RU2363503C2 - Device for carrying out of hysterosalpingography - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention concerns medicine. The device includes a plastic catheter and restrictor. The catheter is executed in the form of the tube having two channels unconnected among themselves, one of them is intended for supply of a radiopaque liquid in a cavity of the uterus, and another - for inflating by means of a liquid entered into the cervical channel of the cuff, placed on the distal extremity of the catheter. The cuff is executed with possibility of acquisition of the cylindrical form after filling of its cavity with a liquid. And in inflated condition diametre of the cuff is not less than twice less than its length, and at a catheter introduction external diametre of the cuff coincides with the size of a two-channel tube. Thus the restrictor is established with possibility of free movement and bracing on a tube between the cuff and a catheter adapter. Application of the given device provides easy introduction and reliable bracing of a handpiece in the cervical channel, and also prevents leak of a contrast liquid from an examined organ.

EFFECT: easy introduction and reliable bracing of a handpiece in the cervical channel, and also prevention of leak of a contrast liquid from an examined organ.

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Description

The invention relates to medicine, namely to gynecology, and can be used for hysterosalpingography (GHA).

The task of the GHA is to identify the patency of the fallopian tubes, the determination of anatomical changes in the uterine cavity, the adhesion process in the small pelvis. To solve this problem, the uterine cavity is filled with a radiopaque substance and an X-ray examination is performed. The result is a clear image of the contours of the uterus and fallopian tubes, while the free flow of contrast into the abdominal cavity indicates their patency.

The procedure is carried out using a special catheter made in the form of a hollow tube, which, as a rule, has two channels that are not interconnected.

From the proximal end of the catheter, the channels are separated using an adapter into two single-channel tubes equipped with connectors for connection with syringes. A latex ball-shaped cuff is placed at the distal end, inflated with distilled water, which is supplied via a syringe through one of the channels.

Another channel of the catheter (through) serves to introduce a radiopaque substance (liquid) into the uterine cavity, as well as to install (if necessary) a guide conductor that is extracted by contrasting the organ under study.

This design makes it easy enough to insert a catheter into the cervical canal and seal it, blocking the inflated cuff, and then fill the uterine cavity with an X-ray contrast drug or a solution of another dye.

Moreover, for a successful procedure, it is necessary to securely fix the tip of the catheter with a swollen cuff in the cervical canal to prevent leakage of the contrast agent during the study.

It is also extremely important to exclude injury to the patient in the initial stage of the procedure - when inserting a catheter into the cervical canal.

For these reasons, GHA catheters are equipped with restrictive nozzles allowing the catheter to be inserted into the cervical canal to a certain depth, usually not more than 4 cm, excluding, on the one hand, trauma to the patient’s internal organs, and, on the other hand, squeezing the inflated cuff from the cervical canal into uterine cavity.

Most often, flat discs are used as limiting nozzles, which are placed on a two-channel tube directly behind the inflated cuff from the side of the catheter center.

So, in US patents US 4430076 and US 5372584, in European application EP 0630658 described catheters, equipped as stops with disks fixed at the required level using the protrusions on the catheter tube.

Despite the rather frequent mention of such a solution, it, however, has a significant drawback, since its use does not exclude the possibility of extruding the tip of the catheter from the cervical canal into the vagina during the procedure. The latter circumstance can lead to leakage of contrast fluid and, accordingly, to the termination of the x-ray examination of the patient.

In addition, as practice shows, a rigidly mounted disk-limiter can irritate and even injure external organs, causing patients pain during movements associated with the need to change position during the procedure.

The device described in US Pat. No. 4,089,337 is less traumatic, in which the limiting disc can be used to move along the axis of the catheter within certain limits and, abutting against the external organs, hold the tip of the catheter at the time it is inserted to the required depth. This device is selected as the closest equivalent. However, the main drawback - the ability to extrude the tip of the catheter into the vagina - is not eliminated.

The same drawback is inherent in the technical solution described in US patent US 5104377, where to achieve complete non-invasiveness of the procedure, a separate elastic cuff is used as a limiter, which is inflated autonomously through the third independent channel of the catheter.

