CN209377809U - A kind of heart valve prosthesis prosthese and its bracket - Google Patents

Abstract

The utility model discloses a kind of heart valve prosthesis prosthese and its bracket, the prosthetic heart valve holder includes outer stent and inner stent；The inner stent is fixedly connected with the outer stent；There is the outer stent axially connected outer layer to flow into road structure and outer layer efferent tract structure；There is the inner stent axially connected inner laminar flow to take part in Taoism structure and internal layer efferent tract structure, and be radially positioned the inside of the outer stent, be provided with anchor structure on the outside of the inner stent.Heart valve prosthesis prosthese and its bracket provided by the utility model, inner stent carries artificial leaflet and rigidity is strong, diameter is small, can reduce artificial leaflet area, reduce leaflet opening and closing movement desired height, improve the leaflet service life；Outer stent relative rigidity is weaker, is relatively large in diameter, can anti-perivalvular leakage.Anchor structure is connect with inner stent, and the anchor force for preventing prosthetic valve mobile is mainly born by the stronger inner stent of rigidity, improves shelf life.

Description

A kind of heart valve prosthesis prosthese and its bracket

Technical field

The utility model relates to a kind of insertion type medical prosthesis more particularly to a kind of heart valve prosthesis prosthese and its branch Frame.

Background technique

Heart contains there are four the chambers of the heart, and atrium sinistrum and left ventricle are located at left side of heart, and atrium dextrum and right ventricle are located at the heart right side Side.Atrium and compartment space form ventricular inflowing tract structure, and left ventricle and aorta form left ventricular outflow tract view structure, right ventricle and lung Arteriogenesis outflow tract of right ventricle structure.There is the valve with " check valve " function at room inflow road structure and ventricular outflow tract view structure Film guarantees the proper flow of heart intracavity blood.When the valve when something goes wrong, cardiac hemodynamics changes, and cardiac function is different Often, referred to as valvular heart disease.

With the development of social economy and the aging of population, the disease incidence of valvular heart disease is obviously increased, and studies table Bright 75 years old or more elderly population valvular heart disease disease incidence is up to 13.3%.Surgical operation therapy is still severe valve lesion The preferred treatment means of patient, but for advanced age, merge Multiple organs disorders, have open chest surgery history and the poor trouble of heart function Person, operation risk is big, and the surgical operation death rate is high or even some patientss lose operative chance.Through conduit valve merging/reparation Art then has without opening chest, and wound is small, and patient restores the advantages that fast.

Primary heart valve structure is different, and the anatomical structure and pathology that heart valve prosthesis needs to face when interventional therapy need Ask also different.

Valve at left room inflow road structure, right ventricular inflow tract endocardium pacing structure is respectively bicuspid valve, tricuspid valve, and valve is combination Body, including annulus, leaflet, chordae tendineae and papillary muscle also include ventricle wall in the document of part.Chordae tendineae as connection mitral leaflet with The support device of cardiac muscle, is distributed between leaflet and ventricle wall.Mitral valve flowering structure (chordae tendineae, papillary muscle, ventricle wall etc.) To maintaining Left Ventricular Structure and function to play an important role, retain native valve structure in surgical operation as far as possible.Therefore, using warp Conduit implantable prosthetic valve prosthese also needs the structure for adapting to native valve as far as possible when replacing native valve, reduce prosthetic valve to original The destruction of raw valve structure.

Valve at left ventricular outflow tract view structure, outflow tract of right ventricle structure is respectively aorta petal, pulmonary valve, with inflow road Valve is different at structure, and the valve at efferent tract structure only includes leaflet and annulus.

The existing prosthetic valve through conduit displacement aorta petal is primarily adapted for use in calcific aortic valve patient, anchor mechanism It generates enough radial support power for the annulus of prosthetic valve radial compression native valve and improves prosthetic valve and native valve Between frictional force, anti-Hemostatic Oral Liquid impact prosthetic valve displacement, so that prosthetic valve plays check valve at the position of native valve Function.Currently on the market be support that nickel-titanium metal or other biological compatible material make through conduit displacement aorta petal Main body contacts fixation with native valve, the fixed fae body leaflet inside supportive body, to realize along direction of flow of blood unilateral side quilt Design dynamic to open, that inverse direction of flow of blood prosthese leaflet is passively closed, the required branch when the annulus of native valve is bigger The size for supportting main body is bigger.

When aorta petal prosthetic valve is implanted into primary bicuspid valve, since anatomically mitral annulus size is much larger than Aorta petal annulus size, be implanted into the supportive body of mitral prosthetic valve to match prosthese leaflet part no matter It is required to bigger size on circumferential diameter or axial height, prosthetic valve is caused to be implanted into the prosthese knot under its valve of after the mitral valve Structure size is larger, and to the valve flowering structure of native valve assembly, there are biggish damage risks.Part mitral regurgitation is suffered from Person can not utilize the radial support power generated between prosthetic valve and native valve using existing without calcification part on valve Come the working principle for preventing prosthetic valve from shifting.

