CN100584292C

Movatterモバイル変換

Info

Publication number: CN100584292C
Application number: CN200510110145A
Authority: CN
Inventors: 温宁
Original assignee: Individual
Current assignee: Beijing Bai Ren Medical Polytron Technologies Inc
Priority date: 2005-11-09
Filing date: 2005-11-09
Publication date: 2010-01-27
Anticipated expiration: 2025-11-09
Also published as: CN1961845A

Abstract

Translated fromChinese

本发明提供了一种人工心脏支架瓣膜。该支架瓣膜包括管形网状支架、瓣膜叶、密封膜、不透X线标志和柔性联结环。其中的网状支架的中段可为圆管形或鼓形，或设有径向突出结构，或设有外层环状结构，或设有外层游离舌，或设有径向突出结构加外层游离舌。本发明的支架瓣膜形状、结构和功能更优化；可径向压缩在介入装置帮助下准确输送到位，然后扩张，扩张释放后的人工支架瓣膜在径向和轴向符合血管壁形状，不会产生瓣周漏；植入后可发挥正常瓣膜的作用，可防止在血液返流瓣膜关闭时，反方向血液造成人工瓣膜滑动。

The invention provides an artificial heart stent valve. The stent-valve includes a tubular mesh stent, valve leaflets, a sealing membrane, radiopaque markers and a flexible coupling ring. The middle section of the mesh stent can be in the shape of a round tube or a drum, or be provided with a radially protruding structure, or be provided with an outer annular structure, or be provided with an outer free tongue, or be provided with a radially protruding structure plus an outer ring structure. Layer free tongue. The shape, structure and function of the stent valve of the present invention are more optimized; it can be radially compressed and accurately transported in place with the help of an interventional device, and then expanded. After expansion, the artificial stent valve conforms to the shape of the blood vessel wall in the radial and axial directions, without Paravalvular leakage: After implantation, it can play the role of a normal valve, which can prevent the artificial valve from slipping due to reverse blood flow when the valve is closed.

Description

Artificial heart stent valve

Technical field

The present invention relates to a kind of succedaneum of tissue, relate in particular to a kind of artificial heart stent valve.

Background technology

Heart is the most important organ of human body, and heart is divided into left and right sides two parts, and each part comprises atrium and ventricle again.Left atrium and left and right ventricles are separated by interatrial septum and interventricular septum respectively.In heart, there are four cardiac valve, i.e. Tricuspid valve, valve of pulmonary trunk, Bicuspid valve and aortic valve.In the blood of human body cycling mechanism, four cardiac valve play crucial effects.The anoxia blood of body cycling mechanism enters right atrium through caval vein, enter right ventricle by Tricuspid valve then, right ventricle shrinks blood is pressed into pulmonary circulation mechanism by valve of pulmonary trunk, get back to left atrium through the blood behind the lung oxygen saturation through pulmonary vein, arrive left ventricle through Bicuspid valve again, the left ventricle contraction enters aorta with blood by aortic valve and returns to the body cycling mechanism.Left and right sides coronary ostium is arranged under the aortic valve.Close when valve-open when four valvular structures have guaranteed blood along direction, contrary direction, prevented blood reflux and the heart burden that causes.But because a variety of causes can cause valvular posteriority damage or pathological changes, as rheumatism, atherosclerosis etc.In addition, congenital heart disease such as fallot's disease, postoperative also can produce the cusps of pulmonary valve pathological changes long term.Show as valvular function after the valve pathological changes and lose gradually, cause blood reflux as valvular insufficiency, valvular stenosis causes blood circulation not smooth, or incompetence and narrow the two merger, so that increase the weight of the heart burden, causes cardiac failure.For valvular posteriority damage or pathological changes, traditional Therapeutic Method is out breast, after the cardiac arrest, under the cryotron outer circulation is supported, opens heart and carries out the surgical repair of pathological changes valve or use artificial cardiac valve replacement.Existing Cardiac valve prosthesis divides two big classes: metal mechanical valve prosthesis and biovalve.Biovalve is made after being handled by animal materials such as bovine pericardium, bovine jugular vein lobe, porcine aortic valve.The method of above-mentioned open heart operation, operating time is long, the expense height, wound is big, has a big risk, and metal mechanical valve prosthesis displacement back patient needs long-term anticoagulant therapy, and the material lifetime of biovalve is limited, needs operation more usually.

In order to solve the problem that above-mentioned open heart operation treatment cardiac valve exists, existing now people attempts not doing open heart operation, and adopts the defeated Cardiac valve prosthesis of putting of percutaneous interventional method.The insertion type Cardiac valve prosthesis of prior art has two kinds:

1, balloon-expandable

This balloon-expandable Cardiac valve prosthesis is a biovalve, its interventional method is a difference fixed biologically valve on the support of a plastically deformable, diminishes by radial compression back diameter on a sacculus, and percutaneous is defeated to be put, pressurization makes the support expansion fixing to sacculus then, reaches duty.

1989 Henning Rud ANDERSEN (patent No. WO9117720) take the lead in having carried out porcine aortic valve through conduit cardiac-valve prosthesis displacement (document ... European Heart Journal 1,992 13,704-708).

Philippe BONHOEFFER (patent No. EP 1057460) in 2000 and Alain CRIBIER

(patent No. EP0967939) carried out replacing through the cusps of pulmonary valve of conduit intervention and the Cardiac valve prosthesis of aortic valve at human body respectively first.

Shortcoming and problem that balloon-expandable artificial valve exists are: its diameter is determined by balloon diameter, if artificial valve's diameter does not choose at the beginning, or after some physiological change, as self-sow, pathologic vessels expansion etc., the caliber size of nature valve may increase, and artificial valve's bore can not increase by adaptability, and the artificial valve has the danger of loosening or slippage, can only carry out the further expansion of secondary sacculus.

2, self expandable type

This artificial valve is provided with a strain support, can expand voluntarily after the radial compression.

(patent No. FR2826863 FR2828091) has also designed through conduit cardiac-valve prosthesis and has replaced for Marc BESSLER (patent No. US5855601) and Jacques SEGUIN.Different is that they have used an elastically deformable support, can expand voluntarily after the radial compression.

(patent No. EP1281375, Cardiac valve prosthesis US2003036791) utilize an elastically deformable support to Philippe BONHOEFFER, at support upstream extremity or far-end contact are housed, and are pressed in inside and outside two sheath pipes.

The applicant had once used the stage casing to strengthen being combined to stent valve as the stent valve and the self-extending type of drum type in the patent application of Chinese invention patent application number 200410054347.0, and the cluster apparatus for delivering.

Shortcoming and problem that self expandable type artificial valve exists are: frictional force is big between self expandable type Cardiac valve prosthesis and sheath pipe, influences the artificial valve and accurately discharges.

The support backguy of cluster apparatus for delivering, frictional force is big when passing artificial valve's deformable unit, and backguy is easily dislocated when not passing.

Common drawback and problem that above-mentioned balloon-expandable and self expandable type Cardiac valve prosthesis exist are:

1, the apparatus for delivering of existing insertion type man-made support valve and the stent valve under the radial compression are harder, and bendability is poor, are not easy through aortic arch, can not aim at nature aortic valve mouth.

Even if 2 under the help of x x ray fluoroscopy x, the axial upstream and downstream location of insertion type man-made support valve and its apparatus for delivering also is not easy because of unstable the becoming of artificial valve under and the blood flow impact inaccurate to the judgement of anatomical position.The resistance coronary ostium if swimming on the upper side, insertion type prosthetic aortic valve position can influence Bicuspid valve, if downstream can be blocked up in the position.

3, the direction of rotation of insertion type aortic valve man-made support valve and its apparatus for delivering location fails to solve.If insertion type prosthetic aortic valve position of rotation is not to blocking up the resistance coronary ostium.

4, under the self-extending type man-made support valve high compression, the rollback of sheath pipe can run into very big resistance.Move back the resistance of sheath pipe and the man-made support valve displacement that difficulty also can make the operator locate.

