Heart valve prosthesis

FIELD: medical engineering.

SUBSTANCE: device has grooves, bevel or ledge on each cusp closure surface to guide limited reverse blood flow directly to articulated members and casing and cusp surfaces adjacent thereto. The cusps allow forced rotation about casing axis due to limited reverse blood flow tangentially arriving when having the cusps closed, to make blood volume whirl about the central axis of the casing when entering the prosthesis and opening cusps.

EFFECT: high resistance to thrombus formation; prolonged service life; high reliability; reduced load applied to patient heart.

3 cl, 10 dwg

 

The invention relates to medical equipment and can be used in heart surgery to replace a diseased natural heart valves person.

Famous prosthetic heart valve (patent RF №2157674, MKI A 61 F 2/24, Appl. 27.07.99, publ. 20.10.2000)containing annular body having outer, inner and end surfaces, two shutters that are installed in the housing can be rotated from the closed position into the open and back, each of which has a bottom surface facing the direct blood flow, downward surface facing the reverse flow of blood, the clamping surface, which interacts with the clamping surface of the other of the sash in the closed position, the side surface that interacts with the inner surface of the housing. The leaf associated with the case using the rotation, which consists of two pairs located on opposite portions of the inner surface of the shell hemispherical recesses made in the form of a triad of communicating with blind holes, and two spherical protrusions located on opposite sides of each sash and included in the recesses of the triad on the body. Each recess triad consists of a Central intended for installation in him hanging sash, and two lateral deaf opened the th, designed for evacuation of blood. The channel bandwidth limited reverse flow of blood behind closed doors is formed by a recess-triad on the opposite parts of the body and the tabs on each leaf.

However, the prosthetic heart valve has the disadvantage of reducing the bandwidth as to secure the sash grooves on the housing must be deep enough, and this leads to the thickening of the walls of the shell mounting locations of the valves and, consequently, a reduction of the hydraulic valve hole.

In addition, during the valve opening and closing of the valves is independently from each other, so as the folds are not connected. Therefore, it is possible timing of the opening and closing of valve cusps. Due to the lack of mechanical connection between the wings and the presence of errors in the manufacture of the valve is one of the shutters can be opened or closed more slowly than the other, so such irregularity at the opening of the valves reduces the throughput of the valve and closing of the valves increases the reverse flow of blood, which leads to deterioration of hemodynamic characteristics specified prosthetic heart valve.

Some of these disadvantages are eliminated in another known design (patent RF №1767723, MKI A61 F 2/24, Appl. 14.08.90, publ. 1995). The specified prosthetic heart valve includes an annular body having outer, inner, end surface, and at least one element with a support surface, the cuff placed on the outer surface of the shell, two shutters that are installed in the housing for movement from the closed position into the open and back, each of which has a bottom surface facing the direct blood flow, downward surface facing the reverse flow of blood, the clamping surface, which interacts with the clamping surface of the other of the sash in the closed position, the side surface that interacts with the inner surface of the housing, a support surface, interacting with the corresponding support surfaces of the element, and the channel bandwidth limited reverse flow of blood with wings closed, whereby the said element is made around the perimeter of the hull.

The disadvantages of this prosthetic heart valve are as follows.

After closing the valves, the pressure from the outlet side of the valve increases, and limited reverse flow of blood passes through the additional grooves located on the side surface of each leaf, and extends into the cavity from the inlet valve to diametrically opposite portions of the inner surface the human body. Thus leaving additional grooves powerful jets limited reverse flow of blood with wings closed partially washed the base surface of the annular ledge facing the reverse flow of blood, and the side surface of the annular ledge facing toward the Central axis of the housing. And the base surface of the annular ledge facing the direct blood flow, is not washed nor backward, nor limited reverse flow of blood, as is the shadow in relation to them, what triggers the formation of blood clots on badly washed by the support surface of the annular ledge on the input side of the valve and reduce thromboresistance specified prosthetic heart valve.

In addition, the leaves in the specified prosthetic heart valve from its entrance protrude from the housing in the closed, intermediate and open positions, increasing the likelihood that touch the valves on adjacent to the implantable heart valve structure when in the human body and can lead to the penetration in the vicinity of the inlet valve of the living body tissues or between leaves, or between the casing and sash, which may lead to dysfunction of the valve in the form of jamming of the valves, which reduces the reliability and durability of the specified prosthetic heart valve.

The disadvantages given the CSOs valve can also be attributed to the absence of a mechanism of rotation of the valves. This is because additional slots removed from the hinge units and placed on a thin part of each leaf, resulting in a limited reverse flow of blood passes through additional slots to the generatrix of the inner surface of the housing and has no tangential component required for rotation of the valves around the axis of the housing, which reduces the reliability and durability of the specified prosthetic heart valve due to intensive wear of the contact surfaces in the same places when the valve and to reduce its thromboresistance due to the formation of shadow, vortex and stagnant zones annular protrusion on the body and not rotating shutters around the Central axis body.

Closest to the technical nature of the claimed object and by the greatest number of similar features is the prosthetic heart valve (patent RF №2113191, MKI A 61 F 2/24, Appl. 14.02.96, publ. 20.06.98), which is selected as a prototype. The specified prosthetic heart valve includes an annular body having outer, inner, end surface and at least one element with a support surface, the cuff placed on the outer surface of the shell, two shutters that are installed in the housing for movement from the closed position into the open and back, each of them is no ascending surface, facing the direct blood flow, downward surface facing the reverse flow of blood, the clamping surface, which interacts with the clamping surface of the other of the sash in the closed position, the side surface that interacts with the inner surface of the housing, the support surface interacting with the corresponding support surfaces of the element, and the channel bandwidth limited reverse flow of blood with wings closed, crossing the clamping surface of each leaf, and the said element is made around the perimeter of the housing or in separate parts on opposite sites.

The disadvantages of this prosthetic heart valve can include the following.

