U.S. patent number 3,796,211 [Application Number 05/278,608] was granted by the patent office on 1974-03-12 for biopsy sampling method and device for the female genital tract.
This patent grant is currently assigned to Medics Research & Development, Inc.. Invention is credited to Gerald C. Kohl.
United States Patent |
3,796,211 |
Kohl |
March 12, 1974 |
BIOPSY SAMPLING METHOD AND DEVICE FOR THE FEMALE GENITAL TRACT
Abstract
The device comprises an elongated tubular sheath which is
adapted to be inserted into the vagina of a patient, and the distal
end portion of which is adapted to engage the cervix of the patient
to locate the sheath in the vagina. An aspirator pipette is
slidably engaged in the sheath, to be extended from the sheath into
the endocervical canal and/or the uterine cavity of the patient, or
alternately to be retracted into the sheath from the canal, while
the sheath is engaged with the cervix. In addition, there are means
whereby after the pipette has been retracted into the sheath, a
specimen can be discharged from the same onto a repository for the
specimen, as well as means whereby the sheath can be maintained in
the vagina while the specimen is discharged onto the
repository.
Inventors: |
Kohl; Gerald C. (Tacoma,
WA) |
Assignee: |
Medics Research & Development,
Inc. (Spokane, WA)
|
Family
ID: |
23065644 |
Appl.
No.: |
05/278,608 |
Filed: |
August 7, 1972 |
Current U.S.
Class: |
600/562; 604/171;
606/205; 604/540; 600/570; 600/578 |
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: |
;128/2B,2R,2F,2M,2W,278,276,304,348 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Howell; Kyle L.
Attorney, Agent or Firm: Christensen, O'Connor, Garrison
& Havelka
Claims
What I claim is:
1. A device for collecting biopsy specimens from the female genital
tract comprising an elongated tubular sheath which is adapted to be
inserted in the vagina and has an open-ended nose at the distal end
thereof adapted for insertion in the cervix, said sheath being
adapted in length to extend outside of the vagina when the nose is
so inserted, and having an open-ended aspirator tube reciprocably
engaged therein, said tube having means thereon whereby it can be
reciprocated from a point outside of the vagina, and the distal end
portion of said tube being adapted to be extended forwardly through
and beyond the open end of the nose into the uterine cavity, and
alternately retracted into the sheath from the cavity, there being
means on the proximal end portion of the tube whereby suction can
be generated therein while the distal end portion thereof is so
extended, and said distal end portion of the tube being flexible,
but having a memoried curve therein, whereby the distal end of the
tube deflects toward the wall of the cavity when said portion is
extended thereinto, yet said portion is accommodatable within the
sheath when it is retracted therein, and the opening in said distal
end of the tube being in substantial coincidence with the distal
end of the curve so that points on the periphery of the cavity can
be sampled by applying suction to the tube while the distal end
thereof is deflected toward the wall of the cavity.
2. The device according to claim 1 wherein the distal end portion
of the tube is slidably guided in the nose of the sheath.
3. The device according to claim 2 wherein the sheath is
substantially circumferentially closed along the length thereof
between the nose and a point on the sheath outside of the
vagina.
4. The device according to claim 1 wherein the distal end portion
of the tube is rotatable with respect to the sheath.
5. The device according to claim 4 wherein there are means
operatively interposed between the tube and the sheath whereby the
distal end portion of the tube can be indexed to the sheath in a
plurality of relatively angularly offset orientations therein.
6. The device according to claim 5 wherein the tube and sheath
include telescopically engageable barrels which are polygonal in
cross section, and the tube is retractably inserted in the sheath
so that the tube can be reoriented by retracting it from the sheath
and rotating it to each new orientation before it is reinserted in
the sheath.
7. The device according to claim 5 further comprising means on the
sheath whereby the sheath can be secured to the patient to fix the
orientation thereof, by operatively interconnecting a tenaculum
therebetween.
8. The device according to claim 4 further comprising means on the
sheath whereby the sheath can be secured to the patient to fix the
orientation thereof, by operatively interconnecting a tenaculum
therebetween.
9. The device according to claim 8 wherein the sheath has a clip
slidably engaged thereon which is equipped with clamping means that
are interengageable between the arms of the tenaculum to clamp the
clip to the sheath in a fixed position thereon.
10. The device according to claim 1 wherein the tube has a length
greater than that of the sheath so that it can be reciprocated by
manipulating the proximal end portion of the same.
11. The device according to claim 1 wherein the distal end portion
of the sheath has locator means thereon which are adapted to abut
the portio vaginalis when the nose is inserted in the cervix.