Atrioventricular valve of the tricuspid valve as right heart, structure is similar with bicuspid valve, also includes leaflet, annulus, chordae tendineae, nipple Flesh and cardiac muscle.It can be applied to replace primary tricuspid valve, native valve size for replacing primary mitral prosthetic valve also The prosthetic valve size of difference, insertion type displacement is different.

However existing prosthetic valve has the problem that

1. the opening area of bicuspid valve native valve is larger, vacation when prosthetic valve is replaced, under implantation its valve of after the mitral valve Body valve structure size is larger, and to the valve flowering structure of native valve assembly, there are biggish damage risks；

2., can not be false using existing aorta petal without calcification part on valve for part patients with mitral incompetence The replacement of body valve, the work for preventing prosthetic valve from shifting using the radial support power generated between prosthetic valve and native valve are former Reason.

Utility model content

The technical problem to be solved by the utility model is to provide a kind of heart valve prosthesis prosthese and its brackets, it is intended to solve Certainly there are problems that biggish damage risk and prosthetic valve are easy displacement to the valve flowering structure of native valve assembly.

The utility model is to solve above-mentioned technical problem and the technical solution adopted is that provide a kind of heart valve prosthesis branch Frame, including outer stent and inner stent；The inner stent is fixedly connected with the outer stent；The outer stent has Axially connected outer layer flows into road structure and outer layer efferent tract structure；There is the inner stent axially connected inner laminar flow to take part in Taoism Structure and internal layer efferent tract structure, and it is radially positioned the inside of the outer stent, anchor is provided on the inner stent Fixing structure.

Preferably, the inner stent and outer stent are made of different biocompatible materials, and the inner stent Rigidity be greater than the outer stent rigidity.

Preferably, the inner stent and outer stent are made of same biocompatible material, and use different knots Structure or heat treatment process make the rigidity of the inner stent greater than the rigidity of the outer stent.

Preferably, in the expanded state, in a tubular form, the maximum tubulose outer diameter of the inner stent is less than the inner stent 75mm。

Preferably, the outer stent or/and inner stent in the axial direction by an at least row along the circumferential direction on phase each other The network cells to connect form, and are provided with hangers on the outer stent or/and inner stent.

Preferably, the distal end of the internal layer efferent tract structure extends along the axis direction away from the inner stent.

Preferably, the inner stent is connected at the internal layer efferent tract structure with the outer stent, and described The axial position of the tie point of inner stent and the outer stent is higher than the connection of the anchor structure and the inner stent Point.

Preferably, connected between the outer stent and inner stent by riveting, welding, suture, animal pericardium or skirt It connects.

Preferably, the outer stent and inner stent are all made of network cells in the axial direction, the netted knot Structure unit has grid edge bars and node, and the node is that adjacent web structural unit connects the tie point to be formed, the net Grid edge of the lattice edge bars between adjacent node；The node of network cells and the internal layer branch on the outer stent The overlapped formation tie point of the node of network cells on frame；Or the grid edge bars on the inner stent with it is described The node of netted cellular construction or grid edge bars overlap to form tie point on outer stent；Or the net on the outer stent The node overlapping of netted cellular construction forms tie point in lattice edge bars and the inner stent.

Preferably, the outer layer flows into road structure proximal end and extends outwardly radially away from the inner stent, the outer laminar flow Structure of taking part in Taoism proximal end minimum diameter is greater than 25mm.

Preferably, the outer layer efferent tract structure distal radial extends to form to the medial cradle side and receives structure in one, Described interior one end for receiving structure is adjacent or connected with the inner stent, and the interior other end for receiving structure and the outer layer flow out The connection of road structure.

Preferably, the main body of the outer layer efferent tract structure is cylindrical, conical, elliptical cylinder-shape, or is cross section D-shaped cylinder.

Preferably, the anchor structure is at least distributed two along the circumferencial direction of internal layer efferent tract structure.

Preferably, the anchor structure has both ends, and wherein one end is fixing end, mutually fixes with the inner stent, separately One end is free end.

Preferably, the anchor structure is rod-like structure, and the fixing end of the rod-like structure is consolidated with the inner stent Fixed point is 1, and the free end of the rod-like structure is spherical in shape or spheroid shape.

Preferably, the anchor structure has both ends, and the both ends are each attached to the reticular structure list of the inner stent In member, the structural unit of the anchor structure and inner stent forms enclosed construction.

Preferably, inner stent side is provided with barbule on the anchor structure, or is arranged to zigzag.