The channel bandwidth limited reverse flow of blood with wings closed in the specified valve consists of three types of slotted holes type, which do not contribute to the improvement of thromboresistance and hemodynamic characteristics of the valve for the following reasons:

a) one part of the slotted holes type placed between the wings and located at opposite sides of the side surface of each fold about hinge units. Part of a limited reverse flow of blood passing through these cracks between the wings at the opposite sides of the lateral surfaces of the valves, napravlennyi the Central axis of the body or parallel to the generatrix of the inner surface of the casing and bad washes the surface about the hinge nodes this is the surface element on the housing, facing the direct blood flow, and the inner surface of the housing at the inlet of the valve between the element and the end surface of the housing facing the direct blood flow, as these surface of the shell near the hinge of the shadow nodes are part of a limited reverse flow of blood passing through slotted holes at opposite sides of the lateral surfaces of the valves, which leads to activation of the thrombotic processes on the above, poorly washed surfaces of the body and to reduce thromboresistance specified prosthetic heart valve;

b) another hole slotted type placed between the wings in the Central part of the valve and does not improve thromboresistance this prosthetic heart valve, it only increases a limited reverse flow of blood, which impairs hemodynamic characteristics of this valve of the heart;

C) the third part of the slotted holes type placed between the side surfaces of the valves and the inner surface of the housing and located on diametrically opposite parts of the side folds near the hinge units. In this case, part of a limited reverse flow of blood passing through the third portion of the slotted holes type, also directed along the generatrix of the inner surface is of ARPUs and bad shadow washes the surface of the hinge units - this is the surface element on the housing, facing the direct blood flow, and a diametrically opposite portion of the inner surface of the inlet valve between the element and the end surface of the housing by direct blood flow that triggers the emergence and subsidence of blood clots in poorly washed surfaces of the body and reduce thromboresistance specified prosthetic heart valve. In addition, the third part of the slotted holes type between the body and leaves the hinge units are made by reducing the strength of the valve by reducing the cross-section of protrusions located on opposite sides of the lateral surface of each leaf and perceiving the maximum load with wings closed, for example, in mitral position, resulting in an increase in the probability of destruction of these support ledges on the doors, made of fragile carbon material, under the action of dynamic loads from the pulsating blood pressure when the valve is in the human body and can lead to loss of folds of the body, which reduces the reliability and durability of the specified prosthetic heart valve.

Fold this flap partially protrude from the end surface of the housing facing the direct blood flow, resulting during operation of the valve in the body is the ne may touch the valves about surrounding the heart valve structure of the direct blood flow, what can cause excessive stress on the heart by the incomplete opening of the valves or heart failure by incomplete closure of the specified valve.

In addition, when performing element on the perimeter of the annular body in the valve leaf in addition to move from the closed position into the open and back can be rotated around the Central axis of the housing, but the conditions and the means to enforce rotation of folds around the body axis in the valve is not created. Therefore, due to the lack of enforcement of rotation of the sash during operation of the prosthetic heart valve moving from the closed position into the open and back, but do not change its location relative to the Central axis of the housing, resulting in reduced thromboresistant specified prosthetic heart valve due to vortex, shadow and stagnant zones around places of fastening of the sashes, contributing to the initiation and activation of the thrombotic processes.

The technical object of the present invention is to improve thromboresistance of prosthetic heart valve, increase its reliability and durability, and reducing the load on the natural man's heart.

This object is achieved in that the prosthetic heart valve that contains concealer the hydrated case, having outer, inner, end surface and at least one element with a support surface, the cuff placed on the outer surface of the shell, two shutters that are installed in the housing for movement from the closed position into the open and back, each of which has a bottom surface facing the direct blood flow, downward surface facing the reverse flow of blood, the clamping surface, which interacts with the clamping surface of the other of the sash in the closed position, the side surface that interacts with the inner surface of the housing, the support surface interacting with the corresponding support surfaces of the element, and the channel for bandwidth limited reverse flow of blood with wings closed, crossing the clamping surface of each leaf, and the said element is made around the perimeter of the housing or in separate parts at its opposite sites, according to the invention the channel bandwidth limited reverse flow of blood is made predominantly radially relative to the inner surface of the housing at the closed shutters, located on the edge of the sash with the largest size and is formed by a groove, and/or bevel, and/or ledge, placed, at least one side surface of each of the sash Oh, and the clamping surface of the other leaf, and the edge of each leaf with the largest size at the level or downstream of the direct blood flow from the end surface of the housing facing the direct blood flow, and the said channel or at least part of the output in the direction of a limited reverse flow of blood is made perpendicular or tilted with respect to the generatrix of the inner surface of the housing at the closed shutters.

The groove and/or the bevel, and/or the ledge located at both sides of the lateral surface of each leaf.

In addition, the sash is made with the possibility of rotation around the Central axis of the housing at the location of these elements around the perimeter of the housing and the channel bandwidth limited reverse flow of blood is placed between the shutters in their closed position, made curved and has in relation to the inner surface of the casing tangentially directed outlet, formed a wedge-shaped protrusion and a chamfer located on opposite sides of the clamping surface of each leaf.

In the inventive design of the prosthetic heart valve channel bandwidth limited reverse flow of blood adjacent to the edge of the sash with the greatest amount of direct blood flow, placed between the doors when they closed the floor of the terms, made predominantly radially relative to the housing and comprises two through holes slotted type, going from one side to the downstream surface of the valves, and on the other hand on the opposite side of the side surfaces of the valves. But since the opposite parts of the side surface of each leaf from the means of rotation of the hinged type and upstream of the direct blood flow to the edge of the sash with the largest size made in relation to the inner surface of the housing with a gap which does not impede the opening and closing of the valves, the slotted holes of the type indicated with the mentioned gap between the casing and the shutters in their closed position. And limited reverse flow of blood at the position of the valves in the closed position, when the blood pressure at the valve outlet will be higher than the input, moves out of the cavity on the output side of the prosthesis and then through the slotted holes type placed between the wings at their opposite sides of the lateral surfaces, goes into the gap between the body and leaves near the hinge of the nodes, and then enters the cavity from the entrance of the prosthesis. This limited reverse flow of blood passing between the wings, moves along the axis of the housing, as in the prototype, but mainly at right angles to it, and is aimed directly at W is Mirnyi nodes, reducing their thrombosis through better omavaheliste. In addition, a limited reverse flow of blood out immediately in the cavity in front of the valve, as in the prototype, and comes first in the gap between the casing and sash, washing not only articulated units, but also the adjacent surface of the body and wings, and then goes into the cavity before the valve. This has improved the quality of rinsing limited reverse flow of blood hinge units and the adjacent surfaces of the casing and the valves, resulting in a decreased probability of sedimentation of blood cells and blood clots on the abutment surfaces of the element body, facing the direct blood flow, and the portions of the inner surface of the shell near the hinge between the end surface of the housing at the inlet of the valve element, and the housing when running the rotation of the hinged type in the form of an annular protrusion on the inner surface of the housing and the slots on the wings or in the form of diametrically spaced projections on the inner surface of the housing and grooves on the doors. Thus, directing limited reverse flow of blood behind closed doors in the side of the hinge units due to the execution of the said channel or, at least, his plot output during a limited reverse flow of blood perpendicular or tilted with respect to prasouda the inner surface of the housing, is more effective washing and washing of the hinge assemblies and the adjacent surfaces of the casing and the valves by supplying powerful jets of blood under high pressure into the clearances between the casing and doors in the area of hinge units, which reduces the probability of formation and sedimentation of blood clots on these surfaces and increases thromboresistance proposed prosthetic heart valve.