12. The device according to claim 11 wherein the length of the nose
of the sheath is adapted so that the nose terminates in the
endocervical canal at a point short of the uterine cavity, when the
locator means is abutted against the portio vaginalis.
13. The device according to claim 11 wherein the locator means take
the form of a spatulated sampling tip.
14. The device according to claim 13 wherein the proximal end
portion of the sheath takes the form of an elongated barrel which
is interconnected with the tip by a flexible sleeve.
15. The device according to claim 1 wherein the tube has stop means
thereon for limiting the extent to which the distal end portion
thereof is extendible beyond the open end of the nose.
16. A method of collecting biopsy specimens from the female genital
tract, comprising inserting into the cervix of the patient, the
open-ended nose of an elongated tubular sheath which is adapted in
length to extend outside of the vagina of the patient when the nose
is so inserted, inserting the open-ended, memoried, flexibly curved
tip of an aspirator tube into the nose of the sheath and extending
the tip forwardly beyond the open end of the nose into the uterine
cavity of the patient, and sampling a plurality of angularly offset
points about the periphery of the cavity by applying suction to the
tube, retracting the tip of the tube into the sheath, discharging
the sample from the tube onto a repository for the same, and
rotating and reextending the tip of the tube into the cavity so
that on reassuming the curve thereof, the tip deflects toward the
next point to be sampled therein.
17. The method according to claim 16 wherein the distal end portion
of the sheath has locator means thereon, and the locator means is
abutted with the portio vaginalis of the patient when the nose is
inserted in the cervix.
18. The method according to claim 17 wherein the locator means
takes the form of a spatulated sampling tip, and the sheath is
rotated to sample the portio vaginalis.
19. The method according to claim 17 wherein the nose of the sheath
is adapted to terminate in the endocervical canal at a point short
of the uterine cavity, when the locator means is abutted against
the portio vaginalis, and suction is also applied to the tube when
the open end of the tip is disposed in the canal.
20. The method according to claim 16 further comprising securing
the sheath to the patient so as to fix the orientation of the
sheath while the tip of the tube is rotated with respect to the
same.
Description
SUMMARY OF THE INVENTION
This invention relates to a biopsy sampling device, and more
particularly to a biopsy sampling device of the type disclosed in
my U. S. Pat. No. 3,554,185, issued Jan. 12, 1971. Relative to the
patented device, however, the present device is greatly improved,
in that it is capable of sampling the whole of the female genital
tract, including the uterine cavity, and if desired, can be
employed to sample a plurality of angularly spaced points on the
perimeter of the cavity, even while the device remains in the
vagina of the patient. Also, if desired, the device can be secured
to the patient, while in position in her vagina, by interengaging
it with a tenaculum or the like which is engaged in turn, for
example, with the cervix of the patient.
According to the invention, I am able to realize these objects and
advantages from a device that comprises an elongated tubular sheath
which is adapted to be inserted into the vagina of the patient, and
the distal end portion of which is adapted to engage the cervix of
the patient to locate the sheath in the vagina. An aspirator
pipette is slidably engaged in the sheath, to be extended from the
sheath into the endocervical canal and/or the uterine cavity of the
patient, or alternately to be retracted into the sheath from the
canal, while the sheath is engaged with the cervix. In addition,
there are means whereby after the pipette has been retracted into
the sheath, a specimen can be discharged from the same onto a
repository for the specimen; as well as means whereby the sheath
can be maintained in the vagina while the specimen is discharged
onto the repository.
As indicated, the device may also include means for sampling a
plurality of angularly spaced points on the perimeter of the
cavity. For example, the pipette may be rotatable in relation to
the sheath, and may have means thereon whereby the distal end
portion of the pipette is engageable with different points on the
perimeter of the cavity when the pipette is successively retracted,
rotated, and extended once again into the cavity. In certain of the
presently preferred embodiments of the invention, for example, the
distal end portion of the pipette is normally curvilinear in
configuration, but is also sufficiently resiliently flexible that
the pipette can be retracted into the sheath from the canal, and
then rotated to another angular position in the sheath, at which
the distal end portion of the pipette will engage another point on
the perimeter of the cavity, when the pipette is reextended into
the canal.