Another technical solution that the utility model uses to solve above-mentioned technical problem is to provide a kind of artificial heart valve Film prosthese, including above-mentioned prosthetic heart valve holder, further include artificial leaflet and skirt, and the artificial leaflet is arranged described interior The inside of layer bracket, the skirt is set to inner surface or/and the outer surface of the outer stent or/and inner stent, described The region of skirt covering includes at least the artificial leaflet and carries out artificial leaflet the covering on inner stent when opening and closing movement Cover area.

Preferably, the skirt is from flowing on the inside of road structure proximal end the outer layer of the outer stent to the internal layer Extend at the tie point of bracket and the outer stent, then takes part in Taoism knot along the outer lateral inner laminar flow of the inner stent Structure direction extends.

The utility model comparison prior art has following the utility model has the advantages that 1, heart valve prosthesis provided by the utility model Bracket is double-layer scaffold, including inner stent and outer stent, and inner stent carries artificial leaflet rigidity height and matching valve prostheses The diameter of leaf is smaller, can reduce artificial leaflet area, reduces leaflet opening and closing movement desired height, improves the leaflet service life, reduce valve Lower height.Outer stent relative rigidity is lower, be bonded with primary structure and realizes sealing function, can anti-perivalvular leakage；Outer layer branch Though the stent diameter of frame is big, it is not subject to traction force when prosthese leaflet closure, and the part that working condition lower bracket is subject to is big The risk of stress is lower, and the service life is higher；2, it is provided with anchor structure on the outside of the inner stent, due to anchor structure and internal layer Bracket stable connection, the anchor force for preventing prosthetic valve mobile are mainly born by the stronger inner stent of rigidity, are realized higher Structural life-time；3, the valve flowering structure height of prosthetic valve is low, reduces the interference risk to primary heart valve flowering structure, reduces ventricle Efferent tract structure blocks risk；4, particularly the inner stent and outer stent integrally cut by same biocompatible material It forms, no longer needs to connect each structure by post-production, each interstructural relative position is stable, accurate, avoids because the later period is each Position deviation bring functional defect between each structure caused by item factor.

Detailed description of the invention

Fig. 1 is the bracket overall structure diagram of the heart valve prosthesis in the utility model embodiment；

Fig. 2 is the structural schematic diagram of the inner stent of the heart valve prosthesis in the utility model embodiment；

Fig. 3 is positional structure schematic diagram of the bracket of the heart valve prosthesis in the utility model embodiment in heart；

Fig. 4 is positional structure schematic diagram of the another heart valve prosthesis in heart in the utility model embodiment；

Fig. 5 is the bracket of the heart valve prosthesis in the utility model embodiment and the connection schematic diagram of anchor structure；

Fig. 6 is the inner stent and the integrally formed knot of outer stent of the heart valve prosthesis in the utility model embodiment Structure schematic diagram；

Fig. 7 is bracket, skirt and the prosthese lobed of the heart valve prosthesis in the utility model embodiment at single Blood flows to access diagram；

Fig. 8 be the utility model embodiment in skirt inner stent and outer stent distribution schematic diagram；

Fig. 9 a-9d is the heart valve prosthesis or inner stent in the utility model embodiment with different anchor structures Structural schematic diagram.

Appended drawing reference:

100: bracket 200: valve 300: skirt

110: inner stent 120: outer stent 130: anchor structure

140: hangers 1110: inner laminar flow is taken part in Taoism structure 1120: internal layer efferent tract structure

1210: outer layer flows into road structure 1220: outer layer efferent tract structure 1111: inner laminar flow is taken part in Taoism structure proximal end

1112: inner laminar flow is taken part in Taoism structure distal end 1121: internal layer efferent tract structure proximal end 1122: internal layer efferent tract structure distal end

1211: outer layer flows into road structure proximal end 1212: outer layer flows into road structure distal end 1221: outer layer efferent tract structure proximal end

1222: outer layer efferent tract structure distal end 131: fixed point 132: free end

210: prosthese leaflet connecting pin

Specific embodiment

In the following description, in order to provide the thorough understanding of the utility model, many concrete details are elaborated.However, The utility model can be practiced in the case where these no concrete details, this will for the common technical staff in this field It is obvious.Therefore, concrete details elaboration is only exemplary, and concrete details can be by bold and unrestrained spirit and model It encloses and changes and be still considered as in the spirit and scope of the utility model.

The utility model provides a kind of heart valve prosthesis prosthese (also referred to as " prosthetic valve ") being implanted into through conduit, is used for Replacement heart valve, predominantly bicuspid valve or tricuspid valve, including prosthetic heart valve holder.Prosthetic heart valve holder is bilayer Bracket, inner stent rigidity is strong, bears the traction force of prosthese leaflet；Outer stent relative rigidity is weaker, is bonded with primary structure, The main anti-perivalvular leakage function of realizing prosthese；Anchor structure is stably connected with inner stent.

