JPH1156882A - Artificial heart valve device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an artificial heart valve device which lessens the danger of thrombus formation, removes the stagnating region of blood, assures the laminar flow of the blood and allows the good washing of all the valves. SOLUTION: This artificial heart valve device includes an annular body 1, upstream side and downstream side supporting surfaces 9, 10, a flange 8 having a flank 11 facing the central axial line 12 of this annular body 1 and lobular bodies 13 which move pivotally between the close position to suppress the back flow 5 of the blood and an open position to allow the flow of the blood flow 4 in a forward direction. The respective lobular bodies have contact surfaces 14 cooperating with the contact surfaces of the other lobular bodtes in the close position and supporting parts 24, 25 interacting on the upstream side and downstream side surfaces 16, 17 and supporting surfaces 10, 9 on the dowen stream side and upper stream side of the flnge 8 with each other. Portions 19 of the outer flanks 15 of at least one lobular bodies have clearances from the flange flank 11 and have upstream side and downstream side projecting parts 20, 21. The upstream side surfaces 22 of these projecting parts 20 form the supporting parts 24, 25.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

FIELD OF THE INVENTION The present invention relates to an annular surface having an upstream end face facing forward blood flow, a downstream end face facing reverse blood flow (backflow of blood), an inner surface, and an outer surface. A main body, a support means having an upstream support surface, a downstream support surface, and a side surface facing the central axis of the annular body, and a closed means mounted in the annular body to suppress reverse blood flow; A leaflet which can be pivoted or pivoted between a position and an open position allowing the flow of blood in the forward direction, each leaflet cooperating with a contact surface of another leaflet in the closed position. Having a contact surface, an outer surface, an upstream surface, a downstream surface, and a support part interacting with the downstream support surface and the upstream support surface of the support means of the annular body, respectively. The present invention relates to an artificial heart valve device having:

[0002]

BACKGROUND OF THE INVENTION The problem of providing a prosthetic heart valve device that allows to provide a satisfactory replacement for the natural heart valve of a human being damaged by a congenital or acquired disease has been thirty years old. Has a history that goes beyond.

[0003] Although many designs have been developed and tested for prosthetic heart valve devices during this long period, these prosthetic heart valve devices ensure forward blood flow when the closed element is in the open position. When the closing element is in the closed position, it functions as a check valve for preventing backflow of blood.

The most commonly used valves in cardiac surgery today are the most commonly used valves in heart surgery, because of their superior hemodynamic parameters and the potential to generate substantially laminar flow in the center. A closed element consisting of two semi-circular leaflets connected by a hinge element, said hinge element being provided by a projection provided on said body or a slot (groove) provided in said leaflet. (See, for example, U.S. Pat. No. 4,863,459), or the hinge element comprises a groove formed in the body of the prosthesis and a projection provided on the leaflet ( For example, U.S. Pat.
76,658 or 4,689,046).

A major difference in the construction of such prosthetic heart valve devices relates to how to overcome the problem of thrombus formation in prostheses. To reduce the risk of thrombus formation, it is necessary to remove stagnant areas of blood, ensure laminar blood flow and allow good cleaning of all elements of the valve.

In an attempt to prevent thrombus formation in an implanted prosthetic heart valve device, an annular body is provided within which the annular body is closed from a closed position to an open position and vice versa. A prosthetic heart valve device in which the elements are pivotally or pivotally connected is disclosed in U.S. Pat. No. 4,308,62.
No. 4 has been proposed. The closed element is composed of two arc-shaped leaflets. The downstream surface of each leaflet facing the backflow of blood presents a concave curved surface when the closing element is in the closed position.

The inner surface of the valve body has a cylindrical shape, and the portion facing the forward blood flow has a smaller diameter than the other portion facing the reverse flow of blood. The area where these two parts meet acts as a valve seat. Two diametrically opposed flats extend over the entire height of the valve body.

[0008] Each leaflet is connected to the valve body by a hinge mechanism. The hinge mechanism is composed of two cooperating elements, one of which is located on a flat part of the inner surface of the valve body, while the other element is located on the opposite side of the closing element .

The elements of the hinge mechanism disposed on a flat portion of the inner surface of the body are formed in the form of two elongated grooves that form an angle of 20 degrees with the diametric plane of the body. The other element of the hinge mechanism, which is arranged on the opposite side of the closing element, is formed as a spherical projection that engages with the groove provided on the inner surface of the valve body, with the respective bearing surface supporting the groove. Work with

[0010] When the valve opens, the leaflets move in the hinge mechanism,
Rotates from the closed position to the open position. Since the leaflets are provided with the concave surface on the downstream side as described above, a passage through which blood flows in the forward direction is formed between the leaflets. Hydrodynamic studies have shown that the composition of the forward blood flow between the leaflets is not homogeneous. In the plane passing through the central axis of the body parallel to the flat part of the body, the blood flow is substantially laminar and fills the entire valve, but in the plane perpendicular to the flat part of the body, the laminar flow is Only in the central part of the heart valve, a large blood stagnation area is formed in the hinge area.

