CN103550015B - Heart valve prosthesis valve frame and intervened heart valve prosthesis using valve frame - Google Patents

Heart valve prosthesis valve frame and intervened heart valve prosthesis using valve frame Download PDF

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CN103550015B
CN103550015B CN201310535292.4A CN201310535292A CN103550015B CN 103550015 B CN103550015 B CN 103550015B CN 201310535292 A CN201310535292 A CN 201310535292A CN 103550015 B CN103550015 B CN 103550015B
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layer
lobe
tie
pole
frame
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CN103550015A (en
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金昌�
钟生平
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JINSHI BIOTECHNOLOGY (CHANGSHU) Co Ltd
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JINSHI BIOTECHNOLOGY (CHANGSHU) Co Ltd
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Abstract

The invention provides a heart valve prosthesis valve frame and an intervened heart valve prosthesis using the valve frame. The valve frame is a cylindrical framework which can be retracted and expanded in the radial direction and comprises an annular inlet layer and an outlet layer which are arranged along the axial direction of the cylindrical framework at an interval and in parallel, an annular middle layer which is arranged between the inlet layer and the outlet layer in parallel, and a plurality of connection beams which are uniformly distributed along the peripheral direction and are parallel to the axial direction of the cylindrical framework, wherein the connection beams penetrate through the middle layer to be connected with the inlet layer and the outlet layer and comprise three main connection beams which are uniformly distributed along the peripheral direction; each layer is respectively provided with a plurality of continuous V-shaped units which are formed by connecting supporting rods which are the same in length and mutually form angles end to end; the length of each supporting rod of the middle layer and the angle between the supporting rods are greater than those of the inlet layer and the outlet layer; the connection beams are connected with all the layers by end points or middle points of the supporting rods. According to the intervened heart valve prosthesis and the valve frame provided by the invention, the pressing diameter can be reduced, sufficient supporting forces are provided while an inner stress of the valve frame is reduced; the stopping of blood entering a coronary artery is reduced.

Description

The intervention Cardiac valve prosthesis of a kind of Cardiac valve prosthesis lobe frame and this lobe frame of employing
Technical field
The present invention relates to the intervention Cardiac valve prosthesis of a kind of Cardiac valve prosthesis lobe frame and this lobe frame of employing, belong to technical field of medical instruments.
Background technology
Valvular heart disease is one of cardiopathic main species at present, and valve disease can cause the great dysfunction of heart and finally need to replace native heart valve with Cardiac valve prosthesis.Majority is needed to change valvular patient, operating mode can be adopted to be implanted by Cardiac valve prosthesis.But the Srgery grafting of Cardiac valve prosthesis needs surgery open chest surgery usually, cardiac arrest during this period, and patient carries out extracorporeal circulation by heart-lung machine.Time in operation process required for extracorporeal circulation is longer, then the mortality risk of patient is higher.Therefore a considerable amount of have the patient of septal defect can not undergo a surgical operation because health is too weak, as high-risk, advanced age with there is the patient that surgery changes lobe contraindication.
Due to the operating above-mentioned shortcoming of conventional Thoracotomy in Management, the method that percutaneous gets involved cardiac valve replacement is shown great attention to.Current intervention cardiac valve is mainly divided into balloon-expandable and self-expansion type, is all implanted by conduit percutaneous.Cardiac valve prosthesis is compressive state in conduit, then by airbag inflation or utilize self expandable principle to expand in desired location.Common intervention Cardiac valve prosthesis is made up of lobe frame, the lobe impeller structure comprising multiple lobe leaf and stitching skirt.Fig. 1 for publication number be the lobe shelf structure schematic diagram of the existing Cardiac valve prosthesis disclosed in the Chinese patent application of CN 103237524 A.Lobe frame 1 as shown in Figure 1, it is the cylindrical frame with entrance point 2 and the port of export 3, in order to ensure support strength, identical V-arrangement cellular construction is adopted to repeat multilamellar arrangement, V-arrangement unit summit between multilamellar is connected, and this makes embedded material too much, and density is larger.
Summary of the invention
The invention provides a kind of lobe frame of Cardiac valve prosthesis, while effective support force is provided, diameter and the internal stress of lobe frame can be reduced, reducing the stop to flowing into coronary flow after implantation.
