Heart valve prosthesis

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

 

The invention relates to medical equipment and can be used in heart surgery to replace the affected natural aortic and mitral valves of the human heart.

Famous prosthetic heart valve [Patent 0403649 EPO, MKI A 61 F 2/24, Appl. 14.12.88, publ. 15.02.95]containing annular body with an outer, inner and end surfaces, the clip with the cuff placed on the outer surface of the housing, and 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 side surface that interacts with the inner surface of the housing, and the rotation mechanism of the valves, made in the form of an annular protrusion on the housing and grooves located on opposite sides of the lateral surface of each leaf and communicating with the annular the tab on the housing. Part of the outer surface of the case is made concave, and the interior is in the form of a cone. The yoke rigidity installed on the outer surface of the shell, with the inner surface of the shroud corresponds vagotomy part of the body.

The disadvantages of this prosthetic heart valve are as follows.

Install the clip on the outer surface is here the valve body can be carried out only by heating of the clip to the desired temperature to increase its diameter to the required size. Heating cartridge (up to 450-500°C) may result in the rejection of geometric shapes not only the cage due to multidirectional internal stresses therein, and valve housing made of carbon material with dense planting clip on the body, which increases the likelihood of jamming or loss of the locking element from the housing during operation of the valve and reduces the reliability and durability of the prosthetic heart valve.

In addition, the yoke rigidity can be installed on the housing by means of heat or by dense planting, then in fragile carbon casing from the metal sleeve arise static electricity, which together with alternating loads from the cyclic operation of the valve can cause the destruction of the body, which reduces the reliability and durability of this prosthesis, or mounted with a clearance fit, then there is axial movement of the casing and the casing relative to each other when the valve is in the body, which increases the wear of the contact surfaces and can lead to premature failure of the specified prosthetic heart valve.

Some of these shortcomings in the following the design of the prosthetic heart valve [Patent 6217611 USA, NCL 623/2-38, MKI A 61 F 2/24, Appl. 26.05.99, publ. 17.04.2001], which contains concealer the hydrated case, having outer, inner and end surfaces, the yoke rigidity with the cuff placed on the outer surface of the housing, and two shutters that are installed in the housing can be rotated from the closed position into the open and back. Each leaf has a side surface that interacts with the inner surface of the housing, the ascending and descending surfaces facing respectively to the forward and backward flow of blood, and a rotation hinge type, made in the form of recesses located on diametrically opposite portions of the inner surface of the shell and the tabs on opposite sides of the lateral surface of each leaf and included in corresponding indentations on the body. In the specified prosthetic heart valve Assembly valve unit consisting of a housing and installed the valves, with transplantation unit consisting of cage stiffness and cuffs, is carried out at ambient temperature, i.e. without heating casing rigidity, using a wire retainer disposed between the housing and the yoke rigidity.

The disadvantage of this design of the prosthetic heart valve is the presence on the outer surface of the carbon body ring grooves, which includes the retaining device. Annular groove on the outer is poverhnosti body is the hub of voltages and reduces the cross-sectional area of the housing, consequently, its strength, which increases the probability of failure of the hull of the fragile carbon material during cyclic operation of the valve and reduces the reliability and durability of the specified prosthetic heart valve.

In addition, to facilitate Assembly, the housing of the specified valve is installed in the yoke rigidity with a gap, and the locking device is in the groove on the outer surface of the housing to limit axial movement of the shroud stiffness relative to the manifold, resulting in increased wear of the contact surfaces of the housing of the fragile carbon material when the axial movement of the shroud stiffness and housing relative to each other during the cyclic operation of the valve, which increases the possibility of destruction of the body and can lead to premature failure of the prosthetic heart valve that reduces its reliability and durability.

Closest to the technical nature of the claimed object and by the greatest number of similar features is the prosthetic heart valve [Patent 2104676 RF, MKI A 61 F 2/24, Appl. 12.04.95, publ. 20.02.98], which is selected by the authors as a prototype.

The specified prosthetic heart valve includes an annular body with an outer, inner and end surfaces, the clip with the cuff placed on the outer surface of the cor the USA, and a locking element mounted in the annular body can be rotated between a position opening for the passage of the direct blood flow and a closed position for restricting reverse flow of blood and having a bottom surface facing the direct blood flow, downward surface facing the reverse flow of blood, and a side surface that interacts with the inner surface of the annular housing, and the locking element is connected with the annular body by using the rotation of the hinged type from the closed position into the open and back, and the body from its outer surface and the yoke are interacting Seating surfaces.

