RU68883U1 - DEVICE FOR STOPPING UTERINE BLEEDING - Google Patents

Abstract

The utility model relates to medical equipment and medicine. The device contains: an intrauterine balloon catheter made of thin elastic rubber, with a length of at least the total length of the uterine cavity and the length of the vagina, 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, laid on the outer surface of the balloon irrigation and drainage tubes made of soft, elastic, mold-containing material, the length of which is slightly greater than the length of the tubular element for delivery and support of the balloon catheter with the possibility of th exit beyond the birth canal to the outside - from the vagina. The distal ends of the tubes are rounded and holes are made on the surface for the outlet and collection of contents. On the proximal end of the tubes, locking (switching) elements are installed on each of them, one of the tubes is made with the possibility of connecting 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 balloon catheter is connected to the reservoir for filling the balloon catheter with sterile fluid, a second tube placed in the reservoir above the fluid level is connected to the pressure gauge and a pressure pump is located at its end. improving the accuracy and efficiency of personnel exposure due to the presence of a pumping device in the form of a pump and a pressure monitoring device - pressure gauge with compact equipment, as well as other structural elements. 1 ill., 2 ave.

Description

The utility model relates to medical equipment and medicine, in particular, to obstetrics and gynecology, and can be used to stop bleeding in puerperas during postpartum hypotonic and atonic bleeding, as well as to stop uterine bleeding caused by uterine fibroids and cancer.

There are various devices for stopping uterine bleeding [copyright certificate SU for the invention: No. 1097302, 288854, 187224, 166104, 125337].

A gynecological probe for stopping hypotonic uterine bleeding is also known [SU copyright certificate No. 1422560], comprising a thin-walled elastic container, a tube with refrigerant supply and removal channels, a perforated elastic plate, a suction tube connected to an elastic container.

A device for stopping uterine bleeding is also known [SU copyright certificate No. 1482681], comprising a balloon with membranes installed with a gap between them, and inlet and outlet pipes communicating with a gap between the membranes. One of the shells is perforated and fixed on the outside, and on the outer surface of the inner shell there are elastic spikes with rounded

the edges. The restoration of contractile ability of the uterine muscle is achieved by the action of the device spikes on the muscle fibers of the uterus, leading to an increase in their length to the optimal value. In order to ensure reliable hemostasis, hemostatic and antiseptic solutions are fed into the uterine cavity through a tube under pressure.

There is also a device for stopping hypotonic uterine bleeding [V.E. Radzinsky, Ya.G. Zhukovsky, M.A., Oleneva, T.V. Zlatovratskaya, T.V. Galina, Ch.G. Gagaev and others. Obstetrics and gynecology , 2007, No. 1, S.48-49]. It contains a silicone balloon, a fluid reservoir, and a hollow tube connecting them. The functioning of the balloon is based on the principle of communicating vessels. Hemostasis when using a balloon is caused by mechanical compression of the bleeding vessels of the uterus, followed by the formation of parietal thrombi. The balloon is also a mechanical irritant and causes a reflex contraction of the walls of the uterus. The functioning of the balloon is based on the principle of communicating vessels. The fluid introduced into the reservoir fills the catheter and allows you to create any desired pressure.

A device is also known for stopping hypotonic uterine bleeding [see the attached booklet with the device of the authors V.E. Radzinsky, Ya.G. Zhukovsky, M.A. Oleneva, T.V. Zlatovratskaya, T.V. Galina, Ch.G. Gagaev and others].

The closest analogue to the claimed utility model is a device for intrauterine balloon tamponade (options) [patent RU No. 66665 for utility model]. It contains a tube, the distal end of which is open into the cavity of the balloon made of elastic material, while the elongation of the elastic material is selected at least 250%, and the volume of the balloon is from 150 to 650 ml, and the wall thickness of the balloon is not more than 50-60 microns . The balloon has, in particular, a teardrop shape. The proximal end of the tube is made with

the possibility of hydraulic connection to a container designed for liquid and having the ability to change the spatial position.