The present invention also provides a kind of intervention Cardiac valve prosthesis adopting above-mentioned lobe frame, in use there is higher-strength, the crimp of minor cusp can be subtracted, there is provided effective support and reduce the stop flowing into coronary flow, the structural stability of lobe leaf and stitching skirt is strong, can reduce the blood reflux after getting involved Cardiac valve prosthesis implantation.
The invention provides a kind of lobe frame of Cardiac valve prosthesis, described lobe frame is cylindrical frame that is radial collapsible and expansion, and it comprises:
Import layer and outlet layer, the axially spaced-apart along described cylindrical frame be arranged in parallel, and respectively along the circumferential formation circular ring of described cylindrical frame;
Intermediate layer, is set in parallel between described import layer and outlet layer, and along the circumferential formation circular ring of described cylindrical frame;
Along the circumferential direction equally distributed many tie-beams, described many tie-beams are parallel with the axis of described cylindrical frame respectively, and connect described import layer and outlet layer through described intermediate layer, and described tie-beam at least comprises along the circumferential direction equally distributed 3 main tie-beams;
Wherein, described import layer, outlet layer and intermediate layer have the continuous V-arrangement unit formed by pole the joining end to end that multiple length is identical and at an angle to each other respectively, the strut lengths forming intermediate layer V-arrangement unit is greater than the strut lengths of described import layer and outlet layer V-type unit, and the described intermediate layer angle be connected between pole is greater than the angle that described import layer is connected between pole with outlet layer, described tie-beam connects each layer by the end points of described pole or mid point.
Further, the width of described intermediate layer pole is more than or equal to the width of described import layer and outlet layer pole.
Further, described import layer and/or the outlet layer double-layer circular ring that is monolayer annulus or be arranged in parallel along the axis of described cylindrical frame.
Further, described import layer and/or outlet layer are double-layer circular ring, described double-layer circular ring comprises the first annular portion and the second annular portion, and the V-arrangement unit of described first annular portion is relative with the V-arrangement unit opening of second annular portion at opposite position place or arrange in the same way.
Further, the V-arrangement unit of described first annular portion is that opening is relative with the V-arrangement unit of second annular portion at opposite position place, and described first annular portion is connected with the pole end points of the second annular portion by V-arrangement unit opening.
Further, described main tie-beam has hole or groove, the width of described hole aperture or groove is 0.4-1.4mm.
Further, the pole forming described intermediate layer has locating hole, and the aperture of described locating hole is 0.4-1.2mm.
Further, described many tie-beams also comprise three along the circumferential direction equally distributed secondary tie-beams.
Further, described import layer, intermediate layer and outlet layer are all connected with described tie-beam by described pole end points; Or described tie-beam connects described import layer and outlet layer by the pole mid point in described intermediate layer, and described tie-beam is connected with the pole end points of described import layer and outlet layer.
Further, the pole of described import layer is identical with the strut lengths of described outlet layer.
Further, in described import layer and/or outlet layer, between adjacent two described main tie-beams, there is 4-8 described V-arrangement unit.
Further, described cylindrical frame is in expansion state, and in described import layer and/or outlet layer, the angle between two poles of formation V-arrangement unit is 80-120 °.
Further, in described intermediate layer, between adjacent two described main tie-beams, there is 2-4 described V-arrangement unit.
Further, described cylindrical frame is in expansion state, and in described intermediate layer, the angle between two poles of formation V-arrangement unit is 90-140 °.
Further, the elliptic arc structure between described pole with by a projection between described pole with described tie-beam is connected, and adopts arc transition between elliptic arc and pole.
Further, described cylindrical frame is formed tubing hollow out, or cylindrical by being rolled into after sheet material hollow out.
The present invention also provides a kind of and gets involved Cardiac valve prosthesis, comprises above-mentioned lobe frame, has the lobe impeller structure of 3 lobe leaves and sews up skirt, wherein,
Described lobe impeller structure is arranged on the inside of described cylindrical frame, fixes main tie-beam and sew up on skirt by stitching thread;
Described lobe leaf is lamellar, has fan-shaped lower limb, and two lateral margins of lobe leaf are connected with adjacent two described main tie-beams respectively;
Described stitching skirt is circumferentially arranged between described cylindrical frame and described lobe impeller structure, and two ends are closed with intermediate layer and import layered suture respectively, and the lower limb of lobe leaf is connected to the inner surface sewing up skirt.
