CN107920862A

CN107920862A - System and method for cardiac valves therapy

Info

Publication number: CN107920862A
Application number: CN201580068145.8A
Authority: CN
Inventors: K·加内桑; R·T·文卡塔苏布磊曼聂; A·T·福斯伯格; C·J·小施魏希; T·J·莫笛尔; E·O·马茨; D·J·科隆
Original assignee: Kaysen Nair Johnson Co Ltd Million Internet
Current assignee: Kaysen Nair Johnson Co Ltd Million Internet
Priority date: 2014-10-23
Filing date: 2015-10-22
Publication date: 2018-04-17
Anticipated expiration: 2035-10-22
Also published as: AU2015335808B2; JP2017531547A; CA2964935C; CA2964935A1; CN107920862B; BR112017008423A2; IL251852A0; BR112017008423B1; AU2015335808A1; JP6727218B2; CA3214673A1; IL251852B

Abstract

Prosthetic mitral valve film described herein can be used through conduit mitral valve delivery system and technology to dispose to be connected with the anatomical structure of natural mitral valve formation interface and cooperative anchor.This document describes prosthetic heart valve design, it forms interface with natural mitral valve structure and is connected to form fluid seal, so as to minimize mitral reflux and Paravalvular leak.There is also described herein for managing by the design of the prosthetic heart valve of the blood flow of left ventricular outflow tract and technology.In addition, this document describes the prosthetic heart valve design and technology that reduce risk of interferences between prosthetic valve and chordae tendineae.

Description

System and method for cardiac valves therapy

Cross reference to related applications

This application claims the rights and interests of following application：In the U.S. Provisional Patent Application NO.62/ that on October 23rd, 2014 submits 067,907；In the U.S. Provisional Patent Application NO.14/671,577 that on March 27th, 2015 submits；Carried on March 30th, 2015 The U.S. Provisional Patent Application NO.14/673,055 of friendship；And in the U.S. Provisional Patent Application submitted on March 31st, 2015 NO.14/674,349.The disclosure of earlier application is considered as a part for disclosure herein and is herein incorporated by reference Into disclosure herein.

Technical field

Present document relates to prosthetic heart valve, can such as use the prosthetic mitral valve film being implanted into through microcatheter technology.

Background technology

The Long-term clinical effect of valvular regurgitation is considered as cardiovascular relevant morbidity and dead major reason.Therefore, For many therapies of planned treatment mitral valve, a main purpose is backflowed to significantly be mitigated or eliminated.By disappearing Except the reflux at mitral valve, the destructive volume overload effect that can decay to left ventricle.The appearance of mitral reflux (MR) Amount excess load excessive kinetic energy required during being related to isotonic contraction wins forward output and the heart to generate always rich output to attempt maintenance Output quantity.It is directed to the pressure potential consumption of the valve leaked during the most energy dissipating portion that the appearances such as cardiac cycle are shunk.This Outside, there may be the high pressure reduced in atrium sinistrum for the treatment that MR mitigates and Pulmonary Vascular mitigates pulmonary edema (hyperemia) and breathing is short Promote the effect of symptom.For MR mitigate these therapies can also for left ventricle (LV) full curve and may be led due to MR The restricted type LV pathology of cause have actively impact.These Pathological Physiology problems show the possibility benefit of MR therapies, but Show the complexity of the system and the needs for focus beyond MR levels or the therapy of grade.

Some therapies for treating MR may aggravate other (non-MR) existing pathological condition or form new disease Reason situation.One of situation to be cured is mitral stenosis or forms inflow gradient.That is, if using without high filling pressure Under do not allow the prosthetic valve that abundant LV is flowed into, then, some benefits that MR mitigates may lose or lose.Volume to be cured Outer situation is left ventricular outflow tract (LVOT) obstruction or forms high LVOT barometric gradients.If that is, using and insufficient obstruction The prosthetic valve system of LVOT, then may lose or lose some benefits of MR mitigations.Moreover, if surgical procedure causes Atrial tissue is damaged in surgical operation, this may increase the possibility of the negative physiological effect of atrial fibrillation Property.Moreover, some prosthetic valve systems add the risk of higher LV wall stress by increasing LV sizes (LV geometries). Since mitral valve and LV geometries may be subject to by mastoid process and chordae tendineae device and integral relation, LV wall stress level Directly affect, cause LV to fill and shrink mechanical change.Therefore, in some cases, due to shrinking physiological change, LV geometry is made The prosthetic valve system that shape deteriorates may offset the benefit of MR mitigations.

The content of the invention

It is all as can using the prosthetic mitral valve film being implanted into through microcatheter technology this document describes prosthetic heart valve.For example, Some embodiments described herein through conduit mitral valve delivery system and method may be deployed as the day with mitral valve Right anatomical structure forms interface and connects and cooperative anchored with the native anatomy of mitral valve.In addition, this document describes It is connected with natural mitral valve structure to form Fluid Sealing into interface so that MR and Paravalvular leak are minimum after being implanted into Prosthetic heart valve.In addition, this document describes prosthetic heart valve system and technology, it is configured to pipe in a particular embodiment Reason is by the blood flow of left ventricular outflow tract (LVOT) so as to alleviate the risk that LVOT is blocked completely or partially.In addition, this The some embodiments of the described prosthetic heart valve system of text and technology may be configured to mitigate prosthetic valve with it is natural Risk of interferences between the chordae tendineae of mitral valve leaflet, this advantageously can facilitate or keep the geometry of LV.

Specific examples described herein includes the mitral valve exchange system for heart.The system may include to expand The anchoring assembly of exhibition, expansible anchoring assembly is configured to be implanted into natural mitral valve, and expansible anchoring assembly can With including the first extensible framework, the first extensible framework can be expanded configuration from delivering experiment material.The system can also wrap The first delivery sheath device is included, it has the distal end portion being inserted into atrium sinistrum and is configured to anchoring assembly distally End pushes out so that anchoring assembly expands to expanded configuration in atrium sinistrum.Alternatively, which may also include promotion apparatus, Apparatus is promoted to be releasably attached to expansible anchorable frame and be configured to make when anchoring assembly is in expanded configuration Anchoring assembly in atrium sinistrum towards natural mitral valve annulus in longitudinal reach.Moreover, the system can include artificial valve Membrane module, artificial valve component include the second extensible framework, and the second extensible framework can be adjusted to deployment shape from compressed configuration State when anchoring assembly is in expanded configuration with anchoring assembly to be selectively engaged.

Some embodiments described herein are used for prosthetic mitral valve membranous system being deployed in the natural of patient including a kind of Method in mitral valve.This method may include：First delivery sheath of navigating in patient causes the distal side of the first delivery sheath End is positioned in atrium sinistrum.This method may also include the anchor that prosthetic heart valve system is pushed from the distal end portion of the first delivery sheath Gu component make it that anchoring assembly extends at least in part when in atrium sinistrum.In addition, this method may include, group will anchored After part is pushed through in atrium sinistrum, move the annulus of anchoring assembly towards natural mitral valve.

Various embodiments described herein includes prosthetic mitral valve membranous system.The system may also include valve assemblies, valve Membrane module can include：Framing component, it limits outer contour and inside casing frame member space；And plugging device, it is placed in inside casing In frame member space.Plugging device has open configuration and closed configuration.Framing component includes proximal end frame part and distal end portion Frame part.Alternatively, the outside of distal end portion frame part includes flat region and automatic adjustment region, and Wherein at least some of flat region is spatially extended towards inside casing frame member.

The method that specific examples described herein includes the use of prosthetic mitral valve membranous system.This method may include：Make The valve assemblies of prosthetic mitral valve membranous system move forward towards natural mitral annulus.Alternatively, which may include frame Frame member, it limits outer contour and inside casing frame member space；And plugging device, it is placed in inside casing frame member space.Frame Component includes proximal end frame part and distal end portion frame part.The outside of distal end portion frame part is alternatively included generally Flat site and automatic adjustment region, and and flat region at least some towards inside casing frame member space Extension.This method may also include by valve assemblies be anchored in natural mitral valve cause flat region adjacent it is natural two point The preceding native leaflet of valve.

Some embodiments described herein include a kind of implantable prosthetic mitral valve membrane system at natural mitral valve System.Prosthetic mitral valve membranous system may include anchoring assembly, anchoring assembly limit in anchoring assembly space and longitudinal axis.Anchoring group Part may include expansible anchorable frame, and expansible anchorable frame includes hub and the ring lower support arm from hub extension.Propped up under ring Bearing arm extension extends to anchoring foot, and anchoring foot has the surface for being configured to engage with the ring lower groove of natural mitral valve. The system may also include valve assemblies, and valve assemblies include：Expansible valve frame, it limits outer contour and inside casing frame member Space；And plugging device, it is placed in inside casing frame member space.Valve assemblies can be with the anchoring in interior anchoring assembly space Component is releasably engaged.Alternatively, from the farthest side of anchoring assembly to the surface, parallel to the distance of longitudinal axis measurement It is at least 14 millimeters.

The method that various embodiments described herein includes the use of prosthetic mitral valve membranous system.This method may also include： The anchoring assembly of prosthetic mitral valve membranous system is set to move forward towards natural mitral annulus.Anchoring assembly can limit interior anchoring assembly Space and longitudinal axis, and anchoring assembly may include expansible anchorable frame, expansible anchorable frame include hub and from One or more ring lower support arms of hub extension.Each in one or more ring lower support arms may extend into anchoring foot, anchoring Foot is configured to engage with the ring lower groove of natural mitral valve.This method may also include：Make the anchor of prosthetic mitral valve membranous system Gu component is engaged with the tissue near natural mitral valve so that each anchoring foot is engaged with ring lower groove, and causes hub It is positioned at the distal side of the farthest side region of apposition position between the front and rear leaflet of natural mitral valve.

Specific examples described herein includes a kind of be used in the natural of prosthetic mitral valve membranous system and mitral valve The method sealed between leaflet.This method may include：By the anchoring assembly of prosthetic mitral valve membranous system and natural mitral valve Tissue anchoring near annulus is together.Alternatively, anchoring assembly space and longitudinal axis in anchoring assembly restriction, and anchor Component may include expansible anchorable frame, and expansible anchorable frame includes hub and propped up under one or more rings of hub extension Bearing arm.Each in one or more ring lower support arms may extend into anchoring foot, the Huan Xiagou of anchoring foot and natural mitral valve Groove engages.This method may also include：It is to be engaged with anchoring assembly by the valve assemblies delivering of prosthetic mitral valve membranous system.It is optional Ground, the valve assemblies may include：Expansible valve frame, it limits outer contour and inside casing frame member space；And it is placed in Organized layer at least a portion of outer contour；And plugging device, it is placed in inside casing frame member space.In anchoring assembly Each anchoring foot when being engaged with ring lower groove, the organized layer of valve assemblies abuts with the native leaflet of mitral valve.

Various embodiments described herein includes prosthetic mitral valve membranous system.The system may include anchoring assembly, anchoring Component includes anchoring foot under expansible anchorable frame and one group of ring, and anchoring foot group is configured to and natural mitral valve under ring Ring lower groove engages.The system may also include valve assemblies, and valve assemblies include：Expansible valve frame, it limits foreign steamer Wide and inside casing frame member space；And it is placed in the organized layer at least a portion of outer contour；And plugging device, it is disposed In in inside casing frame member space.Alternatively, when the anchoring foot group of anchoring assembly is engaged with ring lower groove, along valve assemblies The native leaflet of mitral valve is positioned against around outside the direction of organized layer.

Various embodiments described herein is used for prosthetic mitral valve membranous system being deployed in the natural of patient including a kind of Method in mitral valve.This method may include to navigate delivery sheath so that the distal end portion of delivery sheath is positioned at the left heart of patient In room.In addition, this method may include the anchoring assembly for the prosthetic mitral valve membranous system pushed in atrium sinistrum.Distal side promotes apparatus It can be releasably engaged with anchoring assembly.This method may also include：When distal side promotes apparatus to keep engaging with anchoring assembly, Anchoring assembly is set to be engaged with natural mitral valve.This method, which may additionally include, pushes the prosthetic mitral valve membranous system in atrium sinistrum Valve assemblies.Alternatively, valve assemblies can promote the outside of apparatus to slidably engage with distal side.This method may also include： Valve assemblies are made to be moved in the inner space limited by anchoring assembly.This movement is optionally included in distal side pusher conduit Holding makes slide outside of the valve assemblies along distal side pusher conduit when being engaged with anchoring assembly.This method may also include, After making valve assemblies movement, valve assemblies and anchoring assembly are installed together.In addition, this method may include, in installation valve After membrane module, distal side is set to promote apparatus to be separated with anchoring assembly.

Specific examples described herein includes a kind of implantable medical treatment device delivery system.The system includes first Deflectable conduit, the first deflectable conduit are limited through its first tube chamber, and the distal end of the first deflectable catheter can Control ground is in lateral deflection.The system may also include first device delivery sheath, and first device delivery sheath slideably disposes In in the first tube chamber, and first device delivery sheath can limit the second tube chamber through it.The system may also include the first dress Control sheath is put, first device control sheath is slidably positioned in the second tube chamber, and first device control sheath can limit It is fixed to control fiber tube chamber through its 3rd tube chamber and one or more first devices.The system may also include second and deflectable lead Pipe, the second deflectable conduit is slidably positioned in the 3rd tube chamber, and the second deflectable conduit can be limited through it The 4th the second deflectable catheter of tube chamber distal end controllably in lateral deflection.The system may also include device pusher Conduit, pusher conduit are slidably positioned in the 4th tube chamber, and the device pusher conduit can limit through it Five tube chambers.The distal end of device pusher conduit can be configured to releasedly couple with the first implantable medical device.

Some embodiments described herein are used for prosthetic mitral valve membranous system being deployed in the natural of patient including a kind of Method in mitral valve.This method may also include：When anchoring assembly is releasably secured to the first delivery catheter, make prosthese The anchoring assembly of heart valve system extends in atrium sinistrum so that anchoring assembly expands at least in part when in atrium sinistrum Exhibition.This method also alternatively includes, after anchoring assembly is pushed through in atrium sinistrum, by the top for making the first delivery catheter Part carries out Articulating and anchoring assembly is shaken or is rotated in atrium sinistrum.

Various embodiments described herein is used for prosthetic mitral valve membranous system being deployed in the natural of patient including a kind of Method in mitral valve.This method may also include：When valve assemblies are releasably secured to valve delivery catheter, by prosthese The valve assemblies of heart valve system are pushed through in atrium sinistrum so that valve assemblies expand at least in part when in atrium sinistrum Exhibition.This method also alternatively includes, and after valve assemblies are pushed through in atrium sinistrum, passes through the top ends of valve delivery catheter Divide and carry out Articulating and valve assemblies is shaken or is rotated in atrium sinistrum.

Some embodiments or whole embodiments in embodiment described herein can provide one in advantages below or It is multiple.First, some embodiments of prosthetic mitral valve membranous system provided in this article can be used for a variety of different technologies levels Surgeon carry out it is complete it is percutaneous/through in conduit Mitral v alve replacement, its is safe and reliable and repeats.For example, at certain In a little embodiments, prosthetic mitral valve membranous system can form reliable and consistent anchoring piece/substrate, then, valve/closure Device structure is engaged with this anchoring piece/substrate.Therefore, prosthetic mitral valve membranous system can be specifically designed to use natural two Geometry/mechanical structure of cusp film forms sufficient holding capacity.In a particular aspects, it is present in natural mitral valve Dissection groove below annulus may be used as the position of anchoring prosthetic mitral valve membranous system, but anchor structure can be deployed to tie up The native leaflet function of mitral valve is held, so as to provide what is be individually implanted into completely with the component of prosthetic mitral valve membranous system stage by stage Ability.Therefore, some embodiments of prosthetic mitral valve membranous system described herein are configured to reliable, repeatable and simplified Operation in be implanted into, this operation is widely applicable for a variety of patients and doctor, while also using the method significantly less invaded.

Secondly, some embodiments of prosthetic mitral valve membranous system described herein mitigate easy to effectively lasting MR, and Negative physiologic consequences, including narrow, LV wall stress and atrium fibre will not be caused to cardiorespiratory system (heart, lung, peripheral vessels) The vibration of dimension property.Moreover, the system can provide safe and durable anchoring effect at natural mitral valve, it is effective to provide Mitral reflux therapy and provide and be used for providing sealing benefit and avoid significantly damaging the tendon of natural mitral valve leaflet The structure of rope interface.

