U.S. patent number 3,721,229 [Application Number 05/241,770] was granted by the patent office on 1973-03-20 for obturator device for hysterosalpingography and the like.
Invention is credited to Norman Panzer.
United States Patent |
3,721,229 |
Panzer |
March 20, 1973 |
OBTURATOR DEVICE FOR HYSTEROSALPINGOGRAPHY AND THE LIKE
Abstract
An obturator device for the injection of fluid into a body
cavity through a narrow passageway, comprising an injection tube
reciprocatively moveable through an obturating collar and secured
thereto by an elastic sleeve of intermediate enlarged diameter
disposed around the tube, with the sleeve adapted to be distended
to reduced diameter for movement of the tube through the passageway
and, on release, to return to its natural expanded diameter thereby
to lock the tube to the passageway wall.
Inventors: |
Panzer; Norman (South Orange,
NJ) |
Family
ID: |
22912107 |
Appl.
No.: |
05/241,770 |
Filed: |
April 6, 1972 |
Current U.S.
Class: |
600/435; 604/104;
604/174; 604/278; 606/198 |
Current CPC
Class: |
A61M
31/00 (20130101); A61M 25/04 (20130101); A61B
2017/3419 (20130101); A61B 2017/3484 (20130101); A61B
2017/3492 (20130101); A61B 2017/3488 (20130101) |
Current International
Class: |
A61M
31/00 (20060101); A61B 17/34 (20060101); A61M
25/04 (20060101); A61M 25/02 (20060101); A61b
019/00 (); A61m 003/00 () |
Field of
Search: |
;128/2A,2R,241,242,245,246,341,343,348-351,266,184 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Howell; Kyle L.
Claims
Having described my invention, I claim:
1. An obturator device for the injection of radiopaque substance or
the like into a body cavity, through a passageway leading
thereinto, comprising an obturating collar provided with a central
opening, a tube slideably disposed through the opening and provided
with discharge means in the end thereof extending through the
collar and open at its other end, and elastic distensible means
disposed between the collar and the discharge means said
distensible means fixedly attached to said tube adjacent said
discharge means and fixedly attached to said collar to thereby form
means whereby further extension of the tube through the collar
reduces the diameter of the elastic distensible means to permit the
tube to enter the passageway, and partial retraction of the tube
enlarges the diameter of the distensible means to permit said
distensible means to engage the passageway wall when inserted into
the passageway to secure the tube therein and to provide a fluid
seal therewith.
2. An obturator device as described in claim 1, the discharge means
comprising an opening in the end of the tube.
3. An obturator device as described in claim 1, the discharge means
comprising a plurality of opening in the tube end.
4. An obturator device as described in claim 2, the distensible
means comprising an elastic sleeve disposed around the tube portion
extending through the collar, with one end of the sleeve bonded to
and around the tube adjacent its discharge opening and the other
end thereof bonded to the collar around its central opening, to
limit extension of the tube therethrough in repose, the sleeve
being thicker in cross-section intermediate its ends to define an
enlarged circumference adapted to be reduced by distension of the
sleeve.
5. An obturator device as described in claim 4 in combination with
a booster element comprising a hollow cylinder slideably disposed
around the tube and having an outer diameter smaller than the
diameter of the collar opening and adapted to pass therethrough for
selective extension of the tube.
6. An obturator device as described in claim 5, the tube being
further provided with a peripheral bead integral therewith and
disposed beneath the sleeve adjacent to its union with the tube and
adapted to be abutted by the booster element in the selective
extension of the tube through the collar.
7. An obturator device as described in claim 4, the collar being
further provided with a circular wall around its central opening
and disposed around the tube beneath the sleeve.
8. An obturator device as described in claim 3, the distensible
means comprising an elastic sleeve disposed around the tube portion
extending through the collar, with one end of the sleeve bonded to
and around the tube adjacent its discharge openings and the other
end thereof bonded to the collar around its central opening, to
limit extension of the tube therethrough in repose, the sleeve
being thicker in cross-section intermediate its ends to define an
enlarged circumference adapted to be reduced by distension of the
sleeve.