Further, the pole forming described intermediate layer has locating hole, and described stitching skirt is connected with described intermediate layer by this locating hole.
Further, described tie-beam has hole, and described stitching skirt is connected with described tie-beam by this hole with lobe leaf.
The enforcement of the present invention program, at least has following advantage:
1, lobe frame of the present invention is while the less embedded material of use provides effective support force, is beneficial to reduction and press-fits diameter and press-fit and expand back lobe frame internal stress; And to the stop flowing into coronary flow after effectively can reducing implantation;
2, the valve utilizing lobe frame of the present invention to make, can increase lobe leaf and sew up the stationkeeping ability of skirt and the stability of location in clinical practice, the circumference reduced after getting involved valve implantation is backflowed.
Accompanying drawing explanation
Fig. 1 is the lobe shelf structure schematic diagram of existing Cardiac valve prosthesis.
Fig. 2 is the perspective view of embodiment 1 mesopetalum frame.
Fig. 3 is expanded view along the circumferential direction after cutting along the main tie-beam center line A-A ' of of the frame of lobe shown in Fig. 2.
Fig. 4 is expanded view along the circumferential direction after a main tie-beam midline incision of embodiment 2 mesopetalum frame.
Fig. 5 is expanded view along the circumferential direction after a main tie-beam midline incision of embodiment 3 mesopetalum frame.
Fig. 6 a, Fig. 6 b, Fig. 6 c and Fig. 6 d to be respectively in lobe frame provided by the invention between pole and the enforcement schematic diagram of the junction of pole and tie-beam.
Fig. 7 is expanded view along the circumferential direction after a main tie-beam midline incision of embodiment 4 mesopetalum frame.
Fig. 8 is the artificial valvular perspective view of intervention provided by the invention.
Detailed description of the invention
The invention provides the valve of a kind of Cardiac valve prosthesis lobe frame and this lobe frame of use, after implant into body while effective support force is provided, reducing the stress in lobe frame, reducing the stop to flowing into coronary flow.This lobe frame is cylindrical frame that is radial collapsible and expansion, and it comprises: import layer and outlet layer, and the axially spaced-apart along described cylindrical frame be arranged in parallel, and respectively along the circumferential formation circular ring of described cylindrical frame;
Intermediate layer, is set in parallel between described import layer and outlet layer, and along the circumferential formation circular ring of described cylindrical frame;
Along the circumferential direction equally distributed many tie-beams, described many tie-beams are parallel with the axis of described cylindrical frame respectively, and connect described import layer and outlet layer through described intermediate layer, and described tie-beam at least comprises along the circumferential direction equally distributed 3 main tie-beams;
Wherein, described import layer, outlet layer and intermediate layer have the continuous V-arrangement unit formed by pole the joining end to end that multiple length is identical and at an angle to each other respectively, the strut lengths forming intermediate layer V-arrangement unit is greater than the strut lengths of described import layer and outlet layer V-type unit, and the described intermediate layer angle be connected between pole is greater than the angle that described import layer is connected between pole with outlet layer, described tie-beam connects each layer by the end points of described pole or mid point.
The blood flowing through valve enters valve through import layer, flows out through outlet layer.Described import layer can be monolayer annulus or the double-layer circular ring be arranged in parallel along the axis of cylindrical frame.Above-mentioned double-layer circular ring comprises the first annular portion and the second annular portion, and the V-arrangement unit of the first annular portion and the V-arrangement unit of second annular portion at opposite position place to be opening relative or arrange in the same way, this structure is conducive to sewing up the fixing further of skirt and supporting, and the circumference being decreased through valve blood is after the implantation leaked; And make import layer as one of main part of the force of support blood vessels, increase the support strength to blood vessel.
In the particular embodiment, the V-arrangement unit of the first annular portion is that opening is relative with the V-arrangement unit of second annular portion at opposite position place, and the first annular portion is connected with the pole end points of the second annular portion by V-arrangement unit opening.In addition, tie-beam can also be arranged at the junction of the first annular portion and the second annular portion, more harmonious when making double-layer circular ring in compression process and provide support.
