CN1050823A - Prosthetic heart valve - Google Patents

Abstract

Double small leaf cardiac valve with improved supporting point mechanism, this supporting point mechanism allow valve that blood is commutated and can respond fast, and the lobule chatter of open position is reduced to minimum level.A pair of lobule slidably and rotationally be installed on the cardiac valve in case close and open position between rotate.Groove on the lobule cooperates with the fulcrum raised surface that extends internally from valve body.Complementary surface on downstream block and the lobule meshes so that cushion the last motion of opening, and has reduced the wearing and tearing of key position, has improved service behaviour.

Description

Prosthetic heart valve

The application is the application № .07/537 that proposes June 13 nineteen ninety, 352 continuation part, and application № .07/537,352 is continuation parts of the application 07/419,288 of proposition on October 10th, 1989.

The invention relates to prosthetic heart valve, particularly about adopting rotatable valve spare to comprise the prosthetic heart valve of double small leaf valve.

Developed various types of prosthetic heart valves already, they rely on hemodynamics work under the pumping action of heart.At the cardiac valve kind apoplexy due to endogenous wind that had developed already the cardiac valve that adopts an independent closure member is arranged, this closure member rotates to open and close cardiac valve, as United States Patent (USP) № .4 around an eccentric axis, 011,601,4,423,525 and 4,425, described in 670 and double small leaf cardiac valve, as United States Patent (USP) № .4,484,365 and 4,535, described in 484.Above-mentioned patent has all been described and various closure member or valve spare has been connected in the scheme of a valve body rotationally, and discloses the closure member of different shape.Yet owing to exist most this class design of some defective from failing to reach commercial stage, so still need the improved prosthetic heart valve of implant into body heart forever.

At the open position of pseudovalve, it should be able to provide a big and passage that good flowability characteristics is arranged, so as to make blood can be freely by and can not produce disadvantageous boundary layer separation and make the resistance minimum.In that the pump period cardiac valve of heart should be able to response be opening rapidly fast to blood flow, when heart loosens when stoping the backflow of blood, cardiac valve should be able to be closed rapidly.The opening and closing of valve should be enough gentle, so that the sound interference that the patient can not be produced.Cardiac valve should be by making by biocompatible and antithrombotic material, RESEARCH OF PYROCARBON preferably for example, and importantly all surface all should be by the blood cleaning down to prevent to cause the congestion of blood clotting in this respect.In addition, the action of valve should not cause haemolysis (destruction hemocyte).

The structure of cardiac valve must be able to be born opening and closing many times, and the wearing and tearing of interactional cardiac valve part are just very crucial.Avoid excessive wearing and tearing extremely important in the pivot center part that limits the cardiac valve closure member.The United States Patent (USP) № .4 that on April 24th, 1984 announced, 443,894 have just proposed this problem.In the described double small leaf of this patent valve structure, designed installing mechanism like this, promptly in that each limits the end of the spherical part setting in motion of pivot center to a broken line groove when move the closed position; Part along with the bearing of lobule curved edge withstands on a sealing strip or the seat 26 then, and spherical part is recalled slightly from the final plant closure position.Yet this structure has not only limited the closing movement of a pair of valve leaflet, also be limited in the closely similar structure of described structure in.As a result, still feel to be necessary to continue to improve design to overcome the wearing and tearing of the cardiac valve that adopts various rotation closure members.

The invention provides a kind of cardiac valve with above-mentioned required feature, double small leaf cardiac valve particularly, wherein installing mechanism rotates between the closure member in valve body and, the slip engagement of wherein rotating a closure member and an open position block has cushioned the exercise end of closure member, thereby make closure member can gently arrive the position of opening fully, make the engagement part disengaging engagement in addition that limits pivot center simultaneously.

It is particularly useful in the fulcrum structure of a pair of double small leaf that this mechanism is considered to, wherein be processed with a upstream and downstream plane surface in extended projection from the sidewall of circular flap film body, and wherein lobule has groove, relevant position on the groove is processed with plane surface, when being shown in an open position this plane surface with the projection plane surface and put.Its result arrives preceding upstream, the position plane surface of opening fully at lobule to break away from engagement, thereby has reduced the wearing and tearing of this point and cushioned exercise end.In addition, this position of block can change the stress mode that lobule bears effectively in the moment of final plant closure, thereby has alleviated because of opening and closing the possible fatigue of lobule in this location many times.

