CN1179708A - Bileaflet heart valve - Google Patents
Bileaflet heart valve Download PDFInfo
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- CN1179708A CN1179708A CN 96192954 CN96192954A CN1179708A CN 1179708 A CN1179708 A CN 1179708A CN 96192954 CN96192954 CN 96192954 CN 96192954 A CN96192954 A CN 96192954A CN 1179708 A CN1179708 A CN 1179708A
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Abstract
This invention provides a bileaflet heart valve comprising an annular base (12) and two pivoting leaflets (14). Each leaflet is 'free-floating' without fixed rotational axis, to increase translational movement and redistribute stresses. Each recess (32) fluidly communicates with a groove extending at least partially around the inner surface (30) of the annular base (12), and flow is directed through the recesses (32) at different angles during antegrade circulation, retrograde circulation, and valve closure. A recess entrance angle to each of the recesses preferably being less than about 35 DEG and the pivoting mechanism within the recess (32) including first and second fulcrum edges (164, 166) of each leaflet (14) is shiftingly engaged with side surfaces of the respective recess (32). The leaflets have a beveled bottom surface (74) having two separate planor surfaces which lie at an angle to one another. In preferred embodiments, a central region of each leaflet is spaced apart from the annular base (12) when the leaflet (14) is in a fully closed position to minimize cavitation.
Description
Background of the present invention
The application is the Application No. No.08/412 that files an application March 29 nineteen ninety-five, 696, the Application No. No.08/546 that files an application October 20 nineteen ninety-five, 210 part is extended, the exercise question of this two patent is identical with exercise question recited above, and the application enjoys the priority 35USC § 120 of this patent.
The field of the invention
The present invention relates generally to a kind of two lobules that can make and makes the bilobate hemodynamics heart valve prosthesis of translation and rotation; be particularly related to a kind of mitral low skew prosthetic heart valve (low-excursionprosthetic heart valve) that is suitable for replacing; described displacement comprises protection (preservation) papillary muscles and rope (chordal) structure, and wherein said valve can be positioned in the configuration of dissecting or instead dissecting.
Prior art
Replacing the corrupted cardiac valve with the hemodynamics prosthese is the most general method that is used for treating certain class heart disease and the bad disease of heart body, and these diseases can influence all chambers--promptly, and right chamber (Tricuspid valve) valve and left chamber (Bicuspid valve) valve.Though worked out various tissues and prosthetic heart valve mechanism,, at present among the practitioner, single leaf valve (inclination flat) and bilobate valve are still keeping maximum receptance.These valves comprise one or two pivoting leaflet or occlusion (occluder), and it is inner that they are limited in a bearing ring or stitching (suture) ring, replace described physiology valve and implant.
It is illustrative purposes for example that the operating procedure of being discussed in this article, utilize protection (preseve) papillary muscles each several part and a rope organ (chordalapparatus) is replaced Bicuspid valve; in this operation; preceding lobule is cut into two parts and separate with all circuluses; be ready to described two halfbodies and subsequently they be sutured in the back annulus of mitral valve, and do not touch described papillary muscles and Cable Structure basically.In " 5J.Cardiac Surg. " the 2nd phase 81-85 page or leaf (1990), write by people such as H.Feikes, be entitled as in " Predervation of AllChordae Tendineae and Papillary Muscle During Mitral Valve replacement With aTitling Disc Valve " article and very described a kind of like this operation and its benefit particularly.Ladies and gentlemen author asserts: the mitral valve replacement operation that single leaf of this utilization and bilobate valve carry out is practicable.But, be apparent that comparatively for those skilled persons of (reconstructive) department of cardiac surgery of rebuilding selecting a kind of valve of adequate types and prosthese suitably is orientated is whether this operation of decision obtains long-term successful key factor concerning a given patient.Specifically, because valvular tissue is sutured in the position of back annulus of mitral valve, must be very careful so that can guarantee that in valve is operated normally the lobule periphery can not touch described tissue.This contact can cause that described valve occurs intermittently, partial or malfunction completely, and can make described valvular tissue occur damaging or the displacement phenomenon.
In this article, can be with the type of valve and orientation four kinds main combination think shown in Figure 21-24 like that.Described four kinds of combinations of arranging according to the rising value of risk comprise: single leaf valve M (Figure 21) of orientation before adopt (1); (2) adopt anti-bilobate valve (Figure 22) of dissecting orientation; (3) adopt the bilobate valve (Figure 23) of dissecting orientation; (4) the single leaf valve M (Figure 24) that adopts the back to be orientated.Though, adopt single leaf valve of back orientation to be considered to the bigger structure of a kind of danger usually, and single leaf valve of orientation is considered to dangerous minimum or without any danger before adopting, but, the degree of danger that adopts dissection orientation or anti-bilobate valve of dissecting orientation to be had is the particular type (especially its scope that moves, radial orientation (radial exposure) and lateral position) that depends on selected valve, anatomical features after the operation of all loop configuration, and the requirement of patient's Yu pair some surgical parameters relevant with described valve.
Though single leaf valve of orientation is preferable before adopting in order to make dangerous minimum, but, doctors may still be ready to implant a bilobate valve, to obtain many specific functional benefits relevant with specific bilobed flap membrane structure or that have only specific bilobed flap membrane structure just to have.
People have carried out studying up hill and dale and improving to this bilobate valve.But, still need it is done further improvement.The weakened or the structural failure of all key members are all associated with dynamic mechanically stress and hole in the described valve.Should also be noted in that forward seepage and backward the leakage of seepage all consider in advance usually.But, preferably described leakage is maintained and normal anatomy valve substantially in the corresponding tolerable limit.In addition, the physical size of valve prosthesis is reduced to minimum, especially the longitudinal size with circular base reduces to minimum, can produce bigger displacement phenomenon on the periphery of two lobules, and also can make simultaneously and raise pivot height and become more difficult.And, remain on two lobules in the described circular base and keep pivoting action and required all grooves, crack, corner and barrier also can influence blood circulation, can produce turbulent phenomenon, and can produce the zone that remains in a standstill, each phenomenon all may provide a kind of meeting finally to cause the thrombotic nuclear of thromboembolism.Though the bilobate valve is hemodynamic, and the fixed axis that rotatablely moves of two lobules can be separated with the described second intrinsic axis that rotatablely moves significantly, but it has limited two lobules may reach in two lobule opening and closing processes maximal rate or angular speed.Selection, biocompatibility, intensity at the suitable material of being convenient to make, and weight and especially those comprise weak structure, between the ratio of interior total member vulnerability feasible value, an inherent balance is arranged such as the wire guide that bears big load (wire guide), support and pin.In addition, the structure of many privot mechanisms needs all circular bases having all opposed flat sides, rather than one be circular hole substantially or fully, limits maximum stream flow thus and improves the specified fluid pressure of valve.At last, although be not a functional restriction,, the actual management formality of prosthetic heart valve and the market of competition have brought heavy burden also for designers, thereby for the approval that obtains FDA and doctors are accepted, some traditional characteristics and aesthetic characteristic have been kept.
The U.S. Patent No. 4,276,658 of authorizing Hanson provides a kind of traditional bilobate valvular representative example.This valve has used pair of semicircular shaped pivot " lug ", they are arranged on two opposed edges of each lobule, each lobule is contained in " hourglass shape " slit to control the pivoting action of two lobules--comprise the dihedral that opens and closes between the position scan, away from the banking motion of its restricted pivot axis, and parallel with its normal plane and along the rectilinear motion of described linear flow path by the circular base hole.Hanson ' 658 patents have also described a RESEARCH OF PYROCARBON coating have been coated on a metal or the synthetic substrate, to make all members of described valve.
By comparison, the U.S. Patent No. 3,859,668 of authorizing the U.S. Patent No. 4,240,161 of Huffstutler and authorizing Anderson provides the several typical example of single leaf or " tiltedly flat " valvular feature, structure and operation.
People have done various improvement and have been intended to overcome above-mentioned defective, and each improvement can both obtain success to a certain extent, but all can sacrifice some other advantageous feature inevitably.
Authorize the U.S. Patent No. 3 of Nakib, 903,548 have disclosed a kind of improvement, it has utilized the favorable characteristics that single phyllogen is managed to be used in one and has saved equally in the bilobate valve of stationary pivot axis, but, the described supporting structure that finally obtains can produce a unacceptable little effective hole, and correspondingly produces higher barometric gradient at described valve two ends.
Such as Hanson ' a kind of bilobed flap membrane structure of being disclosed in 658 patents in, two lobules all can pivot 80 every day between described open position and closed position, 000-120,000 time, thus give the standard pulse that per minute 60-80 jumps.The athletic meeting of two lobules by the viscosity aerated fluid such as blood produces noticeable hole-because two lobules apply mechanicals efforts and make mobile fluid towards moving suddenly away from the direction of two little leaf surfaces, can form parital vacuum.These parital vacuums on the two little leaf surfaces or near can produce " bubbles of vacuum ", and when pressure was released, vacuum area had just become the normal pressure zone that can crush all bubbles, thereby can make the lobule surface pitting occur.By when two the lobules stop of instantaneous ground and starting two lobules when described circular base and side edge are touched, can enlarge markedly the probability that described hole occurs, and in the stop process, the movement rate that lobule is had when the lobule stop motion also can enlarge markedly the probability that described hole occurs.Contact between described lobule and the described edge has improved the pressure on the adjacent fluid greatly, and pivots when leaving described edge when lobule, and under the effect of negative pressure that is increased and stronger parital vacuum, expansion effect is enhanced accordingly.Yet, only because the Mechanical Contact between the object of mobile fluid and motion, the standard hole also can make the metal surface pitting occur, thereby inner produces reciprocating and Mechanical Contact fluidic, and then the cavitation bubbles that makes collapse is degraded or sheared material from little leaf surface with the speed accelerated.Though it is that the order of magnitude with nearly molecular size takes place that the hole is played on the surface,, the result is the surperficial impaired of described lobule, this may produce stress fracture (fracture) and divide (fragmentation) phenomenon, thereby can cause the lobule premature depletion.
The U.S. Patent No. 4,078,268 of authorizing Possis has disclosed an almost circular hole by described circular base, and the separator of near-complete between the circular base around two lobule peripheries and the valve circumference.Though this design can solve some hole problem,, its makes seepage forward and leakage of seepage is bigger backward, and all load that will maintain each lobule are added on a pair of pivotal pin that is contained in adjustable bearing split bearing plug (bearing plug) inside.The mutual combination that it is believed that the moment of torsion of increase, the impulsive force that is absorbed, vibration and normal CONTACT WITH FRICTION acts on over-drastic mechanical stress on the relative fragile pivotal pin and bearing spigot.
The U.S. Patent No. 5,080,669 of authorizing Tascon has disclosed a kind of circular base, it can form some grooves, and these grooves intersect with the pivot axis of various angles and two lobules, to center on each intralobular extension that serves as pivot, so just can clean extension, and prevent thrombosis.Yet in the patent of Tascon ' 669, all internal projection that form those grooves that are used for limiting two lobules and obstacle can hinder blood and flow through the circular base hole equably, and have formed and can quicken thrombotic wedge angle and crack.In addition, each extension stops most of by may the flowing of each groove serially, therefore the cleaning action that is realized can be reduced to minimum.
The U.S. Patent No. 4,892,540 of authorizing Vallana has disclosed a pair of protruding formed vertical " chimney " by circular base, they with its in admitted the groove of the lug of each lobule to link to each other.With regard to principle, can pass through between the sidewall of pivot ear and circular base flowing on following current and the backflow direction at blood, to clean groove.Yet the base part that forms the band angle of each wedge shape chorista can remain on each pivot ear and lobule on the position of a rising, the close inlet in this position from chimney to groove, thereby make the flow minimum that flows through chimney.Each pivot ear or can reduce flow velocity in the groove perhaps can make fluid and the groove part that takes place easily to remain in a standstill depart from, and has so just reduced the efficient of cleaning action.Tascon ' 669 patents have been conceived a kind of between a plurality of flow channels that are oriented to different angles, and strengthening " scourings " effect, and Vallana ' 540 patents have only been conceived: along the repeatedly or reciprocal scheme of cleaning of a passage that is used for following current or backflow.At last, patent with regard to Vallana ' 540, be fed into described chimney owing to be formed on the pressure reduction of described inside grooves, it can produce an acceptable cleaning action backward, because circulation has significantly and to reduce forward, so this is to be cost with a remarkable restricted non-circular hole by described circular base.
Though having disclosed, ' 658 patents of Hanson can prevent from the zone that is meshed with all grooves, to take place blood viscous flow phenomenon, but use the echocardiography through esophagus to demonstrate to accepting the metathetical patient of mitral valve: the inner surface along described valve is formed with the fibrin strand that is hanging between all pivot groove and in the zone of all pivot groove of next-door neighbour.When being positioned at described valve inside, these little, very thin abnormal echos are considered to can not cause obstruction; but; their frequent disappearances are pointed out consumingly and are existed a thrombotic origin or beginning, get in touch but people have found that it and thrombosed risk early have significantly.
Several factors all may be the reason that causes the fiber protein yarn bar to form, and they comprise: for thrombosis provides the blood viscous flow of a cradle regional, perhaps directly connect the described valve of all hemocytees in material or structural shortcoming.Therefore, be understood that easily that when design one bilobate cardiac valve, two important goals are to keep best circulation forward and circulation backward, and eliminate the race way of weakening that described valve inside may promote thrombi growth.People propose, though ' 658 patents of Hanson show a kind of relatively more shallow, semi-circular recesses, but, in practice, be impossible obtain one have Zhu Shuer and have a suitable shallow grooves so as to strengthen with normal circulation forward and backward and the feasible commerce of the bileaflet heart valve of the cleaning action that described groove is carried out with embodiment's.For example, commericially feasible embodiment in ' the 658 valve patents of Hanson has all grooves, these grooves are formed on the inlet angle that changes in 35 ° to the 48 ° scopes, described inlet angle is to measure between the tangent abutment surface of the sidewall in described hole and described groove, and depends on the overall dimension on described surface.One 35 ° or less than all grooves at 35 ° angle and described in abutting connection with sidewall, still, its visibly different structure of single leaf valve and working condition but can not successfully be utilized a lot of comparable feature of bilobate valve in single leaf surface, can have been obtained to form.
