The artificial valve prosthese of a kind of band lobe leaf clamping deviceTechnical field:
The invention belongs to medical instruments field, it is specifically related to the artificial valve prosthese of a kind of band lobe leaf clamping device.
Background technology:
Aortic stenosis is primarily of caused by the sequela of rheumatic fever, congenital aortic valve structure exception or senile aortic valve calcification. Patient is in the compensatory phase without symptom, and the patient of aortic valve severe stenosis has burnout, expiratory dyspnea (labour's property or paroxysmal), stenocardia, the dizzy or symptom fainted mostly, even can sudden death.
It is that aortic valve is open when ventricular systole that aortic valve backflows, blood flow in left ventricle enters aorta and penetrates to whole body, close when ventricular diastole, the blood reflux in aorta is stoped to return left ventricle, if when there is aortic incompetence, can not close tightly at diastole phase aortic valve, cause blood to enter left ventricle from aorta adverse current.
In the treatment of aortic valve disease, surgical valve displacement technique is traditional effective methods for the treatment of. Patient many systems advanced age of this kind of disease, having Multiple organs disorders, physical qualification is difficult to accept surgical operation, becomes the patient that clinical treatment is hopeless simultaneously. In addition, the cause of disease of degenerative aortic valve disease is still not fully aware of, cannot carry out etiological treatment, contain that it develops without effective method yet, and medication effect is not good. The symptom that the measure of desirable treatment aortic valve disease should improve patient can extend again its life-span. The percutaneous aortic valve sacculus urethroptasty carried out in one's early years was once used to treatment aortic stenosis, but was no matter the data of single centre or the materials for registration of multicenter all finds that its long-term effect is not good. At home, surgery prosthetic valve replacement is still a kind of main therapeutic choice.
In recent years, some scholars have carried out basis and the clinical study of percutaneous aortic valve film displacement both at home and abroad, and obtain to some breakthrough progress. For needing the high-risk senile aortic valve degeneration patient of surgery valve replacement, it provides a kind of effective methods for the treatment of. 2002, Cribier etc. are successfully made through conduit aortic valve replacement (TranscatheterAorticValveReplacement, TAVR), up to now, research all over the world all shows: changing lobe or surgery changes the patient that lobe exists excessive risk for carrying out surgery, this technology is safely and effectively. Although what carry out TAVR operation mostly is high-risk patient, but after art 30 days survival rates higher than 90%, TAVR postoperative patient hemodynamic index be improved significantly.
In patent US8465540, Jenavalve discloses a expandable stent, it has multiple location arch shape part and multiple maintenance arch shape part, described location arch shape part is positioned at native valve lobe Dou Chu and the side of autologous lobe leaf, described another side keeping arch shape part to be positioned at autologous lobe leaf, described expandable stent also comprises multiple radial deposition part, each location arch shape part connects by single radial direction arch shape part radial direction, each keeps comprising on arch shape part several bending edges, and each bending edge constitutes the point of inflection between two adjacent stems. the deficiency of this design is, owing to support adopts one cutting, the cutting room necessarily non-overlapping copies of described location arch shape part and described maintenance arch shape part, there are 3 problems in the support after sizing like this: one is do not overlap each other between the arch shape part of the location after sizing and maintenance arch shape part, autologous lobe leaf is only the linear contact lay of several shaft when being clamped between described location arch shape part and described maintenance arch shape part, autologous lobe leaf still has shake by a relatively large margin in space between shaft under blood flow effect, affect the proper motion of artificial valve prosthese, reduce effective vent area, two is that holding force deficiency easily causes artificial valve prostheses migration due to the clamping being line contact type between location arch shape part and maintenance arch shape part, three is that the lobe circumferential weld of artificial valve is combined on described maintenance arch shape part by this design, although the bottom of location arch shape part and the lobe ring place of artificial valve maintain an equal level when support cuts, but very likely it is positioned at above the lobe ring of artificial valve after the softened sizing in end of location arch shape part, if relying on location arch shape part to position, artificial valve can be placed on autologous lobe ring position on the lower side artificially, become " ring inner mold " or even " under ring type ", reduce effective vent area further.
Patent CN203029425U discloses the support of a band valve, and the registration arm one end described in it is connected in supplemental support section, and the other end outwards opens, and such design makes registration arm can not play the effect of clamping lobe leaf. Understand from the summary of the invention of this patent and specific embodiment simultaneously, this support is integral type cutting support, the rest part of described registration arm and described support necessarily non-overlapping copies, therefore corresponding with registration arm is the void region of support, autologous lobe leaf still has shake by a relatively large margin under blood flow effect in void region, affect the proper motion of artificial valve prosthese, reduce effective vent area. Similar with Jenavalve, very likely it is positioned at after the softened sizing in the end of this registration arm above the lobe ring of artificial valve, if relying on registration arm to position, artificial valve can be placed autologous lobe ring position on the lower side artificially, become " ring inner mold " or even " under ring type ", reduce effective vent area further.
In patent US8771345, MedtronicVentor discloses a valve prosthesis, this valve prosthesis comprises support and valve, described valve is fixed in described support, described support comprises a far-end fixed cell, described far-end fixed cell is placed at least partly autologous lobe leaf following current side, described far-end fixed cell has also been shaped two or more lobe leaf actuation arm simultaneously, described lobe leaf actuation arm provides first power of the patient tissue of the following current side acting on autologous lobe leaf, in Using prosthesis process, described lobe leaf actuation arm contacts the following current side of autologous lobe leaf but does not contact the juncture of autologous lobe leaf, this support also comprises a near-end fixed cell, described near-end fixed cell is placed at least partly autologous lobe leaf adverse current side, in Using prosthesis process, at least part of described near-end fixed cell contacts the adverse current side of autologous lobe leaf, and described near-end fixed cell provides the 2nd power of the patient tissue of the adverse current side acting on autologous lobe leaf simultaneously, described valve prosthesis is fixed on native valve by described first power and described 2nd power, in Using prosthesis process, autologous lobe leaf is trapped between described lobe leaf actuation arm and described near-end fixed cell. when described near-end fixed cell and described far-end fixed cell are split cutting sizing, there is at least four problems in such design, one is describe according in its subordinate right 10 and embodiment, described lobe leaf actuation arm provides a power straight down, described far-end fixed cell provides a power straight up (in the embodiment of major part, it is described as providing an enough big power straight up, the bottom of described far-end fixed cell is provided with arches upward), lobe leaf is clamped by two power actings in conjunction, described arching upward can increase the compressing for left ventricular outflow tract view, thus cause conductive impairment, needs of patients implants permanent pacemaker after surgery, two is described near-end fixed cell and described far-end fixed cell is split cutting sizing, and the mode then combined, is eclipsed form seam and ties up connection, and overlapping region is caused support to load required sheath pipe size and strengthened, if three is that the opening subtended angle of described lobe leaf actuation arm is excessive, affecting the effect of itself and described near-end fixed cell clamping lobe leaf, if crossing little, being not easy to arrest lobe leaf, four is the auxiliary grappling that this design does not make full use of aorta ascendens, and its grappling performance is not ideal enough. in addition, as figure 2c in its patent and figure 2d and related text describe, described near-end fixed cell and described far-end fixed cell are integrated cutting sizing, and described lobe leaf actuation arm then must be turned up sizing, sizing work difficulty height, the poor fatigue properties of its inflection point after sizing.
