RU2459590C1 - Non-pharmacological method of preventing purulent-septic and hemorrhagic complications in caesarean section - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, namely obstetrics. After removal of placenta before sewing uterus unfilled balloon catheter is introduced into uterus cavity through hysterotomic incision. Its tube is passed through cervical canal into vagina and out. After sewing hysterotomic incision balloon is filled with solution until balloon walls contact with walls of uterus cavity. Anterior abdominal wall is sutured. Filled balloon is left in uterus cavity for 2-3 hours. After that, balloon is emptied and catheter is left in uterus cavity for 2-3 more hours. Then balloon catheter is removed from maternal passages.

EFFECT: method ensures prevention of complications after Caesarean section: atonic bleeding, hematometra, postpartum endometritis, failure of sutures, peritonitis, sepsis.

1 ex, 6 dwg

Description

The invention relates to medicine, namely to obstetrics.

It is known that cesarean section (CS) is the most common of the major operations that women undergo throughout the world. Existing methods for its implementation are accompanied by the risk of a number of serious, life-threatening complications to the mother.

The most formidable complications of CS are infection and bleeding. Existing methods for the prevention of these complications during surgery are reduced to the appointment of medications: for the prevention of bleeding - uterotonics, for the prevention of inflammatory complications - antibiotics.

The effectiveness of these methods of prevention is low. So, endometritis after CS occurs in more than 20% of cases, and uterine bleeding associated with CS is 5-10 times more likely than during natural births (see Emergency conditions in obstetrics: a guide for doctors / V.N.Serov, G.T. Sukhikh, I.I. Baranov, A.V. Pyregov, V.L. Tyutyunnik, R.G. Shmakov. - M .: GEOTAR-Media, 2011, p. 503-527).

The operation of the COP in the lower uterine segment includes the following main surgical stages. Under aseptic conditions, the abdominal cavity is opened in layers by transverse suprapubic section, a hysterotomy section is performed, the fetus is removed, the last one is removed by hand, a control examination of the uterine cavity is performed and digital expansion of the cervical canal is performed from the side of the uterine cavity. Next, the wound on the uterus is sutured, the toilet of the abdominal cavity is sutured, and then the abdominal wall is restored layer by layer (see Blind AS, Abdominal delivery. - L., Medicine, 1986 - the closest analogue).

The disadvantages of the operation of CS include hasty suturing of the hysterotomy incision, which does not include any local preventive measures on the target organ, and the uterus is the source of subsequent possible purulent-septic and hemorrhagic complications in order to prevent them. But it is in the uterus, literally immediately after its suturing or at subsequent stages, with a certain frequency, that various pathological processes start that cause maternal morbidity and mortality in CS.

In addition, the described operation KS provides for digital expansion of the cervix before suturing the uterus, which leads to contamination of the uterine cavity with microflora of the vagina.

The invention is directed to the prevention of purulent-septic and hemorrhagic complications in CS.

The patented non-pharmacological method for the prevention of purulent-septic and hemorrhagic complications in cesarean section is characterized by the following. After removal of the placenta, before filling the uterus through a hysterotomy, an empty balloon catheter is inserted into the uterine cavity, the tail end of its axial tube is passed through the cervical canal into the vagina and out to the position until the catheter balloon is in the uterine cavity. After suturing the hysterotomy incision, the catheter balloon is filled with a solution under a pressure of 30-35 mm water column. until the walls of the balloon are in direct contact with the walls of the uterine cavity, then the anterior abdominal wall is sutured and the filled balloon is held in the uterus for 2-3 hours until reliable hemostasis occurs. Then the balloon is emptied from the solution and the catheter is left in the uterus for 2-3 hours to fix the drainage position of the uterus, prevent its pathological kink, and then the balloon catheter is removed from the birth canal.

The technical result of the method consists in dramatically reducing the incidence of a number of serious complications — atonic bleeding, hematometers, postpartum endometritis, suture failure, peritonitis, sepsis, that is, providing an uncomplicated course of the postoperative period (“dry” clean cavity, a full scar on the uterus, the absence of postpartum anemia, infection, early discharge). An additional technical result is the absence of the need to use antibiotics, un transfused blood, avoiding aspiration, curettage, washing, irrigation of the uterine cavity, transferring to observation-resuscitation.