When the valve closes, the leaflets pivot from an open position to a closed position within the hinge mechanism. During this operation, the leaflets interact with a valve seat provided on the inner surface of the valve.

If there is no blood flow irrigation in the area adjacent to the hinge, there is a high risk of a thrombus being formed at this point. The movement of the leaflets along the blood flow while the leaflets open and close in the elongated groove does not help to solve the thrombus formation problem. The reason is that the stagnation area is not removed and the hinge mechanism is not sufficiently cleaned. In addition, the hinge in the form of the groove and the protrusion engaging the groove does not reduce the antithrombotic or anticoagulant properties of the blood, but the components of the blood are exposed to the friction surface where the groove and the protrusion interact. Further damage to blood components if caught in between.

As an attempt to overcome the above problems, an artificial heart valve device has been developed which embodies one common concept, namely, the concept of enabling the leaflets to rotate about the central axis of the valve body. Was. In particular, US Pat. No. 4,274,
In the artificial heart valve device disclosed in Japanese Patent No. 437, a leaflet is connected to a valve body by a hinge, and as a constituent of the hinge, a leaf is formed on an inner surface of the valve body extending along the entire circumference. Mating projections are provided on both sides of the leaflet. In the artificial heart valve device disclosed in US Pat. No. 5,197,980 or European Patent Application No. 0 403 649 B1, the hinge element includes an annular projection provided on the inner surface of the valve body. Slots formed on both sides of the leaflet that engages the part.

European Patent Application 0 327 790 B1
The prosthetic heart valve device according to the description is the closest device to the prosthetic heart valve device of the present invention and can be regarded as prior art of the present invention. The artificial heart valve device disclosed in the above-mentioned patent application has an annular main body configured to allow blood to flow therethrough, and is provided in the main body and allows blood to freely flow in the forward direction through the annular main body. Two leaflets that can pivot between an open position and a closed position that cooperates to prevent blood flow through the annular body in the opposite direction. These lobules have an upstream surface facing the forward blood flow, and a downstream surface that is concave and faces the reverse flow of blood.

The hinge mechanism for holding the leaflets in the valve body includes two grooves provided on both sides of the leaflets, and an annular projection disposed all around the inner surface of the valve body. And

During valve opening, the leaflets rotate and move to the open position while interacting with each other about the projections of the main body.

At the time of closing the valve, the leaflets rotating on the projection of the main body seal the valve by the interaction between the downstream surface and the support surface of the projection.

As the leaflets move from the open position to the closed position and from the closed position to the open position, the leaflets are capable of rotating about the central axis of the valve body. This moves the blood stagnation area along the periphery of the body, thus eliminating locally resident stagnation areas that cause thrombus formation. Providing a hinge in the form of a protrusion on the body and a groove formed in the leaflet reduces surface friction and improves the cleaning of the hinge components by blood flow.

However, there is no design element that guarantees forcible rotation of the leaflets about the central axis of the valve body. Thus, it is possible with very high probability that such rotation is suppressed or not at all. When such a situation occurs, the blood stagnation region of the hinge portion is locally fixed, and is not washed by the forward blood flow or the backflow of blood. In addition, the protrusions on the inner surface of the valve body reduce the cross-sectional area of the valve orifice, create blood flow disturbances that cause an increase in valve hydrodynamic resistance, and activate the thrombus formation process.

[0020]

SUMMARY OF THE INVENTION It is an object of the present invention to prevent the formation of a thrombus in the valve body in such a way that a local blood stagnation area, which cannot be washed with blood, is blocked. It is an object of the present invention to provide a prosthetic heart valve device having a hinge mechanism for holding a leaflet, having improved hemodynamic characteristics and a long service life.

[0021]

According to a first aspect of the present invention, there is provided an artificial heart valve device belonging to the general category described above, wherein at least one leaflet has an outer surface. At least a portion thereof is formed such that a gap is provided between the portion and the side surface of the support means of the annular body, and at least a portion is provided with a downstream projection and an upstream projection, The problem is solved by forming a supporting portion between the upstream surface of the downstream projection and the downstream surface of the upstream projection.

In the prosthetic heart valve device, the leaflet is provided with a novel hinge connection in the form of a projection, and the annular body element is arranged between the leaflets, so that the above-mentioned portion of the outer surface of the leaflet and the annular body are provided. There is a limited backflow of blood between and to the inner surface of the blood. This limited backflow of blood will wash away blood components adhering to the hinged connection with the body of the lobule and prevent thrombus formation in the heart valve element. Furthermore, with the jet flow of the blood backflow generated in a certain direction between the above-mentioned portion of the side surface of the leaflet and the inner surface of the annular body, a part of the blood located below the upstream end face of the annular body rotates, As a result, a blood stagnation region is removed, and a cleaning effect is obtained at the front of the artificial heart valve.