In patent US8673000, Medtronic also discloses another support, similar with above-mentioned patent US8771345, this support comprises riding over the wing portion on autologous lobe leaf too, described wing portion and main body rack separate making and are connected on main body rack by suture one class method, shortcoming and the above-mentioned patent US8771345 of this design are similar, do not repeat them here.
In sum, the design of existing aortic valve stent can not separate the problem of decision bit and grappling completely, causes coronary artery blocking or postoperative support to come off once generation location is inaccurate, then directly threatens the life security of patient. And existing utilize native valve to carry out clamping the technology improving anchoring effect, also there is problems different separately.
Summary of the invention:
It is an object of the invention to the defect being to improve and make up prior art, it is proposed to the artificial valve prosthese of a kind of band lobe leaf clamping device that can effectively solve various problems. lobe leaf clamping device in the artificial valve prosthese of the band lobe leaf clamping device of the present invention can provide before support discharges and locate accurately, make use of support after support discharges also utilizes lobe leaf clamping device to carry out clamping lobe leaf while lobe ring place anchorage force, and the projection radially arranged carries out auxiliary grappling with being positioned in the skeleton structure of the described valve sewing section of described overlapping region to make use of the support being positioned at aorta ascendens further, realize carrying out grappling from left ventricle-aorta and aorta-left ventricle two directions, artificial valve is worked safely and effectively, reduce complication.
It is an object of the invention to be achieved through the following technical solutions:
The artificial valve prosthese of a kind of band lobe leaf clamping device, comprise support and artificial valve, described support comprises supplemental support gripping section and valve sewing section, described artificial valve is fixedly connected in described valve sewing section, described supplemental support gripping section is by supporting bracket, lobe leaf clamping device and on the section of being connected and fixed composition, described lobe leaf clamping device and described supporting bracket with described on the section of being connected and fixed one cutting and become, described valve sew section is provided with described on the section of being connected and fixed mate mutually under the section of being connected and fixed, described support by the section of being connected and fixed on described and described under the section of being connected and fixed inlay and connect as one, described lobe leaf clamping device and described supporting bracket or described lobe leaf clamping device with described on one end of being connected of the section of being connected and fixed be inboardend, the other end of described lobe leaf clamping device dissociates for free end, it is overlapping that a part for described lobe leaf clamping device sews section with described valve, in its natural state, the described part sewing the overlapping described lobe leaf clamping device of section with described valve is close to the outside surface of described valve sewing section, be positioned at overlapping region described valve sewing section skeleton structure on be provided with projection radially, on the described lobe leaf clamping device of contiguous described inboardend or on the described supporting bracket of contiguous described inboardend or contiguous described inboardend described on the section of being connected and fixed is provided with the bending section bending along the radial direction of described support to the axis direction of described support, when described supporting bracket and described valve sewing section are compressed, the described free end of described lobe leaf clamping device opens along the radial direction of described support, the described free end that described bending length of tape moves described lobe leaf clamping device opens further, it is convenient to the offside that described free end can enter into the closed face of autologous lobe leaf, thus be convenient to autologous lobe leaf and be placed between described lobe leaf clamping device and described valve sewing section, when described supporting bracket and described valve sewing section are completely released, the state that the described part reply sewing the overlapping described lobe leaf clamping device of section with described valve is laminating described valve sewing section makes autologous lobe leaf be clamped between described lobe leaf clamping device and described valve sewing section.
The object of the present invention can also be realized further by following technical scheme:
In certain embodiments, on described, the section of being connected and fixed is positioned at one end of described supporting bracket, under described, the section of being connected and fixed is positioned at one end of described valve sewing section, on described the section of being connected and fixed and described under the section of being connected and fixed is respectively arranged with the mosaic site of stairstepping, wave-like, zigzag fashion or drop shape, the outside surface cover at described mosaic site is installed with the metal tube being driven plain firmly to fix. In certain embodiments, the section of being connected and fixed is provided with step on described, or the section of being connected and fixed is provided with step under described, or on described in the section of being connected and fixed and described under the section of being connected and fixed is provided with step simultaneously.
In certain embodiments, the outer tangent line of described projection arranged in described skeleton structure and the axis of described support form the angle of 5 �� to 75 ��, described projection is the described skeleton structure rod member that extends out of described valve sewing section, or the part that described projection is sewed in the described skeleton structure of section by described valve is formed through heat setting type. In certain embodiments, when the rod member that the described skeleton structure that described projection is described valve sewing section extends out, the free end of described projection inwardly holds together along support shaft wire diameter.
In certain embodiments, on the described lobe leaf clamping device of contiguous described inboardend and on described in contiguous described inboardend, the section of being connected and fixed is provided with radially bending to the axis direction of described support bending section.
In certain embodiments, the bending radius of described bending section is 1mm to 5mm, along described support axis direction described in the center of curvature of bending section apart from the described inboardend 1mm to 10mm of described lobe leaf clamping device.
In certain embodiments, in its natural state, along described support axis direction described in the described free end of lobe leaf clamping device be positioned at the scope of the upper and lower 5mm of lowermost end of lobe ring of described artificial valve.
In certain embodiments, described lobe leaf clamping device has U shape structure or v-shaped structure, or the free end of described lobe leaf clamping device is mastoid process shape structure. In certain embodiments, the described free end of described lobe leaf clamping device is driven plain along the radial direction of described support.
In certain embodiments, be respectively arranged with at the two ends of described support and draw head, described in draw head to be square, circular or oval, or described in draw head to be square hole, circular hole or oval hole.
In certain embodiments, on described the section of being connected and fixed and described under the circular diameter that forms of the tie point of the section of being connected and fixed be less than the maximum diameter of described valve sewing section.
In certain embodiments, the maximum diameter of described supplemental support gripping section is greater than the maximum diameter of described valve sewing section.
In certain embodiments, the surface of described lobe leaf clamping device is provided with hangnail, or the surface-coated film of described lobe leaf clamping device.
In certain embodiments, the surface-coated film of described supporting bracket.