In the proposed design of the prosthetic heart valve edge of each leaf with the largest size, facing the direct blood flow, performed at the level or downstream of the direct blood flow from the end surface of the housing facing the direct blood flow, i.e. the edges of the valves direct blood flow does not protrude from the housing, which prevents the interaction of the valves with the cardiac structures adjacent to the inlet valve, eliminates jamming of the valves in their opening and closing during operation of the valve in the body and increases the reliability and durability of the proposed prosthetic heart valve.

The channel bandwidth limited reverse flow of blood may be formed by a bevel, ledge, groove separately, and in combination with each other, arranged at one or both sides of the side surface of each leaf, and the surface is firm clamping of the other sash, that expands the possibility of using different design decisions in the development of the proposed prosthetic heart valve. When this groove, bevel or step can be performed with the possibility of their intersection with the edge of each leaf with the largest amount of direct blood flow at a point remote from the side surface of each leaf by a distance not greater than the radial size of the hooks of the chassis with leaves, i.e. a>b. This ratio is optimal for a more efficient washer limited reverse flow of blood with closed doors bearing surfaces of the element body, facing the direct blood flow, and adjacent to the hinge nodes surfaces of the body and wings, which increases thromboresistance inventive prosthetic heart valve by increasing the efficiency of washing these surfaces.

When performing channel bandwidth limited reverse flow of blood in the form of a bevel located on opposite sides of the clamping surface of each leaf, the contacting of the valves between them during operation of the valve is stepped, i.e. with a closed valve leaf interact with each other surfaces of the closure in an intermediate position - surfaces of the bevels and when fully open the valve of the back surface is, however, Cams, which in turn decreases the likelihood of sedimentation of blood cells and blood clots on Cams valves by shaking off the settled particles of blood and the best omavaheliste surfaces of the casing and the valves in the areas most dangerous blood clots, including between the Cams, direct, reverse and limited reverse flow of blood, thus reducing the probability of encapsulating Cams adjacent folds the elements of blood due to rupture of contacts adjacent cusps at step move from the closed position into the open and back, which increases thromboresistant proposed prosthetic heart valve.

In addition, due to the bevel on the opposite sides of the clamping surface of each leaf in the initial stage of valve opening movement of the sash from the closed position to the intermediate, i.e. before contact between the surfaces of the bevel is made with minimal friction between the sash and the casing, and upon further opening of the valve, the friction increases as the Cams adjacent cusps interact among themselves, moving sash on the tabs on the chassis from the center to the periphery. Reduction of friction between the body and leaves at the beginning of the opening of the valves reduces the resistance, and hence the pressure gradient across the valve that prevadid reduce the load on the heart and improve the quality of life in the postoperative period.

In addition, the means of rotation of the hinged type interacting annular ledge on the housing and the slots on the frame or annular groove on the housing and the tabs on the frame, and performing channel bandwidth limited reverse flow of blood curved in the plane perpendicular to the Central axis of the housing, due to the wedge-shaped protrusion and chamfer located on opposite sides of the clamping surface of each leaf, allowed to declare the prosthetic heart valve to give the doors an additional degree of freedom is compulsory and guaranteed rotation wings around a Central axis of the housing around its perimeter by entering a limited reverse flow of blood tangentially relative to the inner surface of the housing, which increases thromboresistance inventive prosthetic heart valve, as a result of rotation of folds around the body axis in each cycle opens up new sections of the internal surface of the housing for their powerful washer jets limited reverse flow of blood coming out of the channel slots in the opposite sides and facing the inner surface of the housing near the hinge units. When this wedge-shaped protrusion and a chamfer adjacent cusps form a tangentially directed outlet to the channel.

Consider the mechanism of rotation of the valves around the axis of the housing. After closing the valves, the pressure on the output side of the prosthesis becomes greater than the side of its entrance, and a limited reverse flow of blood through gap junction channels between the wings formed by the groove, bevel and/or ledge, it moves predominantly perpendicular to the inner surface of the housing, i.e. in the radial direction, and then, passing between the wedge-shaped protrusion of one sash and chamfer the other sash, turns and goes into the gap between the body and leaves tangentially relative to the inner surface of the housing by tightening the blood volume from the entrance to the prosthesis. When the maximum pressure on the output side of the prosthesis increases the power tangentially facing jets limited reverse flow, which accelerates blood volume before valve to maximum speed. Then starts to decrease pressure at the outlet of the prosthesis and the increased pressure on his entrance, with untwisted volume of blood at the entrance to the prosthesis continues to rotate around the axis of the housing due to the force of inertia. After reaching the pressure drop across the valve, and hence the efforts on the leaves of this magnitude, when the rotating force of the swirling blood volume at the inlet valve will exceed the friction force between the housing is om and shutters, promoted volume of blood at the entrance of the prosthesis captures the leaf and begins to rotate around the Central axis of the housing in the same direction. After exceeding the inlet pressure in the prosthesis above the pressure at its output is the opening of the prosthetic heart valve, when this flap within gaps first "pop up" and move along with the direct blood flow, and then using the rotation of the hinged type is moved from the closed position into the open, through the direct passage of blood flow. When the movement of the valves with direct blood flow within the guaranteed gaps in the joints of the friction force between the body and leaves minimal, and the speed of rotation of the valves around the Central axis of the housing when it reaches the maximum value. Upon further movement of the sash in open position and speed of rotation will decrease due to increasing frictional forces between the body and leaves. Rotational movement of the shutters around the axis of the housing will be up until the friction force between the body and leaves will not exceed the inertial force hyped blood volume at the entrance of the prosthesis. For each cycle of operation of the first valve is twisted around the axis of the housing, the volume of blood in front of the valve due to the tangentially extending a limited reverse flow of blood with wings closed, and is eaten in the initial stage of opening of the valves promoted blood volume before the valve carries out the rotation of the valves around the Central axis of the housing at a given angle.

Thus, the execution of the channel bandwidth limited reverse flow of blood curved, having a tangentially directed outlet, allowed in addition to opening and closing, to carry out additional guaranteed rotational movement of the shutters around the axis of the housing around its perimeter, which leads not only to increase the reliability and durability of the proposed prosthetic heart valve by reducing the amount of wear of the housing by a uniform distribution on the perimeter of the building, but also to increase thromboresistance valve by improving the quality washer surfaces of the body and shutters limited reverse flow of blood in the areas that are most dangerous for the formation and sedimentation of blood clots.