Be devoted to improve in the process of described privot mechanism, people have also made various modifications.A kind of conception is to eliminate all pivot ears or pivotal pin, and described lobule can be swung on the convex extension part that described circular base extends internally out at all.These structures all need some joggle piece one described convex extension parts between described lobule and all convex extension parts to be contained in a described intralobular recess or inside grooves substantially, and perhaps described lobule forms a flange of capturing that can prevent to export between two convex extension parts that separate each other.For example, the United States Patent (USP) of authorizing Olin N.4,863,459 and the U.S. Patent No. 4,935,030 of authorizing Alonso two lobules have been described, they comprise that one is trapped in relief area or the convex surface between two convex extension parts.Authorize the U.S. Patent No. 4 of Klawitter, 373,216, authorize the United States Patent (USP) NO.4 of Bokros, 692,165, authorize the US Patent No of Hwang: 4,872,875 and the U.S. Patent No. 5,354 of authorizing Hanson, 330 have all described a kind of modification, wherein, described lobule forms a circumferential notch or groove, to hold the convex extension part of described circular base.Though it is more firm that these have used the design of a recess to compare with described flanged structure of capturing in described lobule,, their assembling is but comparatively difficult, and can be with unsuitable stress on two lobules or convex extension part.In addition, these design the hole and the extension that also have Zhu Pingbian and stretch into described hole and the mobile forward convex extension part of obstruction.Because the complexity of these convex extension parts increases, a crack or groove provide the chance of thrombosis nuclear also to increase.Can provide several possible stagnant areas, comparatively the several typical example of complicated pivot structure comprises U.S. Patent No. 5,116,367 of authorizing Hwang and the U.S. Patent No. 5,123,920 of authorizing Bokros.
That one marked feature of above-mentioned bileaflet heart valve is to be shown by two lobules, with respect to the degree of the exposure or the intrusion of described circular base.Displacement can be thought that when valve is opened fully the ultimate range that the end of two lobules protrudes out out from the bottom of circular base, this distance are the solstics on from the k level measurement of described circular base to the periphery of each lobule.But, dissect localized bilobate valve and the localized bilobate valve of anti-dissection when adopting, compare in above-mentioned mitral valve replacement operator step direction, intrusion also has two more complicated mutual relation.
Be understood that easily even be lifted in all the situation in the lobe that the circular base top face is extended at described pivot axis, above-mentioned bilobate valve also has relatively large intrusion.By capturing from circular base or in the situation that the convex extension part kept that structure inwardly protrudes out, described intrusion also can be bigger at those two lobules.Representational example comprises ' 367 patents of authorizing Hwang, authorizes Bokrosd ' 920, authorizes ' 459 patents of Olin and authorizes Alonso ' 030 patent.If the pivot axis of two lobules moves up, the circular base above and below all can be invaded, as authorizing as shown in ' 165 patents of Bokros.Perhaps, can increase the overall height of circular base, rather than raise the pivot axis on all lobes, as authorize the U.S. Patent No. 5,137 of Bkros, shown in 532 like that.But, still have significant penetration phenomenon even increase the height of circular base again.
Authorize the U.S. Patent No. 5,246,453 of Bokros and the U.S. Patent No. 5 of authorizing Bona, 002,567 has disclosed other plants structure, wherein, two lobules are not substantially in a plane, and by being arranged on that all fulcrums on each little infralobar part are supported and pivoting around described fulcrum.Though these designs all can occur in described circular base above and below invading,, to compare with similar bilobate valve, it can reduce the height of described circular base to a certain extent.Although considered a kind of like this design with more responsive to the commutation in flowing forward, it still depends on relative to the moving of the axis that rotatablely moves of two lobule rotary inertias, so can produce different operating characteristic.
A previous factor that influences the valve operating rate of being mentioned is the moving between fixed axis and the corresponding rotary inertia that rotatablely move of lobule.Another factor is the shape of described lobule.About this point, must consider several physical parameters is carried out the selected of optimal parameter.Two lobules must be according to coming from the fluid pressure at the place ahead and rear, moves through a curved channel from the different inceptive directions of described relatively fluid pressure, and in an initial static-initial dynamic environment.Therefore, all valves with good opening feature can close lentamente or resist fully and close, and vice versa.Thereby having a dihedral, arc or the design of two arc can be used to address this problem with two lobules that strengthen reactivity change blood dynamic force at once.Other factor comprise reduce to hinder the turbulent flow or the adverse current of two lobule momentum or increase its look static inertia, reduce described lobule weight or thickness, make described lobule according to forward pressure with pressure is backward swung or " doing the motion that similar cam is controlled ", make the laminar flow maximization of flowing through the lip-deep valve body of whole lobule, and the root of elimination friction, vibration or misalignment, they may influence the mechanical movement of described valve unfriendly.
Other method above-mentioned is the translation that increases described lobule in the described circular base, and described lobule can directly be pivoted around its axis of inertia according to the blood dynamic force more naturally.This method may be than only moving the fixed axis that rotatablely moves to such an extent that more come more favourablely near rotary inertia, because it also helps to reduce friction and other physics hinders so that the valve operate as normal.A defective is need maintain accurate calibration and put the described lobule that can not make all blockages block flow channel, and perhaps packing into to increase the weak structure of the probability of valve depletion.
Authorize the U.S. Patent No. 4,535,484 of Marconi and described a kind of bilobate valve, wherein two lobules are " freely float and put ", can increase translation thus and reduce to be applied to mechanical stress on local pivotal point and other loading end.But, ' 484 patents of authorizing Marconi need the supporting structure of a kind of complexity and fragility to limit two lobules, therefore making or handling in the process of valve, can produce a pair of described valve danger that damage, very big, and increased the probability of the unexpected depletion of valve member, this will cause patient death or cause serious injury, and can use some material such as RESEARCH OF PYROCARBON, and increase the complexity of cost and manufacturing widely.
By comparison, authorize the U.S. Patent No. 4 of Bokros, 689,046 has described a kind of trapezoidal pivot ear with all beveled edge, it has reduced the degree of freedom of translation disputablely, but strengthened " clearing away " effect of described pivot ear, preventing the formation of thrombosis in all grooves, and lateral stress has been distributed on the wideer surf zone.
By analysis, also have comparatively ideally to be, bileaflet heart valve for example disclosed by Hanson ' 658 and Possis ' 268 patents, but the mat lobule is divided into three unequal passages of cross-sectional area with the hole, and corresponding effects should be arranged on hydrodynamics.The observation that the working condition of these valves is done shows: the rate of flow of fluid through these passages is inversely proportional to corresponding cross-sectional area usually.Therefore, in the sort of valve with narrower centre gangway that for example Hanson ' 658 patents are disclosed, blood through the flow velocity of centre gangway greater than its flow velocity through two wing passages.Since at the velocity of blood flow of central authorities greater than both sides, so can be in valve or the downstream cause other eddy current, or in valve, produce pressure differential or venturi effect, this will hinder or destroy the translation or the pivoting action of lobule.The valve of Possis ' 268 patents has a bigger centre gangway and the less passage of both sides cross-sectional area, thereby has the hydrodynamic property opposite with Hanson ' 658 patents.
Though existing bileaflet heart valve prosthese has been realized a lot of common functional targets, about those targets and how to realize that specific result and advantage also have very intensive difference in opinion.Therefore, should be appreciated that these competition factors can influence the design and the optimization of all cardiac valves film greatly, should make other improvement.Cardiac valve provided by the invention has the valvular advantage of the prior art of being better than, and can solve the problem of preexist.
General introduction of the present invention
In brief, bileaflet heart valve prosthese of the present invention comprises that one forms the circular base and a pair of pivoting leaflet in an almost circular hole.Each lobule has a periphery and without any pivot ear or other fixed axis that rotatablely moves substantially uniformly, thus each mechanical stress can be distributed in described periphery one than on the large tracts of land.In all preferred embodiments, two lobules have one can reduce to the running angle between described open position and the closed position minimum inclined end face.The lateral end of each lobule all is contained in all inside grooves, and in all grooves, described all ends all " are freely floated and put ".In all preferred embodiments, each groove is connected with a groove that extends around the circular base inner peripheral surface at least, and in circulation process forward, one pure stream vertically or is obliquely guided by described groove to flow into described groove, and in the process that mobile and valve is closed backward, make described pure stream cross described groove from described all trench flows.The flowing angle that flows through the described pure stream of all grooves changes according to the location of circulating direction and two lobules.The periphery of two lobules presents minimum exposure or invades below described circular base bottom when described valve is opened fully.When two lobules of described valve were all closed, the periphery of each lobule in the central area preferably was kept to minimum with the probability that described circular base separates the hole will occur.In all preferred embodiments, the periphery of each lobule only contacts near the described lobule side zones of next-door neighbour described groove with described circular base.
In all preferred embodiments, the angle that the fluid that cleans described circular base surface flows into all grooves less than 35 ° so that preferable cleaning dynamic characteristic to be provided.It mainly is the dynamic pivot that is configured on the side direction limit of two lobules that described preferable valve also has one, and at this place, two fulcrum edges (fulcrum edge) formed by all indentures in the described periphery.Two lobules are engraved on each fulcrum edge when can be in the opening and closing of described valve circulation variant and pivot.This mechanism can also make two lobules that especially are in full open position make translational motion significantly.It is believed that this mechanism can provide a kind of privot mechanism that more promptly opens and closes described valve than prior art bilobate valve.
A purpose of the present invention is to design a kind of bileaflet heart valve prosthese that is used for replacing Tricuspid valve or mitral valve; a kind of like this bileaflet heart valve prosthese is provided especially; it can provide good service behaviour; and with an operating procedure with its implant patient body in the time; can will reduce to minimum to the danger that patient causes, described operating procedure comprises the protection papillary muscles and is fixed in the Cable Structure of back annulus of mitral valve.
Of the present invention one relevant purpose be to design a kind of can implant be dissect configuration or anti-above-mentioned bilobate valve of dissecting configuration, thereby the intrusion of all peripheries below described circular base bottom surface that can make two lobules and radially exposes as minimum with side direction for extremely low.
Another object of the present invention is to design above-mentioned bilobate valve, thereby make passage that the basic relative velocity that equates is provided by the valve hole between two lobules, alleviate flow resistance, gradient or venturi tube effect thus, otherwise will cause turbulent flow or hinder the translation or the pivoting action of two lobules.
Another purpose of the present invention is to design this bilobate valve, thereby make it can adopt a kind of " freely floating the lobule of putting " structure without any pivot ear or projection, to reduce and to redistribute machinery or contact stress, otherwise will make stress concentration on these pivot axis as traditional bilobate valve.
A further object of the present invention is to design above-mentioned bilobate valve, make it in the zone that lateral end passed, in described circular base, form one and clean groove or groove by two lobules, and to make described cleaning groove be expedite on the vertical direction substantially one in described zone, and, induce or " guiding " fluid vertical and that tilt flows through described zone forward and in the cyclic process backward.
Another object of the present invention is to provide a kind of bilobate valve, thereby at the circular base side direction valve of the described all grooves that maintain two lobules with in abutting connection with the low-angle that forms between the valve less than 35 °, what should believe is, normally forward the circulation and under metacyclic effect, the cleaning action of all grooves will strengthen to some extent.
Another purpose of the present invention is to provide a kind of bilobate valve, thereby make the periphery of each lobule all be contained in an inside grooves, and be positioned at one by the formed bearing of described circular base below, therefore, when from one when the direction of the longitudinal axis of described valve is observed, in the contact area between two lobules and circular base, between described circular base and periphery without any observable gap, but, but be reduced to minimum or be eliminated in the probability that the hole takes place along described lobule periphery core.
A further object of the present invention is to provide a kind of bilobate valve, thereby can improve the height of described pivot axis, and can reduce the height of corresponding lobe, is minimum advantage and also have mobile simultaneously and exposing phenomenon.
A further object of the present invention is to design above-mentioned bilobate valve, thereby the circular base that makes described valve forms all tiltedly curved surfaces, when two lobules move between described open position and closed position, these oblique curved surfaces can touch with all side edge of two lobules, thereby form the smooth and successive curved channel of a cardinal principle, when two lobules pivoted between described open position and closed position, two lobules were to rotate so that stress power is distributed on the extended area and circular base of described lobule along described curved channel.
After being attached to this description and form in claims of the present invention of this description part, pointed out above-mentioned all features, advantage and purpose particularly, and other advantage and novel feature.But, the purpose that obtains in order to understand the present invention, its advantage and the application of the invention better, all accompanying drawings below in conjunction with forming the another part of this description are described several preferred embodiments of the present invention.
Brief description of drawings
In each figure, similar label is represented corresponding components.
