Dilatation balloon catheter with reinforcing bar perfusion sheath

 

(57) Abstract:

The invention relates to medico-surgical instrumentation and supplies, namely the dilation balloon of the catheter and protesilaus the stents used in coronary angioplasty. The dilation balloon catheter includes a catheter tube with radio-opaque markers, a Central shaft for the guide and discharge mine dilatation balloon, the sheath dilatation balloon made of elastic stretchable material, such as polyethylene or polyvinyl chloride. In the dilation balloon catheter over the sheath dilatation balloon placed commensurate reinforcing perfusion sheath, made in the form of a cylinder of metal elastic rods, the ends of which are arranged in two annular clamps placed on the catheter tube. The proximal ends of the rods are pressed into the proximal annular yoke fixedly mounted on the catheter tube and the distal ends of the rods are freely in the annular groove between the catheter tube and fixed on it by sliding the distal annular ferrule with internal radially located by a bracket which is fixed prywatnego with long-term dilatation of the coronary vessel, the risk of acute occlusion and acute myocardial infarction, as well as eliminating the risk of postoperative distant occlusion characteristic of implantation of foreign protesilaus stent-analogue. 8 Il., table 1.

The invention relates to the field of medical and surgical instruments and accessories, and more specifically to surgical instruments and supplies to perform operations on coronary vessels, namely the dilation balloon of the catheter and protesilaus the stents used in coronary angioplasty.

Coronary vascular infarction atherosclerotic plaque, narrowing the lumen of the coronary blood vessels, causes coronary heart disease (CHD), developing in acute myocardial infarction and is the home, including in relation to injuries and cancer, cause of premature disability and death people. To correct the narrowing of the coronary vessels and restore the necessary blood flow are applied cardiology and cardiac surgery methods. Cardiac surgery coronary artery disease is divided into two methods of surgery: cardiac surgery open heart or coronary artery bypass grafting (CABG) and percutaneous (intravascular) surgery or corv:

- the dilation (widening) of the balloon catheter;

- intracoronary denture-stent.

Known design dilated balloon catheter [1], which provides a flexible catheter tube with two or more shafts, through one of which passes a conductor separated by a longitudinal partitions, sealed at the seams on the end segment of the catheter tube sheath dilatation balloon, the cavity which is communicated with the pressure catheter shaft through a side opening in the wall of the tube and attached to the catheter tube radiopaque markers. Catheter tube and the balloon sheath are made of materials having properties of strength, flexibility, elastic elongation and chemical neutrality, for example of polyethylene (PET) or polyvinyl chloride (PVC).

In the original (transport) sheath dilatation balloon tightly to the surface of the catheter tube without interfering with the movement of the catheter in the internal lumen of the coronary vessel. The catheter is introduced into the puncture hole artery access (femoral or axillary) via percutaneous Introducer and vdolca, which is fixed to the dilation balloon to the affected part of the coronary vessel. At the location of atherosclerotic plaques balloon segment of the catheter is fixed by using radiopaque markers observed on the monitor screen. Through dilated syringe through the injection catheter shaft under the sheath dilatation balloon is served physiological radiopaque fluid. Metered fluid injection leads to a managed expansion of the balloon, followed by a forced deformation of the wall of the diseased vessel and the restoration of his clearance to natural anatomical correlations with remote control this process by observing the screen of the x-ray monitor for loop dilatation balloon with radiopaque liquid. After some time of exposure dilated condition of the fluid from the tank is pumped dilated syringe, which leads to the falling of the cylinder to the outer diameter of catheter tube (transport condition), and the catheter is removed from the coronary vessel. Time advanced tank in the area of atherosclerotic plaques is determined by objective evidence about with is indeed the maximum allowable rate, determining the risk of acute myocardial infarction (up to units of minutes). The purpose of FECES is achieved while maintaining the effect of the expansion of the coronary artery at the site of atherosclerotic plaques after removal of the dilation balloon catheter.

The effect of the FECES associated with the action of two mechanisms:

- hyperestraier vascular wall;

- dissection and ousting of atherosclerotic plaques outside of the lumen of the coronary vessel.

When hyperlactatemia vascular wall also undergoing dissection some extent, from the moderate associated with rupture of the endothelium and the formation of cracks intima (dissection type A-C), to the occlusal, accompanied by deendothelization intima its rupture and delamination, cracks or breaks media and all layers of the wall (dissection types D-F). Due to mechanisms dissection there is a risk of negative consequences of surgical intervention, namely distal embolization dilational coronary vessel particles destroyed atherosclerotic plaque or a blood clot resulting from injury of the vessel wall, and the risk of acute occlusion of a coronary vessel flap detached intima in resulte are the main cause of failure in holding the CAP, including those associated with myocardial infarction and death.