Tangentially directed outlet channel formed by a wedge-shaped protrusion and a chamfer adjacent the valves in their closed position, provides a guaranteed tightening of the blood volume at the inlet of the valve and reduces strain on the natural man's heart after implantation of the proposed prosthesis in the aortic position, since the inside of the left ventricle at the moment of opening of the aortic valve of the heart muscle is tightening the emerging blood flow (Vierucci and other Nature of blood flow in the left ventricle of the heart.// "Experimental surgery and anesthesiology. - M., 1976. No. 3. - S-16; Shumakov V.I. and other Artificial heart// - M., Nauka, 1988. - S-159), which coincides with the direction promoted by the volume of blood in front of the valve due to the tangentially extending a limited reverse flow of blood that will relieve the natural heart of man and improve his quality of life in the postoperative period.

In addition, after implantation of the proposed prosthetic heart valve in the aortic position between the left ventricle and the aorta nutrition improves the natural heart of man due to the fact that the tangentially directed under high pressure limited reverse flow of blood spins not only fold, but all of the direct blood flow through the prosthesis in the aorta, resulting in a portion of the oxygenated blood outlet of the prosthesis due to centrifugal force is directed toward the periphery of the aorta, and in a reverse flow through the holes located at the periphery of the bulb of the aorta, is directed to the coronary vessels makeup for a natural human heart that leads to to improve health and enhance the quality of life of the patient not only in the middle postoperative period, but in the more remote periods, throughout life with this prosthesis.

Distinctive features of the proposed technical solution from the prototype are

1) channel for proposin is I limited reverse flow of blood is made predominantly radially relative to the inner surface of the housing at the closed shutters;

2) the channel bandwidth limited reverse flow of blood is located at the edge of the sash with the largest size;

3) the channel bandwidth limited reverse flow of blood is formed by a groove located at one side of the side surface of each leaf, and the clamping surface of the other leaf;

4) the channel bandwidth limited reverse flow of blood is formed by a bevel placed on one side of the side surface of each leaf, and the clamping surface of the other leaf;

5) channel bandwidth limited reverse flow of blood formed by the ledge, placed at one side surface of each leaf, and the clamping surface of the other leaf;

6) channel bandwidth limited reverse flow of blood formed by the groove and bevel placed on one side of the side surface of each leaf, and the clamping surface of the other leaf;

7) channel bandwidth limited reverse flow of blood is formed by a bevel and a ledge located at one side of the side surface of each leaf, and the clamping surface of the other leaf;

8) edge of each leaf with the largest size at the level of the end surface of the housing facing the direct blood flow;

9) edge of each leaf with the largest size made downstream Ave is constituent of blood flow from the end surface of the housing, facing the direct blood flow;

10) the channel bandwidth limited reverse flow of blood is made perpendicular to the generatrix of the inner surface of the housing at the closed shutters;

11) channel bandwidth limited reverse flow of blood performed with an inclination relative to the generatrix of the inner surface of the housing at the closed shutters;

12) part of the channel output in the direction of a limited reverse flow of blood is made perpendicular to the generatrix of the inner surface of the housing at the closed shutters;

13) part of the channel output in the direction of a limited reverse flow of blood performed with an inclination relative to the generatrix of the inner surface of the housing at the closed shutters;

14) groove located at both sides of the lateral surface of each leaf;

15) the bevel is located on both sides of the side surface of each leaf;

16) the ledge located at both sides of the lateral surface of each leaf;

17) groove and bevel are located at both sides of the lateral surface of each leaf;

18) the bevel and the ledge located at both sides of the lateral surface of each leaf;

19) the sash is made with the possibility of rotation around the Central axis of the housing at the location of the element around the perimeter of the body;

20) channel for p is lowering a limited reverse flow of blood, placed between the shutters in their closed position, made curved;

21) channel bandwidth limited reverse flow of blood towards the inner surface of the casing tangentially directed outlet, formed a wedge-shaped protrusion and a chamfer located on opposite sides of the clamping surface of each leaf.

These features of the invention are its differences from the prototype and determine the novelty of the proposal. These differences are significant because they enable the creation of achievable technical result, reflected in the technical task, and are absent in the known technical solutions.

The invention will become more clear from the following specific examples of its implementation and the accompanying drawings, in which

Figure 1 is a longitudinal section of the prosthetic heart valve, the leaf of which is shown in the closed position and conventionally not cut, phantom lines showing the valve in open position; an element of the case is made in the form of two located on diametrically opposite portions of the inner surface of the shell protrusions that are included in the corresponding shaped grooves of each leaf, and the channel bandwidth limited reverse flow of blood is made predominantly radially relative is on the inner surface of the housing at the closed shutters, located on the edge of the sash with the greatest amount of direct blood flow and is formed by a bevel placed on both sides of the side surface of each leaf, in conjunction with the ledge located at one side surface of each leaf, and the clamping surface of the other leaf, the edge of each leaf with the largest size, facing the direct blood flow, does not act outside the housing when moving the sash from the closed position into the open and back.

Figure 2 is a view along arrow a figure 1.

3 - section of the prosthetic heart valve b-B of figure 1, passing through the surface of the closing of the valves, with the edge of the bevel, placed at both sides of the lateral surface of each leaf, made perpendicular to the generatrix of the inner surface of the housing at the closed shutters, and the edge of the ledge, placed at one side surface of each leaf, made with an inclination relative to the generatrix of the inner surface of the housing at the closed shutters.

4 is a longitudinal section of the prosthetic heart valve in which one of the options element of the case is made in the form of two located on diametrically opposite portions of the inner surface of the shell protrusions that are included in the corresponding shaped grooves of each leaf, and the channel bandwidth limited the military back-flow of blood is made radially relative to the inner surface of the housing at the closed shutters, located on the edge of the sash with the greatest amount of direct blood flow and is formed by a bevel placed on both sides of the side surface of each leaf, and the clamping surface of the other leaf, and the ends of the valves facing the direct blood flow, does not protrude from the housing when moving the sash from the closed position into the open and back.

5 is a section of the prosthetic heart valve In figure 4, passing through the surface of the closing of the valves, with the edge of the bevel, placed at both sides of the lateral surface of each leaf, made perpendicular to the generatrix of the inner surface of the housing at the closed shutters.

6 is a longitudinal section of the prosthetic heart valve in which one of the options element of the case is made in the form of two located on opposite portions of the inner surface of the shell grooves, which are appropriate shaped protrusions located on opposite sides of the lateral surface of each leaf, and the channel bandwidth limited reverse flow of blood behind closed doors is formed by a groove placed at both sides of the lateral surface of each leaf, and the clamping surface of the other leaf.

Fig.7 - section of the prosthetic heart valve G-G 6 passing through the surface of the closing of the valves, and the groove is azmeena both sides of the side surface of each leaf, made with an inclination relative to the generatrix of the inner surface of the housing at the closed shutters.

