aligned holes in said one tube are in the wall distal from said
other tube and in direct communication with the walls of the uterus
so that when said washing fluid passes through said row of aligned
openings it will directly contact the walls of the uterus, and at
least one communicating passageway between said adjacent tubes and
opening on the adjacent walls of the forward portions thereof to
facilitate initiation of the proper flow of washing fluid upon
commencement of the collection process.
6. The invention in accordance with claim 3 wherein the outer edges
of the openings in both of said tubes facilitate collection of
additional cellular material to be later collected from said tubes
and placed within the container containing the collected washing
fluid and previously accumulated cellular and other matter.
7. The invention in accordance with claim 1 wherein prior to
sealing of the uterus, the uterus is sounded to assist in properly
ascertaining the location and depth of the uterus.
8. The invention in accordance with claim 7 wherein the uterus is
probed with the sound sufficiently by contacting the uterus inner
walls with the sound to aid in the loosening of cells for the later
washing operation.
Description
BACKGROUND OF THE INVENTION
In the field of diagnosing various types of intrauterine cancer
such as endometrial carcinoma in its early stages, the known
methods for obtaining cells for diagnosis are not entirely
satisfactory. There is a considerable need for an improved
diagnostic method which will greatly improve the results.
As is well known in the art, with the aging population, the
occurrence of endometrial carcinoma is rapidly approaching a
one-to-one ratio with the occurrence of carcinoma of the cervix.
Endometrial carcinoma is in marked contrast to carcinoma of the
cervix uteri with regard to early diagnosis. The recognition of
cervical carcinoma in an asymptomatic patient while the lesion is
still intraepithelial is almost exclusively the result of advances
in exfoliative cytology. Endometrial carcinoma, on the other hand,
is rarely diagnosed in the asymptomatic patient and while it is
frequently an indolent cancer of slow development, this biological
feature is not reflected in survival statistics. Accordingly, if
patient salvage is to be improved in cases of endometrial
carcinoma, early diagnosis must be made more frequently than is
possible with conventional or routine vaginal or cervical
smears.
Routine vaginal and cervical smears are unsatisfactory for use in
detecting endometrial carcinoma due to the fact that the
endometrium does not exfoliate as readily as the cervix uteri or
vagina. Accordingly, the number of cells reaching the vaginal pool
is relatively small and the cells themselves frequently degenerate
whereby the whole sample is heavily diluted by material from the
cervix and vagina.
Various devices have been proposed to increase the efficiency of
the test for endometrial carcinoma, such as the introduction of the
sterile saline solution under pressure. This procedure has been
found to be unsatisfactory due principally to the fact that
diseased cells are often forced into other cavities, such as the
Fallopian tubes thereby spreading the disease to other parts of the
body. Additionally, rotary brush units have been employed, however,
such units are unsatisfactory since they are difficult to sterilize
and a possibility also exists that bristles will break off during
the sampling process and thereby cause irritation and inflammation
to the interior parts of the patient.
From the above, it is apparent that there is a need in the art for
the provision of an intrauterine sampling method which will produce
a sufficient and desirable amount of cell tissue for effective
diagnosis. A method would be desirable which would avoid the
problem of possible irritation of the inner parts of the patient
and in particular the problems coexistent with many painful
procedures of examination. In this manner, the necessity of an
anesthetic is eliminated thereby allowing the doctor to simply
obtain a sample in his office quickly and efficiently. Naturally as
discussed above, it would also be advantageous to provide a
sampling or washing method which would alleviate the danger of
cells being washed to other parts of the body such as out of the
Fallopian tubes.
With the known types of sampling methods, practice thereof is often
very painful and requires an anesthetic to be used as well as other
considerations for the comfort of the patient.
Another existent problem with methods wherein devices are inserted
into the uterus is the danger of the device being inserted too far
so that it will pierce the uterus wall causing serious internal
damaged to the patient. Therefore, it would be advantageous to have
an adjustable device whereby the distance it extends into the
uterus can be regulated for the particular different size or shape
of a uterus.
It should be kept in mind that although the washer has use in
intrauterine diagnosis, particularly for the use of diagnosing
endometrial carcinoma as described herein for exemplary purposes,
it is also possible to adapt the device for many other uses such as
in the lungs. In a similar manner, a sampling of tissue may be
removed from the lungs for testing purposes. Furthermore, the
washer may be used for radiation therapy in which radio opaque dye
may be irrigated through the uterus. Also, this device as well may
be used as a means of introducing therapeutic medicament in that
the application of the fluid is localized.
SUMMARY OF THE INVENTION
A method of irrigating a body cavity using an apparatus consisting
principally of an inlet tube, an outlet tube and a sealing member.
