RU2405479C1 - Method of diagnostics and treatment of postpartum uterine complications and device for method realisation - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: group of inventions relates to obstetrics and gynecology, and can be used in initial postpartum period. Preliminary formed device with folded intrauterine balloon from elastic transparent material is introduced into vagina. Balloon is placed on distal end of hollow cylindrical elongated holder. After distal end of device passes external orifice of uterus, balloon is brought into uterus and blown by means of sterile liquid. Liquid is supplied from proximal end through internal canal of hollow holder into balloon. Endoscope is introduced into blown up balloon through canal of hollow holder from its proximal end. Degree of balloon blowing up is regulated by pressing of the latter to endometrium. Visualisation of uterus cavity is provided with regulation of endoscope focus. Starting with zone of placental site, moving endoscope in region of visualisation and scanning by turns without omission the whole endometrium surface, pathological nidus is detected. By delicate access manipulator is introduced into uterus cavity. Instrument introduced earlier is not removed. Impact on pathological nidus is provided. Method is realised by means of device, which has elongated hollow holder, on whose distal end nozzle is put on. In front on it there is working cylindrical hollow tip with length comparable with length of nozzle along holder, on which placed is detachable balloon from elastic transparent material. Behind tip placed is fastening unit with gadget, washer and nut, placed successively. From proximal side of holder on it coaxially placed is shock-absorbing washer with guide bush. Axial openings of the latter are adapted for introduction and removal of instruments. From proximal side of holder also placed is reservoir for sterile liquid with tap and check valve inside it. In middle part of support holder with possibility of travel installed is disc-shaped locking element from elastic material with slot for supporting medical manipulators.

EFFECT: improved method and device of organ-preserving treatment and diagnostics of complications in initial postpartum period.

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Description

The invention relates to medicine and medical equipment, in particular to obstetrics and gynecology, and can be used for the diagnosis and treatment of postpartum complications, as well as for the production of devices with which this can be done.

A known method of stopping hypotonic bleeding in the postpartum period and during cesarean section [patent RU No. 20144843 for an invention], in which in addition to uterine massage and intramuscular injection of 1-2 ml of methylergometrine and 1 ml of oxytocin in 20 ml of a 40% glucose solution, sinestrol is administered once, 17-hydroxyprogesterone capronate, testenate in one syringe intramuscularly in a ratio of 1.0-1.5: 1: 1.0-0.5, respectively.

The disadvantage of this method is its low efficiency with massive uterine bleeding.

There is also a method of stopping hypotonic and atonic uterine bleeding [Duda V.I., Duda Vl.I., Duda I.V. Operative obstetrics. - Minsk: Inter-Press Service: Book House. - 2002, - p. 386-387], based on massage of the uterus (open), the introduction of uterotonic agents intravenously and into the muscle of the uterus, local hypothermia, electrical stimulation of the uterus, ligation or transcatheter embolization of the internal iliac or uterine arteries from one or both sides.

The disadvantage of this method is the low efficiency and safety in the treatment of uterine bleeding, since open massage of the uterus, the introduction of uterotonic agents intravenously and into the uterus muscle, as well as electrical stimulation of the uterus, carried out in conditions of local hypothermia, do not provide, under conditions of cooling, the development of maximum hypertonicity of uterine smooth muscle myocytes and rapid coagulation of blood located in the uterine cavity. In addition, an open massage of the uterus without additional trauma to the puerpera is possible only with uterine bleeding after cesarean section. Cooling the uterus and the blood in it inhibits the process of thrombus formation, inhibits contractile mechanisms in smooth muscle myocytes located in the vascular walls of the uterine arteries. In addition, massage, electrical stimulation and pharmacostimulation of the uterus accelerate the removal of blood from the uterine cavity to the outside. Intensive outflow of blood from the uterus does not ensure its coagulation inside the cavity.

There is also a method of stopping uterine bleeding [patent RU No. 2288656 for an invention], when a drug is heated into a uterine cavity with a balloon, heated to 42-45 ° C, in a volume exceeding half the volume of the cavity. In this case, dehydrated silicone gel impregnated with an equal volume of a solution of 3% hydrogen peroxide is used as a medicine.

The disadvantage of this method is the risk of developing pulmonary embolism due to the use of hydrogen peroxide, which foams and can form gas bubbles upon contact with blood. In addition, with massive uterine bleeding, the effectiveness of this method is significantly reduced.