The invention is based on the following provisions. It is proposed to prophylactically perform a balloon catheter aseptically during each operation of the CS using a unique access to the uterine cavity - a hysterotomy incision that exists in minutes only during this obstetric operation. This technique is non-invasive and fully meets the canons of the doctrine of wounds, i.e. performs the functions of a pressure dressing, ensures strict adherence to asepsis principles, maintains blood supply to tissues in the wound area, eliminates the “dead” space (uterine cavity lumen - the place of accumulation of blood clots), provides further uterine drainage - outflow of lochia, tissue detritus, wound discharge. A filled balloon catheter ensures non-invasiveness of the pressure bandage - it does not stick to the wound surface, it is easily separated without damaging the blood clots, and this procedure does not involve any risk to the patient. A balloon with a silicone, non-wettable surface fills the uterine cavity, putting pressure on the vessels of the placental site, preventing postpartum hemorrhage and the formation of blood clots - an environment for the multiplication of microorganisms.

In addition, the axial tube of the catheter itself, through which the solution is filled, serves as a rod core organ, which prevents the pathological bending of the operated uterus and fixes its drainage position, which is necessary for the free outflow of lochia in the postoperative period.

An important advantage of the invention is a unique aseptic technique for expanding the cervix by moving the caudal end of the catheter from the sterile to the non-sterile area - from the uterus to the vagina - and in only one direction. This excludes contamination of the uterus by the microbial flora of the vagina.

As a balloon catheter for CS purposes, for example, a thin-walled silicone balloon catheter according to patent RU66665 U1, LLC GinaMed, September 27, 2007, can be used. It contains an axial tube, the distal part of which is open into the cavity of the cylinder made of elastic material, in which the relative elongation of the elastic material is selected at least 250%, and the volume of the cylinder is from 150 to 400 ml, and the wall thickness of the cylinder is not more than 0, 6 mm. The balloon is drop-shaped. The tail end of the tube is made with the possibility of hydraulic connection to the tank, designed for liquid and having the ability to change the spatial position. The volume of the cylinder can be from 450 to 1500 ml, and the wall thickness of the cylinder is selected no more than 50 microns. The open tail end of the axial tube is equipped with a removable plug-tip of a rounded shape that is removed when connected to the tank.

The expansion of the balloon requires minimal effort, and its sole purpose is to keep the injected solution within the uterine cavity and prevent it from flowing out through the cervix and fallopian tubes. Such mechanical characteristics of the balloon make it possible not to block the inlet tube and to perform intrauterine compression using an open circuit and the principle of communicating vessels.

The patented technique makes it possible to obtain information about the state of contractile activity of the uterus and not impede possible fluctuations in its functioning. This is ensured by the correspondence of the shape of the balloon catheter to the contours of the uterine cavity and the choice of the minimum intra-balloon pressure (30-35 mm water column), which ensures the prevention of bleeding.

It is precisely such design features of the system that allow individualized installation of the balloon pressure necessary for prophylactic purposes by changing the placement height of the fluid reservoir connected to the catheter.

The invention is illustrated in the drawings, where:

figure 1, 2 shows the stages 1, 2 of the installation of the catheter in the uterine cavity;

figure 3, 4 - stage 3, 4 filling of the catheter and its removal;

figure 5 - to an explanation of the mechanism of occurrence of contamination and its consequences;

6 is a picture of postpartum endometritis with the existing methodology KS.

Figure 1 shows the procedure for retrograde insertion of a catheter. The catheter 1 has an empty balloon part 2, an axial tube 3, a tail end 4, a cap-tip 5. In the uterine cavity 6, a hysterotomy incision 7 is made; Pos.8 shows the anterior abdominal wall. Arrows 9 show the direction of insertion of the catheter 1 through the hysterotomy incision 7 and the direction of excretion of its caudal end 4 through the cervical canal 10 and the vagina 11. The stiffness of the axial tube 3 is selected so that catheter 1 is inserted into the uterine cavity without clamping.