The above elements are preferably provided along the entire circumference of the annular body. In such a case, the leaflets have an additional degree of freedom, namely the possibility of rotation about the central axis of the annular body. As a result, the forced rotation of the leaflets around the central axis of the annular body in the required direction by the rotating action of the blood portion under the influence of the backflow of the blood from the upstream end face of the annular body. Is realized.

The blood stagnation area adjacent to the hinge portion is not only washed by the backflow of blood passing through the gap between the side surface of the leaflet and the inner surface of the body, but also the leaflet is moved around the center axis of the annular body. When rotating, it is also washed by the forward blood flow.

By arranging the element on the upstream end face of the annular body, when the leaflets are in the open position, the size of the leaflets exposed to the downstream end face of the annular body is reduced, This reduces the risk of the leaflets coming into contact with the surrounding heart tissue. Assuming that such contact occurs, the leaflets may become immobile in their open position.

When the prosthetic heart valve device is used for a patient having a small ventricle, or for a patient having some other obstacle in the ventricle, such as impeding the rotation of the leaflet about the central axis of the annular valve body. When used, the above-described element is embodied in the form of two protrusions disposed on diametrically opposed portions of the upstream end face of the annular body, in which case,
The projections of the projections on a plane perpendicular to the central axis of the annular body are practically
A stopper which is arranged so as to form a circular arc having a center on the center axis of the annular body, and whose end portion can interact with the protrusion of the leaflet on the support surface on the upstream side of each protrusion. Is advantageously provided. The length of the support surface on the upstream side of the protrusion limited by the stopper should be 0.05 to 0.25 of the length of the inner surface of the annular body.

In the configuration or arrangement of the artificial heart valve device as described above, the leaflets are also connected to the valve body by a hinge mechanism, and the components of the hinge mechanism are projections provided on the leaflets, The element in the form of two stepped projections arranged on the upstream end face of the valve body is arranged between the leaflets. The stepped projection also has additional degrees of freedom and can rotate about the central axis of the annular body. However, it is not a full rotation but a vibratory rotational movement. With such movement, the hinge mechanism region also moves,
Its amplitude or magnitude is limited by a stop provided on the upstream face of the body element. In this way, the surgeon is able to orient the prosthetic heart valve into the ventricle in such a way as to avoid contact of the leaflets in the open position with the surrounding heart tissue.

In order to realize the forced vibratory rotational movement of the leaflets about the center axis of the main body, the downstream side of each of the protrusions disposed on the diametrically opposed portion of the upstream end face of the main body. With their longitudinal axes at an angle with respect to the central axis of the body, in which case the absolute value of the angle with respect to the surface provided on the opposite projection is They should be chosen so that they are equal and their signs are opposite. In the structural arrangement of such an artificial heart valve device,
The downstream support surface of the protrusion located on the upstream end surface of the main body is a surface inclined with respect to the backflow direction of blood, and the inclined surface is inclined in one direction due to the pressure of blood on the closing leaflet. Sliding along the downstream support surface, and the open leaflets pivot in the opposite direction due to the force of the rotating portion of the forward blood flow. Thus, the leaflets rotate as a result of the oscillating movement, the rotation being limited by a stop provided at the end of the support surface upstream of the annular body element.

According to a second aspect of the present invention, there is provided an artificial heart valve device belonging to the general category described above in order to solve the above-mentioned problems. Is formed such that a gap is provided between the portion and the side surface of the support means of the annular body. Further, a support portion interacting with an upstream support surface of the support means is formed in the at least one portion, and the downstream surface of the support means is connected to the downstream end surface of the annular body. Arranging at the upstream end face of the annular body at the same height level or at the upstream side improves hemodynamic properties.

In the above arrangement of the prosthetic heart valve device, the body element used to connect the leaflets is arranged outside the orifice of the body. Thus, it is possible to minimize the effective area of the hemodynamic orifice of the body and to minimize the effect of the element on blood flow.

At least a portion of the inner surface of the annular body, which is spaced from the forward blood flow, has a gap with respect to the side surface of the body element and a confluer surface interacting with a protrusion disposed on the side portion of the leaflet. Advantageously, it is formed in the form of a (confuser surface) and the radius of the side surface of the body element is made equal to or greater than the radius of the inner surface of the annular body.

In the arrangement of a prosthetic heart valve device as described above, the body element does not protrude into the annular body, so that the effective area of the orifice does not decrease. Therefore, energy loss when blood flows in the forward direction is reduced, and the hemodynamic characteristics of the artificial heart valve device are improved.

Each leaflet is provided with two outer side portions with a gap to the side surfaces of the main body elements disposed on both sides of the outer side surface, each of which has at least two projections. It is advantageous. One of these projections is
The support provided on the upstream surface interacts with the support surface on the downstream side of the body element, while the other projections are supported on the downstream surface by a support portion provided upstream of the body element. Interacts with the side support surface. A support surface provided on the projection of the leaflet and interacting with the support surface of the main body element is formed in a concave shape.