To reduce the impact of these negative factors are used:

- intracoronary denture-stent;

- perfusion balloon catheter.

Known design intracoronary denture-stent [2] which is a wire or plate frame made of metal, plastic or other durable plastic material, having in the initial state, the shape of a cylinder of small diameter corresponding to the outside diameter of the dilatation balloon in the source, transport condition. When putting the stent on the balloon it provides a snug fit to the outer surface of the container, the possibility of percutaneous introduction of a catheter into the artery of the endovascular access and transportation to the site of lesion of the coronary vessel atherosclerotic plaque. When performing balloon CAP, in the phase of dilatation of the stent is forced to expand with dilated by the balloon. Subsequent compression of the container before it is removed from the coronary artery is accompanied by a release from contact with the stent, preserving, due to the rigidity imparted to him dilated balloon cylindricus is in the coronary vessel as intracoronary prosthesis. Release intracoronary prosthesis is a stent for a long time ruined fragments of atherosclerotic plaque, endothelial or flap of the intima to the inner surface of the coronary vessel, the reinforcement of the wall of the coronary vessel and thereby eliminating the risk of acute occlusion, followed by acute myocardial infarction, is the positive effect of the use of the prosthesis is a stent. The disadvantage of intracoronary restoration is an increased risk of distant (several months) occlusion of a coronary vessel due to increased thrombus formation on foreign coronary vessel material of the stent. The fundamental difficulty of creating thrombogenic, biologically inert materials to create stents known and is a fatal factor for the foreseeable future. The risk of distant occlusion is, according to experimental data, 22 - 35% of the total number of successfully completed transactions with achieved positive postoperative effect of eliminating the causes of coronary heart disease [3].

Known design perfusion Winternitz balloon catheter with vnutricleternmu perfusion [4], having in the wall of the catheter tube side holes, respondistis channel. After the expansion of the dilatation balloon at the location of the stenosis and the overlap of the lumen of the coronary vessel is a coronary guidewire is extended proximal lateral holes and blood perfusion goes through these holes and the Central shaft of the catheter in its bed for the catheter. The effect is to reduce the degree of ischemia and the risk of myocardial infarction during expansion of the balloon and its retention in the expanded state in the area of atherosclerotic plaques within the time calculated in a few minutes. However, the retention of the perfusion catheter with advanced balloon in the coronary vessel in a long time (several hours) for reinforcing the wall of the coronary vessel and thereby eliminate the risk of acute occlusion, followed by acute myocardial infarction, is unavailable due to structurally fundamental failure of the diameter of the Central shaft of the catheter to provide the necessary fullness of perfusion.

Closest to the claimed technical solution is a three-perfusion balloon catheter with milepostwall unicameral perfusion [4] , taken as a prototype. It differs from analogues Metro radar dilatation balloon, fixed externally on the catheter tube at angles of 120oto each other and communicating through openings between themselves and with the pressure catheter shaft tube. When conducting dilatation perfusion blood flow through the space between the inflated petal cylinders and surrounding tissues of the coronary vessel or fragments of atherosclerotic plaques. This type of catheter is also designed to reduce myocardial ischemia if necessary, prolonged dilation.

A three-perfusion balloon catheter with milepostwall unicameral perfusion has the following disadvantages:

- partial reinforcement flap cylinders coronary vessel, that is not isolated from the bloodstream of the segments of the vessel wall that causes the deflection of the walls of the vessel in the space between the flap cylinders, reducing blood flow and the risk of closure of damaged tissues on the surface of the cylinders in megalonyx the Lumina, including occlusion of the lumen when the inversion of the intimal flap;

- the lack of completeness of the blood flow perfusion due to the geometry of the shape of a three-cylinder in cross section, which causes the overlap treglio reachable area of the lumen of the perfusion no more than 10-15% of the cross-sectional area of the vessel in its natural anatomical correlation, that excludes the duration of dilatation of more than a few minutes.

The objective of the proposed technical solution is the creation of a perfusion lumen to provide blood flow precluding prolonged dilatation of the coronary vessel, the risk of acute occlusion and acute myocardial infarction, typical catheters-analogues and the catheter prototype, as well as eliminating the risk of postoperative distant occlusion characteristic of implantation of foreign protesilaus stent-analogue.

