U.S. patent number 3,777,743 [Application Number 05/293,676] was granted by the patent office on 1973-12-11 for endometrial sampler.
This patent grant is currently assigned to The Kendall Company. Invention is credited to William J. Binard, John F. Dye.
United States Patent |
3,777,743 |
Binard , et al. |
December 11, 1973 |
**Please see images for:
( Certificate of Correction ) ** |
ENDOMETRIAL SAMPLER
Abstract
An endometrial sampler comprises a rigid hollow tube having a
sampling end providing a plurality of sampling ports communicating
with the interior of the tube, and sleeve means surrounding the
tube and slidable with respect to it. The tube provides forward
stop means and rearward stop means, and the sleeve means and tube
are reciprocable with respect to one another between a sampling
position in which the sleeve means exposes at least one sampling
port, and a second position in which the sleeve means engages the
forward stop means and covers the sampling ports. Cervical stop
means engages the cervix and cooperates with the rearward stop
means to limit travel of the sampling end to a predetermined
distance beyond the cervix. A source of suction may be connected to
the tube to draw sample material through the sampling ports.
Inventors: |
Binard; William J. (Barrington,
IL), Dye; John F. (Barrington, IL) |
Assignee: |
The Kendall Company (Boston,
MA)
|
Family
ID: |
23130069 |
Appl.
No.: |
05/293,676 |
Filed: |
September 29, 1972 |
Current U.S.
Class: |
600/562; 606/119;
600/573 |
Current CPC
Class: |
A61B
10/0291 (20130101); A61B 2090/036 (20160201) |
Current International
Class: |
A61B
10/00 (20060101); A61B 19/00 (20060101); A61b
010/00 () |
Field of
Search: |
;128/2R,2B,348,305,276,350,278 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1,161,400 |
|
Mar 1958 |
|
FR |
|
483,829 |
|
Feb 1970 |
|
CH |
|
Primary Examiner: Medberry; Aldrich F.
Claims
What is claimed is:
1. Endometrial sampler comprising
a rigid hollow tube having a sampling end providing a plurality of
sampling ports communicating with the interior of said tube and
sleeve means surrounding said tube and slidable with respect to
it
said tube having a distal stop means
said sleeve means and tube being reciprocable with respect to one
another between a sampling position in which said sleeve means
exposes at least one said sampling port, and a second position in
which said sleeve means engages said distal stop means and covers
said sampling ports.
2. The endometrial sampler tube of claim 1 further providing
rearward stop means and
cervical stop means on said sleeve for engaging the cervix of a
patient, said cervical stop means cooperating with said rearward
stop means to limit travel of said sampling end beyond said
cervix.
3. Endometrial sampler comprising
a rigid hollow tube having a stop means on its proximal end and
a distal sampling end having
a closed tip of larger outer diameter than said tube and
a plurality of sampling ports communicating with the interior of
said tube
sleeve means surrounding said tube and slidable with respect to it,
said sleeve means being shorter than the length of said tube
between said tip and said stop means and of an outer diameter
approximately equal to that of said tip
said sleeve means and said tube being reciprocable with respect to
one another between a sampling position in which said sleeve means
exposes at least one said sampling port, and a second position in
which said sleeve means engages said tip and covers said sampling
ports.
4. The endometrial sampler of claim 3 in which said sleeve means
further provides sleeve stop means and cervical stop means for
engaging the cervix of a patient, said cervical stop means
cooperating with said sleeve stop means to limit travel of said
sampling end.
5. The endometrial sampler of claim 4 in which said tube further
provides a connector remote from said sampling end, said connector
being engageable with a source of suction.
6. In combination with a source of suction, an endo-metrial sampler
comprising
a rigid hollow tube having
a connector for engagement with said source of suction
a sampling end remote from said connector and providing
a closed tip of larger outer diameter than said tube end
a plurality of sampling ports communicating with the interior of
said tube
sleeve stop means remote from said sampling end
a portion of said tube adjacent said sampling end and remote from
said tip being smoothly curved through an acute angle and
flexible sleeve means surrounding said tube and slidable with
respect to it, said sleeve means being shorter than the length of
said tube between said tip and said sleeve stop means and of outer
diameter approximately equal to that of said tip
said sleeve means and said tube being reciprocable with respect to
one another between a sampling position in which said sleeve means
exposes at least one said sampling port, and a second position in
which said sleeve means engages said tip and seals said sampling
ports, said sleeve means conforming to said smoothly curved portion
during reciprocation,
said sleeve means further providing cervical stop means for
engaging the cervix of a patient, said cervical stop means
cooperating with said sleeve stop means to limit travel of said
sampling end.