The disadvantages of this prosthetic heart valve are as follows.

In the specified prosthetic heart valve holder is made permanent and non-removable, so in case it can be set by means of heat or with a clearance or interference fit. When installed with an interference fit in the housing and the holder of a carbon material arise static electricity, which together with dynamic loads from the cyclic operation of the valve can cause the formation of cracks in a brittle carbon material housing and clamps, which increases the probability of failure of the housing or casing and leads to presevre nomu failure of the specified prosthetic heart valve.

When installing the clip on the housing with a gap under the action of alternating dynamic loads on the valve during its operation in the heart of man is the reciprocating movement of the valve body relative to the holder with the sleeve, in which the housing and/or the holder of the fragile carbon material formed the risks that contribute to the formation of cracks and subsequent operation of the valve can lead to the destruction of the casing and/or casing, which reduces the reliability and durability of the prosthetic heart valve.

Performing a one-piece clip and fixed in this prosthetic heart valve creates difficulties installing it on the body as the diameter of the cage is less than the diameter of the flange on the housing. Therefore, the installation of the clip on the housing can be effected only by heating of the clip to increase its diameter to the required size. Heating of the casing to the required temperature may cause its deviation from the desired geometric shape due to uneven internal stresses that can lead to distortion of the geometric shape of the hull with dense planting on his cage, to get stuck or falling out of the locking element, and hence a reduction in the reliability and durability of the specified prosthetic heart valve.

In addition, the ring is the first groove in the valve reduces the strength of the hull, because of reduced wall thickness at the location of the clip, which increases the probability of destruction of housing during cyclic operation of the valve and thereby reduces the reliability and durability of the specified prosthetic heart valve.

Due to the fact that the installation cage rigidity of the valve unit is in the final production process, when the temperature of the shroud and its installation in an annular groove on the housing increases the likelihood between them of dust, dirt, that hard-to-reach places difficult to remove, which impairs pyrogen-free properties specified prosthetic heart valve and can lead to complications in the postoperative period.

The technical task of the invention is to improve the reliability and durability of the prosthetic heart valve.

This object is achieved in that the prosthetic heart valve containing an annular body with an outer, inner and end surfaces, the clip with the cuff placed on the outer surface of the housing, and a locking element mounted in the annular body can be rotated between a position opening for the passage of the direct blood flow and a closed position for restricting reverse flow of blood and having a bottom surface facing the direct blood flow, downward over the awn, addressed to reverse the blood flow, and a side surface that interacts with the inner surface of the annular housing, and the locking element is connected with the annular body by using the rotation of the hinged type from the closed position into the open and back, and the body from its outer surface and the yoke are interacting landing surface in accordance with the invention, the outer surface of the housing is fitted with an annular ledge, limited support surfaces, and the clip is located on the perimeter of the annular protrusion has a bearing surface that interacts with the corresponding support surfaces of the annular protrusion on the housing, and the landing surface of the body is placed on its annular ledge while the clip consists of interconnected sleeves and rings and is made detachable and removable.

In addition, the supporting surface of the circular protrusion on the housing and the shell is made conical or flat.

The sleeve and ring are smooth or threaded connection.

Cuff covers the cage with ring lug mounted on the outer surface of the housing and has a height less than the height of the casing, and the casing is made with two free from the cuff areas of the outer surface adjacent to the end surfaces the children of the hull.

Run clip detachable and removable, the presence on the outer surface of the housing an annular projection with a tapered support surfaces cooperating with the respective abutment conical surfaces of the casing, and between the sleeve and ring threaded connections allow you to secure the clip on the housing in the proposed prosthetic heart valve concentric with respect to its outer surface, reliably and without movement relative to the housing, resulting in a static voltage in the case of a split metal sleeve is practically absent or at least minimized, that does not create preconditions to the formation of cracks in a brittle carbon material of the body and increases the reliability and durability of the claimed the prosthetic heart valve, and the metal ferrule and the housing form a monolithic system, able to perceive the cyclic load from the pulsating blood pressure and stress from muscles natural human heart.

In addition, the implementation clip detachable and removable in the proposed cardiac valve prosthesis allows the installation on the case metal clip is not in the heated state, as in the prototype, and to maintain the proper geometric shape at ambient temperature, eliminating the distortion of the geometrician is the political form metal sleeve and casing with dense planting between them, reduces the likelihood or prevents jamming of the locking element, and increases the reliability and durability of the proposed prosthetic heart valve.