This goal is achieved by the fact that on top of the shell dilatation balloon placed commensurate reinforcing perfusion sheath, made in the form of a cylinder made adjacent to each other, the coaxial catheter metallic elastic rods, the ends of which are arranged in two annular clamps placed on the catheter tube with the outer sides of the sealed seams of the dilatation balloon, and the proximal ends of the rods are pressed into the proximal annular ring fixedly mounted on the catheter tube and the distal ends of the rods are freely in the annular groove between the catheter tube and planted on her by sliding the distal annular cage with wew the BCI, providing the possibility of longitudinal movement of the distal ring holder with bracket along the catheter tube to the length of the slot, with retention in the proximal position, the distal annular shroud distal ends of rods fixedly annular protrusion in the groove of the distal ring of the cage, and with their exit from the groove in the distal position, the distal ring clip, bracket, which secures the distal end of the drive string passing through the Central catheter shaft to the outside of the artery access.

The invention is illustrated in the drawings:

Fig. 1 - catheter in the transport condition before use; longitudinal section;

Fig.2 - distal ferrule;

Fig.3 - the catheter is in the phase of dilatation; longitudinal section;

Fig.4 is a cross section along a-a of the catheter in the phase of dilatation;

Fig.5 - catheter in phase reinforcement; longitudinal section;

Fig.6 is a section along a-a of the catheter in the phase reinforcement;

Fig. 7 - catheter in the transport state after phase reinforcement; longitudinal section.

The inventive device comprises a dilatation balloon catheter, representing the catheter tube 1 with radiopaque markers 2, the Central shaft 3 to the conductor 4 and the discharge of siala, for example, polyethylene or polyvinyl chloride, mounted on the catheter tube by means of a sealed seams 7, a side opening 8 in the wall of the catheter tube between blower shaft and sheath dilatation balloon. Over sheath dilatation balloon placed commensurate reinforcing perfusion sheath made of adjacent to each other, the coaxial catheter metallic elastic rods 9, the ends of which are located in the proximal 10 11 and distal annular rings placed on the catheter tube with the outer sides of the sealed seams of the dilatation balloon, and the proximal end 12 of the rod is pressed into the proximal annular cage 10 fixedly mounted on the catheter tube and the distal ends of the rods 13 9 freely enter the annular groove 14 between the catheter tube and planted on her by sliding the distal annular ferrule 11 with the inner radially positioned by the bracket 15, passing in a lateral longitudinal slot 16 in the wall of the catheter tube, providing the possibility of longitudinal movement of the distal ring holder with bracket along the catheter tube to the length of the slot, with retention in the proximal position, the distal calcev the x output from the groove 14 in the distal position, the distal annular casing 11, the bracket 15 to which is attached the distal end of the drive string 18, which is made of a material similar to the material of the conductor and passing through the Central catheter shaft to the outside of the artery access.

The action of the dilatation balloon catheter with reinforcing bar perfusion sheath has four sequential phases:

1) phase of the direct transportation of the catheter in the coronary vessel to the site of his defeat atherosclerotic plaque;

2) phase of dilatation of the coronary vessel in the lesion;

3) phase reinforcement coronary vessel providing blood flow perfusion;

4) phase reverse transportation of the catheter from the coronary vessel.

1. Phase direct transportation of the catheter in the coronary vessel to the site of his defeat atherosclerotic plaque (Fig. 1, 2). Transport condition catheter: sheath 6 dilatation balloon tightly to the surface of the catheter tube 1, the rods 9 reinforcing perfusion membrane tight to the shell 6 of the dilatation balloon, the distal annular ferrule 11 is in position, intermediate between the proximal and distal, in which the distal ends of the rods 13 9 freely and without stop in to the on the catheter tube is fixed by means of the drive string 18, held from longitudinal movement from the outside of the artery access, for example using a collet gripper (not shown in the drawings). The catheter is in the transport state is injected into the coronary vessel to align the balloon segment with site of lesion vessel atherosclerotic plaque or occlusion. Precision alignment is controlled by an x-ray monitor on the position of the radiopaque markers 2.

2. Phase dilatation of the coronary vessel in the lesion (Fig. 3, 4). Is forced dosed filling radiopaque physiological fluid shell 6 dilatation balloon and its expansion in the segment of the affected coronary vessel atherosclerotic plaque. Radiopaque fluid is delivered from the injection shaft 5 of catheter tube 1 through the side hole 8 in the wall of the cavity 19 is fixed in sealed seams shell 6 dilatation balloon, expanding it up to a diameter defined by the cross-section of the coronary vessel in its natural anatomical correlation in this area of the vascular bed and tactics of surgical intervention, controlling the expansion of the dosed supply of the liquid.

