RU2491969C1 - Endoanorectal scale - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely to surgery and medical equipment and can be applied in carrying out fistulography under control of X-ray photography or computer planigraph for visualisation of rectum and anal canal. Endoanorectal scale is made with application of the principle of X-ray contrast, in form of calibrated tube. Tube is made from flexible elastic material and connected with catheter for pumping X-ray contrast solution. Tube diameter constitutes 0.2-2.0 cm. Tube contains rounded X-ray contrast tip and openings, through which X-ray contrast gets into anal canal and sinus tract of rectum. Inside tube one basic and, at least, two additional X-ray contrast labels with step from 3 to 5 mm are placed.

EFFECT: invention ensures accuracy of rectum and internal fistula opening visualisation in case of fistulography, safety and impermeability in introducing into anal canal and rectum.

3 dwg

Description

The invention relates to medicine, namely to surgery and medical equipment, and can be used when performing fistulography under the control of an X-ray or computed tomography scanner to visualize the rectum and anal canal.

The manuals on surgery (Vorobyev G.I. Basics of coloproctology. M., 2006: p. 80) describe such a method for the diagnosis of rectal fistula as fistulography. With some localization of fistulas, for example, complex extrasphincter rectal fistulas, the fistulography method is the main one in diagnostics, but there is no clear indication of the device or instrument used to visualize the rectum and accurately determine the level of contrast output through the internal opening of the fistula.

Known probes (patent RU 2229314 from 12.29.2001; patent RU 2140299 from 05.14.1998; patent RU 2022569 from 04.01.1990), which are flexible tubes with the number of channels from two to three, which can be used for insertion into the rectum when performing fistulography under the control of x-ray or computed tomography.

However, the probes have significant drawbacks: the absence of radiopaque marks, which does not allow us to evaluate the location of the internal fistulous opening in the rectum and the level of contrast output through it during fistulography; lack of tightness when placing them in the anal canal and rectum due to which leakage of contrast occurs, which creates a false picture of the fistulous course on the x-ray or tomogram.

Known probes (patent RU 2226411 from 03/04/2002; patent RU 2240141 from 03/27/2003; patent RU 2029570 from 02/27/1995), which are flexible tubes with a different number of channels (2-4) and the presence of inflated cuffs and cylinders that can use for insertion into the rectum when performing fistulography under the control of an x-ray or computed tomograph.

The disadvantage of these probes is the lack of radiopaque marks, which does not allow us to assess the location of the internal fistulous opening in the rectum and the level of contrast output through it during fistulography.

Known probes (patent RU 2228773 from 03.03.2003; patent RU 2290212 from 09.03.2005), which are flexible two-channel tubes with the presence of X-ray contrast olive at the end, as well as a probe (patent RU 2220748 from 07.15.2002), consisting of internal and external tubes, which additionally contains in the inner tube a third tube, in which a cable is located, terminating outside the tube with olive.

However, these devices have only one radiopaque mark (olive) in the first case or an ungraded radiopaque rod (cable with olive at the end) in the second case, respectively, which does not allow to accurately assess fistulography data using these probes. Also, there is no tightness when placing them in the anal canal and rectum due to which leakage of contrast occurs, which creates a false picture of the fistulous course.

A device is known (patent RU 2358664 dated 03/19/2008) - a two-probe probe with olive filled with liquid, in the center of which is a light source used for intraoperative detection of a rectal stump. When filling olive with X-ray contrast material, this device can be used to visualize the rectum when performing fistulography.

The disadvantage of this device is the lack of separate radiopaque marks and tightness when introduced into the rectum, which leads to leakage of contrast.

A device is known, described under the name "Anorectal ruler" and "Anocontrastor" (Yu.V. Dultsev, VL Rivkin Epithelial coccygeal passage. M. "Medicine" 1988, p. 51 and p. 53), which is X-ray tube graduated in centimeters.

However, the device has significant disadvantages: a rigid structure that can injure or perforate the rectum; a completely radiopaque rod with marks after 1 cm reduces the effectiveness of the study, since it is impossible to accurately assess the level of the internal fistulous opening in the rectum.

The technical result of our device is the development of an endoanectral ruler, which ensures the accuracy of visualization of the rectum and internal fistulous opening during fistulography, safety and tightness when introduced into the anal canal and rectum.

The endoanrectal ruler is a tube of flexible elastic material of figure 1 (1), for example, polyvinyl chloride (PVC); the diameter of the tube is 0.2-2.0 cm. The tube (1) is connected to the catheter of figure 1 (2), through which an X-ray contrast solution is injected. The tube (1) contains one of the main figures 1 (3) and at least two additional radiopaque labels of figures 1, 3 (4), a rounded radiopaque tip of figures 1, 3 (5). The device is equipped with holes through which the radiopaque enters the anal canal and fistulous passages of the rectum of figure 1 (6). Marks (4) are made of X-ray material, such as metal, located inside the tube (1), do not cause pain and inconvenience to the patient when performing the manipulation, the step between the marks (4) is from 3 to 5 mm.

Endoanrectal ruler is used as follows. The patient is placed in a position in which the external fistulous opening will be accessible for surgical manipulation and it will be convenient to perform fistulography.

An endoanrectal ruler is inserted into the rectum so that the main mark (3) corresponds to the edge of the anus.

Then produce x-ray studies. The endoanrectal ruler has additional marks (4), which are clearly visible on the radiograph, which allows you to accurately determine the depth of the inner fistulous opening of the border and the border of the fistulous passages. After the procedure, the endoanrectal ruler is removed from the rectum.

The device is reusable and must be sterilized. It is also possible to produce disposable samples.

