U.S. patent number 3,626,928 [Application Number 05/048,023] was granted by the patent office on 1971-12-14 for intrauterine washing apparatus.
This patent grant is currently assigned to Becton, Dickinson and Company. Invention is credited to Hulbert Van Rensselaer Barringer, George Brody, Robert Gandi, Arduino Riuli.
United States Patent |
3,626,928 |
Barringer , et al. |
December 14, 1971 |
INTRAUTERINE WASHING APPARATUS
Abstract
An intrauterine washing device including an inlet and an outlet
tube in adjacent relationship with their forward end portions
adapted to be inserted into the uterus. The tubes are open at their
rear ends and have a plurality of openings in their forward end
portions. Adjustable sealing means is positioned on the tubes so
that when the forward end portions of the tubes are inserted into
the uterus, the sealing means may be positioned so as to seal the
entrance to the uterus. A connector is mounted on the rear end of
at least one of the tubes and is associated with the rear end of
the other tube. Means are positioned on the connector for mounting
a source of washing fluid thereon in communication with the rear
end of the inlet tube. Additionally, means are positioned on the
connector for mounting a source of suction thereon in communication
with the rear end of the outlet tube. In this manner, when suction
is applied to the device sealed in position with respect to the
uterus a negative pressure will be provided in the uterus and
washing fluid will flow from a connected source of washing fluid
through said inlet tube and into the uterus through the openings in
the forward end portion of the inlet tube. Cells and other matter
will be accumulated from the uterus and will enter the outlet tube
with the washing fluid through the openings in the forward end
portion of the outlet tube and will continue to pass through the
length of the tube for collection at the rear end thereof.
Inventors: |
Barringer; Hulbert Van
Rensselaer (Hohokus, NJ), Brody; George (Waldwick,
NJ), Gandi; Robert (New York, NY), Riuli; Arduino
(Wayne, NJ) |
Assignee: |
Becton, Dickinson and Company
(East Rutherford, NJ)
|
Family
ID: |
21952343 |
Appl.
No.: |
05/048,023 |
Filed: |
June 22, 1970 |
Current U.S.
Class: |
600/563; 604/911;
604/41; 604/38; 604/197 |
Current CPC
Class: |
A61M
1/0062 (20130101); A61M 1/0058 (20130101); A61M
3/0262 (20130101); A61B 10/0291 (20130101); A61M
2210/1433 (20130101); A61M 2209/06 (20130101) |
Current International
Class: |
A61M
3/02 (20060101); A61M 3/00 (20060101); A61M
1/00 (20060101); A61B 10/00 (20060101); A61b
010/00 () |
Field of
Search: |
;128/2,276,278,240,241,227,228,350,304 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Howell; Kyle L.
Claims
We claim:
1. An intrauterine washing device comprising:
an inlet tube and an outlet tube in adjacent relationship side by
side with the forward end portions thereof connected to one another
and adapted to be inserted into the uterus;
said tubes being open at the rear end and having a plurality of
openings spaced longitudinally in the forward portions thereof,
least one of the apertures in the forward end of each tube
communicating with one another, the area of the apertures in the
outlet tube being larger than that of the inlet tube;
adjustable sealing means on said tubes so that when said forward
end portions are inserted into the uterus said sealing means may be
positioned so as to seal the entrance to the uterus;
a connector mounted on the rear end of at least one of said tubes
and associated with the rear end of the other tube;
means on said connector for mounting a source of washing fluid
thereon in communication with the rear end of said inlet tube;
means on said connector for mounting a source of suction thereon in
communication with the rear end of said outlet tube so that when
suction is applied to said device sealed in position in the uterus
a negative pressure will be provided in the uterus and washing
fluid will flow from a connected source of washing fluid through
said inlet tube and into the uterus through the openings in the
forward end of said inlet tube, accumulate cells and matter from
the uterus and enter the outlet tube through the openings in the
forward end portion thereof and pass therethrough for
collection.
2. The invention in accordance with claim 1 wherein a source of
suction is connected to said device.
3. The invention in accordance with claim 1 wherein a source of
washing fluid is connected to said device.
4. The invention in accordance with claim 1 wherein said connector
includes a disc-shaped base portion having a depending annular
skirt extending downwardly therefrom, a pair of diametrically
opposed slots vertically positioned on said connector means, a
domelike projection extending upwardly from the base of said
connector and being in communication with said slots and being open
to the undersurface of the base portion of said connector and being
open at both ends, a sleeve in alignment and connected to said
domelike projection and having a passage therethrough, said outlet
tube being mounted in one end of said sleeve and the other end of
said sleeve being adapted to receive a source of suction, said slot
facilitating positioning of said inlet and outlet tubes with
respect to said connector.
5. The invention in accordance with claim 4 wherein the interior
surface of said skirt is threaded to facilitate interengagement
with the threaded upper portion of a container.
6. The invention in accordance with claim 4 wherein a tubular prong
extends upwardly from the base portion of said connector with the
passage therethrough facilitating transfer of fluid through the
connector into a container attached thereto.