This utility model has the following disadvantages:

- water injection in the proposed way - by raising the tank does not always quickly provide the necessary pressure due to the limited height of the tank; there is a limit on the height, limited by the length of the tubes and tripod;

- the bulkiness of the structure (the presence of a tripod, base, preventing the structure from turning over) is caused by the need to regulate (control) the pressure in the tank and in the cylinder; the design takes up additional space, which complicates the approach to the patient and complicates the work of staff;

- lack of sufficient mobility of the proposed equipment and the possibility of emergency response in critical situations, for example, with a repeated decrease in uterine tone and the resumption of bleeding;

- this device is unacceptable for patients who had arterial hypertension at the time of the balloon tamponade, due to the fact that the pressure created by raising the water column - the reservoir may not be sufficient to achieve the result;

- this device does not provide for drug irrigation of the uterine cavity with hemostatic agents, and also does not allow for optimal visual control during operation;

- this device does not allow to affect the entire area of possible bleeding;

- the lack of fixation of the balloon catheter can lead to the loss of the balloon catheter with increasing pressure in it (- it is known from the experience of a specialized medical institution);

- requires additional training: the location of the equipment relative to the patient at a given level, based on the conditions for determining the zero point of reference pressure in cm of water column.

The objective of the claimed utility model is to develop an organ-saving treatment device with ease of implementation in specialized medical institutions, including in feldsher-obstetric centers.

The essence of the claimed utility model lies in the fact that the device for stopping uterine bleeding includes: an intrauterine balloon catheter made of thin elastic rubber, with a length of at least the total length of the uterine cavity and the length of the vagina, a delivery device and support in the form of a tubular rounded elastic element with a length comparable, but not less than the total length of the uterine cavity and the length of the vagina, irrigation and drainage tubes made of soft elastic formoder laid on the outer surface of the balloon mating material, the length of which is slightly greater than the length of the tubular element for delivery and support of the balloon catheter with the possibility of going outside the birth canal to the outside - from the vagina, the distal ends of the tubes being rounded and holes for exiting and collecting contents on the surface of the proximal end tubes on each of them have locking (switching) elements, one of the tubes is made with the possibility of connection with a syringe for introducing a hemostatic agent into the uterine cavity, etc. the other tubes are connected to a container for collecting the outflowing fluid, while the tubular element for delivery and support of the balloon catheter is connected to the reservoir for filling the balloon catheter with sterile fluid, the second tube, placed in the reservoir above the fluid level, is connected to the pressure gauge and a pump is located at its end for pressure boosting.

The technical result of the claimed utility model is to increase the accuracy and efficiency of personnel exposure due to the presence of a pumping device in the form of a pump and a pressure monitoring device - pressure gauge with compact equipment, as well as other structural elements included in the claimed device: irrigation and drainage tubes with locking elements, their soft but shaped geometry. A few minimal movements provide emergency filling of the balloon completely and create sufficient pressure for hemostasis, while in the prototype it is not always achievable for a number of reasons:

- restriction of the movement of equipment and its parts - tank height;

- the presence of hypertension in patients, complicating the obtaining of an effective result.

When in the prototype the result is achievable and there are no above complicating moments, the result is achieved in a longer period.

The main medical and social effect, along with the above technical result, is achieved by the technique and the claimed device, saturated, in addition to the balloon catheter and tubes for it, with a number of nodes making up the kit (structural module), in which all stages are provided for emergency medical care not only in highly equipped conditions specialized medical institutions, but also in conditions close to field ones. The medical and social effect consists in the ability to stop bleeding with the simplicity of the claimed device, which allows you to save the uterus with massive hypotonic and atonic bleeding, and in some cases allows you to increase the time of the preoperative stage necessary for

transporting the patient to a specialized hospital, by reducing the rate and volume of blood loss.

A device for stopping uterine bleeding is illustrated using the drawing - Fig., In which the positions indicated:

1 - catheter balloon;

2 - means of delivery and support;

3 - irrigation and drainage tubes;

4 - locking / switching element;

5 - a connecting tube;

6 - reservoir for sterile solution with a sealed lid;

7 - manometer;

8 - pump;

9 - locking mechanism of the pump.