There is also a method of treating hypotonic uterine bleeding (V.E. Radzinsky, Y. G. Zhukovsky, M. A. Oleneva, T. V. Zlatovratskaya, T. V. Galina, C. G. G. Gagaev and others. Obstetrics and gynecology, 2007, No. 1, p. 48-49], carried out by mechanically pressing the bleeding vessels to the walls of the uterus using a balloon. Hemostasis when using a balloon is caused by mechanical compression of the bleeding vessels of the uterus with the subsequent formation of parietal thrombi. The balloon is also a mechanical irritant and causes reflex contraction walls m The operation of the cylinder is based on the principle of communicating vessels, the fluid introduced into the tank fills the cylinder and allows pressure to be created.

The disadvantage of this method is the lack of visual monitoring of hemostasis, the lack of the possibility of local drug exposure to bleeding vessels in the uterine cavity for the purpose of hemostasis, insufficient method for massive uterine bleeding.

Also known is the group of inventions "Method for stopping uterine bleeding and a device for stopping uterine bleeding" [RU patent on invention No. 2347589]. Parenteral administration of uterotonic and hemostatic agents is carried out. At the same time, a pre-folded intrauterine rubber balloon is introduced into the cavity of the birth canal, having a delivery device and supports in the form of a tubular elastic element rounded at the distal end with a length comparable to, but not less than the total length of the uterine cavity and the length of the vagina. Irrigation and drainage tubes made of elastic shaped material are located on the outer surface of the container. The length of the tubes exceeds the length of the tubular element for delivery and support of the balloon with the possibility of going beyond the birth canal to the outside of the vagina. The distal ends of the tubes are rounded and holes are made on the surface for the outlet and collection of contents. One of the tubes is made with the possibility of connection with a syringe for introducing a hemostatic agent into the uterine cavity, the other tubes are connected to a container for collecting the flowing fluid. The tubular element for delivery and support of the cylinder is connected to the reservoir for filling the balloon with sterile liquid, the second tube, placed in the reservoir above the liquid level, is connected to the pressure gauge and a pressure pump is located at its end. This device is located from the entrance to the vagina to the bottom of the uterus, fixing the proximal end of the balloon with tubes in the entrance to the vagina. Then, sterile saline is pumped into the balloon through a pump until the bleeding stops, which is visually controlled. When the bleeding stops, the pressure value is fixed, then the pressure changes are recorded in the filled balloon, while the increase in pressure is evaluated as the restoration of contractile activity of the uterus, after which the injection pressure is gradually reduced to a fixed value. With a decrease in the pressure in the cylinder, the pressure is increased to a fixed value. In both cases, they maintain a fixed pressure for stopping bleeding for at least 30 minutes, the reduction is carried out in stages by 10 mm Hg. every 5-10 minutes. Through the irrigation tube, hemostatic preparations are introduced into the uterine cavity in appropriate dosages, then all the tubes are closed for a time sufficient for the formation of a blood clot. If there is no blood separation through the drainage tubes during the phased decrease in pressure, the pressure is released, the liquid is removed from the balloon and removed to the outside.

The closest analogue to the claimed method is precisely this method (patent RU No. 2347589). However, the device from this patent can only be an analogue, but not the closest solution, since in the time elapsed since the filing of RU patent No. 2347589 with a group of inventions, their authors managed to significantly improve the technical means of postpartum care and, therefore, improve the technology of rendering care for patients with postpartum hemorrhages.

The closest analogue to the claimed device is the "Obstetric-gynecological hemostatic complex" of the same authors [patent RU No. 81635], including a supporting hollow rod, on the distal side of which a smooth rounded end is made. In the body of the supporting hollow rod in the area serving as a working tip, extended from the nozzle to the edge of the device from the distal side, slots are made for the outlet of the injected fluid. On the support rod there is a nozzle for a cylinder of the shape of a truncated cone, a node for its fastening in the form of gaskets, washers and fastening nuts sequentially located behind the nozzle. Then follows away from the distal end of the locking element in the form of a spherical body with two grooves located parallel to the support rod, on both sides of it. A rider with two hooks protruding and placed on it is installed with a fixing screw from the proximal end of the support rod to allow fixing of the tongs for the screed. The hooks are equidistant to opposite sides and have bends oriented in the opposite direction from the distal end. Under the rider, a ring is made to accommodate the doctor’s finger. On the edge of the proximal end of the rod there is an emphasis for placing the doctor’s hand in the area between his thumb and forefinger.