In certain embodiments, described valve sew section bottom be provided with along described valve sew section radial direction arch upward prevent lobe week neglected loading put, described in prevent lobe week neglected loading be set to along described valve sew section bottom outer surface circumference stitching ring.
In certain embodiments, described in prevent lobe week neglected loading from putting and be subdivided into multiple dingus, each dingus all has arch structure, and described dingus sews the external circumferential distribution of section along described valve.
In certain embodiments, described in prevent the lobe week neglected loading wavy shaped configuration that is set to metal material with memory silk coiling and become or zigzag structure, the sawtooth point of the crest of described wavy shaped configuration and trough or described zigzag structure is bent to form arch respectively to interior. In certain embodiments, mutually it is wound around between described adjacent silk, forms structure closely. In certain embodiments, described in prevent the lobe outside surface film put of week neglected loading, described film is made up of animal tissues or terylene, tetrafluoroethylene, urethane or silica gel.
In certain embodiments, in its natural state, along described support axis direction described in lobe leaf clamping device described free end distance described in prevent the lobe far-end 0mm to 5mm that puts of week neglected loading.
In certain embodiments, the center of the section of being connected and fixed is provided with and holds hole under described, the lobe leaf top being convenient to adjacent described artificial valve through described in hold hole arrive from the internal surface of the section of being connected and fixed described described under the outside surface of the section of being connected and fixed.
In certain embodiments, the lobe leaf top of described artificial valve through described in hold hole arrive from the internal surface of the section of being connected and fixed described described under the section of being connected and fixed outside surface after, the axis sewing section along described valve hold described under the edge of the section of being connected and fixed.
In certain embodiments, it is provided with threading hole around hole described holding, it is convenient to suture and passes from described threading hole and the lobe leaf top of fixing described artificial valve.
In certain embodiments, along the circumference of described support be evenly provided with on described in three groups the section of being connected and fixed and described under the section of being connected and fixed.
In certain embodiments, described supporting bracket is that the rod member of round and smooth connection or described supporting bracket are made up of latticed rhombus ripple.
In certain embodiments, described artificial valve is made up of animal tissues or high molecular polymer. In certain embodiments, described animal tissues is Pigs Hearts bag, bovine pericardium, horse pericardium etc., and described high molecular polymer is tetrafluoroethylene, urethane, silica gel.
In certain embodiments, described support is self-expandable stent, and the material of described support is shape-memory material, it is preferable to niti-shaped memorial alloy.
Compared with the existing technology, it is an advantage of the current invention that:
1, the present invention is provided with lobe leaf clamping device in the bracket and utilizes its location and last clamping lobe leaf, desirable locating effect can be provided on the one hand, the dependence to support radial support power can be reduced on the other hand, avoid the type selecting of the support complication caused bigger than normal, as oppressed mitral valve work, cause conductive impairment, vascular tear etc., can also expanding indication on the other hand, autologous lobe ring patient that is narrow and autologous lobe leaf incompetence all can apply.
2, the present invention on the described lobe leaf clamping device of contiguous described inboardend or on the described supporting bracket of contiguous described inboardend or contiguous described inboardend described on the section of being connected and fixed is provided with the bending section bending along the radial direction of described support to the axis direction of described support, design make use of lever principle like this, when described supporting bracket and described valve sewing section are compressed, the described free end of described lobe leaf clamping device opens along the radial direction of described support, the described free end that described bending length of tape moves described lobe leaf clamping device opens further, it is convenient to the offside that described free end can enter into the closed face of autologous lobe leaf, thus be convenient to autologous lobe leaf and be placed between described lobe leaf clamping device and described valve sewing section, when described supporting bracket and described valve sewing section are completely released, the state that the described part reply sewing the overlapping described lobe leaf clamping device of section with described valve is laminating described valve sewing section makes autologous lobe leaf be clamped between described lobe leaf clamping device and described valve sewing section, compared to prior art, this design can solve described lobe leaf clamping device and catch the contradiction between autologous lobe leaf ability and holding force. simultaneously, when the described free end of described lobe leaf clamping device opens along the radial direction of described support, the subtended angle utilizing transfer lime the described free end of described lobe leaf clamping device can be made softened from the described bending section that the internal surface of described lobe leaf clamping device is conflicted described lobe leaf clamping device increases further.
3, a part for the leaf clamping device of lobe described in the present invention is overlapping with described valve sewing section, be positioned at described overlapping region described valve sewing section skeleton structure on be provided with projection radially, when autologous lobe leaf is clamped between described lobe leaf clamping device and described valve sewing section, autologous lobe leaf is provided the reactive force radially outward applied along support by described projection, autologous lobe leaf is provided the reactive force radially-inwardly applied along support by described lobe leaf clamping device, and such method of clamping can improve the clamping effect to autologous lobe leaf. Lobe leaf is clamped by up and down two the power actings in conjunction (be generally lobe ring be arranged with the power that arches upward provide up) conventional compared to prior art, radial clamping can avoid the conductive impairment arching upward and causing for the compressing of left ventricular outflow tract view, and patient does not need to implant permanent pacemaker after surgery. Meanwhile, it is spacing that described lobe leaf clamping device provides from aorta to left ventricle direction when artificial lobe leaf is closed, and it is spacing that described projection then provides from left ventricle to aorta direction when artificial lobe leaf is opened, and bidirectionally limited improves stent anchors effect.
4, the present invention states described lobe leaf clamping device and described supporting bracket with described on the section of being connected and fixed one cutting and become, described valve sew section is provided with described on the section of being connected and fixed mate mutually under the section of being connected and fixed, described support by the section of being connected and fixed on described and described under the section of being connected and fixed inlay and connect as one, compared to the support of one cutting, described lobe leaf clamping device and described valve sewing section are processed respectively and are made both can be overlapping, linear contact lay limited in contrast prior art, invention increases the holding area being applied on autologous lobe leaf, improve holding force on the one hand, the significantly shake of autologous lobe leaf under blood flow effect can be prevented on the other hand, ensure proper motion and the effective vent area of artificial valve prosthesis, can guarantee that the end of described lobe leaf clamping device can not because of the positioning error caused after softened sizing cripetura so that support is positioned at after being placed on ring or ring simultaneously, increase effective vent area further.
5, the present invention on described the section of being connected and fixed and described under the section of being connected and fixed is respectively arranged with the mosaic site of stairstepping, wave-like, zigzag fashion or drop shape, outside surface cover at described mosaic site is installed with the metal tube being driven plain firmly to fix, compared to the mode connected by suture after overlap in prior art, so design can avoid overlapping region to cause support to load required sheath pipe size increasing.
6, support described in the present invention by the section of being connected and fixed on described and described under the section of being connected and fixed inlay and connect as one, the support of grid is closed compared to integral type, such design makes one end of described supplemental support gripping section when being subject to the pressure distortion coming from patient tissue, the sewing section distortion of described valve or displacement can not be driven, ensure the normal opening and closing work of the artificial valve being positioned in described valve sewing section.