7. The invention in accordance with claim 4 wherein the sleeve
extending from said
connector has a female luer taper to facilitate connection to a
source of suction, and a projection extends upwardly from the rim
of said sleeve distal from
the base of said connector to facilitate a fixed interengagement
between the source of suction and said connector.
8. The invention in accordance with claim 1 wherein said connector
includes a base portion having two adjacent cylindrical recesses
formed on the undersurface thereof adapted to receive respectively
a first container holding a source of washing fluid and a second
container for collection of the sample from the uterus, said inlet
tube mounted in an opening in said base portion and having its rear
end positioned so as to extend into the washing fluid when a
container holding washing fluid is mounted on said connector, said
outlet tube mounted in an opening in said base portion and
positioned so that the rear end portion thereof extends into the
recess adapted to receive and interengage with a collection
container, a negative pressure applicator tube mounted in an
opening in the base of said connector so that one end portion
thereof extends into the recess adapted to interengage with a
collection container, the other end portion of said negative
pressure applicator tube having an adapter mounted thereon for
connection to a source of suction, a vent opening formed in the
base portion of said connector for communication between the
atmosphere and a container containing washing fluid mounted in the
recess provided therefore in the connector.
9. The invention in accordance with claim 1 wherein said connector
includes a base portion having a first passage therethrough with
two open ends, one open end of said first passage in communication
with the interior of said inlet tube with said inlet tube being
mounted within a portion of said first passage, the other end of
said first passage being adapted for communication with a source of
washing fluid, a second passage through said base portion having
one open end in communication with said outlet tube and having the
end portion of said outlet tube mounted in said second passage, the
other end of said second passage adapted for communication with the
interior of a collection container, said base portion having a
third passage therethrough, one open end of said third passage
having an adapter mounted thereon for connection to a source of
suction and the other open end of said passage positioned so as to
be in communication with a collection container mounted on said
connector, a fourth passage passing through the base portion of
said connector and having one end thereof open to the atmosphere
and the other end thereof in position for communication with a
source of washing fluid mounted on said connector.
10. The invention in accordance with claim 9 wherein a spike having
a penetrating end projects from the base portion of said connector
and is adapted to penetrate the diaphragm of a sealed washing
solution container, said first and fourth passages in the base of
said connector extending through said spike and terminating at the
penetrating end thereof so that when said spike enters said washing
solution container air from the atmosphere may enter said container
through said fourth passage and washing fluid may enter said first
passage and thereafter said inlet tube.
11. The invention in accordance with claim 1 wherein said connector
includes a base portion having a first passage therethrough, one
end of said first passage adapted to communicate with the interior
of said inlet tube and to have the rear end of said inlet tube
mounted therein, the other end of said first passage adapted to
receive a fluid delivery tube mounted therein and to be in
communication with the passage in said delivery tube, said base
portion containing a second passageway having one end thereof
adapted to be in communication with the interior of said outlet
passage and having the rear end of said outlet tube mounted therein
the other end of said second passage in position to be in
communication with a fluid collection container mounted on said
connector, a third passageway in the base portion of said
connector, an adapter mounted in one end of said third passageway
and having a passage therethrough to permit communication between
the interior of a suction source mounted on said adapter and said
third passageway, the other end of said third passageway positioned
so as to be in communication with a collection container mounted on
said connector, a fourth passageway in the base of said connector,
one end of said fourth passageway open to the atmosphere and the
other end of said fourth passageway positioned so as to be in
communication with a source of washing fluid mounted on said
connector, means on said connector to mount a collection container
thereon and said means for mounting a source of washing fluid in
position so that said delivery tube is in communication with said
washing fluid and said fourth passageway is in direct communication
with said washing fluid.
Description
BACKGROUND OF THE INVENTION
Previous to the advent of the negative pressure jet washer, in the
field of diagnosing various types of intrauterine cancer as
endometrial carcinoma in its early stages, the known methods for
obtaining cells for diagnosis were not entirely satisfactory. There
was a considerable need for an improved diagnostic device which
would greatly improve the results. The jet washer of the type
employed as a part of the combination of this invention has
satisfactorily satisfied the deficiency in the medical field.
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 other than the negative pressure jet washer 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 thereby cause irritation and inflammation to the
interior parts of the patient.
From the above, it is apparent that there was a need in the art for
the provision of an intrauterine sampling device which will produce
a sufficient and desirable amount of cell tissue for effective
diagnosis. The solution to this need is the jet washer of the type
disclosed in the combination of this invention. The jet washer
avoids 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 also satisfies the need of providing a
sample of washing device which would alleviate the danger of cells
being washed to other parts of the body such as out the Fallopian
tubes.
Another existent problem which is alleviated by the jet washer
occurs when devices are utilized and inserted into the uterus and
there is a danger of the device being inserted too far so that it
will pierce the uterus wall causing serious internal damage to the
patient. With the jet washer it is possible to have an adjustable
device whereby the distance it extends into the uterus can be
regulated for a particular different size or shape uterus.
It should also 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 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 radiopaque dye may be irrigated
through the uterus. Also, this device as well may be used as a
means for introducing therapeudic medicament in that the
application of the fluid is localized.