5, in dispose procedure, stent valve partly is expanded to full expansion gradually, and required time surpasses a heart beat cycle.The stent valve of expansion can hinder blood flow, and stent valve also can make its position change because of blood flow impacts.Balloon-expandable man-made support valve complete blocking blood flow in the balloon expandable process particularly.

If 6 patients have coronary bypass (Coronary Artery Bypass), the man-made support valve of having implanted should not be in the hemoperfusion that the ascending aorta place influences the bridging opening.

7, the aortic valve self-expanding stent valve of Jacques SEGUIN and Philippe BONHOEFFER if can successfully be implanted, though postoperative can not influence perfusion coronarius at once, but mid-stent is not pasted blood vessel wall at aortic root, allow blood flow from the support mesh, flow through, have thrombotic possibility on the one hand; Can influence or hinder following possible coronary artery intervention diagnosis and treatment on the other hand.

8, also there is following problem in the fixing of stent valve that discharges after expanding:

A) systole and the impact of relaxing period blood flow can make fixing bad man-made support valve move.

B) existing pathologic expansion before its aortic root art of the patient of some aortic incompetence needs

Stent valve that will be very big could coincide fixing with it.

C) some patient implants the part, back at the man-made support valve and has the anatomical variation, as expansion, makes not

The stent valve of energy respective change loses effectively fixing.

9, the man-made support valve after expansion is fixed has perivalvular leakage (Para valvularleaks) under many circumstances, and promptly blood leaked between stent valve and blood vessel wall.

If 10, touch metal rack in the valve leaflet switch, can cause the valve leaflet wearing and tearing.

Can to bear very big stress if 11 adopt major diameter stent valve, lobe leaf to unite point (Commissure) in order fixing, to cause valve leaflet to unite and a little tear damage.

Summary of the invention

Purpose of the present invention is to overcome the problems referred to above that prior art exists, and a kind of artificial heart stent valve of new structure is provided.Both can be used for the insertion type treatment, also can be used for the Minimally Invasive Surgery treatment.

The object of the present invention is achieved like this: a kind of artificial heart stent valve, be characterized in, comprise one can be between expansion state and compressive state the pipe-shaped net rack of radial deformation, this network comprises Upstream section, stage casing and tract, constitute between each netting twine of network or surround a plurality of deformables unit, forming a plurality of open lines at the two ends of network turns, and be provided with the sealed line eye that separates with the deformable unit, being connected with in the inboard in network stage casing can switch and allow the unidirectional valve leaflet of passing through of blood, valve leaflet constitutes lobe leaf associating line with the network place of combining, the lobe leaf associating line of two adjacent valve leaflet intersects formation lobe leaf unites a little, on the inboard of network Upstream section and/or lateral surface, be coated with diaphragm seal and extend to the stage casing, on network, be provided with a plurality of radiopaque markers and flexibly jointed chain ring.

Above-mentioned artificial heart stent valve, wherein, described network can be formed by the elastic wire braiding, also can be formed by the cutting of elasticity tubing.

Above-mentioned artificial heart stent valve, wherein, described network integral body is tubular of the same size, is provided with carrier openings in the stage casing of tubular network.

Above-mentioned artificial heart stent valve, wherein, the stage casing of described network is outwards outstanding cydariform, is provided with carrier openings at the middle part in cydariform stage casing.

Above-mentioned artificial heart stent valve, wherein, the stage casing of described network is out of shape on the basis of tubular or slight cydariform and at least one outwards outstanding radial protrusion structure, be provided with a bigger carrier openings at the center of each radial protrusion structure, radial protrusion structure and network body connecting place form the upstream periphery of one and a half months shape and the downstream perimeter of one and a half months shape, and semi-moon shaped upstream periphery constitutes the lobe leaf associating line that links to each other with valve leaflet.

Above-mentioned artificial heart stent valve, wherein, the radial protrusion structure in described network stage casing is one.

Above-mentioned artificial heart stent valve, wherein, the radial protrusion structure in described network stage casing is two, two radial protrusion structures are that 90-180 degree corner distributes.

Above-mentioned artificial heart stent valve, wherein, the radial protrusion structure in described network stage casing is three, three radially uniform distributions of radial protrusion structure.

Above-mentioned artificial heart stent valve, wherein, the Upstream section flare of described network, the outer rim of tubaeform Upstream section are provided with and the corresponding waveform mouth of the radial protrusion structure in stage casing limit.

Above-mentioned artificial heart stent valve, wherein, the stage casing of described network is an outer double-layer structure in the tubular, on rack body, be connected with an outer circulus, outer circulus and internal layer link to each other with the intersection in stage casing at tract or tract and form fixed edge, and the intersection formation free edge that outer circulus terminates in Upstream section and stage casing also can be provided with sealed line eye to be separated with the deformable unit.

Above-mentioned artificial heart stent valve, wherein, the stage casing of described network is an internal layer with tubular or slight cydariform, the outside is connected with at least one and is surrounded the free tongue skin that forms by single netting twine, described free tongue and internal layer stake body link to each other with the intersection in stage casing at tract or tract and form fixed edge, and begin upstream the intersection formation free edge that section extends to Upstream section and stage casing from fixed edge, the free edge front end can be provided with sealed line eye, can be with radiopaque marker on the line eye.

Above-mentioned artificial heart stent valve, wherein, described free tongue is three, three free tongues distribute with 120 degree corners, and corresponding with valve leaflet.

Above-mentioned artificial heart stent valve, wherein, the stage casing of described network is out of shape on the basis of tubular or slight cydariform and at least one outwards outstanding radial protrusion structure, be connected with on each radial protrusion structure by single netting twine and surround the free tongue that forms, the free edge of free tongue is that semi-moon shaped upstream periphery is overlapping on two parallel curved surfaces with the periphery of radial protrusion structure at least.

Above-mentioned artificial heart stent valve, wherein, described valve leaflet can be made of biomaterial, also can constitute by synthetic material, in the synthetic material valve leaflet, be provided with at least one reinforcing fibre, this reinforcing fibre works different the uniting a little or unite line of two of terminating in same valve leaflet, is connected on the network.

Above-mentioned artificial heart stent valve, wherein, described reinforcing fibre mainly is arranged on the downstream face of valve leaflet, also can be arranged on the free limit or the closed edge of valve leaflet.

Above-mentioned artificial heart stent valve, wherein, described valve leaflet is two to three, and three valve leaflet are 120 degree corners and distribute, and each valve leaflet comprises free limit and closed edge, forms between free limit and the closed edge and closes the closed zone.

Above-mentioned artificial heart stent valve, wherein, described diaphragm seal can be made of biomaterial, also can constitute by synthetic material, be provided with at least one reinforcing fibre in the synthetic material diaphragm seal, this reinforcing fibre is peripheral annular to be arranged, and links to each other with network or connect.

Above-mentioned artificial heart stent valve, wherein, the diaphragm seal eye that described diaphragm seal is interlinked to the outside in corresponding being provided with in the sealed line eye place of network.

Above-mentioned artificial heart stent valve, wherein, described diaphragm seal can extend the mantle that formation does not have bracket supports in upstream direction beyond the network, can extend to lobe leaf associating line with interior downstream at network.

Above-mentioned artificial heart stent valve, wherein, described reinforcing fibre is selected from polyster fibre, polypropylene fiber, polyethylene fibre or carbon fiber.

Above-mentioned artificial heart stent valve, wherein, described radiopaque marker is the tubular point-like sign that is sleeved on the netting twine, and the lobe leaf that this tubular point-like sign is arranged on the network stage casing is united a little, also can be arranged on the Upstream section of network or the intersection or the tract in Upstream section and stage casing.

Above-mentioned artificial heart stent valve, wherein, described radiopaque marker is a wire sign from beginning to end, this wire sign interweaves on the netting twine of network adjacent to lobe leaf associating line.

Above-mentioned artificial heart stent valve, wherein, the open line that described flexibly jointed chain ring is arranged on the network two ends turns the middle part with sealed line eye place and network.