However, this device is not suitable for all cases of care for patients in the initial postpartum period, without exception. The main difficulty lies in changing the architectonics of the cervix as a result of childbirth. Uterine pharynx is formed at the site of the cervix the size of the head of a newly born baby, and installing the necessary equipment to examine the consequences of childbirth, complications and their treatment causes difficulties. The instrument is designed for standard sizes in diameters, and in the initial postpartum period the cervix has not yet formed again and therefore the size of the uterine pharynx does not correspond to the usual standard sizes of equipment. The main objective of the invention is to create the conditions and architectonics of this place, convenient for the diagnosis of complications and their treatment. Those. in fact, with the help of the invention is to create an artificially cervical canal in the uterine throat.

With all the above advantages, the above obstetric-gynecological hemostatic complex-prototype does not provide for the possibility of visualization of the pathological focus, the causes of bleeding are in the nature of "guesses". In the case of residues and even pieces of the remaining placental tissue in the uterus, using a balloon, it will not be possible to eliminate the pathological focus.

The objective of the invention is to improve the method and device of organ-saving treatment and diagnosis of complications in the postpartum period with the simplicity of their implementation in specialized medical institutions.

The essence of the proposed method is characterized in that a preformed device is inserted into the vagina with a folded intrauterine balloon made of an elastic transparent material placed on the distal end of the hollow cylindrical extended holder, then after the uterus passes through the distal end of the device, the balloon is inserted into the uterus and inflated with sterile fluid fed from the proximal end through the internal channel of the hollow holder into the cylinder; an endoscope is inserted through the channel of the hollow holder from its proximal end into a bloated balloon; by adjusting the degree of balloon inflating, pressing the latter against the endometrium, adjusting the focus of the endoscope provide visualization of the uterine cavity; starting from the area of the placental site, by moving the endoscope in the imaging area and scanning, without missing the entire surface of the endometrium, the pathological focus is determined, after which the manipulator is introduced into the uterine cavity with delicate access without removing the previously introduced instruments, and provide exposure to the pathological focus after exposure is completed and To eliminate the pathological focus, the tools are removed, the balloon is deflated, the formed device is removed.

In addition, the method is characterized in that, if necessary, to select an adequate type of treatment, a manipulator is introduced with the possibility of taking a sample of the sample and the manipulator acts by separating the sample of a predetermined amount from the pathological focus.

The method is also characterized in that a photocoagulator fiber is inserted as a manipulator in the detection of bleeding spots into the uterine cavity, then, moving the fiber, it passes between the balloon wall and the endometrium to the problem areas of the uterus and photocoagulation is performed.

The essence of the device claimed in this application is characterized by the fact that it has a cylindrical extended hollow holder, from the distal end of which a nozzle is worn, in front of which is a working cylindrical hollow tip with a length comparable to the length of the nozzle along the holder, on which a removable balloon made of an elastic transparent material is placed , a fixing unit with a gasket, washer and nut placed in series is placed behind the nozzle; on the proximal side of the holder there is a coaxially absorbing washer with a guide sleeve on it, the axial holes of which are adapted to the input and output of the instrument, and a container for sterile fluid with a tap and a check valve inside it from the proximal edge to prevent the sterile fluid from pouring out of the tank through the proximal outlet the channel of the holder, in the middle part of the support holder, a disk-shaped locking element of elastic material with a groove for supporting ki medical manipulators. The technical result of the claimed invention is to improve organ-saving medical technology with ease of action by staff. The method is applicable, including at all levels of medical care by highly specialized medical institutions. The introduction and location of the balloon over the entire area of possible bleeding allows most patients to prevent the continuation of bleeding from previously unspecified locations. The possibility of additional exposure, if necessary, to local hemostasis using photocoagulation makes the method more effective.

The technical result of the claimed invention is to improve the accuracy of diagnosis and the adequacy of the actions of personnel during subsequent treatment by improving technology and equipment in general. According to the technology previously patented by the authors, they provide emergency filling of the balloon completely and in many cases create sufficient pressure for hemostasis. For those cases when the suppression of postpartum hemorrhage is impossible only with these means, the balloon is not inflated to the maximum degree, the introduction of an endoscope with a light guide and subsequent photocoagulation complete the treatment process, as a rule, is irreversible. If, as a result of visual diagnosis, it is necessary to take samples from specific places of the pathological focus for examination, this is possible using, for example, forceps of a manipulation tool. The treatment in the form of photocoagulation is carried out with the help of durable fixation of medical instruments in the inventive device, the treatment being highly reliable.

For comparison - even when in the closest analogue the result is achievable and there are no above complicating moments, the result is achieved in a longer period and relapse is possible after some time.