By providing protrusions on both sides of the outer surface with a gap to the main body element, it is possible to wash and flush out blood components adhering from each region where the leaflets are hinged to the main body. become. By providing the projections on these portions, not only is it possible to hold and pivot the leaflets within the main body, but also to the side surfaces of the leaflets that determine the blood backflow that cleans the area adjacent to the hinge part. A fixed setting of the gap between the inner surface of the main body and the main body becomes possible.

By providing a convex support surface interacting with the support surface of the body element on the projection of the leaflet, a rolling friction interaction which ensures minimum wear of the interacting surface is realized, The reliability and life of the valve are increased. In addition, damage to the formed blood components is prevented.

According to a third aspect of the present invention, an object of the present invention is to provide an artificial heart valve device belonging to the general category, wherein a passage is provided in at least one of the leaflets, and a surface of the passage is provided. Intersects the leaflet contact surface and enhances antithrombotic or anticoagulant properties by allowing limited backflow of blood when the leaflets are in the closed position.

In the above-described arrangement of a prosthetic heart valve, the restricted backflow of blood through the passage cleans areas of the valve surface where blood components are likely to adhere.

[0038] In the above-described prosthetic heart valve device according to the third aspect of the present invention, it is advantageous that each leaflet has at least one of the above-mentioned passages so as to allow a limited backflow of blood. The passage is provided on one side of the outer surface described above, wherein the one side is defined by the inner surface of the annular body;
At the same time, the total area of the passage for blood regurgitation and the clearance between the outer and inner surfaces of the body and the side surfaces of the body element should be 0.2 to 8% of the orifice area of the body. It is advantageous.

According to the above-described arrangement of the artificial heart valve device, not only the downstream surface of the leaflets is cleaned by the backflow of blood, but also the protrusions on the side surfaces of the main body and the leaflets are mutually reciprocated. The working surface is cleaned. In addition, blood regurgitation reaches the surface of the body and is washed of fibrin threads that may extend from the suture ring to the sides of the lobules.

If the above flow rate is large enough, an optimal flow rate with limited backflow is achieved, but the blood flow rate in the reverse direction should exceed 20% of the blood flow rate in the forward direction. is not. Otherwise, the energy loss at the valve would be unacceptably high. In order to obtain an optimal blood backflow, the total area of the passage is 0.2 to 8% of the area of the orifice of the annular body.
Must be within.

The prosthetic heart valve device made according to the present invention reduces the probability of thrombus formation or coagulation,
Ensures improved hemodynamic properties as well as high reliability of the valve structure. The prosthetic heart valve according to the present invention is very effective for applying to the replacement of human degenerative innate aortic and mitral heart valves, and is also equally successful for use in replacing damaged tricuspid valves. Can be stored.

[0042]

Preferred embodiments of the present invention will become apparent from the following description with reference to the accompanying drawings.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. 2, 4 and 7, the dashed line indicates the leaflet at the open position.

The artificial heart valve device shown in FIGS.
Used for replacement with diseased native aorta or mitral heart valve.

The artificial heart valve device according to the first embodiment of the present invention shown in FIG. 1 and FIG.
And an annular body 1 having an upstream end face 2 and a downstream end face 3 facing the backflow 5 of blood, and an inner face 6 and an outer face 7. An annular flange 8 is provided inside the annular body 1, and the flange 8 includes an upstream support surface 9, a downstream support surface 10, and a side surface 11 facing the central axis 12 of the annular body 1. Having. The annular flange 8 is attached to the annular body 1.
Extends along the entire inner surface of the.

Inside the annular body 1, there are two pivotally or pivotally movable positions between a closed position in which the backflow 5 of blood is restricted and an open position in which forward bloodflow 4 is allowed to pass. Leaflet 1
3 is attached. Each leaflet 13 has a contact surface 14, an outer surface 15, an upstream surface 16 and a downstream surface 17 that cooperate with the contact surface of the other leaflet in the closed position.
A portion 18 of the downstream surface 17 of each leaflet 13 provides a forward blood flow 4 between the leaflets 13 when the leaflet 13 is in the open position.
Are formed in a concave shape so that the fluid can flow.

The outer surface 15 of each leaflet 13 is
Each leaflet 13 with a gap to the side surface 11 of the flange 8
It has two portions 19 arranged on both sides of the outer side surface 15.

Each portion 19 includes an upstream protrusion 20 and a downstream protrusion 21, and the interval between the protrusions 20 and 21 is defined by the upstream support surface forming support portions 24 and 25, respectively. 22 and a downstream support surface 23.
In addition, the support parts 24 and 25 interact with the downstream surface 10 and the upstream surface 9 of the flange 8 of the annular main body 1, respectively. The supports 24 and 25 have a smooth convex shape. The distance “h” from the upstream end surface 2 to the upstream support surface 9 of the flange 8 is the axial dimension “h ₁ ” of the protrusion 21.
And forms a protective barrier or barrier for the protrusion 21 of the leaflet 13. The barrier serves to prevent the pseudoarterial intima covering the suture ring from entering the hinge mechanism holding the leaflet 13 inside the valve body 1.