7. In combination with a source of suction, an endometrial sampler
comprising
a rigid hollow metal tube of outer diameter of about 0.07 inch and
inner diameter of about 0.05 inch, and having
a connector end engageable with said source of suction
a sampling end remote from said connector end providing
a smoothly rounded closed tip of outer diameter of about 0.10 inch,
and
a plurality of sampling ports communicating with the interior of
said tube
a portion of said tube adjacent said sampling end and remote from
said tip being smoothly curved through an angle of about 40.degree.
and
flexible sleeve means surrounding said tube and slidable with
respect to it,
said connector end providing a shoulder engageable with said sleeve
means
said sleeve means being shorter than the length of said tube
between said tip and said shoulder and of outer diameter
approximately equal to that of said tip
said sleeve means and said tube being reciprocable with respect to
one another between a sampling position in which said sleeve means
exposes at least one said sampling port for the application of
suction through said tube, and a second position in which said
sleeve means engages said tip and seals said sampling ports, said
sleeve means conforming to said smoothly curved portion during
reciprocation,
said sleeve means further providing rigidly connected cervical stop
means for engaging the cervix of a patient, said cervical stop
means cooperating with said shoulder to limit travel of said
sampling end.
8. The sampler of claim 1, wherein said tube is malleable for
shaping to anatomical conformation.
Description
This invention relates to the sampling or biopsy of the internal
uterine lining (endometrium). Endometrial sampling is a diagnostic
technique used primarily in the detection of carcinoma and other
metaplasias of the endometrial lining. This procedure is not to be
confused with the well-known routine cervical smear, in which a
simple scraping of the easily accessible cervical os is performed
in the physician's office with the assistance of a speculum (a
device for expanding the vaginal vault). The cervical smear
involves no dilation or anesthesia. The endometrial biopsy is a
more complicated procedure because the tissue to be sampled is
relatively inaccessible.
Until recently, means for accomplishing endometrial biopsy have
been limited to dilation and curettage (D&C), in which the
sample is obtained during a surgical procedure requiring
anesthetic, or to entry with a uterine sound (dilator). The latter
procedure requires heavy analgesic sedation because of the
dilatation, and employs the sound in conjunction with a brush,
spatula or other sampling means. More recently a device has been
developed that introduces a saline solution into the uterine cavity
and recovers the solution into a syringe, bringing loose mucosal
cells from the endometrium along with the solution. Use of this
device also requires dilatation of the cervix and analgesia; in
addition, the recovered material is suspended in the saline
solution and must be separated from it, requiring an additional
step in the diagnostic procedure. Furthermore, the irrigation of
the uterus by saline solution creates the possibility of flushing
abnormal cells into the oviducts, thus contributing to the risk of
peritoneal implantation (seeding).
It is an object of the present invention to provide a means for
obtaining a sample of the endometrium that can be used without
dilation and without anesthesia.
It is a further object to provide such means that eliminates the
risk of spreading abnormal cells to other organs of the
patient.
It is another object to provide such means that obtains a direct
sample of the endometrial cells, eliminating the step of separating
sample cells from the solution in which they are suspended.
It is another object to provide such means that samples cells from
several portions of the endometrium, without contamination by cells
from other tissues.
Finally, it is an object to provide endometrium sampling means that
is simple in operation, can be employed quickly, routinely as a
diagnostic screening procedure, and safely, without risk of
perforation of the uterine wall, that is easily employed in aseptic
technique, and that is inexpensive and disposable.
The endometrial sampler of the invention comprises a rigid hollow
tube having a sampling end providing a plurality of sampling ports
communicating with the interior of the tube, and sleeve means
surrounding the tube; the tube and sleeve are slidable with respect
to one another. The tube provides forward stop means and rearward
stop means, and the sleeve means and tube and reciprocable with
respect to one another between a sampling position in which the
sleeve means exposes at least one sampling port, and a second
position in which the sleeve means engages the forward stop means
and covers the sampling ports. Cervical stop means engages the
cervix and cooperates with the rearward stop means to limit travel
of the sampling end within the uterine cavity.
In preferred embodiments, a portion of the tube adjacent the
sampling end and remote from the tip is smoothly curved through an
angle of about 40.degree. to conform to the anatomical structure of
the patient, and the sleeve means is flexible and conforms to the
smoothly curved portion as it is reciprocated. The tube further
provides a connector remote from the sampling end for engagement
with a source of suction, and suction is applied through the tube
to the sampling ports when the sleeve means is in the sampling
position, to draw sample tissue through the ports into the tube.