Fig is a longitudinal section of the prosthetic heart valve in which one of the options element of the case is made around the perimeter of the inner surface of the housing in the form of an annular protrusion, which is included in the corresponding shaped grooves located on opposite sides of the lateral surface of each leaf, and the channel bandwidth limited reverse flow of blood behind closed doors is formed by a ledge, placed at one side surface of each leaf, and the clamping surface of the other leaf.

Fig.9 - section of the prosthetic heart valve d-D Fig passing through the surface of the closing of the valves, in which one of the options the edge of the ledge, placed at one side surface of each leaf, made perpendicular to the generatrix of the inner surface of the housing at the closed shutters.

Figure 10 is a partial cross-section of the prosthetic heart valve o-o Fig.9, in which one of the options the channel bandwidth limited reverse flow of blood is placed between the shutters in their closed position, made curved and has in relation to the inner surface of the casing tangentially directed outlet formed wedge height is upon and chamfer, located on the opposite sides of the clamping surface of each leaf.

The proposed prosthetic heart valve (figure 1) contains a ring-shaped housing 1 having outer 2, 3 and the inner end 4, 5 surface. On the inner surface 3 of the housing 1 is placed, at least one element 6 with the support surfaces 7, 8. Element 6 made in the form of two projections 9, which are located at diametrically opposite portions of the inner surface 3 of the housing 1. On the outer surface 2 of the housing 1 is placed the sleeve 10 by means of which the implantable prosthetic heart valve is attached to the fibrous ring of the natural heart of man instead of the diseased valve. In the annular body 1 can be moved from the closed position to the open back and installed the two openings 11, each of which has a bottom surface 12 facing the direct blood flow, downward surface 13 facing the reverse flow of blood, the surface of the closure 14, which interacts with the clamping surface of the other of the sash in the closed position, the side surface 15, which interacts with the inner surface 3 of the housing 1. On opposite sides of the side surface 15 of each sash 11 are shaped grooves 16, which have support surfaces 17, 18, interacting respectively with the reference surface is Rostami 7, 8 item 6 on the housing 1. On the downward surface 13 of each sash 11 is made Cams 19 which prevents closing of the valves 11 in the open position. Channel 20 for bandwidth limited reverse flow of blood is placed between the wings 11, made predominantly radially relative to the inner surface 3 of the housing 1 with wings closed 11 is turned to direct the blood flow to the edges of the valves 11 with the largest size, and is formed by a bevel 21 in conjunction with the ledge 22 and the clamping surface of the other leaf. Moreover, the bevel 21 located at both sides of the side surface 15 of each sash 11 and the ledge 22 to one side of the side surface 15 of each leaf 11 (Fig.1-3). In addition, the edge of the bevel 21 is located along the surface of the closure 14 and is made perpendicular to the generatrix of the inner surface 3 of the housing 1 behind closed doors 11 and the edge of the ledge 22 is accomplished with an inclination relative to the generatrix of the inner surface 3 of the housing 1 (Fig 3). Thus the edge of the ledge 22 with a slope can cross the edge of the sash 11S greatest amount of direct blood flow, and the distance from the side surface 15 of each sash 11 to its intersection with the edge of the ledge 22 with the edge of the sash 11 should not exceed the radial size of the projections 9 or the depth of the grooves 16 of the sash 11, i.e. a>b. To increase the rigidity and strength of the hull 1On its outer surface 2 a metal ring 23 with a high modulus of elasticity.

One of the variants of the invention (figure 4, 5) channel bandwidth limited reverse flow of blood 20 is formed by a bevel 21 placed at both sides of the side surface 15 of each sash 11, and the clamping surface 14 of the other sash. This edge of the bevel 21 is located along the surface of the closure 14 and is made perpendicular to the generatrix of the inside surface 3 of the housing 1 with wings closed 11.

The proposed (Fig.1-5) a rotation hinge type made in the form of being engaged two projections 9, which are located at diametrically opposite portions of the inner surface 3 of the housing 1, and two slots 16 located on opposite sides of the side surface 15 of each leaf 11. When this flap 11 can only move from the closed position into the open and back and can't perform a rotational movement around the Central axis of the housing 1 due to the presence of rotation limiter (not shown).

Performing channel 20 for bandwidth limited reverse flow of blood predominantly radially, i.e. perpendicular to or tilted with respect to the generatrix of the inner surface 3 of the housing 1 has allowed to direct powerful jets limited reverse flow of blood with wings closed 11 on the supporting surface 7 of the projections 9, is turned to direct the flow of blood, and on the inner surface 3 of the housing 1 located between its front surface 4 at the inlet of the valve element 6, which improves the efficiency of washing hinge units and adjacent the above-mentioned surfaces and increases thromboresistance inventive prosthetic heart valve due to a lower probability of thrombosis near the hinge nodes.

One of the embodiments of the invention (6, 7) channel 20 for bandwidth limited reverse flow of blood formed by the groove 24, is placed at both sides of the side surface 15 of each sash 11, and the clamping surface 14 of the other sash. This groove 24 is made with an inclination relative to the generatrix of the inner surface 3 of the housing 1 with closed valves 11, and a rotation hinge type made in the form of being engaged in the two grooves 25 located on diametrically opposite parts of the body 1, and two protrusions 26 diamond shape, located on opposite sides of the side surface 15 of each leaf 11. Element 6 can be performed not only in the form of two grooves 25 on the opposite parts of the body 1, but also around its perimeter, while the sash 11 in addition to opening and closing can perform a rotational movement around the Central axis of the housing 1.

In the proposed variant implementation of the proposed prosthetic heart valve (Fig-10) channel 20 for bandwidth limited reverse flow of blood formed by the ledge 22, located at one side of the side surface 15 of each sash 11, and the clamping surface 14 of the other sash 11, and a rotation hinge type made in the form which is in engagement ring element 6 located around the perimeter of the inner surface 3 of the housing 1, and the shaped grooves 16 located on opposite sides of the side surface 15 of each leaf 11. This channel 20 for bandwidth limited reverse flow of blood is placed between the wings 11 in their closed position, is made curved in the plane perpendicular to the Central axis of the housing 1, and is in relation to the inner surface 3 of the housing 1 tangentially directed outlet, formed a wedge-shaped protrusion 27 and the chamfer 28 located on opposite sides of the clamping surface 14 of each leaf 11. Moreover, the edge of the ledge 22 is made perpendicular to the generatrix of the inner surface 3 of the housing 1 with closed valves 11 and a wedge-shaped protrusion 27 a single leaf with a chamfer 28 of the other sash form a mechanism of forced rotation of the valves 11 around the Central axis of the housing 1 due to the implementation of the tangentially directed outlet limited reverse flow of blood, which increases the reliability and durability of the inventive prosthesis due to uniform distribution of wear around PERIMET is at enclosure 1, improves thromboresistant valve due to better conditions of washing in areas most dangerous blood clots, and unloads the natural man's heart after implantation of the proposed prosthesis in the aortic position. To increase the power jets limited reverse flow of blood behind closed doors 11 and, consequently, to increase the speed of rotation of the valves 11 around the Central axis of the housing 1 and the efficiency of washing surfaces of the housing 1 and the valves 11 near the hinge units appropriate channel 20 to perform smoothly converging in the flow direction a limited reverse flow of blood.