The artificial heart valve according to the first embodiment shown in FIGS. 1 and 2 operates as follows. In the closed position, the leaflets 13 interacting with the downstream surface of the flange 8 of the annular body 1 by the support portion 24 and the contact surface 14 of the projection 20 close the orifice of the annular body 1 and the prosthetic heart valve The backflow 5 of blood passing through is suppressed. At this point, the suppressed blood backflow 5 due to the excessively high pressure 5
The injection 26 flows through a gap between the portion 19 of the outer surface 15 of the leaflet 13 and the inner surface 6 of the annular body 1. This flushes out blood components adhering in the region where the leaflets 13 are hinged to the annular body 1, thereby preventing the formation of thrombus in the components of the prosthetic heart valve. Furthermore, due to the above-described predetermined shape and size of the protruding portion 20, the backflow 5 of blood at one portion 19 of the outer side surface 15 of the leaflet 13 is achieved.
Is reflected from the support surface 10 downstream of the flange 8 of the annular body 1 and moves at an angle with respect to the central axis 12 of the annular body 1. As a result, the annular body 1
A portion of the blood at the upstream end face 2 begins to rotate in one direction, thereby removing the blood stagnant area and effecting cleaning of the heart tissue in front of the prosthetic heart valve.

When an excessively high pressure is generated from the side of the end face 2 on the upstream side of the annular main body 1, the support portion 25 on the projection 21
Interact with the upstream face 9 of the flange 8 to open the leaflets 13 and allow the forward blood flow 4 to pass.

At this point, with the rotation of the blood described above, which is generated by the jet of the backflow 5 of blood through the orifice of the annular body 1, the opening leaflets 13 are at a certain angle around the central axis 12. Rotate. Thereby, stable forced rotation of the leaflets 13 is realized over the entire circumference of the inner surface 6 of the annular main body 1.

At the same time, the stagnation region located in the hinge region is washed not only by the backflow 5 of blood flowing through the gap between the outer surface 15 of the leaflet 13 and the inner surface 6 of the annular body 1 but also by the forward blood flow 4. Will be done. The washing action by the forward blood flow 4 is caused by the rotation of the leaflet 13 about the annular main body 1 about the central axis.

The forward blood flow 4 between the leaflets 13 is ensured by forming a portion 18 of the downstream surface 17 of the leaflets 13 into a smooth concave shape.

When an excessively high pressure is generated from the side of the downstream end face 3 of the annular body 1, the leaflets interact with the downstream surface 10 of the flange 8 of the annular body 1 through the support portions 24 of the projections 20. 13 rotates to the closed position and suppresses the backflow 5 of blood.

The provision of smooth convex support surfaces 2, 23 on the support portions 24, 25 of the leaflets 13 ensures an interaction with rolling friction, thereby minimizing wear on the interacting surfaces. , The operating reliability of the valve is increased, and not only its life is prolonged, but also damage to blood components is prevented.

The artificial heart valve device according to the second embodiment of the present invention shown in FIGS. 3 and 5 has an upstream end face 2 and a downstream end face facing a forward blood flow 4 and a reverse flow 5 of blood, respectively. 3 and an annular body 1 having an inner surface 6 and an outer surface 7.

An annular flange 8 is provided inside the annular main body 1.
Are provided, and this flange is provided on the upstream support surface 9.
And a support surface 10 on the downstream side, and a side surface 11 facing the central axis 12 of the annular main body 1. The annular flange 8 extends along the entire inner surface of the annular body 1.

The annular main body 1 has an end face 2 on the upstream side of the main body 1.
Has two stepped projections 27 provided at portions diametrically opposed to each other, and each projection has an upstream support surface 9 facing the forward blood flow 4 and the backflow 5 of blood, respectively. And a downstream support surface 10 and a side surface 11. The support surface 10 on the downstream side of the stepped protrusion 27 is located higher on the upstream side as viewed from the forward blood flow 4 than the end surface 2 on the upstream side. A stopper 28 is provided. The length of each upstream end face 10 between the stoppers 28 is 0.05 to 0.25 of the length of the inner face 6 of the annular body 1.
Between. In addition, the longitudinal axis 29 of the support surface 10 on the downstream side of the stepped projection 27 is aligned with the central axis 1 of the annular body 1.
It makes an angle with respect to 2. The above-mentioned longitudinal axis 29 of the surface 10 on the downstream side of the stepped protruding portion 27 provided in the portion facing the diametrical direction also on the upstream end surface 2 of the annular main body 1
Have the same magnitude but opposite signs. The side surfaces 11 of each stepped projection 27 face each other, and their projection in a plane perpendicular to the central axis 12 forms a circular arc centered on said central axis 12.