9. An obturator device as described in claim 8, the collar being
further provided with a circular wall around its central opening
and disposed around the tube beneath the sleeve.
10. An obturator device as described in claim 9, the collar being
extended rearwardly of the sleeve to define a plug formed with
gripping means adjacent its rear surface.
11. An obturator device as described in claim 10, the gripping
means comprising a peripheral groove in the circular wall of the
plug.
Description
BACKGROUND OF THE INVENTION
a. Field of the Invention.
This invention relates to the field of radiography, and more
particularly to the provision of an obturator device for the
obturation of a body cavity and the injection of a radiopaque
substance therein for the purpose of making a radiogram, thereby to
visualize the human organs. One example of such use is in
hysterosalpingography, a radiographic procedure for visualizing the
female organs of reproduction. A second example is radiography of
the human colon, in a procedure professionally known as a barium
enema. The essential object of the present invention, therefore is
to provide a self-retaining obturator which will support itself
within the passageway leading to the cavity by appropriate pressure
against the passageway wall during the procedure, without damage or
injury to the wall and without discomfort to the patient, and which
can easily and conveniently be withdrawn, following completion of
the procedure, by release of the sustaining pressure. In supporting
itself against the passageway wall it also acts as an effective
fluid seal against leakage of the radiopaque fluid during the
procedure.
B. Prior Art
In the present state of the art, one means for the performance of
an hysterosalpingography requires the use of a tenaculum to grasp
the cervix, a procedure which is traumatizing thereto and leads to
unnecessary bleeding and susceptability to infection. A metal
cannula is inserted into the cervical canal and an adjustable olive
tip used to obturate the canal. Too often the length of the
cervical canal is incorrectly estimated and the metal tip
introduced into the uterine cavity, where its presence interferes
with the radiologist's interpretation of the radiogram. Other
disadvantages with this device are well recognized.
Another device presently used for hysterosalpingography employs a
core or cone, which is threaded, or rotated, into the cervical
canal, and held in place by the engagement of the core teeth with
the sensitive wall of the cervical canal, with concomitant hazards
of hemorrhage, inflamation and infection.
Prior art for obturating the rectum in providing a barium enema
involves the use of an inflatable, balloon-like, cuff which is
secured around the rectal nozzle near its discharge opening and
which, with the insertion of the nozzle through the anal opening,
is stuffed into the rectum and thereafter inflated with air by
means of a tube extending therefrom out through the anal opening,
to retain the nozzle within the rectum and seal off the anal canal.
Such a device has been known to rupture the rectum, causing serious
complications, to cause air-embolism, and, at the least, obvious
discomfort to the patient.
BRIEF SUMMARY OF THE INVENTION.
The forementioned disadvantages found with the prior art are
obviated by my invention, which provides for an injection tube
reciprocatively disposed through an obturating collar and provided
with an elastic sleeve encircling the tube between its discharge
tip and the collar, the sleeve being bonded at its upper end to and
around the tube adjacent its discharge tip and to and around the
collar at its other end, with the sleeve having a substantially
thicker area intermediate its ends to define an enlarged
circumference. When the tube is pushed up through the collar the
sleeve is distended to define a uniform, reduced circumference, and
when the tube is released the elastic sleeve returns to its normal
shape, with an intermediate enlarged circumference. In distended
state the sleeve permits the tube to be inserted through a narrow
passageway or canal. In released state the enlarged circumference
of the sleeve presses resiliently against the canal wall to hold
the tube firmly in its inserted position by frictional engagement
thereagainst, as well as providing a fluid seal therewith.
The prime object of my invention, therefore, lies in the provision
of an obturator device for hysterosalpingography and the like,
wherein the injection tube is held in locked position within the
penetrated passageway leading to the body cavity by the pressure of
an elastic sleeve, mounted around the tube and having an enlarged
circumference, against the wall of the passageway.