7, the present invention is respectively arranged with at the two ends of described support and draws head so that described support can carry out safely substep release, avoids described supplemental support gripping section or described valve sewing section to jump out suddenly sheath pipe, it is to increase security also achieves controllable release.
8, the described free end of the leaf clamping device of lobe described in the present invention is driven plain along the radial direction of described support, can reduce sheath pipe size when so design makes described lobe leaf clamping device and described valve sew overlapping press-in sheath pipe together with section.
Accompanying drawing explanation
Fig. 1 a shows in the present invention the explanation of the offside in the closed face about autologous lobe leaf. Fig. 1 b-Fig. 1 e shows the schematic diagram of the numerous embodiments of the present invention.
Fig. 2 a-Fig. 2 b respectively illustrates supplemental support gripping section of the present invention and the schematic diagram of described valve sewing section.
Fig. 3 a-Fig. 3 h respectively illustrate of the present invention on the section of being connected and fixed and described under the schematic diagram of multiple mode of connection of the section of being connected and fixed.
Fig. 4 a-Fig. 4 c shows projection of the present invention and coordinates the schematic diagram clamping autologous lobe leaf with described lobe leaf clamping device.
Fig. 5 a and Fig. 5 b shows the softened schematic diagram of lobe leaf clamping device of the present invention.
Fig. 6 a-Fig. 6 e shows the schematic diagram of the numerous embodiments of the present invention.
Fig. 7 shows the schematic diagram that another kind protruding described in the present invention implements mode.
Fig. 8 a and Fig. 8 b shows the schematic diagram of another embodiment of the invention. Fig. 8 c-Fig. 8 g shows the schematic diagram of numerous embodiments of the present invention.
Fig. 9 a-Fig. 9 d shows the schematic diagram of the numerous embodiments drawing head described in the present invention.
Figure 10 a and Figure 10 b shows the delivery conduit being mounted with artificial valve prosthese along leading guide wire when the mouth direct motion of apex of the heart Wicresoft arrives aortic valvular ring, the schematic diagram of delivery catheter distal end and sectional view.
When the described free end that Figure 11 a and Figure 11 b shows described lobe leaf clamping device is released, the schematic diagram of delivery catheter distal end and sectional view.
When the described free end that Figure 12 a and Figure 12 b shows described lobe leaf clamping device starts to open along the radial direction of described support, the schematic diagram of delivery catheter distal end and sectional view.
When the described free end that Figure 13 a and Figure 13 b shows described lobe leaf clamping device is opened further along the radial direction of described support, the schematic diagram of delivery catheter distal end and sectional view.
Figure 14 a and Figure 14 b show operator adjust the position of described lobe leaf clamping device and angle after entirety pull delivery sheath, when making the offside in closed face that the described free end of described lobe leaf clamping device enters autologous lobe leaf, the schematic diagram of delivery catheter distal end and sectional view.
Figure 15 a and Figure 15 b shows described valve sewing section when being completely released, the schematic diagram of delivery catheter distal end and sectional view.
Figure 16 a and Figure 16 b shows described supporting bracket when being completely released, the schematic diagram of delivery catheter distal end and sectional view.
Figure 17 a and Figure 17 b show described delivery sheath again closed time, the schematic diagram of delivery catheter distal end and sectional view.
Figure 18 shows described delivery sheath when withdrawing from human body, the schematic diagram on patient's aortic valve ring position.
Figure 19 a-Figure 19 f shows the schematic diagram of another embodiment of the invention. Figure 19 g-19j shows the schematic diagram of the numerous embodiments of the present invention.
Figure 20 a and Figure 20 c shows the schematic diagram that the present invention plants the numerous embodiments of described lobe leaf clamping device.
Embodiment:
For making the object of the present invention, technical scheme and advantage clearly understand, developing simultaneously embodiment referring to accompanying drawing, the present invention is described in more detail.
Specific embodiment one:
Far-end described in the present embodiment refers to the one end away from the apex of the heart, and described near-end refers to the one end close to the apex of the heart.
As shown in Figure 1a, when left ventricle 193 contraction makes the blood pressure of left ventricle 193 higher than aorta 192 blood pressure, blood is washed aortic valve open from left ventricle 193 and is entered aorta 192, when left ventricle 193 diastole makes the blood pressure of left ventricle 193 lower than aorta 192 blood pressure, aortic valve closing, at this moment the contact of adjacent autologous lobe leaf 190 forms closed face 1900, the offside in the closed face that the another side 1901 being now positioned at the lobe leaf 190 of aorta 192 is defined as autologous lobe leaf at this. as shown in fig. 1b and fig. lc, the artificial valve prosthese 100 of the band lobe leaf clamping device of the present invention, comprise support 110 and artificial valve 120, described support 110 comprises supplemental support gripping section 111 and valve sewing section 112, described artificial valve 120 is fixedly connected in described valve sewing section 112, described supplemental support gripping section 111 is by supporting bracket 113, lobe leaf clamping device 130 and on the section of being connected and fixed 140 form, described lobe leaf clamping device 130 and described supporting bracket 113 with described on the section of being connected and fixed 140 one cutting and become, described valve sew section 112 is provided with described on the section of being connected and fixed 140 phase mate under the section of being connected and fixed 150, described support 110 by the section of being connected and fixed 140 on described and described under the section of being connected and fixed 150 inlay and connect as one, one end that described lobe leaf clamping device 130 is connected with described supporting bracket 113 is inboardend 131, the other end of described lobe leaf clamping device 130 dissociates for free end 132, it is overlapping that a part 134 for described lobe leaf clamping device 130 sews section 112 with described valve, in its natural state, the described part 134 sewing the overlapping described lobe leaf clamping device 130 of section 112 with described valve is close to the outside surface of described valve sewing section 112, be positioned at overlapping region described valve sewing section 112 skeleton structure on be provided with projection 160 radially, on the described lobe leaf clamping device 130 of contiguous described inboardend 131 or on the described supporting bracket 113 of contiguous described inboardend 131 or contiguous described inboardend 131 described on the section of being connected and fixed 140 is provided with the bending section 133 bending along the radial direction of described support 110 to the axis direction of described support 110, when described supporting bracket 113 and described valve sewing section 112 are compressed, the described free end 132 of described lobe leaf clamping device 130 opens along the radial direction of described support 110, described bending section 133 drives the described free end 132 of described lobe leaf clamping device 130 to open further, it is convenient to the offside 1901 that described free end 132 can enter into the closed face of autologous lobe leaf, thus be convenient to autologous lobe leaf and be placed between described lobe leaf clamping device 130 and described valve sewing section 112, when described supporting bracket 113 and described valve sewing section 112 are completely released, the state that described part 134 reply sewing the overlapping described lobe leaf clamping device 130 of section 112 with described valve is laminating described valve sewing section 112 makes autologous lobe leaf be clamped between described lobe leaf clamping device 130 and described valve sewing section 112. compared to currently available productss such as COREVALVE series and SAPIEN series, the present invention is provided with lobe leaf clamping device 130 in the bracket and utilizes its location and the autologous lobe leaf of last clamping, desirable locating effect can be provided on the one hand, the dependence to support radial support power can be reduced on the one hand, avoid the type selecting of the support complication caused bigger than normal, as oppressed mitral valve work, cause conductive impairment, vascular tear etc., can also expanding indication on the other hand, autologous lobe ring patient that is narrow and autologous lobe leaf incompetence all can apply.Described lobe leaf clamping device 130 has v-shaped structure, in its natural state along described support 110 axis direction described in the position of the described free end 132 of lobe leaf clamping device 130 and the lowermost end 121 of the lobe ring of described artificial valve maintain an equal level, time such design makes by the described free end 132 of described lobe leaf clamping device 130 is placed on position at the bottom of autologous lobe leaf hole positioning, described artificial valve 120 upon discharge described lowermost end 121 can be seated on autologous lobe ring. In one embodiment, as shown in Figure 1 d, the described supporting bracket 113 of contiguous described inboardend 131 is provided with the bending section 133 bending along the radial direction of described support 110 to the axis direction of described support 110. In another embodiment, as shown in fig. le, described inboardend 131 is positioned at the far-end of described supporting bracket 113, being provided with the bending section 133 bending along the radial direction of described support 110 to the axis direction of described support 110 on the described lobe leaf clamping device 130 of contiguous described inboardend 131, the described free end 132 of described lobe leaf clamping device 130 is separated into two sections along the vertical section of described support 110.
