A kind of heart valve prosthesisTechnical field：
The invention belongs to medical instruments fields, and in particular to a kind of heart valve prosthesis.
Background technology：
Mitral position is made of annulus, leaflet, chordae tendineae, papillary muscle, five parts of connection that have a common boundary, is solving in left atrioventricular orificeIt is Mitral valve structure (mitral apparatus) or mitral complex (mitral to cut open the exact name on learningcomplex).Annulus of mitral valve is the fibroid taeniae telarum for being attached to left room room bore edges, for irregular " D " shape shape, bicuspid valveContinuous part of preceding 1/3rd of annulus for preceding valve and aorta, the corresponding atrium of front and rear valve are formed with mitral annulusAngle it is also different, also have the attachment of left auricle of heart at atrium.Mitral valve function is not all one of most common heart disease, such as twoBicuspid valve caused by mitral valve insufficiency caused by mitral valve prolapse illness, such as valve lesions caused by rheumatic inflammation is narrowIt is narrow etc..
Mitral valve insufficiency can be divided into three kinds of functional, degeneration or Combination.Most commonly degeneration and work(It can property mitral valve insufficiency.Functionality is generally damaged secondary to left ventricular wall motion function, left ventricular dilatation, nipple muscular function are differentOften, it is generally found from heart failure patient.This part patient also includes the ischemic mitral regurgitation secondary to coronary heart diseaseAnd the mitral valve insufficiency that Nonischemic cardiolmyopathy is related.Degeneration mitral regurgitation disease is generally considered to be valve structurePathologic variation occurs or valve lower structure pathology sexually revises, abnormal extension or fracture including chordae tendineae.
Mitral stenosis is most common type in rheumatic heart valve disease, wherein 40% patient is pure bicuspid valveIt is narrow.Due to the rheumatic fever that repeated, early stage bicuspid valve is at valve commissure and its basal part oedema, inflammation and neoplasmBased on (exudate) is formed, the later stage gradually forms front and rear valve in agglutination since fibrinous deposition and fibroid becomeThe adhesion of leaf intersection, fusion, valve thickens, is coarse, hardening, calcification and chordae tendineae shortens and stick to each other, limitation valve activityAbility and opening cause valve stenostomia.Other rare causes of disease include calcification, congenital stenosis and knot under senile annulus of mitral valve or ringForm tissue disease etc..
The traditional treatment means of mitral valve disease include being suitable for slightly to the drug therapy of severe reflux and having correspondingThe surgical method of surgical indication.Wherein, surgical method further includes mitral valve replacement and mitral valve repair.In surgery handIn art method, it is invasive excessive typically to open chest, open heart operation, needs to establish extracorporal circulatory system, and there is higher complication to occurRate and infection risk.Patient it is many it is resistance to can't stand huge surgery risk and can only helpless waiting for death.In order to reduce operation windDanger, displacement and repairing operation method through intubation intervention are developed.
For treatment skill of the bicuspid valve through intubation intervention, though there are a small number of products through intubation intervention mitral valve at presentIt is applied on forming and neoplasty, but in terms of through intubation intervention mitral valve replacement, there has been no ripe productions in the worldProduct come out.Nevertheless, numerous percutaneous intervention mitral valve replacement technologies are still presented on everybody at the moment one after another, these technologies are mostIt is in zoopery or clinic trial, respective technology has respective limitation.
Patent CN102639179B and patent US8449599 describes one kind two of Edwards Lifesciences companiesCusp displacement prosthetic appliance, for implantation into the natural bicuspid valve region of heart, the natural bicuspid valve have native annulus andNative valve leaflets, the prosthetic appliance include：Tube-shaped main body, including flowing through chamber therein, atrial end and the heart for bloodRoom end, and being configured for placement in the native annulus, the main body can be radially compressed to radial compression, with deliver intoIn the heart, and radial expanded state can be self-expanded into from the compressive state；It is connected with the main body and is located at instituteAt least one fixing piece of body exterior is stated, the fixing piece is connected with the main body, and expansion is in work as the main bodyDuring state, at least one fixing piece is configured as hooking around native leaflet, at least one fixing piece and describedLeaflet-reception space is limited between main body；The annular flange portion to extend radially outwardly with the atrial end from the main body, it is describedAnnular flange portion includes atrium sealing element, and when the prosthetic appliance is implanted, the atrium sealing element prevents blood flowMore than the atrial end of the main body on the body exterior.Fixed form used by the technology, by institute in its sovereignty descriptionThe fixing piece limited is positioned at the outside of the main body, and the native leaflet will be by flat Stent Implantation main body bloodBetween the medial surface of the lateral surface of channel and the anchoring device, cause fixed firmness place one's entire reliance upon the fixing piece withFrictional force between the main body, and after clamped, native valve is constantly in the leaflet open position in diastole periodAnd unfolded state, the large area annular barrier blood flow of left ventricular outflow tract so that should be in this period from left ventricle streamThe blood flow for entering aorta is stopped by a part, left ventricle is back to, after being chronically implanted, it may appear that the illnesss such as heart failure.
Patent CN201180020556 describes a mitral of Medtronic companies, which includes havingDownstream part and the inner supporting structure of upstream portion, wherein, the upstream portion has the cross section more than the downstream partArea, the inner supporting structure is configured in the atrial side for being positioned at least partially at the native valve association, and is appliedTowards the axial force of left ventricle；And outer supporting structure, the outer supporting structure have two or more engagement arms, wherein,The engagement arm is connected to the inner supporting structure, wherein, the prosthese is configured to the leaflet of native valve when it is transplantedA part be clipped between the inner supporting structure and the engagement arm.It is similar with the design of Edwards, by with larger horizontal strokeSectional area upstream portion is resisted against on mitral annulus, and captures original two point of patient by the engagement arm of outer supporting structureValve.The stent integrally still takes cylindric symmetrical structure, therefore doctor still needs to select larger specification during operationValve enough support forces are provided, huge valve diameter greatly blocks the blood supply of left ventricular outflow tract, aortaValve mouth flow velocity increases, and pressure increases, and is susceptible to heart failure situation in the past for a long time.Meanwhile larger valve diameter is directly all pastedSympetalous ring will be oppressed near including aortic valvular ring and be organized.