The malleable tube may be shaped for introduction into abnormal
situations.
Other objects, features and advantages will appear from the
following description of a preferred embodiment of the invention,
taken together with the attached drawings thereof, in which:
FIG. 1 shows the endometrial sampler of the invention, partially
broken away;
FIG. 2 is an enlarged view of a portion of FIG. 1 with the sleeve
means in sampling position; and
FIGS. 3, 4 and 5 illustrate steps in the procedure of obtaining a
sample using the sampler of the invention.
Referring now to the drawings, and in particular to FIG. 1, the
endometrial sampler 10 of the invention has a disposable plastic
syringe 12 with retractable plunger 14. Secured to syringe 12 by
connection 15 is a rigid hollow tube 16 of metal, preferably
stainless steel, of outside diameter of about 0.072 inch (15 gauge
standard wall, needle dimension) and inside diameter of about 0.054
inch. The sampling end 18 of tube 16, remote from syringe 12,
provides a rounded smooth tip 20 and a plurality of sampling ports
22 each of diameter of about 1/32 inch. Tube 16 is smoothly curved
through an angle of about 40.degree. at a point about two inches
from tip 20, to provide conformation with anatomical shape and
position of the uterus.
A flexible sleeve 24 (preferably made of a thermoplastic such as
polyethylene) closely surrounds tube 16; tube 16 is slidable within
sleeve 24. Sleeve 24 is shorter than tube 16 by about 2 inches.
When tube 16 is retracted with respect to sleeve 24, as seen in
FIG. 1, the sleeve covers all of sampling ports 22 and its distal
end 26 abuts smoothly against tip 20 to provide a smooth closed
exterior surface. Engagement of sleeve 24 with tip 20 (serving as
forward stop means) limits rearward travel of tube 16 within the
sleeve. When tube 16 is fully advanced within sleeve 24, as seen in
FIG. 2, proximal end 34 of sleeve 24 abuts against shoulder 17 of
connector 15 (serving as rearward stop means) and the sleeve
exposes all of sampling ports 22. Engagement of end 34 with
shoulder 17 limits forward travel of tube 16.
Approximately one inch from the distal end 26 of sleeve 24 there is
provided, rigidly connected to sleeve 24, a slightly tapered collar
28 acting as a cervical stop.
In use, the sampler of the invention is introduced into the cervix
30 (FIG. 3) with sleeve 24 and syringe plunger 14 in the positions
shown in FIG. 1. The sampler is advanced into the uterus with
sleeve 24 in the forward position until collar 28 rests against the
cervix. Since sleeve 24 covers sampling ports 22 during this part
of the procedure, no cells can be introduced into tube 16 from the
cervix. Tube 16 is then advanced into the uterine cavity 32 (FIG.
4) through sleeve 24 until as many sampling ports 22 are exposed as
desired (FIG. 4). The number of ports exposed may vary according to
the dimension of the uterus being sampled. The ultimate extent of
penetration into uterine cavity 32 is limited by cervical stop 28
on sleeve 24 in cooperation with shoulder 17 on connector 15, which
engages proximal end 34 of sleeve 24, thus preventing perforation
of the uterine wall. Perforation is further prevented by rounded
tip 20. Cervical stop 28 additionally serves in conjunction with
proximal end 34 as a means for indicating depth of penetration to
the operator.
Plunger 14 of syringe 12 is then withdrawn, creating suction
through tube 16, and drawing a portion of the contents of uterine
cavity 32 through ports 22 into end 18 of tube 16. Suction is
continued in order to draw portions of the surface of the intact
endometrium 33 into sampling ports 22. Tube 16 may further be
rotated slightly during this procedure to ensure sampling of
different portions of the uterine cavity.
Holding sleeve 24 and collar 28 in position (FIG. 5), the physician
withdraws tube 16, detaching small portions of endometrium 33 which
have been drawn into tube 16 through sampling ports 22. End 18 of
tube 16 is completely withdrawn into sleeve 24 before sleeve 24 is
withdrawn from cervix 30; thus no cervical or other cells can be
taken in through ports 22 to contaminate the endometrial
sample.
When the entire sampler has been withdrawn, the sampled cells are
easily ejected from tube 16 by slight positive pressure exerted
through syringe 12.
Suction and pressure may be provided by alternative means such as a
pump or bulb aspirator rather than by the syringe, if
preferred.
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