Above-mentioned artificial heart stent valve, wherein, also comprise sealing ring, the sealing ring is arranged on the outside of the Upstream section and the stage casing intersection of network, described sealing ring is softish semi open model tubular structure, can be annular or with the corresponding waveform of radial protrusion structure, which is provided with inner face or the outside of a plurality of point-like openings, or be provided with the inner face of groove shape opening towards stent valve towards stent valve.

Above-mentioned artificial heart stent valve, wherein, described sealing ring can be made of biomaterial, also can be made of synthetic material.

Artificial heart stent valve of the present invention makes it compared with prior art owing to adopted above-mentioned technical scheme, has following advantage and good effect:

1, man-made support valve shape, 26S Proteasome Structure and Function are more optimized.

2, deformable support both can cooperate with biovalve also and can cooperate with synthetic valve.

3, increase the intensity and the life-span of synthetic valve, do not needed anticoagulant, be expected to replace biovalve.

Contact friction with metal rack when 4, preventing the valve switch, prevent that the valve peripheral blood from leaking.

But 5, man-made support valve radial compression is accurately carried under intervention device helps and is put in place, expansion then.The man-made support valve does not separate with having an accident property of conveyer device before the expansion and when expanding.As find that the man-made support position of valve is undesirable in the process of expansion, can correct.

6, frictional force is low between man-made support valve under the compressive state and the sheath pipe, helps accurately discharging the man-made support valve.

7, the man-made support valve after expansion discharges is in the radial and axial blood vessel wall shape that meets.

8, can bring into normal play after the man-made support valve the is implanted effect of valve.

9, after the man-made support valve is implanted, can prevent that when the blood reflux valve is closed blood causes the artificial valve to slide in the other direction.

10, the stent valve after the expansion can not produce perivalvular leakage.

Description of drawings

By the description of following a plurality of embodiment to the artificial cardiac stent valve of the present invention, can further understand purpose of the present invention, specific structural features and advantage in conjunction with its accompanying drawing.Wherein, accompanying drawing is:

Fig. 1 is in the artificial cardiac stent valve of the present invention, and network integral body is the three-dimensional perspective of the stent valve of tubular;

Fig. 1 a is the plane outspread drawing of the single layer knit structure of stent valve shown in Figure 1;

Fig. 2 is in the artificial cardiac stent valve of the present invention, and the stage casing of network is the three-dimensional perspective of the stent valve of cydariform;

Fig. 3 is in the artificial cardiac stent valve of the present invention, and there is the three-dimensional perspective of the stent valve of radial protrusion structure in the stage casing of network;

Fig. 3 a is the front view of stent valve shown in Figure 3.

Fig. 3 b is the vertical view of Fig. 3 a;

Fig. 3 c is the upward view of Fig. 3 a;

Fig. 3 d is the side view of Fig. 3 a;

Fig. 3 e and Fig. 3 f are that Fig. 3 b is along side shaft bx crosscut sketch map;

Fig. 4 is in the artificial cardiac stent valve of the present invention, and the stage casing of network is the three-dimensional perspective of the inside and outside double-deck stent valve of tubular;

Fig. 4 a is the double braid structural plan expanded view of stent valve shown in Figure 4;

Fig. 5 is in the artificial cardiac stent valve of the present invention, and there is the three-dimensional perspective of the stent valve of free tongue in the stage casing of network;

Fig. 5 a is the double braid structural plan expanded view of stent valve shown in Figure 5;

Fig. 5 b is the vertical view of stent valve shown in Figure 5;

Fig. 6 is in the artificial cardiac stent valve of the present invention, and the stage casing of network has the three-dimensional perspective of the stent valve of radial protrusion structure and free tongue simultaneously.

The specific embodiment

Referring to Fig. 1, cooperation is referring to Fig. 2, Fig. 3, Fig. 4, Fig. 5, Fig. 6, and Figure 10 a, Figure 10 b, Figure 10 c, Figure 10 d, Figure 10 e, Figure 10 f, artificialheart stent valve 1 of the present invention comprises: but the selfexpandable type network 10 of radial deformation, not pass through x-ray sign 311,312, can switch and allow reinforcingfibre 39 and flexibly jointedchain ring 41 in the unidirectional valve leaflet of passing through 33 of blood, diaphragm seal 351,354, sealingring 37, the synthetic film.

Valve leaflet 33, diaphragm seal 351,354, sealingring 37 can be made by biomaterial, also can be made by synthesized polymer material.As being made by biomaterial,valve leaflet 33, diaphragm seal 351,354 and sealingring 37 are sutured on thesupport 10; As being made by synthesized polymer material, self expandabletype stent valve 1 can constitute and seamlessly closes incorporate integral body, but the intensity of reinforcedsupport valve 1 like this, and make slick and sly not sharp-pointed dead limit betweenvalve leaflet 33 and the diaphragm seal 351,354.

But the selfexpandable type network 10 of radial deformation is the pipe type netted structure of central hollow, is made by elastomeric material, and under the situation that does not have the external force restriction, the support expansion is expansion state.Support is compressive state by radial compression under external force.No matter under naturalness or expansion state, selfexpandable type network 10 all can divide three parts by outline: i.e.tract 13,stage casing 15 andUpstream section 18.

Tract 13 under contrary blood flow approach situation, is the near-end of support to the patient with regard to aortic valve.The present invention adopts contrary blood flow approach.Under antegrade blood flow approach situation, be the far-end of support to thepatient.Tract 13 and ascendingaorta match.Tract 13 for xx be major axis around the wide structure of axle runner.Tubular and the tubaeform two kinds of shapes in the garden that can be under naturalness or the expansion state.Whentract 13 when being tubaeform, its osculum end has a common boundary with stage casing 15 bytract 13 and is with 133, and big opening end is by downstream port 134.Tract 13 length can become because of needs, less than 50mm ascending aorta length.The terminaldeformable unit 101 of thedownstream port 134 oftract 13 can be a level, also can be not a level.The terminaldeformable unit 101 of thedownstream port 134 oftract 13 can have open line to turn 102 to lead todeformable unit 101, also can have sealedline eye 103 anddeformable unit 101 to separate.

Stage casing 15 is positioned at the middle part of self expandable type network 10.Stage casing 15 and aorta heel coronary sinus and aortic valve leaf match.Its length can become because of needs, between 15-30mm.Stage casing 15 can be divided into three major types under naturalness or expansion state: 1, be with xx major axis around the wide structure of axle runner: comprise tube-shapedstructure 151 and drum organization 152; 2, be the wide and be the radially composite construction of outstanding profile of side shaft with ax, bx, cx around the axle runner of major axis with xx,stage casing 15 hasradial protrusion structure 153; 3, interior outer double-layer structure: with aforementioned two kinds of contour structures, the composite construction that comprises tube-shapedstructure 151, drum organization 152 and have aradial protrusion structure 153 is as internal layer stake body 154.Outside the internallayer stake body 154 layer structure is arranged, compriseouter circulus 155 and free tongue 156.Internal layer 154 is with 133 to link to each other attract 13 ortract 13 with 15 boundaries, stage casing with outer 155,156.The a certaindeformable unit 101 instage casing 15 can have sealedline eye 103 anddeformable unit 101 to separate.

Can there be following six kinds of versions in the stage casing of the network in the artificialcardiac stent valve 1 of the present invention:

Referring to Fig. 1, cooperate referring to Fig. 1 a, Fig. 1 is first kind of version in stage casing, in this structure,stage casing 15 is for being that the garden tubular 151 of major axis is around axle runner exterior feature with xx.There iscarrier openings 158 at the middle part ingarden tubular 151.

Referring to Fig. 2, Fig. 2 is second kind of version in stage casing, and in this structure,stage casing 15 is for being that the drum type 152 of major axis is around axle runner exterior feature with xx.The middle part 157 external diameter maximums of drum type 152 are had a common boundary with 133 external diameter greater thantract 13 andstage casing 15, have a common boundary with 183 external diameter greater thanUpstream section 18 and stage casing 15.There iscarrier openings 158 at the middle part 157 of drum type 152.