As is known in the art, the negative pressure washing device
employs adjacent inlet and outlet tubes open at both ends and
insertable into the uterus. Sealing means is provided on the tubes
to seal the entrance to the uterus so that when the rear end of one
of the tubes is connected to a source of washing fluid and the rear
end of the other of the tubes is connected to a source of suction,
the uterus will be provided with a negative pressure and washing
fluid will pass from the fluid source through the inlet tube,
circulate through the uterus collecting cells and other matter
therefrom and passed through the outlet tube for collection.
With this type of washing apparatus for irrigating the uterus under
negative pressure within the uterus, a highly desirable amount of
cell tissue can be collected therefrom for analysis while
minimizing the danger of malignant material entering the other body
passages. Furthermore, the apparatus may be easily and painlessly
used 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 processes.
Furthermore, the washer is adjustable so as to properly fit the
uterus into which it is inserted inorder to avoid the danger of
damage to the patient. The apparatus is economic to produce,
efficient to use and is disposable after a single use. It should
also be noted that the outer surface of the end portions of the
tubes inserted into the uterus are roughened so that, if desired,
additional matter may be collected by a slight scraping action as
the device is inserted or removed from the uterus.
As stated above, this type of jet washing type of apparatus has
proven to be at least as successful as any other known method for
obtaining the most uniform type of cell sampling from the interior
of the uterus. Continued use of the negative pressure jet washer
has produced the development in order to use the washer effectively
and efficiently, the assistance of a second person is required to
hold the inlet tube submerged in a container of liquid at its rear
end while the physician taking the sample connects the source of
suction generally a syringe to the rear end of the outlet tube and
applies the suction force to perform the lavage. It would certainly
be an additional improvement to the art to provide an effective
means for coupling the washing device to the source of fluid and to
the suction source so that a single physician may independently
conduct the entire sample taking procedure. Furthermore, it would
be an additional advantage if he, independently, may then use the
same group of elements to transfer the collected sample to the
ultimate container which will be used to transfer the sample to the
area utilized for testing purposes. With the development of a
structure of this type, the need of the second person or the
assistant is eliminated and the washing device and combined
structure can be utilized as efficiently and effectively as the
presently known negative pressure washing device is utilized by two
persons acting in cooperation.
SUMMARY OF THE INVENTION
Along the primary objectives of the invention is to provide a jet
washing device which employs the advantages of the known
intrauterine washing device as well as providing means for
incorporating the washing structure, the source of fluid, and the
source of suction into one interconnected assembly so as to enable
one person to perform the lavage and collect a sample without the
necessity of assistance from another person. Additionally, the
structure of this invention provides means for facilitating the
transfer of the collected sample into the retention container for
shipment to the area where it will be subjected to a variety of
tests. Additionally, this invention provides a more aseptic means
for handling the washing fluid and the collected sample during the
entire washing operation than the technique previously known in the
art.
In summary, an intrauterine washing device is provided which
includes an inlet tube and an outlet tube in adjacent relationship
with the forward end portions of the tubes being adapted to be
inserted into the uterus. The tubes are open at the rear end and
have a plurality of openings in their forward end portions.
Adjustable sealing means are positioned on the tube so that when
the forward end portions are inserted into the uterus the sealing
means are positioned so as to seal the entrance to the uterus. A
connector is mounted on the rear end of at least one of the tubes
and is associated with the rear end of the other tube. Means are
positioned on the connector for mounting a source of washing fluid
thereon in communication with the rear end of the inlet tube. Means
are also positioned on the connector for mounting a source of
suction thereon in communication with the rear end of the outlet
tube. In this manner, when suction is applied to the device in
sealed position with respect to the uterus, a negative pressure
will be provided in the uterus and washing fluid will flow from a
connected source of washing fluid through the inlet tube and into
the uterus. It will pass through the openings in the forward end
portion of the inlet tube, accumulate cells and matter from the
uterus and enter the outlet tube through the openings in the
forward end portion of that tube. It will then pass through the
outlet tube for collection at the rear end thereof.
Other objects and advantages will become apparent from the
following detailed description which is to be taken in conjunction
with the accompanying drawing illustrating several preferred
embodiments of this invention.
BRIEF DESCRIPTION OF THE INVENTION
With the foregoing in mind, reference is made to the accompanying
drawing in which:
FIG. 1 is a perspective view of a commercial type kit incorporating
the invention along with the elements which may be utilized with
the invention to carry out a complete sampling procedure;
FIG. 2 is a perspective view of the apparatus of the kit of FIG. 1
in assembled position with the forward portion of the washing
apparatus inserted within the uterus in sample taking position with
arrows showing the direction of flow;
FIG. 3 is a perspective view of elements of the commercial kit of
FIG. 1 in interconnected relationship for the process of
transferring a collected sample to a container for shipment;
FIG. 4 is a top plan view of the connector portion of the device of
the invention with the remainder of the device broken away and
removed;
FIG. 4A is a side elevation view of a capped collection
container.