For outlet layer, identical structure can be adopted with import layer.In the particular embodiment, outlet layer can adopt monolayer annulus, and this structure effectively can increase the aperture area of blood flow import department lobe frame, reduces valve to the stop flowing into coronary flow.
Forming the strut lengths of import layer and the strut lengths of formation outlet layer and width can be identical or different, but is all less than the strut lengths forming intermediate layer.
In the present invention, the annulus number of plies that should consider pole width or diameter, import layer and outlet layer and the material etc. used, to meet the requirement to lobe frame intensity.Such as, time higher to the requirement of strength of lobe frame, optionally increase pole width or thickness, the annulus number of plies, and the material that selection intensity is higher.
The pole in formation intermediate layer can be provided with locating hole, and for fixing stitching skirt, the aperture of this locating hole can be 0.4-1mm; Also can adopt the conventional structure without locating hole at present, stitching skirt is directly sewn on the pole of closing on.
In the particular embodiment, intermediate layer V-arrangement number of unit can be adopted lower than import layer and outlet layer, and the width of its bar is greater than width or the diameter of import layer and outlet layer king-rod.This structure makes lobe frame while providing enough support strength, adds the area that lobe makes somebody a mere figurehead gap, and be conducive to reducing the stop to blood flow, wider bar makes it can be arranged easily location hole simultaneously.
In the present invention, tie-beam connects each layer by the end points of pole or mid point, such as, import layer, intermediate layer and outlet layer all can be connected with tie-beam by pole end points, or tie-beam connects import layer and outlet layer by the mid point of intermediate layer pole, and tie-beam is connected with the end points (i.e. the summit of V-arrangement unit) of outlet layer pole with import layer.
Above-mentioned tie-beam, except comprising 3 main tie-beams, can also comprise many along the circumferential direction uniform secondary tie-beams.Main tie-beam gets involved the lobe impeller structure of valve for connecting, its width or diameter are equal to or greater than other secondary tie-beam be not directly connected with lobe impeller structure.In order to sew up with lobe impeller structure more easily, main tie-beam can also be provided with hole or elongate slot, the aperture of usual hole or the width of groove are 0.4-1.4mm.
The material category that lobe frame in the present invention, lobe impeller structure and stitching skirt use can refer to prior art, and wherein, lobe frame material is the material of plastically deformable, such as, can use medical Nitinol, cochrome, rustless steel etc.; Lobe leaf can use animal pericardium material, or animal valve, as bovine pericardium, and porcine aorta valve; Sew up skirt and can use dacron fabric etc.
Below in conjunction with accompanying drawing, the specific embodiment of the present invention is described.
Embodiment 1
Present embodiments provide a kind of lobe frame 100 of Cardiac valve prosthesis.Fig. 2 is the perspective view of this lobe frame 100.Fig. 3 is expanded view along the circumferential direction after cutting along the main tie-beam 401 center line A-A ' of of the frame of lobe shown in Fig. 1 100.As shown in Figures 2 and 3, this lobe frame is cylindrical frame 100 that is radial collapsible and expansion, by tubing hollow out is formed, and also can be cylindrical by being rolled into after sheet material hollow out.This lobe frame 100 comprises: the circular import layer 10 of the spaced and parallel setting from bottom to top, intermediate layer 20 and outlet layer 30, and wherein import layer 10 and outlet layer 30 are for limiting the blood flow direction flowing through valve; Intermediate layer 20 is set in parallel between import layer 10 and outlet layer 30, provides support power; And along the circumferential direction equally distributed many tie-beams, it is parallel with the axis of cylindrical frame 100 respectively, and tie-beam 401-406 connects import layer 10 and outlet layer 30 through intermediate layer 20.
As shown in Figures 2 and 3, connect import layer 10, the tie-beam of intermediate layer 20 and outlet layer 30 has six 401-406, wherein tie-beam 401,403,405 is main tie-beam, all the other can be described as secondary tie-beam, main tie-beam 401,403,405 to be separated by 120 ° of symmetric arrays at circumferencial direction, and its width (along the circumferential direction) is greater than other three secondary tie-beams.The main tie-beam of whole piece keeps homogeneous width, flushes, be beneficial to lobe frame and sew up with less axial length and lobe impeller structure with the top of the V-arrangement unit forming outlet layer 30.Article three, main tie-beam is provided with the hole 41 that some apertures are 0.8mm, for connecting the lobe leaf 50 (shown in composition graphs 7) getting involved valve.
