CN109350309A

CN109350309A - A kind of stent valve prosthese and its transportation system

Info

Publication number: CN109350309A
Application number: CN201811462573.0A
Authority: CN
Inventors: 吕世文; 李毅斌
Original assignee: Ningbo Jianshi Biological Science & Technology Co Ltd
Current assignee: Ningbo Jianshi Biological Science & Technology Co Ltd
Priority date: 2018-12-03
Filing date: 2018-12-03
Publication date: 2019-02-19
Anticipated expiration: 2038-12-03
Also published as: WO2020114299A1; CN109350309B

Abstract

This application involves stent valve prosthese and its transportation systems, including bracket, leaflet and clamping piece, bracket includes supporting section and valve sewing section, the proximal end of supporting section is connect with the distal end of valve sewing section, leaflet is connected in valve sewing section, it is placed in patient's annulus and against atrial tissue after supporting section release, clamping piece includes one or more flank, one end of clamping piece is fixedly connected at the outer surface of valve sewing section, from release completely is compressed to, successively for tool there are three form, the first form is that flank is compressed in control device to clamping piece；Second form is flank along valve sewing section radial direction stretching, extension, is reached leaflet and heart wall across the leaflet intersection of adjacent tissue；Third form be flank along valve sew section it is circumferentially extending and recline valve sew section outer surface, release finishes the tissue leaflet of future trouble person and closes on chordae tendineae and is clamped between flank and valve sewing section, be conducive to improve valve bracket anchoring fastness, improve success rate of operation.

Description

A kind of stent valve prosthese and its transportation system

Technical field:

The invention belongs to medical instruments fields, and in particular to a kind of stent valve prosthese and its transportation system.

Background technique:

The entirety that mitral valve apparatus is made of annulus of mitral valve, preceding valve, back lobe, chordae tendineae, papillary muscle, atrium sinistrum and left ventricle. Wherein combined segmentation between front leaflet and posterior valve leaflet, is located at preceding outside portion and rear middle part.Tendon from bilateral papillary muscle Rope is inserted into leaflet, and according to insertion site difference, chordae tendineae is integrally divided into three classes: conjoint tendon, frontal lobe tendon, rear leaf tendon.Conjoint tendon As the term suggests being inserted into valve association area.The fan-shaped bifurcated of single tendon usually issued by papillary muscle is inserted among leaflet joint. Frontal lobe tendon is inserted into the free edge of frontal lobe, provides necessary support for valve frontal lobe.Leaf is free after leaf tendon is then inserted into simultaneously afterwards Edge and basal part.

Mitral valve disease is the most common valvular heart disease, mainly feels concerned about system lesion due to valve pathological change itself or a left side and draws Rise secondary change and cause.Single just to show in the statistical data of U.S. 1994-2003, the quantity of mitral valve surgery was in the past 10 years in be doubled.The quantity of Mitral Valve Replacement in 2003 is more up to 65000, and part of patient carries out simultaneously Coronary Artery Bypass Grafting.In spite of see document report claim Mitral Valve Replacement postoperative death rate and complication compared with two point Valve prosthetic is serious, but can't deny, for certain patients, Mitral Valve Replacement is the unique method for continuing its life.It can Happiness develops by technology in recent years, compared to it is traditional open chest, it is happy, establish the operation of the major traumas such as extracorporal circulatory system, warp The replacement operation of intubation intervention can reduce operating difficulty, shorten patient recovery times, mitigate patient suffering, thus be situated between through conduit The replacement operation entered gradually becomes the mainstream art formula of Mitral Valve Replacement.And through conduit row Mitral Valve Replacement, it urgently solves at present Certainly the problem of following points: displacement instrument how to be accurately positioned in desired position；The carrier of artificial valve is (usually Supporting structure) how to be firmly anchored to desired position；How displacement instrument adapts to the otherness of the physiological structure of annulus.Under Face lists in currently available technology, the technical essential of different mitral valve replacement instruments.

Patent CN103079498A describes a through conduit mitral, and anchoring piece has atrium skirt section, annular Area and ventricle skirt section, the ventricle skirt section further include the triangle anchoring auricle being placed on the front in the ventricle skirt section, institute The first fibrous trigones anchoring that triangle anchoring auricle is adapted to abut against on the first side of the mitral anterior leaflet of patient is stated, thus The chordae tendineae for making anterior leaflet and adjoining is captured between the triangle anchoring auricle and the front surface of the anchoring piece.The heart Room skirt section further includes the second triangle anchoring auricle being placed on the front in the ventricle skirt section, and second triangle anchors auricle It is adapted to abut against the second fibrous trigones anchoring opposite with first fibrous trigones, thus the tendon for making anterior leaflet and adjoining Rope is captured between the second triangle anchoring auricle and the front surface of the anchoring piece.The ventricle skirt section further includes peace The rear ventricle anchoring auricle on the rear portion in the ventricle skirt section is set, and wherein the rear ventricle anchoring auricle is suitable for being anchored at In mitral posterior leaflet of patient, to make the rear ventricle anchoring auricle seat together in the ventricle of the posterior leaflet and heart of patient Between wall.According to the delivery mode in patent, ventricle skirt section described in radial dilatation is to make native mitral valve leaflet radially outward Displacement, while radial dilatation by leaflet and adjoin chordae tendineae clamping.The problem of design, is that the release of the anchoring auricle is not It is reversible to return, it is difficult to ensure primary release can clamp leaflet and its chordae tendineae；Before anchoring auricle release, the ring part Compressing native leaflets have just been partially opened, have at this time occurred that a native leaflets are no longer valid while artificial leaflet fails work The leaflet disabler time, influence patient's normal heart blood supply function；It is limited to releasing position, release form and chordae tendineae ring Border, the region that anchoring auricle is only capable of being relatively free of chordae tendineae from leaflet carry out cladding clamping, and clamping stability is not ideal enough.

In patent US8449599, Edwards discloses a kind of mitral valve replacement bracket, in the rack outer surface packet Include at least one clamping piece.When the bracket is compressed in sheath, the gap of the clamping piece and the rack outer surface is used To capture leaflet.When the bracket is gradually discharged, the gap of the clamping piece and the rack outer surface is smaller and smaller, from And leaflet therein is clamped.The problem of design, there is at 3 points, first is that bracket and clamping piece are integrally cut, the clamping energy of clamping piece Power is affected by tube wall thickness, and wall thickness equally affects bracket, will lead to two point of compressing when bracket support force is excessive The normal work of valve tissue around such as aorta petal, designer, which is difficult to pursuit clamping piece while balance bracket support force, to be had Biggish chucking power；Second is that the complex process of clamping piece overturning sizing, is just shaped into function, the fatigue performance of clamping piece at last It remains to be discussed；Third is that the region that the clamping piece is only capable of being relatively free of chordae tendineae from leaflet carries out cladding clamping, stability is clamped It is not ideal enough；Fourth is that the same clamping piece is only capable of clamping monolithic leaflet, the reflux between leaflet not can avoid.

Patent US20080033541 discloses a kind of method being fixed on mitral valve bracket on mitral annulus, It struts part using one be fixed on bracket and contradicts most atrium sinistrum, to reach anchoring effect.The design is asked Topic is that artificial mitral valve valve bears the biggish impact force shifted up and down during the motion, if described struts part Insufficient rigidity, then it is difficult to play the role of anchoring；If but the described part that struts is rigidly excessive, then is easy to damage atrium group It knits.