Specifically incorporated by reference to shown in Fig. 1 to Fig. 8, a preferred embodiment of the utility model provides a kind of heart valve prosthesis Prosthese, including bracket 100, valve 200 and skirt 300.Bracket 100 includes inner stent 110, outer stent 120, anchor structure 130 and conveyer connection structure (hangers 140).Inner stent 110 is radially positioned 120 inside of outer stent, and bracket 100 is pressed Direction definition according to blood flow is to flow into road structure and efferent tract structure, and double-layer scaffold, which is respectively provided with, flows into road structure and outflow There is axially connected inner laminar flow to take part in Taoism structure 1110 and internal layer efferent tract structure 1120 for road structure, i.e. inner stent 110, outer layer There is bracket 120 axially connected outer layer to flow into road structure 1210 and outer layer efferent tract structure 1220.There is bracket 100 pressure to hold shape Two kinds of forms of state and swelling state, i.e. inner stent 110 and outer stent 120 all have both states.In the utility model It is such as emphasized without special, is to the feature description under stent expansion state.

Inner stent 110 is radially positioned the inside of outer stent 120, and the rigidity of inner stent 110 is strong, for holding By the blood active force that the artificial leaflet of prosthetic valve prosthese is subject to during the motion, and the relative rigidity of outer stent 120 It is weaker, it can be bonded with primary structure, realize the anti-perivalvular leakage function of prosthese.Although outer stent 120 is relatively large in diameter, by Traction force when it is not subject to prosthese leaflet closure, under working condition outer stent 120 by the big stress in part risk compared with It is low, therefore outer stent 120 lasts a long time.And 110 radial dimension of inner stent for carrying artificial leaflet is smaller, therefore artificial The radial dimension of leaflet also can be set smaller, thus the axial dimension occupied by artificial leaflet when carrying out opening and closing movement Small, prosthetic valve entirety axial height also becomes smaller therewith, and size is lower under the valve after entire prosthetic valve implantation, reduces interference The risk of primary structure's structure additionally due to artificial leaflet area is small, therefore greatly improves the fatigue resistance of artificial leaflet, Extend the service life of artificial leaflet.

Due to the heart valve prosthesis prosthese in this preferred embodiment, anchor structure 130 is outer with inner stent 110 Layer bracket 120 is connected, it is therefore prevented that the anchor force of prosthetic valve movement is mainly born by the biggish inner stent 110 of rigidity, it can To realize higher structural life-time.

Inner stent 110 in a tubular form, and the tubulose outer diameter of inner stent 110 be less than native valve diameter, ordinary circumstance Under, the tubulose outer diameter of the diameter range 25-75mm of native valve annulus, inner stent 110 are less than 75mm, usual inner stent 110 tubulose outer diameter is 20-35mm.Inner stent 110 has significant radial direction and axial rigidity, can bear leading for leaflet It draws, wherein the inside of inner stent 110 is stably connected with prosthese leaflet 200.

Inner stent 110 can be made of NiTi or other biocompatible materials with shape memory characteristic, be used Heat treatment, sandblasting, polishing or other techniques that brackets can be processed are made after cutting.As option, inner stent 110 The biocompatible material such as cochrome, stainless steel can be used to be made, in implantation process using balloon expandable to designated modality and It functions.

Inner laminar flow takes part in Taoism structure 1110 as cylinder, and outside maximum gauge is not more than the diameter of the native valve of its replacement, Internal layer efferent tract structure 1120 is the cylinder of the identical inner and outer diameter of structure 1110 of taking part in Taoism with inner laminar flow.Internal layer efferent tract structure proximal end 1121 and inner laminar flow structure distal end of taking part in Taoism 1112 connect, size is also identical.In another embodiment, internal layer efferent tract structure distal end 1122 may be set to be along the axis direction extension far from inner stent 110, so that inner stent 110 is in horn-like (figure Do not show).

Inner stent 110 has multiple network cells or wavy shaped configuration unit, the multiple network cells Or wavy shaped configuration unit is connected with each other in the circumferential along the axial direction of the inner stent 110.

In specific implementation, as shown in figure 3, after valve prosthesis implantation human body, inner laminar flow is taken part in Taoism structure proximal end 1111 and outer The laminar flow close or inner laminar flow of height in the axial direction of inner stent 110 of structure distal end 1212 of taking part in Taoism is taken part in Taoism structure proximal end 1111 Road structure distal end 1212 is flowed into lower than outer layer along towards efferent tract structure direction in the axial direction, so that blood enters ventricle from atrium In the process, no apparent blood is detained.I.e. on axial height, take part in Taoism structure proximal end 1111 and outer layer of inner laminar flow flows into road structure Distally the 1212 close or inner laminar flows of height, 1111 height of structure proximal end of taking part in Taoism flows into road structure distal end lower than outer layer and 1212 (is propping up Frame it is central axial on, close to atrium sinistrum end be height, close to left ventricular end be it is low), at this point, the entire axial direction of inner stent 110 Valve 200 is all covered in height.