The problem solved by the invention is the creation of a simple, cheap, atraumatic and easy to maintain device for GHA, which will allow multi-axis examination of the patient, without hampering its active movements, will provide the possibility of easy insertion and reliable fixation of the catheter tip in the cervical canal, and also prevent leakage contrast fluid from the investigated organ.

To solve this problem, the device for conducting hysterosalpingography includes an elastic catheter and a stopper, while the catheter is made in the form of a tube having two channels not connected to each other, one of which is designed to supply radiopaque fluid to the uterine cavity, and the other to inflate by means of fluid introduced into the cervical canal of the cuff placed on the distal end of the catheter, said cuff being configured to acquire a cylindrical shape after filling its strips With a liquid and in a swollen state, the cylinder diameter is not less than two times smaller than its length, and when a catheter is inserted, the outer diameter of the cuff practically coincides with the size of the two-channel tube, while the stopper is installed with the possibility of free movement and fixation on the tube between the cuff and the catheter adapter.

The technical result from the use of the invention is to provide easy insertion and reliable fixation of the tip of the catheter in the cervical canal, while the leakage of the contrast fluid from the test organ is prevented. The result is achieved due to the presence of a cuff having a cylindrical shape in a swollen state, and a stopper that can both freely move along the catheter tube and so easily and reliably fix at the required distance from the uterine end when the catheter is inserted. As was experimentally established, for reliable fixation of the tip of the catheter, the length of the inflated cuff, regardless of its volume, should be at least 2 times its diameter.

Since for cuffs inserted into the cervical canal, the recommended diameters after bloating are in the range from 1.0 to 1.5 cm, cuff lengths must be in the range 2.0 ÷ 3.0 cm, not less. Practice has shown that with a decrease in this ratio it is not possible to completely eliminate the possibility of extrusion of the catheter tip from the cervical canal. Moreover, the smaller the ratio, the greater the likelihood of extrusion.

On the contrary, the proposed cylindrical shape and dimensions of the cuff after swelling exclude during the entire examination the extrusion of the tip of the catheter from the cervical canal and provide the necessary tightness of the system. The use of a limiter in this case is required only at the stage of catheter insertion, which makes the procedure completely atraumatic, while the possibility of active movements in the patient is fully preserved.

Thus, another technical result from the use of the invention is the ability to perform radiographs in the pelvic area in any projection without causing discomfort in patients.

The claimed device is illustrated by the drawing, which shows the image of the catheter for the GHA after it is inserted into the cervical canal and the inflated cuff.

The hysterosalpingography device comprises an elastic catheter with a two-channel tube 1, to the channels of which are connected single-channel tubes 2, a connector 3, an inflated cuff 4 with a cylindrical shape of the side surface, a stopper 5, a conductor cover 6, a two-way valve 7 with a cover 8, an adapter 9 connecting a single-channel and a two-channel tube, a clamp 10 for fixing and unlocking the limiter 5, and the uterine end 11 of the two-channel tube 1.

After the two-channel tube 1 is inserted into the cervical canal and the cuff 4 is inflated by supplying, for example, distilled water injected with a syringe through one of the channels, the lateral surface of the cuff takes a cylindrical shape. The limiter 5 is then fixed at a distance of about 4 cm from the fallopian end 11 of the two-channel tube 1 with the help of a clamp 10, and then, removing the fixation, the limiter 5 is moved to a position that allows its free movement.

The removal of the device is carried out by pumping liquid from the inflated cuff 4, while the outer diameter of the cuff is reduced to sizes that practically coincide with the size of the two-channel tube. The device is freely removable.

Claims (1)

A device for conducting hysterosalpingography, including an elastic catheter and a stopper, the catheter is made in the form of a tube having two unconnected channels, one of which is used to supply radiopaque fluid to the uterine cavity, and the other to inflate through the fluid introduced into the cervical canal a cuff placed on the distal end of the catheter, characterized in that the cuff is configured to acquire a cylindrical shape after filling its cavity with liquid, and in In this condition, the cuff diameter is at least two times less than its length, and when a catheter is inserted, the outer diameter of the cuff coincides with the size of the two-channel tube, while the stopper is installed with the possibility of free movement and fixation on the tube between the cuff and the catheter adapter.