Patent US20130053950 describes a mitral valve bracket, connects in the ventricular section of valve bracket There is tension unit, one end of the tension unit is connected on bracket, and the other end is connected on cardiac muscle, and the tension unit is used to It reduces due to ventricular contraction bring stress.The problem of design, is, is different from mitral valve repair instrument, replaces bracket in the heart By biggish impact when dirty contraction, only do not ensure that it will not be washed from annulus by the tension unit, even will not Annulus is washed from, can also make to replace backing positions offset, cause largely to backflow.

Patent US20140005778 discloses a kind of method being fixed on mitral valve bracket on annulus of mitral valve, Introduce the fixed device of valve bracket, the fixed device of the valve bracket is made of upper and lower two panels intermediate plate, the intermediate plate by The connection of at least two bridge-jointing units.The fixed device of the valve bracket can be packed into it is intrathecal, out after sheath mitral annulus be located at it is upper Between lower two panels intermediate plate, valve bracket is then conveyed again, it is allowed to strut in the fixed device.The problem of design is, Mitral valve apparatus between different patients is widely different, and supplier is difficult to the trouble different with the fixation device de-clamping of limited specification Person；In heartbeat period, the change in size of the annulus tissue of bicuspid valve back lobe attachment is very big, this also brings to the design tired It is difficult.

Patent US20140142691 discloses a kind of method of fixed mitral valve bracket, disposes on aorta The bracket of the bracket of one auxiliary anchoring, the auxiliary anchoring is connect with mitral valve bracket, and in the hope of reaching, to fix two sharp The purpose of valve valve bracket.The limitation of the design is, will increase the difficulty of operation in the bracket that aorta places auxiliary anchoring, And bring damage risk to aorta.The connecting rod between the bracket and mitral valve bracket of anchoring is assisted to will affect master The normal function of artery valve and its related tissue.If being that aortic valve stent is placed simultaneously with mitral valve bracket, It is suitble to the patient of operation will be very rare, just has this kind of patient at last, operating difficulty also greatly improves.And connection will have each other The risk to interact, once there is deviation in placement location, or inclined due to there are backing positions Difference directly affects patient vitals' safety.

Clinical effectiveness shows there is not a ideal mitral valve replacement instrument at present.Main reason is that bicuspid valve valve Ring has special physiological structure, and has complicated physiological environment below annulus, and product is caused to be accurately positioned and fix very It is difficult.Likewise, replacement of tricuspid valves instrument is faced with similar problem with mitral valve replacement instrument.In conclusion more than although Described technology has certain effect respectively on valve reparation, but existing product in the design of anchor mechanism or More or less existing defects.In bicuspid valve or replacement of tricuspid valves field of surgery, needs one kind and have accurate positioning and secured anchor Fixed prosthese.

Summary of the invention:

The purpose of the present invention is be to improve and make up the defect of the prior art and to propose that one kind can be solved effectively a variety of The stent valve prosthese of problem.The present invention includes flank by being provided with clamping piece, the clamping piece on bracket, the flank It can rotate with the root parallel with the longitudinal stent axis and around the root, the flank is during release along institute Valve sewing section radial direction displacement is stated, is reached leaflet and heart wall across the adjacent tissue leaflet intersection of patient, then It is rotated around the root and the outer surface for the valve sewing section that reclines.Release finishes the tissue leaflet of future trouble person and closes on tendon Rope is clamped between the flank and valve sewing section, is conducive to improve valve bracket anchoring fastness, be greatly improved Success rate of operation.

The purpose of the present invention is what is be achieved through the following technical solutions:

A kind of stent valve prosthese, including bracket, leaflet and clamping piece, the bracket include supporting section and valve sewing Section, the proximal end of the supporting section are connect with the distal end of valve sewing section, and the leaflet is connected the valve sewing section On, the supporting section is placed in patient's annulus after discharging and against atrial tissue, and the clamping piece is including one or more A flank, one end of the clamping piece are fixedly connected at the outer surface of valve sewing section, and the clamping piece is from being compressed to Successively for tool there are three form, the first form is that the flank is compressed in control device for release completely；Second form is described Flank reaches leaflet and heart wall along valve sewing section radial direction stretching, extension across the leaflet intersection of adjacent tissue； Third form, which is the flank along the valve, sews that section is circumferentially extending and the valve of reclining sews the outer surface of section.

The purpose of the present invention can also further realize by the following technical programs:

Preferably, the flank has root, and the clamping piece is fixedly connected on the valve by the root and sews The outer surface of section.

Preferably, the flank can be rotated around the root.

Preferably, the root is parallel with the longitudinal stent axis.

Preferably, the root is arranged on the distal portions of the valve sewing section.

Preferably, the root is fixed on the junction of valve the sewing section and the supporting section.

Preferably, the flank is arcuate structure, and the flank is in its natural state along the appearance of valve sewing section Face circumferentially deploying.Flank release, which finishes the tissue leaflet of future trouble person and closes on chordae tendineae, is clamped in the flank and described Valve sews between section.

Preferably, when the clamping piece is released, the root is located at the adjacent tissue leaflet intersection in target affected part. It is furthermore preferred that the root is located at the mitral preceding valve of patient and back lobe boundary position when the clamping piece is released, or The root be located at the preceding valve of patient's tricuspid valve and septal leaflet boundary position or the root be located at the preceding valve of patient's tricuspid valve with Back lobe boundary position or the root are located at back lobe and the septal leaflet boundary position of patient's tricuspid valve.

Preferably, the flank discharges before valve sewing section is released, and design is advantageous in that in this way, passes through While the flank is positioned, valve sewing section is avoided to partially open compressing native leaflets and lead to a natural valve occur Leaf is no longer valid while artificial leaflet not workable leaflet disabler time, influences patient's normal heart blood supply function.

Preferably, the clamping piece is multiple.

It is furthermore preferred that the both side ends of the clamping piece are arc when the same clamping piece includes even number flank Shape, the flank is arranged symmetrically, wherein each flank has single or multiple continuous arc configurations.It designs in this way It is advantageous in that can be avoided using the end of arc and stabs heart wall tissue and cause bleeding.It is furthermore preferred that being set on the clamping piece It is equipped with salient point, in order to enter sheath.

It is furthermore preferred that when the same clamping piece includes two flanks, positioned at the root two sides of the clamping piece The flank is connected to become closed loop configuration in a free state.It is furthermore preferred that being located at the described of the root two sides of the clamping piece Flank the modes such as is tied up by clamping, welding, seam in a free state and is connected each other, or positioned at the root two sides of the clamping piece The flank be shape-memory alloy wire coiling integral structure, or the side positioned at the root two sides of the clamping piece The wing is integrally cut by marmem pipe.

It is furthermore preferred that when the same clamping piece includes two flanks, positioned at the root two sides of the clamping piece The flank is open loop structure in a free state.Designing in this way is advantageous in that the flank for avoiding two sides while entering sheath Pipe causes sheath pipe size to increase.

Preferably, when the same clamping piece only includes single flank, the flank has single or multiple companies Continuous arc configuration, a side end of the clamping piece are arc, and the flank in the different clamping pieces is in free shape The length that valve described in state lower edge sews the outwardly deploying of section is unequal.

Preferably, the root is using being glued, welding, sew around the modes such as wearing, clamp and be fixedly connected at the valve Section.

It is furthermore preferred that be provided with hole on the distal portions of valve sewing section, the root is around being through the hole In.

It is furthermore preferred that the valve sewing section distal portions on be arranged it is jagged, the root straddle it is described lack At mouthful and around being through in the hole.