Referring to Fig. 3, cooperate referring to Fig. 3 a, Fig. 3 b, Fig. 3 c, Fig. 3 d, Fig. 3 e, Fig. 3 f, Fig. 3 is the third version in stage casing.In this structure, stage casing 15 is a composite construction, is that the garden of major axis is tubular by 151 with xx, or slight drum type 152 is around axle runner exterior feature, and having on the outer surface with ax, bx, cx is the one or more radial protrusion structure 153 of side shaft, extends radially outwardly.Ax, bx, cx side shaft are perpendicular to the xx major axis.Distribute with 120 degree corners between ax, bx, three side shafts of cx.Radial protrusion structure 153 so that 120 degree corners distribute is used for matching with coronary sinus or natural aortic valve leaf.Radial protrusion structure 153 is the support part of the whole.Each radial protrusion structure 153 middle part 157x external diameter is big, and there is a bigger carrier openings 158 at the center.All peripheral 159i, the 159o of each radial protrusion structure 153 with link to each other around the wide stake body of axle runner.The external diameter of the outstanding structure of the external diameter of periphery 159i, 159o middle part 157x is little, and peripheral 159i, 159o are divided into two semi-moon shaped upstream periphery 159i and downstream perimeter 159o, is the boundary to unite a little 160.Semi-moon shaped upstream periphery 159i constitutes the lobe leaf associating line 331 that links to each other with valve leaflet 33.Two adjacent radial protrusion structures 153 link to each other uniting a little 160, unite a little 160 overlapping uniting two into one.The external diameter of uniting a little 160 the outstanding structure of external diameter middle part 157x is little, constitutes the lobe leaf and unites a little 332 binding sites.Radial protrusion structure 153 is at least a leaf.The aortic valve place is the 1-3 leaf that 120 degree corners distribute.Figure 3 shows that network with three radial protrusion structures 153.

Referring to Fig. 4, cooperate referring to Fig. 4 a, Fig. 4 is the 4th kind of version in stage casing.In this structure,stage casing 15 is an outer double-layer structure in the tubular, comprises internallayer stake body 154 and outer circulus 155.Internallayer stake body 154 is with 133 to link to each other attract 13 ortract 13 with 15 boundaries, stage casing withouter circulus 155, claims fixed edge161.Outer circulus 155 terminates inUpstream section 18 and is with 183 with 15 boundaries, stage casing, is free state or active state, claims free edge 162.Internallayer stake body 154 is parallel withouter circulus 155 inside and outside two-layer supports under naturalness or the expansion state.Under internallayer stake body 154 radial compression, be the axle center with fixededge 161,outer circulus 155 can radial compression near internallayer stake body 154, or entad remove after the restrained force expansion away from internallayer stake body 154 flares port one 84 openings upstream.

Referring to Fig. 5, cooperate referring to Fig. 5 a, Fig. 5 b, Fig. 5 is the 5th kind of version in stage casing.In this structure, stage casing 15 is inside and outside two layer composite structure.The garden that with xx is major axis is tubular by 151, or slight drum type 152 is around the internal layer stake body 154 of axle runner exterior feature, having on the outer surface with dx, ex, fx is that one or more of side shaft surround the free tongue 156 that forms by single netting twine, has a common boundary from tract 13 or tract 13 and stage casing 15 to be with 133 beginnings outwards upstream to hold 184 to extend to Upstream section 18 and have a common boundary with stage casing 15 and be with 183 to end.Dx, ex, fx side shaft are perpendicular to the xx major axis.Distribute with 120 degree corners between dx, ex, three side shafts of fx.The free tongue 156 of three 120 degree corners distribution is used for matching with coronary sinus or natural aortic valve leaf.Free tongue 156 is the support part of the whole.Free tongue 156 part peripheries link to each other with internal layer stake body 154 as the downstream periphery, claim fixed edge 163, and another part is free state or active state for the tongue shape structure, claims free edge 164.The fixed edge 163 of two adjacent free tongues 156 165 meets uniting a little.Unite a little 165 and unite a little 332 binding sites on same Plane of rotation with the lobe leaf.Under internal layer stake body 154 radial compression, be the axle center with fixed edge 163, free tongue 156 can radial compression near internal layer stake body 154, or entad remove after the restrained force expansion away from internal layer stake body 154 flares port one 84 openings upstream.

Referring to Fig. 6, Fig. 6 is the 6th kind of version in stage casing.In this structure,stage casing 15 is added with thefree tongue 156 of Fig. 5 simultaneously for theradial protrusion structure 153 of Fig. 3.Radial protrusion structure 153 andfree tongue 156 exist on same angle position simultaneously.Thefree edge 164 offree tongue 156 and peripheral 159i, the 159o ofradial protrusion structure 153, semi-moon shaped at least upstream periphery 159i is overlapping on two parallel curved surfaces.

Continuation is referring to Fig. 1 to Fig. 6, and Upstream section 18 is the other end opposite with tract 13.Upstream section 18 and aortic valve zona match.With regard to aortic valve, when contrary blood flows into dataway operation, concerning the patient the far-end of support.The present invention adopts contrary blood flow approach.When antegrade blood flow is gone into dataway operation, concerning the patient the near-end of support.Upstream section 18 for xx be major axis around the wide structure of axle runner.The garden that can be under naturalness or the expansion state tubular by 181 (referring to Fig. 1, Fig. 5) and two kinds of planforms of tubaeform 182 (referring to Fig. 2, Fig. 3, Fig. 4, Fig. 6).Garden tubular 181 is extensions that stage casing 15 is the tubular port one upstream 84 in garden.Tubaeform 182 is the opening extensions of port one 84 upstream of stage casing 15 flares.Tubaeform 182 is small-bore by stage casing 15, and heavy caliber is a upstream port 184.The diameter of tubaeform 182 upstream port 184 has a common boundary much larger than Upstream section 18 and stage casing 15 with 183 diameter.Upstream section 18 length can become because of needs, are generally less than 20mm, not hinder Bicuspid valve.Upstream section 18 is no matter be garden tubular 181 or tubaeform 182 the sort of schemes, and the terminal deformable unit 101 of Upstream section 18 upstream ports 184 can be a level, and upstream port 184 is flat mouthful.The terminal deformable unit 101 of Upstream section 18 upstream ports 184 also can be a level.As: exist simultaneously with three hemispherical radial protrusion structures 153, the upstream port 184 of tubaeform 182 Upstream sections 18 is not a level.With radial protrusion structure unite a little 160 or the lobe leaf unite that a little tubaeform 182 Upstream sections 18 of 332 opposite positions are shorter, longer with tubaeform 182 Upstream sections 18 of radial protrusion structure 153 middle part 157x opposite positions, the upstream port 184 of the result is tubaeform 182 Upstream sections 18 is and three radial protrusion structures, 153 corresponding SANYE waveform mouths 185.The terminal deformable unit 101 of Upstream section 18 upstream ports 184 can have open line to turn 102 to lead to deformable unit 101, also can have sealed line eye 103 and deformable unit 101 to separate.

But the selfexpandable type network 10 of employing radial deformation of the present invention.Above-mentioned outline is the naturalness or the expansion state of self expandable type network 10.Selfexpandable type network 10 is made by elastomeric material.Known biocompatible elastic material comprises niti-shaped memorial alloy Nitinol, cochrome Phynox, L605, etc.It is the balloon-expandable support that is made of plastic material that above-mentioned outline network is difficult to.Because needing the balloon expandable of given configuration, these outlines reach.The selfexpandable type network 10 of above-mentioned outline can be formed by the elastic wire braiding, also can be formed by the cutting of elasticity tubing.