FIG. 5 is a bottom view thereof;
FIG. 6 is a sectional elevation view thereof taken along the plane
of line 6--6 of FIG. 4;
FIG. 7 is a sectional elevation view thereof taken along the plane
of line 7--7 of FIG. 4;
FIG. 8 is a sectional elevation view thereof taken along the plane
of line 8--8 of FIG. 4;
FIG. 9 is a partially sectional elevation view of an alternate
embodiment of the device of the invention shown in combination with
a source of suction, a source of washing fluid, and a collection
container;
FIG. 10 is a side elevation view of a capped collection container
which may be utilized with the device of this invention;
FIG. 11 is a partially sectional side elevation view of a second
alternate embodiment of the device of this invention shown in
combination with a source of suction, a source of washing fluid,
and a collection container;
FIG. 12 is a fragmentary sectional elevation view of a portion of
the connector part of the second alternate embodiment;
FIG. 13 is a side elevation view of a capped collection container
with a sample contained therein for shipment for testing and with a
central portion of the container having been broken away and
removed;
FIG. 14 is a partially sectional elevation view of a third
alternate embodiment of the invention shown in combination with a
source of suction, a source of washing fluid, and a collection
container;
FIG. 15 is a fragmentary sectional view of the connector portion of
the embodiment of FIG. 14; and
FIG. 16 is an elevation view of a capped collection container
containing a sample ready for shipment for testing purposes with a
central portion of the container having been broken away and
removed.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
FIG. 1 is illustrative of a typical commercial package 20 of
elements which may be utilized to carry out a washing procedure
either by a physician in his own office or in a hospital with all
of the elements being disposable after collection and ultimate
testing of the collected sample. As shown in FIG. 1, the elements
may be all mounted to a mounting board 21 by means of a formed
flexible plastic transparent cover 22 which may be bound to the
board in any common manner such as adhesive bonding. A package such
as package 20 is commonly formed by a vacuum-forming process
whereby the flexible plastic cover 22 is drawn into sealing contact
with the backing board 21 and in surrounding relationship with each
of the elements being packaged so as to retain these elements in
sealed position within the finished package 20.
Packaged within kit or package 20 is an intrauterine washing device
23, a common type of plastic disposable syringe 24 which may
function as a suction source and a temporary collection container,
and a common type of plastic disposable sample container which may
be used for ultimate shipment of the collected sample as well as
being adaptable for various ultimate testing procedures such as
centrifugation. The collection container 25 has a cap 26 positioned
thereon in sealed relationship when it is contained within the
package 20. Cap 26 is naturally removable to permit access to the
interior of tube 25 so that s sample may be positioned therein.
Consequently, package 20 represents all of the elements which a
physician would need to carry out a washing procedure with the
exception of the washing fluid itself. When it is desirable to take
an actual washing, the package 20 is opened and the various
elements are removed for assembly. As shown in FIGS. 1 and 2,
device 23 includes an inlet tube 27, and outlet tube 28, a sealing
means 29, and a connector 30.
As previously discussed, collection container 25 contains a
removable cap 26 which is interengaged with tube 25 by means of
threads on the exterior surface of the upper portion of tube 25.
After cap 26 has been removed from container 25, the threads on the
upper portion of container 25 interengage with a mating surface on
the interior portion of connector 30 so that connector 30 is then
in threaded interengagement with container 25.
Syringe 24 includes a barrel portion 31 and a plunger and stopper
assembly 32 slideably mounted within the barrel. Syringe 24 is a
common type of plastic disposable syringe.
The forward reduced portion 33 of barrel 31 has a threaded inner
surface which interengages with projection 34 on the rear rim of
cylindrical tube portion 35 of connector 30. Projections 34 are
tapered so as to engage with the threaded inner surface of reduced
portion 33 in an interlocking fashion to positively retain syringe
24 in connection relationship with connector 30 and consequently
washing device 23. The engagement between syringe 24 and tube
portion 35 is additionally assisted by the female luer taper on
portion 35 and the corresponding male luer taper on syringe 24.
Cylindrical portion 35 is hollow and therefore permits
communication with the interior of barrel 31 through the forward
opening in syringe 24.
Connector 30 consists primarily of a disc-shaped top surface or
base 36 with a depending sidewall or skirt 37 so as to approximate
the basic shape of a cap. A tubular shaped projection or dome 38
extends from the upper surface or base 36 across the entire
diameter of connector 30 and is also integrally connected with the
rear tubular projection 35. The major portion of projection 38 is
open on its undersurface. The remaining small portion 39 is closed
on its entire circumference and is integral and in communication
with rear cylindrical portion 35.
Between cylindrical portions 39 and 35 which form the tube
retention cylinder or sleeve, there is a small ring 35' mounted
therein to separate portion 39 from portion 35 and provide a
smaller diameter opening then present in either of the two
portions. Ring 35' provides a seat for the rear surface of tube
28.
Tube 28 is cemented into cylindrical retention sleeve or member 39.
Other types of common interengagement means between tubular
concentric cylinders will naturally adequately suffice here also.
As previously discussed, ring 35' acts as a seat or stop to prevent
tube 28 from projecting into sleeve or cylindrical projection 35.
As discussed above, projection 35 has a female luer taper and along
with the projection 34 assures a positive retention when reduced
portion 33 of syringe 24 is attached.