The proposed embodiment of the invention (1-10) of the groove 24, the bevel 21 and step 22 is performed mainly radially relative to the inner surface 3 of the housing 1, can be located at one or both sides of the clamping surface 14 of each leaf 11 separately, and in combination with each other, with the edges of the groove 24, the bevel ledge 21 and 22 can be performed perpendicular or tilted with respect to the generatrix of the inner surface 3 of the housing 1 with closed valves 11 and also in a straight, curved or in the form of two are angled each other sites, but it is in any of the embodiments of the invention limited reverse flow of blood when laid and the valves 11 in the closed position should extend from the channel 20 along the Central axis of the housing 1, as in the prototype, but with a slope or perpendicular to it, i.e., predominantly radially relative to the inner surface 3 of the housing 1.

The inventive prosthetic heart valve works as follows (Fig.1-3).

After exceeding the inlet pressure of the prosthesis above the blood pressure at the output begins with the opening of the prosthetic heart valve. When this flap 11 within the guaranteed gaps first "pop up", i.e. move together with direct blood flow to the interaction of the support surfaces 17 of the valves 11 with the supporting surfaces 7 of the projections 9, and then moved from the closed position into the open, through the direct passage of blood flow. In the initial stage of valve opening rotation of the valves 11 (ranging from 0 to 30°) is performed around the axis passing through the point of intersection of the bearing surfaces 17 of the shaped grooves 16 located on opposite sides of the side surface 15 of each leaf 11, almost without friction, i.e. with minimum effort before contact with the surfaces of the bevels 21 adjacent the valves 11, which reduces the resistance, and hence the pressure gradient across the valve, reducing the burden on the natural heart of the patient. The clamping surface 14 adjacent the valves 11 are opened with the formation of the Central slit for passing through it a specified amount of direct p the blood flow. Upon further movement of the valves 11 to the open position, the friction between the housing 1 and the shutters 11 increases, because the Cams 19 adjacent the valves 11 interact among themselves, moving the sash 11 and the protrusions 9 of the housing 1 from the center to the periphery. The increase in friction between the housing 1 and the shutters 11 when joining pawls 19 adjacent the valves 11 in the interaction between them will not have a significant impact on increasing the pressure gradient across the valve, as the angle of opening of the valves 11 with a minimum of friction at the beginning of the valve opening can be up to 2/3 of the full angle of opening of the valves 11, while at the time of entry of Cams 19 adjacent the valves 11 in interaction with each other, i.e. to the point of increasing the friction between the housing 1 and the shutters 11, the hydraulic aperture of the prosthesis for the passage through it of the direct flow of blood already appears on 60-80% of the maximum open prosthesis heart valve. It is therefore very important to reduce the load on the natural heart of man to have at the beginning of the opening of the valves 11 minimum pressure gradient across the valve. Upon further movement of the valves 11 to the open position of the surface of the bevels 21 adjacent the valves 11 are opened with the increase of the Central slit between the wings 11. With the full opening of the valves 11 their support surfaces 17 and 18 cooperate with the abutment surface is mi 7 and 8 of the projections 9 on the housing 1, and the rear Cam surface 19 adjacent the valves 11 come into contact with each other, and part of the support surfaces 17 of the shaped grooves 16 adjacent to the bubbling surface 12 of each leaf 11, interacts with the supporting surfaces 7 of the projections 9 on the housing 1 facing the direct blood flow, as part of the support surfaces 18 of the shaped grooves 16 adjacent to the surface of the Cams 19, interacts with the supporting surfaces 8 of the projections 9 on the housing 1, is turned to reverse the blood flow. This is achieved by the limitation of the angle of opening of the valves 11 and held in the housing 1.

After exceeding the pressure at the outlet of the prosthesis above the pressure at its input is closing prosthetic heart valve. And the leaf part 11 of the support surfaces 18, adjacent to the surfaces of the Cams 19, interact with the supporting surfaces 8 of the projections 9 on the housing 1 facing the reverse flow of blood, and turned around, closing the valve and preventing the reverse flow of blood, and the rear Cam surface 19 adjacent the valves 11 when it is open. Upon further movement of the valves 11 to the closed position is to clamp and unclamp surfaces of the bevels 21 adjacent the valves 11, and with the full closing of the valve clamping surface 14 adjacent the valves 11 interact among themselves and prevent about the feats of the blood flow. In the closed position of the valve leaf part 11 of the support surfaces 18 of the shaped grooves 16 adjacent to the bubbling surface 12, interact with the supporting surfaces 8 of the projections 9 on the housing 1 facing the reverse flow of blood, and the other part of the bearing surfaces 17 of the shaped grooves 16 adjacent to the bevels 21, interact with the supporting surfaces 7 of the projections 9 on the housing 1 facing the direct blood flow. This is achieved by limiting reverse rotation of the valves 2. After closing of the proposed prosthetic heart valve blood pressure at its output increases to a value greater than the input, and limited reverse flow of blood through the channels 20 slotted type formed by the ledge 22 located on one side of the side surface 15 of each sash 11, the bevel 21 placed at both sides of the side surface 15 of each sash 11, and the clamping surface 14 of the other sash, directed primarily radially in opposite directions and goes into the gap between the housing 1 and the shutters 11, located at the entrance of the bridge with direct blood flow (3), washing not only articulated units, but also adjacent to the support 7 and the inner 3 inlet valve surface of the housing 1, which reduces the probability of thrombosis by increasing efficiency washer powerful jets limited obratno the flow of blood under high pressure. In addition, the presence of the bevels 21 on opposite sides of the clamping surface 14 of each leaf 11 reduces the probability of encapsulating Cams 19 adjacent the valves 11 elements of blood and thrombosis due to periodic rupture of the contact lugs 19 when moving the valves 11 from the closed position into the open and back.

The work of the prosthetic heart valve shown in figure 4, 5, is carried out similarly to the above-described operation of the valve in figure 1-3, with the only difference that the volume limited reverse flow of blood passing between the wings 11 in their closed position, is reduced due to the smaller section of the channel 20.