Thus, the proposed endoanrectal ruler improves the quality of X-ray contrast studies, increasing the accuracy of determining the localization of the internal fistula relative to the edge of the anus due to the presence of the main mark (3), increases the safety of the study and significantly reduces the discomfort and discomfort in patients compared to the use of hard prototypes, for example "Anorectal line" and "Anocontrastor", due to its flexibility.

In addition, it was additionally found that when the device of our design was introduced, there was no leakage of contrast from the tube through the anus, while when using prototype devices, due to their stiffness, there is no tight fit and the radiopaque substance forms streaks, which sharply reduces the quality of the manipulation due to false positive determinations of fistulous passages.

During surgical treatment of fistulas, we found that the x-ray picture of the location of the fistulous passages and the volume of the process when using probes with a single radiopaque mark inserted into the rectum or without the introduction of additional devices do not correspond to reality in 8 out of 12 patients. This is due to insufficient visualization of the rectum, the absence of x-ray positive marks and the lack of sufficient tightness. As a result, when a contrast medium is introduced into the fistulous passage, an inaccurate determination of the localization of the internal fistulous opening occurs, as well as the leakage of contrast through the anus and its penetration into the tissues of the perianal region. As a result, during an X-ray examination, artifacts can be mistaken for streaks and branches of the fistulous course, and when planning surgical treatment, the volume of the operating aid is inadequate to reality.

When performing an intraoperative revision of the nasal and branching of the fistulous passage, falsely created on the radiograph by contact with the skin, the incisions appear to be inadequate during the operation, larger than required, in addition, the patient’s anesthesiological aid turns out to be larger doses of medications than necessary. All of the above has negative consequences in the postoperative period.

When using the endoanrectal line developed by us, the data turned out to be true and confirmed during surgical treatment of fistulas in 15 out of 15 patients (an agreement was signed with each of the patients on informed consent to use the proposed device). This result was achieved due to the presence of the main (3) and additional (4) radiopaque marks, which allow to increase the accuracy of determining the localization of the inner fistula (12) relative to the edge of the anus, and the tightness of the endorectal ruler in the anus. There is no leakage of contrast and contamination of surrounding tissues. With an X-ray examination, fistulography is clear without artifacts and is true. Safety is also significantly increased and negative feelings in patients are reduced during an X-ray contrast study. Based on the above, the patient is provided with an adequate surgical and anesthetic benefit with minimal side effects in the postoperative period.

Thus, the device we offer contains a new set of structural elements, which allows increasing the safety of the study, reducing the number of unpleasant sensations in patients during the examination, increasing the accuracy of determining the localization of the internal fistulous opening relative to the edge of the anal opening, preventing leakage of contrast and achieving tightness when performing fistulography. The absence of contrast leaks allows you to get a true picture of the location of fistulous passages, that is, to achieve an effect that is absent when performing fistulography currently used method.

Clinical example No. 1. A 35-year-old patient K. was in the coloproctology department of the State Health Institution of the Voronezh Regional Clinical Hospital No. 1 with a diagnosis of posterior complete transfunctional rectal fistula. When examining the patient was performed fistulography without using our device (Figure 2). After the necessary additional examination, including general clinical research, the patient's ECG was taken into the operating room. During the operation, false streaks (10) and false branching of the fistulous course (11) were revealed - artifacts on the fistulography image that appeared due to contrast leakage, thereby expanding the scope of the intervention due to inaccurate fistulography data. In the postoperative period, broad-spectrum antibiotics were prescribed for a course of 10 days. The patient was discharged home after 13 days. The postoperative wound after excision of the fistula healed by secondary intention after 25 days.

Clinical example No. 2. Patient N., aged 43, was in the coloproctology department of the State Health Institution of the Voronezh Regional Clinical Hospital No. 1 with a diagnosis of posterior complete transfunctional rectal fistula. When examining the patient, fistulography was performed using the endoanrectal line developed by us (Figure 3). After the necessary additional examination, including general clinical research, the patient's ECG was taken into the operating room. The inner opening of the fistula was closed by applying a ligature suture in the form of a figure eight, the outer fistulous opening was sealed with an aseptic bandage. No unforeseen complications were noted during the operation. In the postoperative period, broad-spectrum antibiotics were prescribed for a 5-day course. After 10 days, the patient was noted fusion fistulous passage from the bottom outward by two-thirds. After 20 days, the fistulous course completely healed.

Description for drawings

FIGURE 1 Endo-rectal ruler general view.

1. A tube from flexible elastic material.

2. Catheter for injection of X-ray contrast into the tube

3. The main radiopaque mark of the tube.

4. Additional radiopaque marks of a tube.

5. The tip of the tube.

6. Holes through which the radiopaque enters the anal canal and fistulous passages of the rectum.

FIGURE 2 X-ray taken during the fistulography procedure by the standard method.

7. The bones of the pelvis.

8. Pubic symphysis.

9. Fistulous course.

10. False streaks (artifacts) established during surgical treatment.

11. False branching of the fistulous course (artifact), established during surgical treatment.

FIGURE 3 X-ray taken during a fistulography procedure using an endoanectral ruler.

4. Additional radiopaque marks of a tube.

5. The tip of the tube.

9. Fistulous course

12. The inner opening of the fistula.

Claims (1)

An endoanrectal ruler made using the principle of x-ray contrast, in the form of a graduated tube, characterized in that the tube is made of flexible flexible material and connected to a catheter for pumping a radiopaque solution; the diameter of the tube is 0.2-2.0 cm, the tube contains a rounded radiopaque tip and holes through which the radiopaque enters the anal canal and fistulous passages of the rectum, inside the tube there is one main and at least two additional radiopaque marks with a pitch of 3 mm or more up to 5 mm.

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