3rd, in a particular embodiment, the extensible framework of wherein anchor part can be used to reach mitral valve position Prosthetic mitral valve membranous system is delivered to natural mitral valve by the technology extended at least in part in atrium sinistrum before putting.According to This, in addition to easy to deliver anchoring piece, before widening parts are advanced to the annulus of mitral valve, cardiac surgeon or its Its user can be seen in heart widening parts (and its orientation) (so that before the component extended reaches annulus to User's chance is come the component that has been extended in laterally pivotable (rotation, shake, redirect)).

4th, some embodiments of prosthetic mitral valve membranous system described herein may be configured to portion after the implants Extend in left ventricle with dividing, but the wheel profile for being configured to reduce the possibility for the blood flow that obstruction passes through LVOT can be included Shape.Therefore, even if some parts of prosthetic mitral valve membranous system are extend into the atrium sinistrum above mitral valve annulus (on ring) Extended to other parts in the left ventricle below mitral valve annulus (under ring), prosthetic mitral valve membranous system is for this natural LVOT is designed and therefore reduces the risk completely or partially leaked of LVOT.

5th, in a particular embodiment, prosthetic mitral valve membranous system can include two different extendable member (examples Such as, anchoring assembly and valve assemblies), they are individually delivered to implant site, and two components can abut and engage two Natural tissue heart at cusp film.For example, first component (for example, anchoring assembly) may be configured to and in natural bicuspid valve Heart tissue engagement and second component (for example, valve assemblies) at or near film annulus may be configured to provide and two points The sealed interface of the native valve leaflets of valve.

It set forth the details of one or more embodiments of the invention in the accompanying drawings and the description below.By description and it is attached Figure and claim, other features, the objects and advantages of embodiment will be evident.

Brief description of the drawings

Fig. 1 is according to some embodiments one of prosthetic mitral valve film deployment system in the sectional view of natural human heart Partial perspective view.

Fig. 2 shows anchoring assembly after the anchoring delivery system of the deployment system of Fig. 1 comes out, in the atrium sinistrum of heart In prosthetic mitral valve film anchoring assembly perspective view.

Fig. 3 shows that the anchoring assembly of Fig. 2 is rotated in atrium sinistrum to make anchoring assembly be essentially perpendicular to natural two Perspective view after cusp membrane orienting.

Fig. 4 shows that the anchoring assembly of Fig. 3 is partly being moved forward through natural mitral valve so as to by anchoring assembly Protuberance is positioned at the perspective view below the ring lower groove of natural mitral valve.

Fig. 5 show with the similar arrangement shown in Fig. 4, but the anchoring assembly in the joint sectional view of heart is saturating View.

Fig. 6 shows the anchoring assembly in retraction Fig. 5 so as to which the protuberance of anchoring assembly is positioned at natural mitral valve Ring lower groove in after perspective view.

Fig. 7 shows the perspective view of the anchoring assembly of Fig. 6 after some components of deployment system are retracted.

Fig. 8 is the top view of natural mitral valve and depicts the groove periphery of the ring lower groove of Fig. 7 (no anchoring group Part).

Fig. 9 shows the perspective top view of the example anchor system of Fig. 2 to Fig. 6 according to some embodiments.

Figure 10 shows the perspective view of the anchoring assembly of Fig. 9, and wherein covering material is placed on the part of anchorable frame.

Figure 11 A show perspective top view (the wherein bicuspid valve of the anchoring assembly for the Fig. 9 being implanted in natural mitral valve Film leaflet is in closure state), and Figure 11 B show the corresponding dissection top view of the anchoring assembly of Figure 11 A.

Figure 12 A show perspective top view (its of the anchoring assembly of Fig. 9 in the natural mitral valve for being implanted in Figure 11 A Middle mitral valve leaflet is in open mode), and Figure 12 B show the corresponding dissection top view of the anchoring assembly of Figure 12 A.

Figure 13 shows the anchoring assembly for the Fig. 7 being implanted in natural mitral valve and the valve group extending into atrium sinistrum The perspective view of part delivery sheath.

Figure 14 shows that the valve assemblies in atrium sinistrum are partly coming out it from the valve assemblies delivery sheath portion of Figure 13 Perspective view afterwards.Valve assemblies are configured to first (part extends) arrangement.

Figure 15 shows the perspective view of the valve assemblies of Figure 14, wherein manipulating valve deployment system to prepare valve assemblies It is installed in anchoring assembly.

Figure 16 shows the perspective view of the valve assemblies for the Figure 15 being positioned in anchoring assembly (still in the first (part During extension arrangement).

Figure 17 shows the perspective view of the valve assemblies of Figure 16, wherein valve assemblies extended in anchoring assembly and with portion Administration's system separation.

Figure 18 shows the front view of the valve frame of the valve assemblies of Figure 17 according to some embodiments.

Figure 19 shows the bottom view of the valve frame of Figure 18.

Figure 20 is the decomposition lateral side view of the anchoring assembly and valve assemblies according to Figure 17 of some embodiments.

Figure 21 is that it includes connecing with anchoring assembly according to the top view of the example prosthetic mitral valve membranous system of some embodiments The valve assemblies of conjunction.

Figure 22 is the bottom view of the example prosthetic mitral valve membranous system of Figure 21.

Figure 23 shows the top view of the prosthetic mitral valve membranous system for the Figure 21 being implanted in natural mitral valve.Prosthese two The plugging device part of cusp membranous system is shown at closure state.

Figure 24 shows the top view of the prosthetic mitral valve membranous system for the Figure 21 being implanted in natural mitral valve.Prosthese two The plugging device part of cusp membranous system is shown at open mode.

Figure 25 is the side section top view for the heart for showing bicuspid valve, sustainer, tricuspid valve and lung valve.

Figure 26 is the schematic diagram in the section for the natural mitral valve for including mitral valve annulus.

Figure 27 shows the front view of the valve assemblies according to some embodiments.The seal area of the front side portion of valve assemblies Domain is demarcated in valve assemblies.

Figure 28 shows the lateral side view of the valve assemblies according to some embodiments.The seal area of the rear lateral portion of valve assemblies Domain is demarcated in valve assemblies.

Figure 29 shows the lateral side view of the valve assemblies according to some embodiments.The lateral side of valve assemblies it is close Region labeling is sealed in valve assemblies.

Figure 30 is the anterior and schematic depiction of the relation of the annulus of natural mitral valve of valve assemblies.

Figure 31 is joint region and the schematic depiction of the relation of the annulus of natural mitral valve of valve assemblies.

Figure 32 is joint domain and the schematic depiction of the relation of the annulus of natural mitral valve of valve assemblies.

Figure 33 is the sectional view of left side of heart, shows the annulus and aortic root of example valve assemblies and mitral valve The relation of annulus.

Figure 34 is the left ventricle outflow of the wherein natural mitral valve with example prosthetic valve, aortic valve and heart The fluoroscopic image in road.Image also shows blood and flows to sustainer by left ventricular outflow tract from left ventricle.

Figure 35 is natural mitral valve, aortic valve and the left ventricle stream wherein with example prosthetic valve of heart The fluoroscopic image engaged in this profession.Image also shows blood and flows to sustainer by left ventricular outflow tract from left ventricle.

Figure 36 be natural mitral valve annulus and aortic root annulus schematic depiction figure.

Figure 37 is the commissure sectional view of heart, shows the prosthese two in the ring lower groove for being engaged in natural mitral valve The anchoring assembly of cusp film.Also illustrate the chordae tendineae in left ventricle.

Figure 38 is the lateral cross-sectional view of the left ventricle of heart, is shown in the ring lower groove for being engaged in natural mitral valve The anchoring assembly of prosthetic mitral valve film.Also illustrate the chordae tendineae in left ventricle.

Figure 39 is the perspective view of anchoring assembly, shows the control silk for the part that can pass through anchoring assembly.

Figure 40 is another perspective view of anchoring assembly, shows the control silk for the part that can pass through anchoring assembly.

Figure 41 is the side view of valve assemblies frame, shows the control silk through the part of valve assemblies frame.

Figure 42 corresponds to the schematic diagram through pattern of the nearside control silk of the valve assemblies frame embodiment of Figure 41.

Figure 43 corresponds to the schematic diagram of the mid-section body control silk of the valve assemblies frame embodiment of Figure 41.

Detailed reference numeral represents similar components in various attached drawings.

Embodiment

The present disclosure describes the embodiment of prosthetic heart valve system, such as prosthetic mitral valve membranous system and for being implanted into vacation Systemic heart valve system through conduit system and method.In certain embodiments, prosthetic mitral valve membranous system can be deployed With the native anatomy of mitral valve formed interface be connected and with the native anatomy of mitral valve cooperative anchor (and Alternatively, in a manner of the chordae tendineae for allowing natural mitral valve leaflet continues with natural function, even in deploying anchoring section After part).Prosthetic mitral valve membranous system as used herein can be deployed as being connected with natural mitral valve structure formation interface To form fluid seal, so as to minimize the MR and Paravalvular leak after implantation.As hereinafter described in more detail, scheme 1 to Figure 17 and Figure 39 to Figure 43 is described through conduit mitral valve delivery system and method, utilizes this system and method, prosthese Mitral valve system can be deployed with the anatomical structure of natural mitral valve formed interface be connected and with natural bicuspid valve The anatomical structure of film cooperative anchors.Moreover, in Figure 18 into Figure 32, prosthetic mitral valve film feature is described, utilizes prosthese two Cusp film feature, prosthetic valve forms interface with natural mitral valve structure and is connected to form fluid seal, so as to reduce The possibility of MR and Paravalvular leak.In Figure 33 into Figure 36, describe and pass through left ventricular outflow tract (LVOT) for managing Blood flow prosthetic mitral valve film feature and technology.In Figure 37 into Figure 38, describe for mitigate prosthetic valve with The prosthetic mitral valve film feature and technology of risk of interferences between chordae tendineae.

With reference to figure 1, example can be oriented to enter patient through conduit mitral valve delivery system 100 by patient vessel Heart 10.Percutaneous, angitomy or minimal invasive techniques are easy to use through catheter delivery system 100 (without carrying out open-chest surgery) To be implanted into prosthetic mitral valve film into pulsatile heart dirty 10.In some embodiments, it is all with reference to one or more imaging patterns Such as x-ray fluoroscopy, echocardiogram, magnetic resonance imaging, computed tomography (CT) are used through catheter delivery system System 100.

Heart 10 (describing from rear view with section) includes atrium dextrum 12, right ventricle 14, atrium sinistrum 16 and left ventricle 18. Tricuspid 13 separates atrium dextrum 12 and right ventricle 14.Mitral valve 17 separates atrium sinistrum 16 and left ventricle 18.Atrial septum 15 separates Atrium dextrum 12 and atrium sinistrum 16.Inferior caval vein 11 converges with atrium dextrum 12.This description that should be appreciated that heart 10 is slightly form Change.Fig. 2 to Fig. 4 is similarly such.Fig. 1 to Fig. 4 provides the entering to mitral valve 17 used in some embodiments The overall description on road.But Fig. 5 and joint sectional view afterwards more accurately depict prosthetic mitral valve film relative to heart 10 Orientation.

In the embodiment depicted, delivery system 100 includes seal wire 110, main deflectable catheter 120 and anchoring delivering Sheath 130.The additional components of delivery system 100 will hereinafter further spread out description.Anchor delivery sheath 130 slideably (and rotatably) be placed in the tube chamber of main deflectable catheter 120.Seal wire 110 is slidably positioned in anchoring delivering shield In the tube chamber of set 130.In this description, anchoring delivery sheath 130 partly extends relative to main deflectable catheter 120, Allow flared section 132 to external expansion, it is as described further below.

In discribed embodiment, seal wire 110 is installed on heart 10 before other components of delivery system 100 It is interior.In certain embodiments, seal wire 110 has the diameter of about 0.035 inch (about 0.89mm).In certain embodiments, seal wire 110 have the diameter in about 0.032 inch to about 0.038 inch (about 0.8mm to about 0.97mm) scope.In some embodiments In, seal wire 110, which has, is less than 0.032 inch (about 0.80mm) or the diameter more than 0.038 inch (about 0.97mm).In some realities Apply in example, seal wire 110 is made of such as (but not limited to) Nitinol, stainless steel, high tensile stainless steel etc. and its combination.Lead Silk 110 can include various tip designs (for example, J-shaped top, straight top etc.), taper, coating, covering, radio-opaque (RO) mark and further feature.

In some embodiments, seal wire 110 is percutaneously inserted into the femoral vein of patient.Seal wire 110 is sent by route To inferior caval vein 11 and arrive in atrium dextrum 12.Formed in atrial septum 15 after opening (for example, transseptal puncture of fossa ovalis), Seal wire 110 is routed in atrium sinistrum 16.Finally, seal wire 110 is routed to left ventricle by mitral valve 17 In 18.In some embodiments, seal wire 110 can be installed in heart 10 along other dissection approach.Used after seal wire 110 Make track, other components of delivery system 100 can transmit in orbit.

In discribed embodiment, by promoting main deflectable catheter 120 mainly may be used to install on seal wire 110 Deflectable catheter 120.In some embodiments, when main deflectable catheter 120 is moving forward on seal wire 110, expander top Used with reference to main deflectable catheter 120.Alternatively, foley's tube may be used as initial expansion device.Led mainly deflectable After the distal end portion of pipe 120 reaches atrium sinistrum 16, expander top can be extracted out.In certain embodiments, main deflectable catheter 120 distal end can turn to.Using steering, the distal end of main deflectable catheter 120 can orient as needed So as to the anatomical structure for the patient that navigates.For example, main deflectable catheter 120 can be at an angle of will mainly may be used in atrium dextrum 12 Deflectable catheter 120 navigates to atrial septum 15 from inferior caval vein 11.

In certain embodiments, main deflectable catheter 120 has the outside diameter of about 28Fr (about 9.3mm).In some implementations In example, main deflectable catheter 120 has the outside diameter in about 26Fr to about 34Fr (about 8.7mm to about 11.3mm) scope.At certain In a little embodiments, main deflectable catheter 120 has the outside diameter in about 20Fr to about 28Fr (about 6.7mm to about 9.3mm) scope.

Main deflectable catheter 120 can include tubulose polymerization or metal material.For example, in certain embodiments, mainly Deflectable catheter 120 can by polymeric material such as (but not limited to) polytetrafluoroethylene (PTFE) (PTFE), fluorinated ethylene propylene (FEP),Nylon, It is made with analog and its combination. In alternate embodiment, main deflectable catheter 120 can by metal material such as Nitinol, stainless steel, stainless steel alloy, titanium, Titanium alloy and analog and its combination are made.In certain embodiments, main deflectable catheter 120 can by these polymer and The combination of metal material be made (for example, with metal braid, coil reinforcer, strenthening member and analog with and combinations thereof Polymeric layer).

Example delivery system 100 further includes anchoring delivery sheath 130.In some embodiments, led mainly deflectable After pipe 120 is positioned to its distal end portion in atrium sinistrum 16, anchoring delivery sheath 130 is installed to main deflectable catheter 120 Move forward in tube chamber (on seal wire 110) and through main deflectable catheter 120.It is as described further below, some In embodiment, anchoring delivery sheath 130 is pre-loaded other components of prosthetic valve anchoring assembly and delivery system 100.

In certain embodiments, anchoring delivery sheath 130 can be by described above with reference to main deflectable catheter 130 Material is made.In certain embodiments, anchoring delivery sheath 130 has at about 20Fr to about 28Fr (about 6.7mm to about 9.3mm) The outside diameter of scope.In certain embodiments, delivery sheath 130 is anchored with (about 4.7mm is to about in about 14Fr to about 24Fr 8.0mm) the outside diameter of scope.

In the embodiment depicted, the distal end 132 that delivery sheath 130 includes opening is anchored.In some embodiments In, do not include such distal end 132 opened.The distal end 132 of opening, which is worked as, is constrained in main deflectable catheter 120 It can be collapsed as compared with low profile when interior.When the distal end 132 of opening is pushed from main deflectable catheter 120, the distal side of opening End 132 is extended to expanded shape certainly.In certain embodiments, the material of the distal end 132 of opening includes fold or folding, It can be continuous flared end or section such as petal-shaped can be separated into, and one or more flexible members can be included, In the case of (such as from be constrained in main deflectable catheter 120) of no force, one or more flexible members will The distal end 132 opened is biased into presentation and opens configuration.The distal end 132 of opening can be favourable, such as from opening After distal end 132 pushes anchoring assembly, for anchoring assembly being trapped in again in the tube chamber of anchoring delivery sheath 130.