The inner surface of depending side wall 37 has threads 40 thereon,
the purpose of which will be discussed in detail below.
Additionally, on the exterior surface of skirt 37 of connector 30,
there are ribs 48 to facilitate gaining a more secure grip on
connector 30 when assembling and disassembling the apparatus. Skirt
37 is interrupted at diametrically opposed points on the
circumference to form a pair of vertical openings 41 and 42 which
are vertically aligned with projection 38.
Connector 30 also includes a vertical tubular prong 42' which has a
passage therethrough for communication with the undersurface of the
connector 30.
Connector 30 is mounted on washer 23 with the rear end portion of
tube 28 extending into the sleeve formed by the combination of
cylindrical portion 39 and rear cylindrical portion 35. Tube 28 is
held in position by a frictional or cemented interengagement
between the inner surface of the sleeve portion of connector 30 and
the outer surface of tube 28 or any other common bonding means.
Inlet tube 27 is of a smaller diameter than outlet tube 28 and is
attached to the forward and intermediate portions of tube 28. The
rear portion 43 of smaller diameter inlet tube 27 is free from
movement with respect to tube 28 and extends a predetermined
distance to the rear of the rear end of tube 28. Naturally since
both tubes are of a flexible material, the rear portion of tube 27
may be bent away from adjacent alignment with tube 28 and, in fact,
may be bent to at least a 90.degree. angle with respect to the axis
of tube 28 as shown in FIG. 1. Since tube 27 extends rearwardly of
the rear end of tube 28, it will pass through openings 41 and 42
and extend to the rear of washing device 23. This makes packaging
of the product much simpler as well as enabling tube 27 to be
deformed so as to extend into container 25 in the manner described
above. Naturally, in preferred use all components are packaged and
sterilized and the package should allow aseptic removal of each
component.
As shown in FIG. 2, when the various elements in kit 20 are
assembled for operation, initially kit 20 is opened and cap 26 is
removed from tube 25. A common type of washing fluid such as a
saline solution is then poured into container 25 to a desired
level. Tube 25 may be externally marked with a volumetric scale.
Tube 25 with saline solution therein is then brought into
communication with washing device 23 and the rear free end portion
43 of tube 27 is then bent to an approximate right angle position
with respect to the axis of the remainder of tubes 27 and 28 and
extended into tube 25 so that the open rear tip of tube 27 is
positioned within the saline solution. Openings 41 and 42 permit
freedom of movement for rear portion 43 of tube 27 so that it may
be deformed as indicated.
Tube 25 is then engaged with connector 30 by means of the threaded
outer surface of tube 25 and threads 40 on the skirt portion 37 of
connector 30. This threaded interengagement positively positions
tube 25 with respect to the washing device 23.
Syringe 24 is then interengaged with rear portion 35 on connector
30 by means of the interengagement between stud 34 and the threaded
surface on the interior reduced portion 33 of syringe barrel 31 in
a luerlike fashion. At this point, washing device 23 is in fixed
connection with a source of washing fluid contained within tube 25
and a source of vacuum represented by syringe 24. The apparatus is
therefore in condition for taking of a sample.
The normal procedure is then followed for taking an intrauterine
washing sample with a jet washer of this type. Initially, the
uterus of the particular patient is sounded to determined the size
and shape of the uterus. Adjustable sealing member 29 is then
positioned with respect to the tip portion of tubes 27 and 28 to
assure that the tip portions extend the desired amount into the
uterus and do not come in contact with or pierce any of the
interauterine walls causing damage to the patient. As previously
discussed, sealing member 29 is adjustable with respect to the
tubes in that it is in a sliding frictional engagement with the
outer surface of tubes 27 and 28 to facilitate its movement.
Sealing member 29 is formed of a common resilient impervious
material and to facilitate its introduction and sealing engagement
it is formed in an acorn-shaped configuration. A material such as
rubber has been found to be adequate for use as sealing member
29.
Subsequent to the sounding operation, the tip portion of washer 23
is extended into the uterus until sealing member 29 seals the
entrance of the uterus by coming into contact and sealing
engagement with the walls of the cervix. As previously discussed,
this operation is substantially painless to the patient and
requires no anesthetic of any type. Furthermore, since both the
source of suction and source of fluid are interconnected with the
washer, there is no need for more than one doctor or person to be
present to handle all of the necessary apparatus for the taking of
a washing. It should be kept in mind that connection to the source
of fluid and source of suction can be made subsequent to insertion
of washer 23 within the uterus. The sequence of operations is a
matter of preference.
With washer 23 properly inserted into the uterus and connected to a
source of washing fluid in tube 25 and to a source of suction in
the form of syringe 24, a sample may now be taken. As shown in FIG.
2, the arrows represent the path of flow of the washing fluid and
the movement of plunger 32 of syringe 24 to initiate movement of
the washing fluid and collection of the sample. As plunger 32 is
withdrawn as shown, air is withdrawn from tube 28, the interior of
the uterus 44 and tube 27 thereby bringing the interior of the
uterus to a condition of negative pressure.