To assist in the sampling operation, moreover, the pipette and the
sheath may have cooperatively engageable means thereon for indexing
the pipette to the sheath at relatively angularly offset positions
corresponding to the points on the perimeter of the cavity. For
example, the pipette as a whole may be retractable from the
proximal end of the sheath, and may have means thereon whereby it
is re-engageable with the sheath at relatively angularly offset
positions corresponding to the points on the perimeter of the
cavity. In the presently preferred embodiments of the invention,
for example, the pipette and the sheath include relatively inner
and outer telescopically engageable barrels which have polygonal
cross sections of three equally dimensioned sides or greater, so
that the pipette can be indexed to the sheath at each angular
position of one within the other.
Preferably the distal end portion of the sheath takes the form of a
spatulated sampling tip of the type disclosed in my aforementioned
patent; and the barrel of the sheath is interconnected with the tip
by a flexible sleeve of the type also disclosed in my patent. In
the present device, however, the pipette is slidably engaged in the
tip, and preferably takes the form of a plastic tube which resumes
a curvature imparted to it, after it is temporarily flexed into a
more rectilinear condition while undergoing passage through the
sheath. The proximal end portion of the tube is secured within the
barrel of the pipette, and is equipped with means on the proximal
end thereof for attaching an aspirator thereto. The pipette also
has a stop thereon, for limiting the extent to which the tube is
extended beyond the sampling tip, and preferably the stop takes the
form of a flange on the proximal end of the barrel of the
pipette.
As indicated, the device may also include means for interengaging
the sheath with a tenaculum or the like which is engaged in turn
with the cervix of the patient. At present, this latter means takes
the form of a collar which is slidably engaged on the barrel of the
sheath, and has an ear outstanding thereon which is interengageable
with the tenaculum in the closed position thereof. The ear may be
interengageable with the ratchet of the tenaculum, as for example,
where the ear has an aperture therein within which the ratchet is
engageable in the closed position of the tenaculum; or the ear may
be interengageable with the tenaculum otherwise, as for example,
where the collar has a pair of grooved ears thereon, the grooves of
which are interengageable with the arms of the tenaculum in the
closed position thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
These features will be better understood by reference to the
accompanying drawings which illustrate certain of the preferred
embodiments.
In the drawings,
FIG. 1 is an elevational view of the device;
FIG. 2 is a longitudinal cross-sectional, part schematic view of
the device;
FIG. 3 is an exploded perspective view of the device;
FIG. 4 is a schematic view of the device at the time of use;
FIG. 5 is another such view of the device;
FIG. 6 is a greatly enlarged plan view of the usage, illustrating
one aspect thereof;
FIG. 7 is a part perspective view of the device, illustrating
another aspect of the usage;
FIG. 8 is an end elevational view of the device, elaborating on the
aspect illustrated in FIG. 7;
FIG. 9 is a cross-sectional view of the device as it is used in
FIG. 6;
FIG. 10 is a plan view illustrating a modified version of the
device as it would be used in FIG. 6; and
FIG. 11 is a cross-sectional of the modified version at the time of
use.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to the drawings, it will be seen that the device 2
comprises and elongated tubular sheath 4 which is adapted to be
inserted into the vagina 6 of a patient, and has a spatulated
sampling tip 8 of the type mentioned, at the distal end thereof,
that is adapted to engage the cervix 10 of the patient to locate
the sheath in the vagina. The device also comprises an aspirator
tube or pipette 12 which is slidably engaged in the sheath, to be
extended from the tip 8 into the endocervical canal 14 and/or
uterine cavity 16 of the patient, or alternately to be retracted
into sheath 4 from the canal, while the tip 8 is engaged with the
cervix 10. The pipette 12 is also removable from the sheath at the
proximal end 18 thereof, so that a specimen can be discharged from
the same onto a repository (not shown) separate from the sheath, as
shall be explained.
Referring to FIGS. 1 - 3 in particular, it will be seen that the
sheath 4 takes the form of an elongated barrel 20 of square cross
section which is interconnected with the tip 8 by a flexible sleeve
22 of the type mentioned. The sleeve 22 has a spiral wound groove
24 therein which provides a corrugated effect whereby the sleeve is
capable of flexing both axially and transversely of the barrel. In
addition, the sleeve has a plain cylindrical neck 26 at either end
thereof, and the barrel and the tip have cylindrical nipples 28 and
30 on the adjacent ends thereof, over which the necks of the sleeve
are engaged and bonded to the respective components. Otherwise, the
tip 8 comprises a flat, generally heart-shaped spatula 32, the
relatively forward edge of which has a pointed nose 34 projecting
from the center portion thereof, which in turn has smoothly
filleted indentations 36 in the upper and lower sides thereof. The
nose 34 is blunt at the forward end thereof, however, and contains
an opening 38 for a smooth cylindrical bore 40 which extends
forwardly from the nipple 30 through the spatula 32 and the nose
34. The nipple 28 of the barrel 20 also has a smooth cylindrical
bore 42 therethrough, which is smoothly countersunk at the rear end
thereof, however, to provide a flared opening 44 for receiving the
pipette when it is reinserted in the sheath, as shall be
explained.