Patent CN201610074782 provides a kind of D-shaped insertion type artificial cardiac valve, including stent, is set to stentThe leaflet of inside and the overlay film being set on stent body wall, stent include sequentially connected first submounts, the second submounts andThird submounts, the first submounts are webmaster, and the second submounts are the webmaster that cross section is D-shaped, and the third submounts are in loudspeakerShape webmaster.The maximum caliber of first submounts is identical with the caliber of second submounts, the third submountsMinimum pipe is identical with the caliber of second submounts.Although it is claimed to through so-called D-shaped webmaster and two point in situThe accommodating space shape that the primary body wall of valve surrounds matches, and is circular stent relative to section, is avoided that stent to not roundedThe excessive compressing of the bicuspid valve profile of shape causes the efferent tract of heart to become narrow.The problem of technology, is, even stentCross section is changed to D-shaped, directly contacts mitral annulus using total-grid structure, but still surrounding tissue can be caused to oppress；Meanwhile the maximum caliber of the first submounts described in the technology is identical with the caliber of second submounts, it is meant that stent is horizontalSection still in itself can still have the influence of efferent tract at least equal to mitral annulus diameter, huge stent；Finally, shouldThe second submounts are arranged to D-shaped in technology, and leaflet is sewn on stent, after non-circular region must influence leaflet sutureFit-state.Although the technology there is no the specific open mode for stitching valve, from its figure we still it can be seen that itsLeaflet is three flaps.Therefore, non-circular suture will be unfavorable for leaflet closing performance and long-term leaflet fatigue.
Patent US20160074160 discloses a kind of valve bracket structure, is made including one by marmemThe outside support of expansion and an internal stent made by marmem；The internal stent is made of two parts, firstFirst part is the structure of expansion during beginning state, and second part is the structure of compression, and artificial valve is arranged on internal stentFirst part, second part are additionally provided with tether；Internal stent connect fixation with outside support.The problem of program, is, incites somebody to actionInside and outside two layers of stent is reconnected after processing respectively and is fixed, and is bound to cause stent overlapping, is on the one hand increased the diameter into sheath, anotherThe ladder that aspect junction is formed is unfavorable for back into sheath and returns receipts, can increase the wind of junction failure in finally overlapping connectionDanger, such as suture breaks, stent contact corrosion etc..
Clinical effectiveness shows there is not a ideal product for being used to intervene mitral valve displacement at present.It is main formerBecause being that mitral complex has special physiological structure, and there is complicated physiological environment below annulus, cause productIt is accurately positioned and fixation is extremely difficult.The technical issues of having sums up as follows：Valve bracket is designed as symmetrical structure, and doctor is oftenIt selects and is equal with patient's bicuspid valve itself annulus or the valve specification of bigger caters to mitral valve tissue profile, it is not only hugeStent in itself can have an impact efferent tract, and directly can be to surrounding tissue using total-grid structure contact mitral annulusIt causes to oppress, further blocks the blood flow of left ventricular outflow tract；Stent is divided into inside and outside two parts in current techniquesIt is reconnected after processing respectively, stent will certainly be caused to be overlapped, on the one hand increase the diameter into sheath, another aspect junction shapeInto ladder be unfavorable for back into sheath and receipts are returned, the risk that junction is failed, such as suture can be increased in finally overlapping connectionFracture, stent contact corrosion etc.；Mainstream technology on the market fails to fully achieve the reentry sheath function of stent at present, if intoEnter to release section components inside heart and cannot recall, once stent is problematic can only promptly to turn surgery open chest surgery, perform the operationRisk is high.
In conclusion although technology described above has certain effect respectively on mitral valve replacement,Still in place of Shortcomings, in the field of surgery for the treatment of valve disorder, there is an urgent need for a kind of new heart valve prosthesis to solveProblem above.
Invention content：
The purpose of the present invention is overcoming the limitation of the prior art, for mitral valve insufficiency or narrow result in the need for being situated betweenEnter to change the patient of valve, propose a kind of heart valve prosthesis, the asymmetric eccentric structure that the present invention uses can not only reduce stentTo the influence of left ventricular outflow tract view after release, and it can ensure that the opening area of valve will not be because of between patient's mitral annulusGreatest differences and change excessive, manufacturer can reduce product specification while optimizing valve performance, and can realize positionAdjustable, accurate positioning and the purpose of secure anchorage, Product Safety of the invention are high.
The purpose of the present invention is what is be achieved through the following technical solutions：
A kind of heart valve prosthesis, including stent and artificial valve, the stent includes atrium section and valve sews section, instituteIt states artificial valve to be fixedly connected in the valve sewing section, the skeleton of the distal portions of the valve sewing section extends to formSupporting section, the supporting section and the valve sewing section are structure as a whole, and one end of the atrium section is remote with the supporting sectionEnd connection, another end dissociative of the atrium section, on the cross section of the artificial valve central axes, the valve stitchesSection processed is located in the supporting section, and the center and the center of the supporting section of the valve sewing section are misaligned, the supporting sectionCross-sectional area be more than the cross-sectional area of valve sewing section, the cross-sectional area of atrium section is more than the horizontal stroke of the supporting sectionSectional area, the cross-sectional area of the valve sewing section is less than the cross-sectional area of autologous patient valve annulus, in free state when instituteSupporting section is stated to be at least partially disposed between autologous patient annulus.
The purpose of the present invention can also further be realized by following technical solution：
In one embodiment, on the cross section of the artificial valve central axes, the supporting section relative toThe valve sewing section is eccentric structure, after the heart valve prosthesis is placed to target location, before native leafletsThe distance at the outer of the supporting section in valve region to the center of valve sewing section is greater than or equal to after native leafletsThe outer of the supporting section in valve region sews the distance at the center of section to the valve.
In one embodiment, on the cross section of the artificial valve central axes, the projection of the supporting sectionFor loop configuration, the loop configuration is cirque structure, oval ring structure or D-ring structure.
In one embodiment, it is provided in the cirque structure, oval ring structure or D-ring structure scarceMouthful.
In one embodiment, on the cross section of the artificial valve central axes, the valve sews sectionOuter is inscribed within the outer of the supporting section.
In one embodiment, the valve sewing section is the network of tubular or valve sewing section is cylinderThe wavy shaped configuration of shape.
In one embodiment, the supporting section is shaped by the local skeleton of valve sewing section distal portions.
In a preferred embodiment, the supporting section is by the part in the skeleton of valve sewing section distal portionsRod piece is shaped or the supporting section is shaped by the subwave in the skeleton of valve sewing section distal portions.It is furthermore preferred that reinforcement wave is provided between the adjacent rod piece, to strengthen the cross-brace power between the rod piece.