With reference to the accompanying drawings, most preferred embodiment of the present invention is described.

Fig. 1 is the perspective view that a pair of lobule cardiac valve is shown in an open position, and it has various feature of the present invention;

Fig. 2 is the amplification sectional elevation of the cardiac valve got along 2-2 line among Fig. 1, and wherein cardiac valve is shown in an open position;

Fig. 3 is the partial plan view of double small leaf cardiac valve shown in Figure 1, and wherein cardiac valve is shown in an open position;

Fig. 4 is the perspective view of a lobule of valve shown in Figure 1;

Fig. 5 is the amplification inclinating view of lobule shown in Figure 4, shows the downstream or the surface of refluxing;

Fig. 6 is being seen along the 6-6 line of Fig. 5, the side view of lobule shown in Figure 4;

Fig. 7 is the view along the being seen lobule of 7-7 line of Fig. 6;

Fig. 8 is the view along the being seen lobule of 8-8 line of Fig. 6;

Fig. 9 is that lobule shown in Figure 4 amplifies fragmentary, perspective view, shows the groove on the lobule extension especially;

Figure 10 is the cutaway view of cardiac valve shown in Figure 1 when in the closed position;

Figure 11 is a partial sectional view that amplifies, and shows the engagement between the groove of lobule fulcrum and lobule during near the position of opening fully;

Figure 12 one is similar to the amplification partial sectional view of Figure 11, shows the engagement between the groove of fulcrum and lobule when lobule is in the position of opening fully;

Figure 13 is the view that is similar to Fig. 2 of another embodiment of cardiac valve, and wherein cardiac valve has various feature of the present invention, and shown lobule is in the position of opening;

Figure 14 is the cutaway view of valve shown in Figure 13, and wherein lobule is in the closed position; With

Figure 15 is an enlarged perspective, shows a lobule of valve shown in Figure 13 and 14.

The cardiac valve of a double small impeller structure has been shown, by 10 expressions in the accompanying drawing.Yet clearly principle of the present invention also is applicable to prosthetic heart valve with an independent closure member concerning the ordinary person who knows this technology.Implement cardiac valve of the present invention and when opening and closing, can respond fast, when lobule contact valve body, impact lessly relatively, and can avoid haemolysis or damage to flow through the hemocyte of valve basically.

Cardiac valve 10 comprises that one is generally annular valve body 12 and a pair of closure member that sways or lobule 14, and lobule 14 opens and closes with control blood along the downward direction proper flow (see figure 2) shown in the arrow 18.Blood flows through passage 16, and passage 16 is limited by columniform inner surface of being generally of valve body 12 or sidewall 20.A pair of radially relative plain wall section 24 is arranged on the cylindrical surface of sidewall 20.A pair of face 26 arranged in the both sides of each plain wall section, and a face 26 cooperates with a bulge or projection 27 in order to stop lobule to rotate when lobule arrives the position of opening fully, as illustrated in fig. 1 and 2.

Shown in Fig. 1 to 3, radially relative projection 42 is vertically extended from plain wall section usually.Each projection 42 has a pair of towards opposite side fulcrum 43.Each fulcrum 43 has three flat face 44a, 44b and 44c.Each face all arrives about 130 ° of preferably about angles of 125 ° face adjacent with the next one with about 110 ° and intersects.In most preferred embodiment, face 44a is roughly parallel to the direction of blood flow, and two face 44b and 44c are positioned at the upstream (seeing Figure 11) of a face 44a in addition.Thereby 47 recessed the lateral surfaces areas on passage 16 mobile blood paths in the middle part of projection 42 reduce to minimum, and projection 42 is flat and parallel with the plain wall section 24 of valve body usually to inner surface 50.Three face 44a, 44b and 44c are perpendicular to the plain wall section 24 of valve body, and perpendicular to parallel flush end part 50.Groove 53 engagements on these fulcrums and the lobule 14.

Each lobule 14 all has a upstream or flows into surface 30 and a relative downstream or flux surface 32.The thickness that lobule is shown along the cutaway view of being got perpendicular to the lobule centrage of lobule pivot center 2 has significant change from its end to end.Because the curvature of the combination of lobule, this design has reduced the resistance of lobule to blood flow.As U.S. Patent application № .392,745(1989 applied for August 11) described (its disclosed content is here as a reference), lobule partly is attributable to linkwork to the fast reaction that direction of flow of blood changes.