Fig. 1 one is in the axonometric chart of complete closed position, bileaflet heart valve of the present invention;
Fig. 2 is a bileaflet heart valve shown in Figure 1 axonometric chart when being in a fully open position;
Fig. 3 is the cutaway view of bileaflet heart valve shown in Figure 1 along Fig. 1 center line 3-3 intercepting;
Fig. 4 is the cutaway view of bileaflet heart valve shown in Figure 1 along Fig. 2 center line 4-4 intercepting;
Fig. 5 is the front view of bileaflet heart valve shown in Figure 1;
Fig. 6 is the side view of bileaflet heart valve shown in Figure 1;
Fig. 7 is the vertical view of bileaflet heart valve shown in Figure 1;
Fig. 8 is along the transverse sectional view of the circular base of Fig. 7 center line 8-8 intercepting, bileaflet heart valve shown in Figure 7;
Fig. 9 be bileaflet heart valve shown in Figure 7 circular base, the side isometric view of part after cut;
Figure 10 is the upward view of the lobule of a prior art, and it has and is used for the valvular semicircle pivot ear of a bilobate;
Figure 11 is first embodiment, the local upward view after cut of a lobule that uses with bileaflet heart valve of the present invention;
Figure 12 is second embodiment, the local upward view after cut of a lobule that uses with bileaflet heart valve of the present invention;
Figure 13 is the upward view of the 3rd embodiment of a lobule that uses with bileaflet heart valve of the present invention;
Figure 14 is the 4th embodiment, the local upward view after cut of a lobule that uses with bileaflet heart valve of the present invention;
Figure 15 is the 5th embodiment, the local upward view after cut of a lobule that uses with bileaflet heart valve of the present invention;
Figure 16 is along the cutaway view of Figure 11 center line 16-16 intercepting, lobule shown in Figure 11;
Figure 17 is the cutaway view of another embodiment of lobule shown in Figure 16;
Figure 18 has a groove of described prior art one semicircle pivot ear and the side view of lobule;
Figure 19 has a groove of described prior art one trapezoidal pivot ear and the side view of lobule;
Figure 20 is the side view of a groove of the present invention and lobule, and wherein said lobule is the translation position that is in fully make progress (or opening);
Figure 21 is a valvular axonometric chart of knowing in described prior art of single leaf of orientation forward;
Figure 22 is the axonometric chart of the bileaflet heart valve of an anti-dissection orientation of knowing in described prior art;
Figure 23 is the axonometric chart of the bileaflet heart valve of a dissection orientation of knowing in described prior art;
Figure 24 is a valvular axonometric chart of knowing in described prior art of single leaf that has backward orientation;
Figure 25 one has the lobule of prior art of a semicircle pivot ear and the sketch map of groove;
Figure 26 one has the lobule of prior art of a trapezoidal pivot ear and the sketch map of groove;
Figure 27 is the sketch map of no lug lobule of the present invention and groove;
Figure 28 is embodiment, the local amplification view after cut of bileaflet heart valve shown in Figure 3;
Figure 29 is the axonometric chart of the bileaflet heart valve of the present invention implanted with a disorientation;
Figure 30 shows the cutaway view of lobule another embodiment in the closed position, bileaflet heart valve shown in Figure 1, described another embodiment has all transverse sides and groove in described circular base, they are limited in the part circular base, are adjacent to the transverse area of described two lobules;
The cutaway view of Figure 31 shows bileaflet heart valve that lobule is shown in an open position, shown in Figure 30;
Figure 32 is the transverse sectional view of the circular base of bileaflet heart valve shown in Figure 30, wherein, has omitted two lobules, and shows wherein transverse sides of described circular base, and is illustrated in one between the definite all grooves of described circular base inwall at interval;
Figure 33 be bileaflet heart valve shown in Figure 1 another embodiment, the side isometric view of part after cut, it show described separator body end face and with all sides perpendicular to all grooves of the line bevel of described longitudinal axis;
The cutaway view of the circular base of similar to Fig. 3, the shown in Figure 33 bileaflet heart valve prosthese of Figure 34 shows the orientation on inclined-plane;
Figure 35 one is positioned at the sketch map of groove in the hole of bileaflet heart valve shown in Figure 1, and it shows the angle between the tangential abutment surface that is formed on described hole sidewall and described groove;
Figure 36 is the upward view of another embodiment of a lobule that uses with bileaflet heart valve of the present invention, and this embodiment is similar to the described embodiment of Figure 13, and comprise one along described cooperation edge, rectangular extension or lip substantially;
Figure 37 is in the described circular base, be used for holding a sketch map of described groove that pivots lobule shown in broken lines between described opening and closing position, the figure shows all oblique curved surfaces, all edges of described lobule pivot between described opening and closing position along described oblique curved surfaces;
Figure 38 is the side view of 38-38 intercepting along the line among Figure 37, and it shows between described sidewall and described hole and described groove floor, and all inclined-planes that extend between described groove floor and described separator body surface;
Figure 39 is the vertical view of another embodiment of a lobule that uses with bileaflet heart valve of the present invention, that this embodiment has is adjacent with the Zhu Ping side, along one opposite to the dihedral path and remove part, in the opposed lateral margin of described lobule, to form two groups of oblique recesses;
Figure 40 is the side view of lobule shown in Figure 39, and wherein said lobule is inverted, the figure shows one group of recess in two groups of recesses that are arranged on the described lobule opposite side;
Figure 41 is the schematic side view of the circular base of bileaflet heart valve of the present invention, and it shows one and compares sidewall that increases to some extent and the lobe height that decreases with circular base shown in Figure 3;
Figure 42 is the axonometric chart of a preferred embodiment of the present invention, and it shows all lobule that is in a fully open position;
Figure 43 is the side view of preferable bileaflet heart valve of the present invention shown in Figure 42;
Figure 44 is the front view of preferable bileaflet heart valve shown in Figure 42;
Figure 45 is the vertical view of preferable bileaflet heart valve shown in Figure 42;
Figure 46 is the upward view of preferable bileaflet heart valve shown in Figure 42;
Figure 47 be preferable bileaflet heart valve shown in Figure 42 circular base, the axonometric chart of part after cut;
Figure 48 is the sectional side view of the circular base of preferable bileaflet heart valve shown in Figure 42;
Figure 49 is the side view cutaway drawing of the circular base of preferable bileaflet heart valve shown in Figure 42;
Figure 50 is the axonometric chart of the bottom surface of preferable lobule shown in Figure 42;
Figure 51 A is the upward view of the lobule of preferable bileaflet heart valve shown in Figure 42;
Figure 51 B is the vertical view of the lobule of preferable bileaflet heart valve shown in Figure 42;
Figure 52 is the first lateral vertical side side view of the described lobule of preferable bileaflet heart valve shown in Figure 42;
Figure 53 is the second lateral vertical side side view of the described lobule of preferable bileaflet heart valve shown in Figure 42;
Figure 54 is the horizontal side view of a upper limb described lobule, that comprise described cooperation edge of preferable bileaflet heart valve shown in Figure 42;
Figure 55 is the horizontal upward view of periphery of the described lobule of preferable bileaflet heart valve shown in Figure 42;
Figure 56 is the cross-sectional schematic of preferable bileaflet heart valve shown in Figure 42, and wherein two lobules are in a position of opening fully;
Figure 57 is the cross-sectional schematic of preferable bileaflet heart valve shown in Figure 42, it show described two lobules from a fully open position to the translation process of closed position fully;
The cutaway view of the described groove of Figure 58 after Figure 48 center line 58-58 intercepting, part are cut;
The cutaway view of the described groove of Figure 59 after Figure 48 center line 59-59 intercepting, part are cut;
Figure 60 is similar to Figure 59, the cutaway view of the described groove of part after cut, but it show when described lobule is in complete closed position shown in Figure 57 as described in the lateral sides of a lobule of groove inwall;
Figure 61 similar to Figure 60 but show described lobule be in as shown in figure 42 fully open position, the cutaway view of part after cut;
Figure 62 is the sketch map of another kind of valve, and this valve has other and plants groove, and has another kind of mutual relation between the diamond shaped surface on two lobules and the two lobule sides;
Figure 63 is the sketch map of another valve, and this surface has other and plants groove, and has another mutual relation between the diamond shaped surface on two lobules and the two lobule sides;
Figure 64 is to be in axonometric chart similar to Figure 42 the complete closed position, preferable bileaflet heart valve of the present invention except two lobules;
Figure 65 be when two lobules are in a complete closed position, shown in Figure 64 preferable bileaflet heart valve, the vertical view of part after cut;
Figure 66 provides a curve, and it is illustrated in the once contraction cyclic process of heart flows through the valvular blood flow of a bilobate, wherein, on the occasion of the mobile forward blood flow of expression, represents mobile backward blood flow in the negative value of " y " axle below; And
Figure 67 is the first lateral vertical side side view of another lobule, thus except described another lobule have all hypotenuses with form again some the surface can match with the edge 134 ' and 138 ' of the groove 132 ' shown in the dotted line among Figure 48, this figure is similar to Figure 52.
The detailed description of preferred embodiment
Bileaflet heart valve prosthese of the present invention is illustrated among Fig. 1-67 of the application, and total being marked by label 10 and 110.Having disclosed a plurality of embodiment, shown in Figure 42-67 is most preferred embodiment wherein.The description of most preferred embodiment is connected on hereinafter after the detailed description to preceding several embodiment.
Now referring to Fig. 1-9, valve 10 comprises an annular base 12 substantially and be contained in a pair of lobule 14 that also can pivot haply in the annular base between the open position shown in the closed position shown in Fig. 1 and 3 and Fig. 2 and 4.
The convex shoulder 22 of annular base 12 separates in the relative transverse side diametric(al) of the diametric(al) of valve 10.The inwall 26 of annular base 12 and the inner surface of convex shoulder 22 30 form a pair of from the hole 16 grooves that extend radially outwardly 32.Each groove 32 is divided into two lobes, and each lobe is corresponding to one in two lobules 14.As visible among Fig. 2,4,8 and 9, the adjacent petals of each groove 32 is separated by centrage 34.Annular base 12 comprises the slider 36 that is arranged between each half groove 32, and this slider forms a general triangular or pyramid top in certain embodiments.
Again referring to Fig. 3,4,8 and 9, annular base 12 also constitutes an interior groove 40, this interior groove 40 stretch out from half and half bottom of groove 32 and with it fluid ground be communicated with and around annular base 12 inwalls 26 circumferencial directions, thereby form around the hole continuous passage that 16 circumferential edges extends.See also Fig. 8 especially, interior groove 40 can be regarded two opposed area of the transverse sides of annular base 12 as, and minimum away from the center 42 place's height between groove 32 or annular base 12 transverse sides.Therefore two transverse sides of annular base 12 meet at right angles with other two transverse sides of annular base, thereby valve 10 and annular base are divided into four equal quadrants.
Expand outwardly along its top margin or surface 44 when groove 32 extends or be inclined upwardly when interior groove 40 crosses inwall 26 to increase the height of groove 40, groove 40 has and slider 36 approximately equalised height like this, and is crossing with adjacent grooves 32 at the top margin 44 of this place's groove 40.Roughly maintenance level during transverse sides that annular base 12 is traversed on the base of groove 40 or surface 46, and cross another annular base 12 transverse sides and roughly maintenance level or slightly be inclined upwardly when crossing from transverse sides when groove 40 with the base of slider 36.The base 46 of groove 40 and slider 36 are on the base 46 of slider 36 inner faces, groove 40 and annular base 12 inwalls 26 keep mutually flushing or intersect at the place, isoplanar.Similarly, groove 40 top margins 44 keep flushing or the isoplanar with convex shoulder 22 inner surfacies 30, intersect with groove 32 at these place's groove 40 top margins 44.
As hereinafter further describing, two opposed ends of a lobule 14 are contained in that lobe of the correspondence of two grooves 32 on each convex shoulder 22 and alignment, and in groove 32 close and open position between can freely pivot.Now referring to Figure 10,13,16 and 17, lobule 14 roughly has straight mating edge 48, stretch out from the opposite end 52,54 of straight mating edge 48 and curved periphery betwixt 50, a plane 56, top and a baseplane 58.From the center 60 equally spaced with each end 52,54 of each lobule 14 mating edge 48, lobule can be divided into angular regions such as three, comprises first lateral part 62, second lateral part 64 and is arranged on core 66 between first and second lateral parts 62,64.First and second lateral parts 62,64 of each lobule 14 constitute and the relative transverse end of surrounding this lobule 14.Each lobule 14 also constitute one parallel with top plane and baseplane 56,58 haply vertically or plane axis 68.
Again referring to Fig. 3,4,8 and 9, can recognize, the surface of top and bottom that constitutes interior groove 40 from the corresponding top margin 44 adjacent and base 46 with inwall to overhanging to converge on radial angle top 70 and near top, angle 70, roughly to meet at right angles therebetween.The top surface of groove 40 and basal surface therefore be oriented to when lobule 14 from the closed position when open position turns over one section arc, the periphery of corresponding lobule 14 can not contact with the basal surface or the base 46 of groove 40.
Accordingly, between lobule 14 lower surfaces and following 46 and peripheral 50, have enough gaps, so that lobule 14 is done translation along its plane axis 68.Therefore, groove 40 basal surfaces preferably bending or camber with the maximum segmental arc of reflection lobule 14 peripheries 50.Similarly, the direction of top surface 44 that can recognize interior groove 40 is for when lobule 14 is pivoted to as shown in Figure 3 complete closed position, along lobule 14 periphery 50 it basically with lobule 14 top surfaces 56 parallel and isoplanars, and therefore on top, angle 70 with between top margin 44 and sidewall 26 junctions, be planar basically.
In order to reduce potential harmful cavitation, the plane, top 56 of lobule 14 and periphery 50 and plane 44, interior groove 40 top are at least in lobule 14 cores 66 or location from a distance.This can realize with multiple mode.
At first, the radius of lobule 14 peripheries 50 can dwindle in lobule 14 cores 66 with diascopy, thereby prevents that lobule 14 contacts with annular base 12 in this part 66, and makes through the isolation of formation or the backflow leakage increase in gap 72.
Second method is that interior groove 40 top surfaces and top margin 44 are bent upwards, and makes top margin 44 arrive the transverse sides of annular base 12 and groove 32, thereby the contact between lobule 14 and the annular base 12 is limited in the lateral part 62,64 of lobule 14.Though contacting between the lateral part 62,64 of lobule 14 and the annular base 12 can produce some holes, but it is contained in the part 62,64 of lobule 14, passes fluidic straight line or angular velocity slow than in the core 66 significantly at these place's lobule 14 peripheries 50.Because the most deleterious cavitation is proportional with the relative velocity of the lobule 14 that passes fluid media, and this pass is not linear around tying up to lobule 14 peripheries 50, the result is by eliminating contacting between lobule 14 peripheries 50 nearly three/part place lobules 14 and the annular base 12, can be reduced to the very most of of cavitation that whole lobule 14 produced.
These two kinds of methods can reduce its speed when lobule 14 is closed.To arrive base portion 12 surperficial 40 the time when lobule 14 periphery 50, and the fluid that 72 pairs in the gap of successively decreasing pushes through gap 72 increases resistance.This resistance to " pushing through stream " reduces lobule 14 speed when closing.
The third method is that contacting of 12 of lobule 14 and annular bases is limited in 36 of groove 32 surfaces and sliders.Though this method can reduce the reciprocating motion and the action by contact of almost whole peripheral 50 all parts except the transverse sides part 62,64 that forms the contact that pivots in groove 32, (making the contact of cavitation minimum and tangential direction can obviously not increase these effects) owing to lobule 14 passes moving more slowly of fluid media (medium), but it also other mechanical stress is accumulated in directly with the pivot axis adjacent area in lobule 14 transverse sides 62,64 and peripheral 50 on.Lobule 14 linear velocities can not be reduced owing to there is not the zone that causes resistance or " pushing through stream ".Therefore, the advantage of redistributing that suppresses pivoting action the produce mechanical stress of lobule 14 on most of periphery 50 must balance each other with the benefit that reduces harmful cavitation along one section periphery 50.
Prevent that the 4th kind of mode that the seated connection between lobule 14 top surfaces 56 and periphery 50 and the annular base 12 touches from should be discontinuous to the lower process (not shown) along the placement of interior groove 40 top surfaces, the plane, top 56 of lobule 14 can closely contact thereon.Yet, can believe this method hole power can be accumulated in surfacewise on 56 on contact point corresponding to lobule 14 peripheries 50 of projection position, and in the lobule 14 that exhales from contact point between lobule 14 and the projection, produce darker fault of construction line.
Can recognize that the isolation or the gap 72 that are formed between lobule 14 peripheries 50 and the annular base 12 will allow some backflow leakage.The flow velocity of this leakage and capacity can reduce in the following manner: (1) is by keeping lobule 14 peripheries very approaching with interior groove 40 basal surfaces, and (2) by being contained in lobule 14 peripheries 50 in the interior groove 40 and being positioned at the seating face below that is made of annular base 12, like this from along just having only little between oblique view annular base 12 sidewalls 26 main lobule 14 peripheries 50 of valve 10 longitudinal axis 28 or unconspicuous isolation or opening.
Foregoing, the pivoting action of lobule 14 is at least in part by the contact inhibition campaign between lobule 14 top surfaces, basal surface 56,58 and groove 32 parts and the slider 36.Particularly, because near the return pressure the mating edge 48 is by contacting in interior groove 40 and 32 junctions of groove between lobule 14 top surfaces 56 and interior groove 40 top margins 44, so move upward by lobule 14, in the fully open position, lobule 14 mating edges 48 are provided with to such an extent that closely face mutually or contact.Move upward along the lobule 14 of annular base 12 transverse sides and also to suppress by interior groove 40 top margins 44, just keep isolating or gap 72 except the core 66 that reduces cavitation.
In fully open position shown in Figure 4, the inclination opposite side 74 of lobule 14 basal surfaces 58 contact sliders 36, near the outerplanar wall 76 of the lobule 14 top surfaces 56 contact grooves 32 the mating edge 48.Like this, the outerplanar wall 76 of slider 36 inclination opposite sides 74 and groove 32 with lobule 14 remain on the slightly acutangulate position of longitudinal axis 28 on, thereby preventing lobule 14 inordinate rotation to a parallel position, this place may be not enough to start valve 10 by the reflux cycle applied pressure and close.
