RU81635U1 - OBSTETRIC AND GYNECOLOGICAL BLOOD REPAIR COMPLEX - Google Patents

Description

The utility model relates to medical equipment and medicine, in particular, to obstetrics and gynecology, and can be used to stop bleeding.

There are various hemostatic devices in the form of:

- systems with the ability to connect to a vacuum source, with a tubular working element in the form of an open loop in which holes are made along the inner loop [copyright certificate SU for the invention of “Hemostatic device” No. 1228833];

- a tool containing articulated jaws with working jaws, a longitudinal groove located in the middle of one jaw with a recess under the hemostatic clamp and a protrusion on the other jaw against the groove [RU patent for the invention of “A tool for applying a hemostatic clamp” No. 2062053];

- devices for stopping uterine bleeding [copyright certificates SU for the invention: No. 1097302, 288854, 187224, 166104, 125337].

A device is also known 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, published 2007, No. 1, P.48-49, entered the press on March 31, 2006]. 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 bleeding vessels with subsequent formation of parietal thrombi. The balloon is also a mechanical irritant and causes a reflex contraction of the walls of the uterus. 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 copy of the booklet with the device of the authors V.E. Radzinsky, Ya.G. Zhukovsky, M.A. Oleneva, T.V. Zlatovratskaya, T.V. Galina, Ch.G. Gagaeva et al., manufacturer of GinaMed LLC ].

The same device is described in patent RU No. 66665 for utility model [priority date 05/03/2006, published 09/27/2007]. It contains a tube, the distal end of which is open into the cavity of the container made of elastic material. In this case, the elongation of the elastic material is selected at least 250%. The volume of the container is from 150 to 650 ml, and the wall thickness of the container 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.

The closest analogue to the claimed obstetric-gynecological complex is a device for stopping uterine bleeding, described in patent RU No. 68883 for a utility model of the authors Salova I.A., Lysenko L.V., Marshalova D.V. et al. - priority date 10/01/2007, published 12/10/2007 [similar

device for stopping uterine bleeding described in application for invention No. 2007136010/14, Extradition Decision of 08.28.2008] * * (* Date of planned publication - January 2008)

This device includes an intrauterine device made of thin elastic rubber. It has 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. If necessary, there are irrigation and drainage tubes made of soft, elastic, material-containing material laid on the outer surface of the container. The length of these tubes slightly exceeds the length of the tubular element for delivery and support of the balloon with the ability to go 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 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 of the container is connected to the reservoir for filling the container with sterile liquid. The second tube, placed in the reservoir above the liquid level, is connected to the pressure gauge and a discharge pump is located at its end. The balloon was fixed by plugging in the vaginal opening and securing it with fixing tapes and a belt.

This utility model has the following disadvantages:

- the lack of sufficient mobility, the inability to correct the error associated with damage to the cylinder is not otherwise than the replacement of the entire plugging system and not guaranteed

the possibility of emergency response in critical situations in a few seconds (due to tapes, belts, tampons).

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

The objective of the claimed utility model is to reduce the time required to prepare the device for action while increasing its reliability.

Distinctive features of the proposed solution are the introduction of new elements into a device of a similar type and the specific implementation of each of them: a nozzle, its fastening, a locking element, other components and parts that provide the doctor with convenience and increase the effectiveness of his efforts in this process of stopping bleeding.

The essence of the claimed utility model - obstetric-gynecological hemostatic complex is characterized by the fact that it has a hollow supporting metal tubular rod, the proximal end of which is connected with the reservoir to the sterile liquid filling the balloon from thin elastic rubber, the second connecting tube placed in the reservoir above liquid level, connected to a pressure gauge and at its end there is a pump for pumping pressure, and from the side of the distal end, the rod has a rounded end with a blind end put on it, at a distance of the length of the cylinder from the side of its open end, a nozzle is installed, made in the form of a round body of the shape of a truncated cone, oriented with a smaller base towards the distal end, and from the side of the larger base of the nozzle