All there is the spill district 70 of a bidimensional bending (resembling a curved tabs) on the inflow surface 30 of each lobule.Just as used herein, a bidimensional curved surface is a kind of like this surface, and it is made of one group of straight line, and these straight lines laterally extend from this end of lobule to that end to limit a curved surface, and all these straight lines all are parallel to each other.In other words, the plane that is parallel to pivot center will flow into the surface along the straight cuts bidimensional, and will flow into the surface along a line cutting bidimensional with same curvature perpendicular to the plane of pivot center, no matter this plane is central plane or the plane of departing from from the center flat transverse.Lobule flows into surface 30 and also comprises a bidimensional curved male district 72, and it is positioned at the downstream in spill district 70.It can be and is similar to a parabola, an ellipse or some other level and smooth arcual bending when with a plane cutting convex district 72 perpendicular to pivot center.

The flux surface 32 of each lobule 14 comprises a convex surface district, and preferably extend with relative inflow spill district 70 and inflow convex district 72 at least jointly in this convex surface district.Lobule has a maximum ga(u)ge, and is relative mutually in this thickness part convex surface.Each lobule all has big curved circular perimeter surface 36, and this curved circular perimeter surface and valve body sidewall adjoin when in the closed position.

Except being positioned at the big curved circular perimeter surface 63 of the lobule trailing edge of opening fully, lobule 14 also has a less flat matching surface 38, and it is positioned at front end relative on the lobule.Less plane surface 38 cooperates with the respective surfaces of relative lobule or adjoins.This less surperficial 38 is divided into the obtuse angle with the planar portions of the flux surface 32 of lobule 14, and this angle selects promptly when valve is in the closed position two less surperficial 38 roughly to recline along their whole length like this.

With reference to Figure 4 and 5, each lobule 14 all comprises a pair of relative lateral parts 51, and they are between big curved surfaces 36 and little matching surface 38.These lateral parts 51 of lobule are preferably flat, and the size that determines lobule like this is promptly in the gap 25 minimum (see figure 3)s that make during the rotation of lobule 14 between the plain wall section 24 of itself and valve body 12.

Can be clear that from Fig. 9, near two lateral parts 51, extend extension 52 from flux surface 32, each extension 52 all has 54, one basal surfaces 55 of a upstream end surface and a downstream surface 59.Thereby the upstream end surface of extension 52 54 is divided into obtuse angle and less continuous, level and smooth surface of flat matching surface 38 formation with the planar portions of the flux surface 32 of lobule 14.Relative little matching surface 38 and extension 52 form the solid aggregate surface of thickness, and this surface has several advantages when valve is closed.For example, when matching surface is in contact with one another, the increase of matching surface 38 surface area power is distributed on the bigger area, the result has reduced stress and the wearing and tearing on the lobule.In addition, when valve is in the position of closing fully, the surface area that the has increased zone that reclines between the lobule matching surface of having extended, and prevented leakage.

Groove 53 is formed on each extension 52 and has two flat or straight surfaces 56 and 57 and one the 3rd curved surfaces 58, surface 56 and 57 with prop up face 44a and 44b and cooperate, and precedent 125 ° of angles according to appointment each other.In most preferred embodiment, first plane surface 57 is roughly parallel to planar section and best and this planar section coplane of the flux surface 32 of lobule; Second plane surface 56 is adjacent with first plane surface 57 and be positioned at its upstream side (when lobule is in the position of opening).Curved surfaces 58 is adjacent with first plane surface 57 and be positioned at its downstream, and curved surfaces 58 extends and preferably tangent with it smoothly since first plane surface 57.The downstream surface 59 of extension 52 is flowed out the about 100 °-Yue 120 ° angle that partly tilts along updrift side with respect to the plane of lobule 14.They with respect to the center line plane of passing valve body into about 60 °-Yue 80 ° angle.Center line plane refers to perpendicular to plain wall section 24 and comprises the plane of the centrage that passes the valve passage.