Figure 2 shows the final installation procedure - bringing the balloon part 2 into contact with the bottom 12 of the uterine cavity 6, after which the hysterotomy incision 7 is sutured (suture is shown pos.13). The incision in the anterior abdominal wall 8 is not sutured. The tail end 4 of the catheter is located in the non-sterile zone of the vagina 11.

Figure 3 shows the filled state of the balloon part 2 in the uterine cavity 6. The tail end 4 is freed from the plug-tip 5 and connected by a main tube with a clip to the tank 14 with a warm solution. The wall of the filled balloon has a compression effect on the entire inner surface of the uterine cavity 6 (including the area of the suture 13, the placental site, and other blood vessels), sufficient to ensure intrauterine hemostasis and prevent the formation of blood clots. The reservoir 14 and the lumen of the balloon part 2 are connected by an open circuit according to the principle of communicating vessels, which makes it possible to adjust the compression effect by the height of the reservoir 14. As a result, there is objectively no free space for the formation of blood clots, and the uterine cavity 6 maintains a drainage position. Even if in the process of suturing the wound a certain number of clots has time to form in the uterine cavity, they will be crushed and displaced into the vagina along the axial tube by a straightening balloon immediately after restoration of the uterus integrity.

Figure 4 shows the final stage of the operation after 5-6 hours after the introduction and filling of the catheter balloon. During the first hour after filling the balloon part 2, suturing of the front wall 8 is carried out (suture is shown pos. 15), and then the filled balloon is held in the uterine cavity 6 for the next 2-3 hours until reliable hemostasis occurs. Then, after draining the solution, the catheter with the empty balloon is kept for another 2-3 hours to fix the drainage position of the uterus and prevent its pathological kink that blocks the outflow. After this, the balloon catheter is removed from the birth canal. It should be noted that the uterine cavity 6 is free of blood clots, and during the pulling of the balloon catheter 1 during its evacuation through the cervical canal, an additional expansion of the canal occurs. There is no contamination of the uterus with pathogenic microflora, since the catheter is moved from the sterile zone to the non-sterile zone - from the uterus to the vagina.

Figure 5 explains how in the method - the closest analogue is the contamination of the uterus with the microbial flora of the vagina with digital expansion of the cervical canal. The manipulation is performed when the obstetric finger moves from the uterus in the direction of the vagina, that is, from the sterile zone to the non-sterile one. However, with the return movement, the tip of the obstetric finger inevitably transfers the microbial flora from the non-sterile vagina to the sterile zone (uterine cavity).

Figure 6 shows the possible development of the infectious process in the method - the closest analogue for 2-3 days after surgery. The uterus 20 is infiltrated, edematous, filled with blood clots 21, scraps of the decidual membrane and fibrin 22. A pathological excess of 23 of the uterus 20 in the area of the postoperative suture 24 creates edema, narrowing of the lumen of the uterine cavity, which worsens the outflow of suckers, blood clots and wound detritus (item 25 ) Swelling of the area of the postoperative suture, spasm of the internal pharynx, and pathological kink of the uterus in the postoperative period contribute to the delay of blood clots in its cavity and the creation of conditions for constant resorption of bacterial and tissue toxins. In this situation, generalization of the infection occurs very quickly.

Clinical example. Patient U., 36 years old.

Diagnosis: full-term pregnancy, head presentation. Large fruit (estimated fruit weight 4200 g). Scar on the uterus (cesarean section in 2006). 2nd degree obesity. In a planned manner, abdominal delivery was performed.

Operation: Transverse suprapubic laparotomy. Cesarean section in the lower uterine segment by transverse section.

Anesthesia: Endotracheal anesthesia with nitrous oxide in combination with antipsychotic and analgesic agents.

Operation progress: Under aseptic conditions, the abdominal cavity was opened in layers by transverse suprapubic section, hemostasis was performed. In the wound lies the uterus, enlarged accordingly to full-term pregnancy. The abdominal cavity is limited by napkins. The vesicoureteral fold is opened and stupidly separated downward. The uterus is dissected by a transverse incision in the lower segment and the wound is bluntly expanded to the sides to 12 cm. The head is placed in the wound. The fetal head was also removed for the axillary hollows; a live boy weighing 4420 g, 55 cm long (with the cord around the neck, trunk) in satisfactory condition was removed without difficulty. Apgar score of 8 points. Mikulich clamps are superimposed on the corners of the cut. The last was removed by hand, a control examination of the uterine cavity was performed. The placenta is intact, the shell is everything.