Self expandable type wovenmesh support 10 can be implemented by following method:

The basic weaving method of self expandable type wovenmesh support 10 is as follows:

Referring to Fig. 1 a, Fig. 4 a, Fig. 5 a, cooperate referring to each figure among Fig. 1 to Fig. 6 and Figure 10 a, Figure 10 b, Figure 10 c, Figure 10 d, Figure 10 e, Figure 10 f, self expandable type woven mesh support 10 is formed by single elasticity litzendraht wire 104 braidings.In 104 liang of end points 105,106 of single line certain is a bit such as starting point 105 beginnings, along aforementioned specific outline 151 or 152 or 153 or 154 or 155 or 156,181 or 182 spirals advance, being folded to symmetric rightabout again behind the support end 134,184 advances along specific outline 151 or 152 or 153 or 154 or 155 or 156,181 or 182 spirals.Repeat all to set up up to all deformable unit 101 with this, certain that put in 105,106 with two ends a bit finishes such as terminal point 106 arrival or above starting point 105.The two-stage nitration line 104 ' of same single line 104 behind folding constitutes cross-point 107 up and down when intersecting.One cross-point 107 is just in time opposite with the upper-lower position relation of the most contiguous four cross-points 107 '.A deformable unit 101 is a tetragon or diamond structure, is made of same single line 104 four limits 104 ' of four sections lines and four cross-points 107,107 ' behind folding.The deformable unit 101 on four limits or by the support radial compression distortion of deformable unit, four limits 101 braiding is mixed with the axially-extending distortion.Single litzendraht wire 104, as behind upstream port 184 and downstream port 134 or behind a deformable unit 101 ends, is folded to symmetric rightabout formation again and turns 102 less than the 360 open lines of spending to the support end.If turning 102 litzendraht wire 104, open line can constitute sealed line eye 103 in the three-sixth turn angle again.Sealed line eye 103 can be at the support two ends, as upstream port one 84 and downstream port 134, and also can be between the two.One or more sealed line eyes 103 can be arranged on each section line.Sealed line eye 103 can with support on same outline curved surface or on the tangent plane, also can with the perpendicular plane of support on (on the diametric plane) inwardly or outwards, also can be between these two.The support end turns 102 as the open line of upstream port one 84 and downstream port 134, and sealed line eye 103 can be in same level, also can be at varying level.For three valve leaflet stent valves, be that three multiple helps three valve leaflet symmetries along the deformable unit number of girth.By the support 10 of single litzendraht wire 104 braidings along girth deformable unit number divided by should being a mark rather than an integer along major axis deformable unit number.Terminal point 106 in the single litzendraht wire 104 arrives and can repeat on same position after starting point 105 has woven a support, comprising: 1, all repeat on all positions, so just constituted the above higher support of radial strength of two-stage nitration line or two-stage nitration line; 2, in the part, repeat as Upstream section, stage casing or tract, the local radial elastic force after the above repetition of two-stage nitration line or two-stage nitration line strengthens.The two-stage nitration line to the multistage line can near or overlap deformable unit 101 not of uniform size, comprise bigger opening 158.The support that is formed by single line braiding also can be formed by multi-thread braiding.Two or more identical or different single lines can be woven together simultaneously.Each single line constitutes a support.But two or more supports overlap and constitute a sectional shelf-unit.Different single lines, thickness can be different.Different single lines, material can be different.Can be the single line of opacity material as a line wherein, as gold, tungsten, platinum, tantalum etc.

Below introduce the concrete weaving method of above-mentioned several structures of the network in the artificialcardiac stent valve 1 of the present invention:

The weaving method of first kind of structure is adopted in the stage casing:

With xx is tubular by 151, the 181 together basic weaving methods of weaving method around axle runner exterior feature support in garden of major axis.

The weaving method of second kind of structure is adopted in the stage casing:

Tract 13 is for being that the garden of major axis is tubular with xx, andstage casing 15 be drum type or garden sphere 152, andUpstream section 18 be tubaeform 182 the same weaving method substantially of the weaving method around the wide support of axle runner.The length of support each section braided wires 104 ' 134 fromupstream port 184 to downstream port is the same.

The weaving method of the third structure is adopted in the stage casing:

On weaving method two bases, the garden that with xx is major axis is tubular by 151, or slight drum type or garden sphere 152 be around axle runner exterior feature, and having with ax, bx, cx on 15 outer surfaces of stage casing is the composite construction support that the one or more radial protrusion structure 153 of side shaft extends radially outwardly.The similar basic weaving method of the weaving method of this profile support.Stage casing 15 can be formed by single litzendraht wire 104 braidings for the support of radial protrusion structure 153.The support that forms by 104 braidings of single litzendraht wire from downstream port 134 through three hemispherical radial protrusion structure 153 different parts, as middle part 157x or unite a little 160, having a common boundary to Upstream section 18 and stage casing 15, it is different to end the length of each section litzendraht wire with 183, and adjacent deformable unit is not isometric.But braided support cross-point 107, the 107 ' slip of going up between the adjacent segment litzendraht wire have guaranteed that support and radial protrusion structure 153 can radial compression, radial dilatation.Exist simultaneously with three hemispherical radial protrusion structures 153, tubaeform 182 Upstream sections 18 and radial protrusion structure unite a little 160 or the lobe leaf unite that a little 332 opposite positions are shorter, tubaeform 182 Upstream sections 18 are longer with radial protrusion structure 153 middle part 157x opposite positions, and the result is tubaeform, and 182 Upstream sections 18 are and three SANYE waveform mouths 185 that radial protrusion structure is relative.Tubaeform 182 Upstream sections 18 than the litzendraht wire of strong point through the outstanding structure of adjacent radial unite a little 160 or the lobe leaf unite a little 332 less external diameters, tubaeform 182 Upstream sections 18 than the litzendraht wire of weakness through radial protrusion structure middle part 157x than external diameter greatly.Support can be equally to the length of each section braided wires the downstream port 134 through three radial protrusion structures 153 from upstream port 184 like this.Each section line state under expansion state and compression is all isometric.It is corresponding with three radial protrusion structures 153 that expansion state lower carriage upstream port 184 is three waveform limits 185.When radial compression, axially-extending, the adjacent segment line slides on the cross-point, and three radial protrusion structures 153 and three waveform limits 185 disappear, and upstream port 184 each deformable unit are parallel.Single line 104 not only can be woven into a netted shell support 10 of monolayer, also can be woven into a multiwalled stereochemical structure support.

The weaving method of the 4th kind of structure is adopted in the stage casing:

After single line 104 was woven into a netted shell support 10 of monolayer, at support tract 13,104 ' two sections line in-situ locallies of another section of same braiding single line 104 repeated.15 single lines 104 stretch out and break away from the internal layer stake body that woven 154 and independent unofficial layer circulus 155 to the stage casing.Stage casing 15 single lines 104 of having compiled outer circulus 155 return 13 pairs of section lines of stake body tract in-situ locally and repeat, repeat back and forth and change the about 360 degree corners of support with this tract stake body 13 and stage casing 15 outer circuluses 155, until the outer circulus 155 that constitutes shown in Fig. 4 a.There is inside and outside two-layer support 154,155 in the stage casing like this.Between the middle and lower reaches section, be connected to fixed edge 161 between two-layer.From tract 13 and stage casing the outer circulus 155 of 15 combined belts, 133 beginnings outwards upstream port ones 84 extend to combined belt 183 horizontal stop between stage casing 15 and the Upstream section 18.Help under these outer circulus 155 radial compression carrying.Under internal layer stake body 154 radial compression, with fixed edge 161 is the axle center, outer circulus 155 can be separately in internal layer stake body 154 radial compression near internal layer stake body 154 or entad remove restrained force after be toroidal away from internal layer stake body 154 to discharging expansion.Be independent of internal layer stake body 154 compression or expansion states, these outer circuluses 155 have been expanded location, fixation separately.These outer circuluses 155 can be smooth on internal layer stake body 154 outer surfaces under internal layer stake body 154 and outer circulus 155 expansion states, also can flare upstream port one 84 extend on the stake body outer surface.13 pairs of section lines of support tract repeating part adds the girth cell number CN ' of the outer circulus 155 in stage casing and the ratio of axial length cell number LN ' is not an integer.These outer circuluses 155 not only can be by forming with same single lines 104 braidings of internal layer stake body 154, also can be woven simultaneously by the litzendraht wire different with internal layer stake body 154 to form.