Like this, can recognize that the top section of each convex shoulder 22 can be removed, perhaps can with the zone of groove direct neighbor on reduce, and can not reduce the action of valve 10.In addition, by removing the material of making convex shoulder 22 along convex shoulder 22 inner surfacies 30, convex shoulder 22 top surfaces can be opened to groove 32 fluid ground and be communicated with.Can be discharged to downwards on the horizontal plane that forms by slider 36 peaks or top ridge 80 or a little more than its a bit in the convex shoulder on the inner surface 30 22 top section.This section is represented with horizontal Section line 77 in Figure 28.The plane outer wall 76 of slider 36 top surfaces 38 and groove 32 is direction as shown bevel, inclination or slightly angled relatively also.In Figure 34,37,38 and 41, these surfaces all are bevels.
The translation of lobule 14 is subjected to the inhibition of the contact between the crooked radial surface that each lobule 14 periphery 50 in the confined area in lateral part 62,64 and groove 32 face.
See also Figure 10,13,18-20 and 26-28 especially, have the lobule 14 of a semicircle pivot ear 84 (Figure 10,18 and 25), a trapezoidal pivot ear (Figure 19 and 26) and do not have translation relative angle between the lobule (Figure 13,20 and 27) of pivot ear with illustrating.Can recognize to be arranged between two flat limits 88 and the translation D of the semicircle pivot ear 84 in half slot 32 will be subjected to the restriction of the isolation distance X between pivot ear 84 limits 88 and groove 32 walls that this depends on both radiuses of pivot ear 84 and groove 32.Similarly, the translation D of trapezoidal pivot ear 86 is subjected to pivot ear 86 height and baseline width and groove 32 degree of depth and face width, adds the control of the relative tilt angle of upper groove 32 and pivot ear 86.In fact, the translation D of trapezoidal pivot ear 86 is less than semicircle pivot ear 84, and can be by increasing the pivot ear 84 terminal width of grooves 32 relatively, perhaps reduces the face width of groove 32 relative pivot ear 84 baseline widths and is restricted selectively.The minimum interval X between pivot ear 86 and the groove 32 also will be controlled in the adjusting angle of inclination.
By comparing, the translation D of the lateral sides 62,64 of no pivot ear lobule 14 only is subjected to the restriction of the lobule height on the longest positive secant S, this positive secant can be divided into the confined areas in lobule 14 lateral sides 62,64 of periphery between 50 two are divided into two, these 2 contact grooves 32 over against crooked radial surface.Therefore, the translation D of no pivot ear lobule 14 can increase more much biggerly than the translation of the lobule 14 with semicircle or trapezoidal pivot ear 84,86.So the degree of depth, width and the arc that do not have shift angle that pivot ear lobule 14 allowed and be by the crooked radial surface 82 of groove 32 limit, this radial surface is in the face of near the corresponding lateral sides 62 and corresponding arcual lobule 14 peripheries 50 of lobule 14 peripheries 50.
Since the translation of no pivot ear lobule 14 can be by regulating groove 32 crooked radial surface 82 accurately control in the arc of its top or bottom or flexibility, so can form a groove 32, when lobule 14 is shown in an open position and is provided with equally as far as possible with annular base 12 when high, as shown in figure 20, the profile of lobule 14 peripheries 50 cooperates with the crooked radial surface 82 of groove 32 basically.In the case, the translation degrees of freedom of lobule are subjected to the arcual control of relative lobule 14 peripheral 50 shapes in groove 32 bottoms.When pivoting between open position (its place lobule 14 be on the extreme lower position of relative annular base 12) and closed position, before lobule 14 contact grooves 32 tops, as shown in figure 20, this can make the possible translation maximum of lobule 14.
Can recognize lobule 14 peripheries 50 can between lateral sides 62,64 and the core 66 and within form complex bend, isolation between sidewall 26 or the interior groove 40 or gap 72 can not be subjected to the influence of the curvature of the periphery 50 in the lateral sides 62,64 like this.Similarly, maximum invade or radially expose the influence that can not be subjected to lobule 14 peripheral 50 curvature in the lateral sides 62,64 conversely, just lobule 14 downward translation degree may be subjected in response to except certain intrusion of the height that depends on annular base 12, pivot axis and lobule 14 shapes when valve 10 is shown in an open position.
Now referring to Fig. 4, compare although can recognize with lobule with pivot ear 84,86, the translation of lobule 14 increases, but 90 times only slightly intrusions or not intrusion in annular base 12 bottom surfaces of lobule 14 peripheries 50, even also like this when valve 10 is in a fully open position.
It is zero penetration distance I substantially that Fig. 4 has described what record from annular base 12 bottom surfaces 90 and lobule 14 peripheries 50.Even invade part that I takes place in minimum, shown in Section line among Fig. 4, should be noted that exposure limits radially is from zone of a bit extending of central plane (being made of longitudinal axis 28) that valve 10 convex shoulders 22 are divided into two half distance between the plane in approximate hole 16 or longitudinal axis 28 and sidewall 26.Similarly, this radially exposes because of being constrained between the plane that is approximately annular base 12 or longitudinal axis 28 and the outer surface 20 half-distance or being slightly less than a half-distance.
Now see also Figure 11-15 especially, there is shown several embodiment of no pivot ear lobule 14.For ease of relatively, be arranged on traditional lobule 14 between two plane surfaces 88 with semicircle pivot ear 84, as Hanson ' 658 patents disclosed the sort of, be illustrated among Figure 10.
Figure 11 shows a lobule 14, and wherein two complex bend 92,94, the first bendings 92 of 50 formation of the periphery in the lateral sides 64 have less radius r and are provided with than second bending, the 94 more contiguous mating edges 48 with more more than half R.Two bendings 92,94 converge in a junction 96, and its two bendings 92,94 in place all combine smoothly.Essential difference between this lobule 14 and the traditional lobule 14 with a pivot ear 84 shown in Figure 10 is that first bending 92 is not subjected to the constraint of a plane surface 88 at dual-side.
As shown in figure 16, mating edge 48 is about 40 ° to 60 ° angles from plane 56, top for 69 one-tenth one to baseplane 58 relative lobule 14 plane axis.Now, can recognize that it can be circle, radial or oblique as required that the lobule 14 that extends exposes limit 48,50 between plane surface 56,58 referring to Figure 17.Because when lobule 14 pivots, pivotal area is an inswept plane or sphere, the profile shown in Figure 11 is called linner ball (FS) design.Though can recognize further that also the periphery 50 in core 66 can be crooked fully in second crooked 94 radius, but the height overall of above-mentioned lobule 14 is represented the core by 98 interceptings of flat portion, thereby expression is used to relax the gap in above-mentioned hole or isolates 72.
Figure 12 shows the version of lobule shown in Figure 11, and wherein first bending 92 is by by intersecting with first end points 52 and being connected on first end points 52 with the first crooked 92 tangent line.The size of this lobule 14 lobule basic and shown in Figure 11 14 is measure-alike, except the length of mating edge 48.Because the surface in the pivotal area scans out a taper and spherical part when lobule 14 pivots, this shape is called conisphere (CS) design.
Figure 13 shows the another kind of embodiment that is called ball flat (SF) design, and wherein first crooked 92 and second bending 94 is separated by a planar section 100.
Figure 14 shows the similar embodiment that is called awl flat (CF) design, wherein first flat section 102 first end points 52 from mating edge 48 stretches to and the first crooked 92 tangent point, first bending 92 is ined succession second flat section 104 with minor radius r, and the latter carries out the transition to second bending 94 again.
Figure 15 shows a kind of more complicated embodiment that is called conisphere awl (CSC) design, and it and form class shown in Figure 14 are second flat section 104 and mating edge 48 is not parallel at the centrage that mid point 60 is divided into two seemingly.In this embodiment, mating edge 48 first end points 52 of periphery on 50 from first flat section 102 stretch out, and one first crooked 92 radiuses are r, and it carries out the transition to second bending 94 that radius is R.In addition, first flat section 102 can also be that two different angles straight section (not shown)s expand outwardly with the most close relative next adjacent flat section or that section of the mating edge 58 that tilts compound, thereby adjacent mating edge 48 forms two conical regions.
Again referring to Figure 21-24 and Figure 29, there is shown the bileaflet heart valve of implanting in the heart of patient 101 of the present invention 10, valve 10 is sewn near on annulus of mitral valve 103 positions of the crown valve of anatomy and be arranged on and be fixed to the mamillary muscle and key band 105 tops of back annulus of mitral valve as previously mentioned.Bilobate valve 10 can be implanted on the complete anatomical orientation or complete anti-anatomical orientation shown in Figure 22 and 23, or is regulating between anatomical orientation and the anti-anatomical orientation fully by rotate valve 10 in the well-known mode in present technique field in corresponding suture ring (not shown).This direction can with single leaflet valve M the place ahead shown in Figure 21 and 24 to the rear to quite.
Referring to Figure 30-34 and 37-38, there is shown two alternate embodiment of bileaflet heart valve 10 of the present invention especially.These embodiment hereinbefore in conjunction with the work of preferred embodiment roughly describe, and describe in more detail separately at this, so as to understand these alternate embodiment can with other characteristics and the combination of elements of bileaflet heart valve 10 in the preferred embodiment.
Can recognize that annular base 12 inwalls 26 can manufacture level and smooth and continuous surface, to constitute the isolation between groove 40 opposite sides, and groove 40 top margins 44 are contact lobule 14 in by lateral sides 62,64 only, and lateral sides is by limiting with straight line that corresponding lobule 14 centrages are approximated to 60 ° of angles.
Now especially referring to Figure 33 and 34, the side surface 76 of the top surface 38 of slider 36 and side surface 74, groove 32 and the groove of adjacent recess 32 40 top margins 44 all are bent away from or separately from Fig. 3,4, normal direction shown in 8 and 9 tiltedly goes out, wherein surface 38,74,76,44 and corresponding fillet are all directed in the plane, these planes roughly with from parallel with the annular base 12 RADIAL (not shown) of stretching out on the longitudinal axis 28 vertical and crossing directions.Like this, in bending shown in Figure 33 and 34 or inclination embodiment, these surfaces 38,74,76,44 all with those from vertical with longitudinal axis 28 and to intersect the radial line that the annular base 12 on the directions stretches out in an acute angle, thereby see as shown in figure 34 formation roughly pyramid or trapezium structure when the perspective direction of longitudinal axis 28.
Now, illustrate in greater detail bending or inclined surface 44,76 between 16 medial walls, hole or horizontal sidewall 26 and groove 32 bottoms among the figure referring to Figure 37 and 38, and bending or inclined surface 38,74 between slider 36 horizontal sidewalls 32 and groove 32 bottoms.
Referring to Figure 37, can recognize that two pairs of curved surfaces 44,76 and 38,74 are connected respectively to form level and smooth substantially and successive curved channel 107 on a radius, pivot between the position or the corresponding region of corresponding lobule 14 peripheries 50 will be along its pivot or " rolling " during motion when lobule 14 is opening and closing, thereby stress or frictional force are distributed on the extended surface of lobule 14 peripheries 50 and on the level and smooth substantially and successive curved channel 107.Referring to Figure 38, the oblique angle scope is 20 ° to 40 °, preferable angle " x " is approximately 30 °, this be relatively and the vertical line of hole 16 horizontal sidewalls 26 or groove 32 bottoms record, the oblique angle also produces a junction 109 between hole 16 horizontal sidewalls 26 or slider 36 surfaces and inclined- plane 44,76 and 38,74, and with inclined- plane 44,76 and 38,74 and the normal that intersects of groove 32 bottoms or vertical line " a " from a distance, record this segment distance along the line parallel and be about .008 with longitudinal axis 28 "-.020 ".
Now see also Figure 35 especially, there is shown the groove 32 on hole 16 sidepieces or the cross wall 26, groove 32 cross wall 26 and with groove 32 surfaces near and be connected or the surperficial tangent line " T " of crossing cross wall 26 between become to be equal to or less than 35 ° of angles.Can recognize, intersecting between cross wall 26 and the groove 32 can be radiating, angled or slightly tilt, this can be artificial or owing to make restriction and cause, but this radiation, angle or be tilted in and measure cross wall 26 and can ignore during near the angle between the regional tangent line " T " of cross wall 26 however.This angle will with cross wall 26 in valve 10 holes 16 in approaching groove 32 zones near and parallel forwards identical with the angle between reverse sanguimotor optimal layer flow vector " V " and " T ", and a part of blood from then on optimal layer flow vector " V " turn to through-going recess 32 surfaces.When being provided in the groove 32 of angle intersection between near cross wall 26 and groove 32 surfaces of verified approximate 30 °, the blood flow of purification can reach required effect effectively.Yet, can recognize that angle changing makes measured angular less than 35 °, also be same suitable, under some applicable cases or performance even more effective.
Now, there is shown another embodiment of lobule 14 shown in Figure 13 referring to Figure 36 and 39-40.Lobule 14 elements of Figure 36 conform to SF shown in Figure 13 design basically, just have the flange of an essentially rectangular or limit 118 to be arranged on lobule 14 mating edges 58 shown in Figure 13 and stretch out from it, substitute mating edge 48 thereby form one.
" reversing " embodiment element of lobule 14 shown in Figure 39,40 is basic identical with those designs shown in Figure 11,13 and 36, just also by remove with lobule 14 two planes 56,58 between two bending sections 92,94 on the angled passage be close to and, form two pairs of inclination gap 121,122 by the lobule 14 part sides 92,94 of its encirclement.Can recognize that gap 121,122 is formed on 14 two planes of lobule 56,58 of close lobule 14 1 or dual-side 92,94,100, and can extend by unspecified angle, this angle can reach the angle that is formed by the angled passage that extends fully between lobule 14 planes 56,68.In lobule 14 parts that this angled gap 121,122 are attached to close two bending sections 92,94 of peripheral 50, and make horizontal static can by get involved flat sides 100 and flange or limit 118 be maintained of lobule 14 in annular base 12, the angle that enters the cross wall 26 of annular base 12 and slider 36 formed contact surfaces 74,76 by groove 32 will reduce one roughly and the proportional amount of concrete angle that forms between the angled surface of gap 121,122 and lobule 14 planes 56,58.
Exceed two groups of diagonal angle gap 121,122 on each corresponding lobule 14 each plane 56,58 of contact area between the surface 74,76 of groove 32 of open position with the pivoting action that prevents lobule 14, with " top " on surface 76 and the correspondence position on " end " relative those surfaces 74,76 on surface 74 are outwards moved angularly, as long as lobule 14 can not occupy gap 121,122 and form a narrower groove 32.Because just meaning, the angle increase of surface 74,76 relative longitudinal axis 28 is used to remove annular base 12 part cross walls 26 to form 124 needs of cutting element, the one narrower or less radian of groove 32, so end face 24 height of annular base 12 can correspondingly increase, just shown in Section line among Figure 41, and allow when cutting element 124 turns over contact surface 74, the 76 necessary radians that form groove 32, to exist the gap.Annular base 12 top surfaces 24 highly increase to have increases hole 16 length and conforming effect, and reduces the relative altitude of convex shoulder 22 effectively, can produce aforesaid advantage.Also can reach same result about the contact surface 38,44 that forms lobule 14 closed positions, yet, the roughly open top of annular base 12 and hole 16 all can be slowed down cutting element 75 pivots to form the interference on those surfaces 38,46, and this method can make the possible angle of the gap 121,122 that the contact surface corresponding with open position 74,76 align reduce, because the gap 121,122 of alignment is arranged on lobule opposite planar 56,58.