In certain embodiments, (about 10.0mm is to about in about 30Fr to about 34Fr for the maximum outside diameter of opening distal end 132 Scope 11.3mm).In certain embodiments, open distal end 132 maximum outside diameter in about 32Fr to about 44Fr (about 10.7mm to about 14.7mm) scope.In certain embodiments, open distal end 132 maximum outside diameter in about 24Fr to about The scope of 30Fr (about 8.0mm to about 10.0mm).In certain embodiments, the maximum outside diameter for opening distal end 132 is less than about 24Fr (about 8.0mm) or greater than about 44Fr (about 14.7mm).

With reference to figure 2, the additional components of example delivery system 100 can include nearside control sheath 140, secondary deflectable lead Pipe 150 and distal side pusher conduit 160.Nearside control sheath 140 is slidably positioned in the tube chamber of anchoring delivery sheath 130 It is interior.Secondary deflectable catheter 150 is slidably positioned in the tube chamber of nearside control sheath 140.Distal side pusher conduit 160 can Slidably it is placed in the tube chamber of secondary deflectable catheter 150.These components of delivery system 100 can be operated by clinical manipulation person To control the position of anchoring assembly 200 and orientation.Anchoring assembly 200 is slidably positioned on seal wire 110.

In the certain embodiments of delivery system 100, nearside control sheath 140, secondary deflectable catheter 150, distal side One or more of pusher conduit 160 and anchoring assembly 200 are advanced to main deflectable catheter in anchoring delivery sheath 130 It is loaded into before 120 in anchoring delivery sheath 130, as shown in Figure 1.I.e., in some cases, anchoring delivery sheath 130 to Distal advancement to after in main deflectable catheter 120 to realize the arrangement shown in Fig. 1, nearside control sheath 140, it is secondary can be inclined Transduction pipe 150, distal side pusher conduit 160 and/or anchoring assembly 200 have been installed in anchoring delivery sheath 130.Other In embodiment, it has been advanced in anchoring delivery sheath 130 in main deflectable catheter 120 to realize the arrangement shown in Fig. 1 Afterwards, one in nearside control sheath 140, secondary deflectable catheter 150, distal side pusher conduit 160 and anchoring assembly 200 Or multiple be distad advanced to is anchored in delivery sheath 130.

Distal side pusher conduit 160 releasedly couples with the hub 210 of anchoring assembly 200.The proximal end of anchoring assembly 200 Nearside control sheath 140 is releasably attached to also by one or more control silk 142.Although discribed embodiment bag A control silk 142 is included, in other embodiments, two, three, four, five or more than five control silks can be included.

With reference to figure 39 and Figure 40, control silk 142 is illustrated with anchoring assembly 200 into example bond pattern.Discribed In embodiment, control silk 142 passes through multiple proximal portions of anchoring assembly 200.In the embodiment depicted, 142 quilt of silk is controlled It is configured to lasso trick arrangement.Therefore, the tensioning of silk 142 is controlled to shrink the proximal end for causing at least anchoring assembly 200.On the contrary, from Control silk 142, which removes tension force, will allow anchoring assembly 200 to extend.In certain embodiments, control silk 142 is disposed through anchoring group Eyelet in the various pieces of part 200.In certain embodiments, control silk 142 be disposed through anchoring assembly 200 covering or Attachment feature on frame in various pieces.Control silk 142 can be tensioned or loosen to realize the proximal end institute of anchoring assembly 200 Desired degree of expansion (for example, atrium keeps enclosing 250 under feature 240a, 240b, 240c and 240d and/or the ring of fluctuating).It is more A control silk 142 may also be used for realizing the asymmetric in check extension of anchoring assembly 300.

Referring again to Fig. 2, by manipulating distal side pusher conduit 160 and/or nearside sheath 140 can be controlled to control anchor Gu the position of component 200.For example, in the embodiment depicted, by being distally moved far relative to anchoring delivery sheath 130 Side pusher conduit 160 and/or nearside control sheath 140, can push out anchor from anchoring delivery sheath 130 (as shown in Figure 2) Gu component 200.In some embodiments, by back pulling anchoring delivery sheath 130 to nearside while generally remaining remote The position of side pusher conduit 160 and/or nearside control sheath 140 causes anchoring assembly 200 to push out.In some embodiment party In formula, by back pulling anchoring delivery sheath 130 to nearside while distal side pusher conduit 160 and/or nearside is controlled shield The distally extending combination in position of set 140 causes to push anchoring assembly 200.

When the constraint of anchoring assembly 200 from anchoring delivery sheath 130 comes out, anchoring assembly 200 is matched somebody with somebody from low profile delivering Put and expand to part expanded configuration (as shown in Figure 2).The degree of expansion of anchoring assembly 200 can be controlled by nearside at least in part Sheath 140 is controlled relative to the relative positioning of distal side pusher conduit 160.For example, as nearside controls sheath 140 relative to remote Side pusher conduit 160 is moved to nearside, and anchoring assembly 200 is in axial elongation and in radial contraction.On the contrary, with nearside control Sheath 140 processed is distally moved relative to distal side pusher conduit 160, and anchoring assembly 200 expands in axial shortening and in radial direction Exhibition.In some embodiments, during anchoring assembly 200 is deployed in natural mitral valve 17, using to anchoring This control of the radial dimension of component 200, as described further below.It is as further described below, control silk The 142 same radial extensions that may also be used for control anchoring assembly 300 (control sheath 140 relative to remote without changing nearside The relative distance of side pusher conduit 160).

Should be appreciated that prosthetic mitral valve film provided in this article include anchoring assembly 200 and separable valve assemblies (for example, With reference to figs. 14 to Figure 20).Before valve assemblies are disposed, anchoring assembly 200 is deployed to be formed in natural mitral valve 17 The arrangement of interface connection.In other words, after anchoring assembly 200 is implanted in natural mitral valve 17, then valve assemblies may be used To be deployed in anchoring assembly 200 and in natural mitral valve 17 (as described further below).Afterwards, it may be said that into making Prosthetic mitral valve film provided in this article is disposed with method for implantation stage by stage, i.e. the portion in a single stage of anchoring assembly 200 Administration, and valve assemblies are disposed in the subsequent stage.In some embodiments, valve assemblies are deployed in anchoring assembly (for example, in identical medical operating program) occurs immediately after 200 deployment.In some embodiments, valve assemblies It is deployed in hours, days, weeks or months of generations after the deployment of anchoring assembly 200.

Since when anchoring assembly 200 is implanted in natural mitral valve 17 in itself, natural mitral valve 17 continues substantially Work without significantly affecting cardiovascular physiology before the upper anchoring assembly 200 such as implantation and be easy to prosthese provided in this article The method for implantation stage by stage of mitral valve.So it is because as described further below, anchoring assembly 200 is in natural mitral valve The leaflet or chordae tendineae that interface is connected and anchored without significantly interfering with natural mitral valve 17 are formed in 17 structure.

Still referring to FIG. 2, in discribed arrangement, the distal end of secondary deflectable catheter 150 is at least partially situated at Inside anchoring assembly 200.Secondary deflectable catheter 150 can be manipulated by clinical manipulation person to make the remote of secondary deflectable catheter 150 Side end is reversibly bent.Since secondary deflectable catheter 150 is bent by clinician, other components of delivery system 100 can To be bent together with secondary deflectable catheter 150.For example, distal side pusher 160 and nearside control one of sheath 140 or More persons can bend in response to the bending of deflectable catheter 150.Since anchoring assembly 200 is connected to 160 He of distal side pusher Nearside controls sheath 140, can rotate anchoring assembly 200 by bending secondary deflectable catheter 150.

With reference to figure 3, as described above, when anchoring assembly 200 is in atrium sinistrum 16, secondary deflectable catheter 150 can To carry out Articulating (also referred to as steering, deflection, bending, bending etc.) so that anchoring assembly 200 (shakes laterally pivotable Dynamic, rotation etc.).This rotation of anchoring assembly 200 be conducive to for example to make anchoring assembly 200 relative to natural mitral valve 17 with Desirable relation is oriented to prepare anchoring assembly 200 being implanted in natural mitral valve 17.In some embodiments, wish Anchoring assembly 200 is orientated its longitudinal axis and is essentially perpendicular to natural mitral valve 17 by prestige.Still constrained with anchoring assembly 200 Anchoring assembly 200 is set to be compared laterally pivotable when in delivery sheath, 16 inside points or the anchoring assembly extended completely in atrium It may be advantageous for 200 laterally pivotable, because the component is relatively large and harder conduit tube component.

Preparation makes anchoring assembly 200 be engaged with natural mitral valve 18, and clinical manipulation person can manipulate anchorable frame 200 Radial dimension causes anchorable frame 200 can be to pass through natural mitral valve 17 without damaging natural mitral valve 17.For example, face Bed doctor can make nearside control sheath 140 relative to distal side pusher conduit 160 to nearside movement so that anchoring assembly 200 exists Radial contraction.In anchoring assembly 200 in the case of radial contraction, anchorable frame 200 can be safely passed natural bicuspid valve Film 17 is without damaging natural mitral valve 17.

With reference to figure 4, although secondary deflectable catheter 150 is maintained at its bending configuration, as described with reference to fig. 3, distal side pushes away Dynamic device conduit 160 and nearside control sheath 140 can move forward at the same time.Because distal side pusher conduit 160 is releasably attached to anchor Gu the hub 210 of component 200 and because nearside control sheath 140 releasedly couple via one or more silk 142a and 142b To the proximal end of anchoring assembly 200, distal side pusher conduit 160 and nearside move forward while controlling sheath 140 causes anchoring group Part 200 moves forward.The reach of anchoring assembly 200 causes the distal end portion of anchoring assembly 200 in left ventricle 18, and anchoring assembly 200 Proximal end is in atrium sinistrum 16.Therefore, some parts of anchoring assembly 200 are on every side of natural mitral valve 17.

In the embodiment depicted, anchoring assembly 200 includes four anchoring feet：Left front foot 220a, left back foot 220b, the right side Rear foot 220c and right front foot 220d.In some embodiments it is possible to including less or more anchoring foot (for example, two, three It is a, five, six or more than six).In certain embodiments, anchoring foot 220a, 220b, 220c and 220d be arranged to The part for the anchoring assembly 200 that the ring lower groove 19 of natural mitral valve 17 contacts.Therefore, anchor foot 220a, 220b, 220c and 220d has atraumatic surface generally suitable with foot.However, in certain embodiments, anchoring foot 220a, 220b, One or more of 220c and 220d are configured to penetrate tissue and can have anchorage characteristics such as barb, coil, hook Deng.

In the arrangement of Fig. 4, anchoring foot 220a, 220b, 220c and 220d are positioned at the lower section of ring lower groove 19.Arrange herein In, the radial dimension of anchoring assembly 200 can increase to be directed at anchoring foot 220a, 220b, 220c and 220d and ring lower groove 19. For example, clinician can be such that nearside control sheath 140 is distally moved relative to distal side pusher conduit 160 so that anchoring group Part 200 anchors foot 220a, 220b, 220c and 220d and ring lower groove 19 in radial expansion to be aligned.This alignment can be performed To prepare to make anchoring foot 220a, 220b, 220c and 220d occupy in ring lower groove 19.

With reference to figure 5, the commissure section of heart 10 is provided on natural 17 arrangement same as shown in Figure 4 of mitral valve Another perspective view of anchoring assembly 200.This joint section of heart 10 is intercepted through mitral valve 17, along through atrium sinistrum 16 and left ventricle 18, parallel to make line that two commissures of mitral valve 17 intersect plane (such as hereinafter with reference to Fig. 8 into One step expansion description).In following Fig. 5 to Fig. 7 and Figure 13 into Figure 17, by using the joint section of heart 10 come describe for Dispose the delivery system 100 and method of prosthetic mitral valve film provided in this article.The view of Fig. 5 to Fig. 7 and Figure 13 to Figure 17 omits Low dip make it that providing anchoring assembly 200 preferably visualizes.

Anchoring foot 220a, 220b, 220c and 220d are positioned at the lower section of ring lower groove 19.In this position, anchoring foot 220a, 220b, 220c and 220d are positioned at contraction and the diastole offset lower section of the leaflet of natural mitral valve 17.In this orientation, anchoring Foot 220a, 220b, 220c and 220d can be aligned with ring lower groove 19 to prepare to make anchoring foot 220a, 220b, 220c and 220d just It is seated in ring lower groove 19.

With reference to figure 6, distal side pusher 160 and nearside control sheath 140 can be at the same time relative to secondary deflectable catheters 150 Retract with main deflectable catheter 120.Therefore, anchoring foot 220a, 220b, 220c and 220d becomes to be placed in ring lower groove 19 In.In this position, anchoring foot 220a, 220b, 220c and 220d are positioned at the contraction of the leaflet of natural mitral valve 17 and relax Offset lower section is opened, and the other structures of anchoring assembly 200 do not hinder leaflet to move.Therefore, anchoring as described above In the case that component 200 is connected in the structure of mitral valve 17, mitral valve 17 can continue and place anchoring assembly 200 it It is preceding to work like that.In addition, anchoring assembly 200 does not result in natural two with the mode that natural mitral valve 17 formation interface is connected Sharp valvular deformity.Therefore, natural mitral valve 17 may continue to working like that before placing anchoring assembly 200.

With reference to figure 7, in the case where anchoring assembly 200 is engaged with natural mitral valve 17, can be extracted out from anchoring assembly 200 The component of delivery system 100.For example, control silk 142 can be separated with the proximal end of anchoring assembly 200.Afterwards, nearside control can be extracted out Sheath 140 processed.Also secondary deflectable catheter 150 can be extracted out.Actually, if desired, nearside control sheath 140, secondary deflectable Conduit 150 and anchoring delivery sheath 130 can extract out from main deflectable catheter 120 completely.Comparatively speaking, in certain embodiments In, distal side pusher conduit 160 is advantageously remained attached on the hub 210 of anchoring assembly 200.As hereinafter will further retouched State, in some embodiments, distal side pusher conduit 160 is used as track, and valve assemblies are deployed in anchoring assembly in orbit 200 inside.However, in some embodiments, anchoring assembly 200 is separated with delivery system 100 completely, and delivery system 100 remove from patient.After the time of 200 hours, days, weeks or months of anchoring assembly is deployed, valve assemblies can To be installed in anchoring assembly 200 to complete the installation of prosthetic mitral valve film.

With reference to figure 8 and Fig. 9, the anatomical structure of natural mitral valve 17 includes can be used in patients and anchoring assembly 200 The some consistent and predictable architectural feature of engagement.For example, natural mitral valve 17 includes foregoing ring lower groove 19.This Outside, natural mitral valve 17 includes D-shaped annulus 28, preceding outside commissure 30a, rear inner side commissure 30b, left fibrous trigone 134a With right fibrous trigone 134b.In addition, natural mitral valve 17 includes anterior leaflet 20 and three parts posterior leaflet 22.Posterior leaflet 22 includes Outside scallop 24a, middle scallop 24b and inner side scallop 24c.The free edge edge of posterior leaflet 22 and anterior leaflet 20 And merge to zygonema 32.

D-shaped annulus 28 limits specific structure, anterior leaflet 20 and posterior leaflet 22 and extends and be hinged from the structure.Left fibrous trigone 134a and right fibrous trigone 134b is located at the left end of anterior leaflet 20 and right end nearby and is usually fanned adjacent to the outside of posterior leaflet 22 Shape recess 24a and inner side scallop 24c.Ring lower groove 19 is along annulus 28, in left fibrous trigone 134a and right fibrous trigone Stretched between 134b along posterior leaflet 22.

The region at or near high collagen annular triangle 134a and 134b is usually relied on to provide anchoring position that is strong, stablizing Put.Muscle region in the region at or near triangle 134a and 134b also provides good tissue ingrowth matrix, with The stability and resistance to migration strengthened for anchoring assembly 200.Therefore, the region difference at or near triangle 134a and 134b Limit left front anchorage zone 34a and right preceding anchorage zone 34b.Left front anchorage zone 34a and right preceding anchorage zone 34b provide favourable target position Put for placing left front foot 220a and right front foot 220d respectively.

The embodiment of discribed anchoring assembly 200 further includes left front foot 220b and right front foot 220c.As described previously, Left back foot 220b and right rear foot 220c can also be advantageously positioned in ring lower groove 19 in order to provide anchoring assembly 200 to naturally Balance and the not damaged connection of mitral valve 17.Therefore, left back anchorage zone 34b and right preceding anchorage zone 34c are defined in ring lower groove In 19.Left back anchorage zone 34b and right preceding anchorage zone 34c can receive left back foot 220b and right rear foot 220c respectively.In some implementations In mode, the position of left back anchorage zone 34b and right preceding anchorage zone 34c can be differently configured from discribed position and remains at ring at the same time In lower groove 19.Should be appreciated that discribed anchoring assembly 200 is that one of anchoring assembly provided in the scope of the present disclosure is non- Limitative examples.