Extension obalnim by giving them the convex shape of the contours of the container. Thus, the distal ends 13 of the rods 9 are moved along the surface of the catheter tube 1 in the proximal direction, held in the annular groove 14 of the distal ring of the cage 11, under the tension of the drive string 18 is forcibly moved along the catheter tube in the proximal position, together with the distal ends of the rods 13 9 fixedly annular ledge 17. This movement is limited by the length of the groove 16. The output ends of the rods of an annular groove clip in the phase of dilatation is eliminated by limiting the expansion shell expansion tank maximum allowable pressure of the injected fluids. The proximal position, the distal ring clip on the catheter tube is fixed by means of the drive string 18 is held from longitudinal movement from the outside of the artery access, for example using a collet gripper, not shown in the drawings.

3. Phase reinforcement coronary vessel providing blood flow perfusion (figs 5, 6). The proximal position, the distal ring holder 11 is fixed by the tension of the drive string 18 is held from longitudinal movement from the outside of the artery access, for example using a collet grip, not pakatan aceveda with the creation of the under cover 6 cylinder negative pressure to ensure a tight seal to the surface of the catheter tube 1. The proximal position, the distal ring holder 11 fixed with the drive string 18, provides for the retention of the distal ends of the rods 13 9 in the annular groove 14 of the distal ring of the cage. Due to the emphasis ends 13 in the annular ledge 17 of the distal ring clip elastic rods 9 retain their shape, the force imparted to them dilated by the balloon during dilatation, and reinforce the wall of the coronary vessel along its entire inner surface of the segment of a cylinder. Formed instead of the cavity 19 of the under cover 6 dilatation balloon through the annular lumen perfusion 20 between the bars 9 and the surface of the catheter tube 1 provides perfusion blood flow in equipped (in operating practice: testirovanie) coronary vessel, sufficient for long-term functioning of the myocardium without the risk of acute occlusion and myocardial infarction. Therefore, the maximum allowable residence time of the catheter in the coronary vessel phase reinforcement of its walls is determined only by the factor eliminate the risk of posttraumatic education and the separation of blood clots.

4. Phase reverse transportation of the catheter from the coronary vessel (Fig. 7). At the end of phase reinforcement of the walls coronarographic capture, not shown in the drawing, causing forced displacement in the distal position, the distal ring of the cage 11. Under the forces of elasticity of the material of the metal rods 9 restore its original straight shape corresponding to the cylindrical shape of the reinforcing bar perfusion shell in the transport condition. Exemption from the groove 14 of the distal annular casing 11 of the distal ends of the rods 13 9 eliminates the risk of traumatic infringement of intimal flaps and tissue of the coronary vessel when the closure rods in a cylindrical shell on the surface of the catheter and provides bestrustees removal of the catheter from the coronary vessel through the free sliding of the surrounding tissues of the coronary vessel with the distal ends of the rods.

The result of applying the dilation balloon catheter with reinforcing bar perfusion sheath is a sequential combination during surgery short-term phase dilatation of the coronary vessel in the segment of his defeat atherosclerotic plaque with a sufficiently long for the partial healing of breaks intimal phase full reinforcement of the walls of the coronary searcha infarction, with the subsequent removal of the catheter from the coronary vessel, which eliminates the risk of postoperative, the long-time occlusion of the coronary vessel to the foreign material of the prosthesis is a stent. This eliminates the disadvantages of dilatation (ballinrobe) and protesilaus stenting listed in the descriptions analogs and prototypes, and achieving the goal of the proposed technical solutions.

The novelty of the invention will emerge from the comparison with the prototype, and is as follows: on top of the shell dilatation balloon placed commensurate reinforcing perfusion sheath, made in the form of a cylinder made adjacent to each other, the coaxial catheter metallic elastic rods, the ends of which are located in the proximal and distal annular rings placed on the catheter tube with the outer sides of the sealed seams of the dilatation balloon, and the proximal ends of the rods are pressed into the proximal annular ring fixedly mounted on the catheter tube, and the distal ends of the rods are freely in the annular groove between the catheter tube and planted on her by sliding the distal annular ferrule with internal radially located crotalinae move the distal ring holder with bracket along the catheter tube to the length of the slot, with retention in the proximal position, the distal annular shroud distal ends of rods fixedly annular protrusion in the groove of the distal ring of the cage, and with their exit from the groove in the distal position, the distal ring clip, bracket, which secures the distal end of the drive string, and passing through the Central catheter shaft to the outside of the artery access.