The inlet tube is open at both ends and has its forward end adapted
to extend into the body cavity when in position and its rear end is
adapted for connection to a source of washing fluid. The outlet
tube is also open at both ends and when in position has its forward
end extending into the body cavity and its rear end is adapted for
connection to a source of suction. The sealing member is positioned
intermediate the ends and on the tubes and is adapted to seal the
entrance to the body cavity. When suction is applied to the outlet
tube a negative pressure is created in the body cavity and washing
solution passes through the inlet tube into the body cavity,
accumulates cells and matter therefrom and then exits through the
outlet tube for collection.
It is a primary objective of this invention to alleviate the above
mentioned problems by providing a method of irrigating a body
cavity which provides a negative pressure within the body cavity
while collecting a highly desirable amount of cell tissue for
analysis thereby minimizing the danger of malignant material
entering the other body passages.
Another object is to provide a method which may be easily and
painlessly practiced in the doctor's office without the necessity
of administering an analgesic or anesthetic to the patient while
still obtaining an improved sample of tissue for further diagnostic
process.
Other objects and advantages will become apparent from the
following detailed description which is to be taken in conjunction
with the accompanying drawing illustrating a preferred embodiment
of this invention.
BRIEF DESCRIPTION OF THE DRAWING
With the foregoing in mind, reference is made to the accompanying
drawing in which:
FIG. 1 is a side view of a washing apparatus embodying this
invention;
FIG. 2 is a schematic view thereof showing the device in position
within a uterus and being connected to a suction source and a
source of washing solution;
FIG. 3 is a fragmentary sectional side view of the forward portion
of a washing apparatus embodying this invention;
FIG. 4 is a fragmentary side elevation view of the forward portion
of the outlet tube part of a washing apparatus embodying this
invention;
FIG. 5 is a sectional end view of the forward portion of a washing
apparatus embodying this invention taken along the plane of line
5-5 of FIG. 3; and
FIG. 6 is a sectional end view thereof taken along the plane of
line 6--6 of FIG. 3.
DESCRIPTION OF THE PREFERRED EMBODIMENT
As stated above, the washing apparatus of this invention is useful
for many applications, however, for descriptive purposes, the
device will be applied as in intrauterine washing device in the
following discussion.
As shown in FIG. 1, the intrauterine washing apparatus 20 is
comprised basically of three main parts. There is an inlet tube 21,
an outlet tube 22, and a sealing member 23.
Inlet tube 21 has an adapter 24 at its rear end which may be
connected to a source of washing solution. At the other end of
inlet tube 21 is a series of aligned apertures 25 along the end
portion surface thereof and an opening 26 at the forward end.
The outlet tube 22 has an adapter 27 at its rear end for connection
to a source of suction. At its forward end it also has a series of
apertures 28 adjacent the end and an opening 29 at its end.
Inlet tube 21, outlet tube 22, and adapters 24 and 27 are generally
constructed of a low-cost plastic material however, other materials
well known in the art having similar properties will work
satisfactorily. The forward portions of inlet tube 21 and outlet
tube 22 are fastened in a permanent connection by any common
well-known nontoxic adhesive means. Adapters 24 and 27 are
similarly fastened to the rear end of tubes 21 and 22. It should be
noted that, alternatively, inlet tube 21 and outlet tube 22 may
consist of a body of one-piece plastic construction with two
separate passageways therein to form tubes 21 and 22.
Turning to FIGS. 3-6, the forward portions of inlet tubes 21 and
outlet tube 22 can be observed in greater detail. To obtain the
desirable negative pressure within the uterus when the washer 20 is
inserted therein, it will be observed that outlet tube 22 is of a
considerably larger diameter than inlet tube 21. Furthermore, there
are a larger number of apertures 28 in outlet tube 22 than there
are apertures 25 in inlet tube 21. In addition, apertures 28 are
also of a considerably larger diameter than apertures 25. This aids
in providing a negative pressure within the uterus and helps in
minimizing the danger of too great an amount of fluid being within
the uterus during the washing operation.
It should also be noted that there are three apertures 30 which
extend through the adjoining surfaces of inlet tube 21 and outlet
tube 22 which thereby communicate the passages through tubes 21 and
22. Holes 30 are valuable in initiating the washing action when the
device has been inserted into the uterus by serving to aid in
providing a priming action.
Turning to the adjustable stop 23, it is generally constructed of a
rubber material although other well-known materials would be
adequate, and is acorn in shape so as to facilitate its insertion
into the opening to the uterus and the forming of a proper seal
therein. Sealing member 23 has an opening therein corresponding to
the combined configuration of the cross section of inlet tube 21
and 22 as seen in FIG. 6. The size of the opening to receive tubes
21 and 22 is of such a dimension that a tight-fitting engagement
will be initiated between sealing member 23 and tubes 21 and 22
when it is positioned thereon. However, the engagement is such
that, with an application of sufficient force, sealing member 23
may be slidably moved along the adjoining surfaces of tubes 21 and
22 so that washer 20 may be adjusted in size to correspond to the
particular size and shape of the uterus being examined.