A second important object of my invention lies in the provision of
an obturator device as above described, wherein the injection tube
is freely movable within the passage, by the distention of the
elastic sleeve to a reduced uniform diameter, to enter the
passageway and to be withdrawn therefrom.
A third important object of my invention lies in the provision of
an obturator device as above described, wherein the device is
provided with an obturating collar disposed to limit introduction
of the tube into the passageway and to fix the extent of
penetration.
A fourth important object of my invention lies in the provision of
an obturator device of the type described wherein the engagement of
the elastic sleeve against the passageway wall provides an
effective fluid seal therewith.
Still another important object of my invention lies in the
provision of an obturator device as above described, which is
inexpensive to manufacture and simple to use, and which is
disposable following a single use, yet adapted for repeated usage
with proper sterilization.
These and other salient objects, advantages and functional features
of my invention, together with the novel features of construction,
composition and arrangement of parts, will become more readily
apparent from an examination of the following specification, taken
with the accompanying drawings, wherein:
FIG. 1 is a side view of a preferred embodiment of my invention in
use for hysterosalpingography, which is shown in position within a
cervical canal;
FIG. 2 is an enlarged, top perspective view of the embodiment of
FIG. 1, partly broken away;
FIG. 3 is a cross-sectional view of the embodiment of FIG. 2, shown
in position within a cervical canal in the process of of
insertion;
FIG. 4 is a view similar to FIG. 3, showing the embodiment thereof
locked to the wall of the cervical canal;
FIGS. 5 and 6 are views similar, respectively, to FIGS. 3 and 4, of
a modified embodiment of my invention; and
FIGS. 7 and 8 are views, similar to FIGS. 3 and 4, showing a second
modified embodiment of my invention, with respect to rectal
disposition for a barium enema.
Similar reference characters designate similar parts throughout the
different views.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Illustrative of the embodiment shown by FIGS. 1-4, inclusive, for
use in hysterosalpingography, my obturator device 10 comprises an
elongated tube 12 having a discharge opening or tip 14 in its upper
end, and open at its other end 16 for engagement, by means of a
coupling 18, to the discharge tube 20 of a syringe 22 filled with a
radiopaque fluid, such as an iodinated compound or one of many such
contrast media presently available for radiography. The tube 12 is
disposed through a central opening 24 of an obturating collar 26
for freely reciprocative movement therethrough. An elastic sleeve
28 is mounted around the tube 12 and is bonded at one end thereof
to and around the tube 12 adjacent its discharge tip 14, and at its
other end to the upper surface 30 of the collar 26, thereby joining
the tube 12 to the collar 26. The sleeve 28 is substantially
thicker in cross-section intermediate its ends to define an
enlarged intermediate circumference 32 in its normal state of
repose, as shown in FIG. 2. The tube 12 is further provided with an
integral bead 34 disposed beneath the sleeve 28 immediately below
its union with the tube 12, as shown in FIGS. 3 and 4. A booster
element 36 is slideably mounted around the tube 12 and comprises a
cylinder open at both ends and having an outer diameter smaller
than the diameter of the central opening 24 in the collar 26, so
that the booster 36 may be passed through the opening 24 to engage
the tube bead 34 within the sleeve 28.
The areas involved in the use of this embodiment of my invention
comprise the human vaginal canal 38, a passageway normally between
3 to 5 inches in length, and the uterus 40, into which the vaginal
canal 38 leads. The uterus 40 is a flat, pear-shaped organ about 4
inches in length, which includes a cervix 42 about one and
one-quarter inches in length and provided with a central canal 44
leading into the uterus 40, and having a diameter normally between
3-5 mm, the larger diameter being centrally located within the
canal 44 and called the spindle 46.