In the annular body 1, two leaflets 13 are
It is pivotally or pivotally mounted between a closed position for suppressing the backflow 5 of blood and an open position for allowing passage of the bloodstream 4 in the forward direction. Each leaflet 13 has a contact surface 14 cooperating with a contact surface of the other leaflet in the closed position, an outer surface 1.
5, an upstream surface 16 and a downstream surface 17 are provided. The upstream surface 16 and the downstream surface 17 face the forward blood flow 4 and the backward flow 5 of blood, respectively. A portion 18 of the downstream surface 17 of each leaflet is formed in a concave shape so that the forward blood flow 4 can flow between the leaflets 13 when the leaflet 13 is in the open position. The outer surface 15 of each leaflet 13 has two portions 19 disposed on both sides of the outer surface 15 of each leaflet 13 with a gap from the side surface 11 of the projection 27 of the annular main body 1.

Each portion 19 has two projections 20 and 21 having an upstream support surface 22 and a downstream support surface 23 forming support portions 24 and 25, respectively. Interacts with the downstream face 10 and the downstream support face 9 of the projection 27 of the annular body 1. Projection 20
And 21 have a smooth convex shape. A portion of the inner surface 6 of the annular body 1 extending from the side of the forward blood flow 4 as a confuser-like surface 30 interacting with a projection 20 provided on a portion 19 of the side surface 15 of the leaflet 13 Is formed. In addition,
The radius “R” of the side surface 11 of the stepped projection 27 is equal to the radius “R ₁ ” of the inner surface 6 of the annular body 1.

The protrusion 60 does not protrude into the valve body 1. Accordingly, the effective flow area of the orifice of the main body is not reduced, the energy loss during the passage of the forward blood flow 4 is reduced, and the hemodynamic characteristics of the artificial heart valve device are enhanced.

The artificial heart valve device according to the second embodiment shown in FIGS. 3 to 5 has the same function as the artificial heart valve device shown in FIGS. 1 and 2 except for the following points. That is,
In the prosthetic heart valve device of the second embodiment, the protrusion 21 is generated by the action of the force exerted from the side of the rotating portion of the forward blood flow 4 due to the action of the backflow jet 26 of blood.
Is that the opening leaflet 13 rotates about the central axis 12 of the annular body 1 until it interacts with the stopper 28 on the upstream face 9 of the stepped projection 27. During closing of the valve, the leaflets 13 slide along the pressure-sloping downstream support surface 10 and at the same time about the central axis 12 until the projections 21 interact with the stops 28. Rotate. The inclination direction of the support surface 10 on the downstream side of the stepped projection 27 is such that the leaflets 13 rotate in one direction during valve opening and in the opposite direction during valve closing around the central axis 12. To be selected.

According to the configuration and arrangement of the artificial heart valve device as described above, the leaflets 13 are provided with an additional degree of freedom, and can be rotated about the central axis 12 of the annular main body 1. However, in that case, it does not mean a complete rotation,
It takes the form of rotational vibrations. Such movement also moves the hinge mechanism region, but the amplitude or magnitude of the movement is limited by the stopper 28 provided on the support surface 9 on the upstream side of the stepped projection 27. Thus, the surgeon can orient the prosthetic heart valve into the ventricle in such a way as to avoid contact of the leaflets 13 with the surrounding heart tissue during valve opening.

The artificial heart valve device according to the third embodiment of the present invention shown in FIGS. 6 and 7 has an upstream end face 2 and a downstream end face facing the forward blood flow 4 and the reverse flow 5 of blood, respectively. 3 and an annular body 1 having an inner surface 6 and an outer surface 7. Inside the annular body 1, the two leaflets 13 are pivotally or pivotally movable between a closed position in which the backflow 5 of blood is restricted and an open position in which the bloodflow 4 in the forward direction is allowed to pass. Is attached. Each leaflet 13 has a contact surface 14, an outer surface 15, which cooperates with a contact surface of the other leaflet in the closed position,
It has an upstream surface 16 and a downstream surface 17.

Each leaflet 13 is provided with one passage 31, which traverses the contact surface 14,
5 is provided on one side. One side of the passage 31
It is defined by the inner surface 6 of the annular body 1. The passage 31
And the total area of the gap between the outer surface 15 and the inner surface 6 of the annular body 1 is such that the restricted backflow of blood does not exceed 20% of the flow rate of the forward blood flow 4 and the area of the orifice of the annular body 1 Is selected to be 0.2 to 8%.

According to the above configuration or arrangement of the artificial heart valve device, when the leaflet 13 is in the closed position, the passage 3 is closed.
The restricted backflow 5 of blood flowing through 1 cleans the area of the downstream surface 17 of the leaflets 13 where the blood components are more likely to adhere. In addition, the jet of the backflow 5 of blood flowing through the passage 31 reaches the upstream end face of the annular body 1 and flushes out the fibrin thread that can spread from the surrounding heart tissue to the side of the leaflet 13.