It is furthermore preferred that the valve sewing section distal portions on be arranged it is jagged, the root straddle it is described lack Collet is socketed at mouthful and in the outer surface of the notch.It is furthermore preferred that the outer surface of the collet is provided with joint-cutting, width of slit Adapt to the diameter of the root.

Preferably, the clamping piece is formed by shape-memory alloy wire coiling or the clamping piece is closed by shape memory Golden tubing cuts and shapes.

Preferably, the diameter of the supporting section be greater than the valve sewing section diameter, the supporting section along its axis to Outer opening is in an inverted cone, and cone angle is 60-160 °.It is furthermore preferred that the cone angle is 135 °.

Preferably, the outer surface of the valve sewing section is by the outer surface of part overlay film or the supporting section by part For overlay film, or both by part overlay film, the material of the film includes polytetrafluoroethylene (PTFE), polyethylene, polypropylene, polyurethane, silicon Glue etc., to effectively prevent perivalvular leakage.

Preferably, the leaflet is made of animal tissue or high molecular polymer.It is furthermore preferred that the animal tissue is Pigs Hearts packet, bovine pericardium, horse pericardium etc., the high molecular polymer are polytetrafluoroethylene (PTFE), polyurethane, silica gel.

Preferably, the bracket is self-expandable stent, and material is shape-memory material or elastic material, preferably NiTi shape Shape memory alloys.It is furthermore preferred that the bracket is using shape-memory material pipe, integrally engraving is made, and preferably NiTi shape is remembered Recalling compo pipe, integrally engraving is made.

The purpose of the present invention is also achieved through the following technical solutions:

A kind of transportation system of stent valve prosthese, the transportation system include stent valve prosthese, epitheca, bracket sheath, Bracket sheath core and clamping piece sheath, the stent valve prosthese include bracket, leaflet and clamping piece, the bracket include supporting section and Valve sews section, and the bracket sheath is arranged on described outer intrathecal with the clamping piece sheath, and the clamping piece sheath is located at the branch Outside frame sheath, the valve sewing section is located in the distal portions of the bracket sheath after being compressed, position after the supporting section is compressed In in the distal portions of the epitheca, the proximal end of the valve sewing section is connect with the distal end of the bracket sheath core, the bracket Sheath core is arranged on that the bracket is intrathecal, and the clamping piece is located in the distal portions of the clamping piece sheath after being compressed, described The proximal end of epitheca is fixedly connected on epitheca operating parts, and the proximal end of the bracket sheath is fixedly connected on bracket sheath operating parts, institute The proximal end for stating bracket sheath core is fixedly connected on bracket sheath core operating parts, and the proximal end of the clamping piece sheath is fixedly connected on clamping piece On sheath operating parts.

It is furthermore preferred that the section of the clamping piece sheath is non-circular.

It is furthermore preferred that be additionally provided with clamping piece sheath core in the clamping piece sheath, the distal end of the clamping piece sheath and described The distal end of clamping piece sheath core is all flexibility, and the distal end of the clamping piece sheath core is contacted with the clamping piece, the clamping piece sheath core Proximal end be fixedly connected on clamping piece sheath core operating parts.

It is furthermore preferred that when the clamping piece needs be compressed into the clamping piece sheath when, the clamping piece with expansion Contrary direction is straightened, and to be compressed in the clamping piece intrathecal.

It is furthermore preferred that the transportation system further includes clamping piece guide wire, the clamping piece guide wire is located at the clamping Part sheath in-core, the flank along the root toward gap is formed after opposite with expansion direction direction compression, when the clamping piece When in the first form, the distal end of the clamping piece guide wire is passed through from the gap, the proximal end of the clamping piece guide wire It is fixedly connected on clamping piece guide wire operating parts.

It is furthermore preferred that the distal portions of the clamping piece sheath are provided with joint-cutting.

It is furthermore preferred that rotating the clamping piece sheath operating parts, enable to the clamping piece sheath together with the institute being located therein Flank is stated to rotate around the root.

Compared with the existing technology, the present invention has the advantages that

1, it is different from the mode of existing clamping leaflet (region for being only capable of being relatively free of chordae tendineae from leaflet carries out axial clamping), The flank on heretofore described clamping piece is real in its natural state along the outer surface circumferentially deploying of valve sewing section An existing clamping piece clamps the purpose of adjacent leaflet tissue and chordae tendineae simultaneously, effectively reduces phase while improving anchoring effect Reflux between adjacent leaflet tissue.

2, middle clamping process is different from the prior art will lead to original leaflet cannot work immediately, mistake of the present invention in release Cheng Zhong, the flank pass through between leaflet and heart wall from the adjacent tissue leaflet intersection of patient and turn around the root Dynamic, from this position, release is avoided that the movement for influencing original mitral leaflet, maintains the normal blood supply of heart, positioning time more fills It is abundant, be conducive to doctor and do position adjustment, improves the accuracy of positioning.

3, the flank of the invention discharges before valve sewing section is released, and design is advantageous in that in this way, While positioning by the flank, valve sewing section is avoided to partially open compressing native leaflets and lead to a day occur Right leaflet is no longer valid while artificial leaflet not workable leaflet disabler time, influences patient's normal heart blood supply function Energy.

4, the one cutting for being different from existing clamping piece and valve bracket designs, heretofore described clamping piece and the valve Film sewing section is to reconnect together after separate design is processed, and the flank can be rotated around the root, can be conveniently described Flank realizes the function of clamping leaflet and its adjacent cords, and designer can pursue while balance bracket support force Clamping piece has biggish chucking power；And the setting process of clamping piece is relatively easy, and fatigue behaviour is good.

5, flank of the present invention is arcuate structure, and the design of arcuate structure enables the flank to be adjacent to the valve The outer surface of section is sewed, and the flank can clamp leaflet and chordae tendineae simultaneously, while the flank is interspersed in chordae tendineae gap In equally enhance clamping effect.

6, root of the present invention is fixed on the junction of valve the sewing section and the supporting section, such design So that the root can be conducive to the flank from patient closer to the adjacent tissue leaflet intersection of patient during release Adjacent tissue leaflet intersection pass through between leaflet and heart wall；The distal end of the flank can contradict patient's annulus simultaneously Position cooperates supporting section clamping patient's annulus, enhances clamping effect.

7, the distal end of clamping piece sheath of the present invention and the distal end of the clamping piece sheath core are all flexible, and its object is to make The deformation of the clamping piece can be complied with by obtaining the clamping piece sheath and the clamping piece sheath core.When the clamp parts expose When the clamping piece sheath, clamping piece sheath described in integrated pushing and the clamping piece sheath core make the clamping piece exposed portion toward the heart Locular wall direction is arched upward, and the flank passes through between leaflet and heart wall from the adjacent tissue leaflet intersection of patient；While this Process is reversible, whole to pull the clamping piece sheath and the clamping piece sheath core that the clamping piece exposed portion be allowed to revert to non-looping The state risen improves positioning accuracy so that doctor can be adjusted multiple times positioning.

8, heretofore described clamping piece guide wire is located at the clamping piece sheath in-core, the flank along the root it is past with Gap is formed after the opposite direction compression of expansion direction, the distal end of the clamping piece guide wire is passed through from the gap, in this way Design can ensure that the flank can be fully opened when the clamping piece guide wire is detached from the gap, avoid institute Flank is stated when discharging from the clamping piece sheath prematurely along the outwardly deploying of valve sewing section, it is ensured that after release The tissue leaflet of patient and close on chordae tendineae be clamped in the flank and the valve sewing section between.

Detailed description of the invention

Fig. 1 a and Fig. 1 b show the schematic diagram of mitral valve apparatus, and Fig. 1 c and Fig. 1 d show the existing skill of bicuspid valve clamping piece The schematic diagram of art.