In a preferred embodiment, the rod piece is located at adjacent in the wavy shaped configuration of valve sewing sectionBetween wave or the rod piece sews the extension of the wave crest in the network of section for the valve.
In one embodiment, hangnail is provided on the supporting section, the hangnail is pierced into patient certainly in free stateIn body mitral valve tissue.
In one embodiment, multiple bending sections are provided on the supporting section, the supporting section one in free statePart is located in autologous patient annulus, and another part is located at below autologous patient annulus, the institute below autologous patient annulusThe deployment diameter for stating supporting section is more than the diameter of autologous patient annulus.
In one embodiment, overlay film on the supporting section.
In one embodiment, the atrium section is structure as a whole with the supporting section, and the atrium section is the supportThe extension of Duan Yuanduan.
In one embodiment, the periphery of the atrium section is additionally provided with leak-proof device, and the leak-proof device has shapeSkeleton made of memorial alloy and film, the leak-proof device are flexibility, can comply with the uneven profile of mitral annulus.
In one embodiment, in the axial direction of the heart valve prosthesis, the distalmost end of the artificial valve is higher by instituteIt states supporting section and sews 1 to 10 millimeter of section connecting place with the valve.
In one embodiment, the atrium section can comply with the uneven wheel of patient's intrinsic atrial cavity wall and valve annulusIt is wide.
In one embodiment, the proximal end of the valve sewing section is provided with necking component, the distal end of the necking componentIt is connect with the proximal end of valve sewing section, the proximal diameter of the necking component is less than the diameter of valve sewing section.
In a preferred embodiment, the necking component and valve sewing section are to be detachably connected.
In a preferred embodiment, the necking component is made or the necking component portion of degradation materialIt is divided into degradation material to be made.
In one embodiment, the necking component sews the extension of the proximal end skeleton structure of section, institute for the valveThe proximal end for stating necking component is connected to one, and in free state, the proximal end of the necking component is fixed on target locationOn.
In a preferred embodiment, the necking component is flexibility.It is furthermore preferred that the necking component is wavyStructure.It is furthermore preferred that the necking component is line.
In one embodiment, the necking component sews the extension of the proximal end skeleton structure of section for the valve,The end set of the necking component has connecting rod, and one end of the connecting rod is connect with the end of the necking component,The other end of the connecting rod is fixed on target location during free state.
In a preferred embodiment, the connecting rod be flexible link or the connecting rod be flexible member and justThe combination of property rod piece.It is furthermore preferred that the connecting rod is made of degradation material or the connection bar part is degradable materialMaterial is made.
In a preferred embodiment, the connecting rod is arranged to the soft of spring-like structures or the connecting rodProperty rod piece be spring-like structures.It is furthermore preferred that the spring-like structures surface is covered with polymeric membrane.It is furthermore preferred that in the bulletBe provided with non-telescoping component in spring shape structure, the both ends of the non-telescoping component respectively with the spring-like structuresBoth ends are connected so that the spring-like structures cannot generate axial stretching.
In a preferred embodiment, the proximal part of the connecting rod is provided with fixing piece.
In a preferred embodiment, the fixing piece stent small for the big centre in both ends, the stent are closed for NiTiSpun gold braiding is shaped.
In a preferred embodiment, the proximal part of the connecting rod is hollow pipe, on the tube wall of the hollow pipeHole is provided with, in free state, the distalmost end of the fixing piece is pierced by from the hole is pierced into target location.
In one embodiment, the necking component is wire-like members, rod component or ribbon-shaped members.It is furthermore preferred thatCombination of the necking component for flexible piece and rigid member.In free state, one end that the necking component dissociates is fixedOn target location.Preferably, the necking component is made of degradation material or the necking component part is degradableMaterial is made.
In one embodiment, the proximal end of the valve sewing section is provided with leaflet clamping piece, the leaflet clamping pieceProximal end and the valve sewing section are fixedly connected, under natural conditions, autologous patient leaflet be clamped in the leaflet clamping piece withBetween the valve sewing section.
In one embodiment, the distal end of the leaflet clamping piece is provided with connecting line, passes through the traction of the connecting lineIt can realize that the leaflet clamping piece is overturn around the junction of the leaflet clamping piece and valve sewing section.
In one embodiment, it is provided with hangnail on the leaflet clamping piece.
In a preferred embodiment, one end of the connecting line and the distal end of the leaflet clamping piece detachably connectIt connects.
Compared with the existing technology, the advantage of the invention is that：
1st, the skeleton of the distal portions of heretofore described valve sewing section extends to form supporting section, perpendicular to the peopleOn the cross section of work valve central axes, valve sewing section is located in the supporting section, the center of the valve sewing section andThe center of the supporting section is misaligned, and the supporting section is eccentric structure relative to valve sewing section so that the valveSewing section is biased to the mitral back lobe region of patient in free state, caused by it is asymmetrical bias effect can not only reduceThe requirement of cross-sectional area after being discharged to stent itself can reduce valve and set to reduce the influence to left ventricular outflow tract viewThe relevance of meter and implant site tissue contours, manufacturer can reduce product specification while optimizing valve performance.When describedWhen heart valve prosthesis is for tricuspid valve intervention displacement, valve sewing section be biased in free state patient's tricuspid valve everyValve region, the thick and solid region of musculature can be adjacent to by being conducive to stent, and anchoring effect is more preferable, and valve movement is more stable.
2nd, heretofore described supporting section is structure as a whole with valve sewing section, is different from the prior art by inside and outsideTwo layers of stent be overlapped again after processing respectively, stitches the structure for tying up connection, on the one hand the structure of integral type reduces the diameter into sheath, and oneThe design of the no step of aspect cause back into sheath and return receive it is more convenient, finally prevented the risk of suture breaks, improveSafety.
3rd, the cross-sectional area of heretofore described valve sewing section is less than the cross-sectional area of autologous patient valve annulus, describedThe extension of local skeleton, the sizing of the distal portions of valve sewing section form supporting section, the supporting section in free state at leastPart is between autologous patient annulus.It is different from setting for most product utilization whole cradle fits annulus in the prior artMeter, especially when the heart valve prosthesis is for tricuspid valve intervention displacement, because patient's Tricuspid annulus size is very big, such asFruit is supported on using valve sewing section in patient's Tricuspid annulus merely, the hardly possible realization from engineering viewpoint, even if exerting oneselfStrong realize can also substantially reduce valve life.The present invention only contacts annulus with local skeleton extension sizing, is ensureing to supportCompressing surrounding tissue can be avoided while power, ensure that the blood flow space of ventricular outflow tract, while valve can be optimizedFunction.