Bileaflet heart valve prosthese 10,110 the most handy metals as titanium of the present invention are made as the carbon compound of RESEARCH OF PYROCARBON or the similar material carbon of low percentage amounts silicon (or contain), metal alloy or with the suitable matrix of well-known in the art RESEARCH OF PYROCARBON covering.
Now, there is shown the preferred embodiment of bileaflet heart valve prosthese 110 referring to Figure 42-67.The preferred embodiment of bileaflet heart valve 110 of the present invention is illustrated among Figure 42, comprises annular base 112 and first and second lobule 114.First and second lobules 114 are installed in this annular base 112, with Figure 42-46,56 and Figure 57 Section line shown in the fully open position and the complete closed position shown in Figure 64-65, Figure 57 between pivot.Annular base 112 has an end face 124 and an inwall 126, and this inwall forms a circular hole 116, this hole pass roughly with longitudinal axis 128 parallel directions that are parallel to the fluid that is used for by hole 116 or sanguimotor channel parallel on annular base 112.
The end face 124 of annular base 112 is elevated to the opposite side near horizontal side 129.On the inwall 126 near the annular base 112 of relative horizontal side 129, traffic steering projection 130 roughly is placed between a pair of groove 132 in the side in base portion 112 each horizontal side 129.
Now referring to Figure 42-49 and 58-59, groove 132 stretches into each horizontal side 129, thereby the cylindrical bottom 140 of groove 132 is shifted from each the horizontal surface 133 near each horizontal side 129 and each groove 132.In preferred embodiment of the present invention, groove 132 leaves traffic steering projection 130.Because groove 132 leaves traffic steering projection 130, so that it passes is radially columniform, it is " the assistant formula spreads out " when periphery 140 arrives joint with each plane of structure 133.
Especially shown in Figure 59, with just at cylindrical surface 140 " the assistant formula spreads out " with a bit tangent line 181 on groove 132 cylindrical bottom 140 before forming another point with horizontal surperficial 133 junctions and tangent line 184 angled " g ' ", this tangent line intersects with line 181 and with horizontal surperficial 133 tangent.Go into angle " g ' " for what suitably measure groove 132, must consider and the identical line of any tangent many and line 181 on the cylindrical surface 140.This can be infinite many lines.Going into angle " g ' " will be the angle between line 184 and 181, it will be line 184 and can draw any one and line 184 intersects and and cylindrical surface 140 on a bit tangent line between maximum angular.The angle that enters that this angle " g ' " representative enters cylinder shape groove 132.In preferred embodiment, groove is gone into the angle approximately less than 55 °.Preferably, this enters angle " g ' " greatly between 15 ° and 35 °.Outstanding good ground, this groove are gone into angle " g ' " and are approximately 8 ° to 34 °.In better embodiment, groove is gone into angle " g ' " and is approximately 21 ° to 33 °.The groove that can recognize the lobule that keep to pivot Already in the bileaflet heart valve prosthese of prior art for some time.Can believe that lower groove goes into the angle and will be convenient to clean groove,, and make the probability minimum that forms the thrombosis accident so that it is minimum to remain in a standstill near the groove 132.So can believe that the angle that reduces to enter groove 132 will provide preferable cleaning vigor and reduce the thromboembolism that the patient that adopts prosthetic heart valve takes place may.
The blood that flow conversion projection 130 also helps to pass in the circular hole 116 is transformed in the groove 132.Can recognize that projection 130 can be fluid and passes hole 116 and ward off the road.Because projection 130 is positioned at an end of each groove 132, so from Figure 48, can clearly be seen that, when lobule 114 is shown in an open position, flow into a part of blood of circular hole 116 will be around flow be changed projection 130 blaze the trail and enter in the adjacent grooves 132 and along the diapire 138 of cylinder shape groove 132.In the preferred embodiment of this bileaflet heart valve prosthese 110 of the present invention, sidewall 138 can the mode shown in Figure 58 tilt to form sidewall " 138 ".
As shown in Figure 50-55 is concrete, lobule 114 has a plane 142, top and an inclined end face, and this inclined end face has near the oblique portion 144 and near the oblique portion 146 in the center of mating edge 148 of the periphery of periphery 50, and mating edge 148 preferably has the straight flange of plane surface.When each lobule 114 is pivoted to when being parked in complete closed position, the mating edge 148 of each lobule is combined together to hinder blood flow significantly and crosses utmost point confined spaces between each mating surface 148.The horizontal side 151 of each lobule 114 has the cylindrical surface near diamond shaped surface 154.Roughly the gap 153,155 of V-arrangement is positioned near the diamond shaped surface 154.Become a mandarin gap 153 roughly between diamond shaped surface 154 and angled plane 152.Roughly the gap 153 of V-arrangement be by cylinder diamond shaped surface 154 go into plane of flow 160 and the sidewall 156 that becomes a mandarin forms.Roughly the gap 155 of V-arrangement, promptly to go out to flow gap 155 be to be gone out plane of flow 162 and go out to flow sidewall 158 to form by diamond shaped surface 154.Particularly shown in Figure 52 and 53, can have one in those figure tiltedly to go out to flow sidewall " 158 ' " shown in the Section line.The gradient that goes out to flow sidewall " 158 ' " may also extend near on a part of side " 161 ' " around the diamond shaped surface 154, and this side will be the part of central bevel 146 or the part surface 161 that do not tilt.This inclined design becomes with the inclination of sidewall 138 to cooperate to form the oblique sidewall " 138 ' " shown in Figure 48 and 58.Each surface " 158 ' ", the sloping portion of " 161 ' " " 138 ' " will cooperate with remain on lobule 114 in the groove 132 and groove 132 is purified preferably and these zones in the surface be able to preferably " cleaning ".
As discussing in the preamble, can believe that blood flow by the heart valve prosthesis 110 of flowing through cleans each surface, crack and zone similarity and reduces one and remain in a standstill and potential thrombosis possibility occurrence is a particular importance.This design of bileaflet heart valve 110 of the present invention.The all surface of valve 110 of the present invention is cleaned in the heart pumping circulation that valve 110 is implanted every now and then.When valve 110 during in the fully open position, all surface of sidewall 26 all is cleaned and flow conversion projection 130 also is cleaned, because it enters groove 132 and especially open up passage towards the counterpart " 138 ' " of sidewall 138 or its inclination for blood flow.When blood lobule 114 when the direct motion direction flows through hole 116 also is cleaned.In addition, flow conversion projection 130 enters groove 132 cut-through on diamond shaped surface 154 on the lobule 114 horizontal sides for blood, and it can be parked on the cylindrical bottom 140 of groove 132.Also there is roughly the consistent cylindrical radius of cylindrical radius with groove 132 bottom surfaces 140 on diamond shaped column surface 154.It is one angled surperficial 152 that each lobule 114 also has, and when lobule 114 was shown in an open position, it can introduce the sidewall 156 that becomes a mandarin of diamond shaped surface 154 along the mobile a certain amount of blood of direct motion direction.Particularly shown in Figure 64, when lobule 114 is in complete closed position, in some blood backflows of contrary direction course of emergency bilobate valve 110.This backflow is to a certain degree needing, only otherwise jeopardize the active energy efficiency of heart pumping.This backflow occurs in many zones.Referring to Figure 64 and other figure of preferable bileaflet heart valve 110 is shown again, process between backflow blood each lobule 114 mating surface 148 shown in can the arrow 194,195 and 196 in Figure 64.Also clear the way for adverse current blood enters groove 132 in the bottom of flow conversion projection 130, at this place it will upwards arrive to by the cylindrical bottom 140 of groove 132 and the isolation between the top 134 form 136 on.The sidewall 158 that goes out to flow of diamond shaped surface 154 also can be adverse current blood and flows into groove 132 and especially enter seat 136 and clear the way.After this flows through seat 136 and comes among Figure 64 near the backflow arrow 191, between lobule 114 and sidewall 126, reflux.Other retrograde blood flow will be cleaned among flow conversion projection 130 and Figure 64 the passage to upward arrow 192 directions simply.Can recognize almost at least some isolation always between the periphery 150 of lobule 114 and sidewall 126.This can make the blood flow of driving in the wrong direction reflux between near the sidewall 126 the periphery 150 and whole peripheral 150.This backflow is especially obvious near horizontal sidepiece 131.This is certain especially situation, because near 126 protuberances of the side wall surface peripheral 150 centers, thereby hinder retrograde blood to flow.Can recognize that seat 136 can fully narrow down to do not have this zone in preferred embodiment.Below and then the discussion of relevant seat 136 is carried out in another description of lobule 114.
Referring to Figure 56-57 and 60-61, when lobule 114 is shown in an open position, exist between each surface in diamond shaped surface 154 zones and the groove 132 in a certain amount of " gap " especially.This " gap " allows a large amount of translations.Owing to when being shown in an open position, between these surfaces, there is the probability of translation to increase, lobule 114 has the degree of freedom bigger than the translation that may exist in the prior art valve, and the valve of prior art has " cooperation " or " parallel " surface in the opening and closing position.This probability of translation is non-existent when lobule 114 is in the closed position.
The axis 165 of and vertical top surface 142 parallel with each little by 114 " rhombus " surface each periphery on 154 will with 167 one-tenth in axis " k " angle, and it is when lobule 114 is in a fully open position, parallel, vertical with groove 132 tops 134 with each groove 132 each cylindrical bottom 140.When lobule 114 was in complete closed position, these axis 165 and 167 were overlapped, or were parallel to each other and angle " k " will be roughly zero.So in this position, periphery 140 will with diamond shaped surface 154 " cooperation " or " parallel " of each horizontal side 151 of each lobule 114.This angle " k " is in when opening fully with move angle " k ' " at lobule and equates.
Can recognize, when lobule 114 is shown in an open position, allow significant translation.This in Figure 56 as seen, the second axis 167 angled " k " of article one axis 165 of lobule and table 140 at the bottom of the cylinder shape groove wherein.Shown in Figure 61, can be translation significant space is provided.The translation of lobule 114 makes lobule 114 shift to its complete closed position from its fully open position than existing apparatus fasterly when being in a fully open position.This is because initial motion is diamond shaped surface 154 upwards parallel in groove 132 when fluidic drive in the wrong direction to flow begin, 136 cooperate in groove 132 with seat until top side bracket edge 166, lobule 114 has overcome when its " stop " any inertia during in the fully open position.Translation will make lobule pivot to complete closed position subsequently.This pivoting action can take place rapidly, because initial translation will provide some will convert the pivot of closing to lobule 114 or the momentum of circular motion to.
When lobule 114 is in complete closed position, next the initial motion of lobule is exactly pivoting action probably, because cylinder diamond shaped surface 154 and cylinder shape groove bottom surface 140 cooperate very tightly, shown in Figure 60, and translation from one end to the other side is very restricted.However and since lobule only bottom side bracket edge 164 with begin pivot after lower wall 138 cooperates, lobule 114 may slide to lower wall 138 from top edge 134.Yet can recognize that each lobule is that the mechanism that pivot adopted is still the problem that needs are probed into, and can't be entirely understood this moment.But can believe that present privot mechanism can make each valve 110 open and close quickly.When valve 110 is shown in an open position, flow direction drives in the wrong direction from the direct motion break-in, can believe that lobule 114 begins its rectilinear motion with flow direction immediately, in case and during near the sidewall 136 top side bracket edge or pivot 166 contact grooves 132 tops 134 the straight line momentum just be transformed into the angle momentum.Can believe that this can make valve of the present invention close quickly than existing device.Similarly, move to the fully open position, can believe that the angle momentum is transformed into the straight line momentum when lobule 114 motion finishes from complete closed position, the result can than existing device possible speed open quickly.
Can believe that bileaflet heart valve prosthese 110 of the present invention preferably makes the thromboembolism probability reduce, because considered cleaning action in direct motion direction and retrograde direction.And, the power privot mechanism that preferable lobule 114 is cooperated with preferable groove 132 can open and close valve in convincing ground fast, and reduce friction in pivotal area, because adopted " rolling " formula privot mechanism, wherein the pivot activity changes to bottom side bracket edge 164 with focus from top side bracket edge 166.Preferable valve 110 also provides the fully open position and has fully minimized traveling angle " k ' " between the closed position.Can believe that move angle in the preferable valve 110 may be at least reduces 15-20 ° than the traveling angle of multiple existing device.The reduction of traveling angle makes angular velocity, wearing and tearing, hole probability and capacity of returns minimum convincingly, and aggregate efficiency is increased.
The seat 134 that is used for preferable lobule 114 makes lobule 114 just slow down before closing convincingly, because the existence of very big Fluid Volume can or be squeezed on the sidewall 126 of annular base 112 by " squeezing ".Because seat just made lobule 114 slow down before closing, can believe that they have to make presumable hole reduce to minimum effectiveness.Can also believe and utilize discontinuous seat, or a plurality of seats that before entering the seat that from relative groove, stretches out continuously, reduce, near the probability that refluxes the lobule core is increased slightly, this hole, place may be the highest basically, because when this zone when sidewall 126 is closed, it may be subjected to a bigger angular velocity.When lobule 114 was in the closed position, seat 134 also can reduce near leakage or the backflow the annular base 112 horizontal sides 129.When lobule 114 is closed, can also believe that seat 134 can make the antegrade flow of increase clean flow channel or groove 132.When lobule 114 was closed, the fluid in the groove 132 began to be subjected on groove 132 tops away from the horizontal side 131 of annular base 112 " squeezing " or extruding.The width of seat 134 reduces when side 131 extends sidelong from groove 132 at them.Owing in most of zone, the center of the horizontal side 131 of preferable bileaflet heart valve 110, do not have seat 134, can think that roughly the fluid that is subjected to seat 134 " squeezings " or pushes has just discharged by hole 116 after it has cleaned at least a portion seat 134.Though lobule 114 is in the closed position, seat 134 is used to reduce the adverse current leakage or refluxes, and at least a portion retrograde flow passes through around diamond shaped surface 154, so that clean these zones up hill and dale when lobule 114 closed positions.When lobule 114 is in a fully open position, can believe that a certain amount of fluid is at lobule 114 angled surfaces 152 with have between the angle base portion 112 fluids conversions projection 130 and pass through.Thereby groove 132 basal surfaces 138 are cleaned when lobule 114 is shown in an open position up hill and dale.
