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without damage or injury to the wall and without discomfort to the patient, and which can easily and conveniently be withdrawn, following completion of the procedure, by release of the sustaining pressure.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.