With reference to Fig. 2, extension 52 provides additional structure support for the upstream portion or the fore-end 60 of lobule 14, and this upstream portion 60 is being born the stress that stops leaflet movement, particularly the position of opening.As U.S. Patent application № .296, described in 428, the zone line between extension 52, the fore-end 60 of lobule 14 has a constant thickness, and this thickness is significantly less than the thickness of downstream part, and this can obviously find out from the cutaway view of Fig. 2 and Figure 10.Extension 52 best and lobule 14 one processing, thus make lobule that the thickness of one thickening be arranged in the part that meets with stresses.

Thereby by radially relatively part be that reference line 2-2 cutting valve body part extruding valve body is installed in lobule 14 on the valve body 12 among Fig. 1.So just make valve body protruding, thereby allow lobule 14 is installed in the passage 16 of valve body at radially relative plain wall section 24 place's outward bulges.The extension 52 of lobule is installed between a fulcrum 43 and the face 26, and fulcrum 43 is positioned at groove 53 simultaneously.Removing extruding force then makes plain wall section return to their home position.With reference to Fig. 3, the side 51 of lobule 14 and the size of extension 52 determine like this, promptly provides a little gap 25 between the plain wall section 24 adjacent with valve body 12.Groove 53 and fulcrum 43 define a pivotal line, are opening and closing between two positions around this pivotal line lobule and are rotating slidably.This will discuss in conjunction with the work of valve hereinafter.

Lobule slidably and be rotatably mounted so that between closed position and open position, rotate, and preferably make lobule open that particularly closing movement is fast as much as possible.Yet carefully the terminal point of design and qualification leaflet movement weares and teares to reduce noise and lobule.For example, when contact limited the seating face of leaflet movement terminal point, lobule should not rebound, and big circumference surface 36 should not exceed valve body 12 when in the closed position.

Fig. 2 shows the inflow surface 30 of lobule 14, and it leans against on the flat and vertical surface of adjacent face 26, and a face 26 defines the opening degree of lobule with downstream block 27, thereby has determined a terminal point of its stroke.Block 27 extends internally from the plain wall section 26 of fulcrum projection downstream part, thus like this position block 27 make they can be as following the explanation and the inclined surface 59 of extension mesh.Be similar to the fulcrum projection, the middle part of block 27 is preferably recessed so that make the horizontal table area of exposure reduce to minimum, and unlikely obstruction blood passes passage 16 and flows.Because the impact at the terminal point lobule of leaflet movement is cushioned, explain as following, so stop the rotation of lobules 14 just to cause having reduced wearing and tearing on the mating surface of fulcrum and groove except a face 26 adopts blocks 27.On the other hand, the little matching surface 38 of lobule recline and the sidewall 20(of big curved surfaces 36 and valve body 12 its go up can process a seating face) contact, prop up the contact last closed position that just define lobule of the inclined surface of face 26 with the edge at P point place.

From Fig. 2 as seen, prop up the abundant open position that face 26 and block 27 define lobule 14 with flat the face 44a and the 44b of fulcrum 43.In most preferred embodiment, when lobule was shown in an open position, matching surface 38 should not exceed valve body.In general wish to give like this lobule orientation of fully opening, soon it is extremely minimum to the downward fluidic resistance drop that flows through valve body passage 16.As shown in Figure 2, the direction of the fore-end 60 of lobule 14 is arranged essentially parallel to the direction of blood flow, and this direction is represented with arrow 18.

Between the position of closing fully and opening fully, control lobule 14 carries out angular displacement.With reference to Fig. 2, the angle of being represented by reference number a of opening (i.e. the angle orientation of lobule when lobule is shown in an open position) is between the scope of about 1 ° and 20 °.Preferably between about 5 ° and 20 °, optimum is between about 7 ° and 13 ° to this angle that lobule is opened.Here used speech " angle of opening " is meant two angles between the plane, these two planes are all perpendicular to plain wall section 24, one of them plane (being represented by alphabetical M) is vertically divided less matching surface 38 equally and is comprised the mid point of big curved surfaces 36, and another plane (being represented by alphabetical L) comprises the centrage of valve body passage.

The centre line L of passing the passage 16 of valve body 10 is positioned at the centre of pivot center, and face-to-face mutually at the flux surface 32 of the position lobule of opening fully in the opposite flank of centre line L, the part of lobule 14 in valve body 12 is arranged essentially parallel to centre line L simultaneously.In complete closed position shown in Figure 10, the less matching surface 38 of lobule 14 preferably reclines mutually along their whole plane surface.Anyway select open angle a, when closing fully, had better not make lobule 14 form line relationship, to avoid occurring the danger of wedging lobule.Therefore, lobule 14 forms an obtuse angle each other, preferably less than 150 °, as shown in figure 10.