4th, in the present invention in the axial direction, the artificial valve distalmost end is higher by the supporting section and is sewed with the valve1 to 10 millimeter of connecting place of section, is different from the deep and narrow gap formed between interior support arm in the prior art, the present invention can be very bigGround improves blood flow movement, it is not easy to form vortex and thrombus, thrombus is avoided to fall into body-internal-circulation blood vessel and forms embolism, improve peaceQuan Xing.
5th, the proximal end of heretofore described valve sewing section is provided with necking component, can play the role of controlled release,And allow stent that can reentry sheath and recall, greatly improve the safety of product.After stent discharges completely, the neckingConnecting rod on component or necking component can be fixed on apex of the heart tissue either in other heart tissues or operative incision padOn piece can prevent stent migration from slipping, and strengthen the effect of anchoring.
6th, heretofore described necking component and valve sewing section are to be detachably connected.In this way design ensure it is describedStent can be under the premise of controlled release, and the necking component can be withdrawn from vivo, greatly reduced implantation material, reduced to the heartThe contact and stimulation in room, facilitate transport system to withdraw human body, and eliminate the limitation of the implantation to day back lobe mesopetalum.
7th, the periphery of heretofore described atrium section is additionally provided with leak-proof device, and the leak-proof device is closed with shape memorySkeleton made of gold and film, and the leak-proof device is flexibility, therefore can comply with the uneven profile of mitral annulus,The compressing to aorta and left atrial wall can be mitigated while mitigating and backflowing.
8th, the proximal end of heretofore described valve sewing section is provided with leaflet clamping piece, can clamp patient's leaflet, preventAutologous patient leaflet is pushed to left ventricular outflow tract view, is further reduced the influence to efferent tract.In addition, the leaflet clamping piece endBe provided with connecting line, described connecting line one end is connected to the distal end of the leaflet clamping piece, the other end of the connecting line with it is defeatedHandle is sent to connect, the leaflet clamping piece can be realized around the leaflet clamping piece and the valve by the traction of the connecting lineThe junction overturning of film sewing section, designing in this way is advantageous in that and can repeatedly be clamped according to leaflet clamping effect, and makeSheath can be reentried by obtaining whole device, improve operation safety.
Description of the drawings
Fig. 1 a- Fig. 1 c show a kind of schematic diagram of preferred embodiment of the present invention, and wherein Fig. 1 b are bowing for Fig. 1 aView.
Fig. 2 a and Fig. 2 b show the schematic diagrames that the present invention is located at patient's bicuspid valve implantation position.
Fig. 3 a- Fig. 3 e show the schematic diagram of the numerous embodiments of the present invention.
Fig. 4 a- Fig. 4 e show the schematic diagram of the numerous embodiments of the present invention, and the stent that wherein Fig. 4 c are Fig. 4 d is cutFigure.
Fig. 5 a- Fig. 5 c show the schematic diagram of the numerous embodiments of atrium section in the present invention.
Fig. 6 a- Fig. 6 c show the schematic diagram of the numerous embodiments of the present invention.
Fig. 7 a- Fig. 7 c show the schematic diagram of another preferred embodiment of the present invention, and wherein Fig. 7 b are Fig. 7 a'sVertical view.
Fig. 8 a- Fig. 8 c show the stent cutting drawing of the numerous embodiments of the present invention, and Fig. 8 d- Fig. 8 e show the present inventionNumerous embodiments schematic diagram.
Fig. 9 a- Fig. 9 d show the schematic diagram of the numerous embodiments of the present invention.
Figure 10 a- Figure 10 c show the schematic diagram of the numerous embodiments of the present invention.
Figure 11 a- Figure 11 d show the schematic diagram of the numerous embodiments of the present invention.
Figure 12 a- Figure 12 b show the schematic diagram of another embodiment of the invention.
Figure 13 a- Figure 13 e show the schematic diagram of another preferred embodiment of the present invention, and wherein Figure 13 b are figureThe stent cutting drawing of 13a, Figure 13 c are the vertical view of Figure 13 a.
Figure 14 a- Figure 14 c show the schematic diagram of the numerous embodiments of the present invention.
Figure 15 a- Figure 15 g show the schematic diagram of the numerous embodiments of the present invention.
Figure 16 a- Figure 16 e show the schematic diagram of the numerous embodiments of the present invention.
Figure 17 a- Figure 17 d show the schematic diagram of one embodiment of the present invention.
Figure 18 a- Figure 18 d show the schematic diagram of one embodiment of the present invention.
Specific embodiment：
To make the objectives, technical solutions, and advantages of the present invention more comprehensible, develop simultaneously embodiment referring to the drawings, rightThe present invention is further described.
Distal end of the present invention refers to one end far from the apex of the heart, and the proximal end refers to one end close to the apex of the heart.