Fig. 2 a to Fig. 2 d shows the schematic diagram of an embodiment of stent valve prosthese of the invention.

Fig. 3 a and Fig. 3 b show the schematic diagram of the another embodiment of stent valve prosthese of the invention.

Fig. 4 a to Fig. 4 f shows the schematic diagram of the numerous embodiments of clamping piece of the present invention.

Fig. 5 a to Fig. 5 d shows the schematic diagram of multiple embodiments of stent valve prosthese of the invention.

Fig. 6 a to Fig. 6 h shows the schematic diagram of a variety of connection types between clamping piece and valve sewing section of the present invention.

Fig. 7 a to Fig. 7 f shows the schematic diagram of the numerous embodiments of clamping piece of the present invention.

Fig. 8 a to Fig. 8 e shows a kind of schematic diagram of embodiment of the transportation system of stent valve prosthese of the present invention.

Fig. 9 a to Fig. 9 e shows the schematic diagram of the another embodiment of the transportation system of stent valve prosthese of the present invention.

Figure 10 a to Figure 15 c gradually shows stent valve prosthese of the invention and realizes a kind of fixed operating process.

Figure 16 a and Figure 16 b show the schematic diagram of the another embodiment of stent valve prosthese of the invention.

Figure 17 a to Figure 17 d shows the another embodiment schematic diagram of the transportation system of stent valve prosthese of the present invention.

Figure 18 a to Figure 23 c gradually shows stent valve prosthese of the invention and realizes fixed another operating process.

Figure 24 a and Figure 24 b show the schematic diagram of tricuspid valve structure, and Figure 24 c and Figure 24 d show the present invention and applies three A kind of schematic diagram of embodiment when cusp field.

Specific embodiment:

To make the objectives, technical solutions, and advantages of the present invention more comprehensible, right hereinafter, referring to the drawings and the embodiments, The present invention is further described.

Distal end of the present invention refers to one end far from the apex of the heart, and the proximal end refers to one end close to the apex of the heart.

Specific embodiment one:

Mitral valve apparatus 010 as illustrated in figs. 1A and ib, mitral valve apparatus 010 be by annulus of mitral valve 011, preceding valve 012, after The entirety that valve 013, chordae tendineae 014, papillary muscle 015, atrium sinistrum 016 and left ventricle 017 are constituted.Wherein front leaflet 012 (A1, A2, A3) combined segmentation between posterior valve leaflet 013 (P1, P2, P3), be located at preceding outside portion and rear middle part.Such as Fig. 1 c and Fig. 1 d Shown, the TIARA etc. of the FORTIS and Neovasc of existing product Edwards are to utilize the anchoring auricle being fixed on bracket Structure 018 approaches from dissociating from leaflet at annulus, then (rack body is omitted in figure from position shown in Fig. 1 d by leaflet clamping Do not draw), the process that either anchoring auricle 018 is inserted into leaflet bottom still clamps result and avoids chordae tendineae (anchoring ear substantially Piece 018 is located substantially at the area A2 and P2), clamping effect is extremely limited, is anchored not solid and reliable enough.

As shown in figs. 2 a-2 c, in order to improve the effect of positioning and anchoring, the present invention provides a kind of stent valve prostheses 100, including bracket 110, leaflet (not shown) and clamping piece 130, the bracket 110 include that supporting section 111 and valve sew section 112, the proximal end of the supporting section 111 is connect with the distal end of valve sewing section 112, and the leaflet is connected the valve It sews in section 112, the supporting section 111 is placed on patient's annulus or more after discharging and against atrial tissue, the bracket valve Film prosthese 100 includes two clamping pieces 130.Each clamping piece 130 includes single or two flanks 131, described Flank 131 has the root 132 parallel with 110 longitudinal axis of bracket and can rotate around the root 132, the clamping piece 130 one end is fixedly connected on the outer surface that the valve sews 112 distal portions of section, the clamping by the root 132 From release completely is compressed to, successively for tool there are three form, the first form is that the flank 131 is compressed in control device to part 130 It is interior；Second form is the flank 131 along valve sewing 112 radial direction of section stretching, extension, across the adjacent tissue valve of patient Leaf intersection reaches between leaflet and heart wall；Third form is that the flank 131 is circumferentially extending simultaneously along valve sewing section 112 The outer surface for the valve sewing section 112 that reclines.The flank 131 sews section radial direction side along the valve during release It to displacement, reaches leaflet and heart wall across the adjacent tissue leaflet intersection of patient, is then rotated around the root 132, Circumferentially extending along valve sewing section 112 and the valve sewing section 112 that reclines outer surface.It is described adjacent in the present invention Tissue leaflet intersection refers to that having a common boundary between anterior mitral valve and bicuspid valve back lobe (is commissure of mitral valve valve in physiology dissection Place), have a common boundary before tricuspid valve between valve and posterior tricuspid leaflet, have a common boundary between valve and tricuspid valve septal leaflet before tricuspid valve and tricuspid valve Have a common boundary between back lobe and tricuspid valve septal leaflet.

The leaflet is made of animal tissue or high molecular polymer.It is furthermore preferred that the animal tissue be Pigs Hearts packet, Bovine pericardium, horse pericardium etc., the high molecular polymer are polytetrafluoroethylene (PTFE), polyurethane, silica gel.The bracket 110 is from swollen Formula bracket, material are shape-memory material or elastic material, preferably niti-shaped memorial alloy.It is furthermore preferred that the branch Using shape-memory material pipe, integrally engraving is made frame 220, and preferably integrally engraving is made niti-shaped memorial alloy pipe.

As shown in Figure 2 c, the flank 131 is arcuate structure, and the flank 131 is stitched along the valve in its natural state The outwardly deploying of section processed, the flank 131 discharge the tissue leaflet for finishing future trouble person and close on chordae tendineae be clamped in it is described Between flank 131 and valve sewing section 112.The design of arcuate structure enables the flank 131 to be adjacent to the valve The outer surface of section 112 is sewed, and the flank 131 can clamp leaflet and chordae tendineae simultaneously, while the flank 131 is interspersed in Chordae tendineae equally enhances clamping effect in gap.The one cutting for being different from existing clamping piece and valve bracket designs, the present invention Described in clamping piece 130 and the valve sewing section 112 be separate design, reconnected after processing together, 131 energy of flank It is enough to be rotated around the root 132, the flank 131 can be facilitated to realize the function of clamping leaflet and its adjacent cords, designer The clamping piece 130 can be pursued with biggish chucking power while balance bracket support force；And the clamping The setting process of part 130 is relatively easy, and fatigue behaviour is good.As shown in Figure 2 d, existing clamping leaflet is different from (to be only capable of from leaflet phase Axial clamping is carried out to the region of not chordae tendineae) mode (Fig. 1 c and Fig. 1 d), heretofore described clamping piece 130 can be along described Valve sews the outer surface circumferentially deploying of section 112, realizes a clamping piece while clamping the mesh of adjacent leaflet tissue and chordae tendineae , the reflux between adjacent petals leaf texture is effectively reduced while improving anchoring effect.During release, the flank 131 It passes through, is reached between leaflet and heart wall and around described from the adjacent tissue leaflet intersection (in figure from solid black rectangle) of patient Root rotation, is avoided that the movement for influencing original mitral leaflet, maintains the normal blood supply of heart, positioning time is more abundant, favorably Yu doctor does position adjustment, improves the accuracy of positioning.