As shown in Figure 2 a, described lobe leaf clamping device 130 and described supporting bracket 113 with described on the section of being connected and fixed 140 one cutting and become, the benefit of design is to reduce and presses sheath diameter and improve juncture corrosion resistance and fatigue property like this. in the present invention, as shown in Figure 2 a and 2 b, described supplemental support gripping section 111 and described valve sewing section 112 separately cutting and after shaping separately again by the section of being connected and fixed 140 on described and described under the section of being connected and fixed 150 inlay and connect as one, design is compared to the support of one cutting in prior art like this, described lobe leaf clamping device 130 and described valve sewing section 112 can be overlapping, linear contact lay limited in contrast prior art, invention increases the holding area being applied on autologous lobe leaf, improve holding force on the one hand, the significantly shake of autologous lobe leaf under blood flow effect can be prevented on the other hand, ensure proper motion and the effective vent area of artificial valve prosthesis 120, can guarantee that the end of described lobe leaf clamping device 130 can not because of the positioning error caused after softened sizing cripetura so that after support is placed, artificial valve is positioned on ring or ring simultaneously, increase effective vent area further.
In one embodiment, as illustrated in figs. 3 a-3d, on described, the section of being connected and fixed 140 is positioned at the near-end of described supporting bracket 113, under described, the section of being connected and fixed 150 is positioned at the far-end of described valve sewing section 112, the effect being fixedly connected with to improve, on described the section of being connected and fixed 140 and described under the section of being connected and fixed 150 is respectively arranged with stairstepping (Fig. 3 a), wave-like (Fig. 3 b), the mosaic site 155 of zigzag fashion (Fig. 3 c) or drop shape (Fig. 3 d), outside surface cover at described mosaic site 155 is installed with the metal tube 156 being driven plain, firmly to fix, compared to the mode connected by suture after overlap in prior art, so design can avoid overlapping region to cause support to load required sheath pipe size increasing. for improving the erosion resistance of described mosaic site 155, the selected energy of position for the described metal tube 156 being socketed is as far as possible fair with the energy of position of described rack body, avoiding the potential corrosion that local occurs in patient's body, conventional metal tube material comprises platinum, gold, platinum iridium alloy and tantalum metal etc. meanwhile, mark that this place's metal tube can be used as development location puts use, and described metal tube 156 position is positioned at artificial valve lobe angle top, it is possible to provide position reference to doctor, and auxiliary Intraoperative position, avoids blocking coronary opening. in another embodiment, the section of being connected and fixed 140 is provided with step 141 (Fig. 3 e) on described, or the section of being connected and fixed 150 is provided with step 151 (Fig. 3 f) under described, described step plays the effect of spacing described metal tube, avoids it to be pressed at described support in sheath and dispose procedure and moves. in another enforcement mode, on described in the section of being connected and fixed 140 and described under the section of being connected and fixed 150 is provided with step 141,151 (Fig. 3 g) simultaneously, can play position-limiting action for described metal tube 156 to maximum degree like this, but need described metal tube 156 to be through described mosaic site 155 for slotted pipe (Fig. 3 h) can overlap.
As shown in fig. 4 a, be positioned at overlapping region described valve sewing section 112 skeleton structure on be provided with projection 160 radially, the outer tangent line of described protruding 160 arranged in described skeleton structure and the axis shape of described support 110 angle at 45 ��, described protruding 160 is the described skeleton structure rod member that extends out of described valve sewing section 112, in order to avoid stabbing autologous tissue, the described free end of protruding 160 inwardly holds together along support shaft wire diameter. As shown in figures 4 b and 4 c, when autologous lobe leaf 190 is clamped between described lobe leaf clamping device 130 and described valve sewing section 112, autologous lobe leaf 190 is provided the reactive force radially outward applied along support by described projection 160, autologous lobe leaf 190 is provided the reactive force radially-inwardly applied along support by described lobe leaf clamping device 130, and such method of clamping can improve the clamping effect to autologous lobe leaf 190. Lobe leaf is clamped by up and down two the power actings in conjunction (be generally lobe ring be arranged with the power that arches upward provide up) conventional compared to prior art, radial clamping can be avoided arching upward the conductive impairment that the compressing for left ventricular outflow tract view causes, and patient does not need to implant permanent pacemaker after surgery. Simultaneously, it is spacing that described lobe leaf clamping device 130 provides from aorta to left ventricle direction when artificial lobe leaf is closed, it is spacing that described projection 160 provides from left ventricle to aorta direction when artificial lobe leaf is opened, and bidirectionally limited improves stent anchors effect. The angle that the outer tangent line of described protruding 160 and the axis of described support are formed should be moderate, increasing of angle is spacing despite what be beneficial to from left ventricle to aorta direction, but it pushes autologous lobe leaf 190 place open has and stops coronary ostium risk, is unfavorable for its processing characteristics and fatigue property and easily causes and wreck simultaneously. Thus, in actual design, planner should consider these relations.