Thickening on the outer surface of the shell increases its strength and creates preconditions for improving the reliability and durability of the proposed prosthetic heart valve.

Performing metal sleeve detachable and removable allows the installation of the locking element into the housing with the technological ring of metal with a high modulus of elasticity, i.e. the valve Assembly is made without the clip. Then process the ring is removed and in its place installed a metal ferrule regular geometric shape, resulting in the holder is not subject to deformation and heat when the valve Assembly that eliminates the distortion of the geometric shape of the shroud and the housing reduces the likelihood of jamming or loss of the locking element and results in these to increase the reliability and durability of the proposed prosthetic heart valve.

Furthermore, the presence of removable and detachable metal clip allows you to install one cuff to the valve carefully and efficiently wash not only the housing Assembly with the locking element, but separately from the valve sleeve with the ring forming the ferrule, and then clean liners which have to ring mounted on the housing and to sheathe cuff, that simplifies and improves the technology of manufacturing of prosthetic heart valve, eliminates the ingress of dust and dirt between the yoke and the body and promotes pyrogen-free properties of the prosthetic heart valve and reduce the likelihood of complications in the postoperative period.

As in the natural heart of man the time spent in the closed position at the aortic valve (ventricular diastole) is almost two times larger than the mitral valve (ventricular systole), and the limit value of the reverse power flow GOST 26997-86 for mechanical prosthetic heart valves during their implantation in the aortic and mitral positions of the same, the execution of a metal cage in the proposed prosthetic heart valve detachable and removable allows in case of exceeding the limit according to GOST 26997-86 magnitude of the reverse flow to the aortic valve to perform a reinstall of the cage, resulting in aortic valve becomes mitral, with less time spent in the closed position and a lower reverse flows not exceeding the limit values according to GOST 26997-86 that expands the scope and use of the valve, reduces the range of valve parts and accessories for its production and reduce the cost of the proposed prosthetic heart valve.

The implementation of the we detachable and removable in the form of a threaded sleeve and ring when tightening to choose the axial gaps between the yoke and the body and eliminate them move relative to each other, that reduces the likelihood of cracking in brittle carbon casing material during cyclic operation of the valve and leads to increased stiffness of the body and increase the reliability and durability of the proposed prosthetic heart valve.

The placement of the cuff and an annular ledge with the yoke in the middle part of the hull and running on its outer surface two free from the cuff sections of the same diameter, adjacent to the end surfaces of the body allows after implantation of the proposed prosthetic heart valve to reduce the likelihood of growth and napoletane living tissues of the body (pannus) inside the valve and hit them between the locking element and the housing, which increases the reliability and durability of the proposed prosthetic heart valve [Karaskov A.M. and other Results of surgical treatment of valvular dysfunction.//Bulletin Bakulev them. A.N. Bakulev RAMS, abstracts of the VI all-Russian Congress of cardiovascular surgeons. - M., 2000. No. 2. - P.40].

In addition, the presence of two free cuff areas of the outer surface of the shell adjacent to its end surfaces, increases the distance from the cuff to the inner surface of the housing, resulting after implantation of the valve decreases the likelihood that nodes from surgical sutures that secure the valve to FIB the religious ring inside the valve between the locking element and the housing, it also increases the reliability and durability of the proposed prosthetic heart valve.

Distinctive features of the proposed technical solution from the prototype are:

1) the outer surface of the housing is fitted with an annular ledge, limited support surfaces;

2) the clip is located on the perimeter of the annular protrusion has a bearing surface that interacts with the corresponding support surfaces of the annular protrusion on the body;

3) the landing surface of the body is placed on its annular ledge;

4) the clip consists of interconnected sleeves and rings and is made detachable and removable;

5) supporting surface of the circular protrusion on the housing and the shell is made conical;

6) of the supporting surface of the circular protrusion on the housing and the shell is made flat;

7) the sleeve and the ring have a smooth connection;

8) the sleeve and the ring have a threaded connection;

9) cuff covers the cage with ring lug mounted on the outer surface of the housing and has a height less than the height of the casing, and the casing is made with two free from the cuff areas of the outer surface adjacent to the end surfaces of the body.