Thus, the technical solution meets the criterion of "novelty."

The validity of the proposed technical solutions and achieve clinical goals of its application is provided:

1) proof of technical feasibility of the proposed design with the requisite blood flow during the reinforcement phase of the coronary vessel;

2) confirmation of the effectiveness of long, but time limited reinforcement of the coronary vessel and the opportunity to cancel the installation of the permanent prosthesis is a stent.

1. Proof of the technical feasibility of the proposed design with the requisite blood flow during the reinforcement phase (Fig. 8).

The area of Sperpthe annular clearance 20 perfusion will be sufficient, if it relates to the area S stenosis, for which surgery is shown:

< / BR>
The value of kSis the ratio of the weight of perfusion reinforcing bars with possible values of kS= 0 for dilatation balloon to kS= 1 for a perfect protesilaus stent. The minimum value of the coefficient corresponding to critically significant stenosis (75% of the area of the vessel), is

kS. Crete= 0,25 [1,4]

In phase reinforcement design of the catheter has a radius Rthe stentcorresponding to the radius of the vessel in its natural anatomical cross-section and is defined by the sum of the radius rcat, catheter tube 1 and height hpdeflection of the reinforcing bars 9, in the transport state adjacent to the catheter tube

Rthe stent= rcat+ hp(2)

The area of the anatomical cross-section of the vessel, expressed in these settings is

Seat= (rcat+ hp)2(3)

The area of coverage of reinforcing rods in their open polozheniii, in the ultimate, most neblagopriyatnom case, the corresponding continuous location bar on the catheter tube, is

< / BR>
where n is the number of rods;

dCR- d is the dominant rods, and is determined only by the radius of the catheter tube and the height of the deflection of bars in the reinforcement phase:

Sperp= Seat- Sthe cross - - Scat= (rcat+ hp)2- 2rcathp- r2cat(5)

Taking into account (3) and (5) the ratio of the weight of the perfusion catheter of the proposed design is

< / BR>
The solution of equation (6) for the critical value of the ratio of the weight of perfusion defines the design requirement to the magnitude of the deflection of the reinforcing bars:

< / BR>
Thus, the acceptable area of the perfusion lumen is achieved when the magnitude of the deflection of the reinforcing bars equal to the radius of the catheter tube. Further expansion of the balloon and the corresponding increase in the deflection of the reinforcing rods improves the quality of the design coefficient of fullness perfusion.

Approximately the profile of the curve of deflection of the rods 9 is a at the ends of the rods on two related one-quarter of a circle, in the amount each having the length of a semicircle. When the maximum height deflection of hp. max= 3rcatdetermined by current demand expansion balloons and prosthetic devices-stents three times [1], bitches, accordingly, the movement of the distal ring of the cage will be hp. max, i.e., approximately 9 times greater than the radius of the catheter tube. While the ratio of perfusion will be, according to the formula (6), kSmax= 0,56.

Main characteristics of the balloon catheter with reinforcing bar perfusion sheath that define the possible appearance of their designs in sizes listed in the table.

Technical attainability of these characteristics is proof of feasibility by providing the specified quality indicators according to the degree of expansion of the container and the area of the perfusion lumen, the corresponding physiologically adequate blood flow for a long phase reinforcement of the walls of the coronary vessel.

2. The proof is long, but time limited reinforcement of the walls of the coronary vessel and opt-out installation of the permanent prosthesis is a stent.

Statistics postoperative surveillance and surveys indicate the following([1],[2],[4]):

a) acute occlusion of the coronary vessel leads to the development of acute myocardial infarction;

in 65 % of cases within the first hour after eating - during the first days after surgery, mainly within the next 2-4 hours;

b) one week after angioplasty, there was complete coverage of the damaged intima of the newly formed endothelium.

In General, in accordance with these data, the risk of acute myocardial infarction caused by acute occlusion of coronary vessel operated is reduced in case of reinforcement after dilatation approximately exponential dependence:

- reinforcement for 1 hour at 65%;

- when the reinforcement within 2-4 hours to 90%.

Conclusion: the application of the dilation balloon catheter of the proposed design with a new element - a reinforcing bar perfusion sheath for holding coronary angioplasty and subsequent reinforcement of walls dilational coronary vessel at the time of healing of damaged intima from 1 hour up to 2-4 hours is necessary and sufficient to reduce the risk of adverse effects on the 65 - 90%, without the use of protesilaus stents, creating the risk of distant postoperative occlusion, which determines the achievement of objectives and the effectiveness of the proposed technical solutions.