Import layer 10, intermediate layer 20 and outlet layer 30 are monolayer circular ring structure.The strut lengths forming intermediate layer 20 is greater than the strut lengths forming import layer 10 and outlet layer 30, and therefore between adjacent two main tie-beams, the V-arrangement unit forming import layer 10 and outlet layer 30 respectively has 4, and the V-arrangement unit forming intermediate layer 20 has 2.Between main tie-beam and the secondary tie-beam be adjacent, the V-arrangement unit forming import layer 10 and outlet layer 30 respectively has 2, and the V-arrangement unit forming intermediate layer 20 only has 1.In order to be more conducive to the radial contraction of implantation process mesopetalum frame 100, lobe frame 100 is under expansion state, and for import layer 10 and outlet layer 30, between adjacent struts, angle is 80-120 °, and for intermediate layer 20, the angle between adjacent struts is 90-140 °.The bar of the v-shaped structure in intermediate layer 20 only has on the bar adjacent with main tie-beam and there is the locating hole 21 that aperture is 0.6mm, can be used for fixing stitching skirt 300 and lobe leaf 50 (shown in composition graphs 7).
Elliptic arc structure 70 between pole with by a projection between pole with tie-beam 401-406 is connected, and is beneficial to contraction and the expansion of cylindrical frame 100.As shown in Figure 6 a, the junction of adjacent struts adopts the elliptic arc structure 70 of projection to connect, and elliptic arc structure 70 and pole junction adopt circular arc 71 transition.In addition, tie-beam 401-406 is also connected with each layer by above-mentioned projection elliptic arc structure 70.Particularly, as shown in Figure 6 b, tie-beam 402 can be connected with its summit via the inside of V-arrangement unit opening, and elliptic arc structure 70 and the tie-beam 402 of junction projection form Y-shaped structure jointly; Or as fig. 6 c, tie-beam 406 is connected with its summit via the outside of V-arrangement unit opening, elliptic arc structure 70 and the tie-beam 406 of junction projection form M shape structure jointly.
In the present embodiment, intermediate layer 20 be arranged so that the material that lobe frame uses reduces.Therefore the lobe frame 100 that the present embodiment provides can while providing effective support force, reduce the stop to flowing into coronary flow, hole 41 and arranging of locating hole 21 can increase lobe leaf 50 and sew up the stationkeeping ability of skirt 300 and the stability of location, reduce the blood reflux (shown in composition graphs 7) after getting involved valve 400 implantation.
Embodiment 2
As shown in Figure 4, the lobe frame 100 that provides of the present embodiment is substantially identical with the structure in embodiment 1.Difference is, outlet layer 30 and intermediate layer 20 are monolayer annulus, and import layer 10 is double-layer circular ring, have the first annular portion 11 and the second annular portion 12, the opening of its V-arrangement unit is relative, and the first annular portion 11 is not connected with the V-arrangement unit summit at the second annular portion 12 opposite position place.This structure is conducive to, to sewing up the fixing further of skirt 300, reducing the circumference being decreased through valve blood after the implantation after the implantation and leaking; And make import layer 10 as one of main part of the force of support blood vessels, increase the support strength to blood vessel; Increasing the aperture area of blood flow import department simultaneously, reducing the stop to flowing into coronary flow.
As shown in Figure 4, connect import layer 10, the tie-beam of intermediate layer 20 and outlet layer 30 has six 401-406, wherein 401,403,405 is main tie-beam, all the other are secondary tie-beam, main tie-beam 401,403,405 to be separated by 120 ° of symmetric arrays at circumferencial direction, its width or diameter are greater than other three company's pairs and connect beam, main tie-beam have the elongated slot 42 of 0.8mm, for the lobe leaf 50 of fixing intervention valve.In order to reduce embedded material, the main tie-beam not width of the part of trough of belt 42 or diameter can be less than the part of trough of belt 42.