In certain embodiments, anchoring assembly 200 includes structure and ring lower structure on ring.For example, the ring of anchoring assembly 200 Lower structure includes foregoing anchoring foot 220a, 220b, 220c and 220d and hub 210.In certain embodiments, as retouched above State, hub 210 serves as the connection structure (for example, with reference to figure 2) of delivery system 100.In addition, hub 210 can serve as rock-steady structure portion Part, left front ring lower support arm 230a, left back ring lower support arm 230b, it is right after ring lower support arm 230c and right front ring lower support arm 230d extends to anchoring foot 220a, 220b, 220c and 220d from rock-steady structure component respectively.

In certain embodiments, in all embodiments as depicted, structure includes on the ring of anchoring assembly 200：The left front heart Room keeps feature 240a, left back atrium to keep atrium holding feature 240c and preceding atrium holding feature behind feature 240b, the right side 240d；Preceding anchoring bow-shaped structural 250a, left anchoring bow-shaped structural 250b, rear anchoring bow-shaped structural 250c and right anchoring bow-shaped structural 250d；And connecting bridge 260.Preceding anchoring bow-shaped structural 250a, left anchoring bow-shaped structural 250b, rear anchoring bow-shaped structural 250c It is coupled to each other to form with right anchoring bow-shaped structural 250d on the ring of fluctuating and encloses 250, circle 250 is served as anchoring assembly on ring Structural detail on 200 ring.It is as further described below, 250 are enclosed on ring and further defines anchoring assembly inner space It is open, the space inside anchoring assembly 200 is configured to receive and engage valve assemblies.Atrium holding feature 240a, 240b, 240c and 240d is configured to contact tissue surface in the rack-like annulus above mitral valve annulus so that anchoring assembly 200 is steady It is scheduled in annulus in region, region is usually opposite with anchoring foot 220a, 220b, 220c and 220d respectively in annulus.

In certain embodiments, when during heart contraction valve it is (not shown) close and stop pressurization blood when, it is right In the vertically-oriented power on adjoint artificial valve component, connecting bridge 260 provides the stability and fatigue resistance of enhancing.Anchor Gu component 200 can also be included in one or more of the frame part of neighbouring foot hole 226, this is to be used to delivering and fetching group The extra control point of part, or stationary positioned delivering frame can be used for.

In certain embodiments, it is all as depicted in embodiment, on the ring of anchoring assembly 200 structure and ring lower structure by Connect between the front ring of outside behind connecting portion 270a, outside behind interannular connecting portion 270b, inner side between interannular connecting portion 270c and inner side front ring Socket part 270d is interconnected.For example, preceding anchoring foot 220a keeps special with the preceding atrium in outside on the outside of connecting portion 270a connections between the front ring of outside Levy 240a.In addition, preceding on the outside of connecting portion 270a connections between the front ring of outside anchor foot 220a and preceding anchoring bow-shaped structural 250a and a left side Anchor bow-shaped structural 250b.In the embodiment depicted, each in other interannular connecting portion 270b, 270c and 270d makes ring The part of upper structure and ring lower structure interconnects, in a manner of similar to connecting portion 270a between the front ring of outside.For example, between the front ring of outside Anchoring foot 220b and left anchoring bow-shaped structural 250b and rear anchoring bow-shaped structural 250c before on the outside of connecting portion 270b connections；Before outside Anchoring foot 220c and rear anchoring bow-shaped structural 250c and right anchoring bow-shaped structural 250d before on the outside of interannular connecting portion 270c connections；With And foot 220d and right anchoring bow-shaped structural 250d and preceding anchoring arch knot are anchored between the front ring of outside before connecting portion 270d connections outside Structure 250a.

In certain embodiments, the slender member of anchoring assembly 200 is by monolithic precursor material (for example, thin plate or pipe) shape Into monolithic precursor material is cut, extends and is connected on hub 210.For example, some embodiments are made out of tubes, pipe is by swashing Light cutting (or mechanical processing, chemical etching, water jet cutting etc.) and then extension and thermal finalization are big for its final extension Small and shape.In certain embodiments, anchoring assembly 200 is by multiple slender members (for example, line or cutting element) compound landform It is bound up into, these components with hub 210 and is coupled to each other to form anchoring assembly 200.

The slender member of anchoring assembly 200 can include a variety of materials and combination of materials.In certain embodiments, Nitinol (NiTi) be used as anchoring assembly 200 slender member, but can use other materials such as stainless steel, L605 steel, polymer, MP35N steel, stainless steel, titanium, cobalt/nickel alloy, polymeric material, the appropriate biocompatible material of Pyhnox, Elgiloy or any other Material and its combination.The super-elasticity of NiTi causes its particularly preferred candidate material for being the slender member for anchoring assembly 200, because For (such as) NITi can be using thermal finalization as desirable shape.That is, NiTi can using thermal finalization as so that when anchoring assembly 200 from Such as when anchoring assembly 200 comes out from the anchoring deployment of delivery sheath 130, anchoring assembly 200 tends to voluntarily expand to during constraint Desirable shape.Such as anchoring assembly 200 can have spring property made of NiTi, it allows 200 bullet of anchoring assembly Property collapse or " extruding " delivers into low profile and configure and be then reconfigured for the expanded configuration shown in Fig. 9.Anchoring assembly 200 usually can be conformal, antifatigue and elastic so that when anchoring assembly 200 is deployed in the natural mitral valve of patient Anchoring assembly 200 can meet the pattern of surrounding tissue when middle.

In certain embodiments, diameter one or more in the slender member of anchoring assembly 200 or width/thickness are formed Degree can in about 0.008 " to about 0.015 " (the about 0.20mm to about 0.40mm) or about 0.009 " to about 0.030 " (about 0.23mm to about 0.76mm) either about 0.01 " to about 0.06 " (about 0.25mm to about 1.52mm) or about 0.02 " to about 0.10 " In the range of (about 0.51mm to about 2.54mm) or about 0.06 " to about 0.20 " (about 1.52mm to about 5.08mm).In some implementations In example, the slender member for forming anchoring assembly 200 can have smaller or greater diameter or width/thickness.In some realities Apply in example, form each in the slender member of anchoring assembly 200 with substantially the same diameter or width/thickness. In some embodiments, formed one or more with other elongated with anchoring assembly 200 in the slender member of anchoring assembly 200 One or more different diameters or width in component.In certain embodiments, formed in the slender member of anchoring assembly 200 One or more one or more parts can it is tapered, widen, be constriction, bending, rounding, in wave shape, spiral shape, angled And/or the whole length of the slender member along anchoring assembly 200 is in non-linear and/or inconsistent in other ways.These are special The technology of seeking peace can also merge with the valve assemblies of prosthetic mitral valve film provided in this article.

In certain embodiments, forming diameter, thickness and/or the width of the slender member of anchoring assembly 200 can change In order to change the power applied by anchoring assembly 200 in its specific region, so as to increase or decrease anchoring assembly 200 specific The flexibility in region, is prepared for disposing and disposing with promoting resistance to migration, and/or control compression process (crushability) Expansion process during anchoring assembly 200.

In certain embodiments, circular cut can be had by forming one or more of slender member of anchoring assembly 200 Face.In certain embodiments, rectangular cross sectional shape can be had by forming one or more of slender member of anchoring assembly 200 Or and non-rectangle other cross sectional shapes.Forming the example of the cross sectional shape of the slender member of anchoring assembly 200 can include It is circle, C-shaped, square, avette, rectangle, ellipse, triangle, D-shaped, trapezoidal, including formed not by braiding or constructed into stock Regular sections shape and analogous shape.In certain embodiments, one or more of slender member of anchoring assembly 200 is formed May be substantially it is flat (i.e. so that width and thickness ratio are about 2:1st, about 3:1st, about 4:1st, about 5:1 or greater than about 5: 1).In some examples, formed one or more of slender member of anchoring assembly 200 can use centreless grinding technology and Formed so that length change of the diameter of slender member along slender member.

Anchoring assembly 200 can include the one or more desirable features for being intended to enhancing prosthetic mitral valve film device The feature of energy characteristic.For example, some features of anchoring assembly 200 can be used for strengthening the conformal performance of prosthetic mitral valve film device. This feature can device for example meets irregular tissue topography and/or the tissue topography that dynamically changes is easy to by allowing The improved performance of prosthetic mitral valve film device.This conformal performance characteristic can be conducive to provide prosthetic mitral valve film device effectively simultaneously And durable performance.In some embodiments of anchoring assembly 200, some parts of anchoring assembly 200 are designed to than same The other parts of anchoring assembly 200 are more conformal.That is, the conformal performance of single anchoring assembly 200 can be designed in anchoring assembly 200 regional is different.

In certain embodiments, anchoring assembly 200 includes being used for the visual feature of reinforcement inner rays photograph.Some In embodiment, the part of anchoring assembly 200, such as anchoring one or more of foot 220a, 220b, 220c and 220d can have There are attached one or more radiopaque marks thereon.In certain embodiments, it is some or complete in anchoring assembly 200 Portion can be applied (for example, sputtering coating) radiopaque coating.

Still referring to FIG. 8 and Fig. 9, as described hereinbefore, foot 220a, 220b, 220c and 220d size and shape is anchored It is adapted to engage with the ring lower groove 19 of mitral valve 17.In certain embodiments, front foot 220a and 220d each other with about 30mm extremely The distance of about 45mm either about 20mm to about 35mm or about 40mm to about 55mm are spaced apart.In certain embodiments, the rear foot 220b and 220c is each other with the distance interval of about 20mm to about 30mm, either about 10mm to about 25mm or about 25mm to about 40mm Open.

In certain embodiments, anchoring foot 220a, 220b, 220c and 220d has to about 12mm or is more than in about 8mm The height of about 12mm.In certain embodiments, anchoring foot 220a, 220b, 220c and 220d has about 6mm²To about 24mm²Ditch Groove surface area of engagement (when fabric covers).In certain embodiments, anchoring foot 220a, 220b, 220c and 220d respectively has base Identical groove engagement surface area in sheet.In a particular embodiment, one or more is anchored in foot 220a, 220b, 220c and 220d It is a to have different from groove engagement surface area one or more in other anchoring foot 220a, 220b, 220c and 220d.Anchor foot 220a, 220b, 220c and 220d can have about 1.5mm to about in the range of 4.0mm or bigger width, and in about 3mm extremely In about 6mm or bigger length.The size and shape of anchoring foot 220a, 220b, 220c and 220d cause anchoring assembly 200 not The natural function of mitral valve chordae tendineae, natural mitral valve leaflet and papillary muscle is significantly damaged, even in anchoring assembly anchor It is fixed in after mitral valve position.

As described previously, anchoring assembly 200 is designed to avoid the function of disturbing natural mitral valve 17.Therefore, may be used In some time by replacement valve deployment of components before wherein, anchoring assembly 200 is implanted in natural mitral valve 17, and Will not anchoring piece be implanted into and valve implantation between period in make 17 function of valve degrade (no matter the time be several minutes or Even a couple of days or several months).In order to avoid this interference between anchoring assembly 200 and natural mitral valve 17, interannular connection Portion 270a, 270b, 270c and 270d are approximate by zygonema 32.More particularly, left front interannular connecting portion 270a is adjacent to preceding outer Side commissure 30a passes through to zygonema 32.In a similar manner, the neighbouring rear inner side commissure 30b of connecting portion 270d pass through between right front ring To zygonema 32.In some embodiments, left back interannular connecting portion 270b and it is right after interannular connecting portion 270c from natural pairing Biased position passes through natural mitral valve 17 to line 32 backward.Posterior leaflet 22 will be tended to around left back interannular connecting portion 270b and the right side Interannular connecting portion 270c is compliantly wrapped up in order to seal mitral valve 17 afterwards, and anchoring assembly 200 has been coupled on mitral valve 17.

With reference to figure 10, in certain embodiments, anchoring assembly 200 includes being placed in the one or more of anchoring assembly 200 Covering material 270 on part.Covering material 270 can provide various benefits.For example, in some embodiments, cover material Material 270 can be easy to tissue ingrowth and/or endothelialization, so as to enhance the resistance to migration of anchoring assembly 200 and prevent Thrombus is formed on contacting blood element.In another example, as described further below, covering material 270 can be used for being easy to Couple in anchoring assembly 200 with being received between valve assemblies therein.Covering material 270 is also prevented or minimized in anchoring group Abrasion and/or fretting between part 200 and valve assemblies 300.Covering material 270 is also prevented from organizing abrasion related outside valve Abrasion.

In the embodiment depicted, covering material 270 is substantially placed on whole anchoring assembly 200.In some realities To apply in example, covering material 270 is placed on one or more parts of anchoring assembly 200, and one of anchoring assembly 200 or more A other parts simultaneously do not have the covering material 270 being placed in thereon.Although discribed embodiment includes covering material 270, It is required in covering material 270 and not all embodiments.In certain embodiments, independent of one another and/or different covering materials 270 two or more parts can be placed on anchoring assembly 200.I.e., in certain embodiments, certain types of covering Material 270 is placed in some regions of anchoring assembly 200 and different types of covering material 270 is placed in anchoring assembly On 200 other regions.

In certain embodiments, covering material 270 or part thereof includes fluoropolymer, such as expanded ptfe (ePTFE) polymer.In certain embodiments, covering material 270 or part thereof includes polyester, silicone, urethane, ELAST- EONTM (silicone and urethane polymer), another biocompatible polymer,Polyethylene terephthalate (PET), copolymer or a combination thereof and sub-portfolio.In certain embodiments, using such as (but not limited to) extruding, extension, heat The technologies such as processing, sintering, knitting, woollen yarn knitting, braiding, chemical treatment manufacture covering material 270.In certain embodiments, cover Material 270 or its part, including biological tissue.For example, in certain embodiments, covering material 270 can include natural group Knit, such as (but not limited to) ox, pig, sheep or horse pericardium.In some such embodiments, using glutaraldehyde, formaldehyde or three Glycidyl group amine (TGA) solution or other suitable tissue crosslinking agents are come to organizing to be chemically treated.

In the embodiment depicted, covering material 270 be placed in anchoring assembly 200 it is inside and outside on.Some In embodiment, covering material 270 is only placed on the outside of anchoring assembly 200.In certain embodiments, covering material 270 is only It is placed on the inside of anchoring assembly 200.In certain embodiments, some parts of anchoring assembly 200 be coated to cover material 270 with Covered different from the mode of the other parts of anchoring assembly 200.

In certain embodiments, covering material 270 is attached at least some of anchoring assembly 200 using adhesive On.In certain embodiments, PEP (fluorinated ethylene propylene) is used as adhesive so that covering material 270 is attached to anchoring assembly 200 On upper or part thereof.For example, FEP coatings can be coated on some or all part of anchoring assembly 200, and FEP can be with Bonding agent is served as to adhere to covering material 270 on anchoring assembly 200.In some embodiments it is possible to use parcel, seam Covering material 270 is attached on anchoring assembly 200 by conjunction, binding, bondage and/or clip etc..In certain embodiments, use Covering material 270 is attached on anchoring assembly 200 by the combination of technology.

In certain embodiments, covering material 270 or its part have microcellular structure, and it is inside that microcellular structure provides tissue Stent is grown for lasting sealing and/or the anchoring strength of supplement anchoring assembly 200.In certain embodiments, material is covered Material 270 is made up by suppressing or reducing blood of the membrane material that covering material 270 is transmitted.In certain embodiments, covering material 270 or part thereof have prevent or prevent tissue ingrowth and/or endothelialization to covering material 270 material composition and/ Or configuration.

In certain embodiments, covering material 270 can by one of some physical properties of enhancing covering material 270 or Multiple chemically or physically process modifications.For example, hydrophilic coating can be coated to covering material 270 to improve covering material 270 Wettability and echo translucence.In certain embodiments, covering material 270 can be by promoting or preventing endothelial cell attached , endothelial cell migration, endotheli ocytosis and prevent the chemical modification such as thrombosis and modify.In some embodiments In, covering material 270 can utilize covalent attachment heparin to change or utilize the one or more medicine dippings discharged in the original location.

In certain embodiments, the fluid that covering material 270 is perforated to modulate by covering material 270 in advance flows And/or the tendency on influence tissue ingrowth to covering material 270.In certain embodiments, covering material 270 is processed into So that covering material 270 is firmer or adds surface texture.For example, in certain embodiments, the FEP powder of covering material 270 End reason hardens covering material 270 or roughened surface to be provided in covering material 270.In certain embodiments, it is also right The selected part of covering material 270 is handled, without handling the other parts of covering material 270.It can also use The material process technology of other covering materials 270 interacts to provide beneficial engineering properties and tissue response.In some realities Apply in example, the part of covering material 270 there can be attached one or more radiopaque marks thereon with reinforcement Inner rays irradiation is visual.