The medical and social effect, along with the above technical result, is achieved by the technique of the case (method) and the claimed device, saturated, except for the cylinder, with a number of nodes, some of which were absent both in the closest analogue and in all the analogs mentioned. Another part of those present both in the claimed and in the previous, closest analogue is modified, in a number of nodes - significantly. This, including the working tip. It was long and tightly closed, in this device it was open in the center and short. The miniature size of both the details of the claimed device, and of it as a whole, cannot but be overlooked. This was reflected in the weight of the device in the direction of relief.

A fully formed medical complex, designed to consolidate standard equipment in one "nest", makes the device convenient and reliable, which was absent in medical devices used to treat patients with an initial postpartum period.

The invention of the method and device is illustrated using figures 1-2, in which the positions indicated:

1 - supporting holder;

2 - working tip;

3 - nozzle;

4 - gasket for attachment nozzle;

5 - washer;

6 - fixing nut;

7 - disk-shaped locking element;

8 - groove of the locking element;

9 - a directing sleeve;

10 - a shock-absorbing washer;

11 - capacity of the fluid supply unit;

12 - crane.

The invention is a method as follows.

A preformed device with a removable folded intrauterine balloon made of an elastic transparent material fixed to the distal end of a cylindrical extended hollow holder 1 is inserted into the vagina with delicate access. In essence, an artificially cervical canal is created by installing the formed device in the uterine pharynx, in which it is firmly and firmly fixed diagnostic and surgical constructions. After the uterine pharynx passes through the distal end of the device, a device balloon is inserted in the uterine vestibule and inflated with a sterile fluid supplied from the proximal end through the internal channel of the hollow support holder 1 to the balloon using a container 11 with a valve 12 and a check valve. An endoscope is inserted through the shock absorbing washer 10 with the guide sleeve 9, placed coaxially on the hollow support holder 1 from its proximal end and adapted to the input and output of the instrument, into the uterus and, by adjusting the degree of balloon ballooning by pressing the latter against the endometrium, provide a clear visualization of the uterine cavity. When the endoscope barrel is inserted into the channel of the hollow support holder, the barrel pushes with its distal end a shut-off check valve, the end of which is fixed in the fluid container, opens it and passes the channel. Starting from the area of the placental site, the endoscope is moved to the imaging area and the entire surface of the endometrium is scanned alternately without a pass, until a pathological focus is determined. Then, without taking out the previously introduced instrumentation, the manipulator is inserted into the uterus and provide the necessary, adequate to the pathology found, effect on the pathological focus. After completion of treatment, the instrumentation is removed. The balloon is deflated for ease of removal. Remove the formed device.

The method is feasible using the inventive device, which, in addition to the above nodes and elements when setting out the methodology, has a nozzle 3 with a working tip 2. It is made mainly in the form of a truncated cone, oriented with a smaller base toward the distal end, with a large base toward the proximal end of the supporting holder 1, with sloping, well-machined edge surfaces for contact with a cylinder of thin durable transparent elastic material, eliminating burrs sharp edges. High-class metal processing should eliminate any microtrauma to the patient or damage to the balloon. Otherwise, effective treatment will not be carried out, the bleeding will not be stopped due to cylinder failure, or the diagnosis of the pathology of the uterine mucosa in the postpartum phase due to balloon breakthrough will not be performed. The nozzle 3 may be metal or from another equivalent material that holds its shape well. The working tip 2 has a length comparable to the length of the nozzle 3 along the support holder 1, and the shape of which is a horizontally positioned hollow cylinder with an open outlet towards the distal edge for the outlet of the injected fluid. The working tip 2 is a continuation of a hollow cylindrically elongated support holder 1, which is separated by a hollow nozzle 3. In contrast to the closest analogue - a device (patent RU No. 81635) it is several times shorter. During manipulations, the endoscope barrel passes through them. At the back of the nozzle 3, a mounting unit with a gasket 4, a washer 5 and a nut 6 placed in series is placed. Parts included in the assembly of the mounting unit also have modern round shapes of high precision processing of the material of their manufacture. In the middle part of the support holder 1 is mounted with the ability to move a disk-shaped locking element 7 of elastic material with a groove 8 to support medical manipulators.