As shown, the washing fluid is then drawn by the vacuum created
from tube 25 into the rear opening of tube 27 and through tube 27
and out of the forward end portion thereof through small openings
45. The fluid then washes against the walls of the uterus and
enters the larger and more plentiful openings 46 in the forward end
portion of outlet tube 28 along with accumulated cell samples from
the interior of the uterus and passes through tube 28 into syringe
barrel 31 for initial collection. In this manner, the desired
amount of washing fluid is transferred from tube 25 through the
uterus and into barrel 31 with the accumulated cell and tissue
matter from the interior of the uterus.
The device is held securely during taking of a sample either by
holding container 25 or by the syringe barrel 31 with one hand
while plunger 32 is pulled back with the other hand.
It should be noted that outlet tube 28 is of considerably larger
diameter than inlet tube 27 and that the holes 46 in the tip of
outlet tube are larger than the openings 45 in the tip of inlet
tube and additionally are more plentiful. This gives an effective
suction or outlet area which is significantly greater than the
effective inlet area as represented by the total of all of the
openings in the outlet and inlet tubes. In this manner, the uterus
is constantly under negative pressure which facilitates the
prevention of fluid filling up the uterus and extending into other
body passages such as the Fallopian tubes 47 which could cause
spread of diseased tissue to other portions of the body.
The negative pressure within the uterus due to the increased
suction area also facilitates the action of the washing fluid as it
enters the uterus through openings 45. It has been found with the
shown arrangement of holes that the fluid will exit from openings
45 at substantially right angles to the axis of inlet tube 27 so as
to directly contact the adjacent walls of the uterus in the form of
a spray. This spray action serves to loosen tissue from the walls
of the uterus and facilitates collection of an effective cross
sectional sample from the interior of the uterus walls. The fluid
coming out of openings 45 in the form of a spray then circulates
through the uterus in contact with the walls thereof and is drawn
into openings 46 of outlet tube 28 and passes into barrel 31 of
syringe 24 with accumulated cell tissue and other matter. In this
manner, a particularly effective sampling of cell tissue from the
interior of the uterus is obtained and collected within syringe 24
along with the washing fluid from tube 25.
The next step in the sequence of operations is to remove the
apparatus including washer 23 from the uterus once again without
pain or discomfort to the patient either during sampling or removal
of the device from the uterus and then to disconnect syringe 24
from connector 30 with the sample still being contained within
barrel 31 of syringe 24. The forward reduced portion 33 of syringe
24 is then positioned on cylindrical prong 42' so that the opening
therein is in communication with the opening in syringe barrel 31
at the forward end thereof and then plunger 32 is depressed to
transfer the collected sample from barrel 31 into tube 25. FIG. 3
of the drawing shows this step in the sequence of operations with
the arrow showing the direction of travel of the plunger of syringe
24 and the direction of flow of the washing fluid and sample from
barrel 31 into tube 25.
Tube 25 is then threadedly disengaged from connector 30 and cap 26
is threadedly interengaged therewith to seal container 25 with the
collected sample. This tube is then shipped to whatever laboratory
desired for ultimate testing of the sample. All of the components
of the assembly including the source of suction and the source of
fluid are disposable after use. Common plastic materials have been
found to work satisfactorily for construction of the various
components. It should also be kept in mind that connector 30 makes
possible the entire sequence of operations from initial connection
to the ultimate collection of the sample without the necessity of
nonconnected elements so that one doctor or operator may carry out
the entire sampling procedure quickly and efficiently without the
necessity of an additional person being present to assist.
To assist in assuring that proper flow occurs within the uterus
from initiation of the suction means until ultimate collection of
the sample within syringe barrel 31, at least one primer hole is
positioned between the interconnected forward portions of the tubes
27 and 28 to initiate flow between those tubes and the forward tips
of tube 27 and 28 have openings therein to also direct additional
flow into the uterus and between tubes 27 and 28.
When connector 30 is removed from tube 25 after collection of the
sample, naturally the rear portion 43 of tube 27 also is removed
from tube 25 thereby permitting complete disassociation of tube 25
from washer 23 and to permit the ultimate capping of tube 25 for
transmittal to a laboratory for testing.
An alternate embodiment is depicted in FIGS. 9 and 10. The flow
characteristics in regard to the inlet and outlet tubes and through
the uterus and the method of inserting the washer into the uterus
and taking a sample is identical in this embodiment as described in
regard to the initially discussed embodiment of this disclosure and
applies equally as well to the additional two embodiments described
below.
For operation of washer 23a with its connector means, the following
elements are utilized and interconnected in order to carry out a
sampling process. A wash solution container 25a and a specimen
collection container 49a are utilized with each container having a
threaded upper outer surface portion for interengagement with the
connector portion 30a of the washer 23a. Both containers 25a and
49a are similar in construction to container 25 utilized in
connection with the above discussed embodiment.
The washer includes an inlet tube 27a, an outlet tube 28a and the
adjustable acorn-shaped rubber sealing means 29a. These elements
are substantially identical to the corresponding elements of the
above discussed embodiment. However, the difference in structure of
washer 23a from washer 23 lies in connector 30a. Connector 30a has
a base portion and two threaded cylindrical recesses in its
undersurface to receive the threaded upper end portions of
containers 25a and 49a respectively in threaded interengagement.