As shown in Figure 2 a and 2 b, the root 132 using be glued, welding, around wear, the modes such as clamping connection are fixedly connected at The junction (boundary) of valve the sewing section 112 and the supporting section 111, it is described when the clamping piece 130 is released Root 132 is located at the adjacent tissue leaflet intersection in target affected part.As shown in Figure 3a and Figure 3b shows, it is preferred that when the clamping piece 130 when being released, and the root 132 (position 132a and 132b in Fig. 3 b) is located at the mitral preceding valve of patient and back lobe is had a common boundary Position (A and B location in Fig. 3 a).Such design is so that the flank 131 can be closer to the phase of patient during release Neighbour's tissue leaflet intersection, is conducive to the flank 131 and passes through from the adjacent tissue leaflet intersection of patient, reach leaflet and the heart Between wall；The distal end of the flank 131 can contradict patient's annulus position simultaneously, and the supporting section 111 is cooperated to clamp patient's valve Ring enhances clamping effect.

As shown in Fig. 4 a-4f, in one embodiment, the clamping piece 130 includes two flanks 131, the flank 131 be it is arranged symmetrically, such design so that the clamping piece 130 after be compressed in sheath when release, the flank 131 It can symmetrically discharge, be conducive to the effect of clamping anchoring.The both side ends of the clamping piece 130 are arc, and that designs in this way is good Being in, which can be avoided in the end using arc, stabs heart wall tissue and causes bleeding.The flank 131 has single or multiple Continuous arc configuration provides bigger holding area, enhances clamping effect.Positioned at the side of 130 two sides of clamping piece The wing 131 is connected to become closed loop configuration in a free state, and connection means include that clamping, welding, seam such as tie up at the modes.As another Preferred embodiment, the flank 131 positioned at the root two sides of the clamping piece 130 are shape-memory alloy wire coiling Integral structure.As a preferred embodiment, as shown in fig. 4f, it is provided with salient point 133 on the clamping piece 130, so as to In entering sheath.

As shown in Figure 5 a, in one embodiment, the diameter of the supporting section 111 is greater than valve sewing section 112 Diameter, the supporting section 111 be flared out along its axis it is in an inverted cone, cone angle be 60-160 °.Preferably, the cone angle is 135°.Such design can play the role of automatic positioning and support, that is, when the displacement bracket with valve is at implantation position When release, the supporting section 111 is pressed in former heart valve annulus to undertake the function of automatic positioning automatically, and can be It is provided a supporting role after displacement bracket release, displacement bracket is avoided to shed into ventricle.As shown in Fig. 5 b-d, preferably as one Embodiment, the outer surface of the supporting section 111 is by part overlay film 140 or the outer surface quilt of valve sewing section 112 For part overlay film 140, or both by part overlay film 140, the material of the film 140 includes polytetrafluoroethylene (PTFE), polyethylene, poly- third Alkene, polyurethane, silica gel etc., to effectively prevent perivalvular leakage.

As shown in Fig. 6 a-d, in one embodiment, hole is provided on the distal portions of valve sewing section 112 1120, the root 132 is around being through in the hole 1120.Fig. 6 a is diplopore, and the diameter in the hole 1120 is than the root 132 Diameter it is bigger；As shown in Figure 6 b, four up and down side by side are provided on the distal portions of valve sewing section 112 Hole, such design are the bonding strengths in order to improve the root 132 with valve sewing section 112, prevent the root 132 spin in the hole 1120；As fig. 6 c, left and right is provided with simultaneously on the distal portions of valve sewing section 112 Row, but four holes to misplace up and down, such design is also for preventing the root 132 from spinning in the hole 1120； As shown in fig 6d, two non-circular holes 1121 up and down, the root are provided on the distal portions of valve sewing section 112 132 two Nitinol filament windings are worn in the non-circular hole 1121.As shown in fig 6e, in the remote of valve sewing section 112 Non-circular hole 1121 and two circular holes 1120 are provided in end part, form two nitinol alloy wires of the root 132 rotating around Wear the non-circular hole 1121 and circular hole 1120.As shown in Figure 6 f, in another embodiment, section is sewed in the valve Jagged 1122 are arranged on 112 distal portions, the root 132 straddles at the notch 1122, and in the notch 1122 outer surfaces are socketed metal collet 1123.Such design can make the root 132 sew the remote of section 112 with the valve End part is connected firmly, and is able to bear and is rotated and bring torque due to the flank around the root 132.As shown in figure 6g, The outer surface of the metal collet 1123 is provided with joint-cutting 1124, root 132 described in the width adequate of the joint-cutting 1124 it is straight Diameter, such design can prevent the root 132 from slipping from the notch 1122.As shown in figure 6h, preferably as another Embodiment, the valve sewing section 112 distal portions on be arranged jagged 1122, the root 132 straddles institute It states at notch 1122 and around being through in the hole 1121.

As shown in figs. 7 a and 7b, in one embodiment, when the same clamping piece 130 only includes single flank When 131, the flank 131 has single or multiple continuous arc configurations, and a side end of the clamping piece 130 is arc Shape.As shown in Figure 7 c, the flank (131a and 131b) in the different clamping pieces 130 is in a free state along the valve The length that film sews the outwardly deploying of section is unequal (L1 ≠ L2).It is such to design the width that different flanks is clamped It is enough to be adjusted with clamped leaflet, such as bicuspid valve back lobe is longer than anterior mitral valve in axially expanded length, therefore The flank of clamping back lobe is longer than the flank of valve before clamping to be capable of increasing holding area, enhances clamping effect.As shown in Fig. 7 d-f, make For another embodiment, the clamping piece 130a and 130b respectively contains a flank 131a and 131b, the root 132a The junction of valve the sewing section and the supporting section is fixed on 132b, when the clamping piece 130a and 130b is released When, the root 132a and 132b is located at the adjacent tissue leaflet intersection in target affected part.Preferably, as the clamping piece 130a When being released with 130b, the root 132a and 132b is located at the mitral preceding valve of patient and back lobe boundary position.It is such to set Meter can individually control loading and the release of the flank 131a and 131b.

As shown in Fig. 8 a-8e, to realize above-mentioned technical proposal, the present invention also provides a kind of conveyings of stent valve prosthese System 160, the transportation system include stent valve prosthese, epitheca 161, bracket sheath 162, bracket sheath core 163 and clamping piece sheath 164, the stent valve prosthese includes bracket, leaflet (not shown) and clamping piece 130, and the bracket includes 111 He of supporting section Valve sews section 112, and the bracket sheath 162 is located in the epitheca 161 with the clamping piece sheath 164, the clamping piece sheath 164 Outside the bracket sheath 162, the valve sewing section 112 is located in the distal portions of the bracket sheath 162 after being compressed, institute State after supporting section 111 is compressed in the distal portions of the epitheca 161, the proximal end of valve sewing section 112 with it is described The distal end of bracket sheath core 163 connects, and the bracket sheath core 163 is located in the bracket sheath 162, and the clamping piece 130 is compressed Afterwards in the distal portions of the clamping piece sheath 164, the proximal end of the epitheca 161 is fixedly connected on epitheca operating parts 1610 On, the proximal end of the bracket sheath 162 is fixedly connected on bracket sheath operating parts 1620, and the proximal end of the bracket sheath core 163 is fixed It is connected on bracket sheath core operating parts 1630, the proximal end of the clamping piece sheath 164 is fixedly connected on clamping piece sheath operating parts 1640 On.