The device operates as follows. With continued uterine postpartum hypotonic and atonic bleeding, they are stopped as follows. A pre-formed, folded intrauterine balloon catheter is introduced into the uterine cavity, which is a product - a balloon made of elastic medical rubber, the folded length of which is not less than the total length of the uterine cavity and the length of the vagina. The delivery support device for this balloon is a tubular element rounded at the distal end, made of soft, flexible, mold-containing material (polyvinyl chloride, silicone, rubber, etc.) with a length comparable to, but not less than, the total length of the uterine cavity and the length of the vagina. The diameter of the tube is about 0.4-1.0 cm for quick filling of the balloon with liquid. In addition, several tubes (irrigation and drainage) made of soft shaped material (diameter of about 2-4 mm) were laid and fixed on the outer surface of the container. Fixation of these tubes is carried out at the end of the cylinder in order to avoid obstacles to its inflation by liquid. On

the tubes have holes for drug irrigation and for collecting uterine discharge.

By increasing the volume of the balloon catheter, mechanical compression of the bleeding vessels of the uterus and vagina is performed. After the introduction of a balloon catheter with tubes into the uterus and its fixation by plugging in the vaginal entrance and securing with fixing tapes and a belt, the formation of a balloon catheter at its proximal end is completed by connecting with a reservoir filled with 2-3 liter sterile saline. A sterile physiological saline solution is pumped into the cylinder by a pump, controlling the pressure in the cylinder with a manometer. The value of pressure is fixed at the moment of stopping the bleeding, the termination of which is judged by the absence of blood flow through the drainage tubes. Additional control is carried out by an ultrasound machine. When the manometer needle oscillates in the direction of increasing pressure, the restoration of uterine contractile activity is judged. Regulate and maintain the pressure in the balloon catheter using the locking mechanism on the pump. Hemostatic drugs are injected directly into the uterine cavity through an irrigation tube in an amount corresponding to the dosage adopted for the selected medical device, all tubes are closed for a time sufficient for the formation of a blood clot of the order of 5-10 minutes. Then, the pressure is relieved, the fluid is removed from the balloon catheter and removed to the outside.

Example 1. Patient S., 36 years old, was admitted to the maternity ward of Moscow Medical University “1st City Clinical Hospital” with a diagnosis of Pregnancy 38-39 weeks; head presentation; OASA; Obesity II degree; DUZHZH I-II degree, a condition of euthyroidism; Mild anemia in pregnant women.

This pregnancy in a woman is 4th, childbirth is 2nd. 1st pregnancy ended in preterm birth at 36 weeks. A live boy was born weighing 2650 g, height 45 cm. The postpartum period proceeded without

complications. 2nd and 3rd pregnancy in 2000, 2001 ended with an artifact abortion, without complications. This pregnancy proceeded to the threat of preterm birth in the second and third trimesters, about which examination and treatment were performed twice in a hospital setting.

At 7.30 a.m., bright amniotic fluid flowed. At 8.30 a.m. regular contractions appeared and 13.10 a.m. delivery with a living female fetus weighing 3300 g, length 50 cm: with an Apgar score of 7-8 points. The placenta separated on its own. Blood loss during childbirth was 250 ml. The birth canal was examined - no injuries.

In the early postpartum period from the genital tract appeared abundant spotting in a volume of 300 ml. The clots are friable, the amount of discharge increases. Diagnosed with Early postpartum, hypotonic bleeding. With a blood loss of 500 ml and ongoing bleeding during infusion therapy, a manual examination of the uterine cavity was performed, parietal clots were removed, the integrity of the walls of the uterus was not broken, the uterus was massage on a fist, stitches were sewn along Lositskaya, uterotonics were infused, the uterus was prone to relaxation, bleeding was not stopped. The volume of blood loss reached 650 ml. At 14:00 a balloon of the proposed design was introduced into the uterus, in which a pressure of 45-50 mm Hg was maintained by injecting sterile saline. The device was fixed with a swab and fixing tapes on the belt.