Specific embodiment one：
As illustrated in figures la-c, a kind of heart valve prosthesis 100, including stent 110 and artificial valve 120, the stent 110Including atrium section 111 and valve sewing section 112, the artificial valve 120 is fixedly connected in the valve sewing section 112,The skeleton of the distal portions of the valve sewing section 112 extends to form supporting section 113, and the supporting section 113 is stitched with the valveSection 112 processed is structure as a whole, and one end of the atrium section 111 is connect with the distal end of the supporting section 113, the atrium section 111Another end dissociative, on the cross section of 120 central axes of artificial valve, the supporting section 113 is projected as ringShape structure, valve sewing section 112 are located among the supporting section 113, the valve sew 112 center 1120 of section with it is describedThe center 1130 of supporting section 113 is misaligned, and the cross-sectional area of the supporting section 113 is more than the transversal of valve sewing section 112Area, the cross-sectional area of the atrium section 111 are more than the cross-sectional area of the supporting section 113, the horizontal stroke of the valve sewing section 112Sectional area is less than the cross-sectional area of autologous patient valve annulus, and in free state, the supporting section 113 is at least partially disposed at troubleBetween the self annulus of person.Existing Edwards and Medtronic patented technology (referring to CN102639179B andCN201180020556 in), stent integrally still takes cylindric symmetrical structure, therefore doctor needs to select during operationThe valve of larger specification provides enough support forces, and huge valve diameter greatly blocks the confession of left ventricular outflow tractBlood, aorta petal mouth flow velocity increase, and pressure increases, and is susceptible to heart failure situation in the past for a long time.Meanwhile larger valve diameter is straightAll fitting annulus are connect, will oppress near including aortic valvular ring and organize.In embodiments of the present invention, such as Fig. 2 aShown in Fig. 2 b, on the cross section of the artificial valve central axes, the supporting section 113 is stitched relative to the valveSection 112 processed is eccentric structure so that the valve sewing section 112 is biased to the mitral back lobe region of patient in free state.Designing in this way is advantageous in that, asymmetrical eccentric structure not only reduces the requirement of the cross-sectional area after being discharged to stent itselfTo reduce the influence to left ventricular outflow tract view, but also the relevance of valve designs and implant site tissue contours can be reduced, it is excellentManufacturer can reduce product specification while having changed valve performance.In other implementations, when the heart valve prosthesisWhen intervening displacement for tricuspid valve, the valve sewing section is biased to the septal leaflet region of patient's tricuspid valve in free state, favorablyThe thick and solid region of musculature can be adjacent in stent, anchoring effect is more preferable, and valve movement is more stable.It is further, since describedValve sewing section 112 need not be excessive, and the present invention simplifies release step under the effects equivalent for ensuring to stop left ventricular outflow tract viewSuddenly, success rate of operation is improved.
As a preferred embodiment, as shown in figs 3 a-3 c, perpendicular to the transversal of the artificial valve central axesOn face, the supporting section 113 is projected as loop configuration, and the loop configuration is cirque structure or oval ring structure,The geometric center 1130 of the loop configuration and the center 1120 of valve sewing section 112 are misaligned.Implement as another kindMode, as shown in Figure 3d, after the heart valve prosthesis is placed to target location, perpendicular to the artificial valve axisOn the cross section of line, the outer of the supporting section 113 in valve region to valve sewing section center before native leafletsThe outer that 1120 distance is greater than or equal to the supporting section 113 positioned at native leaflets back lobe region sews section to the valveThe distance at center 1120, such as the loop configuration are D-ring structure, in free state, the flat region of the D-ring structureMitral preceding valve region is biased in domain in circumferential direction, and the arc area of the D-shape configuration is biased to two points in circumferential directionThe back lobe region of valve, such design more match the physiological anatomic architecture of patient's mitral annulus, can further avoid to valveThe overdistension of ring, so as to reduce the influence to aortic valvular ring and other adjacent tissues.In one embodiment, such as Fig. 3 eIt is shown, it is set in the cirque structure, oval ring structure or D-ring structure 113 jagged.
As a preferred embodiment, as shown in figures 4 a and 4b, the valve sewing section 112 is the grid of tubularStructure or the wavy shaped configuration that valve sewing section 112 is tubular.As shown in Fig. 4 c and 4d, the supporting section 113 is by instituteThe local skeleton for stating valve sewing 112 distal portions of section is further shaped.For example, the supporting section 113 is by the valvePart rod piece 1121 in the skeleton of sewing 112 distal portions of section is shaped or the supporting section 113 is stitched by the valveSubwave 1122 in the skeleton of 112 distal portions of section processed is shaped, and the wave 1122 is zigzag or waveform.Such as Fig. 4 eIt is shown, hangnail 1131 is provided on the supporting section 113, the hangnail is pierced into autologous patient mitral valve tissue in free stateIn.
As a preferred embodiment, as shown in figure 5, atrium section 111 weaves for marmemPetal-like structures (Fig. 5 a), star structure (Fig. 5 b), wavy shaped configuration (Fig. 5 c) or network.As shown in Figure 6 a, it is describedOne end of atrium section 111 is connected on the distal end of the supporting section 113, another end dissociative of the atrium section 111.As one kindPreferred embodiment as shown in Figure 6 b, connecting hole 1132, the atrium is provided on the skeleton of 113 distal end of supporting sectionOne end of section 111 is connected to by the connecting hole 1132 on the distal end of the supporting section 113.As fig. 6 c, the atriumSection 111 in the circumferential with the angle different from of artificial valve plane, positioned at the atrium in anterior mitral valve region section 111 withThe 112 axial angle α of valve sewing section is less than to be stitched positioned at the atrium in bicuspid valve back lobe region section 111 with the valveThe axial angle β of section 112 processed, since the space structure of mitral annulus is saddle-shaped configuration, design is so that the atrium in this waySection 111 can be close to patient's atrial tissue in free state, comply with the uneven of patient's intrinsic atrial cavity wall and valve annulusProfile.111 films of the atrium section, the membrane material include metal material, polytetrafluoroethylene (PTFE), polyethylene, polypropylene, teryleneOr animal derived material.
Specific embodiment two：
As shown in figs. 7 a-c, a kind of heart valve prosthesis 200, including stent 210 and artificial valve 220, the stent 210Including atrium section 211 and valve sewing section 212, the artificial valve 220 is fixedly connected in the valve sewing section 212,The skeleton of the distal portions of the valve sewing section 212 extends to form supporting section 213, and the supporting section 213 is stitched with the valveSection 212 processed is structure as a whole, compared with the prior art in inside and outside two layers of stent is processed respectively after be overlapped again, stitch the knot for tying up connectionOn the one hand structure, integral structure of the invention reduce diameter into sheath, on the other hand without the design of step cause back intoSheath and returning is received more convenient, has finally prevented the risk of suture breaks, has improved safety.One end of atrium section 211 withThe distal end connection of the supporting section 213, another end dissociative of the atrium section 211, perpendicular to 220 axis of artificial valveOn the cross section of line, the supporting section 213 is projected as loop configuration, the center 2120 of the valve sewing section 212 with it is describedThe center 2130 of loop configuration is misaligned, and the outer of the valve sewing section 212 is inscribed within the outer of the supporting section 213, thisSample design, which is advantageous in that, maximizes the eccentric effect of the supporting section 213, and the valve sews section 212 in free stateIt is adjacent to the mitral back lobe region of patient so that stent is more firm in mitral annulus, improves anchoring effect, avoids positionThe supporting section in back lobe region has activity space so as to damage back lobe and ventricle wall.The cross-sectional area of the supporting section 213More than the cross-sectional area of valve sewing section 212, the cross-sectional area of the atrium section 211 is more than the horizontal stroke of the supporting section 213Sectional area, in free state, the supporting section 213 is at least partially disposed between autologous patient annulus.