These features of the invention are its differences from the prototype and determine the novelty of the proposals the Oia. 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, on which:

Figure 1 is a longitudinal section of a bileaflet prosthetic heart valve in accordance with the invention in the closed position of the sash (the sash is not cut) with an annular protrusion on the outer surface of the shell with a detachable and removable metal sleeve, consisting of a sleeve and rings interconnected by means of a thread, with a cylindrical Seating and a conical support surfaces on the annular ledge of the housing and a housing with mitral cuff, located in the middle of the outer surface of the shell and forming two free from the cuff area of the outer surface of the shell adjacent to its end surfaces, and a rotation hinge type made in the form of a protrusion located around the perimeter of the inner surface of the housing, and grooves located on opposite sides of the lateral surface of each leaf;

Figure 2 is a longitudinal section of a bileaflet prosthetic heart valve in which one of the options detachable and con the Naya ferrule consists of a sleeve and ring, having between a smooth non-threaded connection, the landing surface of the circular protrusion on the housing and the ferrule is cylindrical and the base is flat, the cuff is made for the aortic position of the implant and forms on the outer surface of the body there are two available from the cuff of the site, adjacent to its end surfaces, and a rotation hinge type made in the form of recesses type “butterfly”, which are located in pairs on diametrically opposite portions of the inner surface of the shell and lugs located on opposite sides of the lateral surface of each leaf;

Figure 3 is a longitudinal section of a single leaf of the prosthetic heart valve in which one of the options detachable and removable ferrule consists of a sleeve and a ring having between a threaded connection, boarding and support surface on the annular ledge of the housing and the ferrule is made conical, the cuff is made for the mitral position implantation with a height less than the height of the housing, on the outer surface of which there are two available from the cuff of the site, adjacent to the end surfaces of the housing, and a rotation hinge type, made in the form of upper and lower limiters on the housing and an annular recess in the disk locking element.

The prosthetic heart valve of content is it the annular body 1 with the outer 2, the inner 3 and the end surfaces 4 and 5 (figure 1). The holder 6 is placed on the outer surface 2 of the housing 1. The sleeve 7 comprises a holder 6 and held in place with polyester yarns on the outer surface 2 of the housing 1. The locking element 8 is installed in the housing 1 can be rotated from the closed position into the open and back and has a bottom surface 9 facing the direct blood flow, downward surface 10 facing the reverse flow of blood, and the side surface 11, which interacts with the inner surface 3 of the housing 1. The locking element 8 is connected with the housing 1 through the rotation of the hinged type. The outer surface 2 of the housing 1 provided with an annular ledge 12, with boarding 13 and the bearing 14 and 15 of the surface. The yoke 6 is located on the perimeter of the annular projection 12 and is provided with a landing 16 and the base 17 and 18 surfaces cooperating respectively with a bore 13 and the corresponding reference 14 and 15 surfaces of the annular protrusion 12. The yoke 6 is made detachable and removable and consists of a sleeve 19 and ring 20. Cuff 7 to secure the prosthesis in the human heart is located in the middle of the outer surface 2 of the housing 1, has a height less than the height of the housing 1 and forms two free from the cuffs of section 21 and 22 of the outer surface 2 adjacent to the respective end surfaces 4 of the 5 of the housing 1. Support surfaces 14 and 15 of the annular projection 12 on the housing 1 and communicating respectively with them abutment surfaces 17 and 18 of the metal sleeve 6 can be performed not only conical (figure 1), but flat or radial, directed perpendicular to the outer surface 2 of the housing 1 (figure 2). The landing surface 13 of the annular protrusion 12 and interacting with it landing surface 16 of the cage 6 can be performed not only cylindrical (Fig 1, 2), and conical (Fig 3). When this tapered seat, combined with the support surfaces of the annular protrusion 12 and the shell 6 (Fig 3). The sleeve 19 and the ring 20 forming the ferrule 6 can have a threaded connection (1, 3) or a smooth, non-threaded connection (figure 2). The prosthetic heart valve in accordance with the invention can be made single leaf (figure 3), double (1, 2) or tricuspid.

A rotation hinge type for double prosthetic heart valve (1) is made in the form of an annular protrusion 23 is placed on the inner surface 3 of the housing 1, and the shaped grooves 24 located on opposite sides of the side surface 11 of each leaf 8. When this flap 8 can not only be rotated from the closed position into the open and back, but also to perform a rotational movement around the axis to the pus 1 around its perimeter. A rotation hinge type for double valve (2) is made in the form of recesses 25 of the type “butterfly”, which are located in pairs on diametrically opposite portions of the inner surface 3 of the housing 1, and the protrusions 26 that are located on opposite sides of the side surface 11 of each leaf 8.