Laboratory observations have shown that pressure loss in a prosthetic heart valve constructed in accordance with the present invention is minimized during forward blood flow at an optimal backflow rate.

As a result of an accelerated life test over a period equivalent to 50 years of use of the artificial heart valve device in vivo, it was found that the artificial heart valve device according to the present invention had great durability and high reliability. . There was no accident that the prosthetic heart valve could not operate. Wear of the interacting components of the prosthetic heart valve device was insignificant, and the hemodynamic and functional properties of the prosthetic heart valve device remained substantially unchanged.

After comprehensive laboratory testing and investigation,
When a sample of the prosthetic heart valve device constructed according to the present invention was subjected to a long-term clinical test, high antithrombotic or anticoagulant properties, hemodynamic efficacy and high reliability were confirmed. It is believed that a prosthetic heart valve device with a design based on is suitable for replacement with a human injured innate heart valve.

EXAMPLE The above described artificial heart valve device was manufactured in six or larger sizes with a mounting diameter in the range of about 14 to 33 mm. The following dimensions are applicable to each artificial heart. 1) The width of the face 10 downstream of the element 8 in the radial direction is equal to about 0.5 to 1 mm. 2) The shape and dimensions of the concave portion 18 of the leaflet 13 satisfy the condition that the three passage portions of the orifice have substantially the same area. 3) The gap between the side surface 11 of the element 8 and the portion 19 is approximately
It is in the range of 0.5 to 0.25 mm. 4) The gap between the inner surface 6 of the valve body 1 and the portion 19 is about 0.
It is in the range of 55 to 1.25 mm. 5) h is equal to about h ₁ + (0.5-1.0) mm. 6) β is equal to about 10 °. 7) The width of the passage 31 is in the range of about 0.05 to 0.25 mm, and its length is about 1/10 to 1/3 of the length of the contact surface 14 of the leaflet 13.

[Brief description of the drawings]

FIG. 1 is an enlarged view showing a prosthetic heart valve device according to a first embodiment of the present invention as viewed from a downstream side with respect to a forward blood flow, with a leaflet in a closed position.

FIG. 2 is a partial cross-sectional view taken along line II-II of FIG.

FIG. 3 is an enlarged view showing the prosthetic heart valve device according to the second embodiment of the present invention as viewed from an upstream side with respect to a forward blood flow, with a leaflet in an open position.

FIG. 4 is a partial sectional view taken along line IV-IV in FIG. 3;

5 is a partially enlarged cross-sectional view of the prosthetic heart valve device taken along line VV in FIG. 4;

FIG. 6 is an enlarged view showing a prosthetic heart valve device according to a third embodiment of the present invention viewed from a downstream side with respect to a forward blood flow, with a leaflet in a closed position.

FIG. 7 is a partial sectional view taken along line VII-VII in FIG. 6;

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 ... Annular main body, 2 ... End face on the upstream side, 3 ... End face on the downstream side,
4 forward blood flow, 5 reverse blood flow, 6 inner surface, 7 outer surface, 8 annular flange (supporting means), 9 upstream support surface, 10 downstream support surface, 11 ... Side surface, 12: center axis, 13: leaflet, 14: contact surface, 15: outer surface, 1
6 ... upstream surface, 17 ... downstream surface, 19 ... part of outer surface, 20 ... upstream projection, 21 ... downstream projection,
22: Upstream surface, 23: Downstream surface, 24, 25: Supporting part, 26: Backflow injection of blood, 27: Stepped projection (supporting means), 28: Stopper, 29: Longitudinal longitudinal axis , 30 ... confluer surface, 31 ... passage.

 ──────────────────────────────────────────────────続 き Continued on the front page (71) Applicant 597115484 MK. 5, D. 10 A / YA 716, 440056 PENZA, RUSSIAN FEDERATION (71) Applicant 597115495 UL. TERNOVSKOGO D. 174 KV. 213, 440004 PENZ A, RUSSIAN FEDERATION (72) Inventor Sergey V. Evdkimov Russian Federation, 440056 Penza, MK5, Dom 10, A / Way 716 (72) Inventor Alexander P. Melnikov Russian Federation, 440004 Penza , Ulica Ternovskogo, Dom 174, Kubarti La 213

Claims (10)