In one embodiment, the valve sews section 212 as the wavy shaped configuration of tubular or the network of tubular,The supporting section 213 is shaped by the part rod piece 2121 in the local skeleton of valve sewing 212 distal portions of section, instituteSupporting section 213 is stated to be at least partially disposed in free state between autologous patient annulus.It is different from most in the prior artThe design of product utilization whole cradle fits annulus, especially when the heart valve prosthesis is for tricuspid valve intervention displacement, becauseIt is very big for patient's Tricuspid annulus size, if be supported in patient's Tricuspid annulus using valve sewing section merely, from workHardly possible realization in journey angle, even if valve life can also be substantially reduced reluctantly by realizing.The present invention is only with local skeletonExtension shapes to contact mitral annulus, and compressing surrounding tissue can be avoided while support force is ensured, also ensures the left heartThe blood flow space of ventricular outflow tract view, while valvular function can be optimized.As figures 8 a and 8 b show, the rod piece 2121 is located atBetween adjacent wave in valve sewing 212 wavy shaped configuration of section or the rod piece 2121 sews section for the valveThe extension of wave crest in 212 networks.In another embodiment, as shown in Figure 8 c, the adjacent rod piece 2121 itBetween be provided with strengthen wave 2123, to strengthen the cross-brace power between the rod piece 2121.213 film of supporting section,The membrane material includes metal material, polytetrafluoroethylene (PTFE), polyethylene, polypropylene, terylene or animal derived material.
In another embodiment, as shown in figure 8d, multiple bending sections 2131 are provided on the supporting section 213,213 part of supporting section is located in autologous patient annulus 280 during free state, and another part is located at autologous patient annulusIt is straight to be more than autologous patient annulus 280 positioned at the deployment diameter of the supporting section 213 of 280 lower section of autologous patient annulus for 280 lower sectionsDiameter plays the role of positioning action, and enhancing anchoring effect is played after stent discharges completely.
In another embodiment, as figure 8 e shows, the supporting section 213 is structure as a whole with atrium section 211.Multiple bending sections 2131 are provided on the supporting section 213.
In one preferred embodiment, the atrium section 211 is structure as a whole with the supporting section 213, the heartRoom section 211 is the extension of 213 distal end of supporting section.As illustrated in fig. 9, the periphery of the atrium section 211 is additionally provided with anti-neglected loading230 are put, the leak-proof device 230 has skeleton 2301 made of marmem and film, and the leak-proof device 230 isFlexibility can comply with the uneven profile of mitral annulus, can mitigate to aorta and left atrial wall while mitigation is backflowedCompressing.As shown in Fig. 9 b and Fig. 9 c, the skeleton 2301 of the leak-proof device 230 by more support bar groups into or it is described anti-The skeleton 2301 of leakage device 230 is the wavy shaped configuration or zigzag structure that metal memory material filament winding system forms.The metalMemory material silk is Nitinol, and diameter is in the range of 0.1-0.6mm.As shown in figure 9d, the skeleton of the leak-proof device 230It is mutually wound between 2301 adjacent bar, forms close structure, to provide the elastic-restoring force of bigger.
In one embodiment, as shown in Figure 10 a, in the axial direction of the heart valve prosthesis 200, the artificial valveThe distalmost end of film 220 is higher by the supporting section 213 and sews 1 to 10 millimeter of 212 connecting place of section (L) with the valve.It is different from existingThere is the deep and narrow gap formed between interior support arm in technology, design is advantageous in that the supporting section 213 and the valve in this wayGap between film sewing section 212 is shallower, can significantly improve blood flow movement, it is not easy to form vortex and thrombus, avoid bloodBolt, which is fallen into body-internal-circulation blood vessel, forms embolism, improves safety.As shown in Figure 10 b and Figure 10 c, the valve sews section 212By partially or fully overlay film.Preferably, the membrane material includes metal material, polytetrafluoroethylene (PTFE), polyethylene, polypropylene, teryleneOr animal derived material.
In one embodiment, as shown in Figure 11 a and Figure 11 b, the proximal end of the valve sewing section 212 is provided with neckingComponent 240, the distal end of the necking component 240 are connect with the proximal end of valve sewing section 212, the necking component 240Proximal diameter is less than the diameter of valve sewing section 212.In one embodiment, as shown in fig. 11c, the chokePart 240 sews the extension of the proximal end skeleton structure of section 212 for the valve, and the necking component 240 is flexibility.It is furthermore preferred thatThe necking component 240 is wavelike structure.As illustrated in fig. 11d, the proximal end of the necking component 240 is connected to one,The proximal end of the necking component 240 is fixed in interventricular septum during free state.
In another embodiment, the necking component 240 is wire-like members, rod component or ribbon-shaped members.InstituteIt is the combination that flexible or described necking component 240 is flexible piece and rigid member to state necking component 240.In free state, instituteIt states the free one end of necking component 240 and is fixed on apex of the heart tissue either in other heart tissues or operative incision gasketOn.Preferably, the necking component 240 is made of degradation material or 240 part of necking component is degradation materialIt is made.The necking component 240 is advantageous in that using degradation material：As figure 12 a shows, the heart valve prosthesis 200It works early period in patient's body, necking component 240 is still undegraded made of degradation material, and the necking component 240 is freeOne end be fixed on apex of the heart tissue either in other heart tissues or on operative incision gasket, it can be ensured that heart valve is falseBody, which will not shift, to come off, and enhances anchoring effect；As shown in Figure 12b, as Implantation Time increases, stent is gradually climbed by endothelium to be covered,The anchoring effect of stent and mitral annulus more enhances, and the necking component 240 is more weakened by the tractive force of valve, togetherWhen, heart valve prosthesis prosthese may consequently contribute to patient's ventricle level back to normal after working normally, i.e., from preoperative larger ventricleChamber is restored to normal ventricle size, further reduced tractive force of the valve to the necking component.Degradation material at this timeDegradation will so that either other heart tissues or operative incision gasket are detached from for the necking component 240 and apex of the heart tissue, are kept awayThe strength of heartbeat is exempted to pass to heart valve prosthesis, reduces the volume of ventricle implant, reduces thrombus generationStimulant and landing point are beneficial to the long-term function of the postoperative valve of patient, improve safety.