To perform local hemostasis through an irrigation tube, a bolus of 5% aminocaproic acid was administered at a dose of 80 ml, after which the lumen of the tube was blocked. The hemostasis was monitored by ultrasound, as well as visually, by the allocation of blood through two drainage tubes. After 12 minutes, blood flow through the outlet tube stopped. Continued infusion and uterotonic therapy. The uterus is well contracted, tight. Signs of ongoing

no bleeding. The uterine balloon exposure was 80 minutes. 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.

Example 2. Patient B., 32 years old, was admitted to the maternity ward of MMU "1st City Clinical Hospital" with a diagnosis of Pregnancy 38-39 weeks; head presentation; OASA; uterine fibroids; hypotonic vegetative-vascular dystonia; SCH I degree, the state of euthyroidism; mild myopia.

This pregnancy in a woman is 2nd, childbirth is 2nd. 1st pregnancy ended in urgent delivery. A live boy was born weighing 3850 g, height 52 cm. The postpartum period was uneventful. This pregnancy in the first trimester proceeded with the threat of termination of pregnancy, and therefore, the patient underwent outpatient treatment. During the third trimester, there was a threat of premature birth, about which an examination and treatment were also carried out in a hospital.

At 12:00, regular contractions appeared when the uterine pharynx was opened - 4-5 cm, an amniotomy of a flat dense bladder was performed, and 18 hours 17 minutes a delivery was performed with a living male fetus weighing 3,500 g, 51 cm long: with an Apgar score of 7-8 points. The placenta separated on its own. Blood loss during childbirth was 150 ml. When examining the birth canal, there is a moderately bleeding rupture of the lateral wall of the vagina.

In the early postpartum period, copious spotting appeared from the genital tract. The amount of discharge progressively increased. Diagnosed with Early postpartum, hypotonic bleeding. With a blood loss of 500 ml, a manual examination of the cavity was performed.

of the uterus, the uterine cavity is not deformed, the integrity of the walls is not broken, sutures along Lositskaya, the uterus is prone to relaxation, the uterotonics are infused, the uterus is hypotonic. The rate of bleeding has not decreased. The volume of blood loss reached 800 ml. At 18 h 30 min a balloon of the proposed design was introduced into the uterine cavity. An inserted catheter with a balloon made of elastic thin medical rubber was fixed in the vagina with a tampon. A sterile physiological saline solution was injected through the system into the cylinder under pressure, controlling its size with a pressure gauge, and the degree of filling of the balloon with an ultrasonic apparatus and the volume of saline injected. 60 ml of a 5% solution of aminocaproic acid were bolus injected through an irrigation tube. 10 minutes after the introduction of the solution, blood flow through the drainage tubes stopped. There are no signs of bleeding. The uterus is well contracted, tight. The pressure in the cylinder system was gradually reduced, after which the structure was finally removed from the genital tract. The uterine balloon exposure was 60 minutes. After that, the vaginal rupture was sutured. The postpartum period was uneventful, the woman was discharged with the child on the sixth day. In this case, the use of the proposed device was effective in the treatment of postpartum hemorrhage.

Claims (1)

A device for stopping uterine bleeding, characterized in that it includes: an intrauterine balloon catheter made of thin elastic rubber with a length of at least the total length of the uterine cavity and the length of the vagina, a delivery device and support in the form of a tubular rounded elastic element at a distal end with a length comparable to but not less than the total length of the uterine cavity and the length of the vagina laid on the outer surface of the balloon irrigation and drainage tubes made of soft elastic shaped material, the length of which is slightly exceeds the length of the tubular element for delivery and support of the balloon catheter with the possibility of going outside the birth canal to the outside - from the vagina, the distal ends of the tubes are rounded and holes are made on their surface for exit and collection of contents, from the proximal end of the tubes on each of them locking (switching) elements are installed, one of the tubes is made with the possibility of connection with a syringe for introducing a hemostatic agent into the uterine cavity, other tubes are connected to the container to collect the flowing fluid, while the tubular element for delivery and support of the balloon catheter is connected to the reservoir for filling the balloon catheter with sterile fluid, the second tube, placed in the reservoir above the fluid level, is connected to the pressure gauge and a pump is located at its end to pump pressure.