The weaving method of the 5th kind of structure is adopted in the stage casing:

After single line 104 is woven into a netted shell support 10 of monolayer, at support tract 13,104 ' two sections line in-situ locallies of another section of same braiding single line 104 repeat, and changeing the about 60 degree angles of support, 15 single lines 104 ' stretch out and break away from 154 dozens of half circular arc lines 166 of stake body that woven or make a call to a full circle camber line 166 ' and return the repetition of 13 pairs of section lines of support tract in-situ locally to the stage casing.Like this single line 104 go out a little 167 with advance a little 167 ', or advance a little 167 and go out a little between 167 ' support commentaries on classics 120 and spend.With this tract stake body 13 and stage casing 15 outer free tongues 156 back and forth triplicate until the free tongue 156 of skin that constitutes shown in Fig. 5 a.There are internal layer stake body 154 and outer free tongue 156 two-layer supporting structures in the stage casing like this.Between the middle and lower reaches section, be connected to fixed edge 163 between two-layer.Outwards upstream hold 184 to extend to combined belt 183 horizontal stop between stage casing 15 and the Upstream section 18 from the outer free tongue 156 of 133 beginnings of combined belt between tract 13 and the stage casing 15.Free tongue 156 fixed edge 163 separately of two adjacent skins has one commonly to unite a little 165.Help carrying under these outer free tongue 156 radial compression.Under the stake body radial compression, be the axle center with fixed edge 163, outer free tongue 156 can be separately in internal layer stake body 154 radial compression near stake body, or entad remove and radially to discharge expansion after the restrained force and be toroidal away from stake body.Before stake body 154 expansion, the free tongue 156 of the skin of expansion separately can push up earlier in the natural valve leaf bag of aortic valve and play automatic positioning action.No matter stake body is in compressive state or expansion state, these outer free tongues 156 can independent radial compression, and independent radially release expanded fixation.These outer free tongues 156 enter nature valve leaflet bag, are pressed at the bottom of the natural valve leaf bag and natural lobe leaf is united a little.When the valve leaflet of diastole stent valve is closed, blood reflux stream, outer free tongue 156 can play fixation, prevents that stent valve from being rushed in the left ventricle by blood flow.These outer free tongues 156 can be smooth on the stake body outer surface under internal layer stake body 154 and outer free tongue 156 expansion states, and the opening of also can flare upstream holding extends on the stake body outer surface.The local multiple girth deformable unit number CN of two section lines of tract 13 same braiding single lines 104 and the ratio of axial length deformable unit number LN are an integer, guarantee that like this single line gets back to initial point 105,106.Single line goes out a little 167 and to advance a little can be one and half arcs 166 between 167 ', also can be one the 360 above collar-shaped 166 ' of degree.The collar 166 ' can dissociate entirely, also can enroll in the stake body again by tract.Outer free tongue 156 is a self expandable type single line support part of the whole.Outer free tongue 156 has two to three, between 120 degree angles.Outer free tongue 156 is generally the first quarter moon arc, and the curved line two ends are connected on the stake body.Outer free tongue 156 also can have other variation schemes.As: 1, small circle of the curved formation of 360 degree is made a call to increase distortion elastic force in the arc top; 2, great circle of the curved formation of 360 degree is made a call on the arc top, and the radius of great circle is almost with half radius of curvature; 3, the downstream of making a call to 360 degree great circles is enrolled the downstream stake body again.Outer free tongue 156 is because line is few, so elastic force is lower than stake body 154.The free tongue 156 of the skin of low elastic force does not hinder the stake body expansion in lumen of vessels.Outer free tongue 156 is consistent under expansion state with form with the stake body cross-sectional sizes.These outer free tongues 156 not only can be by forming with 154 same single lines 104 braidings of internal layer stake body, also can be woven simultaneously by the litzendraht wire different with internal layer stake body 154 to form.

The weaving method of the 6th kind of structure is adopted in the stage casing::

Be added with thefree tongue 156 of weaving method five simultaneously for theradial protrusion structure 153 of weaving method three.Support can have theradial protrusion structure 153 and the outerfree tongue 156 of size, shape, position, quantity unanimity simultaneously.After the radial compression, outerfree tongue 156 discharges expansion earlier, and corresponding back with natural valve cup embeds nature valve cup, reaches rotation location and axial length location with this.Radial protrusion structure 153 and stake body expansion then.Outerfree tongue 156 is because line is few, so elastic force is lower than stake body.Thefree tongue 156 of the skin of low elastic force does not hinder the stake body expansion in lumen of vessels.Radial protrusion structure 153 and outerfree tongue 156 all play fixation.The two 153 and 156 is clipped in the middle the nature valve leaflet and seals.

Open line among thepresent invention turn 102 and sealedline eye 103 also can form by tube of material cutting.Radial protrusion structure 153 also can be formed by tube of material cuttingdistortion.Outer circulus 155 and outerfree tongue 156 also can be formed by tube of material cutting distortion, weld together then.

Continuation is provided with radiopaque marker referring to Fig. 1 to Fig. 6 in the artificialcardiac stent valve 1 of the present invention, comprises point-like sign 311 andwire sign 312.

Point-likeradiopaque marker 311 can be cast, coaxial being enclosed within on one or more litzendraht wires 104.The downstream 134 of support has one or more opacity point-like sign 311 at least.Theupstream extremity 184 of support or Upstream section andstage casing intersection 183 have one or more opacity point-like signs 311 at least, and the position of these signs is near the cup end of valve leaflet.Thestage casing 15 of support has one or more opacity point-like signs 311 at least, and the position of these signs can be positioned at thebinding site 160 that tworadial protrusion structures 153 link, suitable two a little 332 the positions of uniting adjacent to valve leaflet.

Referring to Fig. 5, from theUpstream section 18 and thestage casing 15association region lines 183 of support, end to middle part, stage casing 157,radiopaque markings 312 are made two to three waveforms, and from beginning toend.Markings 312 shuttle back and forth up and down in support braiding netting twine 104.These markings are adjacent to thejoint line 331 of valve leaflet and support.Three waveform markings can be used for the fixed biologically valve leaflet on support in the support.

Radiopaque material can be biocompatible heavy metals such as gold, tungsten, platinum, tantalum.

Continuation is referring to Fig. 1 to Fig. 6, and the valve leaflet 33 in the artificial cardiac stent valve 1 of the present invention can have two to three, as is that three valve leaflet then are 120 degree corners distribution.Each valve leaflet comprises free limit 333 and closed edge 334.Be closed zone 335, pass between free limit 333 and the closed edge 334.The valve leaflet cup is curved, is divided into falling the district and rising the district.The cup end, can be a little less than the associating line 331 of valve leaflet and support.Valve leaflet and the support place of combining constitute associating line 331.The associating line of two adjacent valve leaflet communicates and constitutes the lobe leaf and unite a little 332.The lobe leaf unites a little 332 on litzendraht wire 104 cross-points 107,107 '.The lobe leaf is united a little 332 levels that are equivalent to valve leaflet closed edge 334.Valve leaflet is made by softish material, and naturalness is closed condition, and the free limit 333 of adjacent valve leaflet and the closed zone, pass 335 between the closed edge 334 contact, and valve is closed, and blood can not pass through.It is tighter that the interior vasodilation pressure of diastole aorta is closed valve leaflet.Paradoxical expansion blood is broken through valve leaflet 33, makes valve leaflet 33 be affixed to support or blood vessel wall, and stent valve 1 is opened.Valve leaflet 33 can be made of biomaterial, also can be made of synthetic material.Synthetic material can be an elastomer, as silica gel or polyurethane.A bar reinforcing fibre 39 is at the most arranged in the synthetic material valve leaflet, work two different lobe leaves terminating in same valve leaflet 33 and unite a little 332 or unite line 331, be connected on the support 10.Reinforcing fibre 39 is mainly in aorta face 340 sides of valve leaflet, and making the valve blade face is the wire face, and valve leaflet ventricular side 341 sides are bright finish.