Sources of information

1. A. M. Babunashvili, I. H., Rabkin, B. A. Ivanov. Coronary angioplasty. -M.: Publishing House. DIA, 1996. - 352 p. Illus.

2. Gianturko-Roubin Flex-stent coronary stent.- guidelines for coronary stenting. -Workshop of COOK ink., Vienna, Austria, April, 1994.

3. Practical angioplasty / edited by David P. Faxon. - Raven Press, New York, 1993. - 273 p.

4. Meier C. Coronary angioplasty. - Grune & Stratton inc., Orlando, USA, 1989, 279 p. the prototype.

5. U. Sigwart, M. Bertrand, P. W. Serruys, C. Livingstone. Handbook of Cardiovascular Interventions. - Nev York, Edinburg, London, Madrid, Melbourne, San Francisko, Tokyo, 1996, 948 p.

Dilatation balloon catheter with reinforcing bar perfusion sheath containing catheter tube with radio-opaque markers, a Central shaft for the guide and discharge mine dilatation balloon, the sheath dilatation balloon made of elastic stretchable material, such as polyethylene or polyvinyl chloride, mounted on the catheter tube by means of a sealed seams, a side opening in the wall of the catheter tube between blower shaft and sheath dilatation balloon, wherein the top shell dilatation balloon placed commensurate reinforcing perfusion sheath, made in the form of a cylinder made adjacent to each other, coaxially ka is the Mach posted on catheter tube with an external sides of the sealed seams of the dilatation balloon, and the proximal ends of the rods are pressed into the proximal annular yoke fixedly mounted on the catheter tube and the distal ends of the rods are freely in the annular groove between the catheter tube and planted on her by sliding the distal annular ferrule with internal radially located by a bracket held in a lateral longitudinal slot in the wall of the catheter tube, providing the possibility of longitudinal movement of the distal ring holder with bracket along the catheter tube to the length of the slot, with retention in the proximal position, the distal annular shroud distal ends of rods fixedly annular protrusion in the groove of the distal ring of the cage, and with their exit from the groove in the distal position of the ring shroud, bracket, which secures the distal end of the drive string passing through the Central catheter shaft to the outside of the artery access.

 

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2 ex

FIELD: medicine; gynaecology.

SUBSTANCE: hemostatics and uterotonic agents are parenterally introduced. Previously folded intrauterine rubber balloon catheter with delivery and support in the form of tubular element rounded at distal end with length that is comparable to but not less than total length of uterine cavity and vagina is introduced into cavity of birth canal. Irrigation and drain tubes from elastic shape-holding material are located on external surface of balloon. Length of tubes exceeds length of tubular element for delivery and support of balloon catheter with possibility of exit beyond the limits of birth canal - from vagina. Distal ends of tubes are rounded with openings on the surface for contents outlet and collection. One of tubes is arranged with the possibility of connection with syringe for introduction of hemostatic into uterine cavity, other tubes are connected with reservoir for collection of drained liquid. Tubular element for delivery and support of balloon catheter is connected with reservoir for filling of balloon catheter with sterile liquid, the second tube installed in reservoir above liquid level is connected to manometer, and pump for pressure charging is located at its end. This device is located from entry to vagina to uterus bottom, fixing proximal end of balloon catheter with tubes in entry to vagina. Then sterile physiological solution is pumped into catheter by means of pump until visually controlled bleeding is arrested. After bleeding has been stopped, pressure value is fixed, then pressure changes are registered in filled balloon catheter, at that pressure rise is treated as restoration of uterus contractive activity, afterwards pulled pressure is reduced in successive steps down to fixed value. If pressure value in catheter drops, it is increased up to fixed value. In both cases fixed pressure of bleeding arrest is maintained for at least 30 minutes, reduction is carried out in successive steps by 10 mm of mercury column every 5-10 minutes. Hemostatics are introduced into uterine cavity by irrigation tube in appropriate doses, then all tubes are isolated for the time sufficient for creation of blood clot. If no bleeding takes place through drain tubes in process of stepwise pressure reduction, pressure is dropped, liquid is removed from balloon catheter, and it is withdrawn outside.

EFFECT: fast and efficient arrest of metrorrhagia by coverage of the whole area of possible bleeding and simultaneous additional effect at local hemostasis by introduction of medicines into uterine cavity.

2 cl, 3 dwg, 2 ex

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