Describe the work of cardiac valve 10 with lobule from the position setting in motion of closing fully now, wherein two of each groove 53 plane surfaces 56 and 57 have a little gap (see figure 10) all with the face 44b and the 44c of fulcrum 43 and put between these adjacently situated surfaces.When the heart circulation was walked around, blood flowed (Fig. 2) along the direction of arrow 18, and opens the baseline of motion at valve, and lobule is pressed on the face 44b and 44c of fulcrum projection 42 along the plane surface 56 and 57 of downstream direction displacement up to groove 53.Owing to be pressed in and flow into surperficial 30(it is usually located at the downstream of pivot center) on power, the eccentric position of pivot center has caused a unbalanced moments.This unbalanced moments makes lobule begin to rotate around fulcrum 43 along the direction of opening valve, and their less matching surface 38 separates also near a face 26 simultaneously; Contact is between the plane surface 56,57 and fulcrum 43 of groove.Because the lobule surface area transversely at the blood flow path constantly reduces, the more and more wideer power of opening with lobule that acts on the fulcrum 43 reduces.Along with lobule 14 is swung towards the fully open position, the edge B of groove 53 and fulcrum 43 and the contact point between the C continuously change, and the effect that contact point is vacillated has continuously been done discussion in above-mentioned application.

As shown in figure 11, its projection from the valve body medial wall of the size relationship of groove 53 and fulcrum 43 and downstream block 27() space between is like this, promptly along with the approaching position of fully opening of lobule, the upstream edge D of block 27 contacts and meshes with the inclined surface 59 of extension 52.This contact has two effects.At first it has cushioned the lobule 14 of rotation and the impact between the downstream block 27.The second, realized described buffering thereby disengage by surface 56 afterburning and that lobule is upstream raise slightly make edge C and groove, so just alleviated may wearing and tearing of this some place.The rising of lobule causes the edge B slip of the plane surface 57 of groove along a face 44a.The result as shown in figure 12, when lobule arrived the position open fully, the plane surface 56 of a face 44b and groove closely and put but did not contact.Yet a face 44a contacts with the plane surface 57 of groove, and the end of inclined surface 59 contacts with the edge D of downstream block 27, and all these is in order to eliminate the vibration of the lobule that is shown in an open position.In addition, in the position of opening fully, the planar section that lobule flows into surface 30 may contact the surface of propping up face 26 parallel with the valve centrage, although have a little gap between these two surfaces as shown in figure 12.At open position, possible vibration only is a slight motion extremely, and move distance finds out that thus a face 26 and downstream block 27 make this double small leaf valve be in extremely stable open position with groove in the scope of allowing.

In case putting upside down blood, cardiac cycle promptly flows along updrift side (opposite) with the direction of arrow 18 shown in Figure 2.The power that backflow blood acts on the flux surface 32 makes lobule 14 slightly upstream move (promptly along the direction that makes progress among Fig. 2), and beginning is rotated along closing direction.In case each lobule moves, the downstream edge A on the fulcrum 43 just with curved surfaces 58 engagement of groove, and the lower limb P of a face 26 contacts with the planar section that flows into surperficial 30.This move makes lobule 14 begin quick rotation along closing direction, and the major part of lobule flux surface 32 all is exposed under the direct active force of backflow blood then.Along with lobule flux surface 32 inserts the blood a fluid stream, the speed of closing increases.

In case less matching surface 38 is in contact with one another, and/or curved surfaces 36 contacts with the inner surface (can process a seating face as required on it) of the sidewall 20 of valve body 12 greatly, and lobule moves with regard to phase down.During the major part of lobule closing movement, flow into surface 30 and all contact, and when lobule reaches a fully closed position (Figure 10), the edge P that props up on the face 26 contacts with inflow surperficial 30 with edge P on the face 26.