The bottom surface of groove 132 is curved surface or cylinder is planar, it has been generally acknowledged that it roughly is cylindrical shape.In this article, the face of cylinder or cylindrically mean a kind of surface configuration that forms by the rectilinear translation of curve, or the sort ofly have a surface configuration radius, that be similar to the part of a periphery.The diamond shaped surface 154 of lobule 114 has with the curved surface shaped of groove 132 or cylindrical so bottom surface 140 " coincide " mutually or the cylindrical shape of " cooperation ".Yet, shown in Figure 60, to have only when lobule 114 is in the close position, the bottom surface of diamond shaped surface 154 ability and groove 132 fits like a glove.Shown in Figure 61, when lobule is shown in an open position, sizable translation space is arranged.In addition, preferably, when lobule was on other any position of non-complete make position, the diamond shaped surface 154 and the misalignment of the bottom surface of groove 140 and the lobule that matches with it 114 had so just formed significant gap between the terminal edge of the terminal edge of lozenge 154 and groove 132.Because the probability of translational motion increase when lobule 114 is on other position of non-complete make position, thereby with the description of above prior art being done in mention, have on all positions traditional lobule all parallel or surface that matches and compare, have bigger translation freedoms.
Shown in Figure 56, central inclined-plane 146 on the lobule bottom surface and perimeter ramps 144 roughly lay respectively at by on tangent line 172 and 174 planes of representing especially.Because the angle between the tangent line 172 and 174 is " a ", so perimeter ramps and central inclined-plane roughly are on the plane of intersect each other angled " a ".In preferred embodiment, this angle can be from about 5 ° to 16 °, or about 164 ° to 175 °, be more preferably about 166 ° to 173 °.In most preferred embodiment, angle " a " is about 167 ° to 172 °.In optimum mode of operation, angle " a " is about 169 °.Inclined design on the lobule 114 can make the mobile angle of incidence that be parallel to longitudinal axis 128 of blood on the backflow direction become like this, that is, the angle of incidence of perimeter ramps 144 is greater than the angle of incidence on central relatively inclined-plane relatively.Be more favourable like this, reason has two at least.At first, because angle of incidence is bigger, thus can produce bigger impact to lobule 114 along the mobile blood of backflow direction, thus lobule is pivoted with the speed that the surpasss the expectation position towards complete closure.In addition, compare with the lobule with parallel surfaces, the differential seat angle of tangent line 176 on two inclined-planes and plane 142, top can make all end margins 150 radially closing motion distance before lobule 114 arrives complete make position shorter.
In preferred embodiment, the angle of central inclined-plane 146 relative horizontal planes 170, promptly the angle between tangent line 172 and the plane 170 is angle " a ＇ ".In preferred embodiment, " a ＇ " is about 80 ° to 97 °, is preferably about 82 ° to 94 °, is more preferably about 84 ° to 88 °, and in a most preferred embodiment, " a ＇ " is 86 °.Similarly, the angle between perimeter ramps 144 and the horizontal plane 170 " b ＇ " angle between tangent line 174 and the horizontal plane 170 just.In preferred embodiment, angle " b ＇ " is preferably less than 86 ° less than 87 °.In preferred embodiment, " b ＇ " is about 68 ° to 84 °, is preferably about 70 ° to 80 °, is more preferably about 73 ° to 77 °, preferably about 75 °.Similarly, when lobule was in a fully open position, the plane, top 142 of blade top side and the angle between the horizontal plane 170 " c ＇ " can be represented with the angle between tangent line 176 and the horizontal plane 170.In preferred embodiment, angle " c ' " is preferably about 80 ° to 86 ° greater than about 78 °, be more preferably about 81 ° to 83 °, in most preferred embodiment, " c ＇ " is about 81.5 °.
Particularly shown in dotted portion among Figure 57, when lobule 114 in response to the power that is applied on the perimeter ramps, begin from the fully open position when complete make position pivots, described power can cause the initial translational motion of lobule, thereby lobule 114 is risen in groove 132.When lobule 114 arrives complete make position shown in Figure 57; the zone of close all end margin 150 (this edge roughly close horizontal side 131) of top on the plane 142 can prop up the bearing 136 on the horizontal sidepiece 129 usually, and extends at least partially into contiguous across portion 131.When lobule 114 is in complete make position, the edge 148 that matches roughly mutually against, allow simultaneously some blood to reflux between the edge 148 matching at least.
Preferably, the bileaflet heart valve prosthese 110 of preferred embodiment is without any sharp-pointed edge according to the present invention, and in fact all edges all are polishings, level and smooth or featheredge, when crossing these edges with convenient blood flow, make the shearing force minimum of blood.By planing of all edge or polishing, just can between these surfaces, realize level and smooth transition, so can allow these edges become blunt circle and transition smoothly from a plane to another plane the time.Certainly, also can be with any radial surface polishing.
Shown in Figure 64, the reflux flow of blood on the backflow direction is bigger.As long as adverse current does not reduce the work efficiency of heart, cardiac valve normally is designed at least some adverse currents.What can believe is, with regard to each surface of the prosthetic appliance that cleans the present invention, it is very important that certain adverse current is arranged.Figure 66 represents when valve has the initiative the arteries and veins position, the valvular blood flow volume of a bilobate (Q) of flowing through in a contraction cycle.In contraction cycle, the blood flow volume of going up by valve in downbeam (+) is sizable.When systaltic power from peak, just hump (Qsys) begins to weaken and when following current finishes, blood begins to flow on the backflow direction, lobule 114 remains on the open position.Then, at the curve minimum point place that is in " y " axle below, the blood of backflow is pushed lobule 114 to make position.When lobule 114 closures, can block great majority, but not be the blood that all reflux.Remaining backflow blood is because the leakage around the lobule 114.The leakage that refluxes was discussed in this article, can believe, they have positive effect to each surface of cleaning prosthetic heart valve, that is to say that these " adverse currents " can " clean " prosthetic surface and reduce blood resident, thereby reduce thrombosis.
Especially as Figure 47 and 49 and shown in Figure 65 diagram, in preferred embodiment, top edge 134 be fade-in or the inwall 126 of " cutting " circular base 112 in.Can believe, owing to reduced the probability in hole, so above structure has very positive effect to the maintenance of the globality on the plane, top 142 of corresponding lobule 114.Especially true for about 15 ° zone, centrage 184 both sides of intersecting with a lobule.Travel angle when the position on plane, top 142 when lobule is in a fully open position and lobule are in complete make position between the position (by 179 expressions of the tangent line among Figure 57) on plane 142, top shortens to " k ＇ ", also can reduce the unfavorable phenomenon in generation hole on plane 142, top.Because preferable lobule 114 has the bottom surface of a kind of " double inclined plane " among the present invention, thereby the position of end face 142 opposing sidewalls 126 can reduce to minimum, moving radially distance " k ＇ " thereby reduce plane 142, top when make position moves.In this manner, the angular velocity of the least significant end part of close all end margins 150 on plane 142, top is maximum normally, when lobule 114 reduces during near make position gradually.Because the inclined design of lobule 114 makes distance minimum, thereby also make the probability in hole reduce to minimum.Thus, preferably, when lobule pivots a bigger radial distance, it will continue acquisition speed.Therefore, by the radial distance between open position and the make position being reduced to minimum, can make the radial velocity of lobule 114 also reduce to minimum.In each preferred embodiment, travel angle " k ＇ " can be from about 30 ° to 50 °, is preferably about 33 ° to 52 °, be more preferably about 34 ° to 50 °, be more preferably about 35 ° to 49 ° again, be more preferably about 37 ° to 47 ° again, preferably about 40 ° to 45 °.Because the bearing 136 that each groove 32 from the horizontal side of lobule extends can be slowed down or " buffering " lobule props up the closure of sidewall 126, thereby also can reduce the probability in hole, described cushioning effect must realize in the space that lobule 114 " is extruded " between the adjacent bearing 136 when make position pivots because of the blood between the close with it part that is in all end margins 150 and plane 142, top.In addition, gap 171 makes blood continuous-flow on the backflow direction, and this helps to prevent producing vacuum near on the plane, top 142 of all end margins 150, and this vacuum phenomenon normally produces the root in hole on plane, lobule 114 top." buffering " effect of this partial or " discontinuous " bearing 136 also helps to prevent the stress that the other parts of lobule 114 produce with sidewall 126 or bearing 136 collisions the time.
In Figure 65, show centrage 184 one that overlap with the bottom surface of lobule 114, that extend from central point 182.In each preferred embodiment, the corresponding bearing 136 of extending from each groove 132 can only extend to the radius 185 and 186 with centrage 184 equidistant intervals.Therefore, the radial angle between radius 186,185 and the centrage 184 " i ＇ " and " h ＇ " equate that radial angle " j ＇ " then equals the twice of angle " i ＇ " or " h ' ".In preferred embodiment, radial angle " j ＇ " is from about 5 ° to 55 °, is preferably about 10 ° to 30 °.In the reason that the bearing 136 of extending along whole inwall 126 limit near 131 places, horizontal side some be because: but need make the hole probability that usually occurs in plane, top 142 15 ° of scopes in centrage 184 both sides in two of the pivoting leaflet 114 of bileaflet heart valve reduce to minimum.Should be appreciated that, the zone of tool hole probability is likely the distal-most end of counting from central point 182, because when lobule when make position pivots, on this aspect of lobule 114, can obtain maximum angular rate, and most probable produces the power that can generate the hole bubble on plane 142, top.Therefore, on this specific region, remove bearing 136, thereby the reflux flow by gap 171 is increased, just can reduce to minimum to the probability in hole.
Now see also Figure 62 and 63, the groove 132 of preferable valve 110 can be changed with form as shown in the figure.In the change type lobule " 114 ' " shown in Figure 62, show the groove " 132 ' " that does not have bearing or extension, they are that position from groove shown in Figure 48 132 radially turns over certain amount.Groove shown in Figure 63 " 132 " " turned over the amount of size in the middle of.In each case, preferably diamond shaped surface " 154 ' ", " 154 " " in lobule " 114 ' ", " 114 " " corresponding horizontal sidepiece " 151 ＇ " " 152 " " go up reorientation so that adapt to change type groove " 132 ＇ " " 132 " " the Different Plane at top and bottom sidewall place.In conjunction with Figure 48 and comparing that 56-57 discusses, total mechanism did not change with before.In each case, groove " 132 ' " and " 132 " " this design can be when lobule be shown in an open position; allow groove " 132 ' " and " 132 " " the end some translations are arranged, up to fulcrum edge " 166 ＇ " and " 166 " " and upper side wall " 136 ' " and " 136 " of top side face " contact.Lobule " 114 ＇ " and " 114 " when change type " when being in complete make position; can believe; the translational motion in following current cycle starting point will mainly be subjected to diamond shaped surface " 154 ＇ " and " 154 " " " side direction " mobile restriction, up to bottom side fulcrum edge " 164 ' " with " 164 " " with lower wall " 138 ' " and " 138 " " contact, and " 114 ＇ " and " 114 " " is in fulcrum edge " 164 ' " and " 164 " " on begin to pivot.When lobule gradually when the fully open position pivots, can carry out bigger translational motion as talking about herein.
Though describe the valve 10,110 of preferred embodiment above in detail in conjunction with each accompanying drawing according to the present invention, should be appreciated that, under the prerequisite of the spirit and scope that do not depart from claims, can also make various variations and change.Should be appreciated that; although above set forth the numerous characteristics and the advantage of various embodiments of the present invention; and describe the 26S Proteasome Structure and Function of various embodiments of the present invention in detail; but the content of these announcements only is to play illustration; in essential scope of the present invention, still can make the variation on a lot of details; particularly at the aspects such as layout of shape, size and parts, therefore, protection domain of the presently claimed invention should be limited by claims.
Claims
Modification according to the 19th of treaty
1. one kind is used for controlling a heart of patient inner fluid circulation bileaflet heart valve prosthese, and described bileaflet heart valve prosthese comprises:
One circular base and first and second lobules, described first and second lobules are installed in the circular base, between a complete make position and a fully open position, to make pivoting action, described circular base defines one and passes the hole that described pedestal extends, described circular base has a tool first horizontal lateral first horizontal sidepiece, one tool, the second horizontal lateral second horizontal sidepiece, and a pair of be arranged on separately between the described first and second horizontal sidepieces across portion, described circular base also define one from described aperture to first groove that extends outward into described circular base and be communicated with described hole, one from described aperture to second groove that extends outward into described circular base and be communicated with described hole, described first groove is arranged in the described first horizontal sidepiece, described second groove is arranged in the described second horizontal sidepiece, wherein at least one first sidepiece of first lobule is received within described first groove, and at least one second sidepiece of described first lobule is received within described second groove, thereby described first lobule is remained in the described circular base, wherein circular base also defines from described aperture to third and fourth groove that extends outward into described circular base and be communicated with described hole, described the 3rd groove is arranged in the described first horizontal sidepiece, described the 4th groove is arranged in the described second horizontal sidepiece, wherein at least one the 3rd sidepiece of accessory flocculus is received within described the 3rd groove, and at least one the 4th sidepiece of described accessory flocculus is received within described the 4th groove, thereby described accessory flocculus is remained in the described circular base; It is characterized in that, first of each lobule, second, third and fourth sidepiece all has a plurality of groove fit faces, two in a plurality of groove fit faces have formed one first fulcrum edge, and in a plurality of groove fit faces two have formed second fulcrum edge of removing from described first fulcrum edge, each groove has a upper and lower groove side, when lobule is switched to complete make position or when complete make position is switched to the fully open position from the fully open position, first and second fulcrum edges with its in be combined with each respective side portion groove go up or the low groove side cooperates, thereby the cooperation between the respective side of one of fulcrum edge and each groove is variable, promptly, when lobule when a position is pivoted to another position, by changing into cooperating of a side and second fulcrum edge cooperating between a side and first fulcrum edge.
2. bileaflet heart valve prosthese as claimed in claim 1 is characterized in that, each lobule all has one first and second sidepiece, first sidepiece is a top side portion, second sidepiece is a bottom side, and when lobule was shown in an open position, the bottom side of each lobule was roughly faced mutually; Each bottom side has the lower surface that a upper surface and that roughly is positioned at first plane roughly is positioned at second plane, and described first plane and described second plane have a certain degree.
3. bileaflet heart valve prosthese as claimed in claim 1 is characterized in that each groove all has a groove floor, and at least a portion of each groove floor is the face of cylinder.
4. bileaflet heart valve prosthese as claimed in claim 1, it is characterized in that, each sidepiece of lobule all have one along be received in corresponding recesses in the mutually close lobule of sidepiece week end margin cylindrical side, when lobule is in the close position, described cylindrical side and admitted the cylinder bottom surface of the groove of corresponding sidepiece to coincide in it.
5. bileaflet heart valve prosthese as claimed in claim 3, it is characterized in that, described first lobule has all end margins, and each sidepiece that is received in described first lobule in described first and second grooves has one along the face of cylinder near all end margins that are received in interior each sidepiece of described first and second grooves.
6. bileaflet heart valve prosthese as claimed in claim 5, it is characterized in that, described first lobule has a pair of complementary breach in all end margins near first each sidepiece of lobule that is received within first and second grooves, this is to complementary breach synergism, described lobule can be pivoted in corresponding recesses, when first lobule is in the close position, the face of cylinder of each all end margin and admitted the cylinder bottom surface of each corresponding recesses of each sidepiece to coincide in it.