As shown in figure 5 a and 5b, one end of described lobe leaf clamping device 130 is connected with described supporting bracket 113, for inboardend 131, the described lobe leaf clamping device 130 of contiguous described inboardend 131 is provided with radially bending to the axis direction of described support 110 bending section 133, the radius of curvature R of described bending section 133 is 2.5mm, radius of curvature R is more big, when described supporting bracket 113 and described valve sewing section 112 are compressed, the angle that described bending section 133 drives the described free end 132 of described lobe leaf clamping device 130 to open further is more big, be conducive to Intraoperative position, along described support 110 axis direction described in the center of curvature of bending section 133 be 6mm apart from the height H of the described inboardend 131 of described lobe leaf clamping device 130. it should be noted that, it is overlapping that described bending section 133 should not sew section 112 with described valve, avoid the described part 134 sewing the overlapping described lobe leaf clamping device 130 of section 112 in its natural state with described valve cannot reply the state for described valve sewing section 112 of fitting, cause autologous lobe leaf can not be effectively clamped between described lobe leaf clamping device 130 and described valve sewing section 112, reduce anchoring effect.
Specific embodiment two:
Far-end described in the present embodiment refers to the one end away from the apex of the heart, and described near-end refers to the one end close to the apex of the heart.
In another embodiment of the present invention, as shown in fig. 6a-6c, the artificial valve prosthese 200 of described band lobe leaf clamping device, comprise support 210 and artificial valve 220, described support 210 comprises supplemental support gripping section 211 and valve sewing section 212, described artificial valve 220 is fixedly connected in described valve sewing section 212, described supplemental support gripping section 211 is by supporting bracket 213, lobe leaf clamping device 230 and on the section of being connected and fixed 240 form, described lobe leaf clamping device 230 and described supporting bracket 213 with described on the section of being connected and fixed 240 one cutting and become, described valve sew section 212 is provided with described on the section of being connected and fixed 240 phase mate under the section of being connected and fixed 250, described support 210 by the section of being connected and fixed 240 on described and described under the section of being connected and fixed 250 inlay and connect as one, described lobe leaf clamping device 230 with described on one end of being connected of the section of being connected and fixed 240 be inboardend 231, the other end of described lobe leaf clamping device 230 dissociates for free end 232, it is overlapping that a part 234 for described lobe leaf clamping device 230 sews section 212 with described valve, in its natural state, the described part 234 sewing the overlapping described lobe leaf clamping device 230 of section 212 with described valve is close to the outside surface of described valve sewing section 212, be positioned at overlapping region described valve sewing section 212 skeleton structure on be provided with projection 260 radially, the described lobe leaf clamping device 230 of contiguous described inboardend 231 is provided with the bending section 233 bending along the radial direction of described support 210 to the axis direction of described support 210, design make use of lever principle like this, when described supporting bracket 213 and described valve sewing section 212 are compressed, the described free end 232 of described lobe leaf clamping device 230 opens along the radial direction of described support 210, described bending section 233 drives the described free end 232 of described lobe leaf clamping device 230 to open further, it is convenient to the offside that described free end 232 can enter into the closed face of autologous lobe leaf, thus be convenient to autologous lobe leaf and be placed between described lobe leaf clamping device 230 and described valve sewing section 212, when described supporting bracket 213 and described valve sewing section 212 are completely released, the state that described part 234 reply sewing the overlapping described lobe leaf clamping device 230 of section 212 with described valve is laminating described valve sewing section 212 makes autologous lobe leaf be clamped between described lobe leaf clamping device 230 and described valve sewing section 212, compared to prior art, this design can solve described lobe leaf clamping device 230 and catch the contradiction between autologous lobe leaf ability and holding force.
In one embodiment, described supporting bracket 213 is made up of latticed rhombus ripple, described supporting bracket 213 is positioned at the aorta ascendens of patient after being completely released, such design can make full use of aorta ascendens to the grappling effect of support, it is to increase anchoring effect. along the circumference of described support 210 be evenly provided with on described in three groups the section of being connected and fixed 240 and described under the section of being connected and fixed 250, described support 210 by the section of being connected and fixed 240 on described and described under the section of being connected and fixed 250 inlay and connect as one, the support of grid is closed compared to integral type, such design makes the distal portions of described supplemental support gripping section 211 when being subject to the pressure distortion coming from patient's aorta ascendens place, described valve sewing section 212 can not be driven to be out of shape or displacement, ensure the normal opening and closing work of the artificial valve 220 being positioned in described valve sewing section 212. described artificial valve 220 is made up of animal tissues or high molecular polymer. described animal tissues is Pigs Hearts bag, bovine pericardium, horse pericardium etc., and described high molecular polymer is tetrafluoroethylene, urethane, silica gel. described support 210 is self-expandable stent, and material is resilient material, such as shape-memory material, it is preferable to niti-shaped memorial alloy. in another embodiment, described lobe leaf clamping device has U shape structure, described lobe leaf clamping device 230 with described on one end of being connected of the section of being connected and fixed 240 be inboardend 231, such design increases described lobe leaf clamping device 230 to the radial holding force of autologous lobe leaf, improves anchoring effect. in its natural state along described support 210 axis direction described in the described free end 232 of lobe leaf clamping device 230 be positioned at the far-end 1mm of lowermost end 221 of lobe ring of described artificial valve.
In one embodiment, as shown in fig 6d, in its natural state along described support 210 axis direction described in the described free end 232 of lobe leaf clamping device 230 be positioned at the near-end 1mm of lowermost end 221 of lobe ring of described artificial valve. Such design makes described artificial valve lobe ring 221 position a little more than autologous lobe ring, it is possible to the artificial valve prosthese described in guarantee is " on ring " type after release completely, increases effective vent area.
In one embodiment, as shown in fig 6e, described lobe leaf clamping device 230 is provided with radially bending to the axis direction of described support bending section 233, when the described free end 232 of described lobe leaf clamping device 230 opens along the radial direction of described support 210, the subtended angle that delivery sheath can make the described free end 232 of described lobe leaf clamping device 230 softened from the described bending section 233 that the internal surface of described lobe leaf clamping device 230 is conflicted described lobe leaf clamping device 230 increases further.
In one embodiment, as shown in Figure 7, be positioned at overlapping region described valve sewing section 212 skeleton structure on be provided with projection 260 radially, described protruding 260 sew the point of the sawtooth in the skeleton structure of section 212 by described valve is formed through heat setting type, and the outer tangent line of described protruding 260 and the axis of described support form the angle of 30 ��.