Referring now to Figure 11 A and Figure 12 A, anchoring assembly 200 is illustrated to be implanted in natural mitral valve 17.Figure 11 B and figure 12B is the photo for corresponding respectively to Figure 11 A and Figure 12 A.In Figure 11 A, mitral valve 17 is shown at closure state.Scheming In 12A, mitral valve 17 is shown at open mode.These diagrams are regarding from the atrium sinistrum watched towards mitral valve 17 Angle.For example, in fig. 12, chordae tendineae 40 can be seen by the opening leaflet of mitral valve 17.

The figures illustrate structure on the ring of anchoring assembly 200 and ring lower structure and the relation of its natural mitral valve 17. For example, the closure state of the natural mitral valve 17 in Figure 11 A allows to see that such as left front atrium of structure keeps feature on ring Atrium keeps feature 240c and right preceding atrium to keep feature 240d after 240a, left back atrium keep feature 240b, the right side.It is in addition, preceding Anchor bow-shaped structural 250a, left anchoring bow-shaped structural 250b, rear anchoring bow-shaped structural 250c, right anchoring bow-shaped structural 250d and company Bridge 260 is connect to be visible.However, ring lower structure is not seen in Figure 11 A, because these structures are by anterior leaflet 20 and three parts Posterior leaflet 24a, 24b and 24c are blocked and can't see.

Comparatively speaking, in fig. 12, some ring lower structures of anchoring assembly 200 are visible, because natural mitral valve 17 be to open.Such as ring lower support arm 230a, 230b, 230c and 230d and hub are seen by the mitral valve 17 of opening 210.However, anchoring foot 220a, 220b, 220c and 220d still can't see, because their position is in the ring of mitral valve 17 In lower groove.

With reference to figure 13, (for example, according to being retouched above after anchoring assembly 200 is implanted in natural mitral valve 17 Performed by the Fig. 1 to Fig. 7 stated), the valve delivery sheath 170 of delivery system 100 can be used for valve assemblies being deployed in anchoring In component 200.As described by above by referring to Fig. 7, in distal side, pusher conduit 160 couples with the hub 210 of anchoring assembly 200 In the case of, distal side pusher conduit 160 can be used for guiding valve assemblies to the inside of anchoring assembly 200.

In some embodiments, it is positioned to situation of its distal end portion in atrium sinistrum 16 in main deflectable catheter 120 Under, valve delivery sheath 170 be installed in the tube chamber of main deflectable catheter 120 (on distal side pusher conduit 160) and Moved forward by main deflectable catheter 120.It is as described further below, in certain embodiments, valve delivery sheath 170 It is pre-loaded other components of prosthetic valve component and delivery system 100.Main deflectable catheter 120 can be for delivering The same conduit of anchoring assembly 200, or it can be that different conduits (but for simplicity, can still be claimed herein Make main deflectable catheter 120).

In certain embodiments, valve delivery sheath 170 can be by being retouched above by referring to main deflectable catheter 120 The material stated is made.In certain embodiments, (about 6.7mm is to about with about 20Fr to about 28Fr for valve delivery sheath 170 9.3mm) the outside diameter of scope.In certain embodiments, valve delivery sheath 170 is with about 14Fr to about 24Fr, (about 4.7mm is extremely About 8.0mm) scope outside diameter.

In the embodiment depicted, valve delivery sheath 170 includes the distal end 172 opened.In some embodiments In, do not include such distal end 172 opened.When being constrained in main deflectable catheter 120, the distal end portion of opening Portion 172 can be collapsed as compared with low profile.When the distal end 172 of opening is pushed out from main deflectable catheter 120, opening Distal end 172 can expand to expanded shape certainly.In certain embodiments, the material of the distal end 172 of opening includes pleat Wrinkle folds, and can be continuous flared end or be segmented into section such as petal-shaped, and can include one or more bullets Property element, in the case of there is no restraining force (all Tathagata is constrained in main deflectable catheter 120), flexible member will open Distal end 172 is biased into the configuration for presenting and opening.After the valve assemblies extrusion of distal end 172 from opening, The distal end 172 opened can for example be advantageously used in and valve assemblies are trapped in the tube chamber of valve delivery sheath 170 again.

In certain embodiments, the maximum outside diameter of the distal end 172 of opening about 30Fr to about 34Fr scope (about 10.0mm to about 11.3mm).In certain embodiments, the maximum outside diameter of the distal end 172 of opening is in about 32Fr to about 44Fr The scope of (about 10.7mm to about 14.7mm).In certain embodiments, the maximum outside diameter of the distal end 172 of opening is in about 24Fr To the scope of about 30Fr (about 8.0mm to about 10.0mm).In certain embodiments, the maximum outside diameter for opening distal end 172 is small In about 24Fr (about 8.0mm) or greater than about 44Fr (about 14.7mm).

With reference to figure 14, in some embodiments, keep substantially stationary with by valve assemblies in valve delivery catheter 180 300 from the tube chamber of valve delivery sheath 170 extrusion when, valve delivery sheath 170 can be extracted to main deflectable catheter 120 It is interior.Valve delivery sheath 170 and valve delivery catheter 180 are the additional components in some embodiments of example delivery system 100.

Valve assemblies 300 are releasably attached to valve delivery catheter 180 and are maintained at low profile.In some realities Apply in example, the distal end portion and proximal end of valve assemblies 300 are releasably attached to valve delivery catheter 180.In some embodiments In, the only one in the distal end portion or proximal end of valve assemblies 300 is releasably attached to valve delivery catheter 180.Specific In embodiment, one or more control silks can be included so that one or more parts of valve assemblies 300 releasedly to be coupled To valve delivery catheter 180.

With reference to figure 41 to Figure 43, valve assemblies 300 can via control silk 342b in the middle part of nearside control silk 342a and main body It is connected to valve delivery catheter 180 to release.Silk 342a and 342b are controlled through the one or more in valve delivery catheter 180 Tube chamber.Control silk 342a and 342b leave valve delivery catheter 180 and are each passed through the proximal end in valve assemblies 300 and master Eyelet on body mid portion.Then control silk 342a and 342b is back penetrated into valve delivery catheter 180.Controlled by manipulating Throwing 342a and 342b, clinical manipulation person can control valve assemblies 300.For example, passed by manipulating control silk 342a and 342b The tension force in conduit 180 and position are sent, the extension and contraction of valve assemblies 300 can be controlled, and valve assemblies can be controlled 300 with the separation of valve delivery catheter.

Referring again to Figure 14, the tube chamber of valve delivery catheter 180 slideably surrounds distal side pusher conduit 160.Therefore, The reach of valve delivery catheter 180 causes valve assemblies 300 to move forward on distal side pusher conduit 160 towards anchoring assembly 200.

With reference to figure 15 and Figure 16, delivery system 100 can be manipulated to perform valve assemblies 300 on a left side by clinical manipulation person Laterally pivotable (shake, rotation etc.) in atrium 16.The rotation of valve assemblies 300 by the alignment of valve assemblies 300 from it is main The distal end of deflectable catheter 120 generally axially align become with anchoring assembly 200 generally axially aligning (prepare Valve assemblies 300 are installed to inside anchoring assembly 200).

In some embodiments, can be as got off to perform the foregoing rotations of valve assemblies 300.As shown in figure 15, due to master Want influence of the deflectable catheter 120 to valve delivery catheter 180, the axis of valve assemblies 300 initially with main deflectable catheter The axis of 120 distal end in general alignment with.From this arrangement, distal side pusher conduit 160 can be performed by clinician Moved backward while between valve delivery catheter 180 rotate valve assemblies 300.That is, distal side is pulled with to nearside Pusher conduit 160, distad promotes valve delivery catheter 180.Due to this reverse movement, valve assemblies 300 are with relatively Minor radius rotates, as the constraint as atrium sinistrum 16 is required.Afterwards, valve delivery catheter 180 can further move forward So that valve assemblies 300 are positioned coaxially inside anchoring assembly 200, as shown in figure 16.

Referring now also to Figure 17, in certain embodiments, before or during the extension of valve assemblies 300,300 He of valve assemblies Anchoring assembly 200 becomes coaxially to each other, to be linearly aligned (along its axis) and rotatably, causes in valve assemblies 300 and anchor Gu engaged between component 200.Afterwards, delivery system 100 can be extracted out from heart 10 and prosthetic mitral valve film can perform its work( Energy.

Realized using the valve delivery catheter 180 on distal side pusher conduit 160 is slidably positioned in such as institute above Coaxial alignment between the valve assemblies 300 and anchoring assembly 200 of description.Can be by the distal side of valve delivery catheter 180 Interaction between end feature 182 and the hub 210 of anchoring assembly 200 come realize valve assemblies 300 and anchoring assembly 200 it Between linear alignment.For example, in certain embodiments, distal end portion feature 182 and the abutting of hub 210 are likely to result in valve group Appropriate linear alignment between part 300 and anchoring assembly 200.

It can realize that rotating against between valve assemblies 300 and anchoring assembly 200 is aligned (around its axis in a variety of ways Line).For example, in certain embodiments, valve delivery catheter 180 is mechanically keyed to distal side pusher conduit 160 with slidably Ground is fixed on desirable rotary alignment between valve assemblies 300 and anchoring assembly 200.In some embodiments it is possible to including Other types of mechanical features (for example, pin/hole, projection/socket etc.) in order to valve assemblies 300 and anchoring assembly 200 it Between desirable rotation/spin alignment.As an alternative or supplement, in valve assemblies 300 and on anchoring assembly 200 to represent Valve assemblies 300 include radiopaque with the position for rotating against orientation (around its axis) of anchoring assembly 200 and/or pattern Mark.(for example, when valve delivery catheter 180 " can reverse ") in certain embodiments, valve delivery catheter 180 can be around it Axis is rotated up the mark before valve assemblies 300 finally extension and is in appropriate location relative to anchoring assembly 200.It can make Radiopaque mark and 200 desirable orientation of corresponding valve assemblies 300 and anchoring assembly are obtained with fluoroscopy.

With reference to figure 18 and Figure 19, example valve assemblies 300 are shown, any covering or valve/plugging device leaflet is not shown. Therefore, the valve assemblies frame 301 of valve assemblies 300 is shown.Figure 18 shows the front view of valve assemblies frame 301, And Figure 19 shows the bottom view of valve assemblies frame 301.It can use above with reference to (such as the reference chart of anchorable frame 200 9) described a variety of materials and manufacturing technology construct valve assemblies 300.It should be understood that discribed valve assemblies 300 simply exist One non-limiting example of the valve assemblies provided in the scope of the present disclosure.

Valve assemblies 300 include proximal end 302 and distal end 304.Valve assemblies include the outer skirt 303 opened simultaneously And oral area 305 in limiting.When valve assemblies 300 are implanted in natural mitral valve, proximal end 302 is located on ring (on a left side In atrium) and distal end 304 be located under ring (in left ventricle).Proximal end 302 limits valve assemblies 300 generally Circular inlet port, it is as described further below.

In the embodiment depicted, valve assemblies 300 are flared out generally along distal direction.In other words, with nearside End 302 is compared, and distal end 304 is flared out.Therefore, compared with distal end 304, proximal end 302 limits smaller Outer contour.However, the inside archwise of some regions of distal end 304.Especially, for example, the rear inner side of valve assemblies 300 connects Closing turning 330a and preceding outside joint turning 330b can inside archwise.It should be appreciated that compared with proximal end 302, distal end 304 example arrangement for being flared out the simply profile of valve assemblies 300.In certain embodiments, for example, shoulder (valve A part for membrane module 300 has maximum outside) nearside positioned at the middle part of valve assemblies 300.

Valve assemblies 300 are additionally included in the front side between rear inner side joint turning 330a and preceding outside joint turning 330b 306.When valve assemblies 300 are implanted in natural mitral valve, anterior leaflet of the front side 306 towards natural mitral valve.Distal side The front side 306 of end 304 limits flat surface, and other sides of distal end 304 are roundings.Therefore, distal end portion Substantially D-shaped around portion 304.Around the D-shaped of distal end 304 provide have favourable outer contour with natural mitral valve Form the valve assemblies 300 of interface connection and sealing.It is as described further below, pass through the D-shaped week in distal end 304 Enclose between the leaflet of natural mitral valve and in certain embodiments around the D-shaped in skirt section 303 with natural valve annulus it Between engagement come realize sealing.

In the embodiment depicted, the proximal end 302 of valve assemblies 300 includes three atrium leaflet bow-shaped structurals 310a, 310b and 310c, they are limited to the fluctuating circle at proximal end 302 together.Leaflet bow-shaped structural 310a, 310b and Each in 310c includes the vertex with attachment apertures 312a, 312b and 312c respectively.In certain embodiments, attachment apertures 312a, 312b and 312c are used to the proximal end of valve assemblies 300 being connected to delivery catheter that (such as the valve of Figure 14 to Figure 16 to be passed Send conduit 180).

Valve assemblies 300 further include three joints column 320a, 320b and 320c, each is from three leaflet bow-shaped structurals The cross-shaped portion of 310a, 310b and 310c are distally extending.Joint column 320a, 320b and 320c are positioned to each other with about 120 ° points Open.Joint column 320a, 320b and 320c respectively have a series of holes, this some holes can be used for attached leaflet, such as pass through suture.Three A leaflet bow-shaped structural 310a, 310b and 310c and three joint columns 320a, 320b and 320c are the areas in valve assemblies 300 Domain, three prosthetic valve leaflets are become attached on these regions to form three leaflet plugging devices (for example, with reference to figure 22 to figure 25)。

Such as most preferably find out in Figure 19, three leaflet bow-shaped structural 310a, 310b and 310c and joint column 320a, 320b The generic cylindrical frame of three leaflet stopper configurations is limited with 320c.As such, valve assemblies 300, which provide, is used for three leaflets envelope The verified favourable frame of stifled device.Three leaflet plugging devices provide the flowing of opening during diastole and in hearts Flowing is provided during contraction to block.

With reference to figure 20, the exploded view of example prosthetic mitral valve film 400 includes anchoring assembly 200 and valve assemblies 300.This Figure provides the lateral side view of anchoring assembly 200 and valve assemblies 300.

Valve assemblies 300 include covering 340.Covering 340 can be made of any material and use above with reference to Any technological maheup in 270 described technology of covering.In addition, in certain embodiments, covering 340 can include day So tissue, such as (but not limited to) ox, pig, sheep or horse pericardium.In some such embodiments, using glutaraldehyde, formaldehyde Or triglycidyl group amine aqueous solution or any other suitable crosslinking agents are crosslinked these histochemistries.

When valve assemblies 300 and anchoring assembly 200 are linked together, valve assemblies 300 are in the inside of anchoring assembly 200 Interlocking is (for example, in certain embodiments, utilize the valve on the ring of anchoring assembly 200 in circle and inner space in structure The pyramidal structure of component 300).Especially, in certain embodiments, valve assemblies 300 are contained in circle 250 and ring lower support on ring In inner space between arm 230a, 230b, 230c and 230d.As described above, by by valve assemblies 300 with low profile Configuration is positioned at the inside of anchoring assembly 200 and allows valve assemblies 300 to be realized in the internal extended of anchoring assembly 200 in valve Interlock arrangement (for example, with reference to figure 16 and Figure 17) between membrane module 300 and anchoring assembly 200.

With reference to figure 21 and Figure 22, the deployment configuration of example prosthetic mitral valve film 400 includes being engaged in anchoring assembly 200 Valve assemblies 300.Figure 21 shows top (atrium) view of prosthetic mitral valve film 400 and Figure 22 shows prosthetic mitral valve film 400 bottom (ventricle) view.

In certain embodiments, such as in the embodiment of description, valve assemblies 300 include three leaflets 350a, 350b And 350c, they perform the closure function of prosthetic mitral valve film 400.The cusp of three leaflets 350a, 350b and 350c are fixed to Three atrium leaflet bow-shaped structural 310a, 310b and 310c and fixed to three joint column 320a, 320b and 320c (with reference to 18 He of figure Figure 19).The free edge of three leaflet 350a, 350b and 350c can by be engaged with each other during heart contraction seal and Opened during diastole.

Three leaflets 350a, 350b and 350c can include natural or synthetic material.For example, three leaflets 350a, 350b It can be included in hereinbefore with reference to any material in 340 described material of covering, including natural tissues with 350c, such as (but not limited to) ox, pig, sheep or horse pericardium.In some such embodiments, using glutaraldehyde, formaldehyde or three-glycidyl Base amine aqueous solution or other suitable crosslinking agents are crosslinked histochemistry.In certain embodiments, leaflet 350a, 350b and 350c has Have that (about 0.20mm is to about in about 0.005 " to about 0.020 " (about 0.13mm to about 0.51mm) or about 0.008 " to about 0.012 " 0.31mm) the thickness of scope.In certain embodiments, leaflet 350a, 350b and 350c, which has, is less than about 0.005 " (about 0.13mm) or greater than about 0.020 " (about 0.51mm) thickness.