In another specific implementation, as shown in figure 4, inner laminar flow is taken part in Taoism structure proximal end 1111 after prosthetic valve implantation human body Road structure distal end 1212 is flowed into axially along outer layer is higher by far from efferent tract structure direction.Guaranteeing needed for fixed fae body leaflet On the basis of designing total height, height under the valve of inner stent 110 is minimized, thus height under reducing the valve of bracket totality, reduction The risk of blood efferent tract structure obstruction.It, can be suitably by inner stent i.e. in the case where inner stent 110 is total high constant 110 atrial end movements to the left, so that inner laminar flow is taken part in Taoism, structure proximal end 1111 is higher than outer layer inflow road knot on bracket axial height Structure distal end 1212, at this point, the proximal end of the valve 200 on inner stent 110 flows into road structure distal end 1212 lower than outer layer, or in axis Upwards, close namely inner stent 110 the inner laminar flow of the two height structure proximal end 1111 of taking part in Taoism is not completely covered by valve 200.

As shown in figure 5, outer stent 120 is connect in efferent tract structure side with inner stent 110, in bracket axial height On, the tie point of inner stent 110 and outer stent 120 is higher than the tie point of anchor structure 130 and inner stent 110.Outer layer Direct or indirect connection is carried out on the outside of efferent tract structure distal end 1222 and inner stent 110, at the two tie point, entirety or portion The network cells of outer stent 120 are divided to connect with inner stent 110.Outer stent 120 and inner stent 110 are in the axial direction It is all made of network cells, the network cells have grid edge bars and node, and the grid edge bars are shape The rod piece of structural unit is reticulated, the node is that at least two grid edge bars connect the tie point to be formed；For example, internal layer branch Frame 110 and outer stent 120 are connect by node with node weld, and in junction, outer stent 120 has 18 nodes, internal layer Bracket 110 has 18 nodes, successively can all weld respective 18 nodes one by one, can also respectively circumferentially equably selection pair The node number of the several node welds answered, inner stent 110 and the respective junction of outer stent 120 can identical not yet Together, the corresponding node of appropriate number can be selected to be attached according to actual needs.Tie point can be node and connect with node (i.e. on outer stent 120 on the node and inner stent 110 of network cells network cells the overlapped shape of node At tie point), node and the connection of grid edge bars, grid edge bars the various suitable connection shapes such as connect with grid edge bars Formula, it may be assumed that the node or grid edge bars of netted cellular construction in the grid edge bars and outer stent 120 on inner stent 110 Overlap to form tie point；Or the node of the grid edge bars on outer stent 120 and netted cellular construction on inner stent 110 Overlap to form tie point.Tie point can be circumferentially distributed on the grid of same axial height, can be uniformly also uneven, can also be fitted When mutually staggering, i.e., adjacent several tie points are located on the grid of upper and lower axially different height.Connection type can be The various suitable connection types such as riveting, welding, suture connection, can also be attached by animal pericardium and skirt.

Outer layer flows into 1210 flare shape of road structure and extends to far from 110 side of inner stent, the inflow of outer stent 120 Road structure covers atrioventricular orifice, and outer layer flows into diameter at road structure proximal end 1211 and is greater than native valve diameter.Outer layer flows into road structure Diameter at proximal end 1211 can be 25-75mm.

It is adjacent that outer layer efferent tract structure proximal end 1221 and outer layer flow into road structure 1210, outer layer efferent tract structure 1220 with it is interior Laminar flow is engaged in this profession, and structure 1120 is adjacent, and 1220 main body full-size of outer layer efferent tract structure is greater than native valve diameter.Outer layer outflow 1220 main body of road structure can be cylindrical or conical, can be effectively bonded with primary leaflet, without circumferential right Position.Preferably, 1220 main body of the outer layer efferent tract structure column D-shaped in elliptical cylinder-shape or cross sectional shape, can more adapt to The form of native valve.Radially-inwardly layer bracket 110 extends for outer layer efferent tract structure distal end 1222, forms interior receipts structure, interior receipts One end of structure is adjacent with inner stent 110 or connects, and the interior other end for receiving structure and outer layer flow into 1210 main body of road structure and connect It connects.

The structure list that outer stent 120 can be changed by the axial form such as network cells or wavy shaped configuration unit Member composition.It is made of on outer stent 120 is axial the structural unit being interconnected with one another in at least circumferential direction of a row.Outer stent It can be connected to each other directly or be indirectly connected between 120 axial multiple rows of units.There is outer stent 120 pressure to hold state and swelling state Two kinds of forms, pressure is held structural unit axial dimension described under state and is increased and circumferential diameter reduction, conversely, swelling state lower axle To size reduction, circumferential diameter increases.Network cells can form close-shaped for diamond shape, pentagon, hexagon etc. Unit.