Through a hysterotomy incision, a balloon catheter is inserted into the uterine cavity retrogradely, with the tail end forward (Fig. 1), to such a depth that the balloon itself is located within the uterine cavity, and the tail end is brought out through the lower segment, cervical canal, and vagina. The wound on the uterus is sutured with a single-row twisted continuous vikrilovy seam.

The caudal end of the catheter, located between the patient’s hips, is connected by an assistant to the main tube of the reservoir, filled with warm sterile saline and mounted on a rack, at a height of 30 cm above the level of the intrauterine catheter. After that, the terminal on the trunk was open. The level of the solution in the tank quickly decreased due to its movement into the lumen of the cylinder. The midwife synchronously filled the reservoir with an additional volume of solution until its level stabilized in the middle of the height of the reservoir.

There are no signs of intraoperative uterine bleeding.

Continued suturing of the uterus, peritonization with a continuous vikrilovy seam due to the vesicoureteral fold. Uterus appendages without features. The abdominal toilet. Operating sister report - material and tools on hand. The abdominal wall is restored in layers. Aseptic dressing. Urine excreted via catheter in an amount of 120 ml, light. Total blood loss 950 ml. The duration of the operation is 35 minutes The clearance of the axial tube of the catheter is blocked by a terminal, the main tube of the reservoir is disconnected.

The postpartum with the filled intrauterine balloon catheter is transferred to the intensive care unit, where the tail end of the catheter is again connected to the main tube of the filled reservoir and then the terminal is open.

Dynamic monitoring of the patient for 3 hours. Control ultrasound examination of the uterus: the correct intrauterine location of the slightly filled balloon was confirmed.

After 3 hours, the patient's condition is stable, AD-110/80 mm Hg, pulse 78 beats / min. There are no signs of external uterine bleeding and the accumulation of blood clots in the uterine cavity. The balloon catheter was emptied. Two hours later, in the absence of signs of bleeding, the catheter was lightly traction, effortlessly removed from the uterine cavity. Discharge from the birth canal is scarce, bloody.

After a day, the patient was transferred to the postpartum ward.

An ultrasound scan was performed, there were no signs of uterine subinvolution, the suture was without edema, the uterine cavity was slit-like, ultrasound did not show signs of blood clots, detritus, or decidual tissue in the uterine cavity.

On the 4th day in satisfactory condition, the patient was discharged home with the child. Further postoperative course is smooth.

Conclusion: despite the patient's belonging to a high-risk group for the development of hemorrhagic and purulent-septic complications of CS (large fetus, uterine scar, obesity, etc.), the preventive intraoperative use of a balloon catheter made it possible to avoid these formidable complications for mother's life and to ensure an uncomplicated postoperative course period.

Thus, the patented method allows you to observe the principles of asepsis 100%, virtually eliminate the likelihood of atonic bleeding intraoperatively and in the early postoperative period. The method makes it possible to prevent the imposition of compression sutures, dressings of the main vessels of the pelvis, the need to perform arterial embolization, hysterectomy. The method allows to prevent the development of hemorrhagic shock, to prevent the formation of hematometers, postpartum endometritis, divergence of sutures, peritonitis, sepsis.

Claims (1)

A non-drug method for the prevention of purulent-septic and hemorrhagic complications with cesarean section, characterized in that after removal of the placenta before suturing the uterus through the hysterotomy incision, an empty balloon catheter is inserted into the uterine cavity, the caudal end of its axial tube is passed through the cervical canal into the vagina and out to the position until the catheter balloon is in the uterine cavity, after suturing the hysterotomy section, the catheter balloon is filled with a solution under a pressure of 30-35 mm of water. Art. until the walls of the said balloon come into direct contact with the walls of the uterine cavity, then the anterior abdominal wall is sutured and the filled balloon is held in the uterus for 2-3 hours until reliable hemostasis occurs, then the balloon is emptied from the solution and the catheter is left in the uterine cavity for 2- 3 hours to fix the drainage position of the uterus, prevent its pathological excess, and then remove the balloon catheter from the birth canal.

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