In some embodiments it is possible to perform prosthetic mitral valve film 400 using the configuration of not three leaflet plugging devices Block function.For example, two leaflets, four leaflets or mechanical valve prosthesis can be used to construct in certain embodiments.

With reference to figure 23 and Figure 24, prosthetic mitral valve film 400 is illustrated to be implanted in natural mitral valve 17.In fig. 13, Prosthetic mitral valve film 400 is shown at closure state (closure).In fig. 24, prosthetic mitral valve film 400 is shown at beating Open state.These figures are towards the visual angle from mitral valve 17 from atrium sinistrum.For example, in fig. 24, the hub of anchoring assembly 200 210 and ring lower support arm 230a, 230b, 230c and 230d by leaflet 350a, 350b of the opening of prosthetic mitral valve film 400 and 350c as it can be seen that and in fig 23, hub 210 and ring lower support arm 230a, 230b, 230c and 230d are sightless because closure Leaflet 350a, 350b and 350c blocked hub 210 and can't see.

Figure 25 to Figure 33 is depicted and in natural mitral valve structure and implantable prosthesis mitral valve described herein Between seal related additional aspect.During heart contraction, the sealing of ventricle to atrium is for via implantation prosthetic mitral valve Film for MR is relevant to effectively treat.In addition, during diastole, retouched in natural mitral valve structure and this paper Atrium between the prosthetic mitral valve film stated to ventricle seal for prevent or reduce Paravalvular leak and good sealing and It is relevant for long-time stability.Prosthetic mitral valve film described herein is configured to have offer and natural mitral valve The various structures that structure is effectively sealed.

Strengthen a feature of the sealing of prosthetic mitral valve film provided in this article and the shape relative to natural mitral valve The shape of the prosthetic valve framework of shape is related.As described above, the annulus of natural mitral valve put on greatly be D-shaped (for example, ginseng Examine Fig. 8).In addition, as described above, the distal end of prosthetic mitral valve film described herein is D-shaped (for example, reference chart 19).In other words, the part for the prosthetic valve for being designed to be connected into interface with natural valve annulus, which has, is similar to annulus shape D-shaped profile.This shape similarity can be in the area of the outside scallop 24a and inner side scallop 24c of posterior leaflet 22 Specific sealing effect (with reference to figure 8) is provided in domain.

The another feature for strengthening the sealing of prosthetic mitral valve film provided in this article is related to especially in paradoxical expansion Between, relative to the size of natural mitral valve, the size of selected prosthetic valve.In some embodiments, prosthetic valve is selected The outer contour that will intentionally there is the annulus size for being equal or slightly larger than natural mitral valve (when unfettered).That is, counting Draw in the region in the valve surface adjacent with natural valve annulus, valve size may result in the line with natural valve annulus To line cooperation or slight interference fit.Therefore, in some embodiments, the atrium during diastole is sealed with ventricle With Line To Line between valve and natural valve annulus or slight interference fit provides.

The another feature for strengthening prosthetic mitral valve film provided in this article sealing is related to valve relative to natural mitral valve Ring, opposite geometric orientation of the sealing surfaces on prosthetic valve.Although in some embodiments, by the outer contour and day of valve Mechanical engagement between the receiving structure of right mitral valve provides some sealings, in some embodiments, by native leaflet Engagement between the sealing surfaces on prosthetic valve periphery (contacts to provide significantly sealing so as to be formed during diastole Seal and left ventricle pressurization is provided during heart contraction).Such sealing can be referred to as small herein Leaf seals valve bodies.As described further below, prosthetic mitral valve film provided in this article provides sealing surfaces, close Envelope surface to provide sealing of the leaflet to valve bodies relative to the geometric orientation of natural valve annulus.Although leaflet is to valve Body seal is not the sealing for being entirely the sealing of machinery pressure miniature or being attached to natural tissues (actively fixed) type, some In embodiment, this mechanical or attached type sealing can be alternatively or additionally incorporated to.

In certain embodiments, effective leaflet seals valve bodies (being not based entirely on compressing or attaching) and may need Some native leaflets are wanted to be moved to the sealing surfaces of valve bodies.Therefore, imitating the valve shape of natural mitral valve shape is Favourable.As described above, in certain embodiments, the outside of valve assemblies provided in this article have usually with naturally Around the relevant D-shaped of D-shaped annulus of mitral valve.Accordingly, it is capable to make native valve leaflets to the displacement distance of valve sealing surfaces Minimum (or substantially eliminating in some embodiments) and it therefore can strengthen sealing.

In addition, effective leaflet shows valve bodies sealing the whole surrounding around prosthetic valve main body in native leaflet Continuously engaging between prosthetic valve main body.It is as described further below, prosthetic mitral valve film provided in this article Profile is designed to be connected in order to provide around the continuous engagement of the whole surrounding of prosthetic valve with native leaflet formation interface.In order to Realize this point, in certain embodiments, the profile of some regions of prosthetic mitral valve film is different from other regions of some valves Profile (for example, corresponding to different anatomical structures in the various pieces of natural mitral valve).

With reference to figure 25, the outer lateral section atrium of heart 10 shows mitral valve 17, aortic valve 510, tricuspid valve Valve 520 and lung valve 530.As described by above by referring to Fig. 8, mitral valve 17 includes the anterior leaflet 20, (bag of posterior leaflet 22 Include inner side scallop 24a, centre scallop 24b and outside scallop 24c), left fibrous trigone 134a and right fiber three Angle 134b.

On the sealing between prosthetic mitral valve film and natural mitral valve, the various pieces of natural mitral valve 17 Different anatomic feature causes tricuspid 17 advantageously is thought have three different sealing areas, these three different sealings Region forms whole mitral valve 17 together.These three different sealing areas are：Forefoot area 25a, rear region 25b and two companies Close region 25c.Forefoot area 25a generally linearly extends between left triangle 134a and right triangle 134b.Rear region 25b includes Middle part scallop 24b and the rear portion of outside scallop 24a and inner side scallop 24c.Joint region 25c is in forefoot area Extend between 25a and rear region 25b.Joint region 25 generally includes commissure 30a and 30b and outside scallop 24a and interior The front portion of portion scallop 24c.These three sealing areas 25a, 25b and 25c will be referring again to Figure 28 to Figure 33.

With reference to figure 26, the schematic cross-section of natural 17 valve of bicuspid valve shows the position of tricuspid annulus 28.Also show Go out to be used for quantify opposite geometry of the sealing surfaces on prosthetic valve relative to the annulus 28 of natural mitral valve 17 Three set variables (S, W and H) of orientation.Term " sealing surfaces " as used herein be defined as planning on prosthetic valve with To form surface region in sealing contact with the structure of natural mitral valve 17 (the especially leaflet of natural mitral valve 17).Cause This, sealing surfaces are the regions for being used for sealing to valve bodies easy to leaflet on prosthetic valve.

Geometry variable S quantifies from annulus 28 to the radial distance on adjacent prosthetic valve framework surface.Negative s value represents annulus 28 It is spaced apart from each other with adjacent prosthetic valve surface.For example, the S values of negative 2mm represent annulus 28 and adjacent prosthetic valve surface it Between there are 2mm spaces.When S is equal to zero, represent that annulus 28 and adjacent prosthetic valve surface are connect each other with Line To Line matching relationship Touch.When S be on the occasion of when, represent annulus 28 and adjacent prosthetic valve surface into interference engagement relation.In other words.When S be on the occasion of when, Some compression stresses are applied in annulus 28 by adjacent prosthetic valve surface.

Geometry variable H quantifies from the upper limit (top edge) of the sealing surfaces of prosthetic valve to the distance of lower limit (lower edge). Measurement H values (referenced in schematic) downwards.For example, the H values of 10mm represent to stop for specific sealing area, the sealing surfaces of prosthetic valve At the 10mm of sealing surfaces upper limit lower section.In another example, when the upper limit is at annulus 28, the H values of 7mm represent sealing surfaces Lower limit below annulus 28 at 7mm.In general, the upper limit of the sealing surfaces on prosthetic valve in annulus 28 slightly above Or omit lower section (for example, the about 2mm or lower section about 2mm above annulus 28 in certain embodiments).

Geometry variable W quantifies to be limited to the radial distance of the lower limit of the sealing surfaces of prosthetic valve from sealing surfaces.Negative W The lower limit of value expression sealing surfaces is relative to the upper limit of sealing surfaces in inner radial (for example, at least a portion of sealing surfaces Distal end portion inwardly open or archwise).Positive W values represent that the lower limit of sealing surfaces is outside in footpath relative to the sealing surfaces upper limit Portion (for example, at least a portion of sealing surfaces distal end portion be flared out or archwise).Zero W values represent the lower limit of sealing surfaces Positioned at the upper limit same radial position with sealing surfaces.

With reference to figure 27, the front view of valve assemblies 300 includes the preceding sealing surfaces 360a according to some embodiments.Institute In the embodiment of description, lower parts of the preceding sealing surfaces 360a across the front side of valve assemblies 300.Preceding sealing surfaces 360a is included in Plan is used for forming surface region in sealing contact with the knot of natural mitral valve on the front side of prosthetic valve component 300.It is preceding close Sealing surface 360a includes the structural support member and tissue surface 361 from valve frame 301.Preceding tissue surface 361a provides sealing Interface height (H) but its flexible nature reduces LVOT amount of blockage, as will be described below.For example, preceding sealing surfaces At least a portion plan of 360a and the anterior leaflet of natural mitral valve are into sealing contact.

With reference to figure 28, the lateral side view of valve assemblies 300 includes the rear sealing surfaces 360b according to some embodiments.Retouching In the embodiment painted, rear sealing surfaces 360b crosses over the lower part of the rear side of valve assemblies 300.Sealing surfaces 360b is included in vacation afterwards Plan and the knot of natural mitral valve form surface region in sealing contact on the rear side of body valve assemblies 300.For example, rear sealing At least a portion plan of surface 360b and the posterior leaflet of natural mitral valve are into sealing contact.

With reference to figure 29, joint (lateral) side view of valve assemblies 300 includes the joint enclosed watch according to some embodiments Face 360c.This view is slightly biased into the front side of valve assemblies 300.In the embodiment depicted, joint sealing surfaces Lower parts of the 360c across the joint side of valve assemblies 300.Joint sealing surfaces 360c is included in the outside of prosthetic valve component 300 Upper plan and the knot of natural mitral valve form surface region in sealing contact.For example, at least the one of joint sealing surfaces 360c The inner side scallop or outside scallop of the posterior leaflet of partial plan and natural mitral valve or natural mitral valve Leaflet tissue in joint region is into sealing contact.

With reference to figure 30, in natural mitral valve annulus and the preceding sealing surfaces of the prosthetic mitral valve film according to some embodiments Between geometrical relationship such as represented above by referring to Figure 26 expansion descriptions by S, H and W value.For example, in certain embodiments, The S values of the preceding sealing surfaces of prosthetic mitral valve film are in the scope from about 0 millimeter to about positive 2 millimeters.In other words, relative to natural two Sharp valve annulus, the S values of preceding sealing surfaces are contacted to the scope of about 2 millimeters of interference in about Line To Line.It should be appreciated that in this situation Under, interference engagement may not represent that natural valve annulus is stretched or deformed due to this interference.But it is more likely to, prosthetic valve group Part will be hindered by annulus without being expanded to its free size of extension completely.Although in the embodiment depicted, S values exist About minus 2 millimeters to about positive 1 millimeter of scope, in certain embodiments, scope of the S values at about minus 2 millimeters to about positive 1 millimeter, or The scope or about zero millimeter to about positive 4 millimeters of scope that about minus 1 millimeter to about positive 3 millimeters of person.In certain embodiments, S values Can be more negative than about minus 2 millimeters more or than about positive 4 millimeters just more.

In certain embodiments, about 14 millimeters of the H values of the preceding sealing surfaces of prosthetic mitral valve film.In other words, in some realities Apply in example, the distance of the lower edge from the top edge of preceding sealing surfaces to preceding sealing surfaces is about 14 millimeters.More specifically, it is preceding The H values of sealing surfaces are segmented into two parts：(1) top H_LVOT(2) lower part H_TISSUE。H_LVOTValue is generally corresponded to along preceding Sealing surfaces 360a is in each position from the top edge of preceding sealing surfaces to the distance (reference chart of the lower end of valve frame 301 27)。H_TISSUEValue corresponds to from the lower end of the valve frame 301 of each position along preceding sealing surfaces 360a in those positions The lower end of the preceding tissue surface 361a put.Although in the embodiment depicted, H_LVOTValue and H_TISSUEValue is equal to each other, at certain In a little embodiments, in H_LVOTValue and H_TISSUERatio between value is about 3:1st, about 2:1st, about 1.5:1st, about 1:1.5th, about 1:2 or about 3: 1。

Although in the embodiment depicted, total H values are about 14 millimeters, in certain embodiments, H values at about 8 millimeters extremely About 10 millimeters either about 10 millimeters to about 12 millimeters or about 12 millimeters to about 14 millimeters or about 14 millimeters to about 16 millimeters or The scope that about 13 millimeters to about 15 millimeters of person.In certain embodiments, H values can be less than about 8 millimeters or greater than about 16 millimeters.

In certain embodiments, the W values of the preceding sealing surfaces of prosthetic mitral valve film are 2 millimeters about minus.In other words, some In embodiment, the radial distance of the lower edge of the preceding sealing surfaces from the top edge of preceding sealing surfaces to prosthetic valve is about negative 2 millimeters.The milli of top edge inner radial about 2 of sealing surfaces before the lower edge of sealing surfaces is positioned at before minus 2 millimeters of W values represent At rice.This also illustrates that the inside opening of preceding valve assemblies or archwise under ring, such as represented by valve bodies contour line 362a.Though So in the embodiment depicted, W values are about 2 millimeters, in certain embodiments, W values at about minus 6 millimeters to 4 millimeters about minus, or Either about minus 2 millimeters to about zero millimeter or about zero millimeter to about positive 2 millimeters or about minus 3 of about minus 4 millimeters to about minus 2 millimeters of person The scope of millimeter to about minus 1 millimeter.In certain embodiments, W values can be born more or than about positive 2 milli than about minus 6 millimeters Rice just more.

With reference to figure 31, in natural mitral valve annulus and the joint enclosed watch of the prosthetic mitral valve film according to some embodiments Geometrical relationship between face such as can be unfolded description above by referring to Figure 26 and be represented by S, H and W.For example, in some embodiments In, the S values of the joint sealing surfaces of prosthetic mitral valve film are in the scope from about 0 millimeter to about positive 2 millimeters.In other words, relative to Natural mitral valve annulus, the S values of joint sealing surfaces are contacted to the scope of about 2 millimeters of interference in about Line To Line.It should be appreciated that Under this situation, interference engagement may not represent that natural valve annulus is stretched or deformed due to this interference.But be more likely to, it is false Body valve assemblies will be hindered by annulus and cannot be expanded to its free size of extension completely.Although in discribed implementation Example in, S values about negative zero millimeter to about positive 2 millimeters scope, in certain embodiments, S values about minus 2 millimeters to about it is positive 1 in the least The scope of rice, either about minus 1 millimeter to about positive 3 millimeters of scope or about zero millimeter to about positive 4 millimeters of scope.In some realities Apply in example, S values can be more negative than about minus 2 millimeters more or than about positive 4 millimeters just more.

In certain embodiments, model of the H values of the joint sealing surfaces of prosthetic mitral valve film at about 8 millimeters to about 14 millimeters Enclose.In other words, in certain embodiments, from natural valve annulus to joint sealing surfaces under (lower section) edge distance about 8 millimeters to about 14 millimeters of scope.This scope, from about 8 millimeters to about 14 millimeters, it is close to be at least partly due to composition joint The shape for sealing the joint turning 364 (with reference to figure 29) of the part on surface causes.Therefore, the lower edge of joint sealing surfaces is in joint Merely due to the change of properties of the shape of joint sealing surfaces in the lateral width of sealing surfaces.Although in discribed embodiment In, scope of the H values at about 8 millimeters to about 14 millimeters, in certain embodiments, scope of the H values at about 4 millimeters to about 10 millimeters, Either about 6 millimeters to about 12 millimeters of scope either about 8 millimeters to about 14 millimeters of scope or about 10 millimeters to about 16 millis The scope or about 7 millimeters to about 15 millimeters of scope of rice.In certain embodiments, H values can be less than 4 millimeters or be greater than about 15 millimeters.

