US3721229A - Obturator device for hysterosalpingography and the like - Google Patents

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.

Description

United States Patent 1191 Panzer 1March 20, 1973 [54] OBTURATOR DEVICE FOR 2,456,257 12/1948 HYSTEROSALPINGOGRAPHY AND .2 1 2;

3, 85,300 5 l9 THE LIKE 3,421,509 1/1969 [76] Inventor: Norman Panzer, 7l Blanchard 3,459,175 8/1969 Road, South Orange, NJ. 07079 Primary Examiner--l(yle L. Howell 22 Fl 72 1 1 ed l9 Attorney-Sydney B. Schlessel [21] Appl. No.: 241,770

, [57] ABSTRACT Cl 128/24 1 An obturator device for the injection of fluid into a 1 128/348 body cavity through a narrow passageway, comprising Int. Cl. an injection tube recip ocatively moveable through an Field of Search 128/2 A, 2 R, 241, obturating collar and secured thereto by an elastic 128/246 348-351, 266, 184 sleeve of intermediate enlarged diameter disposed around the tube, with the sleeve adapted to be [56] References C'ted distended to reduced diameter for movement of the UNITED STATES PATENTS tube through the passageway and, on release, to return to its natural expanded diameter thereby to lock the 526,353 9/1894 Lamb et al. ..128/24l tube to the passageway wall. 983,871 2/1911 Brin ..l28/244 989,550 4/1911 Aber ..128/245 X 11 Claims, 8 Drawing Figures PATENTEnuARzoma 3 1, 29

SHEEI10F 2 "III/[III III/lull OBTURATOR DEVICE FOR IIYSTEROSALPINGOGRAPHY AND THE LIKE 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 selfretaining 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 radiologists 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 engage ment 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. l-4, inclusive, for use in hysterosalpingography, myobturator device 10 comprises anelongated tube 12 having a discharge opening ortip 14 in its upper end, and open at its other end' 16 for engagement, by means of acoupling 18, to thedischarge tube 20 of asyringe 22 filled with a radiopaque fluid, such as an iodinated compound or one of many such contrast media presently available for radiography. Thetube 12 is disposed through acentral opening 24 of an obturatingcollar 26 for freely reciprocative movement therethrough. Anelastic sleeve 28 is mounted around thetube 12 and is bonded at one end thereof to and around thetube 12 adjacent itsdischarge tip 14, and at its other end to theupper surface 30 of thecollar 26, thereby joining thetube 12 to thecollar 26. Thesleeve 28 is substantially thicker in cross-section intermediate its ends to define an enlarged intermediate circumference32 in its normal state of repose, as shown in FIG. 2. Thetube 12 is further provided with anintegral bead 34 disposed beneath thesleeve 28 immediately below its union with thetube 12, as shown in FIGS. 3 and 4. Abooster element 36 is slideably mounted around thetube 12 and comprises a cylinder open at both ends and having an outer diameter smaller than the diameter of thecentral opening 24 in thecollar 26, so that thebooster 36 may be passed through theopening 24 to engage thetube bead 34 within thesleeve 28.

The areas involved in the use of this embodiment of my invention comprise the humanvaginal canal 38, a passageway normally between 3 to inches in length, and theuterus 40, into which thevaginal canal 38 leads. Theuterus 40 is a flat, pear-shaped organ about 4 inches in length, whichincludes acervix 42 about one and one-quarter inches in length and provided with acentral canal 44 leading into the uterus'40, and having a diameter normally between 3-5 mm, the larger diameter being centrally located within thecanal 44 and called thespindle 46.

In the composition of the above described embodiment, therefore, I prefer thetube 12, for the conveyance of the radiopaque fluid into theuterus 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 to 12 inches in length, thecollar 26 of a transparent, rigid plastic material, preferably saucer-shaped to fit snugly against thecervical 0s 48, as shown in FIGS. 3 and 4, and about one inch in diameter, and thesleeve 28 of latex, having,

thecanal spindle 46 so as to frictionally engage the latter in untensioned state of thesleeve 28.