For single leaf of prosthetic heart valve (Fig 3) a rotation hinge type made in the form of upper 27 and lower 28 stops on the housing 1 and the annular recess 29 in the disk locking element 8.

Thickening of the wall of the housing 1 by placing on its outer surface 2 of the ring lip 12, no heating and deformation of the cage 6 due to its release and razumnosti, the lack of static stress on the body 1 from the cage 6 by performing a smooth or threaded connection between the bushing 19 and the ring 20 of the cage 6, reducing the likelihood of napoletane living tissue (pannus) under the locking element 8 due to less in comparison with the case 1 by the height of the cuff 7 and having on the outer surface 2 of the housing 1 two identical diameter free from the cuffs 7 sections 21 and 22 adjacent to the respective the end surfaces 4 and 5 of the housing 1, and excluding the moving body 1 and the holder 6 relative to each other when the valve is allowed in the aggregate to reliably increase the TB and durability of the proposed prosthetic heart valve, which can be one-, two - or tricuspid and subsequent implantation in aortic and mitral position.

The execution of the reference surfaces on the annular ledge 12 and the ferrule 6 conical eliminates the gaps between the housing 1 and the holder 6 is not only axially but also radially, resulting in no movement of the housing 1 and the casing 6 relative to each other during operation of the valve in the body, reduce the likelihood of destruction of the housing 1 and to improve the reliability and durability of the proposed prosthetic heart valve.

The holder 6 may be made of Nickel or titanium alloys, corrosion-resistant, stainless steel or other metal, or carbon material, and the housing 1 to improve its thromboresistance may be made of pyrographite, placitella or other carbon material.

Detachable ferrule 6 and the housing 1 by a threaded connection between the bushing 19 and the ring 20 is formed between a strong and sturdy construction with no stress and clearances between the casing 1 and the holder 6, is able to perceive as the cyclic load from the pulsating blood pressure, and strain on the muscles natural human heart during operation of the proposed cardiac valve prosthesis in the human body. This design done is in the cage increases the radial stiffness of the hull, resulting in improved working conditions of the prosthetic heart valve and reduces the likelihood of jamming or loss of the locking element, which increases the reliability and durability of the proposed prosthetic heart valve.

The presence of the threaded connection between the bushing 19 and the ring 20 allows them twisting between them by hand to eliminate axial and radial clearances between the casing 1 and the holder 6, resulting in a static pressure in the housing 1 from the cage 6 are absent or at least minimized.

In addition, to reduce the probability of getting the locking element 8 is preferable that the ferrule 6 at least partially covers the tool rotation hinge type.

The two free from the cuffs 7 sections 21 and 22 having the same diameter and adjacent to the respective end surfaces 4 and 5 of the housing 1, improves the alignment of the prosthesis relative to the annulus when it is supra-annulare (natalizia) versions.

The inventive prosthetic heart valve (figure 1) works as follows.

After exceeding the blood pressure at the input of the prosthetic heart valve over the blood pressure at its output begins opening the valve for the passage of the direct blood flow. With the full opening of the valves 8 two parallel plot shaped grooves 24 of each leaf 8 inter is astout with the annular protrusion 23, located on the perimeter of the inner surface 3 of the housing 1. This is achieved by limiting the angle of opening of the valves 8 and hold them in the housing 1.

After exceeding the blood pressure at the output of the prosthetic heart valve over pressure of blood on his entrance is closing prosthetic heart valve. When this flap 8 is moved from the open position to the closed, preventing the backward flow of blood. After the closure of the cardiac valve prosthesis other two parallel between a section shaped grooves 24 of each leaf 8 communicate with the annular protrusion 23 on the inner surface 3 of the housing 1. This is achieved by limiting reverse rotation of the valves 8. When the valves 8 in the closed position, the blood pressure on the output side of the prosthetic heart valve reaches the maximum value, therefore, the housing 1 is secured in position on the holder 6 and the leaf 8 at this time subject to the maximum load, when the metallic ferrule 6, sensing the load of the maximum blood pressure from the outlet side of the valve, prevents leaves 8 to fall out of the housing 1. In addition, during cyclic operation of the proposed prosthetic heart valve metal ferrule 6 installed without heating with minimal impact force on the body 1 will take the load not only from the pulsating blood pressure, but also loads the key from the muscles natural human heart. When the leaf valve 8 in addition to their opening and closing can be rotated around the Central axis of the housing 1 around its perimeter, reducing wear on the housing 1 due to the uniform distribution around the perimeter of the annular protrusion 23 located on the inner surface 3 of the housing 1.