120 material of outer stent is NiTi or other biocompatible materials with shape memory characteristic.Outer stent 120 Silk braiding can be used, or be used in conjunction with using cutting technique manufacture, or both, through techniques such as Overheating Treatment, sandblasting, polishings It is fabricated, the technique that other manufacture brackets can also be used is made, such as 3D printing etc..

Outer stent 120 can also use silk weaving, be woven using one or more silk.Inner stent 110 It is made after being cut using tubing, at the two tie point, 110 providing holes of inner stent, during outer stent 120 weaves It is attached between fixation, or both using line or other materials behind the hole.

Outer stent 120 can also using after cutting technique by through the manufacture of the techniques such as Overheating Treatment, sandblasting, polishing and At with the progress direct or indirect connection of inner stent 110.It is described to be directly connected to such as weld metal connection type, between described It connects in succession as used third party's component, as rivet connects the two or high molecular material between outer stent and inner stent.

As shown in fig. 6, preferably, in a further preferred embodiment, outer stent 120, inner stent 110 and anchor structure 130 pass through one cutting manufacture, that is to say, that outer stent 120, inner stent 110 and anchor structure 130 are integrally formed.Cutting After the completion, it is designed using special support Design and heat treatment, by techniques such as sandblasting, polishings, bracket is made to form inner stent 110 rigidity are strong, the weak feature of 120 rigidity of outer stent.After the completion of one cutting, the structural unit of outer stent 120 from its with The tie point of inner stent 110 extends radially away from medial cradle, extends to form outer stent then to road structure direction is flowed into 120 structure.Bracket 100 is by one cutting manufacture, and inner stent 110, outer stent 120 and anchor structure 130 are initial State is just an entirety, no longer needs to connect each structure by post-production, and each interstructural relative position is stable, accurate, is kept away Position deviation bring functional defect between each structure caused by having exempted from because of later period items factor, such as positioning when connection processing Each interstructural loosening etc. caused by stress after error, prosthetic valve implantation.

In other embodiments, outer stent 120 can also be using cutting, weaving combination manufacture.For example, outer laminar flow The structure that structure of taking part in Taoism 1210 is formed using braided wires, the structure that outer layer efferent tract structure 1220 is formed using cutting technique, Outer layer efferent tract structure side 1220 and inner stent 110 carry out direct or indirect connection.The outer layer of outer stent 120 flows into road knot There are direct or indirect connections with outer layer efferent tract structure side 1220 for structure 1210.It is directly connected to have for the structural unit of different parts Tie point, employing mode is as welded.It is indirectly connected with to flow into road structure side unit and efferent tract structure side unit connectionless point, It is such as connected using third party's component, such as outer stent 120 and inner stent 110 are indirectly connected with by rivet.In specific implementation, Outer layer efferent tract structure 1220 is integrally formed with inner stent 110, and then the outer layer with weaving manufacture flows into road structure 1210 carry out direct or indirect connection.

As shown in fig. 7, the valve 200 includes at least two panels prosthese leaflet, the prosthese leaflet using animal pericardium or The compatible high molecular material of other biological, prosthese leaflet connecting pin 210 are directly or indirectly stably connected with inner stent 110, false The body leaflet other end is free edge 220.Under prosthetic valve working condition, prosthese leaflet substitutes primary leaflet and realizes opening and closing The function of blood channel.

The prosthese leaflet of valve is connected to 110 inside of inner stent, 110 inner surface of inner stent or outer surface or interior appearance Face covers skirt 300, and the region that skirt 300 covers includes at least artificial leaflet and carries out when opening and closing movement including the artificial leaflet Overlay area on layer bracket 110, realizes the sealing function of skirt 300, guarantees that the single channel of blood is from prosthese leaflet Flow into the efferent tract structure end that structure end in road flows to prosthese leaflet.

Outer stent 120 and inner stent 110 skirt as caused by pericardium or other biological compatible high molecular material system 300 coverings, cooperation prosthese leaflet 200 form single blood and flow to channel.The gravity flow of skirt 300 is taken part in Taoism on the inside of structure proximal end 1211 It rises and extends at the tie point of inner layer bracket 110 and outer stent 120, then flowed sideways into along the outer of inner stent 110 Structure direction extends, and covers entire inner stent 110.It skirt 300 can also be from the inflow road structure proximal end of outer stent 120 1211 insides are risen to be extended at the tie point of inner layer bracket 110 and outer stent 120, then lateral outside inner stent 110 It flows into road structure direction to extend, covering part inner stent cellular construction, i.e., takes part in Taoism the portion of structure proximal end 1111 close to inner laminar flow Sub-unit does not cover skirt.Skirt 300 can also be covered with the inner side and outer side of inner stent 110, at least within the skirt of side Side 300 covers overlay area when artificial leaflet is opened on inner stent.