In the composition of the above described embodiment, therefore, I
prefer the tube 12, for the conveyance of the radiopaque fluid into
the uterus 40, to be composed of a transparent, flexible plastic
material, such as a narrow gauge, thin-walled polyethelene, about 2
mm in diameter and at least 10 to 12 inches in length, the collar
26 of a transparent, rigid plastic material, preferably
saucer-shaped to fit snugly against the cervical os 48, as shown in
FIGS. 3 and 4, and about one inch in diameter, and the sleeve 28 of
latex, having a high degree of elasticity as well as resiliency.
The booster element 36 is likewise composed of transparent flexible
plastic material, thereby having sufficient rigidity to stretch the
sleeve 28 to a uniform reduced circumference when the booster 36
abuts the bead 34 to move the tube 12 upwards within the collar 26.
The sleeve 28 is approximately 10 mm in length, bonded to the tube
12 to expose about 3 mm of the tube 12, with the sleeve 28 having
an enlarged outer intermediate circumference 32 of about 6 mm in
repose, such diameter being sufficiently larger than the diameter
of the canal spindle 46 so as to frictionally engage the latter in
untensioned state of the sleeve 28.
OPERATION OF THE PREFERRED EMBODIMENT
In the operation of my invention, as above disclosed, the vaginal
canal 38 is stretched by means of a speculum(not shown) as is well
known in the art. The tube 12 is then engaged, by means of the
coupling 18 to the syringe 22 containing 10 cc. of radiopaque
fluid, and the syringe plunger 50 slightly depressed to fill the
tube 12 and clear all air therefrom. The booster element 36 is
urged against the bead 34 to lift the tube 12 and stretch the
sleeve 28 to a uniform outer diameter, and held in such position.
Pressing the patient's abdomen flat to immobilize the uterus 40,
the physician inserts the tube 12 and booster 36 through the
vaginal canal 38 and past the cervical os 48 into the cervical
canal 44 until the collar 26 abuts the cervical os 48 and the
sleeve 28 is fully distended within the canal 44. The booster 36 is
then slid down along the tube 12, releasing the sleeve 28 to resume
its natural shape, the enlarged circumference 32 expanding against
the spindle 46 of the canal 44 to lock the tube 12 into position
and effectively seal the canal 44 from leakage of the radiopaque
fluid, with the collar 26 in abutment against the cervical os 48.
The radiopaque fluid is then injected into the uterus 40 from the
syringe 22 and the radiogram taken. Following completion of the
radiography the booster 36 is once forced against the bead 34 to
distend the sleeve 28 and reduce its diameter, and the tube 12 is
easily withdrawn from the cervical and vaginal canals 38 and 44,
and from the patient, with the radiopaque fluid permitted to drain
from the patient and the area cleansed by a douche.
MODIFIED EMBODIMENT OF THE INVENTION
In FIGS. 5 and 6 there is shown a modified embodiment 10' of my
invention, likewise for use in hysterosalpingography. In this
embodiment 10' the tube 12' is composed of a more rigid plastic
material, although of the same length and gauge as the prior
embodiment. The bead 34 and booster element 36 of the latter,
however, have been eliminated. Instead, the collar 26' is provided
with a circular guide wall 52 extending from and around the central
opening 24' in the collar 26', and encircling the tube 12' within
the sleeve 28, In this embodiment the sleeve 28 is distended to a
reduced uniform diameter by manual extension of tube 12' through
collar 26' as it enters the cervical canal 44 and the collar 26'
abuts the cervical os 48. After the tube 12' has been suitably
inserted it is released, causing the sleeve 28 to contact to its
normal shape, thereby expanding centrally to resiliently press
against the cervical spindle 46 and thus lock the tube 12' firmly
in position therein and effectively seal the canal 44 from fluid
leakage. Other procedures are the same as those heretofore
described. In removal of the tube 12' following completion of the
radiography, the tube 12' is drawn out of the cervical canal 44,
and as it is withdrawn the sleeve 28 stretches to its reduced
diameter, enabling it to disengage from the spindle 46 easily and
without discomfort.