7. one kind is used for controlling a heart of patient inner fluid circulation bileaflet heart valve prosthese, and described heart valve prosthesis comprises:
One circular base and first and second lobules, described first and second lobules are installed separately in circular base, between a make position and an open position, to make pivoting action, described circular base defines one and passes the hole that described pedestal extends, described pedestal has one and is roughly parallel to the flow through longitudinal axis of loop direction in this hole of described hole and fluid, described circular base has a tool first horizontal lateral first horizontal sidepiece, one tool, the second horizontal lateral second horizontal sidepiece, and a pair of be arranged on separately between the described first and second horizontal sidepieces across portion, described circular base also define one from described aperture to first groove that extends outward into described circular base and be communicated with described hole, one from described aperture to second groove that extends outward into described circular base and be communicated with described hole, described first groove is arranged in the described first horizontal sidepiece, described second groove is arranged in the described second horizontal sidepiece, described first groove has one first groove floor, intersect the first horizontal side of first groove floor and pedestal, thereby first groove floor and the first horizontal side formed one first joint, the angle of incidence of first groove be with near tangent one first straight line in the first horizontal side of first joint and be in one first plane, and first straight line intersects and makes peace greatly near that of maximum in a plurality of angles between any in tangent unlimited many second straight lines of any part of first groove floor of described first joint, described first plane is perpendicular to the first horizontal side, described second groove has second groove floor that intersect the one and second horizontal side, thereby second groove floor and the second horizontal side formed one second joint, the second groove angle of incidence be roughly with near tangent one the 3rd straight line in the second horizontal side of second joint and be in one second plane, and described the 3rd straight line intersects and makes peace greatly near that of maximum in the angle between any in tangent unlimited many 4th straight lines of any part of second groove floor of second joint, and second plane is perpendicular to the second horizontal side; Wherein, at least one first sidepiece of described first lobule is received within described first groove, and at least one second sidepiece of described first lobule is received within described second groove, so that described first lobule is remained in the described circular base; It is characterized in that the angle of incidence of first and second grooves is all less than about 35 °.
8. bileaflet heart valve prosthese as claimed in claim 7 is characterized in that, the described first and second groove angle of incidence are about 20 ° to 34 °.
9. bileaflet heart valve prosthese as claimed in claim 7 is characterized in that at least a portion of described first and second groove floor is the face of cylinder.
10. bileaflet heart valve prosthese as claimed in claim 7, it is characterized in that, described circular base also define one from described aperture to third and fourth groove that extends outward into described circular base and be communicated with described hole, described the 3rd groove is arranged in the first horizontal sidepiece, described the 4th groove is arranged in the described second horizontal sidepiece, the 3rd groove has the 3rd groove floor that intersect the one and first horizontal side, thereby the 3rd groove floor and the first horizontal side formed one the 3rd joint, the 3rd groove angle of incidence be roughly with near tangent one the 5th straight line in the first horizontal side of the 3rd joint and be in one the 3rd plane, and the 5th straight line intersects and makes peace greatly near that of maximum in a plurality of angles between any in tangent unlimited many 6th straight lines of any part of described the 3rd groove floor of the 3rd joint, described the 3rd plane is perpendicular to the second horizontal side, described the 4th groove has the 4th groove floor that intersect the one and second horizontal side, thereby crossing one the 4th joint that formed of the 4th groove floor and the second horizontal side, the 4th groove angle of incidence be roughly with near tangent one the 7th straight line in the second horizontal side of the 4th joint and be in Siping City's face, and the 7th straight line intersects and makes peace greatly near that of maximum in the angle between any in tangent unlimited many 8th straight lines of any part of the 4th groove floor of the 4th joint, and described Siping City face is perpendicular to the 4th horizontal side; The third and fourth groove angle of incidence is all less than about 35 °, wherein, at least one the 3rd sidepiece of described accessory flocculus is received within described the 3rd groove, at least one the 4th sidepiece of described accessory flocculus is received within described the 4th groove, thereby described accessory flocculus is remained in the described circular base.
11. bileaflet heart valve prosthese as claimed in claim 9, it is characterized in that, described first lobule has all end margins, and each sidepiece that is received in described first lobule in described first and second grooves has one along the face of cylinder near all end margins that are received in interior each sidepiece of described first and second grooves.
12. bileaflet heart valve prosthese as claimed in claim 11, it is characterized in that, described first lobule has a pair of complementary breach in all end margins near first each sidepiece of lobule that is received within first and second grooves, this is to complementary breach synergism, described lobule can be pivoted in corresponding recesses, when first lobule is in the close position, the face of cylinder of each all end margin and admitted the cylinder bottom surface of each corresponding recesses of each sidepiece to coincide in it.
13. bileaflet heart valve as claimed in claim 7, it is characterized in that, first lobule has one first and second sidepiece, first sidepiece is a top side portion, second sidepiece is a bottom side, bottom side has the lower surface that a upper surface and that roughly is positioned at one first plane roughly is positioned at one second plane, and described first plane and second plane are mutually at angle.
14. one kind is used for controlling a heart of patient inner fluid circulation bileaflet heart valve prosthese, described bileaflet heart valve prosthese comprises:
One circular base and first and second lobules, described first and second lobules are installed separately in circular base, between a make position and an open position, to make pivoting action, described circular base defines one and passes the hole that described pedestal extends, described circular base has a tool first horizontal lateral first horizontal sidepiece, one tool, the second horizontal lateral second horizontal sidepiece, and a pair of be arranged on separately between the described first and second horizontal sidepieces across portion, described circular base also define one from described aperture to first groove that extends outward into described circular base and be communicated with described hole, one from described aperture to second groove that extends outward into described circular base and be communicated with described hole, described first groove is arranged in the described first horizontal sidepiece, described second groove is arranged in the described second horizontal sidepiece, wherein at least a portion of first lobule is received within described first groove, and at least a portion of described first lobule is received within described second groove, thereby described first lobule is remained in the described circular base, wherein circular base also defines from described aperture to third and fourth groove that extends outward into described circular base and be communicated with described hole, described the 3rd groove is arranged in the described first horizontal sidepiece, described the 4th groove is arranged in the described second horizontal sidepiece, wherein at least a portion of accessory flocculus is received within described the 3rd groove, and at least a portion of described accessory flocculus is received within described the 4th groove, thereby described accessory flocculus is remained in the described circular base; Wherein, each lobule all has all end margins of a upper surface and a bending, and each groove all has a bottom surface and a upper lateral part and a following side, described upper lateral part and following side define respectively the bottom surface on, lower limb, described upper lateral part from extend near the groove of corresponding horizontal sidepiece one adjacent across in the portion a bit, the top edge of each groove has formed a bearing near the upper surface of its crooked all end margin that can prop up the lobule that is received in the corresponding recesses when a lobule is in the close position, it is characterized in that, each top edge has all formed a bearing, this bearing is roughly extended to another from a groove, and fades away and form a smooth surface that flushes with each horizontal side.
15. bileaflet heart valve prosthese as claimed in claim 14, it is characterized in that, each upper lateral part all has an end points, described being seated against disappears on this end points in the corresponding horizontal side, no longer become allow near the upper surface of all end margins against bearing, wherein, described circular base has an inwall that comprises each horizontal side and cross-span, and described circular base has around the radial distance of 360 ° of described inwall extensions, the upper lateral part that extends from described first groove is first upper lateral part, the upper lateral part that extends from described second groove is second upper lateral part, and the radial distance between the corresponding endpoint of the described first and second upside faces is about 5 ° to 55 °.
16. one kind is used for controlling a heart of patient inner fluid circulation bileaflet heart valve prosthese, described heart valve prosthesis comprises:
One circular base and first and second lobules, described first and second lobules are installed separately in circular base, between a make position and an open position, to make pivoting action, described circular base defines one and passes the hole that described pedestal extends, described pedestal has one and is roughly parallel to the flow through longitudinal axis of loop direction in this hole of described hole and fluid, described circular base has a tool first horizontal lateral first horizontal sidepiece, one tool, the second horizontal lateral second horizontal sidepiece, and a pair of be arranged on separately between the described first and second horizontal sidepieces across portion, described circular base also define one from described aperture to first groove that extends outward into described circular base and be communicated with described hole, one from described aperture to second groove that extends outward into described circular base and be communicated with described hole, described first groove is arranged in the described first horizontal sidepiece, described second groove is arranged in the described second horizontal sidepiece, first groove has one first groove floor, intersect the first horizontal side of first groove floor and pedestal, thereby first groove floor and the first horizontal side formed one first joint, second groove has one second groove floor, intersect the second horizontal side of second groove floor and pedestal, thereby second groove floor and the second horizontal side have formed one second joint; At least one first sidepiece of described first lobule is received within first groove, and at least one second sidepiece of described first lobule is received within second groove, thereby first lobule is remained in the described circular base; It is characterized in that at least a portion of described first and second groove floor is the face of cylinder.
17. bileaflet heart valve prosthese as claimed in claim 16, it is characterized in that, each horizontal sidepiece all has a shunting projection of extending to the center in hole from each horizontal side, each shunting projection has all been served as the fluidic barrier by the circulation of described hole, thereby can introduce two adjacent grooves to fluid by corresponding shunting projection, a major part of described shunting projection each groove on each horizontal sidepiece separately.
18. bileaflet heart valve prosthese as claimed in claim 16, it is characterized in that, the first groove angle of incidence be with near tangent one first straight line in the first horizontal side of first joint and be in one first plane, and first straight line intersects and makes peace greatly near that of maximum in a plurality of angles between any in tangent unlimited many second straight lines of any part of first groove floor of described first joint, described first plane is perpendicular to the first horizontal side, the second groove angle of incidence be roughly with near tangent one the 3rd straight line in the second horizontal side of second joint and be in one second plane, and described the 3rd straight line intersects and makes peace greatly near that of maximum in the angle between any in tangent unlimited many 4th straight lines of any part of second groove floor of second joint, and second plane is perpendicular to the second horizontal side; Wherein, the angle of incidence of first and second grooves is all less than about 35 °.
19. one kind is used for controlling a heart of patient inner fluid circulation bileaflet heart valve prosthese, described heart valve prosthesis comprises:
One circular base and first and second lobules, described first and second lobules are installed separately in circular base, between a complete make position and a fully open position, to make pivoting action, described circular base defines one and passes the hole that described pedestal extends, described circular base has a tool first horizontal lateral first horizontal sidepiece, one tool, the second horizontal lateral second horizontal sidepiece, and a pair of be arranged on separately between the described first and second horizontal sidepieces across portion, described circular base also define one from described aperture to first groove that extends outward into described circular base and be communicated with described hole, one from described aperture to second groove that extends outward into described circular base and be communicated with described hole, described first groove is arranged in the described first horizontal sidepiece, described second groove is arranged in the described second horizontal sidepiece, wherein, at least one first sidepiece of described first lobule is received within first groove, and at least one second sidepiece of described first lobule is received within second groove, thereby first lobule is remained in the described circular base, described circular base also defines from described aperture to third and fourth groove that extends outward into described circular base and be communicated with described hole, described the 3rd groove is arranged in the described first horizontal sidepiece, described the 4th groove is arranged in the described second horizontal sidepiece, wherein, at least one the 3rd sidepiece of described accessory flocculus is received within the 3rd groove, and at least one the 4th sidepiece of described accessory flocculus is received within second groove, thereby accessory flocculus is remained in the described circular base; Each lobule all has first and second sides, and described first side is a top side portion, and described second side is a bottom side, and when lobule was shown in an open position, the bottom side of each lobule was roughly faced mutually; It is characterized in that each bottom side has the lower surface that a upper surface and that roughly is positioned at first plane roughly is positioned at second plane, described first plane and described second plane have a certain degree.
20. bileaflet heart valve prosthese as claimed in claim 19, it is characterized in that, when each lobule is in a fully open position, described first and second planes are respectively first angle and second angle with respect to an angle that horizontal plane became through the circular base cross section, first angle is about 84 ° to 88 °, and second angle is about 68 ° to 84 °.
21. the described bileaflet heart valve prosthese of claim 19 is characterized in that, the angle between described first and second planes is about 164 ° to 175 °.
22. bileaflet heart valve prosthese as claimed in claim 19, it is characterized in that, described top side portion has the end face that roughly is positioned at the respective top plane, when lobule from the fully open position during to the change of complete make position, each plane, top all varies to a second position from a primary importance, the angle of travel of this motion is when lobule is in first and second positions, the angle between the respective top plane, and the angle of travel of first and second lobules all is about 35 ° to 49 °.
23. bileaflet heart valve prosthese as claimed in claim 22, it is characterized in that, one with the vertical horizontal plane of horizontal sidepiece of described circular base be a level cross-sectionn through described pedestal, each relative horizontal plane angulation in plane, top is greater than the second plane angulation on its described relatively lower surface.
24. bileaflet heart valve prosthese as claimed in claim 19, it is characterized in that, one with the vertical horizontal plane of horizontal sidepiece of described circular base be a level cross-sectionn through described pedestal, when each lobule is in a fully open position, the described relatively horizontal plane in described second plane at angle, this angle is about 68 ° to 84 °.
Claims (20)
1. one kind is used for controlling a heart of patient inner fluid circulation bileaflet heart valve prosthese, and described bileaflet heart valve prosthese comprises:
One circular base and first and second lobules, described first and second lobules are installed separately in circular base, between a make position and an open position, to make pivoting action, described circular base defines one and passes the hole that described pedestal extends, described pedestal has one and is roughly parallel to the flow through longitudinal axis of loop direction in this hole of described hole and fluid, described circular base has a tool first horizontal lateral first horizontal sidepiece, one tool, the second horizontal lateral second horizontal sidepiece, and a pair of be arranged on separately between the described first and second horizontal sidepieces across portion, described circular base also define one from described aperture to first groove that extends outward into described circular base and be communicated with described hole, one from described aperture to second groove that extends outward into described circular base and be communicated with described hole, described first groove is arranged in the described first horizontal sidepiece, described second groove is arranged in the described second horizontal sidepiece, intersect the first horizontal side of first groove floor and pedestal, thereby first groove floor and the first horizontal side formed one first joint, the angle of incidence of first groove be roughly and near tangent one first straight line in the first horizontal side of first joint and and first straight line intersect and make peace greatly near that of maximum in a plurality of angles between any in tangent unlimited many second straight lines of any part of first groove floor of first joint, described second groove has second groove floor that intersect the one and second horizontal side, thereby second groove floor and the second horizontal side formed one second joint, the second groove angle of incidence be roughly and near tangent one the 3rd straight line in the second horizontal side of second joint and and the 3rd straight line intersect and make peace greatly near that of maximum in the angle between any in tangent unlimited many 4th straight lines of any part of second groove floor of second joint; Wherein, at least a portion of described first lobule is received within described second groove, so that described first lobule is remained in the described circular base; It is characterized in that the angle of incidence of first and second grooves is all less than about 35 °.
2. bileaflet heart valve prosthese as claimed in claim 1 is characterized in that, the described first and second groove angle of incidence are about 18 ° to 34 °.
3. bileaflet heart valve prosthese as claimed in claim 1 is characterized in that, described first and second groove floor are faces of cylinder.