a gasket for contact and tight fastening without damage to the open end of the cylinder is placed, behind which the washer and fastening nut are located, perforation in the form of a series of slots spaced from the smaller base of the nozzle to the edge of the distal end of the rod, proximal to the fastening nut with the possibility of moving along the rod has a locking element in the form of a cork-shaped body of rounded shape made of soft elastic form-containing material, fitted with its inner surface to W a hatch with a screw clamp mounted on a metal tubular rod, with a rider mounted on its proximal end by a fastening screw with two hooks protruding and placed on it to fix the tongs for the screed, the hooks are equidistant to opposite sides and have bends oriented in the opposite direction side from the distal end, in the body of the locking element, extended recesses are made on both sides for the possibility of supporting manipulation tools on them, under the rider in A ring has been made to accommodate the doctor’s finger, an emphasis is placed on the edge of the proximal end of the rod to place the doctor’s hand in the area between his thumb and forefinger.

The technical result of the claimed utility model is to increase the reliability of the equipment and the ability to instantly start work of personnel, measured in seconds at the initial critical moment of bleeding.

When in the analogs and in the prototype the result is that the bleeding stop is achievable and there are no above complications

moments, the result is achieved, however, in a longer period than in the claimed utility model because the improvement proposed in this application is including a nozzle for the cylinder with its strong fastening that does not interfere with the instantaneous start of pumping fluid without leakage, the shut-off element in the shape of a cork-shaped body of rounded shape from a soft elastic material holding the shape allows almost instantly, in a few seconds, to block the exit from both the uterus and the vagina of the patient, and it is reliable, since a flexible circular plug-like body material after entering aimed to the former, in particular, the spherical shape.

The main medical and social effect is achieved by the claimed complex, saturated, in addition to the bottle and tubes for it, with a number of nodes that make up the design module, which provides all the stages for emergency medical care not only in highly equipped specialized medical institutions, but also in conditions close to field . The medical and social effect consists in the ability to stop bleeding with the simplicity of the claimed complex, which allows you to save the uterus in case of massive hypotonic 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.

The obstetric-gynecological hemostatic complex is illustrated using FIG. - a complete set of elements in the system for creating hydrostatic pressure for the dynamics of the work of the claimed obstetric-gynecological hemostatic complex, in which the positions indicated:

1 - metal rod;

2 - nozzle;

3 - cylinder;

4 - gasket;

5 - washer;

6 - fixing nut;

7 - a series of slots;

8 - locking element;

9 - sleeve;

10 - screw lock;

11 - rider;

12 - fixing screw;

13 - hooks;

14 - extended recesses;

15 - ring to accommodate the finger of the doctor;

16 - emphasis;

17 - the first connecting tube;

18 - tank;

19 - the second connecting tube;

20 - manometer;

21 - the pump.

The obstetric-gynecological hemostatic complex has a hollow supporting metal tubular rod 1, the end of the distal end of which is made in a rounded shape.

The nozzle 2 for the balloon 3 (made of thin elastic rubber) is made in the form of a round body in the shape of a truncated cone, oriented with a smaller base towards the distal end. On the side of the larger base of the nozzle 2, a gasket 4 is placed for contact and tight sealing without damage to the open end of the cylinder 3, behind which the washer 5 and the fastening nut 6 are installed. Perforation is made in the rod 1 in the form of a series of slots 7 spaced from the smaller base of the nozzle 2 to the distal the end of the rod 1. Proximal to the fastening nut 6 on the rod 1 is a locking element 8 in the form of a body of a cork-shaped rounded shape of soft elastic form-containing material with the filling of its internal volume with elastic rubber m materials under amenable to compression and subsequent recovery form for entry overlap. The locking element 8 is mounted with its inner surface on the sleeve 9 with a screw lock 10 and is arranged to move along the rod 1. A rider is installed from the proximal end of the rod 1 * ((* This term has been used for moving platforms along the support rod to fix the tool [see , for example, RU patent for the invention No. 2014804 "Gynecological device"].)) 11 with the possibility of fixing it with a fixing screw 12 on the rod 1, with two hooks 13 protruding and placed on the rider 11, equally spaced olezhaschie side of the rod 1 and having pleats oriented in opposite direction from the distal end. In the hooks 13 are fixed, if necessary, tongs for screed - to the left and to the right of the rod 1. In the body of the locking element 8 there are extended recesses 18 on both sides of the rod 1 for the possibility of supporting manipulation tools on them. Under the rider 11 is made ring 15 to accommodate the finger of the doctor. On the edge of the proximal end of the rod 1 there is a stop 16 for

placing the doctor’s hand in the area between his thumb and forefinger.