The work of the prosthetic heart valve depicted in Fig.6, 7, is carried out similarly to the above-described operation of the valve in figure 1-3 with the only difference that the limited reverse flow of blood passes through the channel 20 formed by the groove 24 at opposite sides of the side surface 15 of each sash 11 and the clamping surface 14 of the other sash 11 in the closed position. In addition, the sash 11 is constantly in contact with each other in the points of intersection of the surface of the closure 14 and the rear surface of the Cam 19 when the valves 11 in the closed, open and intermediate positions.

In embodiments of the invention, depicted in figure 1-7, sash 11 cannot rotate about Central and the housing 1, and only move from the closed position into the open and back.

The work of the prosthetic heart valve depicted in Fig-10, is carried out similarly to the above-described operation of the valve in figure 1-3 with the only difference that the blades 11 in addition to move from the closed position into the open and back can perform a rotational movement around the Central axis of the housing 1. After closing the valves 11, when the blood pressure at the exit of the prosthesis becomes greater than the input, limited reverse flow of blood through the channels slotted type 20 between the wings 11, formed by the ledge 22 located on one side of the side surface 15 of each sash 11, and the clamping surface 14 of the other sash, it moves along the surface of the closure 14 in the radial direction, i.e. perpendicular to the inner surface 3 of the housing 1, and then, passing between the wedge-shaped protrusion 27 of one of the sash 11 and the chamfer 28 of the other sash, turns and goes into the gap between the housing 1 and shutters 11 tangentially relative to the inner surface 3 of the housing 1, by tightening the blood volume at the entrance of the prosthesis. At maximum pressure on the output side of the prosthesis provides maximum power tangentially facing jets limited reverse flow of blood, promoting blood volume at the inlet of the valve to max the second speed, and the leaf 11 at this time is pressed, the maximum force to the housing 1 can not rotate around the axis of the housing 1 due to the frictional forces acting between the housing 1 and the shutters 11. Then starts to decrease pressure at the outlet of the prosthesis and the pressure increase on his entrance, with untwisted volume of blood at the entrance of the prosthesis continues its rotation around the axis of the housing 1 due to inertia forces. After achieving differential across the valve, and hence the efforts on the wings 11 of this magnitude, when the rotating force of the swirling blood volume at the entrance of the prosthesis will exceed the friction force between the housing 1 and the shutters 11, untwisted blood volume at the inlet valve captures the sash 11 and begins to rotate around the Central axis of the housing 1 in the same direction. When reaching higher than the inlet pressure of the prosthesis above the pressure at its output is the opening of the prosthetic heart valve, through the direct passage of blood flow. When this flap 11 within the gap first move with a direct blood flow with minimum friction and maximum speed of rotation around the Central axis of the housing 1, and then using the rotation of the hinged type is moved to the open position, increasing the direct passage of blood flow. Upon further movement of the valves 11 to the open position, their speed of rotation, the mind is neetsa at the expense of increasing the friction force between the housing 1 and the shutters 11. Turn the valves 11 around the axis of the housing 1 will be up until the friction force between the housing 1 and the wings 11 will not exceed the inertial force hyped blood volume at the entrance of the prosthesis. For each cycle of operation of the first prosthesis is twisted blood volume before the valve through the use of the mechanism of forced rotation of the valves 11, providing a tangential exit powerful jets limited reverse flow of blood behind closed doors 11, and then in the initial stage of opening of the valves 11 hyped blood volume before the valve carries out the rotation of the valves 11 around the Central axis of the housing 1 at a given angle. The presence of the bevels 21 on opposite sides of the clamping surface 14 of each sash 11 and the mechanism of forced rotation of the valves 11 around the Central axis of the housing 1 after implantation of the prosthesis in the aortic position has allowed dual unloading of the natural man's heart:

(a) by reducing the pressure gradient on the prosthesis at the location of the bevels 21 at both sides of the clamping surface 14 of each leaf 11;

b) by tightening the blood volume at the entrance of the prosthesis from the left ventricle, coinciding in direction with the tightening of blood flow in the same left ventricular sequential contraction of the muscles natural human heart.

Thus, the OS is westlea the direction of powerful jets limited reverse flow of blood with wings closed on the hinge assemblies and the adjacent surface of the shell and the valves due to the execution of the grooves, bevels or scarps on surfaces of the closure of each leaf predominantly radially relative to the inner surface of the housing, helped to increase thromboresistant proposed prosthetic heart valve by increasing the efficiency washer hinges and located near the surfaces of the body and wings.

Furthermore, the presence of the bevel on the surface of the closure of each leaf, located at the opposite sides of the side surface, allowed not only to reduce the workload of the heart and to improve the quality of life of the patient after implantation of the proposed prosthetic heart valve by reducing the pressure gradient across the valve by reducing the friction between the body and leaves in the initial period of opening of the valve, but also to increase thromboresistant proposed prosthesis due to the break contact of adjacent leaflets at their step-by-step movement from the closed position into the open and back, i.e. by eliminating the constant contact of the valves together in one place.

Performing element on the housing around its perimeter and channel bandwidth limited reverse flow of blood with curved tangentially directed outlet formed wedge-shaped protrusion and a chamfer located on opposite sides of the clamping surface of each leaf, gave the target is am additional degree of freedom - this exercise forced and guaranteed rotation of the valves around the Central axis of the enclosure, which allowed not only to relieve the natural heart of man and to improve the quality of life of the patient after implantation of the proposed prosthetic heart valve in the aortic position between the left ventricle and the aorta due to the tightening of the blood volume at the entrance of the prosthesis from the left ventricle, coinciding in direction with twisted blood flow in the same left ventricular sequential contraction of the muscles natural human heart, but also to increase the service life of the prosthesis by reducing the amount of wear of the housing by a uniform distribution on the perimeter of the body and increase thromboresistant proposed prosthetic heart valve through the gradual the opening of the new sections of the inner surface of the body for more effective washing powerful jet of blood limited reverse flow of blood during rotation of the valves for each cycle of operation of the prosthesis. The inventive prosthetic heart valve with improved thromboresistance and reduced load on the natural man's heart can be used to replace diseased natural as aortic and mitral valves of the human heart, regardless of age.

1. The prosthetic heart valve containing concealers the corps, having outer, inner, end surface and at least one element with a support surface, the cuff placed on the outer surface of the shell, two shutters that are installed in the housing for movement from the closed position into the open and back, each of which has a bottom surface facing the direct blood flow, downward surface facing the reverse flow of blood, the clamping surface, which interacts with the clamping surface of the other of the sash in the closed position, the side surface that interacts with the inner surface of the housing, the support surface interacting with the corresponding support surfaces of the element, and the channel for bandwidth limited reverse flow of blood with wings closed, crossing the clamping surface of each leaf, and the said element is made around the perimeter of the housing or in separate parts at its opposite sections, characterized in that the channel bandwidth limited reverse flow of blood is made predominantly radially relative to the inner surface of the housing at the closed shutters, located on the edge of the sash with the largest size and is formed by a groove and/or the bevel, and/or ledge, placed, at least one side surface of each of the second leaf, and the clamping surface of the other leaf, and the edge of each leaf with the largest size at the level or downstream of the direct blood flow from the end surface of the housing facing the direct blood flow, and the said channel or at least part of the output in the direction of a limited reverse flow of blood is made perpendicular or tilted with respect to the generatrix of the inner surface of the housing at the closed shutters.