From release completely is compressed to, successively for tool there are three form, the first form is the clamping piece 130 to the clamping piece 130 It is compressed in the clamping piece sheath 164, the second form is that the flank 131 of the clamping piece 130 sews 112 diameter of section along the valve It is displaced to direction, across the adjacent tissue leaflet intersection of patient, reaches between leaflet and heart wall, third form is the flank 131 around the rotation of its root 132 and the outer surface for the valve sewing section 112 that reclines.

In order to ensure the clamping piece 130 can be discharged from the clamping piece sheath 164, in a preferred embodiment In, clamping piece sheath core 165, the distal end of the clamping piece sheath core 165 and the clamping are additionally provided in the clamping piece sheath 164 Part 130 contacts, and the proximal end of the clamping piece sheath core 165 is fixedly connected on clamping piece sheath core operating parts 1650.It is of the present invention The distal end of clamping piece sheath 164 and the distal end of the clamping piece sheath core 165 are all flexibility, and its object is to make the clamping piece sheath 164 and the clamping piece sheath core 165 can comply with the deformation of the clamping piece 130.When institute is exposed in 130 part of clamping piece When stating clamping piece sheath 164, clamping piece sheath 164 described in integrated pushing and the clamping piece sheath core 165 reveal the clamping piece 130 Part is arched upward toward ventricle wall direction out, and the flank 131 is passed through from the adjacent tissue leaflet intersection of patient, reaches leaflet and the heart Between wall；This process is reversible, whole to pull the clamping piece sheath 164 and the clamping piece sheath core 165 that allow the clamping piece 130 Exposed portion reverts to the non-state to arch upward, so that doctor can be adjusted multiple times positioning, improves locating effect.It is preferred as one Embodiment, when the clamping piece 130 needs are compressed into the clamping piece sheath 164, the flank 131 is along the root 132 past opposite with expansion direction directions compression post-tensionings it is straight enter the clamping piece sheath 164.It is different from common be straightened at sheath Reason can sew section 112 along the valve when such design allows the flank 131 all to expose the clamping piece sheath 164 Circumferentially deploying is arcuate structure, improves clamping force.

As shown in Fig. 9 a-9e, in one embodiment, the section of the clamping piece sheath 164 be it is non-circular, compared to circle Tee section, noncircular cross section can make full use of space, reduce sheath pipe size.As another preferred embodiment, this hair Transportation system 160 described in bright further includes clamping piece guide wire 166, and the clamping piece guide wire 166 is located at the clamping piece sheath In core 165, the proximal end of the clamping piece guide wire 166 is fixedly connected on clamping piece guide wire operating parts 1660.The flank 131 along the root 132 toward gap 1310 is formed after opposite with expansion direction direction compression, when the clamping piece 130 is in When the first form, the distal end of the clamping piece guide wire 166 is passed through from the gap 1310, and such design can ensure institute Stating flank 131 can fully open when the clamping piece guide wire 166 is detached from the gap 1310, avoid the flank 131 prematurely sew the circumferentially deploying of section 112 when discharging from the clamping piece sheath 164 along the valve, it is ensured that release finishes Afterwards the tissue leaflet of patient and close on chordae tendineae be clamped in the flank 131 and the valve sewing section 112 between.

It will gradually illustrate the operating process of the transportation system 160 of heretofore described stent valve prosthese below:

(1) as shown in Figure 10 a-10c, the transportation system 160 of the stent valve prosthese is provided, the transportation system includes Stent valve prosthese, epitheca 161, bracket sheath 162, bracket sheath core 163 and clamping piece sheath 164, the stent valve prosthese 100 wrap Bracket, leaflet (not shown) and clamping piece are included, the bracket includes supporting section 111 and valve sewing section 112, each clamping Part includes single or two flanks 131, and the flank 131 has the root 132 parallel with 110 longitudinal axis of bracket, institute Stating flank 131 can rotate around the root 132, and the clamping piece is fixedly connected on the valve seam by the root 132 The outer surface of 112 distal portions of section processed.

It is pre- after the flank 131 of the clamping piece is compressed along the root 132 toward the direction opposite with expansion direction In the clamping piece sheath 164, it is in the first form (referring to that the clamping piece is compressed in intraluminal state), the clamping piece The distal end of guide wire 166 is passed through from the gap 1310 that the flank 131 is formed by compression；The valve is sewed into section It is taken in the bracket sheath 162 after 112 compressions；Then by it is compressed it is described strut section 111, the clamping piece sheath 164 together with The bracket sheath 162 is taken in together in the epitheca 161.The distal end of the epitheca 161 enters at patient's bicuspid valve through the apex of the heart.

(2) as shown in figures 11a-11c, the stent valve prosthese is transported to patients target position, operates the epitheca Operating parts 1610 makes the epitheca 161 along axial toward proximal slide until described strut section 111 and be released expansion；Described in adjusting The position for strutting section 111 is allowed to be placed on more than patient's annulus and against atrial tissue.

(3) it as shown in Figure 12 a-12c, operates the clamping piece sheath operating parts 1640 and makes the clamping piece sheath 164 along axis Proximal slide is yearned for until the clamping piece is released half, at this moment due to the limitation of the clamping piece guide wire 166, the side The wing 131 fails to complete expansion；The position for adjusting the root 132 makes the root 132 close to the adjacent tissue leaflet of patient Intersection.

(4) as shown in Figure 13 a-13c, clamping piece sheath operating parts 1640 described in integrated pushing, clamping piece sheath core operation Part 1650 and the clamping piece guide wire operating parts 1660, so that the clamping piece 130 in heart turns from first form It turns to the second form and (refers to that the clamping piece 130 arches upward along valve sewing section radial direction, across the adjacent tissue valve of patient Leaf intersection reaches between leaflet and heart wall)；This process is reversible simultaneously, whole to pull the clamping piece sheath operating parts 1640, institute Stating clamping piece sheath core operating parts 1650 and the clamping piece guide wire operating parts 1660 can make 130 exposed portion of clamping piece extensive It is again the non-state to arch upward, doctor can be adjusted multiple times positioning, improve positioning accuracy.Flank 131 of the present invention is in the valve Film discharges before sewing the release of section 112, and design is advantageous in that in this way, while positioning by the flank 131, avoids Valve sewing section 112 partially open compressing native leaflets and cause to occur native leaflets are no longer valid and meanwhile artificial leaflet not The workable leaflet disabler time influences patient's normal heart blood supply function.

(5) as shown in Figure 14 a-14c, the clamping piece sheath operating parts 1640 is operated, so that the clamping piece sheath 164 is opposite The clamping piece sheath core 165 is toward proximal slide, until the clamping piece 130 deviates from the clamping piece sheath 164.Operate the clamping Part guide wire operating parts 1660, so that the relatively described clamping piece sheath core 165 of the guide wire 166 realizes the folder toward proximal slide The gradually release of gripping member 130.Since the clamping piece 130 has shape memory, when the guide wire 166 gradually disengage it is described When clamping piece 130, the flank 131 is rotated around the root 132, the clamping piece 130 from second Forms Transformation be the Three forms (refer to the flank 131 rotate around the root 132 and the outer surface for the valve sewing section 112 that reclines), at this moment suffer from The tissue leaflet of person and close on chordae tendineae be clamped in the flank 131 and the valve sewing section 112 between.

(6) as shown in Figure 15 a-15c, the bracket sheath operating parts 1620 is operated, so that the bracket sheath is along axial toward close End sliding so that valve sewing section 112 is completely released, the tissue leaflet of patient and close on chordae tendineae be clamped at it is described Between flank 131 and valve sewing section 112.

(7) operating the epitheca operating parts 1610 makes the epitheca 161 along axial toward distal end sliding until the epitheca Target seeker is touched in 161 distal end, and then the transportation system 160 withdraws human body from the apex of the heart.