OPERATION OF THE PREFERRED EMBODIMENT In the operation of my invention, as above disclosed, thevaginal canal 38 is stretched by means of a speculum(not shown) as is well known in the art. Thetube 12 is then engaged, by means of thecoupling 18 to thesyringe 22 containing 10 cc. of radiopaque fluid, and the syringe plunger 50 slightly depressed to fill thetube 12 and clear all air therefrom. Thebooster element 36 is urged against thebead 34 to lift thetube 12 and stretch thesleeve 28 to a uniform outer diameter, and held in such position. Pressing the patients abdomen flat to immobilize theuterus 40, the physician inserts thetube 12 andbooster 36 through thevaginal canal 38 and past thecervical os 48 into thecervical canal 44 until thecollar 26 abuts thecervical os 48 and thesleeve 28 is fully distended within thecanal 44. Thebooster 36 is then slid down along thetube 12, releasing thesleeve 28 to resume its natural shape, the enlargedcircumference 32 expanding against thespindle 46 of thecanal 44 to lock thetube 12 into position and effectively seal thecanal 44 from leakage of the radiopaque fluid, with thecollar 26 in abutment against thecervical os 48. The radiopaque fluid is then injected into theuterus 40 from thesyringe 22 and the radiogram taken. Following completion of the radiography thebooster 36 is once forced against thebead 34 to distend thesleeve 28 and reduce its diameter, and thetube 12 is easily withdrawn from the cervical andvaginal 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. Thehead 34 andbooster element 36 of the latter, however, have been eliminated. Instead, the collar 26' is provided with acircular guide wall 52 extending from and around the central opening 24' in thecollar 26, and encircling the tube 12' within thesleeve 28, In this embodiment thesleeve 28 is distended to a reduced uniform diameter by manual extension of tube 12' throughcollar 26 as it enters thecervical canal 44 and the collar 26' abuts thecervical 0s 48. After the tube 12' has been suitably inserted it is released, causing thesleeve 28 to contact to its normal shape, thereby expanding centrally to resiliently press against thecervical spindle 46 and thus lock thetube 12. firmly in position therein and effectively seal thecanal 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 thecervical canal 44, and as it is withdrawn thesleeve 28 stretches to its reduced diameter, enabling it to disengage from thespindle 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, theinjection tube 12" is composed of a rigid plastic material or the like, and is topped by an olive-pitshaped nozzle 54 having a plurality ofopenings 56, with the other end of thetube 12 connected to a suitable enema apparatus (not shown) containing a suitable radiopaque liquid, such as a barium sulphate suspension. Thetube 12" is slideably mounted in anobturating collar 58 having a convexupper surface 62 and a central opening 60'therethrough, thecollar 58 extending rearwardly to a reducedlower surface 64 and being intermediately formed with a deepperipheral groove 66 adapted to act as a gripping means for thecollar 58. Thecollar 58 is joined to thetube 12" by anelastic sleeve 68 disposed around the tube 12'', thesleeve 68 being bonded to and around theupper surface 62 of thecollar 58 at one end thereof and to and around thetube 12", adjacent itsnozzle 54, at its other end. Thesleeve 68 is substantially thicker in cross-section at its upper one half to define anenlarged circumference 72 in its normal state, as shown in FIG. 8. Similar to the embodiment of FIGS. 5 and 6, thecollar 58 is provided with anintegral wall 74 extending from and around theopening 60 therein, and encircling thetube 12" within thesleeve 68, adapted to act as a guide for thetube 12".

In the construction and composition of this embodiment I prefer thetube 12" to be composed of a rigid plastic material approximately three-eighth inch in diameter, with thecollar 58 and itsintegral wall 74 of the same material and the collar about one and onehalf inches in diameter. Theelastic sleeve 68 should be at least two inches in length, with its upper edge bonded to and around thetube 12" just below thenozzle 54, so that the tip of the nozzle 5d extends from thecollar 58 approximately three inches in repose. The upper one half of thesleeve 68, having theenlarged circumference 72 in untensioned condition, is adapted to have said enlarged circumference reduced, under tension, to an uniform diameter for thesleeve 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, thetube 12" is coupled to a syringe (not shown) containing the barium sulphate or other radiopaque liquid and cleared. The collar 5% is then firmly grasped at itsfinger groove 66 by the technician and thetube 12" forced through thecollar 58 to distend thesleeve 68 to a uniform diameter, as shown in FIG. 7, and thetube 12" inserted through theanal opening 76 and past theexternal sphincter 78 andinternal sphincter 80 and to clear theanal canal 82, which is approximately one inch in length, until thecollar 58 abuts theanal opening 76, as shown in FIG. 7. Thetube 12" is then released, causing thesleeve 68 to contract to its normal shape, whereby theenlarged circumference 72 resiliently presses against theinternal sphincter 80 above theanal canal 82, thereby holding thenozzle 54 firmly within the rectum and forming a fluid seal therewith at such point. The radiopaque solution is then discharged through therectum 84 to enter the colon(not shown), and the radiogram taken. On completion of the radiography theobturator device 10" is removed by once again forcing thetube 12" upwards to stretch thesleeve 58 to release its abutment against theinternal sphincter 80, whereby thetube 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.

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 inclaim 1, the discharge means comprising an opening in the end of the tube.

3. An obturator device as described inclaim 1, the discharge means comprising a plurality of opening in the tube end.

4. An obturator device as described inclaim 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.

1 1. An obturator device as described inclaim 10, the gripping means comprising a peripheral groove in the circular wall of the plug.

Claims (11)

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.

Images