The pipette 12 takes the form of an elongated barrel 46 of square
cross section which is telescopically engageable in the barrel 20
of the sheath, and has a flexible plastic tube 48 with a "memory"
capability, secured therein. The tube projects forwardly from the
distal end 50 of the barrel, but terminates at the proximal end 51
of the same, where it is bonded within the bore of a flanged
coupling 52 that is secured to the latter end of the barrel. The
coupling 52 is threaded for attachment to an aspirator (not shown),
and has a knurled surface 54 on the perimeter thereof, for ease in
gripping the pipette.
In use, the sheath is inserted in the vagina 6 of the patient, and
the tip 8 is abutted against the portio vaginalis of the cervix,
with the nose 34 of the same protruding into the endocervical canal
14. Thereafter, the pipette 12 is introduced into the sheath, with
the tube 48 of the same, bent and oriented so that it will curve
upwardly within the uterine cavity 16, when it recovers its normal
curvature after passing through the sheath and the canal. See FIGS.
6 - 8. A specimen is then withdrawn into the pipette, and the
pipette in turn is withdrawn from the sheath, to enable the
specimen to be discharged onto the repository for the same.
Meanwhile, the sheath is left in the vagina. The pipette is then
returned to the sheath, but at a different position, such as the
"three o'clock position" of FIGS. 6 - 8, in which it is curved to
the right in a horizontal plane. The specimen and pipette are then
withdrawn as before, and after the additional specimen is
discharged, the pipette is returned to the sheath, and to the
cavity, at still another position, such as the "six o'clock
position." Ultimately, all four quadrants of the cavity are sampled
in this fashion, and if desired, the device may also be employed to
sample the endocervical canal, and/or the portio vaginalis, as in
the case of my earlier device. Moreover, as illustrated in FIGS.4
and 5, this is possible whether the uterus is aligned with the
vagina, or askew from it, as in FIG. 5.
Each time the pipette is returned to the sheath, the fact of
abutting the flange 56 of the coupling 52 against the proximal end
18 of the sheath, reveals that the tip of the curved memoried tip
of the tube 48 is in position in the cavity, and that another
sample can be immediately taken. Moreover, as the sample is
withdrawn, it is fully enclosed in the sheath, and since the sheath
is sterile, it protects the sample from contamintion, during the
passage of the sample through the vagina.
A speculum (not shown) is normally employed to dilate the vaginal
canal. As seen, moreover, the sheath is equipped with means whereby
the device can be secured to the patient in her vagina during the
sampling operation. Referring to FIGS. 6 - 11, it will be seen that
the barrel 20 of the sheath has a clip 58 mounted thereon, which
can be cooperatively engaged with a tenaculum 60, after the
tenaculum is also inserted in the vagina of the patient. In FIGS. 6
and 9, the clip comprises a split G-shaped collar 62 which is
slidably engageable on the barrel 20, and has a ring-shaped ear 64
outstanding thereon, through which the ratchet members 66 of the
tenaculum may be engaged with one another, to fix the position of
the sheath, and incidentally, the position of the tenaculum as
well. The members 66 are engaged when the pincers 68 of the
tenaculum are in position to engage the flesh of the cervix, and
when the collar 62 is in position to receive them, there being
sufficient frictional engagement between the collar 62 and the
barrel 20 to maintain the arrangement which results. See FIG.
6.
In FIGS. 10 and 11, the tenaculum is also employed to tighten the
grip of the clip 58' on the barrel. In this instance, the clip 58'
also has a G-shaped collar 70, but there is a pair of ears 72 on
the collar at the split side thereof, and each of the ears has a
notch or groove 74 adjacent the free end thereof to receive one arm
76 of the tenaculum. In use, the ears 72 are interposed between the
arms 76 of the tenaculum, and the arms are engaged in the grooves
74 as they are ratcheted together to grip the cervix between the
pincers of the tenaculum. The clamping action on the ears, in turn
clamps the collar more firmly about the barrel, so as to assure
that the collar remains stationary on the barrel in the position
assigned to it. Otherwise, however, the collar may be moved along
the length of the barrel to position it in relation to the
tenaculum.
* * * * *