Continuation is provided with diaphragm seal referring to Fig. 1 to Fig. 6 in the artificialcardiac stent valve 1 of the present invention, comprises Upstreamsection diaphragm seal 351 and stagecasing diaphragm seal 354.

Be surrounded bydiaphragm seal 351 atsupport Upstream section 18tubulars 181 or horn opening 182.This diaphragm seal can extend themantle 352 that formation does not have bracket supports in upstream direction beyond the support.This diaphragm seal can extend to lobeleaf associating line 331 with interior downstream at support.This diaphragm seal is at supportupstream port 184, and open line turns 102 or sealedline eye 103 places, has thediaphragm seal eye 353 that is interlinked to the outside at least, passes through for the support backguy 70 of apparatus for delivering 2.Blood did not leak with the limit fromstent valve 1 when this Upstreamsection diaphragm seal 351 guaranteed heart contraction.Do not make its damaged when contacting with natural mitral valve leaflet whenmantle edge 352 guarantees heart contraction.

Upstreamsection diaphragm seal 351 continues downstream from lobe leafjoint line 331 and extends formation stage casing diaphragm seal 354.Stagecasing diaphragm seal 354 is along the almost wide contoured shape film band of lobe leaf joint line 331.153middle part 157x do not have film at radial protrusion structure.A little 160,332 places are narrower uniting for the ruffled membrane band, guarantee that blood flow is to arteria coronaria.At diastole, stage casingdiaphragm seal 354 top under aorta blood backflows impact has guaranteed that to blood vessel wall diastole blood does not leak the transmission from one meridian to another aortic regurgitation to left ventricle fromstent valve 1 with the limit.The support tract is played ondiaphragm seal 354 limits in stage casing does not have diaphragm seal, guaranteed blood at diastole to side shoot such as arteria coronaria perfusion.Arteria coronaria is got involved after guaranteeing.

Support tract 13 is not established diaphragm seal, guaranteed blood at diastole to side shoot such as the coronary artery bypass grafting perfusion that enters the mouth.

Do not have to comprise on the metal rack line ofdeformable unit 101 of diaphragm seal on the cross-point 107,107 ' and can be surrounded by elastic synthesis material.

Diaphragm seal 351,354 can be biomembrane or synthetic film.Biomembrane can be in support inboard, the outside, or the interior outside exists simultaneously.

Synthetic diaphragm seal 351,354 can be elastomer such as silica gel, in the middle of support is wrapped in.

Continuation is referring to Fig. 1 to Fig. 6, can contain reinforcingfibre 39 in the synthetic diaphragm seal 351,354, is peripheral annular and places, and link to each other with support orconnect.Reinforcing fibre 39 can be in synthetic diaphragm seal border, asmantle 352 edges and stagecasing diaphragm seal 354 edges.Synthetic diaphragm seal can be made up of the elasticity macromolecular material, as silica gel, latex, polyurethane.The deformable unit of insulting shape or other shape is surrounded by elastomer, during radial compression, insults shape deformable unit and prolongs along longitudinal axis X X, shortens along vertical transverse axis.Longitudinal axis X X prolongs prolongs elasticity macromolecular material elasticity, and external force is removed icepro shape deformable unit, back will recover the original length, and the elasticity macromolecular material makes support produce extra radially outer expansive force.The compression after-poppet is elongated, and material is to two side flow, and material reduces on each cross section, helps reducing the external diameter under the stent valve compressive state.

Referring to Fig. 3, can also be provided with sealingring 37 in the artificialcardiac stent valve 1 of the present invention, sealingring 37 is a softish tubular structure, around one week of support, be positioned atsupport Upstream section 18 and have a common boundary with outside 183 the support, can be around the annular of XX axle or three waveforms ofedge associating line 331 with stage casing 15.Tubular structure can be sealed, also can be semi open model.Point-like opening 373 (referring to Fig. 3 f) is arranged towardsstent valve 1 inner face or outside on the sealingring 37 of semi open model, or groove shape opening 373 ' (referring to Fig. 3 e) is arranged towardsstent valve 1 inner face.Tubular structure can be made of biomaterial or synthetic material.It can link to each other with diaphragm seal 35.Head on blood vessel wall after the support expansion, tubulose sealingring 37 can be compressed it is adapted to, and fills up the slit between support and the blood vessel wall.

Be provided with reinforcingfibre 39 in the elastic synthesis material film that adopts in the artificialcardiac stent valve 1 of the present invention.Different with valve leaflet and diaphragm seal that biomaterial constitutes, invalve leaflet 33 that elastic synthesis material constitutes and the diaphragm seal 351,354 reinforcingfibre 39 can be arranged.Abar reinforcing fibre 39 is at the most arranged in the synthetic material valve leaflet, rise two of terminating in same valve leaflet different unite a little 332 or uniteline 331, be connected on thesupport 10; Reinforcingfibre 39 can be in thefree limit 333 ofvalve leaflet 33, mainly at thedownstream face 340 of valve leaflet, make valve leaflet downstreamface aorta side 340 be the linear drawn grain, and valve leaflet upstreamface ventricular side 341 is a bright finish.The material of reinforcingfibre 39 comprises polyster fibre, high-molecular polythene fiber, nylon and carbon fiberetc.Reinforcing fibre 39 can be strengthened the elastic synthesis material film strength by selectivity, also can strengthen the intensity between synthetic film andsupport.Reinforcing fibre 39 can also be on the radiopaque marker 311,312.

Continuation is provided with flexibly jointedchain ring 41 referring to Fig. 1 to Fig. 6 in the artificialcardiac stent valve 1 of thepresent invention.Turn 102 and sealedline eye 103 places at the open-ended line of support, two-stage nitration litzendraht wire cross-point 107,107 ' is located between two ends of the middle part of support, and the flexible cord that materials such as available terylene, nylon, polyester, polypropylene glycol are made constitutes flexibly jointed chain ring 41.Thin and soft flexible cord is at first formed aring 412, the varying in size of ring, line different in size.Two the end of a thread on ring other one side of the 412ring bundle 413 of tie a knot on support joins together with it, can not move.Apparatus for delivering backguy 70 can be passed from flexibly jointedchain ring 41, slides compressed stent.Flexibly jointedchain ring 41 is used to limit the hunting range of backguy 70 and prevents dislocation.

In sum, artificial heart stent valve of the present invention has following characteristics and advantage:

1, is provided with radially prominentprojective structure 153

The circular section that cydariform expander 152 shapes at stent valve middle part 15 are changed tract 13 and Upstream section 18 can be divided into one or more radial protrusion structures 153.Radial protrusion structure 153 is a spherical shell face on the rack outer surface, the outstanding structure of shapes such as parabolic surface.Radial protrusion structure 153 on the stent valve 1 is support 10 part of the whole.Can be same braiding single line 104 constitutes.Be desirably the hemispheric radial protrusion structure 153 that distributes about three 120 degree.Three radial protrusion structure 153 middle part 157x diameters are bigger, help axially and around xx axle direction of rotation playing location and fixation along xx.With middle reaches section 15 is that the stent valve 1 in garden barrel-shaped 151 is opposite, and radial protrusion structure 153 pastes blood vessel wall.Adjacent two radial protrusion structures 153 link to each other uniting a little 160 on the same plane, constitute the lobe leaf and unite a little 332.Two adjacent radial protrusion structures unite a little 160 and the lobe leaf unite a little in 332 and receive, the external diameter of the outstanding structure of external diameter middle part 157x is little.The major diameter support has the minor diameter valve leaflet under the duty like this, but enough aperture areas are arranged, and valve leaflet tension force is descended; Valve leaflet 33 is united a little at the lobe leaf, and 332 damages reduce; Valve leaflet 33 open blood by the time do not reach support 10, make the valve leaflet can be not frayed because of colliding with support; Under the constant situation of valve leaflet 33 thickness, the valve leaflet diameter reduces then that volume reduces, and helps radial compression.Semi-moon shaped upstream periphery 159i constitutes the lobe leaf associating line 331 that links to each other with valve leaflet 33.Though the adjacent deformable unit of the outstanding structure 153 of same horizontal radial is not isometric, the slip on the braided support cross-point 107 between the adjacent segment braided wires 104 has guaranteed that support and radial protrusion structure can radial compression, radial dilatation.The upstream port 184 at the Upstream section horn mouth 182 of a level is not and three radial protrusion structures, 153 corresponding three waveform limits 185.134 braided wires, 104 every section length are the same from upstream extremity 184 to downstream for support.When radial compression, axially-extending, the adjacent segment line slides on the cross-point, and three radial protrusion structures 153 and three waveforms 185 disappear, and each deformable unit of upstream extremity is parallel.Help upstream extremity 184 open lines turn 102 and sealed line eye 103 cooperate with the support backguy of apparatus for delivering 2.