[Claims] 1. An upstream end face (2) facing a forward blood flow (4), a downstream end face (3) facing a reverse blood flow (5), an inner face (6) and an outer face (7). ), An upstream support surface (9), a downstream support surface (10), and a side surface (11) facing the central axis (12) of the annular body (1). Support means (8) and said annular body pivoting between a closed position in which said backflow of blood (5) is suppressed and an open position in which said forward blood flow is allowed to flow. A leaflet (13) mounted in (1), wherein each leaflet (13) cooperates with a contact surface of another leaflet in a closed position, an upstream face ( 16), a downstream surface (17), and the downstream support surface (10) of the support means (8) of the annular body (1) and the downstream surface, respectively. A leaflet (13) comprising a support portion (24, 25) interacting with a flow-side support surface (9), comprising: at least one of the leaflets (13); At least a portion (19) of the outer surface (15) of one leaflet is provided with a gap between the portion (19) and the side surface (11) of the support means (8) of the annular body (1). And at least a portion (19) is provided with a downstream projection (2).
0) and an upstream projection (21) are provided, and an upstream surface (22) of the downstream projection (20) and a downstream surface (23) of the upstream projection (21) are provided. A prosthetic heart valve device, characterized in that said support portions (24, 25) are formed. 2. An upstream end face (2) facing the forward blood flow (4), a downstream end face (3) facing the reverse blood flow (5), an inner face (6) and an outer face (7). ), An upstream support surface (9), a downstream support surface (10), and a side surface (11) facing the central axis (12) of the annular body (1). Support means (8) and said annular body pivoting between a closed position in which said backflow of blood (5) is suppressed and an open position in which said forward blood flow is allowed to flow. A leaflet (13) mounted in (1), wherein each leaflet (13) cooperates with a contact surface of another leaflet in a closed position, an upstream face ( 16), the downstream surface (17), and the downstream support surface (10) and the upper surface of the support means (27) of the annular body (1), respectively. A leaflet (13) comprising a support portion (24, 25) interacting with a lateral surface (16), wherein the leaflet (13) comprises at least one leaflet of the leaflet (13). At least a part (19) of the outer surface (15) of the body is provided such that a gap is provided between said part (19) and the side surface (11) of the support means (8) of the annular body (1). Forming said at least one portion (19) with said support means (8)
Part (2) interacting with the support surface (9) upstream of the
5), wherein the supporting means (27) has the downstream face (10) of the supporting means (27) at the same height as the upstream end face (2) of the annular body (1) or An artificial heart valve device, which is disposed on the upstream end surface (2) of the annular body (1) so as to be located on the upstream side thereof. 3. The prosthetic heart valve device according to claim 1, wherein two of said portions (19) are arranged on both sides of an outer surface (15) of said leaflet (13). 4. The prosthetic heart valve device according to claim 1, wherein the support portions (24, 25) have a smooth concave shape. 5. At least a part of the inner surface of the annular body (1) located downstream of the support means (8) of the annular body (1) is a support surface downstream of the support means (8). 2. The method according to claim 1, wherein the confluer has a shape that cooperates with a projection that interacts with the surface.
An artificial heart valve device according to any one of claims 1 to 4. 6. The support means (8) is arranged along the entire circumference of the annular body (1), and at least a part (18) of the downstream surface (17) of each leaflet (13) is provided. The forward blood flow (4) between the leaflets (13) in the open position;
6. The prosthetic heart valve device according to any of the preceding claims, wherein the prosthetic heart valve device has a smooth concave shape to allow the flow of the heart valve. 7. The support means (8) is formed by two projections (27) provided on diametrically opposed portions of the upstream end face (2) of the annular body (1),
The side faces (11) of the two projections (27) face each other,
The protrusion on the side surface is provided at the center axis (1) of the annular body.
An artificial heart valve device according to any of the preceding claims, characterized in that on a plane perpendicular to (2) an arc of a circle centered on said central axis (12). 8. A support surface (1) on the upstream side of each projection (27).
0) at the end (2) so as to cooperate with the projection (27) interacting with the upstream support surface (10).
8), and the length of each upstream surface (10) between the stoppers (28) is equal to the inner surface (6) of the annular body (1).
8. The prosthetic heart valve device according to claim 7, wherein the length is in the range of 0.05 to 0.25. 9. An upstream end face (2) facing forward blood flow (4), a downstream end face (3) facing backflow (5) of blood, an inner surface (6), and an outer surface (7). ), An upstream support surface (9), a downstream support surface (10), and a side surface (11) facing the central axis (12) of the annular body (1). Support means (8); and said annular body pivoted between a closed position in which said backflow of blood (5) is suppressed and an open position in which said forward blood flow is allowed to flow. A leaflet (13) mounted in (1), wherein each leaflet (13) cooperates with a contact surface of another leaflet in a closed position, an outer surface (15). , The upstream surface (16) and the downstream surface (1
7) and support portions (24, 2) which interact with the downstream support surface (10) and the upstream support surface (9) of the support means (8) of the annular body (1), respectively.
An artificial heart valve device comprising: (5) a leaflet (13), wherein at least one of the leaflets (13) is provided with a passageway (31); An artificial heart, characterized in that the surface of the passage (31) allows a controlled backflow (5) of blood across the contact surface (14) of the leaflets (13) when the is in the closed position. Valve device. 10. At least one passage (31) in each leaflet (13) on one side of said outer surface (15), one side of said passage (31) being connected to said annular body (1). And the at least one passage (3)
1) and the total area of the gap between the outer surface (15) of the leaflet (13) and the inner surface (6) of the annular body (1) is from 0.2 to the area of the orifice of the annular body. 8%
The artificial heart valve device according to claim 9, wherein