Specific embodiment two:

In order to improve the effect of positioning and anchoring, as shown in fig 16 a and fig 16b, the present invention provides a kind of stent valves Prosthese 200, including bracket 210, leaflet (not shown) and clamping piece 230, the bracket 210 include that supporting section 211 and valve stitch The proximal end of section 212 processed, the supporting section 211 is connect with the distal end of valve sewing section 212, and the leaflet is connected to described Valve sews in section 212, and the supporting section 211 is placed on patient's annulus or more after discharging and against atrial tissue, the branch Frame valve prosthesis 200 includes two clamping pieces 230, and the clamping piece 230 is formed or described by shape-memory alloy wire coiling Clamping piece 230 is cut and is shaped by marmem pipe material.

The clamping piece 230 includes two flanks 231a and 231b, and the flank 231 has and 210 longitudinal axis of bracket The parallel root 232 of line and can be rotated around the root 232, the root 232 using be glued, welding, around wearing, clamp etc. just Formula is fixedly connected on the outer surface of valve sewing 212 distal portions of section, and the clamping piece 230 is solid by the root 232 Surely it is connected to the outer surface of the valve sewing section 212.The flank 231 sews section along the valve during release The displacement of 212 radial directions.Across the adjacent tissue leaflet intersection of patient, reach between leaflet and heart wall, then around described Portion 232 rotates and the outer surface for the valve sewing section 212 that reclines.The flank 231 is arcuate structure, and the flank 231 exists Valve described in nature lower edge sews the outwardly deploying of section 212, and the flank 231 discharges the tissue leaflet for finishing future trouble person And it closes on chordae tendineae and is clamped between the flank 231 and valve sewing section 212.Preferably, it is located at the clamping piece The flank 231 of 230 232 two sides of root is open loop structure in a free state.Designing in this way is advantageous in that and avoids two The flank 131 of side enters a root sheath pipe simultaneously and sheath pipe size is caused to increase.Preferably, the institute of 230 two sides of clamping piece State the integral structure that flank 231 is shape-memory alloy wire coiling, or the flank positioned at 230 two sides of clamping piece 231 are integrally cut by marmem pipe.

As illustrated in figures 17 a-17 c, to realize above-mentioned technical proposal, the present invention also provides a kind of the defeated of stent valve prosthese System 260 is sent, the transportation system 260 includes stent valve prosthese, epitheca 261, bracket sheath 262, bracket sheath core 263 and clamping Part sheath 264, the stent valve prosthese include bracket, leaflet (not shown) and clamping piece 230, and the bracket includes supporting section 211 and valve sew section 212, the bracket sheath 262 is located in the epitheca 261 with the clamping piece sheath 264, the clamping piece Sheath 264 is located at 262 outside of bracket sheath, and the distal end of the clamping piece sheath 264 is flexibility, and the valve sewing section 212 is pressed After contracting in the distal portions of the bracket sheath 262, the supporting section 211 is located at the distal end of the epitheca 261 after being compressed In part, the proximal end of the valve sewing section 212 contradicts the distal end of the bracket sheath core 263, and the bracket sheath core 263 is located at institute It states in bracket sheath 262, the clamping piece 230 is located in the distal portions of the clamping piece sheath 264 after being compressed, the epitheca 261 proximal end is fixedly connected on epitheca operating parts 2610, and the proximal end of the bracket sheath 262 is fixedly connected on bracket sheath operating parts On 2620, the proximal end of the bracket sheath core 263 is fixedly connected on bracket sheath core operating parts 2630, the clamping piece sheath 264 Proximal end is fixedly connected on clamping piece sheath operating parts 2640.

The flank 231a and 231b of 230 two sides of clamping piece is respectively by compression loaded in two clamping piece sheaths In 264a and 264b.As shown in Figure 17 d, in one embodiment, the distal portions of the clamping piece sheath 264 are provided with joint-cutting 2642.The joint-cutting 2642 has directionality, so that the distal portions of the clamping piece sheath 264 have at least two bendings, institute The distal portions for stating clamping piece sheath 264 can comply with the bending and carry out flexible bending.Folder is additionally provided in the clamping piece sheath 264 Gripping member sheath core 265, the distal end of the clamping piece sheath core 265 are flexibility, the distal end of the clamping piece sheath core 265 and the clamping piece 230 abut, and the proximal end of the clamping piece sheath core 265 is fixedly connected on clamping piece sheath core operating parts 2650.

The distal end of clamping piece sheath 264 of the present invention and the distal end of the clamping piece sheath core 265 are all flexibility, and operation is located at The external handle of patient makes the clamping piece sheath 264 arch upward toward ventricle wall direction, and the clamping piece sheath 264 is together with being located therein The flank 231 radially arch upward from the adjacent tissue leaflet intersection of patient, reach between leaflet and heart wall；This process can It is inverse, the external handle of operation patient, such as the clamping piece sheath 264 is made to revert to the non-state to arch upward, so that doctor can be more Secondary adjustment positioning, improves locating effect.After the completion of positioning, the external handle of operation patient make the clamping piece sheath 264 together with The flank 231 being located therein is rotated around the root 232, at this moment the tissue leaflet of patient and is closed on chordae tendineae and is clamped in Between the clamping piece sheath 264 and valve sewing section 212.The last relatively described clamping piece sheath core 265 is dropped back the clamping Part sheath 264, the flank 231 gradually discharge, and after the flank 231 discharges, the tissue leaflet of patient and close on chordae tendineae It is clamped between the flank 231 and valve sewing section 212.

It will gradually illustrate the operating process of the transportation system 260 of heretofore described stent valve prosthese below:

(1) as shown in Figure 18 a-18c, the transportation system 260 of the stent valve prosthese is provided, the transportation system includes Stent valve prosthese, epitheca 261, bracket sheath 262, bracket sheath core 263 and clamping piece sheath 264, the stent valve prosthese include Bracket, leaflet (not shown) and clamping piece, the bracket include supporting section 211 and valve sewing section 212, each clamping piece Including single or two flanks 231, the flank 231 has the root 232 parallel with 210 longitudinal axis of bracket, described Flank 231 can be rotated around the root 232, and the clamping piece is fixedly connected on the valve sewing by the root 232 The outer surface of 212 distal portions of section.

It is pre- after the flank 231 of the clamping piece is compressed along the root 232 toward the direction opposite with expansion direction In the clamping piece sheath 264, it is in the first form (referring to that the clamping piece is compressed in intraluminal state)；By the valve Sewing section 212 is taken in the bracket sheath 262 after compressing；Then described section 211, the clamping piece sheath are strutted for compressed 264 take in the epitheca 261 together with the bracket sheath 262.The distal end of the epitheca 261 enters to patient two through the apex of the heart At cusp.

(2) as shown in Figure 19 a-19c, the stent valve prosthese is transported to patients target position, operates the epitheca Operating parts 2610 makes the epitheca 261 along axial toward proximal slide until described strut section 211 and be released expansion；Described in adjusting The position for strutting section 211 is allowed to be placed on more than patient's annulus and against atrial tissue；Operate the bracket sheath operating parts 2620 make the bracket sheath 262 slide axially until valve sewing section 212 is partially released.