Specific embodiment three：
As shown in figures 13 a-e, a kind of heart valve prosthesis 300, it is described including stent 310 and artificial valve (not shown)Stent 310 includes atrium section 311 and valve sewing section 312, and the artificial valve is fixedly connected at the valve sewing section 312On, the skeleton of the distal portions of the valve sewing section 312 extends to form supporting section 313, the supporting section 313 and the valveSewing section 312 is structure as a whole, and one end of the atrium section 311 is connect with the distal end of the supporting section 313, the atrium section311 another end dissociative, on the cross section of the artificial valve central axes, the supporting section 313 is projected as ringShape structure, the valve sewing section 312 are located among the supporting section 313, the center of the valve sewing section 312 and the branchThe center for supportting section 313 is misaligned, and the cross-sectional area of the supporting section 313 is more than the cross-sectional area of valve sewing section 312, instituteThe cross-sectional area for stating atrium section 311 is more than the cross-sectional area of the supporting section 313.In free state the supporting section 313 toSmall part is between autologous patient annulus.The proximal end of the valve sewing section 312 is provided with necking component 340, the contractingMouthpiece 340 sews the extension of the proximal end skeleton structure of section 312 for the valve, is set in the end of the necking component 340Connecting rod 342 is equipped with, one end of the connecting rod 342 is connect with the end of the necking component 340, in free state when instituteThe other end for stating connecting rod 342 is fixed on apex of the heart tissue either in other heart tissues or on operative incision gasket.ThisThe design of sample can play the role of controlled release, and allow stent that can reentry sheath and recall, and greatly improve productSafety.It after stent discharges completely, can prevent stent migration from slipping, strengthen the effect of anchoring.
In one embodiment, the connecting rod 342 is wire-like members, rod component or ribbon-shaped members.The connectionThe combination that bar 342 is flexible link or the connecting rod 342 is flexible member and rigid bar.Preferably, the connecting rod342 are made or 342 part of the connecting rod is made of degradation material of degradation material.The connecting rod 342 usesDegradation material is advantageous in that：The heart valve prosthesis 300 works early period in patient's body, by the degradation material systemInto connecting rod it is still undegraded, one end of the connecting rod 342 be fixed in apex of the heart tissue or other heart tissues orOn person's operative incision gasket, it can be ensured that heart valve prosthesis, which will not shift, to come off, and enhances anchoring effect；As Implantation Time increasesAdd, stent is gradually climbed by endothelium to be covered, and the anchoring effect of stent and mitral annulus more enhances, and the connecting rod is by valveTractive force more weakens, meanwhile, patient's ventricle level back to normal is may consequently contribute to after heart valve prosthesis prosthese normal work, i.e.,Normal ventricle size is restored to from preoperative larger ventricular chamber, further reduces tractive force of the valve to the connecting rod.ThisWhen degradation material degradation will cause the necking component 340 and apex of the heart tissue either other heart tissues or operative incisionGasket is detached from, and the strength of heartbeat is avoided to pass to heart valve prosthesis, reduces the volume of ventricle implant, reducesThe stimulant and landing point of thrombus generation, are beneficial to the long-term function of the postoperative valve of patient, improve safety.
As shown in Figure 14 a and Figure 14 b, in another embodiment, the connecting rod 342 is arranged to spring-like knotStructure or the flexible member of the connecting rod 342 are spring-like structures.Preferably, the spring-like structures surface is covered with high scoreSub- film.As shown in figure 14 c, non-telescoping silk or bar 3420, the silk or bar 3420 are provided in the spring-like structuresBoth ends of the both ends respectively with the spring-like structures be connected so that the spring-like structures cannot generate axial stretching.
As shown in fig. 15 a, the proximal part of the connecting rod 342 is provided with fixing piece 350.The fixing piece 350 is silkShape, threadiness or strip, one end of the fixing piece 350 are fixed in the connecting rod 342, another end dissociative.In free stateWhen, the free-end of the fixing piece 350 is fixed on apex of the heart tissue either in other heart tissues or operative incision gasketOn.
As illustrated in fig. 15b, the proximal part of the connecting rod 342 is hollow pipe, is provided on the tube wall of the hollow pipeHole 3421, in free state, the distalmost end of the fixing piece 350 is pierced by from the hole 3421, be pierced into apex of the heart tissue orOther heart tissues of person.The distalmost end of the fixing piece 350 is tip shape, and the distal portions of the fixing piece 350 are scheduled shape,The distal portions of the fixing piece 350 are scheduled combination of the shape for one or more of following shape：Spiral shape, circumferenceShape, arc, the combination shape of camber line and straight line, bifurcated double hook shape, 3D Curveds, multistage Curved, the distal end of the fixing piece 350Without hangnail or with one or more hangnail.
As shown in fig. 15 c, the fixing piece 350 be adapt to apex of the heart profile suction discoid component, the connecting rod 342 it is nearEnd, which is set up separately, is equipped with screw thread, is provided with threaded hole on the fixing piece 350, the proximal part of the connecting rod 342 with it is described solidDetermine 350 thread fitting of part.
As shown in Figure 15 d-f, the fixing piece 350 is the suction discoid component for adapting to apex of the heart profile, on the fixing piece 350It is provided with pillar 3501, fastener 3502 and nut 3503.The pillar 3501 is hollow, and the fastener 3502 is located at described convexIn column 3501,3501 inner surface of pillar is provided with screw thread.The fastener 3502 is hollow, the outer diameter of the fastener 3502Match with the internal diameter of the pillar 3501, the internal diameter of the fastener 3502 is interior with the proximal part of the connecting rod 342Diameter matches, and the connecting rod 342 is located in the fastener 3502, and 3502 top of fastener is provided with inclined-plane, describedFastener 3502 is provided with parallel cutting seam 3504 in the axial direction.It is provided in the nut 3503 more than the fastenerThe inclined-plane of 3502 top bevel angles, when the nut 3503 and 3501 thread fitting of pillar, the fastener 3502On cutting seam 3504 gap become smaller so that the connecting rod 342 is fixed between the fastener 3502.
As shown in fig.15g, the fixing piece 350 stent small for the big centre in both ends, the stent are compiled for nitinol alloy wireIt knits and shapes.After the instrument discharges completely, cardiomyopathy musculature is clamped in the stent both ends.