As the U.S. Patent application № .392 that proposed on August 11st, 1989, explained that when the lobule closing movement begins, close the moment advantageous particularly greatly for one, it can make lobule can respond fast reverse liquid stream in 745.Yet, continuation along with closing movement, because the change of contact point between groove 53 and the fulcrum 43, the instantaneous centre (IC) of the point on the lobule changes, compare with the impact that a similar valve spare that rotates around the fulcrum of a circular cross section produces, its result has reduced impact when the curved surfaces 36 contact valve sidewalls of lobule.In addition, the frictional resistance that a longshore current is gone into the planar section on surface 30 (it is along the slip of P point), the impact when also having reduced to close have also been produced with contacting of edge P in the down periods.As a result, alleviated " water attack " effect by the IC effect of above-mentioned variation and this soft closing greatly of frictional resistance generation, " water attack " effect is considered to cause that to the prejudicial cavitation of RESEARCH OF PYROCARBON RESEARCH OF PYROCARBON is to make the cardiac valve optimal material of part in addition.Equally, when lobule 14 begins to open motion, open the moment advantageous particularly greatly for one, it can make lobule can respond fast reverse liquid stream.Along with the continuation of opening, the IC displacement, thus having reduced impact, the engagement of inclined surface 59 and edge D has further cushioned impact.

Cardiac valve 10 according to above-mentioned principle manufacturing has numerous advantages, a kind of embodiment of viable commercial particularly is provided, this embodiment oppositely can respond very apace to liquid stream, and at the terminal point of the terminal point of opening motion or closing movement, when impacting, can not make relatively thin lobule too stressed, at the terminal point of closing movement, the trend of generation " water attack " effect and the chance of cavitation erosion have been reduced greatly.This is considered to very important, because must carry out many times opening and closing at center valve of the whole life-span of user, particularly can transfer to possible abrasion point concerning rotating is not crucial zone, be the edge D of inclined surface 59 and downstream block, can allow a spot of wearing and tearing, and can adverse effect not arranged the performance of valve.

Although the cardiac valve of structure shown in-12 that effect described in the top paragraph and advantage are specially adapted to have Fig. 1 adopts the lobule of simplicity of design also can obtain all these these advantages, Figure 13-15 for example, another shown embodiment, promptly cardiac valve 10 '.This embodiment adopted the valve body identical valve body 12 of the valve 10 shown in a structure and Fig. 1-12 ' and a pair of lobule 14 '.When from downstream surface 32 ' when looking, lobule 14 ' as if identical with the lobule 14 shown in Fig. 1-12, but from a side sectional view, can obviously find out lobule 14 ' except fulcrum extension 52 ' present position, a homogeneous thickness is arranged.In this respect, as can be seen each flow into surface 30 ' the downstream part be recessed into, and its curvature and flux surface 32 ' relative projection identical.Correspondingly, big circumference surface 36 ' length and profile with aforesaid identical.Similarly, little matching surface 38 ' also with aforesaid identical.

Generally speaking, lobule 14 ' planar section 60 ' basic identical with the counterpart of lobule 14, difference is at the downstream sweep.One of each extension 52 ' all have and the identical groove 53 of aforementioned structure ', the downstream inclined surface 59 of each extension ' the terminal point of opening motion will be foregoing like that and downstream block 27 ' edge D mesh.As a result, the terminal point of will be foregoing opening motion at them like that produces buffering effect on lobule.More specifically say, along with lobule 14 ' approaching position of opening fully, block 27 ' upstream edge D just with inclined surface 59 ' engagement, thereby force the lobule upstream direction to raise slightly and make the surface 56 of edge C and groove ' disengage (mode is described identical with Figure 12), therefore cushioned impact at the terminal point of opening motion.As a result, thus since the thickness of lobule is even and its curvature on most of also evenly be considered to manufacture more or less freely, although cardiac valve 10 ' fairly simple can have all advantages of cardiac valve 10 basically.

Although the application has described the most preferred embodiment of realizing best mode of the present invention in the above, be to be understood that variation and remodeling are conspicuous for knowing those skilled in the art, and do not exceed the scope of the invention that the accessory claim book is limited.For example, although preferably realize buffering, also can promptly locate the edge and the engagement of the inclined surface on the block of downstream of lobule conversely by the engagement between the edge of inclined surface on the lobule and block.Although valve body and lobule are preferably made (having the advantages that not form the thrombosis surface) by RESEARCH OF PYROCARBON or coated with the isotope graphite of RESEARCH OF PYROCARBON, also can adopt other suitable material to obtain aforesaid same advantage.In addition, just as noted earlier, although most preferred embodiment has adopted a pair of lobule, principle of the present invention also can be applicable to known cardiac valve, and known cardiac valve has adopted an independent closer and such downstream block mechanism.