Connector 30a has an opening in its upper surface to receive the
rear end portion of inlet tube 27a in alignment with one of the
recesses so that the rear end portion of inlet tube 27a can pass
therethrough and come into communication with washed solution
container 25a to receive the washing fluid. Similarly, connector
30a has a passage in its upper surface in communication with the
other recess in its undersurface so that the rear end portion of
outlet tube 28a can extend therethrough and into communication with
the interior of collection container 49a. Tubes 27a and 28a are
permanently affixed to connector 30a in that the tubes are cemented
in position respectively within openings 50a and 51a in connector
30a. An attachment may be accomplished in a similar manner as
utilized in regard to the tube and connector connection of the
above discussed initial embodiment.
A negative pressure application tube 52a passes through another
opening 53a in the upper surface of connector 30a and aligned so as
to be in communication with the interior of collection tube 49a
when it is connected to connector 30a. Tube 52a is mounted in
opening 53a similar to the manner in which tubes 27a and 28a are
mounted to the connector. At the opposite end of tube 52a is
adapter 54a designed to receive and connect to the forward end of
the syringe 24a so that there is communication between the interior
of tube 52a and the interior of syringe 24a. Connector 30a also
contains a vent in its upper surface which is positioned so as to
permit communication from the atmosphere to the interior of a
washing solution container 25a mounted to connector 30a. This
facilitates natural flow of the fluid through the system during
operation and collection of the sample.
Operation may once again be accomplished by a single doctor or
operator and is initiated by attachment of tubes 25a and 49a to
connector 30a and additionally the connection of syringe 24a to
adapter 54a. The washer is then properly positioned within the
uterus and the plunger 32a is withdrawn so as to provide the
negative pressure in the uterus and the system. Washed solution
travels up through tube 27a into the uterus and then is drawn
therefrom through outlet tube 28a with the collected cellular
material into collection container 49a. After an adequate sample
has been collected, the instrument is removed from the uterus and
the collection container 49a is unscrewed from the connector 30a
and a spare cap 26a is applied to it for transport to the
laboratory. The remainder of the equipment would be normally
discarded.
A second alternate embodiment is shown in FIGS. 11-13. Once again
there is an inlet tube 27b, an outlet tube 28b, and adjustable
sealing member 29b and a connector member 30b. Operation of members
27b, 28b and 29b including fluid flow through the tubes is
identical to that described in respect to the above first two
discussed embodiments. The difference in this embodiment lies in
the connector member 30b which is of a molded plastic or similar
material.
Connector 30b is adapted to receive a standard commercial type of
diaphragm sealed prefilled wash solution vial of known volume 56b.
Additionally, a standard type of transport centrifuge specimen
collection container 49b is also receivable on connector 30b as
well as syringe 24b. Connector 30b contains an inlet passage 57b
passing therethrough which is open at two positions on the surface
of connector 30b. The rear end of inlet tube 27b is mounted in one
opening of passage 57b, the other end portion of passage 57b
extends through spike 59b which is adapted to penetrate the
diaphragm in vial 56b to permit communication between the solution
within the vial 56b and passage 57b and consequently inlet tube
27b.
A second passage 60b separated from passage 57b in connector 30b
extends through spike 59b into communication with the interior of
vial 56b when the diaphragm on the forward end thereof is punctured
by spike 59b. The other end of opening 60b communicates with the
atmosphere. In this manner, passage 60b forms an atmospheric vent
for vial or container 56b so that the solution therefrom may
adequately serve as a washing solution for the system. A third
passageway in connector 30b is passageway 58b which is open at two
positions on the surface of connector 30b. Outlet tube 28b is
mounted in one end of passage 58b to provide communication between
the interior of outlet tube of 28b and passage 58b. The other end
of passage 58b is open to the interior of a collection container
49b frictionally mounted on connector 30b. A seal ring or gasket
61b is provided in recess on the exterior surface of connector 30b
to form a seal with the interior surface of collection container
49b in frictional engagement with connector 30b.
The fourth passageway passing through connector 30b and open at two
positions on the surface of connector is passageway 62b. This
passageway is open on one end to the interior of a collection
container 49b mounted to connector 30b and communicates at the
other end with an adapter 63b extending from the adjacent side face
of connector 30b. The adapter is adapted to receive syringe 24b so
that the interior of the syringe barrel is in communication with
passage 62b.
In operation in performing a washing procedure, the diaphragm of a
standard wash solution vial 56b which usually contains saline or
sterile water is forced down over the diaphragm puncture spike 59b
containing the solution delivery orifice or passageway 57b and vent
orifice or passageway 60b and is firmly seated thereon. An empty
specimen collection container 49b is force fitted onto connector
30b on the opposite face thereof. Adjustable rubber stopper 29b is
then set at the most desirable distance from the forward tip of the
washing apparatus.