The proximal end of the rod 1 through the first connecting tube 17 is communicated with the reservoir 18 to fill the cylinder 3 with sterile liquid. The second connecting tube 19, placed in the reservoir 18 above the liquid level, is connected to the pressure gauge 20 and at its end there is a pump 21 for pumping pressure

The inventive obstetric-gynecological hemostatic complex operates as follows. With continued uterine postpartum hypotonic bleeding, they are stopped as follows. Dress the balloon 3 with the blind end on the distal edge of the rod 1, and on the edge of the nozzle 2 with the open end. They straighten it along the generatrix of the nozzle, start the open edge of the cylinder 3 over the edge of the nozzle 2 with approaching its end part, move gasket 4 close with clamping. The latter has the shape of a cone with geometric dimensions that allow its edge to enter the expanded part of the conical nozzle 2. Enter the nozzle 2 until it stops in a hollow truncated cone, thereby fixing the edge of the cylinder 3 inside - between the conical surfaces. Using the fastening nut 6, the washer 5 is fixed, which follows the gasket 4. The remaining air is discharged from the cylinder 3. The rod 1 is filled with sterile liquid using a system of tubes 17, 19 and a reservoir 18 with sterile liquid. The water system of the tubes 17, 19 with liquid is closed, the device is inserted into the uterine cavity, the screw lock 10 is loosened and it is slightly pushed along the rod 1 towards the balloon 3, and a pair of forceps are attached from each side of the right and left rod 1 to the proximal end devices, and

provide the passage of the forceps through the grooves - extended recesses 14 in the locking element 8, make contact of the working lips of the forceps with the edges of the cervix. Loosen the mounting screw 12 of the rider 11, allowing it to move along the rod 1 with the possibility of grabbing the tongs of the tongs by the hooks 13 of the rider 11. The tongs are moderately tensioned on the rod 1, then fix them, push the locking element 8 to the distal side, introduce it 1 / 3-1 / 2 of the length of the vagina, pump 21 fluid under pressure with a pomp. The balloon 3 is straightened, filled, inside the uterus presses its surface bleeding vessels. Ballon 3 is in the patient's body until bleeding is complete.

The inventive utility model is implemented in an experimental sample manufactured at one of the enterprises of the city of Saratov with a high-precision level of the machine park. The product is being prepared for practical testing in medical conditions.

Claims (1)

An obstetric-gynecological hemostatic complex, characterized in that it has a hollow supporting metal tubular rod, the proximal end of which is connected to the reservoir with a reservoir for filling a sterile liquid balloon made of thin elastic rubber, the second connecting tube placed in the reservoir above the liquid level is connected with a pressure gauge and at its end there is a pump for pumping pressure, and from the side of the distal end, the rod has a rounded end with a with a blind end, at a distance of the length of the cylinder from the side of its open end, a nozzle is installed, made in the form of a round body of the shape of a truncated cone, oriented by the smaller base towards the distal end, and from the side of the larger base of the nozzle there is a gasket for contact and tight sealing without damage to the open the end of the container, behind which the washer and fastening nut are located, perforation in the form of a series of slots spaced from the smaller base of the nozzle is made in a metal tubular rod about the edge of the distal end of the rod, proximal to the fastening nut with the possibility of movement along the rod, a locking element is made in the form of a cork-shaped body of rounded shape made of soft elastic form-containing material, mounted on its inner surface on a sleeve with a screw clamp, mounted on a metal tubular rod, from the proximal end of which is installed with the possibility of fixing it with a fastening screw, a rider with two hooks protruding and placed on it to fix the tongs for the screed, the handles are equidistant to opposite sides and have bends oriented in the opposite direction from the distal end, in the body of the locking element there are extended recesses on both sides to support manipulation tools on them, a ring is placed under the rider to accommodate the doctor’s finger, located on the edge of the proximal end of the rod emphasis for placing the doctor’s hand in the area between his thumb and forefinger.