4. bileaflet heart valve prosthese as claimed in claim 1, it is characterized in that, described circular base also define one from described aperture to third and fourth groove that extends outward into described circular base and be communicated with described hole, described the 3rd groove is arranged in the first horizontal sidepiece, described the 4th groove is arranged in the described second horizontal sidepiece, the 3rd groove has the 3rd groove floor that intersect the one and first horizontal side, thereby the 3rd groove floor and the first horizontal side formed one the 3rd joint, the 3rd groove angle of incidence be roughly and near tangent one the 5th straight line in the first horizontal side of the 3rd joint and and the 5th straight line intersect and make peace greatly near that of maximum in a plurality of angles between any in tangent unlimited many 6th straight lines of any part of described the 3rd groove floor of the 3rd joint, described the 4th groove has the 4th groove floor that intersect the one and second horizontal side, thereby the 4th groove floor and the second horizontal side formed one the 4th joint, the 4th groove angle of incidence be roughly and near tangent one the 7th straight line in the second horizontal side of the 4th joint and and the 7th straight line intersect and make peace greatly near that of maximum in the angle between any in tangent unlimited many 8th straight lines of any part of the 4th groove floor of the 4th joint, the third and fourth groove angle of incidence is all less than about 35 °, wherein, at least one the 3rd sidepiece of described accessory flocculus is received within described the 3rd groove, at least one the 4th sidepiece of described accessory flocculus is received within described the 4th groove, thereby described accessory flocculus is remained in the described circular base.
5. bileaflet heart valve prosthese as claimed in claim 3, it is characterized in that, described first lobule has all end margins, and each sidepiece that is received in described first lobule in described first and second grooves has one along the face of cylinder near all end margins that are received in the interior respective side portion of described each groove.
6. bileaflet heart valve prosthese as claimed in claim 5, it is characterized in that, described first lobule has a pair of complementary breach in all end margins near first each sidepiece of lobule that is received within first and second grooves, this can pivot described lobule to complementary breach synergism in corresponding recesses.
7. bileaflet heart valve prosthese as claimed in claim 1, it is characterized in that, described first lobule has first and second sides, described first side is a top side portion, and described second side is a bottom side, bottom side has the lower surface that a upper surface and that roughly is positioned at first plane roughly is positioned at second plane, and described first plane and described second plane have a certain degree.
8. one kind is used for controlling a heart of patient inner fluid circulation bileaflet heart valve prosthese, and described heart valve prosthesis comprises:
One circular base and first and second lobules, described first and second lobules are installed separately in circular base, between a make position and an open position, to make pivoting action, described circular base defines one and passes the hole that described pedestal extends, described circular base has a tool first horizontal lateral first horizontal sidepiece, one tool, the second horizontal lateral second horizontal sidepiece, and a pair of be arranged on separately between the described first and second horizontal sidepieces across portion, described circular base also define one from described aperture to first groove that extends outward into described circular base and be communicated with described hole, one from described aperture to second groove that extends outward into described circular base and be communicated with described hole, described first groove is arranged in the described first horizontal sidepiece, described second groove is arranged in the described second horizontal sidepiece, wherein at least a portion of first lobule is received within described first groove, and at least a portion of described first lobule is received within described second groove, thereby described first lobule is remained in the described circular base, wherein circular base also defines from described aperture to third and fourth groove that extends outward into described circular base and be communicated with described hole, described the 3rd groove is arranged in the described first horizontal sidepiece, described second groove is arranged in the described second horizontal sidepiece, wherein at least a portion of accessory flocculus is received within described the 3rd groove, and at least a portion of described accessory flocculus is received within described the 4th groove, thereby described accessory flocculus is remained in the described circular base; Wherein, each lobule all has all end margins of a upper surface and a bending, and each groove all has a upper side and a downside, described upper side from extend near the groove of corresponding horizontal sidepiece adjacent across in the portion a bit, the top edge of each groove has formed a bearing near the upper surface of its crooked all end margin that can prop up the lobule that is received in the corresponding recesses when a lobule is in the close position, it is characterized in that, each top edge has all formed a bearing, this bearing is extended to another from a groove, and fades away and form a smooth surface that flushes with each horizontal side.
9. bileaflet heart valve prosthese as claimed in claim 8, it is characterized in that, each upper side all has an end points, described being seated against disappears on this end points in the corresponding horizontal side, no longer become allow near the upper surface of all end margins against bearing, wherein, described circular base has one and comprises horizontal lateral inwall, and described circular base has around the radial distance of 360 ° of described inwall extensions, the upper side that extends from described first groove is first upper side, the upper side that extends from described second groove is second upper side, and the radial distance between the corresponding endpoint of described first and second upper sides is about 5 ° to 55 °.
10. one kind is used for forward and reverse control one heart of patient inner fluid circulation bileaflet heart valve prosthese, and described heart valve prosthesis comprises:
One circular base and first and second lobules, described first and second lobules are installed separately in circular base, between a make position and an open position, to make pivoting action, described circular base defines one and passes the hole that described pedestal extends, described circular base has a tool first horizontal lateral first horizontal sidepiece, one tool, the second horizontal lateral second horizontal sidepiece, and a pair of be arranged on separately between the described first and second horizontal sidepieces across portion, described circular base also define one from described aperture to first groove that extends outward into described circular base and be communicated with described hole, one from described aperture to second groove that extends outward into described circular base and be communicated with described hole, described first groove is arranged in the described first horizontal sidepiece, described second groove is arranged in the described second horizontal sidepiece, wherein at least one first sidepiece of first lobule is received within described first groove, and at least one second sidepiece of described first lobule is received within described second groove, thereby described first lobule is remained in the described circular base, wherein circular base also defines from described aperture to third and fourth groove that extends outward into described circular base and be communicated with described hole, described the 3rd groove is arranged in the described first horizontal sidepiece, described second groove is arranged in the described second horizontal sidepiece, wherein at least one the 3rd sidepiece of accessory flocculus is received within described the 3rd groove, and at least one the 4th sidepiece of described accessory flocculus is received within described the 4th groove, thereby described accessory flocculus is remained in the described circular base; It is characterized in that, each horizontal sidepiece all has a shunting projection of extending to the center in hole from each horizontal side, each shunting projection has all been served as the fluidic barrier by the circulation of described hole, thereby can introduce two adjacent grooves to fluid by corresponding shunting projection.
11. bileaflet heart valve prosthese as claimed in claim 10 is characterized in that, a major part of described shunting projection each groove on each horizontal sidepiece separately, each groove all has a groove surfaces that is the face of cylinder.
12. bileaflet heart valve prosthese as claimed in claim 10, it is characterized in that, described first and second lobules all have match edge and all end margins, described all end margins have a plane near match edge and all end margins intersection, wherein, when lobule was in a fully open position, described plane can be incorporated into the part of circulation of fluid in the corresponding recesses of the neighbouring part of having admitted lobule, but thereby mat these turn to fluid to wash each groove.
13. one kind is used for controlling a heart of patient inner fluid circulation bileaflet heart valve prosthese, described heart valve prosthesis comprises:
One circular base and first and second lobules, described first and second lobules are installed separately in circular base, between a complete make position and a fully open position, to make pivoting action, described circular base defines one and passes the hole that described pedestal extends, described circular base has a tool first horizontal lateral first horizontal sidepiece, one tool, the second horizontal lateral second horizontal sidepiece, and a pair of be arranged on separately between the described first and second horizontal sidepieces across portion, described circular base also define one from described aperture to first groove that extends outward into described circular base and be communicated with described hole, one from described aperture to second groove that extends outward into described circular base and be communicated with described hole, described first groove is arranged in the described first horizontal sidepiece, described second groove is arranged in the described second horizontal sidepiece, wherein at least one first sidepiece of first lobule is received within described first groove, and at least one second sidepiece of described first lobule is received within described second groove, thereby described first lobule is remained in the described circular base, wherein circular base also defines from described aperture to third and fourth groove that extends outward into described circular base and be communicated with described hole, described the 3rd groove is arranged in the described first horizontal sidepiece, described second groove is arranged in the described second horizontal sidepiece, wherein at least one the 3rd sidepiece of accessory flocculus is received within described the 3rd groove, and at least one the 4th sidepiece of described accessory flocculus is received within described the 4th groove, thereby described accessory flocculus is remained in the described circular base; Each lobule all has first and second sides, and described first side is a top side portion, and described second side is a bottom side, and when lobule was shown in an open position, the bottom side of each lobule was roughly faced mutually; It is characterized in that each bottom side has the lower surface that a upper surface and that roughly is positioned at first plane roughly is positioned at second plane, described first plane and described second plane have a certain degree.
14. bileaflet heart valve prosthese as claimed in claim 13, it is characterized in that, when each lobule is in a fully open position, described first and second planes are respectively first angle and second angle with respect to an angle that horizontal plane became through the circular base cross section, first angle is about 84 ° to 88 °, and second angle is about 68 ° to 84 °.
15. the described bileaflet heart valve prosthese of claim 13 is characterized in that, the angle between described first and second planes is about 164 ° to 175 °.
16. bileaflet heart valve prosthese as claimed in claim 13, it is characterized in that, described top side portion has the end face that roughly is positioned at the respective top plane, when lobule from the fully open position during to the change of complete make position, each plane, top all varies to a second position from a primary importance, the angle of travel of this motion is when lobule is in first and second positions, the angle between the respective top plane, and the angle of travel of first and second lobules all is about 35 ° to 49 °.
17. bileaflet heart valve prosthese as claimed in claim 16, it is characterized in that, one with the vertical horizontal plane of horizontal sidepiece of described circular base be a level cross-sectionn through described pedestal, each relative horizontal plane angulation in plane, top is greater than the second plane angulation on its described relatively lower surface.
18. bileaflet heart valve prosthese as claimed in claim 13, it is characterized in that, one with the vertical horizontal plane of horizontal sidepiece of described circular base be a level cross-sectionn through described pedestal, when each lobule is in a fully open position, the described relatively horizontal plane in described second plane at angle, this angle is about 68 ° to 84 °.
19. one kind is used for controlling a heart of patient inner fluid circulation bileaflet heart valve prosthese, described heart valve prosthesis comprises:
One circular base and first and second lobules, described first and second lobules are installed in the circular base, between a complete make position and a fully open position, to make pivoting action, described circular base defines one and passes the hole that described pedestal extends, described circular base has a tool first horizontal lateral first horizontal sidepiece, one tool, the second horizontal lateral second horizontal sidepiece, and a pair of be arranged on separately between the described first and second horizontal sidepieces across portion, described circular base also define one from described aperture to first groove that extends outward into described circular base and be communicated with described hole, one from described aperture to second groove that extends outward into described circular base and be communicated with described hole, described first groove is arranged in the described first horizontal sidepiece, described second groove is arranged in the described second horizontal sidepiece, wherein at least one first sidepiece of first lobule is received within described first groove, and at least one second sidepiece of described first lobule is received within described second groove, thereby described first lobule is remained in the described circular base, wherein circular base also defines from described aperture to third and fourth groove that extends outward into described circular base and be communicated with described hole, described the 3rd groove is arranged in the described first horizontal sidepiece, described the 4th groove is arranged in the described second horizontal sidepiece, wherein at least one the 3rd sidepiece of accessory flocculus is received within described the 3rd groove, and at least one the 4th sidepiece of described accessory flocculus is received within described the 4th groove, thereby described accessory flocculus is remained in the described circular base; It is characterized in that, first of each lobule, second, third and fourth sidepiece all has a plurality of groove fit faces, two in a plurality of groove fit faces have formed one first fulcrum edge, and in a plurality of groove fit faces two have formed second fulcrum edge of removing from described first fulcrum edge, each groove has a upper and lower groove side, wherein, when lobule is switched to complete make position or when complete make position is switched to the fully open position from the fully open position, first and second fulcrum edges with its in be combined with each respective side portion groove go up or the low groove side cooperates, thereby the cooperation between the respective side of one of fulcrum edge and each groove is variable, promptly, when lobule when a position is pivoted to another position, by changing into cooperating of a side and second fulcrum edge cooperating between a side and first fulcrum edge.
20. bileaflet heart valve prosthese as claimed in claim 19 is characterized in that, each lobule all has one first and second sidepiece, first sidepiece is a top side portion, second sidepiece is a bottom side, and when lobule was shown in an open position, the bottom side of each lobule was roughly faced mutually; Each bottom side has the lower surface that a upper surface and that roughly is positioned at first plane roughly is positioned at second plane, and described first plane and described second plane have a certain degree.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 96192954 CN1179708A (en) | 1995-03-29 | 1996-03-29 | Bileaflet heart valve |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/412,696 | 1995-03-29 | ||
| US08/546,210 | 1995-10-20 | ||
| CN 96192954 CN1179708A (en) | 1995-03-29 | 1996-03-29 | Bileaflet heart valve |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1179708A true CN1179708A (en) | 1998-04-22 |
Family
ID=5128556
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 96192954 Pending CN1179708A (en) | 1995-03-29 | 1996-03-29 | Bileaflet heart valve |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1179708A (en) |
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| CN1849104B (en) * | 2003-07-16 | 2011-08-03 | 戴维·彼得·肖 | Prosthetic valves for medical application |
| CN104039271A (en) * | 2011-07-29 | 2014-09-10 | 卡内基梅隆大学 | Artificial valved conduits for cardiac reconstructive procedures and methods for their production |
| US10722631B2 (en) | 2018-02-01 | 2020-07-28 | Shifamed Holdings, Llc | Intravascular blood pumps and methods of use and manufacture |
| CN113332001A (en) * | 2013-12-17 | 2021-09-03 | 爱德华兹生命科学公司 | Inverted leaflet prosthetic valve |
| US11185677B2 (en) | 2017-06-07 | 2021-11-30 | Shifamed Holdings, Llc | Intravascular fluid movement devices, systems, and methods of use |
| US11511103B2 (en) | 2017-11-13 | 2022-11-29 | Shifamed Holdings, Llc | Intravascular fluid movement devices, systems, and methods of use |
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1996
- 1996-03-29 CN CN 96192954 patent/CN1179708A/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1849104B (en) * | 2003-07-16 | 2011-08-03 | 戴维·彼得·肖 | Prosthetic valves for medical application |
| CN104039271A (en) * | 2011-07-29 | 2014-09-10 | 卡内基梅隆大学 | Artificial valved conduits for cardiac reconstructive procedures and methods for their production |
| CN104039271B (en) * | 2011-07-29 | 2016-09-07 | 卡内基梅隆大学 | Artificial valve conduit and production method thereof for cardiac reconstruction operation |
| CN113332001A (en) * | 2013-12-17 | 2021-09-03 | 爱德华兹生命科学公司 | Inverted leaflet prosthetic valve |
| US11185677B2 (en) | 2017-06-07 | 2021-11-30 | Shifamed Holdings, Llc | Intravascular fluid movement devices, systems, and methods of use |
| US11717670B2 (en) | 2017-06-07 | 2023-08-08 | Shifamed Holdings, LLP | Intravascular fluid movement devices, systems, and methods of use |
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