Claims (9)

1, a prosthetic heart valve comprises

One has the annular valve body of being generally of medial wall, and the medial wall defines one and is used for along the central passage that runs through of downstream direction circulation blood,

Have a closure member that flows into a surface and a flux surface, it is installed on the described valve body so that permission blood flows through and stop the backflow of blood along downstream direction,

Described valve body and described closure member have a supporting point mechanism, be installed into and can between open position and the closed position of stop refluxing, rotate by the described closure member of this supporting point mechanism, when described closure member is in the closed position described flux surface in the face of the downstream and

Described valve body has block, it the downstream part of described supporting point mechanism from the described valve body inwall to projecting inward, described downstream block can mesh with the extension on the described closure member flux surface because of its present position before described closure member arrives its position of opening fully, thereby the terminal that has cushioned it is opened motion.

2, cardiac valve according to claim 1, wherein said closure member comprises the lobule that a pair of design is roughly the same, they are installed into can be around the intravital rotation that parallels to the axis of a pair of described valve.

3, cardiac valve according to claim 2, wherein said supporting point mechanism comprise and a pair ofly extend into the projection of described central passage from described valve body sidewall, and comprise that a pair of being used on described closure member hold the groove of described projection,

Each described fulcrum projection is processed have directed at a predetermined angle each other upstream and downstream plane surface, each described troughed belt have each other with flat upstream face of identical oriented at predetermined angles and flat intermediate surface and

Described each plane surface in location like this is promptly when described closure member is shown in an open position, at a pair of plane surface on the described projection and the described plane surface on the described groove and put.

4, cardiac valve according to claim 3, near wherein said extension flux surface from each the described lobule lateral parts of described lobule extends, described groove is formed on the described extension, each extension all has a processing surface that faces the downstream of inclination thereon, and the such positioning instant in this surface arrives at described lobule before the position of opening fully and should the surface to mesh with the upstream edge of described block.

5, cardiac valve according to claim 4, wherein each described lobule all has a planar section, described extension promptly extends from this planar section, described inclined surface and described planar section are into about 100 ° to 120 ° angle, and wherein said block comprises a surface that is approximately perpendicular to the centrage of described central passage, there is a localized like this edge on this surface, promptly before lobule arrives its position of opening fully, along with the rotation of lobule towards open position, the engagement of described edge and described inclined surface makes the lobule of described rotation be forced to raise slightly, and makes the upstream face of described fulcrum projection and the upstream face of described groove break away from engagement.

6, cardiac valve according to claim 5, wherein said downstream block is with respect to as a surface alignment on described the face of upstream block, thereby aim at the planar section of lobule fully, make the planar section of lobule be parallel to the centrage of the passage that passes described valve body.

7, replacement cardiac valve according to claim 1, wherein said closure member comprises the lobule that a pair of design is roughly the same, they are installed into can be around a pair of in the intravital rotation that parallels to the axis of described valve, each lobule all has one to flow into surface and a flux surface, described supporting point mechanism allows described lobule to rotate between the closed position of open position and prevention backflow, described flux surface is in the face of downstream direction when described lobule is in the closed position

Described supporting point mechanism comprises and a pair ofly puts in the projection and a pair of groove that is used to hold described projection on each described lobule of described central passage from described valve body sidewall,

Described valve body has the face that extends into described central passage, and they are usually located at the upstream of described projection, as the upstream block and

Described downstream block, before described lobule arrives its position of opening fully, a surface engaged of the extension on described downstream block and each the described lobule flux surface, and along the described lobule of updrift side jack-up.

8, cardiac valve according to claim 7 wherein is processed with a plane surface on each described projection, each described groove has a plane surface,

Described each plane surface in location like this is promptly when described lobule is shown in an open position, at described plane surface on the described projection and the described plane surface on the described groove and put.

9, cardiac valve according to claim 8 is wherein located described upstream block and described downstream block so that aim at the planar section of described lobule, makes the planar section of lobule be parallel to the centrage of the central passage of passing described valve body.

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