Specific embodiment four：
As shown in fig 16 a and fig 16b, a kind of heart valve prosthesis 400, it is described including stent 410 and artificial valve 420Stent 410 includes atrium section 411 and valve sewing section 412, and the atrium section 411 can comply with patient's intrinsic atrial cavity wall and valveThe uneven profile of film annulus, the artificial valve 420 are fixedly connected in the valve sewing section 412, the valve seamThe skeleton of the distal portions of section 412 processed extends to form supporting section 413, and the supporting section 413 is one with valve sewing section 412Body structure, the atrium section 411 are structure as a whole with the supporting section 413, and another end dissociative of the atrium section 411 is hanging downDirectly on the cross section of the artificial valve central axes, the valve sewing section 412 is located in the supporting section 413, the valveThe center and the center of the supporting section 413 of film sewing section 412 are misaligned, and the cross-sectional area of the supporting section 413 is more than describedValve sews the cross-sectional area of section 412, and the cross-sectional area of the atrium section 411 is more than the cross-sectional area of the supporting section 413,The supporting section 413 is at least partially disposed between autologous patient annulus during free state.The proximal end two of the valve sewing section 412Side is both provided with leaflet clamping piece 415, and the proximal end of the leaflet clamping piece 415 is fixedly connected with valve sewing section 412, fromUnder right state, autologous patient leaflet 481 is clamped between the leaflet clamping piece 415 and valve sewing section 412.In this wayDesign, which is advantageous in that, can clamp patient's leaflet 481, and autologous patient leaflet is prevented to be pushed to left ventricular outflow tract view, is further reducedInfluence to efferent tract.
In one embodiment, as shown in figure 16 c, the proximal end of the valve sewing section 412 is provided with necking component440, extension of the necking component 440 for the proximal end of the leaflet clamping piece 415, at the end of the necking component 440Portion is provided with connecting rod 442, and one end of the connecting rod 442 is connect with the end of the necking component 440, in free stateThe other end of Shi Suoshu connecting rods 442 is fixed on apex of the heart tissue.
In another embodiment, as shown in figure 16d, the proximal end of the valve sewing section 412 is provided with necking component440, the necking component 440 sews the extension of the proximal end of section 412 for the valve, at the end of the necking component 440Portion is provided with connecting rod 442, and one end of the connecting rod 442 is connect with the end of the necking component 440, in free stateThe other end of Shi Suoshu connecting rods 442 is fixed on apex of the heart tissue.
In another embodiment, as shown in figure 16e, the proximal end of the valve sewing section 412 is close to anterior mitral valveSide be provided with leaflet clamping piece 415.Guide rail 4122, the leaflet clamping piece 415 are provided in the valve sewing section 412It is pierced by from the guide rail 4122, such design enables the leaflet clamping piece 415 to sew section 412 with the valve and dividesStep release.And the leaflet clamping piece 415 can reentry sheath, help to clamp self anterior mitral valve.
In another embodiment, as shown in Figure 17 a and Figure 17 b, 415 end set of leaflet clamping piece has connectionLine 4150, described 4150 one end of connecting line are connected to the distal end of the leaflet clamping piece 415, the other end of the connecting line 4150It is connect with conveying handle, can realize that the leaflet clamping piece 415 is pressed from both sides around the leaflet by the traction of the connecting line 4150Gripping member 415 and the junction of valve sewing section 412 are overturn.As shown in fig. 17 c, when the heart valve prosthesis 400 needsDuring by compression loaded in delivery sheath, by the traction of the connecting line 4150 by the leaflet clamping piece 415 around the valveThe junction of leaf clamping piece 415 and the valve sewing section 412 is overturn, and designs that be advantageous in that can be by sheath pipe diameter most in this waySmallization.As shown in Figure 17 d, when the heart valve prosthesis 400 is gradually discharged, by controlling the connecting line 4150, makeIt obtains the leaflet clamping piece 415 to restore to clamp autologous patient leaflet 481 to precalculated position, can lead to if clamping effect is undesirableIt crosses the connecting line 4150 and the leaflet clamping piece 415 is sewed into section 412 around the leaflet clamping piece 415 and the valve againJunction overturning.This process can repeat, until clamping effect meets operation requirement.Moreover, such design makesSheath can be reentried by obtaining whole device, improve operation safety.As a preferred embodiment, the connecting line 4,150 1End and the distal end of the leaflet clamping piece 415 are detachably connected, when the leaflet clamping piece 415 restores patient to precalculated positionAfter native leaflets 481 are clamped, the connecting line 4150 is withdrawn, to reduce patient's body implantation material.In another embodiment,As shown in figure 18 a, the necking component 440 and valve sewing section 412 are to be detachably connected.In this way design ensure it is describedStent can be under the premise of controlled release, and the necking component 440 can be withdrawn from vivo, greatly reduce implantation material, reducesContact and stimulation to atrium, facilitate transport system to withdraw human body, and eliminate the limitation of the implantation to day back lobe mesopetalum.Such as figureShown in 18b, the proximal end of valve sewing section 412 is provided with cavernous structure 4125, the distal end of the necking component 440 staggeredly intoEnter in the cavernous structure 4125, lock hole 4401 is provided on the distal end of the necking component 440, in the lock hole 4401Middle insertion locking level 4126 realizes locking；It is described when the locking level 4126 detaches the lock hole 4401 as shown in Figure 18 cThe distal end of necking component 440 is detached from from the cavernous structure 4125 of valve sewing section 412, realizes the necking component440 sew the dismounting of section 412 with the valve.In another embodiment, as shown in Figure 18 d, 413 overlying of supporting sectionFilm 4132, the film 4132 are made by high-molecular fabric or by polytetrafluoroethylene (PTFE), are provided with down on the leaflet clamping piece 415Thorn 4152, when the leaflet clamping piece 415 overturns clamping native leaflets 481, the hangnail 4152 passes through native leaflets 481 simultaneouslyIt is pierced into the film 4132 on the supporting section 413, chucking power can be improved in this way, prevent native leaflets 481 from the leafletIt comes off between clamping piece 415 and the supporting section 413.
The technology of the present invention applies also for the patient for the treatment of tricuspid disease except applying in addition to bicuspid valve.
Finally it should be noted that the foregoing is merely the present invention preferred embodiment, not limiting thisInvention, all any modification, equivalent and improvement made all within the spirits and principles of the present invention etc., should be included in this hairWithin bright protection domain.