Embodiment 3
As shown in Figure 5, the lobe frame 100 that provides of the present embodiment is substantially identical with the structure in embodiment 2.Difference is, the first annular portion 11 is connected with the V-arrangement unit summit at the second annular portion 12 opposite position place.Fig. 6 d is the enlarged drawing of the tie-beam 406 of Fig. 5 mesopetalum frame and the junction c of above-mentioned first annular portion 11 and the second annular portion 12.As shown in fig 6d, when tie-beam 406 is connected with the first annular portion 11 and the second annular portion 12, the elliptic arc structure of junction projection forms M shape structure and Y-shaped structure.When lobe frame 100 compresses installation, it is parallel more harmonious that the structure that this double-layer circular ring connects is conducive to double-layer circular ring.
The pole in each formation intermediate layer 20 is provided with the hole that an aperture is 0.6mm, and it is for the position of fixing stitching skirt 300 and further fixed lobes leaf 50.
In addition, in the present embodiment, the width forming the bar in intermediate layer 20 is greater than the pole forming import layer 10 and outlet layer 30, and this structure is beneficial to provides better support effect.
Embodiment 4
As shown in Figure 7, the lobe frame 100 that provides of the present embodiment is substantially identical with the structure in embodiment 1.Difference is, tie-beam 401-406 structure is identical, is the beam of not apertured or groove.In addition, tie-beam 401-406 connects import layer 10 and outlet layer 30 by the mid point of intermediate layer 20 pole, the V-arrangement unit arranged opposite of import layer 10 and outlet layer 30, and tie-beam 401-406 is connected with end points (i.e. the summit of the V-arrangement unit) point of the pole in outlet layer 30 with import layer 10.
Embodiment 5
The present embodiment provides a kind of and gets involved Cardiac valve prosthesis 400.As shown in Figure 8, this valve comprises the cylindrical frame 100 in embodiment 1, the lobe impeller structure 200 with 3 lobe leaves and stitching skirt 300.Lobe impeller structure 200 is arranged on the inside of cylindrical frame 100, has the shape similar to physiology lobe leaf, is fixed on intermediate layer 20 and main tie-beam 401,403,405 by stitching thread 60.In the present embodiment, each lobe leaf 50 is lamellar, has fan-shaped lower limb, and two lateral margins of lobe leaf 50 are sewn on the hole 41 of two adjacent main tie-beams 403 and 405 respectively.Sewing up skirt 300 is circumferentially arranged between cylindrical frame 100 and lobe impeller structure 200, and upper and lower two ends are sewed up with intermediate layer 20 and import layer 10 respectively.Sew up skirt 300 to sew up with tie-beam hole 41 in the circumferential, and can sew up further by locating hole 21 and intermediate layer 20, play effect fixing further, and the lower limb of lobe leaf 50 is connected to the inner surface sewing up skirt 200.
The intervention Cardiac valve prosthesis 400 that the present embodiment provides can reduce the stop to inflow coronary flow in use, and the structural stability of lobe leaf 50 and stitching skirt 200 is strong, can reduce the blood reflux after getting involved Cardiac valve prosthesis 400 implantation.
Last it is noted that above each embodiment is only in order to illustrate technical scheme of the present invention, be not intended to limit; Although with reference to foregoing embodiments to invention has been detailed description, those of ordinary skill in the art is to be understood that: it still can be modified to the technical scheme described in foregoing embodiments, or carries out equivalent replacement to wherein some or all of technical characteristic; And these amendments or replacement, do not make the essence of appropriate technical solution depart from the scope of various embodiments of the present invention technical scheme.

Claims (19)

1. a lobe frame for Cardiac valve prosthesis, is characterized in that, described lobe frame is cylindrical frame that is radial collapsible and expansion, and it comprises:
Import layer and outlet layer, the axially spaced-apart along described cylindrical frame be arranged in parallel, and respectively along the circumferential formation circular ring of described cylindrical frame;
Intermediate layer, is set in parallel between described import layer and outlet layer, and along the circumferential formation circular ring of described cylindrical frame;
Along the circumferential direction equally distributed many tie-beams, described many tie-beams are parallel with the axis of described cylindrical frame respectively, and connect described import layer and outlet layer through described intermediate layer, and described tie-beam at least comprises along the circumferential direction equally distributed 3 main tie-beams;
Wherein, described import layer, outlet layer and intermediate layer have continuous print V-arrangement unit respectively, described continuous print V-arrangement unit is formed by pole the joining end to end that multiple length is identical and at an angle to each other, the strut lengths forming intermediate layer V-arrangement unit is greater than the strut lengths of described import layer and outlet layer V-type unit, and the described intermediate layer angle be connected between pole is greater than the angle that described import layer is connected between pole with outlet layer, described tie-beam connects each layer by the end points of described pole or mid point.