Example. Approbation of the method. Patient S., 26 years old, was admitted to the maternity ward of the Municipal Clinical Hospital “1st City Clinical Hospital named after Yu.Ya. Gordeeva "with a diagnosis of:" The first period of the second urgent birth; preeclampsia of the second half of pregnancy, edematous-hypertensive variant, mild course against the background of vegetative-vascular dystonia of a hypertonic type; burdened obstetric and gynecological history. "

This pregnancy in a woman is 3rd, childbirth is 2nd. The first pregnancy in 2002 ended in an urgent delivery. A live boy was born, weighing 3,600 g and a height of 52 cm. The postpartum period was uneventful. The second pregnancy in 2003 ended in an artifact abortion without complications. This pregnancy proceeded against the backdrop of the threat of preterm birth in the second and third trimesters, about which examination and treatment were performed twice in a hospital setting.

At 15:30, amniotic fluid flowed away. Regular contractions appeared at 6.30 p.m. and at 10.10 p.m. there was a birth of a living female fetus weighing 3500 g, length 50 cm, with an Apgar score of 7-8 points. The placenta separated on its own. Blood loss during childbirth was 350 ml. The birth canal was examined - no injuries. Blood secreted from the genital tract has a long coagulation period - the formation of a clot in 48 "(at a rate of no more than 20").

In the early postpartum period from the genital tract appeared abundant spotting in a volume of 450 ml. The clots are friable, the amount of discharge increases. Diagnosed with Early Postpartum Hemorrhage. With a blood loss of 500 ml and ongoing bleeding against the background of infusion therapy, a manual examination of the uterine cavity was performed, parietal blood clots were removed, the integrity of the walls of the uterus was not broken. Bleeding did not stop. The volume of blood loss reached 600 ml. At 11 h 35 min a balloon of the proposed design was introduced into the uterus, in which a pressure of 45-50 mm Hg was maintained by pumping sterile fluid.

Hemostasis was monitored by an endoscope inserted into the inflated balloon through a channel along the hollow device holder. After detecting bleeding spots, a photocoagulator fiber was inserted into the uterine cavity. Then, promoting the light guide, they ensured its passage between the wall of the balloon and its endometrium to problem areas. Carried out photocoagulation. The uterine cavity was examined, the integrity of the uterus was not compromised, no placental tissue residues were detected. There are no signs of ongoing bleeding. The uterus is well contracted, dense. Subsequently, the postpartum period was uneventful. The woman was discharged with the child on the 7th day. In this case, the use of the proposed device was effective in the treatment of massive postpartum hemorrhage.

Claims (4)

1. A method for the diagnosis and treatment of postpartum uterine complications, characterized in that a preformed device is inserted into the vagina with a folded intrauterine balloon made of an elastic transparent material placed on the distal end of the hollow cylindrical extended holder, and then after the uterus passes through the distal end of the device, a balloon is inserted into the uterus and inflate it by means of a sterile fluid supplied from the proximal end through the internal channel of the hollow holder into the container; an endoscope is inserted through the channel of the hollow holder from its proximal end into the inflated balloon, adjusting the degree of balloon inflation, pressing the latter against the endometrium, adjusting the focus of the endoscope provide visualization of the uterine cavity; starting from the area of the placental site, by moving the endoscope in the imaging area and scanning, without missing the entire surface of the endometrium, the pathological focus is determined, after which the manipulator is introduced into the uterine cavity with delicate access without removing the previously introduced instruments, and provide exposure to the pathological focus after exposure is completed and To eliminate the pathological focus, the tools are removed, the balloon is deflated, the formed device is removed. 2. A method for the diagnosis and treatment of postpartum uterine complications according to claim 1, characterized in that, if necessary, a manipulator is introduced to select an appropriate type of treatment, with the possibility of taking a sample of the sample and the manipulator acts by separating the sample of a given amount from the pathological focus. 3. The method for the diagnosis and treatment of postpartum uterine complications according to claim 1, characterized in that the photocoagulator fiber is inserted into the uterine cavity as a manipulator, and then, moving the fiber, ensure its passage between the wall of the balloon and its endometrium to the problem areas and carry out photocoagulation. 4. The device for implementing the method according to claim 1, comprising a cylindrical extended hollow holder, from the distal end of which a nozzle is fitted, in front of which a working cylindrical hollow tip with a length comparable to the length of the nozzle along the holder, on which a removable balloon of elastic transparent material is placed, at the rear of the nozzle is a mounting unit with a gasket, washer and nut placed in series; on the proximal side of the holder there is a shock-absorbing washer coaxially mounted on it with a guide sleeve, the axial openings of which are adapted to the input and output of the instrument, and a container for sterile fluid with a tap and a check valve inside it from the proximal edge to prevent sterile fluid from pouring out of the tank through the proximal outlet the channel of the holder, in the middle part of the support holder, a disk-shaped locking element of elastic material with a groove for supporting ki medical manipulators.

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