Anchor structure 130 from 1120 side of internal layer efferent tract structure radially away from inner stent 110, and anchor structure 130 Fixed point 131 of the free end 132 far from anchor structure 130 and inner stent 110 is towards flowing into road structure direction, outer stent 120 segment sections are between free end 132 and fixed point 131.The fixed point 131 can be located at appointing for internal layer efferent tract structure side Meaning position.Preferably, the fixed point be located at inner laminar flow take part in Taoism structure distal end 1112.

Anchor structure 130 is circumferential to be at least distributed two, and two leaflets of bracket 100 and native valve are carried out anchor respectively Gu.Under prosthetic valve stent expansion state, the leaflet of native valve is clamped between anchor structure 130 and outer stent 120, prevents Only valve prosthesis is flowed into road structure direction to bracket by blood pressure and obviously shifted.The anchor structure 130 and inner stent 110 Can be integrated between being process, or both using riveting, welding, buckle etc. are any can be stably connected with by the way of connected It connects.

In specific implementation, as illustrated in fig. 9, anchor structure 130 is cantilever design, and the base portion of the cantilever is fixed point 131, the free end of cantilever is 132, and prosthetic valve has 8 cantilever designs, and 8 cantilever designs are circumferentially divided at equal intervals Cloth is on inner stent 110.Cantilever design may be rod-like structure, the fixed point of each cantilever design and inner stent 110 For 1 position, free end 132 is the shapes without obvious corner angle such as spherical shape, spheroid shape.

In specific implementation, as shown in figure 9b, the first and last end of anchor structure 130 is each attached to the inner stent 110 On network cells, so that the structural unit of anchor structure 130 and inner stent 110 forms enclosed construction, each anchoring knot The fixed point of structure and inner stent 110 is at least two.

In specific implementation, as is shown in fig. 9 c, there are barbule or it is arranged on anchor structure towards 120 side of outer stent Zigzag, barbule or sawtooth are pierced into leaflet under swelling state, can further increase anchor force.

In specific implementation, as shown in figure 9d, anchor structure and primary leaflet bonding position side, i.e. direction on anchor structure Zigzag fashion is presented in 120 side of outer stent, increases the frictional force between anchor structure and leaflet, improves anchoring stability.

In specific implementation, hangers 140 is the connection knot between prosthese bracket 100 and the transportation system for transporting prosthetic valve Structure, hangers 140 can be manufactured on inner stent 110, and can also be manufactured on outer stent 120, or both all has, and position can Flow into road structure proximal end 1211 positioned at outer layer, outer layer efferent tract structure distal end 1222, inner laminar flow take part in Taoism structure proximal end 1111 or/and Internal layer efferent tract structure distal end 1122.Hangers 140 is taken part in Taoism structure proximal end 1111 in inner laminar flow, and prosthetic valve is using bilateral release Mode.Bilateral release is before prosthetic valve discharges completely, and flowing into road structure side and efferent tract structure side can be detached from Transportation system, first releases anchor structure 130, and primary leaflet is located at anchor by subsequent discharge section outer layer efferent tract structure 1220 After between fixing structure 130 and outer stent 120, gradually releases outer layer and flow into road structure 1220, finally release inner laminar flow and take part in Taoism knot Structure 1110.

Atrioventricular valve of the tricuspid valve as right heart, structure is similar with bicuspid valve, also includes leaflet, annulus, chordae tendineae, nipple Flesh and cardiac muscle.It can be applied to replace primary tricuspid valve, native valve size for replacing primary mitral prosthetic valve also The prosthetic valve size of difference, insertion type displacement is different.

To sum up, the valve flowering structure height of heart valve prosthesis prosthese provided by the utility model, prosthetic valve is low, reduction pair The interference risk of primary heart valve flowering structure reduces ventricular outflow tract structure and blocks risk；Double-layer scaffold design, inner stent 110 rigidity are high and match that the diameter of prosthese leaflet is smaller, and the service life of inner stent 110 and prosthese leaflet is high；Outer stent 120 is rigid It spends low, be bonded with primary structure and realize sealing function, though the stent diameter of outer stent 120 is big, it is not subject to prosthese The risk of traction force when leaflet is closed, the big stress in the part that working condition lower bracket is subject to is lower, and the service life is higher；Due to anchoring Structure 130 is stably connected with inner stent 110, the main inner stent strong by rigidity of the anchor force for preventing prosthetic valve from shifting 110 bear, and can preferably resist heart compression power, prevent bracket 100 with movement is squeezed, realize higher structural life-time； It when each structural integrity cutting manufacture of double-layer scaffold, no longer needs to connect each structure by post-production, each interstructural opposite position It sets and stablizes, is accurate, position deviation bring functional defect between each structure caused by avoiding because of later period items factor.

Although the utility model is disclosed as above with preferred embodiment, so it is not intended to limit the utility model, any Those skilled in the art, without departing from the spirit and scope of the utility model, when can make a little modification and it is perfect, therefore this The protection scope of utility model, which is worked as, to be subjected to the definition of the claims.