2. lobe frame according to claim 1, is characterized in that, the width of described intermediate layer pole is more than or equal to the width of described import layer and outlet layer pole.
3. lobe frame according to claim 1, is characterized in that, the double-layer circular ring that described import layer and/or outlet layer are monolayer annulus or be arranged in parallel along the axis of described cylindrical frame.
4. lobe frame according to claim 3, it is characterized in that, described import layer and/or outlet layer are double-layer circular ring, described double-layer circular ring comprises the first annular portion and the second annular portion, and the V-arrangement unit of described first annular portion and the V-arrangement unit of second annular portion at opposite position place to be opening relative or arrange in the same way.
5. lobe frame according to claim 4, it is characterized in that, the V-arrangement unit of described first annular portion is that opening is relative with the V-arrangement unit of second annular portion at opposite position place, and described first annular portion is connected with the pole end points of the second annular portion by V-arrangement unit opening.
6. lobe frame according to claim 1, is characterized in that, described main tie-beam has hole or groove, and the aperture of described hole or the width of groove are 0.4-1.4mm.
7. lobe frame according to claim 1, is characterized in that, the pole forming described intermediate layer has locating hole, and the aperture of described locating hole is 0.4-1.2mm.
8. lobe frame according to claim 1, is characterized in that, described many tie-beams also comprise three along the circumferential direction equally distributed secondary tie-beams.
9. the lobe frame according to any one of claim 1-8, is characterized in that, described import layer, intermediate layer and outlet layer are all connected with described tie-beam by described pole end points; Or described tie-beam connects described import layer and outlet layer by the pole mid point in described intermediate layer, and described tie-beam is connected with the pole end points of described import layer and outlet layer.
10. lobe frame according to claim 1, is characterized in that, the pole of described import layer is identical with the strut lengths of described outlet layer.
11. lobe framves according to claim 10, is characterized in that, in described import layer and/or outlet layer, have 4-8 described V-arrangement unit between adjacent two described main tie-beams.
12. lobe framves according to claim 10 or 11, it is characterized in that, described cylindrical frame is in expansion state, and in described import layer and/or outlet layer, the angle between two poles forming V-arrangement unit is 80-120 °.
13. lobe framves according to claim 1 or 11, is characterized in that, in described intermediate layer, have 2-4 described V-arrangement unit between adjacent two described main tie-beams.
14. lobe framves according to claim 13, it is characterized in that, described cylindrical frame is in expansion state, and in described intermediate layer, the angle between two poles of formation V-arrangement unit is 90-140 °.
15. lobe framves according to claim 1, is characterized in that, the elliptic arc structure between described pole with by a projection between described pole with described tie-beam is connected, and adopts arc transition between described elliptic arc and described pole.
16. lobe framves according to claim 1, is characterized in that, described cylindrical frame is formed tubing hollow out, or cylindrical by being rolled into after sheet material hollow out.
17. 1 kinds of intervention Cardiac valve prosthesiss, is characterized in that, described intervention Cardiac valve prosthesis comprises the lobe frame described in any one of claim 1-16, also comprise the lobe impeller structure and stitching skirt with 3 lobe leaves, wherein,
Described lobe impeller structure is arranged on the inside of described cylindrical frame, fixes main tie-beam and sew up on skirt by stitching thread;
Described lobe leaf is lamellar, has fan-shaped lower limb, and two lateral margins of lobe leaf are connected with adjacent two described main tie-beams respectively;
Described stitching skirt is circumferentially arranged between described cylindrical frame and described lobe impeller structure, and two ends are closed with intermediate layer and import layered suture respectively, and the lower limb of lobe leaf is connected to the inner surface sewing up skirt.
18. intervention Cardiac valve prosthesiss according to claim 17, it is characterized in that, the pole forming described intermediate layer has locating hole, and described stitching skirt is connected with described intermediate layer by this locating hole.
19. intervention Cardiac valve prosthesiss according to claim 17 or 18, it is characterized in that, described main tie-beam has hole, and described stitching skirt is connected with described main tie-beam by this hole with lobe leaf.
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