The work of the prosthetic heart valve of figure 2 is similar to the above-described operation of the valve prosthesis with the only difference that the blades 8 can not rotate around the Central axis of the housing 1, and the limitation of the opening angle and the reverse rotation of the valves 8 is due to the interaction of the protrusions 26 on the frame 8 with portions of the recesses 25 of the type “butterfly” on the housing 1.

The work of the prosthetic heart valve in figure 3 is carried out similarly to the above-described operation of the valve prosthesis of figure 1 with the only difference that the disk locking element 8 single prosthetic valve from the closed position into the open and moved back between the top 27 and bottom 28 limiters.

Thus, the implementation clip detachable and removable in the proposed design of the prosthetic heart valve allows the installation of the locking element into the housing and secure the clip on the outer surface of the housing in the absence of heat and deformation bands, which reduces the likelihood of distortion of the geometric shape of the shroud and to the of Cusa prosthesis and leads to the exclusion of jamming the locking element when the valve hence to improve the reliability and durability of the proposed prosthetic heart valve.

Thickening of the wall of the casing by placing on its outer surface an annular ledge and the creation between the housing and the ferrule solid, with no gaps, but at the same time demountable mechanical connection in the absence in the case of static stresses from the metal sleeve has improved the reliability and durability of the proposed prosthetic heart valve.

In addition, the presence of two free cuff areas of the outer surface of the shell adjacent to its end surfaces, reduces the likelihood of growth and napoletane living body tissues inside of the valve prosthesis and separates from the movable locking element at a safer distance surgical sutures and knots to secure the prosthesis to the fibrous ring that reduces the likelihood of them falling between the locking element and the housing and leads thus to increase the reliability and durability of the proposed prosthetic heart valve. The proposed prosthetic heart valve can be used to replace diseased natural as aortic and mitral valves of the human heart.

1. The prosthetic heart valve containing an annular body with an outer, inner and end surfaces, the clip from the cuff, the size of the military on the outer surface of the housing, and a locking element mounted in the annular body can be rotated between a position opening for the passage of the direct blood flow and a closed position for restricting reverse flow of blood and having a bottom surface facing the direct blood flow, downward surface facing the reverse flow of blood, and a side surface that interacts with the inner surface of the annular housing, and the locking element is connected with the annular body by using the rotation of the hinged type from the closed position into the open and back, and the body from its outer surface and the yoke are interacting landing surface,characterized in that the outer surface of the housing is fitted with an annular ledge, limited support surfaces, and the clip is located on the perimeter of the annular protrusion has a bearing surface that interacts with the corresponding support surfaces of the annular protrusion on the housing, and the landing surface of the body is placed on its annular protrusion, and the yoke consists of interconnected sleeves and rings and is made detachable and removable.

2. The prosthetic heart valve according to claim 1, characterized in that the supporting surface of the circular protrusion on the housing and the shell is made conically and or flat.

3. The prosthetic heart valve according to claims 1 and 2, characterized in that the sleeve and the ring have a smooth or threaded connection.

4. The prosthetic heart valve according to claims 1 to 3, characterized in that the sleeve covers the cage with ring lug mounted on the outer surface of the housing and has a height less than the height of the casing, and the casing is made with two free from the cuff areas of the outer surface adjacent to the end surfaces of the body.



 

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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.

SUBSTANCE: the method deals with valvular reprosthetics. After dissecting a prosthesis and treating infectious foci with antiseptics it is necessary to implant a carcass xenoprosthesis faced with epoxy-treated xenopericardium. At implanting xenoprosthesis into mitral position it should be fixed in position of fibrous ring by separate P-shaped sutures, one part of which could be upon interlayers. At implanting xenoprosthesis into tricuspid position it should be fixed in position of fibrous ring, moreover, septal valve should be fixed with separate P-shaped sutures, anterior valve - in the middle with a single P-shaped suture, The rest length of xenoprosthesis should be fixed with uninterrupted blanket suture.

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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