In certain embodiments, the W values of the joint sealing surfaces of prosthetic mitral valve film are 2 millimeters about minus.In other words, at certain In a little embodiments, from upper (top) edge of the joint sealing surfaces of prosthetic valve to the footpath at (lower part) edge under sealing surfaces It is 2 millimeters about minus to distance.Minus 2 millimeters of W values represent that the lower edge of joint sealing surfaces is located at the top of joint sealing surfaces At about 2 millimeters of edge inner radial.This also illustrates that ring infracommissure valve assemblies inwardly opening or archwise, such as by valve bodies wheel Shown in profile 362b.Although in the embodiment depicted, W values are 2 millimeters about minus, in certain embodiments, W values are about minus 6 Millimeter is to about minus 4 millimeters of scope, either about 4 millimeters to about minus 2 millimeters of scope or about minus 2 millimeters to about zero millimeter The scope or about minus 3 millimeters to about minus 1 millimeter of scope of scope, either about zero millimeter to about positive 2 millimeters.In some implementations In example, W values can be born than about minus 6 millimeters more or than about positive 2 millimeters just more.

With reference to figure 32, in natural mitral valve annulus and the rear sealing surfaces of the prosthetic mitral valve film according to some embodiments Between geometrical relationship can such as above by referring to Figure 26 be unfolded description by S, H and W represent.For example, in certain embodiments, The S values of the rear sealing surfaces of prosthetic mitral valve film are in the scope from about 0 millimeter to about positive 2 millimeters.In other words, relative to natural two Sharp valve annulus, the S values of rear sealing surfaces are contacted to the scope of about 2 millimeters of interference in about Line To Line.It should be appreciated that in this situation Under, interference engagement may not represent that natural valve annulus is stretched or deformed due to this interference.But it is more likely to, prosthetic valve group Part will be hindered by annulus and cannot be expanded to its free size of extension completely.Although in the embodiment depicted, S values In about zero millimeter to about positive 2 millimeters of scope, in certain embodiments, scope of the S values at about minus 2 millimeters to about positive 1 millimeter, or The scope or about zero millimeter to about positive 4 millimeters of scope that about minus 1 millimeter to about positive 3 millimeters of person.In certain embodiments, S values Can be more negative than about minus 2 millimeters more or than about positive 4 millimeters just more.

In certain embodiments, the H values of the rear sealing surfaces of prosthetic mitral valve film are about 8 millimeters.In other words, in some realities Apply in example, from natural valve annulus to rear sealing surfaces under the distance at (lower part) edge be about 8 millimeters.Although discribed In embodiment, H values are about 8 millimeters, in certain embodiments, scope of the H values at about 4 millimeters to about 6 millimeters, or about 6 millimeters To about 8 millimeters of scope, either about 8 millimeters to about 10 millimeters of scope or about 10 millimeters to about 12 millimeters of scope or About 7 millimeters to about 9 millimeters of scope.In certain embodiments, H values can be less than 4 millimeters or greater than about 12 millimeters.

In certain embodiments, the W values of the joint sealing surfaces of prosthetic mitral valve film are 2 millimeters about positive.In other words, at certain In a little embodiments, from upper (top) edge of the rear sealing surfaces on prosthetic valve to the footpath at (lower part) edge under sealing surfaces It is 2 millimeters about positive to distance.The lower edge of sealing surfaces is located at the top edge footpath of rear sealing surfaces after positive 2 millimeters of W values represent To at about 2 millimeters exterior.Valve assemblies are flared out or archwise after this is also illustrated that under ring, such as by valve bodies contour line Shown in 362c.Although in the embodiment depicted, W values are 2 millimeters about positive, in certain embodiments, W values are 4 millimeters about minus To about minus 2 millimeters of scope, either about minus 2 millimeters to about zero millimeter of scope or about zero millimeter to about positive 2 millimeters of model Enclose, either about positive 2 millimeters to about positive 4 millimeters of scope or about positive 1 millimeter to about positive 3 millimeters of scope.In some embodiments In, W values can be more negative than about minus 2 millimeters more or than about positive 3 millimeters just more.

With reference to figure 33, during heart contraction, aortic valve 510 receives the blood flowed out from left ventricle 18.Blood passes through Aortic valve 510 is flowed to by left ventricular outflow tract (LVOT) 512.In some cases, it is implanted in natural mitral valve 17 Prosthetic mitral valve film 600 (anchoring assembly is for simplicity not shown) may stop LVOT 512, such as by obturator 514 It is represented, cause ejection of the blood from 18 reduction of left ventricle.As described herein, the prosthetic mitral valve film provided by the disclosure It may be configured to reduce or exclude LVOT obstructions 514.

With reference to figure 34 and Figure 35, hindered in fluoroscopy dye injection to left ventricle with strengthening blood flow and blood flow After the visualization of plug, the first fluoroscopy image 700 and the second fluoroscopy image 730 are obtained.Image show blood from Left ventricle flows to sustainer by left ventricular outflow tract (LVOT).

First fluoroscopy image 700 is shown as caused by blocking LVOT from the blood of 720 reduction of prosthetic mitral valve film Flow region 710.Second fluoroscopy image 730 is shown by the improved blood flows 740 of LVOT.Improved blood flow 740 can be due to that the obstruction of reduction caused by prosthetic mitral valve film 750 causes.For example, in certain embodiments, the point of prosthese two Valve 750 can position or be designed so that less structure of valve 750 below natural mitral valve annulus, cause valve 750 less structure is in LVOT.In addition, can to position or be designed so that valve 750 less for prosthetic mitral valve film 750 Structure is in LVOT, such as by making the structure away from LVOT is tapered, archwise or shaping.

Referring again to Figure 33, the part towards the prosthetic mitral valve film 600 of aortic valve 510 is preceding sealing surfaces 625a.Therefore, whether preceding sealing surfaces 625a is to cause to hinder with prosthetic mitral valve film 600 relative to the geometric orientation of LVOT 512 Fill in 514 relevant factors.

Referring also to Figure 36, can use LVOT 512, natural mitral valve annulus 28 and preceding sealing surfaces variable (S values, H values and W values, as with reference to described by figure 25, Figure 26 and Figure 30) between geometrical relationship come quantify LVOR obstruction 514.In LVOT Angle-determining between 512 and natural mitral valve annulus 28 is θ.R values are responsible for from prosthetic valve relative to natural valve valve The variable of the expection of ring/ideal position positioning change.

Using geometry, 514 distance of LVOT obstructions (being to be determined as " O " in below equation) can be come using below equation Calculate：

Equation #1：

Wherein：

O is the distance of the LVOT obstructions calculated；

R be from natural valve annulus to preceding sealing surfaces at the top of distance；

θ is the angle between natural valve annulus and LVOT；

W is the radial distance of the lower edge from the top edge of the sealing surfaces on prosthetic valve to sealing surfaces；

H_LVOTBe lower structure (frame) edge from the top edge of the sealing surfaces on prosthetic valve to sealing surfaces away from From；And

S is the radial distance from mitral valve annulus to adjacent prosthetic valve surface.

The example below is provided to illustrate equation above #1.

Example	R(mm)	S(mm)	H_LVOT(mm)	W(mm)	θ°	O(mm)
							1	0	2	8	-2	164	2.2
2	0	0	8	-2	119	6.0
							3	0	2	8	-4	119	6.0
4	0	2	5	-4	119	3.4
							5	0	0	14	-2	164	1.9

Pass through comparative example #1 and #5 and example #2, #3 and #4, it may be determined that when θ biggers, O (LVOT obstructions) tends to Smaller.Pass through comparative example #3 and example #4, it can be seen that the H of bigger_LVOTTend to lead to the O of higher.Pass through comparative example # 2 with example #3, it may be determined that the effect of bigger S values may be offset with negative more W values.In short, ordinary skill Personnel can select to be used for the R values, S values, H for giving θ (being based on patient anatomy) using these teachings_LVOT- value and W Value, to realize acceptable O (LVOT obstructions).

With reference to figure 37 and Figure 38, anchoring assembly 200 can be engaged with natural mitral valve 17 so that foot 220a, 220b, 220c and 220d is placed in the ring lower groove 19 of natural mitral valve 17, and leaflet 20 and 22 and chordae tendineae 40 are substantially from anchor Gu component 200 hinders.As described above, anchoring assembly 200 is designed to be implanted in natural mitral valve 17, without showing Writing ground interference natural valve 17 enables natural valve 17 to continue to work as before placing anchoring assembly 200.For reality This existing point, leaflet 20 and 22 and chordae tendineae 40, especially, the chordae tendineae 40 being attached in anterior leaflet 20 is needed substantially from anchoring group Part 200 hinders.

In some embodiments, hub 210 relative to the positioning of the anatomical features of mitral valve 17 for easy to substantially It is important for unimpeded leaflet 20 and 22 and chordae tendineae 40.For example, depth 810 of the hub 210 in left ventricle 18 is one A important consideration.In order to substantially prevent from hindering leaflet 20 and 22 and chordae tendineae 40, depth 810 should at least be slightly less than mitral valve 17 pairing depth.Pairing depth is that the maximum from annulus to the pairing area native leaflet 20 and 22 of mitral valve 17 is erected Straight distance.Therefore, substantially unimpeded leaflet 20 and 22 and chordae tendineae will be easy to by hub 210 being positioned at below pairing depth 40.In some embodiments, scope of the depth 810 in about 14mm to about 20mm, or about 10mm is to the scope of about 16mm, or The scope of person about 12mm to about 18mm, or about 16mm is to the scope of about 22mm.In some embodiments, depth 810 is less than About 10mm or greater than about 22mm.

Hub 210 relative to the positioning between leaflet 20 and 22 to zygonema (for example, shown in Fig. 8 to zygonema 32) also for Easy to important for substantially unimpeded leaflet 20 and 22 and chordae tendineae 40.For example, in some embodiments, by hub 210 It is positioned to that brigadier is used for substantially to prevent from hindering leaflet 20 and 22 and chordae tendineae 40 with generally vertical to zygonema.

In some embodiments, ring lower support arm behind left front ring lower support arm 230a, lower-left ring lower support arm 230b, the right side 230c and right front ring lower support arm 230d is positioned for easy to substantially unimpeded relative to the angle of natural mitral valve 17 It is important for leaflet 20 and 22 and chordae tendineae 40.In some embodiments, ring lower support arm 230a, 230b, 230c and 230d is arranged to symmetrical on long axis of left ventricle line (LAX) 840.That is, LAX 840 divides front support arm angle 830 and rear support equally Arm angle 820.

In order to minimize the interference to anterior leaflet 20 and chordae tendineae 40, front support arm 220a and 220d are positioned substantially in chordae tendineae Between 40.In certain embodiments, scope of the front support arm angle 830 at about 100 ° to about 135 °, or about 80 ° to about 120 ° Scope, or about 120 ° to about 160 ° of scope.In order to minimize the interference to posterior leaflet 22 and chordae tendineae 40, in some embodiment party In formula, rear support arm 220a and 220b can substantially extend between chordae tendineae 40.In certain embodiments, rear support arm angle 820 at about 50 ° to about 120 °, either about 40 ° to about 80 ° either about 60 ° to about 100 ° or about 80 ° to about 120 ° or about 100 ° to about 140 ° of scope.

Several embodiments that the invention has been described.It will be appreciated, however, that it can be done in the case of without departing from the scope of the present disclosure Go out various modifications.Therefore, other embodiments are within the scope of the claims.

Claims

1. a kind of method for being used for being deployed in prosthetic mitral valve membranous system in the natural mitral valve of patient, the method bag Include：

First delivery sheath of navigating in the patient is so that the distal end portion of first delivery sheath is positioned in atrium sinistrum；

The anchoring assembly that the prosthetic heart valve system is pushed from the distal end portion of first delivery sheath to work as position The anchoring assembly extends at least in part when in the atrium sinistrum；And

After in the pushing anchoring assembly to the atrium sinistrum, make the anchoring assembly towards the natural mitral valve Annulus moves.

2. according to the method described in claim 1, it is further included：

After in the pushing anchoring assembly to the atrium sinistrum, the anchoring assembly is set to be rotated in the atrium sinistrum；

After the anchoring assembly is rotated in the atrium sinistrum, by the propelled longitudinally anchoring assembly to the day Position in the annulus of right mitral valve performs the shifting for making the anchoring assembly towards the natural mitral valve It is dynamic；And

The anchoring assembly is set to be engaged with the tissue near the natural mitral valve.

3. according to the method described in claim 1, it is further included：

Second delivery sheath of navigating in the patient is so that the distal end portion of second delivery sheath is positioned at the atrium sinistrum It is interior；

Cause from the valve assemblies of the distal end portion pushing prosthetic heart valve system of second delivery sheath described Valve assemblies extend at least in part when in the atrium sinistrum；And

After the valve assemblies are located in the atrium sinistrum at least partly extension, the valve assemblies are made to be moved to by described In the inner space that anchoring assembly limits；And

After the movement valve assemblies, the valve assemblies extension is set to coordinate with the anchoring assembly.

4. according to the method described in claim 3, wherein, anchored in the anchoring assembly near the natural mitral valve Tissue after, the valve group to the prosthetic heart valve system from the distal end portion of second delivery system occurs The pushing of part.

5. according to the method described in claim 4, wherein, the valve assemblies include can be relative to the first of the anchoring assembly The second extensible framework that extensible framework individually extends, second extensible framework of the valve assemblies further include： Generally D-shaped outside region；And circular valve mouth, its be located at the generally D-shaped outside region inner radial and Valve leaflet is carried, the valve leaflet is limited to the circular periphery at the circular valve mouth.

6. according to the method described in claim 1, wherein, when the anchoring assembly is engaged with the natural mitral valve, institute The native leaflet for stating natural mitral valve continues to function, without interfering significantly with from the anchoring assembly.

7. a kind of method for being used for being deployed in prosthetic mitral valve membranous system in the natural mitral valve of patient, the method bag Include：

Navigation delivery sheath causes the distal end portion of the delivery sheath to be positioned in the atrium sinistrum of the patient；

The anchoring assembly of the prosthetic mitral valve membranous system is pushed in the atrium sinistrum, wherein distal side promotes apparatus and the anchor Gu component is releasably engaged；

When the distal side promotes apparatus to keep engaging with the anchoring assembly, make the anchoring assembly and the natural bicuspid valve Film engages；

The valve assemblies of the prosthetic mitral valve membranous system are pushed in the atrium sinistrum, the valve assemblies are pushed away with the distal side The outside of dynamic apparatus slidably engages；

The valve assemblies is moved in the inner space limited by the anchoring assembly, wherein the movement be included in it is described Distal side pusher conduit keeps making the valve assemblies along the distal side pusher conduit when engaging with the anchoring assembly Slide outside；

After the valve assemblies are moved, the valve assemblies and the anchoring assembly are installed together；And

After the valve assemblies are installed, the distal side is set to promote apparatus to depart from the anchoring assembly.

8. according to the method described in claim 7, wherein, the valve assemblies are releasably attached to control conduit, the control Conduit processed limits tube chamber, and wherein described valve assemblies by distal side promotion apparatus by being slidably positioned in the control The outside of apparatus is promoted to slidably engage with the distal side in the tube chamber of conduit processed.

9. a kind of method for being used for being deployed in prosthetic mitral valve membranous system in the natural mitral valve of patient, the method bag Include：

When the anchoring assembly is releasably secured to the first delivery catheter, make the anchoring group of the prosthetic heart valve system Part extends in atrium sinistrum so that the anchoring assembly extends at least in part when in the atrium sinistrum；And

After the anchoring assembly is pushed through in the atrium sinistrum, by make the tip portion of first delivery catheter into Row Articulating and the anchoring assembly is shaken or is rotated in the atrium sinistrum.

10. according to the method described in claim 9, further include：After the anchoring assembly is pushed through in the atrium sinistrum, The anchoring assembly is set to be longitudinally oriented the annulus reach of the natural mitral valve.

11. according to the method described in claim 10, wherein, make the anchoring assembly towards the annulus of the natural mitral valve Carrying out the longitudinal direction reach is included the anchoring assembly in the propelled longitudinally annulus to the natural mitral valve Position causes the anchoring assembly to be engaged with the tissue near the natural mitral valve.

12. the method according to claim 11, wherein, when the anchoring assembly is engaged with the natural mitral valve, The native leaflet of the natural mitral valve continues to function, without interfering significantly with from the anchoring assembly.