(3) as shown in Figure 20 a-20c, the position for adjusting the root 232 makes the root 232 close to the adjacent of patient Leaflet intersection is organized, clamping piece sheath operating parts 2640 and the clamping piece sheath core operating parts 2650 described in integrated pushing, so that The clamping piece sheath 264 in heart arches upward together with the flank 231 therein along 212 radial direction of valve sewing section, and from The adjacent tissue leaflet intersection of patient passes through, and reaches between leaflet and heart wall, and the clamping piece is from first form at this time It is converted into the second form；This process is reversible, whole to pull the clamping piece sheath operating parts 2640 and clamping piece sheath core operation Part 2650 can make the clamping piece sheath 264 revert to the non-state to arch upward, and doctor can be adjusted multiple times positioning, improve accurate positioning Property.

(4) as shown in Figure 21 a-21c, rotate the clamping piece sheath operating parts 2640 so that the clamping piece sheath 264 together with The flank 231 being located therein is rotated around the root 232, the clamping piece 230 from second Forms Transformation be third Form (refer to the flank 231 rotated around the root 232 and the outer surface for the valve sewing section 212 that reclines), at this moment patient Tissue leaflet and close on chordae tendineae be clamped in the clamping piece sheath 264 and the valve sewing section 212 between.

(5) as shown in Figure 22 a-22c, the clamping piece sheath operating parts 2640 is operated, so that the clamping piece sheath 264 is opposite In the clamping piece sheath core (not shown) toward proximal slide, the clamping piece 230 is completely released, at this moment the tissue leaflet of patient And it closes on chordae tendineae and is clamped between the clamping piece 230 and valve sewing section 212.

(6) as shown in Figure 23 a-23c, the bracket sheath operating parts 2620 is operated, so that the bracket sheath (not shown) phase For the bracket sheath core (not shown) toward proximal slide, the valve sewing section 212 is completely released, at this moment the tissue of patient Leaflet and close on chordae tendineae be clamped at the clamping piece 230 and the valve sewing section 212 between.

(7) operating the epitheca operating parts 2610 makes the epitheca 261 along axial toward distal end sliding until the epitheca Target seeker is touched in 261 distal end, and then the transportation system 260 withdraws human body from the apex of the heart.

Specific embodiment three:

Stent valve prosthese 300 of the present invention can be applied in replacement of tricuspid valves field.Such as Figure 24 a and Figure 24 b It is shown, tricuspid valve structure 020 by Tricuspid annulus 021, septal leaflet 022, preceding valve 023, back lobe 024, chordae tendineae 025, papillary muscle 026, The entirety that atrium dextrum 027 and right ventricle 028 are constituted.As shown in Figure 24 c and Figure 24 d, in one embodiment, the bracket Valve prosthesis 300 includes three clamping pieces 330, and each clamping piece 330 includes two flanks 331, and the flank 331 has There is the root 332 parallel with 310 longitudinal axis of bracket, the clamping piece 330 is fixedly connected on described by the root 332 Valve sews the outer surface of 312 distal portions of section, and the flank 331 can be rotated around the root 332.When the clamping piece 310 when being released, and the root 332 is located at preceding valve 023 and 022 boundary position of septal leaflet or the root of patient's tricuspid valve After the 332 preceding valves 023 for being located at patient's tricuspid valve are located at patient's tricuspid valve with 024 boundary position of back lobe or the root 332 Valve 024 and 022 boundary position of septal leaflet.

Finally it should be noted that the foregoing is merely preferred embodiments of the invention, not to limit this Invention, any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in this hair Within bright protection scope.

Claims

1. a kind of stent valve prosthese, which is characterized in that including bracket, leaflet and clamping piece, the bracket include supporting section and Valve sews section, and the proximal end of the supporting section is connect with the distal end of valve sewing section, and the leaflet is connected the valve Film sews in section, and the supporting section is placed in patient's annulus after discharging and against atrial tissue, and the clamping piece includes one A or multiple flanks, one end of the clamping piece are fixedly connected at the outer surface of the valve sewing section, the clamping piece From release completely is compressed to, successively for tool there are three form, the first form is that the flank is compressed in control device；Second shape State is the flank along valve sewing section radial direction stretching, extension, and the leaflet intersection across adjacent tissue reaches leaflet and the heart Between wall；Third form, which is the flank along the valve, sews that section is circumferentially extending and the valve of reclining sews the appearance of section Face.

2. stent valve prosthese according to claim 1, which is characterized in that the flank has root, the clamping piece The outer surface that the valve sews section is fixedly connected on by the root.

3. stent valve prosthese according to claim 2, which is characterized in that the flank can be rotated around the root.

4. stent valve prosthese according to claim 2, which is characterized in that the root and the longitudinal stent axis are flat Row.

5. stent valve prosthese according to claim 2, which is characterized in that the root is arranged on the valve sewing On the distal portions of the section or root is fixed on the junction of valve the sewing section and the supporting section.

6. stent valve prosthese according to claim 1, which is characterized in that the flank is arcuate structure, the flank In its natural state along the outer surface circumferentially deploying of valve sewing section.

7. stent valve prosthese according to claim 1, which is characterized in that the flank is released in valve sewing section It is discharged before putting.

8. stent valve prosthese according to claim 1, which is characterized in that the clamping piece is multiple.

9. stent valve prosthese according to claim 8, which is characterized in that when the same clamping piece includes even number When flank, the flank is arranged symmetrically.

10. stent valve prosthese according to claim 1, which is characterized in that each flank has single or more A continuous arc configuration.

11. a kind of transportation system of stent valve prosthese according to claims 1 to 10, which is characterized in that the conveying System includes stent valve prosthese, epitheca, bracket sheath, bracket sheath core and clamping piece sheath, the stent valve prosthese include bracket, Leaflet and clamping piece, the bracket include supporting section and valve sewing section, and the bracket sheath is arranged on the clamping piece sheath Described outer intrathecal, the clamping piece sheath is located at outside the bracket sheath, and the valve sewing section is located at the bracket sheath after being compressed Distal portions in, the supporting section is located in the distal portions of the epitheca after being compressed, the proximal end of valve sewing section It is connect with the distal end of the bracket sheath core, it is intrathecal that the bracket sheath core is arranged on the bracket, after the clamping piece is compressed In the distal portions of the clamping piece sheath, the proximal end of the epitheca is fixedly connected on epitheca operating parts, the bracket sheath Proximal end be fixedly connected on bracket sheath operating parts, the proximal end of the bracket sheath core is fixedly connected on bracket sheath core operating parts, The proximal end of the clamping piece sheath is fixedly connected on clamping piece sheath operating parts.

12. the transportation system of stent valve prosthese according to claim 11, which is characterized in that in the clamping piece sheath It is additionally provided with clamping piece sheath core, the distal end of the distal end of the clamping piece sheath and the clamping piece sheath core is all flexible, the clamping The distal end of part sheath core is contacted with the clamping piece, and the proximal end of the clamping piece sheath core is fixedly connected on clamping piece sheath core operating parts On.

13. the transportation system of stent valve prosthese according to claim 11, which is characterized in that when the clamping piece needs When being compressed into the clamping piece sheath, the clamping piece is straightened with the direction opposite with expansion direction and is compressed in the clamping Part is intrathecal.

14. the transportation system of stent valve prosthese according to claim 11, which is characterized in that the transportation system is also wrapped Include clamping piece guide wire, the clamping piece guide wire is located at the clamping piece sheath in-core, and the flank is past with exhibition along the root Evolution forms gap after compressing in the opposite direction, when the clamping piece is in the first form, the clamping piece guide wire Distal end is passed through from the gap of the clamping piece, and the proximal end of the clamping piece guide wire is fixedly connected on the operation of clamping piece guide wire On part.

15. the transportation system of stent valve prosthese according to claim 11, which is characterized in that the clamping piece sheath it is remote End part is provided with joint-cutting.