SECOND MODIFIED EMBODIMENT
In FIGS. 7 and 8 there is shown a further modification of my
invention, for use in colon radiography. As is obvious from the
nature of the body area involved, the injection tube 12" is
composed of a rigid plastic material or the like, and is topped by
an olive-pit-shaped nozzle 54 having a plurality of openings 56,
with the other end of the tube 12" connected to a suitable enema
apparatus (not shown) containing a suitable radiopaque liquid, such
as a barium sulphate suspension. The tube 12" is slideably mounted
in an obturating collar 58 having a convex upper surface 62 and a
central opening 60 therethrough, the collar 58 extending rearwardly
to a reduced lower surface 64 and being intermediately formed with
a deep peripheral groove 66 adapted to act as a gripping means for
the collar 58. The collar 58 is joined to the tube 12" by an
elastic sleeve 68 disposed around the tube 12", the sleeve 68 being
bonded to and around the upper surface 62 of the collar 58 at one
end thereof and to and around the tube 12", adjacent its nozzle 54,
at its other end. The sleeve 68 is substantially thicker in
cross-section at its upper one half to define an enlarged
circumference 72 in its normal state, as shown in FIG. 8. Similar
to the embodiment of FIGS. 5 and 6, the collar 58 is provided with
an integral wall 74 extending from and around the opening 60
therein, and encircling the tube 12" within the sleeve 68, adapted
to act as a guide for the tube 12".
In the construction and composition of this embodiment I prefer the
tube 12" to be composed of a rigid plastic material approximately
three-eighth inch in diameter, with the collar 58 and its integral
wall 74 of the same material and the collar about one and one-half
inches in diameter. The elastic sleeve 68 should be at least two
inches in length, with its upper edge bonded to and around the tube
12" just below the nozzle 54, so that the tip of the nozzle 54
extends from the collar 58 approximately three inches in repose.
The upper one half of the sleeve 68, having the enlarged
circumference 72 in untensioned condition, is adapted to have said
enlarged circumference reduced, under tension, to an uniform
diameter for the sleeve 68 in tensioned condition, as shown in FIG.
7. Other material of similar properties may be substituted in place
of the described materials, as is obvious.
OPERATION OF THIS EMBODIMENT
In the operation of the embodiment of a barium enema, the tube 12"
is coupled to a syringe (not shown) containing the barium sulphate
or other radiopaque liquid and cleared. The collar 58 is then
firmly grasped at its finger groove 66 by the technician and the
tube 12" forced through the collar 58 to distend the sleeve 68 to a
uniform diameter, as shown in FIG. 7, and the tube 12" inserted
through the anal opening 76 and past the external sphincter 78 and
internal sphincter 80 and to clear the anal canal 82, which is
approximately one inch in length, until the collar 58 abuts the
anal opening 76, as shown in FIG. 7. The tube 12" is then released,
causing the sleeve 68 to contract to its normal shape, whereby the
enlarged circumference 72 resiliently presses against the internal
sphincter 80 above the anal canal 82, thereby holding the nozzle 54
firmly within the rectum and forming a fluid seal therewith at such
point. The radiopaque solution is then discharged through the
rectum 84 to enter the colon(not shown), and the radiogram taken.
On completion of the radiography the obturator device 10" is
removed by once again forcing the tube 12" upwards to stretch the
sleeve 58 to release its abutment against the internal sphincter
80, whereby the tube 12" is easily removed, and the radiopaque
solution discharged.
From the foregoing it is to be noted that the divers embodiments of
my invention, because of the extremely low cost of production, are
intended to be disposable, that is to say, adapted for one-time use
only. However, they are adaptable, if desired, for repeated usage
with appropriate sterilization, such as, for example with Gamma ray
radiation.
It is also to be recognized that the embodiments shown and
described are by way of illustration and not of limitation, and
that various changes may be made in the construction, composition
and arrangement of parts without limitation upon or departure from
the spirit and scope of the invention, or sacrificing any of the
advantages thereof inherent therein, all of which are herein
claimed.
* * * * *