13. according to the method for claim 12, it is further included：

When the valve assemblies are releasably secured to the second delivery catheter, by the valve group of the prosthetic heart valve system Part is pushed through in atrium sinistrum so that the valve assemblies extend at least in part when in the atrium sinistrum；And

After the valve assemblies are located in the atrium sinistrum at least partly extension, the valve assemblies are made to be moved to the anchor Gu the position of the inner radial of component；And

After the movement valve assemblies, the valve assemblies extension is set to be installed together with the anchoring assembly.

14. according to the method for claim 13, wherein, it is attached to anchor to the natural mitral valve in the anchoring assembly After near tissue, the pushing of the valve assemblies to the prosthetic heart valve system occurs.

15. according to the method for claim 13, wherein, the valve assemblies include can be relative to the of the anchoring assembly The second extensible framework that one extensible framework individually extends, second extensible framework of the valve assemblies also wrap Include：Generally D-shaped outside region；And circular valve mouth, it is located at the generally D-shaped outside region inner radial And valve leaflet is carried, the valve leaflet is limited to the circular periphery at the circular valve mouth.

16. a kind of method for being used for being deployed in prosthetic mitral valve membranous system in the natural mitral valve of patient, the method bag Include：

When the valve assemblies are releasably secured to valve delivery catheter, by the valve group of the prosthetic heart valve system Part is pushed through in atrium sinistrum so that the valve assemblies extend at least in part when in the atrium sinistrum；And

After the valve assemblies are pushed through in the atrium sinistrum, by make the tip portion of the valve delivery catheter into Row Articulating and the valve assemblies is shaken or is rotated in the atrium sinistrum.

17. according to the method for claim 16, it is further included：The valve assemblies are being pushed through in the atrium sinistrum it Afterwards, the valve assemblies are made to be longitudinally oriented the annulus reach of the natural mitral valve.

18. according to the method for claim 17, wherein making the valve assemblies towards the annulus of the natural mitral valve Carry out the longitudinal direction reach include by the valve assemblies it is propelled longitudinally arrive previously engaging it is described naturally near mitral valve Tissue anchoring assembly inner radial position.

19. according to the method for claim 16, further include：

20. according to the method for claim 19, wherein when the anchoring assembly is engaged with the natural mitral valve, institute The native leaflet for stating natural mitral valve continues to function, without interfering significantly with from the anchoring assembly.

21. the method according to claim 11, wherein it is attached to anchor to the natural mitral valve in the anchoring assembly After near tissue, the pushing of the valve assemblies to the prosthetic heart valve system occurs.

22. according to the method for claim 19, wherein the valve assemblies include can be relative to the of the anchoring assembly The second extensible framework that one extensible framework individually extends, second extensible framework of the valve assemblies also wrap Include：Generally D-shaped outside region；And circular valve mouth, it is located at the generally D-shaped outside region inner radial And valve leaflet is carried, the valve leaflet is limited to the circular periphery at the circular valve mouth.

23. a kind of mitral valve exchange system for heart, including：

Expansible anchoring assembly, it is configured to be implanted at natural mitral valve, and the expansible anchoring assembly includes First extensible framework, first extensible framework can be expanded configuration from delivering experiment material；

First delivery sheath device, it has the distal end portion being inserted into atrium sinistrum and is configured to the anchoring assembly Push out from the distal end portion so that the anchoring assembly expands to the expanded configuration in the atrium sinistrum；

Apparatus is promoted, it is releasably attached to the expansible anchorable frame and is configured at the anchoring assembly Make when the expanded configuration anchoring assembly in the atrium sinistrum towards the natural mitral valve annulus in longitudinal direction Reach；And

Artificial valve component, it includes the second extensible framework, and second extensible framework can be adjusted to portion from compressed configuration Form is affixed one's name to be selectively engaged when the anchoring assembly is in the expanded configuration with the anchoring assembly.

24. system according to claim 23, wherein the anchoring assembly includes protuberance under multiple rings, dashes forward under the ring Go out the tissue that portion is configured to engage near the annulus of the natural mitral valve and keep the natural mitral valve at the same time Front and rear leaflet natural function.

25. system according to claim 23, it is further included：Second delivery sheath device, it, which has, is inserted into the left heart Distal end portion in room and it is configured to push out so that the artificial valve from the distal end portion by the artificial valve component Extended at least in part in atrium sinistrum described in membrane module.

26. system according to claim 23, wherein the artificial valve component includes guide structure with the promotion For slidably engaging the outside for promoting apparatus when apparatus is releasably attached on the expansible anchorable frame.

27. system according to claim 23, wherein the described second expansible frame of the artificial valve component can Extend and further include separately from the anchoring assembly：Generally D-shaped outside region；And circular valve mouth, it is located at institute State generally D-shaped outside region inner radial and carry valve leaflet, the valve leaflet is limited to the circular valve Circular periphery at mouthful.

28. system according to claim 23, wherein the artificial valve component is releasably attached to control conduit, institute State control conduit and limit tube chamber, and wherein by the way that the promotion apparatus is slidably positioned in described in the control conduit Slidably engage the outside of the artificial valve component and the promotion apparatus in tube chamber.

29. system according to claim 23, it is further included：Seal wire, it is slidably positioned in the promotion apparatus.

30. system according to claim 23, it is further included：Anchoring assembly controls silk, it is slidably positioned in described In first delivery sheath device, wherein anchoring assembly control silk couples with the anchoring assembly.

31. system according to claim 23, it is further included：Secondary deflectable catheter, it is slidably positioned in described Between first delivery sheath device and the promotion apparatus.

32. system according to claim 31, wherein the distal end of the secondary deflectable catheter is controllably in side To deflection.

33. a kind of implantable medical treatment device delivery system, including：

First deflectable conduit, it is limited through its first tube chamber, wherein the distal end of first deflectable catheter Controllably in lateral deflection；

First device delivery sheath, it is slidably positioned in first tube chamber, and the first device delivery sheath limits Through its second tube chamber；

First device controls sheath, it is slidably positioned in second tube chamber, and the first device control sheath limits The 3rd tube chamber and one or more first devices passed through controls fiber tube chamber；

Second deflectable conduit, it is slidably positioned in the 3rd tube chamber, the second deflectable conduit limit through Its 4th tube chamber, wherein the distal end of second deflectable catheter is controllably in lateral deflection；

Device pusher conduit, it is slidably positioned in the 4th tube chamber, described device pusher conduit limit through Its 5th tube chamber, the distal end of described device pusher conduit are configured to the first implantable medical device releasedly Connection.

34. delivery system according to claim 33, it further includes seal wire, and the seal wire is slidably positioned in described In four tube chambers.

35. delivery system according to claim 33, it further includes second device delivery sheath, the second device delivering Sheath is slidably positioned in first tube chamber, and the second device delivery sheath is limited through its 6th tube chamber.

36. delivery system according to claim 35, it further includes second device control sheath, it is slidably positioned in In 6th tube chamber, the second device control sheath is limited through its 7th tube chamber and one or more second device controls Throwing tube chamber；The distal side pusher conduit is slidably positioned in the 7th tube chamber.

37. delivery system according to claim 36, it, which is further included, is slidably positioned in one or more of first The intraluminal first device control silk of device control silk controls silks with one or more of second devices are slidably positioned in Intraluminal second device controls silk.

38. a kind of prosthetic mitral valve membranous system, including：

Valve assemblies, including：

Framing component, it limits outer contour and inside casing frame member space；And

Plugging device, it is placed in the inside casing frame member space, and the plugging device has open configuration and closed configuration,

Wherein described framing component includes proximal end frame part and distal end portion frame part, wherein the distal end portion frame part Outside include flat region and automatic adjustment region, and wherein described flat region at least certain The inside casing frame member space is partially toward in distal side to extend.

39. the prosthetic mitral valve film according to claim 38, further includes：Anchoring assembly, it is empty that it limits internal anchoring assembly Between, wherein the valve assemblies can coordinate with the interior anchoring assembly spatial selectivity.

40. prosthetic mitral valve film according to claim 39, wherein, the anchoring assembly includes expansible anchoring frame Frame, the expansible anchorable frame includes hub and the ring lower support arm from hub extension, wherein the ring lower support arm prolongs Anchoring foot is reached, the anchoring foot has the surface for being configured to engage with the ring lower groove of natural mitral valve.

41. prosthetic mitral valve film according to claim 40, wherein, from the farthest side of the anchoring assembly to the table The distance that face, the longitudinal axis parallel to the valve assemblies measure is at least 14 millimeters.

42. the prosthetic mitral valve film according to claim 38, wherein, the distal end portion frame part includes：It is generally D-shaped Outside, and wherein described proximal end frame part includes：Circular valve mouth, it is located at the generally D-shaped outside area Domain inner radial and valve leaflet is carried, the valve leaflet is limited to the circular periphery at the circular valve mouth.

43. a kind of method using prosthetic mitral valve membranous system, including：

The annulus of valve assemblies towards the natural mitral valve of the prosthetic mitral valve membranous system is set to move forward, the valve assemblies bag Include：

Wherein described framing component includes proximal end frame part and distal end portion frame part, wherein the distal end portion frame part Outside include flat region and automatic adjustment region, and wherein described flat region at least certain It is spatially extended to be partially toward the inside casing frame member；And

The valve assemblies are anchored in the natural mitral valve to cause natural two described in the flat region adjacent The preceding native leaflet of cusp film.

44. according to the method for claim 43, further include：Before the valve assemblies are implanted into, make the point of prosthese two The anchoring assembly of valve system is engaged with the tissue near the annulus of the natural mitral valve, and the anchoring assembly limits internal Anchoring assembly space, and the anchoring wherein to the valve assemblies includes making the valve assemblies in the interior anchoring group Interlocked in part space.

45. according to the method for claim 44, wherein, the anchoring assembly includes expansible anchorable frame, it is described can The anchorable frame of extension includes hub and the ring lower support arm from hub extension, wherein the ring lower support arm extends to anchoring Foot, the anchoring foot have the surface for being configured to engage with the ring lower groove of natural mitral valve.

46. according to the method for claim 45, wherein, from the farthest side of the anchoring assembly to the surface, parallel In the valve assemblies longitudinal axis measure distance be at least 14 millimeters.

47. according to the method for claim 43, wherein, the distal end portion frame part includes：Generally D-shaped outside, And wherein described proximal end frame part includes：Circular valve mouth, it is inside that it is located at the generally D-shaped outside region footpath Portion and valve leaflet is carried, the valve leaflet is limited to the circular periphery at the circular valve mouth.

48. a kind of prosthetic mitral valve membranous system, its is implantable at natural mitral valve, the prosthetic mitral valve membranous system bag Include：

Anchoring assembly, its limit in anchoring assembly space and longitudinal axis, the anchoring assembly includes expansible anchorable frame, The expansible anchorable frame includes hub and the ring lower support arm from hub extension, wherein the ring lower support arm extends to Foot is anchored, the anchoring foot has the surface for being configured to engage with the ring lower groove of natural mitral valve；And

Valve assemblies, including：

Expansible valve frame, it limits outer contour and inside casing frame member space；And

Wherein described valve assemblies are releasably engaged with the anchoring assembly in the interior anchoring assembly space, and wherein The distance measured from the farthest side of the anchoring assembly to the surface, parallel to the longitudinal axis is at least 14 millimeters.

49. prosthetic mitral valve membranous system according to claim 48, wherein, the valve assemblies include having generally D The distal end portion frame part of shape outside, and wherein described valve assemblies include proximal end frame part, the proximal end frame Frame part has circular valve mouth, and the circular valve mouth is located at the generally D-shaped outside region inner radial and takes Band valve leaflet, the valve leaflet are limited to the circular periphery at the circular valve mouth.

50. a kind of method using prosthetic mitral valve membranous system, the described method includes：

The annulus of anchoring assembly towards the natural mitral valve of the prosthetic mitral valve membranous system is set to move forward, the anchoring assembly limit Anchoring assembly space and longitudinal axis, the anchoring assembly include expansible anchorable frame, the expansible anchoring in fixed Frame includes hub and one or more ring lower support arms from hub extension, wherein in one or more of ring lower support arms Each extends to anchoring foot, and the anchoring foot is configured to engage with the ring lower groove of the natural mitral valve；And

The anchoring assembly of the prosthetic mitral valve membranous system is set to be engaged with the tissue near the natural mitral valve so that The surface of each anchoring foot is engaged with the ring lower groove, and causes the hub to be positioned at the front and rear of the natural mitral valve The distal side in farthest side pairing area between leaflet.

51. according to the method for claim 50, further include：It is attached in the engagement anchoring assembly and the natural mitral valve After the near tissue, the valve assemblies of the prosthetic mitral valve membranous system are delivered to the anchoring assembly, valve assemblies Including：Expansible valve frame, it limits outer contour and inside casing frame member space；And plugging device, it is placed in described In framing component space, the plugging device has open configuration and closed configuration.

52. method according to claim 51, wherein, the valve assemblies include remote with generally D-shaped outside Side frame part, and wherein described valve assemblies include proximal end frame part, and the proximal end frame part has circle Shape valve orifice, the circular valve mouth are located at the generally D-shaped outside region inner radial and carry valve leaflet, institute State the circular periphery that valve leaflet is limited at the circular valve mouth.

53. method according to claim 51, wherein, from the farthest side of the anchoring assembly to the surface, parallel In the valve assemblies longitudinal axis measure distance be at least 14 millimeters.

54. a kind of prosthetic mitral valve membranous system, including：

Anchoring assembly, it includes anchoring foot under expansible anchorable frame and one group of ring, and foot group is anchored under the ring and is configured to Engaged with the ring lower groove of natural mitral valve；And

Valve assemblies, including：Expansible valve frame, it limits outer contour and inside casing frame member space；It is placed in described outer Organized layer at least a portion of profile；And plugging device, it is placed in the inside casing frame member space,

Wherein when the anchoring foot group of the anchoring assembly is engaged with the ring lower groove, along the institute of the valve assemblies State the native leaflet that peripheral layer of the organized layer outside is positioned against the mitral valve.

55. prosthetic mitral valve membranous system according to claim 54, wherein, the valve assemblies include having generally D The distal end portion frame part of shape outside, and wherein described valve assemblies include proximal end frame part, the proximal end frame Frame part has circular valve mouth, and the circular valve mouth is located at the generally D-shaped outside region inner radial and takes Band valve leaflet, the valve leaflet are limited to the circular periphery at the circular valve mouth.

56. a kind of method for being sealed between prosthetic mitral valve membranous system and the native leaflet of mitral valve, the method Including：

By the anchoring assembly of the prosthetic mitral valve membranous system together with the tissue anchoring near the annulus of natural mitral valve, Anchoring assembly space and longitudinal axis in the anchoring assembly restriction, the anchoring assembly include expansible anchorable frame, institute Stating expansible anchorable frame includes hub and one or more ring lower support arms from hub extension, wherein one or more Each in a ring lower support arm extends to anchoring foot, and the anchoring foot is engaged with the ring lower groove of the natural mitral valve； And

It is to be engaged with the anchoring assembly by the valve assemblies delivering of the prosthetic mitral valve membranous system, the valve assemblies bag Include：Expansible valve frame, it limits outer contour and inside casing frame member space；And it is placed in the outer contour at least Organized layer in a part；And plugging device, it is placed in the inside casing frame member space, and the plugging device, which has, to be opened Configuration and closed configuration,

Wherein when each anchoring foot of the anchoring assembly is engaged with the ring lower groove, the tissue of the valve assemblies Layer is abutted with the native leaflet of the mitral valve.

57. method according to claim 56, wherein, the valve assemblies include remote with generally D-shaped outside Side frame part, and wherein described valve assemblies include proximal end frame part, and the proximal end frame part has circle Shape valve orifice, the circular valve mouth are located at the generally D-shaped outside region inner radial and carry valve leaflet, institute State the circular periphery that valve leaflet is limited at the circular valve mouth.

58. delivery system according to claim 33, it further includes seal wire, and the seal wire is slidably positioned in described In four tube chambers.

59. the delivery system according to any one of preceding claims 33 or 58, further includes：Second device delivery sheath, The second device delivery sheath is slidably positioned in first tube chamber, the second device delivery sheath limit through Its 6th tube chamber.

60. according to the delivery system any one of claim 33,58 and 59, further include：Second device controls sheath, its Be slidably positioned in the 6th tube chamber, second device control sheath limit through its 7th tube chamber and one or Multiple second devices control fiber tube chamber；The distal side pusher conduit is slidably positioned in the 7th tube chamber.

61. according to the delivery system any one of preceding claims 33 or 58-60, further include：It is slidably positioned in The intraluminal first device control silks of one or more of first devices control silk and be slidably positioned in it is one or Multiple intraluminal second device control silks of second device control silk.