In operation, as shown in FIG. 2, the washer is inserted into the
opening in the uterus until sealing member 23 enters into sealing
engagement with the lower portion thereof. By prior examination the
proper length of the forward portion of tubes 21 and 22 can be
determined and the device properly adjusted so that it will not
extend too far into the uterus and pierce the rear or upper walls
thereof causing internal damage to the patient.
Generally, the particular configuration and shape of the uterus
will cause it to have its lower portion positioned adjacent to the
openings in inlet and outlet tubes 21 and 22 when the washer 20 is
properly positioned. As shown, adapter 24 is positioned into a
beaker of saline solution 32. Beaker 32 is merely exemplary as many
types of devices for holding the saline solution. Likewise, adapter
27 is connected to the forward end of a syringe 33 which will
provide a source of vacuum when plunger 34 is drawn from barrel 35.
Naturally, other types of vacuum-producing devices well known in
the art will work adequately in place of syringe 33.
As plunger 34 is removed from syringe barrel 35, negative pressure
will be created within uterus 36 and saline solution will flow
through inlet 21 and will exit through apertures 25 in the forward
portion thereof. It is generally believed that the flow of the
solution will be at substantially right angles to the longitudinal
axis of inlet tube 21 as it exits therefrom so that it will come in
contact with the adjacent wall of uterus 36 and gather tissue
therefrom. A small amount of fluid will also exit from end opening
26 of inlet tube 21.
It should also be noted that, as discussed above, a priming action
also occurs because of fluid flowing through apertures 30 into the
adjacent larger diameter outlet tube. This initiates the proper
flow pattern and turbulence and the fluid within the uterus will
generally circulate in the lower portion thereof and the majority
of it will enter larger apertures 28 in the outlet tube carrying
with it a good sampling of tissue for diagnosis. A small portion of
the fluid within the uterus will also exit through opening 29 in
the end of outlet tube 22. The fluid and tissue combination will
exit through outlet tube 22 in syringe 33 for collection and later
testing.
The fact that outlet tube 22 is of a much larger diameter than
inlet tube 21 and that holes 28 are of a larger number and a larger
diameter than holes 25, facilitates the provision of negative
pressure within the uterus so that the fluid may exit more freely
than it enters the uterus. In this manner, the uterus does not fill
up with fluid which could cause some of the fluid and possibly
undesirable tissue to enter Fallopian tubes 31. Furthermore, in
some instances, the negative pressure within the uterus may be
great enough so as to cause the Fallopian tubes to be squeezed
together and thereby closing off the entrance thereto which would
of course render it substantially impossible for any malignant
tissue to enter the Fallopian tubes 31.
Apertures 28 and 25 have roughened edges thereon which aids in
enabling tissue to collect at the entrance to these holes thereby
providing a better sample when the washer is inserted or removed.
Furthermore, as the washer is removed these roughened edges will
perform a scraping operation to remove additional tissue from the
adjacent sidewalls of the uterus and entrance thereto which also
adds in obtaining the most desirable sample for testing. The cells
collected by all of the above discussed means when using washer 20
provide a very effective sampling for diagnostic purposes.
Therefore, the results obtained by using the washer 20 have been
much improved over any other known methods.
It should also be kept in mind that the use of washing apparatus 20
causes a minimal amount of discomfort to the patient. There is
relatively no accompanying pain during the sampling operation.
Therefore, there is no need for any anesthetic to be used and the
device may be used right in the individual doctor'office thereby
facilitating the rapid and early detection of any malignancy in the
uterus.
When the doctor is to use the device in his office, in order to
obtain a proper sample, he begins by the normal operations of
inserting an unlubricated speculum into the vagina and doing Pap
smear tests of the cervix in a routine manner. He then removes the
speculum and does a bimanual examination while noting the sides and
position of the uterus. He then reintroduces the speculum and
cleans the cervix with a cleansing solution. He sounds the uterus
to determine the adjustment necessary for the sealing member
further probing the entire uterine cavity with the sound
sufficiently to aid in the loosening of cells for the later washing
operation. He then adjusts sealing member 23 of the washer 20 to
provide the proper length of the tubes to extend into the uterus.
The washer is then extended into the patient until sealing member
23 forms a seal in the mouth of the cervix. Inlet tube 21 is then
inserted into the receptacle holding the sterile saline solution
and a syringe or similar device is attached to outlet tube 22 for
providing the proper vacuum. The plunger is then withdrawn to draw
a desired amount of solution into the syringe. This specimen is
then expelled from the syringe into a standard centrifuge tube or
similar device for processing in the laboratory. The washer 20 may
then be disposed of or it may be resterilized for further use.
Thus the aforementioned objects and advantages are most effectively
attained. Although a preferred embodiment of this invention has
been disclosed in detail herein, it should be understood that this
invention is in no sense limited thereby, and its scope is to be
determined by that of the appended claims.
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