A negative pressure source such as syringe 24b is then attached to
adapter 63b. The doctor or operator would then introduce and seat
the apparatus properly within the uterus until stopper 29b forms a
seal in the cervical os. Syringe barrel 32b is then retracted to
apply negative pressure and cause the washing solution to travel
through passageway 57b and inlet tube 27b into the uterus. After
the solution washes through the uterus it is drawn by the negative
pressure into the openings in the forward end of outlet tube 28b
and return through outlet tube 28b into passageway 58b and
connector 30b and ultimately into collection container 49b. After
an adequate sample has been collected the instrument is removed
from the uterus and the specimen collection container is removed
from the connector 30b and a cap 26b is applied to it to seal it
for transport to the laboratory for ultimate testing purposes. The
remainder of equipment is generally discarded.
A fourth embodiment is disclosed in FIGS. 14-16. In this
embodiment, the washing device 23c includes substantially all of
the same elements as in the previous embodiment including inlet
tube 27c, outlet tube 28c and sealing means 29c. The difference in
structure from the previous embodiment once again lies in connector
30c. The sequence of the washing operation from the point of
passage of fluid through inlet tube 27c to the passage of fluid and
collection sample out through outlet tube 28c is the same as that
discussed in regard to the previously considered embodiment.
However, connector means 30c is of a somewhat different structure
and operates slightly differently in its adaptability to the source
of washing fluid and the source of suction to be utilized in the
washing operation.
Initially it should be pointed out that the rear end of inlet tube
27c is mounted in passage 63c in connector 30c. Passage 63c
communicates with the exterior of connector 30c at two positions on
its outer surface. Similarly, outlet tube 28c is mounted in one
open end of passageway 64c which communicates with the exterior of
connector 30c at two positions on its outer surface. The method of
mounting tubes 27c and 28c within passages 63c and 64c are the same
as that which may be employed to mount the inlet and outlet tubes
in the connector of the previous embodiments. As discussed, this
may be accomplished in a common manner such as by cementing the end
portions of the tubes within the passageways. In any event,
communication is provided between the respective passageways and
the tubes mounted therein. A third passageway is also provided in
connector 30c and also communicates with the exterior of the
connector 30c at two separate positions. An adapter 66c having a
passage therethrough is mounted by any common means within passage
65c at one open end thereof and the adapter 66c is designed to
receive a source of suction such as syringe 24c so that the
interior of syringe 24c communicates with the passage through
adapter 66c and passageway 65c. The other end of passageway 65c is
open on connector 30c adjacent to one end of passageways 63c and
64c.
A washing solution delivery tube 67c is mounted in the open end of
passageway 63c which is remote from the end of passageway 63c
having tube 27c mounted therein. Once again, delivery tube 67c is
mounted within passageway 63c in any common well-known manner.
Connector 30c is adapted to receive a collection container 49c in
frictional engagement with its exterior surface and in position so
that the interior of collection container 49c communicates with
passageways 65c and 64c on the surface at which position they
adjacently open. A sealing ring or gasket 68c is provided in a
recess on the surface of connector 30c to assure that an effective
seal is provided between container 49c and connector 30c. A wash
solution container is mounted on connector 30c in a frictional or
similar type of interengagement and is positioned so that the
solution delivery tube 67c extends into wash solution container 69c
so that the fluid therein may be drawn up through delivery tube
67c. A vent passageway 70c extends from the exterior of one
opposing surface of connector 30c to the exterior of the other
opposing surface to provide a passage through the connector and is
positioned so that its one end communicates with the atmosphere and
the opening at its other end communicates with the interior of
washing solution container 69c. In this manner, passageway 70c
forms an atmospheric vent to facilitate passage of the washing
solution through the system.
As will be noted from the drawing, the exterior diameter of washing
solution container 69c is considerably less than the interior
diameter of collection container 49c as well as being of lesser
length so that the entire washing solution container may be
positioned within collection container 49c while still providing
additional space therebetween for collection of the sample. As in
the previous embodiments, the arrows depict the path of fluid flow
during a sampling procedure.
To perform a washing procedure with this embodiment, the wash
solution container 69c which could be manufactured prefilled or
could be loaded at any time with a preferred amount of wash
solution which is usually saline or sterile water is force fitted
installed on the nipple or projection 71c on connector 30c. An
empty specimen collection container 49c is placed over wash
solution container 69c and force fitted onto connector 30c.
The rubber sealing means 29c would be preset a given distance from
the end of tubes 27c and 28c for the particular uterus to be
sampled as discussed above. A negative pressure source such as
syringe 24c is then attached to adapter 66c. The doctor or operator
would then introduce the assembly into the uterus in the proper
manner until rubber stopper sealing means 29c forms a seal in the
cervical os. He then applies the negative pressure by means of
withdrawing plunger 32c of syringe 24c to cause the wash solution
to travel up through solution delivery tube 67c, through passageway
63c and connector 30c and through inlet tube 27c into the uterus.
After the solution washes through the uterus it is withdrawn by the
negative pressure through outlet tube 28c and passageway 64c into
collection container 49c. After an adequate sample has been
collected the instrument is removed from the uterus and the
specimen collection container 49c, is removed from connector 30c
and a spare cap 26c is applied to it to seal it for transport to
the laboratory. Once again, the remainder of the equipment may be
discarded if desirable.
Thus the aforementioned objects and advantages are most effectively
attained.
* * * * *