In an embodiment, as figures 8 a and 8 b show, described valve sew section 212 bottom be provided with along described valve sew section 212 radial direction arch upward prevent lobe week neglected loading put 270, described prevent lobe week neglected loading put 270 for along described valve sew section 212 bottom outer surface circumference stitching rings, described prevent lobe week neglected loading from putting 270 in order to the spaces blocking described valve sewing section 212 and autologous patient lobe ring and flow out between road, reduce and leak in lobe week. In one embodiment, as shown in Figure 8 c, described preventing lobe week neglected loading from putting 270 and be subdivided into multiple dingus (270a, 270b......), each dingus all has arch structure, and described dingus sews the external circumferential distribution of section 212 along described valve. Described preventing lobe week neglected loading from putting wavy shaped configuration (Fig. 8 d) or the zigzag structure (Fig. 8 e) that 270 become for metal material with memory silk 271 coiling, the sawtooth of the crest of described wavy shaped configuration and trough or described zigzag structure point is bent to form arch respectively to interior. As illustrated in fig. 8f, mutually it is wound around between described adjacent silk 271, forms structure closely. In another embodiment, described in prevent lobe week neglected loading put 270 outside surface overlay films, described film is made up of animal tissues or terylene, tetrafluoroethylene, urethane or silica gel. As illustrated in fig.8g, in its natural state, prevent described in being positioned at along the described free end 232 of lobe leaf clamping device 230 described in described support 210 axis lobe week neglected loading put 270 far-end and with its axially distance L be 2mm, design prevents described lobe leaf clamping device 230 from preventing from all neglected loadings of lobe from putting 270 overlapping causing increase sheath pipe size with described under pressure sheath state like this. In one embodiment, the described free end 232 of described lobe leaf clamping device 230 is driven plain along the radial direction of described support 210, can reduce sheath pipe size when so design makes described lobe leaf clamping device 230 and described valve sew overlapping press-in sheath pipe together with section 212.
In one embodiment, as shown in Figure 8 c, it is respectively arranged with at the near-end of the far-end of described supporting bracket 213 and described valve sewing section 212 and draws 299, make described support 210 can carry out safely far-end and near-end substep release, distal portions or the near-end part of support is avoided to jump out suddenly sheath pipe, it is achieved controllable release is to improve security. Described draw 299 for square, circular (Fig. 9 a) or oval (Fig. 9 b), or described in draw 299 to be square hole, circular hole (Fig. 9 c) or oval hole (9d).
In order to illustrate the principle of work of the present invention better, the dispose procedure of the artificial valve prosthese of a kind of band lobe leaf clamping device of the present invention will be progressively described below:
(1) as as-shown-in figures 10 a and 10b, the delivery sheath being mounted with the artificial valve prosthese 200 of band lobe leaf clamping device guiding wire from apex of the heart Wicresoft opening's edge and is entered patient's aortic valvular ring 191 position, now described supporting bracket 213 is arranged in distal sheath pipe 291, the head that draws of described supplemental support gripping section 211 far-end snaps onto on distal stent web member 292, described valve sewing section 212 is arranged in near-end sheath pipe 293, the head that draws of described valve sewing section 212 near-end snaps onto on proximal stent web member 294, the free end 232 of described lobe leaf clamping device 230 is positioned at described near-end sheath pipe 293.
(2) as shown in Figure 11 a and Figure 11 b, recession near-end sheath pipe 293, now the free end 232 of described lobe leaf clamping device 230 exposes near-end sheath pipe 293, and described protruding 260 in the skeleton structure of described valve sewing section 212 return back to state of nature;
(3) as depicted in figs. 12 a and 12b, now described supporting bracket 213 and described valve sewing section 212 are compressed by distal sheath pipe 291 and near-end sheath pipe 293 respectively, move forward distal sheath pipe 291 gradually, the described free end 232 of described lobe leaf clamping device 230 opens along the radial direction of described support 210, and described bending section 233 drives the described free end 232 of described lobe leaf clamping device 230 to open further;
(4) as shown in Figure 13 a and Figure 13 b, reach near-end sheath pipe 293, the subtended angle that now described near-end sheath pipe 293 makes the described free end 232 of described lobe leaf clamping device 230 softened from the described bending section 233 that the internal surface of described lobe leaf clamping device 230 is conflicted described lobe leaf clamping device 230 increases further, it is convenient to the offside 1901 that described free end 232 can enter into the closed face of autologous lobe leaf 190, thus be convenient to autologous lobe leaf 190 and be placed between described lobe leaf clamping device 230 and described valve sewing section 212, described protruding 260 again it is compressed in near-end sheath pipe 293 simultaneously,
(5) as shown in Figure 14 a and Figure 14 b, in vitro under the guiding of image documentation equipment, rotate the position of the described free end 232 of the described lobe leaf clamping device 230 of adjustment, then pull overall for described delivery sheath toward near-end, making described free end 232 can enter the offside 1901 in closed face of autologous lobe leaf 190, now autologous lobe leaf 190 is placed between described lobe leaf clamping device 230 and described near-end sheath pipe 293;
(6) as shown in Figure 15 a and Figure 15 b, recession near-end sheath pipe 293 to described valve sews section 212 and is released completely, described protruding 260 make autologous lobe leaf 190 local protruding (referring to Fig. 4 b), and the outside surface radial direction of described valve sewing section 212 is resisted against patient's lobe ring 191 and flows out on road;
(7) as shown in fig 16 a and fig 16b, reach distal sheath pipe 291 is completely released to described supporting bracket 213, described supporting bracket 213 is resisted against in patient's aorta ascendens 192, and the state that described part 234 reply now sewing the overlapping described lobe leaf clamping device 230 of section 212 with described valve is laminating described valve sewing section 212 makes autologous lobe leaf 190 be clamped between described lobe leaf clamping device 230 and described valve sewing section 212;
(8) as shown in Figure 17 a and Figure 17 b, original position replied by recession distal sheath pipe 291, and reach near-end sheath pipe 293 makes the far-end of near-end sheath pipe 293 and the proximal anastomosis of distal sheath pipe 291;
(9) as shown in figure 18, delivery sheath is withdrawn human body, closed apex of the heart wound.
Specific embodiment three:
Far-end described in the present embodiment refers to the one end away from the apex of the heart, and described near-end refers to the one end close to the apex of the heart.