Claims (18)

1. a kind of prosthetic heart valve holder, which is characterized in that including outer stent and inner stent；

The inner stent is fixedly connected with the outer stent；

There is the outer stent axially connected outer layer to flow into road structure and outer layer efferent tract structure；

There is the inner stent axially connected inner laminar flow to take part in Taoism structure and internal layer efferent tract structure, and be radially positioned institute The inside of outer stent is stated, is provided with anchor structure on the inner stent.

2. prosthetic heart valve holder according to claim 1, which is characterized in that the inner stent and outer stent by Different biocompatible materials are made, and the rigidity of the inner stent is greater than the rigidity of the outer stent.

3. prosthetic heart valve holder according to claim 1, which is characterized in that the inner stent and outer stent by Same biocompatible material is made, and using different structure or heat treatment process the rigidity of the inner stent is greater than The rigidity of the outer stent.

4. prosthetic heart valve holder according to claim 1, which is characterized in that in the expanded state, the internal layer branch In a tubular form, the maximum tubulose outer diameter of the inner stent is less than 75mm to frame.

5. prosthetic heart valve holder according to claim 1, which is characterized in that the outer stent or/and internal layer branch Frame is made of the network cells that at least a row is interconnected with one another on along the circumferential direction in the axial direction, and the outer stent And/or hangers is provided on the inner stent.

6. prosthetic heart valve holder according to claim 1, which is characterized in that the distal end of the internal layer efferent tract structure Radially extend away from the axis direction of the inner stent.

7. prosthetic heart valve holder according to claim 1, which is characterized in that the inner stent and the outer layer branch Frame is connected at the internal layer efferent tract structure, and the axial position of the tie point of the inner stent and the outer stent Higher than the tie point of the anchor structure and the inner stent.

8. prosthetic heart valve holder according to claim 7, which is characterized in that the outer stent and inner stent exist It is all made of network cells in axial direction, the network cells have grid edge bars and node；The outer stent The overlapped formation tie point of the node of network cells on the node of upper network cells and the inner stent；Or Grid edge bars on the inner stent are Chong Die with the node of netted cellular construction on the outer stent or grid edge bars Form tie point；Or the node weight of the grid edge bars on the outer stent and netted cellular construction on the inner stent It is folded to form tie point.

9. prosthetic heart valve holder according to claim 1, which is characterized in that the outer layer flows into road structure proximal end diameter Extend outwardly to far from the inner stent, the outer layer flows into road structure proximal end minimum diameter and is greater than 25mm.

10. prosthetic heart valve holder according to claim 1, which is characterized in that the outer layer efferent tract structure distal end Radial extend to form to the medial cradle side receives structure in one, described interior one end for receiving structure it is adjacent with the inner stent or It is connected, the interior other end for receiving structure is connect with the outer layer efferent tract structure.

11. prosthetic heart valve holder according to claim 1, which is characterized in that the master of the outer layer efferent tract structure Body is cylindrical, conical, elliptical cylinder-shape, or the cylinder D-shaped for cross section.

12. prosthetic heart valve holder according to claim 1, which is characterized in that the anchor structure is flowed out along internal layer The circumferencial direction of road structure is at least distributed two.

13. prosthetic heart valve holder according to claim 1, which is characterized in that the anchor structure has both ends, Middle one end is fixing end, is mutually fixed with the inner stent, the other end is free end.

14. prosthetic heart valve holder according to claim 13, which is characterized in that the anchor structure is rod-shaped knot The fixed point of structure, the fixing end of the rod-like structure and the inner stent is 1, and the free end of the rod-like structure is spherical in shape Or spheroid shape.

15. prosthetic heart valve holder as described in claim 1, which is characterized in that the anchor structure has both ends, described Both ends are each attached on the network cells of the inner stent, and the structural unit of the anchor structure and inner stent is formed Enclosed construction.

16. prosthetic heart valve holder as described in claim 1, which is characterized in that towards described interior on the anchor structure The side of layer bracket is provided with barbule, or is arranged to zigzag.

17. a kind of heart valve prosthesis prosthese, which is characterized in that including the artificial heart as described in any one of claim 1-16 Dirty valve bracket, further includes artificial leaflet and skirt, and the inside of the inner stent, the skirt is arranged in the artificial leaflet It is set to inner surface or/and the outer surface of the outer stent or/and inner stent, the region of the skirt covering includes at least The artificial leaflet carries out overlay area of the artificial leaflet on inner stent when opening and closing movement.

18. heart valve prosthesis prosthese as claimed in claim 17, which is characterized in that the skirt is from the outer stent The outer layer, which flows on the inside of road structure proximal end, to be risen to extension at the tie point of the inner stent and the outer stent, then suitable The outer lateral inner laminar flow of the inner stent take part in Taoism structure direction extension.