2, can be provided withouter circulus 155

Outer circulus 155 blow-by films allow blood pass through.Support backguy specific onouter circulus 155 and the apparatus for delivering 2 cooperates, and can discharge separately prior to stake body 154.Theouter circulus 155 of expansion has location and fixation.

3, can be provided with outerfree tongue 156

Outerfree tongue 156 blow-by films allow blood pass through.Support backguy specific on outerfree tongue 156 and the apparatus for delivering 2 cooperates, and can discharge separately prior to stake body 154.Thefree tongue 156 of the skin of expansion has location and fixation.Outerfree tongue 156 unite a little 165 and the lobe leaf unite a little 332 definite rotation relationship can be arranged, as on same Plane of rotation.

4,network 10 can be made of singleelasticity litzendraht wire 104 braidings

The self expandable type support 10 that no matter is what profile all can be formed by single elasticity litzendraht wire 104 braidings.The support that single line constitutes, globality is strong, and is more solid on the mechanics, and do not need to weld between each line.The welding or overlapping that can link to each other of single line starting point 105 and terminal point 106.Litzendraht wire two 105,106 of single line support is all 15 of support tract 13 and middle reaches sections.Two statures 105,106 can be towards a direction, end upstream, or downstream.Single elasticity litzendraht wire 104 can the open line of coiled turns 102 and sealed line eye 103.Sealed line eye 103 can with support on same outline curved surface or on the tangent plane, also can with the perpendicular plane of support on (on the diametric plane) inwardly or outwards, also can be between these two.For three valve leaflet stent valves, be that three multiple helps three valve leaflet symmetries along the deformable unit number CN of girth.By the support 10 of single litzendraht wire 104 braidings along girth deformable unit number CN divided by should being a mark rather than an integer along major axis deformable unit number LN.Same single line 104 can constitute radial protrusion structure 153 on network 10.Cross-point 107, the 107 ' slip of going up between the adjacent segment litzendraht wire have guaranteed that support and radial protrusion structure 153 can radial compression, radial dilatation.Same single line 104 can or repeatedly repeat overlapping at twice of the same position of braided support 10.Same single line 104 can or all repeat at the local of braided support 10, can also be woven into the outer circulus 155 or the outer free tongue 156 of support.

5, can be provided with sealingring 37

Head on blood vessel wall after the stent valve expansion, tubulose sealingring 37 can be compressed it is adapted to, and fills up the slit between support and the blood vessel wall.

6,stent valve 1 upstream extremity can be provided with the loudspeaker opening

Theupstream port 184 oftubaeform 182Upstream sections 18 is and three radial protrusion structures, 153 corresponding SANYE waveform mouths 185.Upstreamsection diaphragm seal 351 can extend themantle 352 that formation does not have bracket supports in upstream direction beyond the support.

7, be provided with radiopaque marker 311,312

Radiopaque marker 311 can be positioned at the upstream extremity of stent valve, downstream and valve leaflet binding site.Braided support single line or eclipsed multi-line section stud with radiopaque endless tube outward.Radiopaque endless tube can be used as X line index location; Prevent two lines or multi-thread dislocation on the same position; Protection braiding the end of a thread 105,106 is damaged tissue not.

If 8,stent valve 1 constitutesvalve leaflet 33, diaphragm seal 351,354 and sealingring 37 by elastic synthesis material and can have following four kinds of functions simultaneously:

A,valve leaflet 33 prevent backflowing the basic function of diaphragm seal 351,354 and sealingring 37 leakproof barriers.

The strain of b,stent valve 1 is good

After intersecting, self expandablesupport litzendraht wire 104 constitutes tetragon deformable unit 101.Be coated with elastic synthesis material film 351,354 on the cross point, twowires 107 between coating or the tetragon.The two is elastomeric material support and film, strain simultaneously under the radial compression force effect.Tetragondeformable unit 101 is at the xx axially-extending, and coverlay prolongs at the xx axial elasticity in the tetragon deformable unit 101.With under the poised state that blood vessel wall is resisted mutually or the stent valve under the duty, before diaphragm seal 351,354 and elastic synthesis material surface layer did not return to the original length and shape on its support, the resilience force of elastic synthesis material film elasticity distortion had increased the expanded radially power and the axial resilience force of stent valve.Valve leaflet and diaphragm seal by elastomeric material is made after stent valve discharges, can pass through the super expansion of sacculus, and stent valve still are the unlikely damaged of strain.

C, elastic synthesis material wrap on the metal rack line, anti-hemostatic tube epithelial cell length on the metal rack line, make the man-made support valve not with the blood vessel wall adhesion, in order to taking out again.

D, different with the biovalve leaf, synthetic valve leaflet and diaphragm seal can be low temperature resistant below 0 ℃, can not propose special conditions of contract for transportation, particularly air transport.Before assembling and compression, drop to below the Af as Nitinol niti-shaped memorial alloy stent valve temperature, Nitinol becomes the Martensitic state from the Austenitic state, the material deliquescing, elasticity disappears, and helps radial compression.After entering in the body,heat 37 ℃, Ultimum Ti recovers the Austenitic state, gets back to the super-elastic property state.

9, be provided with reinforcingfibre 39

Reinforcingfibre 39 in thestent valve 1 has directional selectivity ground to improve the intensity of elastic synthesismaterial valve leaflet 33 and diaphragm seal 351,354, reduces the probability that it is torn.Reinforcingfibre 39 in thesynthetic stent valve 1 is reinforcedsynthetic valve leaflet 33 annulars, does not hinder the valve leaflet switch;Synthetic valve leaflet 33 free edge strengthenings prevent that it from tearing; The line reinforcing is united a little and united tosynthetic valve leaflet 33 with the support interconnecting part, makes interconnecting part become solid, is not torn; Make interconnecting part become slick and sly, reduce thrombosis; 10 reinforcings of diaphragm seal 351,354 and support; Two lines are bound fixing on the litzendrahtwire cross point 107.

10, the open line ofstent valve 1turn 102, the effect ofclosed line eye 103 and with the support backguy cooperation of apparatus for delivering: makeopen line turn 102 and sealedline eye 103 increase radical elasticities, reduce material deformation; Reinforcing fibre in the synthetic film of elasticity can be fixed on open line and turn 102 and above the sealedline eye 103; Sealedline eye 103 can the secure valve leaf unite a little 332.If sealedline eye 103 turn 90 degrees angle and vertical with tangent plane to the inside, it can make to unite a little in 332 and move, and valve leaflet tension force descends;Open line turn 102 and sealedline eye 103 be used for cooperating with the support backguy of apparatus for delivering,stent valve 1 is temporary fixed, be compressed on the interior pipe 51 of apparatus for delivering.The support backguy is as passing from sealedline eye 103, it will be can slippage and move.

11, be provided with flexibly jointedchain ring 41

The support backguy is passed as the flexibly jointedchain ring 41 on fromstent valve 1, it will be can slippage and move.