In another embodiment of the present invention, as shown in Figure 19 a-19d, the artificial valve prosthese 300 of described band lobe leaf clamping device, comprise support 310 and artificial valve (not shown), described support 310 comprises supplemental support gripping section 311 and valve sewing section 312, described artificial valve (not shown) is fixedly connected in described valve sewing section 312, described supplemental support gripping section 311 is by supporting bracket 313, lobe leaf clamping device 330 and on the section of being connected and fixed 340 form, described lobe leaf clamping device 330 and described supporting bracket 313 with described on the section of being connected and fixed 340 one cutting and become, described valve sew section 312 is provided with described on the section of being connected and fixed 340 phase mate under the section of being connected and fixed 350, described support 310 by the section of being connected and fixed 340 on described and described under the section of being connected and fixed 350 inlay and connect as one, described lobe leaf clamping device 330 with described on one end of being connected of the section of being connected and fixed 340 be inboardend 331, the other end of described lobe leaf clamping device 330 dissociates for free end 332, it is overlapping that a part 334 for described lobe leaf clamping device 330 sews section 312 with described valve, in its natural state, the described part 334 sewing the overlapping described lobe leaf clamping device 330 of section 312 with described valve is close to the outside surface of described valve sewing section 312, be positioned at overlapping region described valve sewing section 312 skeleton structure on be provided with projection 360 radially, the described lobe leaf clamping device 330 of contiguous described inboardend 331 is provided with the bending section 333 bending along the radial direction of described support 310 to the axis direction of described support 310, when described supporting bracket 313 and described valve sewing section 312 are compressed, the described free end 332 of described lobe leaf clamping device 330 opens along the radial direction of described support 310, described bending section 333 drives the described free end 332 of described lobe leaf clamping device 330 to open further, it is convenient to the offside that described free end 332 can enter into the closed face of lean type lobe leaf, thus be convenient to autologous lobe leaf and be placed between described lobe leaf clamping device 330 and described valve sewing section 312, when described supporting bracket 313 and described valve sewing section 312 are completely released, the state that described part 334 reply sewing the overlapping described lobe leaf clamping device 330 of section 312 with described valve is laminating described valve sewing section 312 makes autologous lobe leaf be clamped between described lobe leaf clamping device 330 and described valve sewing section 312.
In one embodiment, on described the section of being connected and fixed 340 and described under the circular diameter that forms of the tie point of the section of being connected and fixed 350 be less than the maximum diameter of described valve sewing section 312. the maximum diameter of described supplemental support gripping section 311 is greater than the maximum diameter of described valve sewing section 312. in one embodiment, on the described lobe leaf clamping device 330 of contiguous described inboardend 332 and on described in contiguous described inboardend 332, the section of being connected and fixed 340 is provided with radially bending to the axis direction of described support 310 bending section 333, 343, such design has at least 2 benefits, one is that described bending section 343 is as arc transition between described supporting bracket 313 and described valve sewing section 312, make to be positioned at described under the tangent line at described artificial lobe leaf (not shown) top of the section of being connected and fixed 350 and support axis have 7 �� of angle [alpha] held together, contribute to artificial lobe leaf good closure, two be the described inboardend 331 of described lobe leaf clamping device 330 be fixedly connected at described in the section of being connected and fixed 340, oppress described on described bending section 343 in the section of being connected and fixed 340 described lobe leaf clamping device 330 can be made softened, the far-end of the bending section 333 of described lobe leaf clamping device 330 it is positioned at due to the bending section 343 in the section of being connected and fixed 340 on described, corresponding " lever " arm of force lengthens, the softened subtended angle of described lobe leaf clamping device 330 is bigger, the subtended angle that the described bending section 333 now conflicted described lobe leaf clamping device 330 from the internal surface of described lobe leaf clamping device 330 can make the described free end 332 of described lobe leaf clamping device 330 softened increases further.
In one embodiment, as shown in Figure 19 e, described supporting bracket 313 is the rod member of round and smooth connection, the far-end of described supplemental support gripping section 311 is provided with and draws 399, described 399 are drawn inwardly to hold together along the axis footpath of described supplemental support gripping section 311, it is different from exposed rhombic-shaped grid structure, such design reduces the radial support power of supporting bracket 313 on the one hand, prevent from excessively tearing aorta ascendens, make when described supporting bracket 313 is positioned at the aorta ascendens of patient after being completely released on the other hand, round and smooth end face is unlikely to damage aorta ascendens inwall, prevent that aorta ascendens is hemorrhage and interlayer is formed. in certain embodiments, the surface-coated film of described supporting bracket 313.
In one embodiment, as shown in Figure 19 f and Figure 19 g, under described, the section of being connected and fixed 350 is provided with and holds hole 351 and multiple groove 352, adjacent lobe leaf 320a, 320b top being convenient to described artificial valve 320 through described in hold hole 351 arrive from the internal surface of the section of being connected and fixed 350 described described under the outside surface of the section of being connected and fixed 350, described artificial valve 320 firmly is sewn in described valve sewing section 312 by suture 354 again around described groove 352. In another embodiment, as shown in Figure 19 h, lobe leaf 320a, 320b top of described artificial valve 320 through described in hold hole 351 arrive from the internal surface of the section of being connected and fixed described 350 described under the section of being connected and fixed 350 outside surface after, the axis sewing section 312 along described valve hold described under the edge of the section of being connected and fixed 350, such design makes described artificial valve 320 sew up more reliable with described valve sewing section 312. In another embodiment, as shown in Figure 19 i and Figure 19 j, threading hole 353 it is provided with around hole 351 described holding, it is convenient to suture 354 pass from described threading hole 353 and lobe leaf 320a, 320b top of fixing described artificial valve 320, avoids described lobe leaf 320a, 320b too much pin hole to occur thus improves the wearing quality of described artificial valve 320.
In one embodiment, as illustrated in fig. 20, the surface of described lobe leaf clamping device 330 is provided with hangnail 335, described hangnail 335 cooperatively interacts with described valve sewing section 312, make to be clamped in the autologous lobe leaf 190 between described lobe leaf clamping device 330 and described valve sewing section 312 to be not easy pine de-, it is to increase to the holding force of autologous lobe leaf 190. In another embodiment, as shown in Figure 20 b and Figure 20 c, the free end 332 of described lobe leaf clamping device 330 is mastoid process shape structure, such design can avoid the cutting width due to the free end 332 of described lobe leaf clamping device 330 excessive cause naturally arch upward, reduce dress sheath size; Secondly the process that described lobe leaf clamping device 330 is finalized can be evenly distributed in stress on described lobe leaf clamping device 330, avoid the described free end 332 of described lobe leaf clamping device 330 and described inboardend 331 stress to concentrate and repeated stress failure occurs. In another embodiment, the surface-coated film 336 of described lobe leaf clamping device 330, adds and the contact area of autologous lobe leaf 190, it is to increase to the holding force of autologous lobe leaf 190.
Except the treatment being applied in aortic valve, the present invention can also be applied to the treatment of mitral valve, pulmonary artery lobe and tricuspidal valve.
Finally should be noted that; the foregoing is only the preferred embodiment of the present invention; not in order to limit the present invention, all any amendment, equivalent replacement and improvement etc. done within the spirit and principles in the present invention, all should be included within protection scope of the present invention.