2. The prosthetic heart valve according to claim 1, wherein the groove and/or the bevel, and/or the ledge located at both sides of the lateral surface of each leaf.

3. The prosthetic heart valve according to claim 1 or 2, characterized in that the sash is made with the possibility of rotation around the Central axis of the housing at the location of these elements around the perimeter of the housing and the channel bandwidth limited reverse flow of blood is placed between the shutters in their closed position, made curved and has in relation to the inner surface of the casing tangentially directed outlet, formed a wedge-shaped protrusion and a chamfer located on opposite sides of the clamping surface of each leaf.



 

Same patents:

FIELD: medical engineering.

SUBSTANCE: device has working member manufactured as viscoelastic ring-shaped corrugation having blank wall, tightly embracing a base ring with passage orifice of round or oval shape. Movable part of the working member is represented with one or several cusps belonging to the blank wall of the viscoelastic corrugation. The cusps have thickenings in diametric or radial direction and/or supporting pins transecting the passage opening to prevent them from being drawn by pressure into passage opening of the base ring.

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FIELD: medicine, cardiosurgery.

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EFFECT: decreased chance for prosthetic infectioning.

2 ex

FIELD: medicine.

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FIELD: medical engineering.

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FIELD: medical engineering.

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FIELD: medical engineering.

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FIELD: medical engineering.

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The invention relates to medical equipment and can be used in heart surgery to replace a diseased natural heart valves person

FIELD: medical engineering.

SUBSTANCE: device is designed as flexible hose segment of flat cross-section enveloping base member manufactured as circular or oval ring. The opposite end is left free. The valve has an additional member like supporting plate (contour frame or contour loop) rigidly fixed on the base member and embraced with free end of the flexible hose. To achieve better conditions for blood flow to wash working member surface, the member is perforated in zone of its attachment to the base member. To achieve better biocompatibility conditions, valve member is manufactured from natural patient blood vessel.

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FIELD: medical engineering.

SUBSTANCE: device has two leaflets. The leaflets are mounted on finger member allowing rotation about artery axle and have working ends and shank. The working ends have fitting surfaces restricted with thrusting and holding ribs. A holding rib has internal and external end surface. The external end surface of holding rib of each leaflet has protrusions having centering surfaces manufactured as portions of the same revolution surface having diameter of Dc. Revolution surface axis coincides with the central axis of the holder.

EFFECT: excluded valve displacement relative to fibrous ring; reduced risk of canal dysfunction; improved long-term prosthetic operation results.

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FIELD: medical engineering.

SUBSTANCE: device has body having external and end face surfaces and envelope box cuff. Locking member is mounted in the device body. The locking member is connected to the device body by means of rotation unit of hinge type. External surface of the device body has ring-shaped protrusion having fitting and supporting surfaces. The envelope box is collapsible and detachable. It has bushing and ring having smooth or threaded connection between them. The device body has two external surface areas free of the cuff adjacent to end face surfaces of the body.

EFFECT: high reliability and long service life.

4 cl, 3 dwg

FIELD: medical engineering.

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6 cl, 5 dwg

FIELD: medical engineering.

SUBSTANCE: device has cylindrical body and locking disk member mounted therein with rotation about axis displaced relative to diameter being in parallel to it. Disk member center of gravity is deviated relative to its geometrical center and set so that its rotation axis passes through the center of gravity and the member itself is engageable with opposite device body ends in closed state. The device body has locking disk member stroke stopper manufactured as prominence located between the locking disk member rotation axis and device body diameter arranged in parallel to the rotation axis.

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6 cl, 1 dwg

FIELD: medical engineering.

SUBSTANCE: device has connection member manufactured from absorbable material connected to thread on one of its ends. The thread transmits longitudinal pulling force for introducing the connection member into valve ring tissue to set up it therein. The second device embodiment has different needle design. The needle is introduced into endomyocardium of valve ring and brought through a part of the opening perimeter. The needle is brought out and the connection member is introduced into endomyocardium by means of the thread in a way that free end of the connection member is to be at introduction point. The connection member is fixed in the endomyocardium and brought through the ring to the position characterized in that the other end is located in removal point and exits in this way from the endomyocardium. The second end is fixed.

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29 cl, 9 dwg

FIELD: medicine.

SUBSTANCE: method involves arranging testee and additional valves in system circulation canal with parameters of working liquid flow having physiological values. The working liquid has blood viscosity. Hemolysis degree is determined from changed elastic stress relaxation time in working liquid samples taken in course of the experiment. Preliminary tests are carried out with several additional valves of different hemolytic properties under working liquid flow parameters being fixed. Total hemolysis degree is measured in various combinations of mounted additional valves in circulation system canal. After having solved a linear equations system, hemolysis degree values as contributions caused by circulation system and additional valves. Hemolysis degree of a valve under test tested in combination with one of additional valves is calculated from a formula ΓNΣ0add, where ΓΣ is the total hemolysis degree, Γ0 is the hemolysis degree contributed by circulation system, Γadd is the hemolysis degree of additional valve used.

EFFECT: high accuracy in determining hemolysis degree.

1 dwg

FIELD: medicine, cardiosurgery.

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EFFECT: decreased chance for prosthetic infectioning.

2 ex

FIELD: medical engineering.

SUBSTANCE: device has working member manufactured as viscoelastic ring-shaped corrugation having blank wall, tightly embracing a base ring with passage orifice of round or oval shape. Movable part of the working member is represented with one or several cusps belonging to the blank wall of the viscoelastic corrugation. The cusps have thickenings in diametric or radial direction and/or supporting pins transecting the passage opening to prevent them from being drawn by pressure into passage opening of the base ring.

EFFECT: simplified valve design.

7 cl, 10 dwg

FIELD: medical engineering.

SUBSTANCE: device has grooves, bevel or ledge on each cusp closure surface to guide limited reverse blood flow directly to articulated members and casing and cusp surfaces adjacent thereto. The cusps allow forced rotation about casing axis due to limited reverse blood flow tangentially arriving when having the cusps closed, to make blood volume whirl about the central axis of the casing when entering the prosthesis and opening cusps.

EFFECT: high resistance to thrombus formation; prolonged service life; high reliability; reduced load applied to patient heart.

3 cl, 10 dwg

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